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Speaker Profiles - Discovery Stream

Dr Jan Huebner, Alliance Manager Technology, Drug Discovery,
Bayer AG
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Education:
1992-1997 Student of chemistry at the Humboldt-University of Berlin
1996-1997 Diploma thesis in the group of Prof Dr J Liebscher, "Nitroalkenes as Building Blocks for Optical Active Cyclopropyl Amino Acids"
Oct 1997 Diploma in Chemistry
1997-2001 PhD work in the laboratory of Prof Dr R Brückner, Göttingen and Freiburg, “Development of a New y‑Butyrolactone to 1,3-Diol Approach – Towards the Total Synthesis of Roxaticin, Mycoticin A and Mycoticin B”

Professional Experience:
2001-2005 Lab head in Process Research, Schering AG
2005-2013 Lab head in Medicinal Chemistry, Schering AG and BAYER Healthcare
from 2013 Alliance Manager BAYER
- Scouting, evaluation, negotiation and management of research partnerships with Universities, Start Ups and CROs
- Management of entire FTE-based strategic outsourcing business for Lead Discovery/Screening and MedChem (target idea - PCC) in BAYER´s Pharmaceutical division

Read Abstract...

Confirmed presentation title:  "Principles and processes - building a robust, process driven discovery outsourcing operation at BAYER"

Dr Ulrich Schopfer, Head of Integrated Target & Lead Discovery,
Novartis Pharma AG
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Dr Ulrich Schopfer obtained a Ph.D. in Chemistry from the University of Marburg, Germany. After a postdoc with Prof. R. Noyori at Nagoya University, Japan, he joined Novartis Pharma AG in Basel, Switzerland in 1998. After a fellowship as Novartis Visiting Scientist with Prof. C. F. Barbas III at The Scripps Research Institute, La Jolla, USA he returned to Basel to start his career as medicinal chemist and project team leader in Neuroscience.

In 2001, Ulrich assumed responsibility for compound library management in a newly formed Lead Discovery Center at the Novartis Institutes for BioMedical Research (NIBR). In 2008, Ulrich became Head of Biochemical Screening at NIBR, leading team with expertise in molecular biology, protein expression and purification, assay development, and High Throughput Screening.

In 2012 he became Integrated Lead Discovery Head and member of a global leadership team that pioneered a multidisciplinary, matrix-based department that integrated capabilities and expertise in screening, structure biology, natural product research and in silico lead discovery in a project-centric organization.

Since 2017, Ulrich assumed global responsibility for Integrated Target and Lead Discovery and is site hea Basel of the newly formed Chemical Biology and Therapeutics department at NIBR.

Ulrich Schopfer is the author of 40 publications and book chapters in the areas of chemical biology, lead discovery, medicinal chemistry, compound library management, and organic chemistry.

Read Abstract...

Confirmed presentation title:  Drugging the undruggable – integrated discovery with a chemical biology mindset

Dr Thomas Woltering, Section Head Therapeutic Modalities Medicinal Chemistry,
Roche Pharmaceuticals Ltd
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Background & Experience:
since 2014 Outsourcing Manager Medicinal Chemistry Basel
2004-2005 Process Research (Roche Palo Alto LLC, USA)
1996-now Medicinal Chemistry (F. Hoffmann-La Roche, Ltd., Basel Switzerland)
1995-1996 PostDoc with Prof. Chi-Huey Wong (Scripps Research Institute, USA)
1990-1991 Research with Prof. Barry M. Trost (Stanford University, USA)
1986-1995 PhD in Organic Chemistry (University of Hannover, Germany)
https://www.linkedin.com/in/thomas-woltering-444973a9/

Selected Awards & Honors or Selected Publications:
2010 Roche internal Leo Sternbach Award for Innovation in Chemistry (in recognition of his pioneering synthetic chemistry in the context of the BACE-1 project)
selected publications:
1.) Fort, D. A.; Woltering, T. J.; Alker, A. M.; Bach, T. An Intramolecular [2 + 2] Photocycloaddition Approach to Conformationally Restricted Bis-Pyrrolidines J. Org. Chem. (2014), 79(15), 7152-7161.
2.) Fort, D. A.; Woltering, T. J.; Alker, A. M.; Bach, T. Photochemical Reactions of Prop-2-enyl and Prop-2-ynyl Substituted 4-Aminomethyl- and 4-Oxymethyl-2(5H)-furanones Heterocycles (2014), 88(2), 1079-1100.
3.) Fort, D. A.; Woltering, T. J.; Alker, A. M.; Bach, T. Conformationally restricted pyrrolidines by intramolecular [2+2] photocycloaddition reactions Chem. Commun. (2013), 49(29), 2989-2991.
4.) Fort, D. A.; Woltering, T. J.; Nettekoven M.; Knust, H.; Bach, T. Synthesis of Fluorinated Tricyclic Scaffolds by Intramolecular [2+2] Photocycloaddition Reactions Angew. Chem. Int. Ed. (2012), 51(40), 10169-10172.

Read Abstract...

Confirmed presentation title:  "[2+2]-photocycloaddition for the synthesis of cyclobutanes:  access to novel sp3-rich building blocks for medicinal chemistry"

Abstract:  Cyclobutanes are an underrepresented structural motif in Pharma screening libraries, and yet offer a well-defined three-dimensional vectorised topology that can readily overcome the molecular ‘flatness’ (low sp3 character) which is associated with poor physico-chemical properties. Indeed, compounds with a low sp3 character (low “3D shape”) generally have lower aqueous solubility, selectivity and may display higher CYP inhibition, plasma-protein and hERG binding which negatively impact drug likeness.

The synthetic access to four-membered rings such as cyclobutanes is indeed a challenge using conventional methods - which explains their underrepresentation in Medicinal Chemistry. We have developed a rapid access to complex compounds using photochemistry – irradiation with light to trigger specific reactions – to form cyclobutanes as novel medicinal chemistry scaffolds through a [2+2]-photocycloaddition. Intramolecular photocycloaddition were first performed by irradiation of readily accessible compound 1 with ultraviolet light resulted in the high yield formation of complex scaffold 2 – further steps affording novel diamines 4.

Diamines 4 have been used as a starting point for the enrichment of our compound collection – the rigid, well defined scaffold is used to display a range of substituents through specific vectors.

In conclusion we were able to demonstrate that intramolecular [2+2]-photocycloaddition can be a performed in a quite simple and practicable experimental set-up and leading in all cases to the desired cyclobutane derivatives in excellent yields. It clearly shows the power of photochemistry in producing cyclobutanes – for the generation of novel building blocks of distinct three-dimensional shape as new starting points for medicinal chemistry.

Dr Brice Campo, Director Drug Discovery,
Medicines for Malaria Venture
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Brice is a Director Drug Discovery at Medicines for Malaria Venture (MMV). He leads drug discovery activities in the context of individual projects and pharmacology platforms. As Director Drug Discovery, Brice provides scientific advices and leadership to portfolio of drug discovery activities projects and pharmacology platforms. He works with partners from both academia and industry in order to deliver pertinent and optimal biological test cascades as well as safe and efficacious pre-clinical candidate which will be part of the next generation of anti-malarials. Brice has a particular interest in molecules and biological assays that tackle the liver stage of the parasite and more precisely the hypnozoites reservoir in order to find the new drugs that will help eradicate Malaria. He joined MMV in November 2011, bringing with him more than 14 years of experience in drug discovery, gained primarily with the Genomic Institute of the Novartis Foundation (GNF) and Addex Pharmaceuticals S.A. He has broad experience in molecular pharmacology and drug discovery in several disease areas such as Neuroscience, Metabolic Disease and Inflammation, and has successfully led and contributed to teams at all stages of drug discovery. Brice holds a PhD in Neuroscience and Immunology from the University of Sheffield (UK) and has published a significant number of scientific papers and patent applications.

 

Read Abstract...

Confirmed presentation title: Outsourcing strategy to support Discovery– a PDP perspective

Frederic Martin, Senior Externalisation Specialist (Drug Safety & Metabolism),
AstraZeneca
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Frederic Martin is a Senior Externalisation Specialist in the Alliance & Project Management team, part of the Innovative Medicines Biotech Unit in AstraZeneca, Cambridge, UK. The team is responsible for the outsourcing of all Drug Safety & Metabolism activities and for ensuring efficient processes and good relationships with our strategic partners and other collaborators.

Previously, Frederic was a pre-clinical CNS pharmacologist for Organon, Shering-Plough and MSD in Scotland then a study coordinator and data manager for the Safety & Toxicology group in UCB, Belgium.

Since joining AstraZeneca in 2015, he took over the responsibility for a collaborative tool to schedule and visualise outsourced studies with our different partners, he is the Operation Lead for a number of collaborations and a project manager on different exciting projects!

Read Abstract...

Confirmed presentation title: Use of a collaborative tool to simplify the outsourcing of preclinical safety studies: an insight into the AstraZeneca-Charles River Labs strategic relationship 

Abstract:  

In 2012, AstraZeneca entered into a strategic relationship with Charles River Laboratories whereby preclinical safety packages comprising safety pharmacology, toxicology, formulation analysis, in vivo ADME, bioanalysis and pharmacokinetics studies are outsourced. New processes were put in place to ensure seamless workflows with the aim of accelerating the delivery of new medicines to patients. Here, we describe in more detail the AstraZeneca preclinical safety outsourcing model and the way in which a chosen collaborative tool, iTraX, has helped to translate the processes in AstraZeneca and Charles River Laboratories into simpler integrated workflows that are efficient and visible across the two companies.

Dr Andy Merritt, Associate Director and Head of Chemistry,
LifeArc
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Dr Andy Merritt has held the post of Head of Chemistry at the LifeArc (formerly MRC Technology) Centre for Therapeutics Discovery (CTD since the summer of 2009. In close collaboration with academic scientists, the CTD develops and subsequently prosecutes innovative drug discovery programmes emerging from academic research. Prior to his current position Andy was a Director of Discovery Medicinal Chemistry at GlaxoSmithKline, covering early lead discovery from screening campaigns, global responsibility for outsource support for lead discovery chemistry and the supply of tool compounds for target validation. Between 1995 and 2001 as part of the GlaxoWellcome organisation he led interdisciplinary teams focusing on lead discovery and optimisation incorporating the development of new chemical technologies. Andy joined the former Glaxo organization as a senior medicinal chemist in 1988 following postdoctoral studies in the US, and initially worked on oncology and pain drug discovery programs, leading to one clinical candidate submission. Andy sits on the RSC Chemistry World editorial board, has been a regular undergraduate lecturer in pharmaceutical medicine at Imperial College, Warwick and Sussex universities, and was the industrial organiser for the RSC Medicinal Chemistry residential summer school between 1999 and 2005.

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Confirmed Presentation: Antibody Assisted Drug Discovery – an industry-academia partnership

Dr Peter Hamley, Global Head, External Innovation Drug Discovery,
Sanofi
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Peter Hamley joined AstraZeneca (formerly Astra) after completing a BSc in Chemistry at Imperial College, a PhD at Cambridge University and postdoctoral studies at the University of Pennsylvania.  In 2003 he moved to Frankfurt to join Sanofi (formerly Aventis) and lead global chemistry, natural product and antibody drug conjugate departments in Germany, France and the US and has contributed to the advancement of many projects into clinical development.  More recently in Business Development he has responsibility for external partnering in drug discovery and has a strong interest in new business models, disruptive technology including AI and open innovation in R&D.  He holds an MBA from Bath University.

Read Abstract...

Confirmed presentation title:  "Creating transformative business partnerships in drug discovery" 

Abstract:  Innovation and success rates are major challenges in drug discovery.  In order to improve these in Sanofi’s pipeline we have introduced new business models which leverage the value of internal Sanofi research, while risk-sharing with a wide variety of external partners, and searching for innovation in new ways.  The result should be value generation: increasing the successful translation of exciting biology into commercial projects.

Dr Anita Wegert, Director Medicinal Chemistry,
Mercachem
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Dr. Anita Wegert is a Director Medicinal Chemistry at Mercachem with extensive knowledge in Medicinal Chemistry regarding GPCRs, PPIs, epigenetic targets and antiinfectives. She is leading various projects from hit to lead up to the development of preclinical candidates.

Before joining Mercachem in 2014 Anita Wegert gained extensive experience as a lab head and project leader at Grünenthal, Aachen in the disease area pain.

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Confirmed Presentation: Unlocking drug discovery power through collaborative efforts between academia and CRO : bringing novel Tankyrase inhibitors towards the clinic

Professor Stefan Krauss, Research Team Leader,
University of Oslo Hospital
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Professor Stefan Krauss is a developmental biologist that works on Wnt signaling and discovered the key vertebrate signal Shh. He has studied aspects of both pathways in different developmental and disease models and is now using chemical biology to deepen the understanding of these pathways and to develop novel therapeutic principles. In addition of being research tools, drugs that attenuate Hh and Wnt signaling have therapeutic implications in various disease areas, including cancer, regenerative medicine and metabolic disorders.

At current, Professor Stefan Krauss is director of the Centre of Excellence “Hybrid Technology Hub” and is working at the University of Oslo and the Oslo University Hospital. The Centre works on “organ on a chip” technology.

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Confirmed Presentation: Unlocking drug discovery power through collaborative efforts between academia and CRO : bringing novel Tankyrase inhibitors towards the clinic

Dr Ben Perry, Senior Discovery Manager,
Drugs for Neglected Diseases initiative (DNDi)
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Ben Perry is currently Senior Discovery Manager at Drugs for Neglected Diseases initiative (DNDi), where he is responsible for Discovery Open Innovation. At DNDi he has led the NTD Drug Discovery Booster since inception, and has been involved with the conception and implementation of several other initiatives focused on leishmaniasis and Chagas disease drug discovery at DNDi, including the Open Synthesis Network and the MycetOS projects. Prior to joining DNDi, Ben spent 15 years in various medicinal chemistry roles at Celltech (UK), UCB (UK; Belgium), Addex Therapeutics (Switzerland) and Genkyotex (Switzerland). He has worked extensively in early-stage drug discovery across a variety of disease indications including oncology, autoimmune disorders, neurodegeneration and psychiatry. His areas of research interest include the use of chemoinformatic and computational tools within medicinal chemistry, alternative research mechanisms, and the use of new technologies and research collaborations to further the drug discovery process. Ben holds a PhD in organic chemistry from Imperial College London and a MBA from IE Business School, Madrid.

Read Abstract...

Confirmed presentation title:  "Collaborative virtual screening to boost neglected tropical disease drug discovery"

The NTD Drug Discovery Booster is an innovative collaboration designed to swiftly and efficiently maximise the Structure-Activity Relationship (SAR) space around new chemical hits and leads targeting Leishmania donovani and Trypanosoma cruzi, the Kinetoplastid parasitesresponsible for visceral leishmaniasis and Chagas disease respectively. Screening for new leads against these parasites has evolved with increased throughput over the past decade, yet valid starting points remain scarce. It is essential that the existing hits and leads that are identified are investigated thoroughly and efficiently.

In partnership with our consortium partners, we have implemented a novel in silico screening process that allows us to advance various chemical series through the hit-to-lead process via the mining of each pharmaceutical company’s vast chemical library in an iterative and collaborative manner. The innovation of the NTD Booster lies in the companies simultaneously accepting to share with DNDi upfront structural and biological information about a promising chemical series that is essential for its rapid development. Thus, by exploring the combined libraries containing several million compounds, the chances of pulling out the best possible hit series with a pooled collection of valuable information are dramatically increased. 

We demonstrate that this original, cooperative approach allows us to rapidly expand the SAR around hits, including examples of progressing hit IC50 potencies from >10 µM to in silico screening approaches.

The NTD Drug Discovery Booster consortium currently consists of Abbvie Inc., AstraZeneca plc., Celgene Corporation, Eisai Co, Ltd., Merck Shionogi & Co, Ltd., Takeda Pharmaceutical Ltd., Institut Pasteur Korea and the Drugs for Neglected Diseases initiative.

Dr Keith Barnes, Assistant Director, Medicinal Chemistry,
AMRI
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Keith has 38 years of research experience in the discovery and optimization of biologically active compounds.  For the past 17 years, Keith has worked at AMRI and progressed to the rank of Assistant Director/Department Head with oversight for medicinal chemistry activities at AMRI’s Albany, NY and Buffalo, NY sites.   During this time, Keith has lead and managed teams in a number of therapeutic areas, especially CNS.  In the CNS area, he has worked on neurodegenerative diseases like Spinal Muscular Atrophy, Huntington’s Disease, Alzheimer’s and Macular Degeneration.  Since 2011, Keith has been the Principal Investigator at AMRI for the NIH’s Blueprint for Neurotherapeutics Program for which AMRI provides medicinal chemistry services to assist NIH sponsored investigators to develop preclinical candidates/optimized drug leads.  Prior to joining AMRI, he spent 21years in the agrochemical industry with his research efforts focused on the discovery and optimization of novel herbicides and insecticides. 

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Confirmed presentation title:  "Oral RBP4 antagonists as a treatment for atrophic age-related macular degeneration – NIH Blueprint Neurotherapeutics Network (BPN) sponsored research"

Abstract:  The National Institutes of Health (NIH) Blueprint Neurotherapeutics Network (BPN) provides support for small molecule drug discovery and development to companies and academic researchers to develop new medicines to treat nervous system disorders by providing neuroscience researchers a “virtual pharma” including consultants with extensive pharma experience and industry-standard contract services.  Since 2011, AMRI has been providing medicinal chemistry support to the BPN including compound design, synthesis, computational chemistry and ADMET services.  This presentation will cover the efforts within one of the BPN programs to identify RBP4 antagonists as potential therapeutics for the treatment of atrophic age-related macular degeneration.  The development of a conformationally restricted analog with a unique isostere of the anthranilic acid moiety of the lead molecule will be described. 

Dr Werngard Czechtizky, Senior Director, Head Medicinal Chemistry, IMED RIA,
AstraZeneca
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Werngard Czechtizky obtained her PhD at ETH Zürich. After a postdoctoral stay at Harvard University, she worked on GPCR lead generation in a global Chemical Biology platform at Aventis. At Sanofi, from 2005, she moved into a parallel synthesis team working in the fields of CNS and CV diseases. In 2010, she became leader of a Medicinal Chemistry section working on Diabetes programs. In 2014, she was appointed Head of Chemistry at Sanofi R&D Germany, with therapeutic focus on Diabetes, pain and inflammatory indications. Since 2017, she is Head of Medicinal Chemistry, Respiratory, Inflammation and Autoimmunity, at AstraZeneca in Sweden.

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Confirmed presentation title:  "New modalities in respiratory disease - opportunities and challenges for medicinal chemistry"

Abstract:  Besides classical small molecule and antibody therapies for asthma and COPD, alternative molecular entities (“new modalities”) become increasingly important in clinical pipelines and preclinical research.

This presentation covers past and present clinical compounds as well as an overview of AZ’s current New Modality platforms. It further describes the challenges for Medicinal Chemistry to tackle the optimization of peptides, PROTACs and oligonucleotides towards clinical candidates.

Dr Richard D Connell, Head of External Research Solutions,
Pfizer Inc
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For the past fourteen years, Rick has designed and implemented the non-GLP Research sourcing strategy for Pfizer.  Beginning with his work in Chemistry sourcing, Rick helped deliver key change initiatives such establishing strategic, offshore partnerships in India and China, insourcing Chemistry operations at the Pfizer UK Research site, and centralizing Pfizer’s solid sample collection of building blocks and screening compounds to an external, 3rd party provider.  As the scale of operations increased, the emphasis shifted to evolving the key Chemistry partnerships into integrated screening operations and enhancing both the cycle times to data as well as the efficiency and effectiveness of these resources to drive program decision making and unlock value for Pfizer.    

Rick obtained his PhD at the University of Notre Dame and was an NIH Post-doctoral fellow at Harvard under the direction of Professor E.J. Corey.  He was hired in 1999 as a Medicinal Chemist at Bayer in West Haven, CT and was promoted to Director of Diabetes and Obesity Chemistry in 1996 after a two-year seconding to Wuppertal, Germany. He joined Pfizer in 1999 as Director of Oncology Medicinal Chemistry and became an Executive Director of Research Operations in 2005.  In 2008, he was named Vice President of Research Outsourcing.

Read Abstract...

Confirmed presentation title:  "Establishing an effective chemistry/research outsourcing strategy between large pharma and CROs.  Lessons learned from 14 years at Pfizer"

Abstract:  Research Outsourcing, be it Chemistry synthesis or ADME and Pharmacology services, play a key, enabling tool in the Drug Discovery tool box.  In fact, the speed with which many biotech or virtual pharma companies are moving from concept to a clinical asset is a testament to how wide spread and accessible quality domestic and off-shore CROs and CMOs have become.  

For established Pharma companies with existing Research operations, productively engaging a CRO relationship presents some unique challenges.  These challenges range from determining what activities are suitable for externalization, integrating these resources seamlessly into project team operating models, and variable-izing the cost of existing, internal operations.  For CROs and CMOs seeking to influence decision makers at such a company, there can be misunderstandings and frustration if the supplier does not understand what attributes to emphasize when marketing their wares to decision makers.  

This talk will provide one person’s view on outsourcing partnerships between large Pharma and CROs/CMOs and provides some learnings that may help reduce friction and unlock trapped value in these important relationships.

Dr Vikas Shirsath, Senior Vice President, Global Operations,
Jubilant Biosys
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Dr. Vikas is a creative, result oriented medicinal chemist with broad experience in Drug Discovery operations including Medicinal, Synthetic chemistry, Biology and IP management with major contribution in the area of CNS therapeutics.

During his 15 years of industrial experience with Drug Discovery and services in India, he has lead the science, operations, IP strategies and has mainly contributed to the growth of two start-up companies which grew to the critical mass of 250 team. At Zydus Research Center he worked on discovery of novel modulators for nuclear receptors. During his association with Suven Life sciences, a start-up Discovery group, he developed an integrated team for Drug Discovery and filed over 20 PCT applications in the area of CNS therapeutics in a short span of 4.5 years with a candidate in clinic for the mild to moderate cognition.

As Head of Medicinal chemistry / CSO at Oxygen Healthcare Research, a Cambridge based start-up, he developed the effective and knowledge driven, customer centric teams. With the team of over 200 and annual growth rate of over 20 % in 5 years, Oxygen Bio was acquired by Piramal healthcare in 2011.

A Pharmacist by training from Pune University, he completed his Masters and Ph.D. with Medicinal chemistry specialization from L. M. College of Pharmacy, Gujarat University.

Read Abstract...

Confirmed presentation title:  "Partnering for discovery - target to IND capability overview"

Dr Gordon Saxty, Head of Chemistry,
Fidelta
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Gordon Saxty did his Masters in Medicinal Chemistry at the University of Manchester (UMIST) where, as part of this degree, he also worked at Sanofi-Aventis (formally RPR). He then went on to do a PhD in Synthetic Organic Chemistry at Imperial College, London under the supervision of Professor Donald Craig. He previously held the position of Associate Director, Medicinal Chemistry at Astex Pharmaceuticals in Cambridge, UK where he worked for just over 12 years on Fragment Based Drug Discovery (FBDD) programmes. Several of these have progressed into clinical trials as potential new drugs to treat cancer. He is also an inventor on over 40 published patents and is an author on one of the most accessed Journal of Medicinal Chemistry articles from 2007, on FBDD of PKB/Akt inhibitors. As an individual who has made a significant contribution to industry in the early stages of their career, he was recently recognised with the Royal Society of Chemistry Young Industrialist of the Year Award 2013. One of those contributions was recognised by the U.S. Food and Drug Administration (FDA) and erdafitinib has been granted Breakthrough Therapy Designation for the treatment of urothelial cancer.


He has worked in Fidelta as Head of Chemistry for over 4 years. This work has been in various therapeutic areas, macrocycles and bRo5 in an integrated drug discovery setting.

Read Abstract...

Confirmed presentation title:  "Orally bioavailable and in vivo active macrocycles for idiopathic pulmonary fibrosis"

Abstract:  The last decade was marked by an increased interest in intractable targets not amenable to traditional small molecules. Diseases that need a single ‘hard target’ interaction are known, however, a polypharmacology that attains many interactions is an alternative and perhaps less well exploited approach.

Macrocycles belong to an alternative chemical space with properties between small molecules and biologicals, and although they do not follow Lipinski rule of 5, they do have druggable PhysChem properties1. Macrolides are an interesting class of macrocyclic molecules used clinically.

Our macrocyclic library was built using our long-term experience and in-house knowledge on the chemistry and pharmacology. Macrocycles were designed to diversify and enrich chemical space with different ring sizes, a variety of 3D shapes and potential pharmacophoric features with the aim to maintain the attractive PK and permeability properties.

We will present our recent in vivo data of our compound at 5 mpk po bid with comparable activity to Nintendanib at 60 mpk qd in a model of idiopathic pulmonary fibrosis. It will include the latest in vitro Fibroblast to Myofibroblast Transition (FMT) results and pharmacokinetic data.  We hope these compounds can address the unmet clinical need in idiopathic pulmonary fibrosis.

Dr Wahid Awad, Business Development Manager,
CILcare
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Dr. Wahid Awad is the Business Development Manager for CILcare: The world-leading Contract Research Organization (CRO) dedicated to hearing disorders. Dr. Awad has more than ten years of professional expertise in the field of Life Sciences. He completed a postdoc in genetics and biotechnology at INRA, France, a Ph.D in genetics from Colorado State University, USA and a master degree in Biotechnology from Wageningen University, Netherlands. With great passion for science and innovation, Dr. Awad was selected a NOVA (top talent community) member in France. Moreover, he was honoured with more than 12 awards in science, research creativity, community service and leadership.

Read Abstract...

Confirmed presentation title:  "Assessing compound efficacy in age-related hearing loss model"

Abstract:  

Age-related hearing loss (ARHL) is the most common sensory disorder in the elderly population. SAMP8 mouse model presents accelerated senescence and has been identified as a model of gerontological research. SAMP8 displays a progressive age-related decline in brain function associated with a progressive hearing loss mimicking human aging memory deficits and ARHL. The molecular mechanisms associated with SAMP8 senescence process involve oxidative stress leading to chronic inflammation and apoptosis. Here, we studied the effect of N-acetylcysteine (NAC), an antioxidant, on SAMP8 hearing loss and memory to determine the potential interest of this model in the study of new antioxidant therapies. We observed a strong decrease of auditory brainstem response thresholds from 45 to 75 days of age and an increase of distortion product amplitudes from 60 to 75 days in NAC treated group compared to vehicle. Moreover, NAC treated group presented also an increase of memory performance at 60 and 105 days of age. These results confirm that NAC delays the senescence process by slowing the age-related hearing loss, protecting the cochlear hair cells and improving memory, suggesting that antioxidants could be a pharmacological target for age-related hearing and memory loss.

Dr Andy McElroy, CEO,
The Research Network
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Andy graduated from Churchill College Cambridge in 1980 with a first-class degree in Natural Sciences and completed a PhD in synthetic organic chemistry before joining Glaxo as a medicinal chemist in 1983. IN 1993, Andy joined Pfizer as a Medicinal Chemistry Manager and oversaw a portfolio of projects in the Cardiovascular, Neurodegeneration, Dermatology and Pain therapeutic areas, leading projects up to first in human.

In 2008 Andy built and led a new team at Pfizer Sandwich responsible for coordinating external research and in 2011 founded TRN – The Research Network Ltd, an associate network of drug discovery specialists focussed on enabling drug discovery and development. Since 2014, TRN have pioneered the Virtual Bioincubator, an integrated solution to support early drug discovery and development ventures which has led to the creation of several new drug discovery ventures.

Read Abstract...

Confirmed presentation title:  "VBio: The Virtual Bioincubator “pay as you go” therapeutics discovery"

Abstract:  The Virtual Bioincubator is a Life Sciences collaboration and new venture support service.

Since 2011, we have partnered with academics, charities, start-ups, biotech and the pharma industry to support lean translation of new targets, technology and therapeutics from lead identification through to clinical proof of concept. Unlike traditional bioincubators/ accelerators, VBio has global reach, unconstrained by capital investment and local infrastructure.

We have pioneered a disruptive, cost-effective business model to address the knowledge and funding gaps to translate early stage therapeutics discovery projects to further investment and beyond. A simplified, contracting framework means V-Bio provides a swift gateway to an integrated team of drug discovery and development experts with multi-disciplinary life sciences and health technology industry knowledge.

We can build a bespoke, robust package utilising >1500 years of market insights, backed by an extensive global network of validated CROs and consultants. Our aim is to mitigate risks and maximise value for limited start-up funds and stakeholders, to accelerate progression of innovative treatments towards the clinic.

Along with case studies, this presentation will discuss the challenges inherent in the start-up ecosystem and how the Virtual Bioincubator can help accelerate the decision-making process, provide time/cost savings and links to investment.  Please come and speak to us about how we can meet your requirements, to support and accelerate your business.

Broad industry expertise available:

  • Anti-infectives, Respiratory, Inflammation, Immunology, Virology, CVMD, Dermatology, Pain, Oncology, CNS, Rare & Orphan Diseases,
  • Small molecules, Biotherapeutics and Advanced Therapies
  • Biology, Chemistry, Bio-informatics, Drug Safety, DMPK, Formulation, Clinical, Regulatory, Patent writing
Dr Joann Rhodes, Translation and Early Development Support,
The Research Network
Read Profile...

Joann is a translational pharmacologist with 19 years’ experience spanning the life sciences R&D eco-system, across industry, academia, and biotech. Her work, leading and managing teams to scout, create and deliver global multi-disciplinary strategic partnerships and enable drug and gene therapy development, has covered multiple fields: Rare disease, Inflammation, Immunology, Respiratory and Neuroscience. Joann’s has been a consultant at The Research Network since 2011, following 12 years as a discovery lead at Pfizer Global R&D, Sandwich, in novel target and biomarker evaluation for kinase inhibitor and epigenetic programmes. Now, having obtained a BSc Pharmacology (Sheffield), Translational Medicine (Edinburgh) and currently studying for an Executive MBA (Imperial), she has a keen interest in creation of a positive infrastructure, for businesses to harness novel technologies for future life science innovation.

Joann’s current role leverages the Virtual Bio-Incubator’s collective expertise to provide bespoke support packages to address clients’ business challenges, bridge the translational gap and accelerate development towards therapies which will benefit patients.

Read Abstract...

Confirmed presentation title:  "VBio: The Virtual Bioincubator “pay as you go” therapeutics discovery"

Abstract:  The Virtual Bioincubator is a Life Sciences collaboration and new venture support service.

Since 2011, we have partnered with academics, charities, start-ups, biotech and the pharma industry to support lean translation of new targets, technology and therapeutics from lead identification through to clinical proof of concept. Unlike traditional bioincubators/ accelerators, VBio has global reach, unconstrained by capital investment and local infrastructure.

We have pioneered a disruptive, cost-effective business model to address the knowledge and funding gaps to translate early stage therapeutics discovery projects to further investment and beyond. A simplified, contracting framework means V-Bio provides a swift gateway to an integrated team of drug discovery and development experts with multi-disciplinary life sciences and health technology industry knowledge.

We can build a bespoke, robust package utilising >1500 years of market insights, backed by an extensive global network of validated CROs and consultants. Our aim is to mitigate risks and maximise value for limited start-up funds and stakeholders, to accelerate progression of innovative treatments towards the clinic.

Along with case studies, this presentation will discuss the challenges inherent in the start-up ecosystem and how the Virtual Bioincubator can help accelerate the decision-making process, provide time/cost savings and links to investment.  Please come and speak to us about how we can meet your requirements, to support and accelerate your business.

Broad industry expertise available:

  • Anti-infectives, Respiratory, Inflammation, Immunology, Virology, CVMD, Dermatology, Pain, Oncology, CNS, Rare & Orphan Diseases,
  • Small molecules, Biotherapeutics and Advanced Therapies
  • Biology, Chemistry, Bio-informatics, Drug Safety, DMPK, Formulation, Clinical, Regulatory, Patent writing
Pierre Charrier, CEO,
Diverchim
Read Profile...

After spending more than 25 years in Custom & Contract Manufacturing Industries during which he exercised several functions from Head of Business Development up to Executive Management, Pierre Charrier, together with other investors, took over:

-    Diverchim CDMO in July 2017 dedicated to « small » quantity API manufacture as well as

-    Centre Lab in February 2018 specialized in « small » series of non sterile product manufacture.

Pierre Charrier graduated from ESCOM, a Chemical Engineering School in Paris. He also holds an MSc in Biochemistry from the University of Colorado and a Master of Marketing from HEC Paris.

Read Abstract...

Confirmed presentation title:  "An efficient link from « Small quantity » commercial c-GMP API manufacture to clinical needs"

Dr Michael Rugaard Jensen, Director Head of ONC Discovery Pharmacology,
Novartis
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Michael Rugaard Jensen has a Ph.D. degree in molecular and cellular biology combined with an extensive experience in genetically engineered mice and more than 13 years of leading Oncology Drug Discovery efforts. Michael has for the past 5 year lead the Drug Discovery Pharmacology team that is using a diverse set of innovative in vivo technologies to ensure delivery of novel treatments for cancer patients.  

Read Abstract...

Confirmed presentation title:  "Mouse clinical trials: large scale in vivo screening predicts drug response in cancer patients"

Dr Jeyaprakashnarayanan Seenisamy, Associate Research Director, Discovery Chemistry,
Syngene International Ltd
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Jeyaprakash (JP) is an Associate Research Director at Syngene and heads one of the sections of MedChem at Syngene. He joined Syngene in 2005 and has more than 13 years of drug discovery and synthetic chemistry experience.  JP in his current role at Syngene, worked in various capacities viz., led multiple integrated medicinal chemistry projects involving kinase inhibitors, protease inhibitors, amino peptidases, phosphatases, CNS drugs, antibacterial, Antibody Drug Conjugates, Flow Chemistry, synthesis of natural products, synthesis of focused libraries etc. He works with partners from virtual biotechs, small and medium pharma companies and involved in the successful delivery of 3 preclinical candidates from hit molecules and cost effective route development for the clinical candidates.  As a Chemist by training after his PhD in IIT, India; JP moved to Arizona Cancer Centre, Tucson, Arizona, USA for a postdoctoral stay with Professor Laurence Hurley, where he was involved in the design, development and screening of duplex and multiplex DNA interacting drugs and kinase inhibitors. JP is the author of 27 publications in internationally reputed journals and 13 patent applications.

Read Abstract...

Confirmed presentation title:  "“Putting Science to Work” – a journey of CRO with a virtual pharma company"

Dr Dave Madge, Vice President Research Services Division,
WuXi AppTec
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Dr Dave Madge received his Ph.D in organic chemistry from Imperial College, London, and spent the early part of his career working at the Wellcome Foundation as a medicinal chemist. In 1995, Dave joined a new integrated biochemical research group at UCL in London as co-founder of the medicinal chemistry group. In this role Dave helped establish new drug discovery projects as collaborative and commercial ventures with other scientists at UCL, including a neuroscience company and an anti-infective company, both of which were acquired by pharma. In 2001 Dave and colleagues established a drug discovery services company, NCE discovery (now Domainex) which Dave joined as chief operating officer. In 2005 Dave joined the ion channel drug discovery company Xention, as VP, Chemistry and then VP, Research. Dave is now VP of the Research Services Division at WuXi AppTec, a China-based drug discovery contract research organisation with over 18,000 staff and a worldwide client base.

Read Abstract...

Confirmed presentation title:  "Enabling diverse drug discovery organisations"

Abstract:  This presentation will address the growing strength of the relationships between drug discovery and contract research organisations in China and the academic, biotech and pharma community in Europe and the US. WuXi AppTec has played a major role in bringing China-based life sciences activities onto the global stage, and fostering exchange of services and technologies in this sphere. Some of these success stories will be discussed as models for further collaboration.

Dr Anatol Luther, Head of Chemistry,
Polyphor Ltd
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Dr. Anatol Luther obtained a Ph.D. from the University of Bochum, Germany. After a postdoc with Prof. A.Eschenmoser at The Scripps Research Institute, La Jolla, USA, he joined Polyphor Ltd, Allschwil, Switzerland in 2001. He led focused library projects for discovery research programs of pharmaceutical industry partners. In 2005, Anatol became Head of General Library Synthesis responsible for a team designing and synthesizing Polyphor’s nonexclusive small molecule screening library (50’000 cpds).

In 2010, he assumed responsibility for the Proteine Epitope Mimetic (PEM) chemistry group and led the entire parallel chemistry operations including high throughput purification of the company. Over the years Anatol has been involved in numerous external and internal drug discovery projects from hit finding to preclinical development. Since 2012, Anatol leads the medicinal chemistry efforts of Polyphor’s proprietary antimicrobial platform. 2017, Anatol became responsible for the entire chemistry operations as Head Chemistry.

Read Abstract...

Confirmed presentation title:  "Discovery and development of the OMPTA class of antibiotics - impact of CROs"

Abstract:  The OMPTAs (outer membrane protein targeting antibiotics) are a new class of antibiotics being developed for the treatment of Gram-negative infections belonging to the clinically relevant priority 1 ESKAPE pathogens. The first member of this class, Murepavadin (POL7080) with potent Pseudomonas-specific antimicrobial activity has started phase III clinical trials for treatment of life-threatening lung infections. We describe here a novel class of fully synthetic antibiotics that was inspired from natural product-derived scaffolds. The new compounds of the OMPTA class display potent activity against a broad panel of Gram-negative bacteria, including both MDR- XDR-, and colistin resistant strains. In addition, they do not show any cross-resistance with standard-of-care antibiotics. The presentation covers the discovery and optimization of advanced lead compounds and exemplifies the impact of CROs to their development. 

Dr Karl Karlsson, CSO,
3Z Pharmaceuticals
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Karl joined Reykjavik University in 2006 as an assistant professor and became a full professor in 2015. Karl underwent post-doctoral training at UCLA and prior to that had obtained a doctorate degree in behavioral neuroscience at the University of Iowa. Karl completed a bachelor´s degree in psychology from the University of Iceland. Since 2012 Karl has also been a group leader at the rapidly growing, University of Iceland based, Biomedical Center. The company 3Z (www.3z.is) was formed as a spin-off from ongoing research projects in 2008.

In early stages of his career Karl has worked on elucidating the neural substrates of sleep either using humans or rodent and zebrafish as models. This work formed the foundation for the general approach of generating zebrafish based disease models for drug screening. The core methods employed include: automated behavioral analysis, generation of transgenic lines, histology and in vivo/in vitro electrophysiology.

Read Abstract...

Confirmed presentation title:  "ALS screening assays that track and monitor zebrafish behaviour"

Abstract:  One of the largest bottleneck in the discovery of novel compounds is the lack of robust and cost-effective in vivo disease models. 3Z has developed an assay of ALS that combines the cost-effectiveness and throughput of in vitro assays with the information high-content of in vivo assays. The model revolves on using human SOD1_G93R transgenic zebrafish line that expresses the hallmarks of ALS at early age and precisely determining the behavioral parameter that differentiates between the mutant and wild-type lines. We show that the disease onset occurs between day 6 and 11 post-fertilization. During this period the larvae is incubated in test compounds, then the behavioral parameters are used to determine hit compounds. Next, the effect of the compound is verified using co-localization measurements between the motor neuron presynaptic vesicles and muscle receptors. Currently 3Z is generating four novel strains that each represent different mutations known to affect ALS.

Speaker Profiles - Small Molecule Stream

Dr Frederik Beck, Senior Outsourcing Manager,
Zealand Pharma
Read Profile...

Dr. Frederik Beck has more than 20 years of experience from pharmaceutical and biotech companies. He is the CMC Senior Outsourcing Manager at Zealand Pharma and has held this position for the past four years and has successfully completed 2 IMPD’s for two new chemical entities. As CMC outsourcing manager Dr. Beck is responsible for the outsourcing of all activities relating to clinical trials, both DS and DP. Prior to joining Zealand Pharma Dr. Beck worked for CMC Biologics as Project Director and as scientist/ project manager at Hexal. Dr. Beck received a Master of Chemical Engineering in 1992 from the Technical University of Denmark and an industrial Ph.D. from the University of Copenhagen in collaboration with DAKO A/S in 1999.

Read Abstract...

Confirmed joint presentation title:  "ZP4207:  selection of a late stage API vendor"

with Frank Dettner

Abstract:  The topic will be the selection process of an API vendor for late stage and commercial manufacturing and the following process set-up, qualification and process validation carried out at Bachem.

Dr Simone Tortoioli, Technical Project Leader Drug Substance,
Idorsia Pharmaceuticals
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Simone Tortoioli was born in Perugia (Italy) where he pursued undergraduate studies in Chemistry achieving a Master degree in 2000 and completed his PhD in 2005 at the same university in the group of Professors F. Fringuelli and F. Pizzo developing in close knit with Dr. L. Vaccaro the use of Lewis and Brönsted catalysts for the ring opening of oxiranes in water or under solvent-free conditions. He then moved to Geneva (Switzerland) for a postdoctoral stay with Professor J. Lacour where he was involved in the development of asymmetric Ru(II)-catalyzed Carroll rearrangement.

He joined GSK late 2006 at the research center in Verona (Italy) as senior scientist in the synthetic chemistry group of Chemical Development, with the tasks of optimizing and preparing for scale-up synthetic routes to APIs to support Phase I and II in the CNS area as well as developing 2nd generation routes.

In 2010 he moved to Basel (Switzerland) to work as Lab Head with Actelion Pharmaceuticals in the Process Research group led by Dr. Stefan Abele. In 2013 he was promoted to Senior Lab. Head. In his role, he has been responsible for the route scouting and scale-up of new APIs up to the first 1-2 kg to support preclinical studies and preparing for Phase I manufacturing. Following a demerge of Actelion in June 2017, and the creation of Idorsia Pharmaceuticals, he has been Senior Scientist in the new Chemical Development group. Since February 2018, he took a position of Technical Project Leader Drug Substance, with the responsibility of coordinating the CMC activities and the outsourcing for the manufacturing of APIs in clinical development.

 

Read Abstract...

Confirmed presentation title:  "Dancing in the dark: development of a scalable synthesis of a novel CXCR3 antagonist through strategic outsourcing" 

Dr Yogeshwar Bachhav, Associate Director Pharmaceutical Development,
AiCuris GmbH
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Dr. Yogeshwar Bachhav is associated with AiCuris Anti-infective Cures GmbH Wuppertal (Germany) for around 4 years. AiCuris (name derived from 'anti-infective cures') is focused exclusively on the discovery, research and development of novel antiviral and antibacterial drugs.

Yogeshwar has around 12 years of experience in Pharmaceutical development (CMC) of poorly soluble/stable drugs for oral, parenteral and topical route from the start-up and mid-size Pharmaceutical companies in Europe. In his current role at AiCuris, he is responsible for the outsourcing of drug product for preclinical and clinical trials up to phase II. His experience involves both in house and external Pharmaceutical development of poorly soluble/labile APIs for oral parenteral and topical route.

Read Abstract...

Confirmed presentation title: "Development of complex parenteral formulations"

Abstract:   The focus of the talk would be to cover critical attributes of the IV formulations such as pH, osmolality, drug load, absence of excipients with irritation potential, absence of precipitation upon mixing with plasma. It would also cover possible options to develop IV formulations of poorly soluble drugs or difficult to formulate drugs (one case study from the market or literature) viz. Cyclodextrins (Captisol, HPBCD), Liposomes, Mixed micelles/miceller solutions (use of surfactants), Intralipid emulsion, Nanosuspension. Some case studies would also be covered for difficulty in formulating IV formulation is complex such as potent/cytotoxic drugs (case studies) e.g. anticancer drugs and Penicillin or cephalosporin type of compounds.

Maarten van Geffen, Senior Director, Clinical Supplies & Logistics,
ProQR Therapeutics
Read Profile...

Maarten van Geffen’s is currently responsible for the outsourced production of drug product to support the clinical development of Leiden based biopharmaceutical ProQR Therapeutics NV. Recently Maarten had a similar position supporting vaccine development for Janssen Vaccines and Prevention. Before that he had several leading CMC positions in Biotech SME’s including Vice President Quality & CMC for Amakem NV, head of CMC  for Shire-Movetis,  Director of CMC Regulatory Affairs at Barrier Therapeutic NV and Janssen Biologics. Before initiating his career in the industry, Mr Van Geffen was assessor of quality part pharmaceutical dossiers for the Dutch Health and Environmental agency.

Read Abstract...

Confirmed presentation title:  RNA therapeutics drug product development and experiences of outsourcing for ultra orphan indications. 

Dr Hanu Ramachandruni, Senior Director Technical Product Development,
Medicines for Malaria Venture
Read Profile...

As Senior Director of Technical Product Development, Dr. Ramachandruni leads all CMC related activities at MMV, a non-profit organization based in Geneva. He provides scientific input into CMC strategies for antimalarial drug development and works closely with pharma partners in late stage drug development. As MMV is a virtual organization, Hanu is responsible for overseeing drug substance and drug product development at contract organizations to facilitate clinical studies sponsored by MMV. As children constitute a majority of malaria patients, Hanu’s emphasis is on development of acceptable paediatric formulations and evaluating technologies that facilitate cost effective drug delivery.

Prior to joining MMV in 2015, Hanu was based in the US where he worked for over 15 years at Schering-Plough, Forest Laboratories and Allergan, in various areas of CMC development including formulation and process development, scale-up, technology transfer and validation. Hanu holds a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.

Read Abstract...

Confirmed presentation title:  "Managing the scale up of drug product development and how to ensure effective CMO selection"

Abstract:  

As a donor-funded non-profit virtual organisation, MMV conducts all its antimalarial development activities at CROs, CMOs and other partners. Drug substance and drug product development is typically conducted at CMOs that have scale up and commercial capabilities, and have GMP compliant sites recognized by stringent regulatory authorities to ensure product of highest quality. Since MMV out-licenses the drug after proof of concept to a pharma partner, CMOs recognised by pharma partners as potential commercial sites are favoured. As the eventual commercialisation is in low to middle income countries, emphasis is on low cost of goods and cheaper scalable technologies. CMOs with proven record in paediatric formulation development are usually preferred as the target population is mostly children.

Dr Susanne Ziffels, Group Head Formulation Research & Development,
Roche
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Dr. Susanne Ziffels is a pharmacist by education and obtained her PhD from Christian Albrecht University of Kiel, Germany, in 2009. In 2010, following a postdoc research at University of North Carolina at Chapel Hill, US, she joined Haupt Pharma Amareg GmbH in Regensburg, Germany, as Head of Pharmaceutical Development. Since 2014 she is working in her current role as Group Head in Formulation Research & Development, Small Molecules, at F. Hoffmann-La Roche AG in Basel, Switzerland.  With more than seven years of experience in pharmaceutical development units she has expertise in solid and liquid drug product development including pediatric drug products and handling of highly potent APIs.  

Read Abstract...

Confirmed presentation title:  "Building a robust formulation strategy for phase 1 and beyond"

Dr Frank Dettner, Director R&D III,
Bachem AG
Read Profile...

Director R&D III Bachem AG

Frank studied chemistry in Tübingen (Germany).

He obtained his PhD from the Technical University of Berlin and was already trained in synthetic peptide chemistry during his thesis with Prof. Suessmuth.

He started in Bachem’s R&D group as laboratory head in 2009 and held a director position from 2012 to 2014 focusing on non-GMP synthesis of peptides and small proteins and process research.

Since 2015 he has been holding a director position in the R&D group at Bachem headquarters in Bubendorf focusing on GMP manufacturing of peptide based active pharmaceutical ingredients (APIs) and new chemical entities (NCEs).

Read Abstract...

Confirmed joint presentation title:  "ZP4207:  selection of a late stage API vendor"

With Dr Frederik Barfœd Beck

Abstract:  The topic will be the selection process of an API vendor for late stage and commercial manufacturing and the following process set-up, qualification and process validation carried out at Bachem.

Ms Gudrun Fridgeirsdottir, Senior Formulation Scientist,
Juniper Pharma Services
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Gudrun has recently joined Juniper Pharma Services as a senior scientist after finishing her PhD at the University of Nottingham, which was focused on the stability of solid dispersion formulations. Before that Gudrun graduated with a MSc from Uppsala University in Sweden, focusing on drug development and discovery, and a BSc from the University of Iceland. Gudrun worked in a global pharmaceutical company alongside her undergraduate studies and has experience from different stages of the drug development process.

Read Abstract...

Confirmed presentation title:  "Predicting solid dispersion stability - using multiple linear regression models"

Abstract:

Purpose
The aim of this study was to produce a support tool for the formulation development of solid dispersions. A predictive statistical model was built using experimentally obtained stability data and the physiochemical properties of the APIs used. The model is intended to provide an indication of which polymer and manufacturing method is most likely to give a stable solid dispersion for a new drug.

Methods
Three commercially available polymers (Soluplus, PVP-VA and HPMCAS) and ten chemically diverse, neutral, poorly soluble APIs (Aprepitant, Celecoxib, Estradiol, Felodipine, Fenofibrate, Itraconazole, Nifedipine, Orlistat, Probucol and Ritonavir) were used to produce solid dispersions. Each binary formulation, containing one polymer and one API (10% w/w), was produced twice, once using hot melt extrusion (HME) and once using spray-drying (SD). The stability of each formulation was determined over 12 months at accelerated conditions (40°C/75%RH). The amorphicity of the formulation was confirmed at the start of the stability study.

Subsequently at each time-point the physical stability (time to crystallisation) was determined using polarised light microscopy (PLM), differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD).

Instant JChem (ChemAxon) was used to calculate and predict physicochemical properties of the APIs. R and RStudio was then used to build multiple linear regression models (MLR) for each combination of polymer and manufacturing method.
Results

Out of 60 produced solid dispersions 59 were amorphous at the start point of the stability study. One formulation crystallised immediately after production. This was observed visually as a cloudy glass, and confirmed with PLM and DSC. Some APIs started crystallising within a week while others remained amorphous for the 12 months tested. Such differences were observed both between different polymers as well as between the two processing methods. No clear trends could be observed visually from the experimental data.

A set of six models, one for each combination of polymer and manufacturing method, were built using the physicochemical properties and stability data. Each model was validated with leave-one-out cross validation (LOOCV) and mean square error (MSE) calculated between predicted and measured values. The models were used to rank formulation, comparing stability of different combinations of polymer and manufacturing method (Figure 1). An external validation (based on measured data from [1]) was performed on the spray-dried models which showed very good agreement between predicted and measured values.

Conclusions
Some important differences have been observed from the stability data, both between polymers and processing methods. Several MLR models were built with R2adj ranging from 0.8 to 0.9. An external validation showed that the models were able to correctly rank stability of solid dispersion formulations. Furthermore, the predicted stability was in very good agreement with the measured one. These models highlighted correlations between physicochemical properties of the APIs and stability of solid dispersions. The models can be used to provide a basis for selection of polymer and manufacturing process.

Dr Wolfgang Schiek, Director, Business Development and Sales,
Cambrex
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Dr. Wolfgang Schiek has been Director Sales and Business Development at Cambrex since 2015, located in Düsseldorf, Germany.

Wolfgang is a chemist by training with a PhD in chemistry from Heidelberg University.

Having started his industrial career gathering experience in various technical roles, he has gained a good understanding of the chemical and technical constraints of API development and manufacturing.

Wolfgang also has 10 years’ experience in Business Development and Sales within this industry, working in various roles. He combines work experience from three major companies in the API CDMO field and is a technically and commercially solution oriented and supportive partner for the customers of Cambrex.

Read Abstract...

Confirmed presentation title:  "Continuous flow chemistry for APIs and intermediates"

Dr David Elder, Consultant and former Director Due Diligence (PQRM),
GlaxoSmithKline
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Dr Elder studied chemistry at Newcastle upon Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in Crystallography. He is a visiting professor (King’s College, London). Dr Elder has 40-years experience at a variety of different pharmaceutical companies (Sterling, Syntex and GSK).  He is currently an independent CMC consultant.  
 
Dr Elder is a member of the British Pharmacapoeia (Expert Advisory Group PCY: Pharmacy) and a past chairman of the Joint Pharmaceutical Analysis Group, UK.  He is a fellow of the RSC (FRSC).
 
He has presented regularly on drug development and drug delivery. He has authored 17 book chapters, 133 publications, 14 posters, 18 webinars and given 138 national/international presentations. He has co-edited two books on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities and on ICH Quality Guidelines.

Read Abstract...

Session chair of the Technical operations outsourcing - early phase module

Dr Andy Walker, Head of API, Global External Development,
GlaxoSmithKline
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Andy Walker is the API Head of Global External Development and Supply at GSK, and is based in Stevenage, UK. Andy joined GlaxoSmithKline in 1992 after completing a Ph.D in organic chemistry at the University of Salford and postdoctoral studies at the University of Oxford. He has led both chemistry line and matrix project teams within Chemical Development and has been involved in the externalisation of API and Drug Product projects since 2006, including several APIs that have reached commercialisation. More recently, Andy has provided overall leadership of an API externalisation group within GSK, and has a strong interest in delivering effective oversight across an expanded portfolio of externalised CMC projects.

Read Abstract...

Confirmed presentation title:  "Accelerating early API development and manufacture – challenges and opportunities for externalisation"

Abstract: This talk will explore the challenges faced in early phase API development and manufacture to provide First Time in Human supplies and where there are opportunities to accelerate this through an externalised network. This will consider the transition from Discovery into Development, describe levers for acceleration and how they are reflected in GSK’s oversight model as we seek to develop mutually-beneficial relationships with external partners.

Dr Mikael Bisrat, Development & Technology Sales Director,
Recipharm
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Mikael Bisrat is a Sales Director in the Development Sales team at Recipharm, involved in business development with a focus on the Nordic market. Mikael, who has a Ph.D. in Pharmaceutics from Uppsala University and an EMBA from Stockholm School of Economics, has a wealth of experience in the pharmaceutical industry. He has extensive knowledge about late stage discovery, formulation development and the production of clinical trial materials.

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Confirmed presentation title:  "Recipharm Pathway to Clinic® - from formulation to clinical trial"

Abstract:  

At Recipham, we understand the need to get a product successfully through phase 1 as quickly and safely as possible. To support this Recipharm have partnered with the Clinical Trial Consultants (CTC) to offer Recipharm Pathway to Clinic®.

Recipharm Pathway to Clinic® offering guides customers from formulation development to clinical supply manufacture and trial management. A complete, seamless solution, reducing the complexity of all first in human projects. We take complete control over all the links in the chain so activities can be run in parallel, adjusted at each step to avoid delays, deadlines met and value built into clinical data.

Our priority is to reduce risk, time and cost for our phase 1 customers, delivering regulatory compliant first in human studies. Recipharm are your first in human partner.

Dr Edwin Aret, Principal Scientist, Solid State Chemistry ,
Alcami
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Dr. Aret is currently the principal scientist for solid state chemistry at Alcami Corporation. He holds a PhD in solid state chemistry from Radboud University Nijmegen, Netherlands and has 15 years of experience ranging across the entire pharmaceutical development cycle, from discovery to commercialization, covering small molecules, drug substance and drug product. His expertise is on crystallization, form selection, stability studies, solubility determination, bioavailability and crystal habit optimization. 

Read Abstract...

Confirmed presentation title:  "Accelerating drug development by automation"

Dr Massimiliano Forcato, R&D Director,
Zach Systems SA
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Massimiliano obtained his PhD in Chemistry at the University of Padova (Italy) in 2003. After a post-doctoral fellowship at the same university and scientific missions at the KTH (Stockholm, Sweden) and at Universté Louis Pasteur (Strasbourg, France) he joined the R&D laboratory of Zach System in Lonigo (Italy), a company operating as fine chemical and pharmaceutical CMO, where he worked until 2010 as process chemist and NMR specialist. In 2010 he was appointed Head of R&D at Zach System S.A. in Avrillé (France), his current position, in charge of the process chemistry R&D, analytical development and process safety departments.   

Read Abstract...

Confirmed presentation title:  "Free flowing API powders through spherical agglomeration"

Dr François Besselievre, Account Manager,
PCAS
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François got a PhD in Organic and Medicinal Chemistry in 2010. He spent some time in Aachen as a post-doctoral fellow in Pr. Magnus Rueping group. He then worked for two different companies as a medicinal chemist and then as a process chemist before joining PCAS. He started in the company as a chemical development project Manager and switch to a position in the Sales department in January 2017. Since then, he is in charge of the European customers and especially of the emerging companies.

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Confirmed joint presentation title:  "API development, production and biocatalysis"

Dr Audrey Robic, Scientific Manager,
Protéus
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Audrey has a dual training in pharmacy and biochemistry. She is a Scientific Manager at Protéus. She manages R&D teams and projects.

These projects concern biocatalyst screenings, biocatalyst optimizations from lab to industrial scale for pharmaceuticals and cosmetic ingredients.

Before joining Protéus, Audrey has held several project manager positions in the biotechnology units of feed and food companies.

Read Abstract...

Confirmed joint presentation title:  "API development, production and biocatalysis"

Abstract:  Protéus is a biotechnology company specializing in the discovery, engineering and production of enzymes for industrial applications, as well as in the development of innovative bioprocesses featuring these enzymes.

Protéus is a subsidiary of the PCAS Group, actor in fine chemicals and specialty products and producer of high-value complex molecules. Protéus's expertise combined with the PCAS’s capabilities allows the production of new molecules with high productivity in a context of green chemistry.

Enzymes allow considering unique functionalizations that are difficult to achieve by conventional chemical means. Examples involving the screening of our ready to use tool box of enzymes, the engineering of wild-type enzymes and the scale-up of biocatalytic processes will be presented.

Dr Brian Freer, Sales and Marketing Manager,
Chiral Technologies Europe
Read Profile...

2003 to date Chiral Technologies
2000 to 2003 Rhodia ChiRex
1991 to 2000 Dow Corning.

1989 – 1991 Ph.D. Heriot Watt University –Novel Heterocycles for use as Near Infra red Absorbers

Read Abstract...

Confirmed presentation title:  "Isomeric purity analysis to Kg"

Abstract:  An overview of the options for chiral chromatography from analysis to preparative separation.

Lisa Burns, Clinical Development Manager,
Custom Pharma Services
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Lisa is the Clinical Development Manager with Custom Pharma Services in Brighton, UK, a CDMO established in 1979 which offers a full clinical to commercial drug product development service, specialising in solid oral dosage forms of both immediate and modified release. She joined the company in 2014 after 15 years of analytical and formulation experience having previously worked for Cancer Research UK, Aptuit, Encap and BioReliance. Within Custom, Lisa is responsible for managing and delivering exceptional service to clinical customers to ensure that drug products are developed, tested and manufactured to the highest quality, ensuring that your journey to clinic exceeds your expectations whilst meeting your budget.

Read Abstract...

Confirmed presentation title:  "Automated drug-in-capsule dosing - overcoming the challenges for GMP clinical supply"

Dr Joke de Gelder, Analytical Project Manager,
Anacura – anaRIC biologics
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Dr Joke De Gelder joined anacura after obtaining a PhD. in Chemistry from the University of Ghent, Belgium. During 10 years as an Analytical Project Manager, she has been leading analytical small molecule projects in both early and late phase, supporting method development, validation, transfer, release and stability studies. Her principal expertise is to unify a profound scientific approach and GMP regulations with an efficient process flow. From this incentive, she successfully completed several quality & process improvement projects at anacura.

Read Abstract...

Confirmed presentation title:  "All aboard:  analytical insights fast track your time to market"

Abstract:  In drug development, making rapid and targeted decisions is key to allow short lead times and acceptable costs. With GMP and validation prospects in mind, anacura has optimized the analytical activities in early phases resulting in short lead times. Scientific expertise, risk mitigation and stability modelling play a key role in this process.  In close cooperation with product developers, we enhance method development, fast drug product selection and predictive shelf-life claim.

Dr Andrew Henderson, Sales and Marketing Director,
Sterling Pharma Solutions Ltd
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Andrew Henderson is the Sales and Marketing Director at Sterling Pharma Solutions. He is responsible for all of Sterling’s commercial activities, including business development, marketing, key account and product management. Andrew has a PhD in organic chemistry and started his career as a development chemist. He has then spent the last 10 years in more commercially focussed roles holding positions at Onyx Scientific and Aesica Pharmaceuticals before joining Sterling Pharma Solutions in 2015.

Read Abstract...

Confirmed presentation title:  "Application and advantages of hazardous chemistry in API development and manufacturing"

Prof Chris Frampton, JM Scientific Adviser,
Johnson Matthey
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Professor Chris Frampton obtained his B.Sc in Chemistry and his Ph.D in Inorganic Chemistry from the University of Essex in 1981 and 1985 respectively. After completion of his Ph.D research he took up a postdoctoral position in the laboratory of Professors Tom Birchall and Ron Gillespie at McMaster University Hamilton, Ontario, Canada, researching into the correlation of crystal structure data with Mössbauer spectroscopic parameters of high-oxidation state main-group compounds. He subsequently took up the management position of the single-crystal X-ray facility at McMaster University. Prior to his more recent academic positions, Professor Frampton was a cofounder and Chief Scientific Advisor of Nuformix (2009), a company devoted to the exploitation of cocrystal technology to improve the pharmaceutical characteristics and generate new IP for new and existing drug products. Cofounder and Director of Pharmorphix Ltd. (July 2003-May 2014), consultancy and solid-form research services to the pharmaceutical and biotechnology sectors. He joined Pharmorphix full time in January 2005 as Chief Scientific Officer. Pharmorphix was acquired by SAFC Pharma, A Sigma-Aldrich Company Ltd. in August 2006 and more recently by Johnson Matthey PLC, October 2015.

He held the position of Director of Strategic Marketing at Bruker AXS where he was responsible for new technology in the bio-market. He joined Bruker AXS after 9 years at Roche Discovery Welwyn, a UK-based semi-autonomous research and development division of F. Hoffman La-Roche AG, with the primary responsibility for the establishment of a single crystal X-ray diffraction laboratory to support both medicinal chemistry and the pre-clinical Pharmaceutical Development Department. This included participating in research projects that led to the successful market launch of drugs such as the influenza neuraminidase inhibitor Tamiflu® (oseltamivir phosphate) and a first-generation HIV protease inhibitor Invirase® (saquinivir mesylate). He is the author and co-author of over 30+ patents and over 140 peer-reviewed research publications which have appeared in many high-impact journals. He is a member of the editorial board of for the IUCr journal Acta Crystallographica, Sect. C.

He has acted as an expert witness in a number of high profile legal cases, involving the solid form of pharmaceutical drug substances, in both the US and the UK. More recently, (November 2013- January 2018), he took a Chair in Structural Chemistry and Crystal Engineering within the Wolfson Centre for Materials Processing at Brunel University and currently holds the post of visiting Professor of Structural Chemistry within the ETC at Brunel University. In April 2015 he was named in the Global Top 100 Most Influential Medicine Makers Power List. He is currently the CEO of Rbar3 Ltd., a Solid-form and Crystallographic Consultancy service to the pharmaceutical and fine chemical industry sectors

Read Abstract...

Confirmed presentation title: "Complex chemistry, simply delivered:  co-crystal design, development and scale-up"

Abstract:  The physicochemical properties of many functional industrial materials including that of active pharmaceutical ingredients, API’s, are dependent upon the crystal structure of that material.  Along with polymorph screening and salt selection, the emerging area of cocrystallisation offers a further unique and exciting opportunity for solid form development to enhance or change deficient properties that may be inherent within a particular development candidate, e.g. hygroscopicity, melting point, dissolution rate and processability by modification of the crystal structure.  This presentation will highlight aspects of the design, development and scale-up for a specific example of the weakly basic agrochemical active Pyrimethanil.  

Dr David Elder, Consultant and former Director Due Diligence (PQRM),
GlaxoSmithKline
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Dr Elder studied chemistry at Newcastle upon Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in Crystallography. He is a visiting professor (King’s College, London). Dr Elder has 40-years experience at a variety of different pharmaceutical companies (Sterling, Syntex and GSK).  He is currently an independent CMC consultant.  
 
Dr Elder is a member of the British Pharmacapoeia (Expert Advisory Group PCY: Pharmacy) and a past chairman of the Joint Pharmaceutical Analysis Group, UK.  He is a fellow of the RSC (FRSC). 
 
He has presented regularly on drug development and drug delivery. He has authored 17 book chapters, 133 publications, 14 posters, 18 webinars and given 138 national/international presentations. He has co-edited two books on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities and on ICH Quality Guidelines.

Read Abstract...

Confirmed presentation title:  "Setting specifications in the early development phases (phase I/II)"

Abstract:  

Introduction
Specification expectations for Marketed products
Specification expectations for Phase I/II
Specific tests
Likely specifications for Phase II
Tech Transfer and Scale Up
Conclusions

Speaker Profiles - Biologics Stream

Dr Ulrich Rümenapp, Head of Launch Preparation and Co-ordination, Biological Development ,
Bayer AG
Read Profile...

Dr. Rümenapp is based in Wuppertal, Germany and working within the Biological Development organization of Bayer AG, where he is responsible for the transfer of Bayer’s pipeline candidates (antibodies and antibody-drug-conjugates) to external manufacturing partners and regulatory submission and launch preparations.

Prior to working in Development, Dr. Rümenapp was Head of Biotech Projects in Product Supply Biotech at Bayer, where he was responsible for contract manufacturing partnerships in the field of biotechnological drug substances and drug products and interdisciplinary project management with the goal to ensure market supply.

Before it was acquired by Bayer, Dr. Rümenapp hold a similar position at Schering AG, and before that, he worked in the Production & Logistics department of Schering, where he was responsible for production aspects of in- and out-licensing deals, due diligences, and product acquisitions of small molecule products and biologics.

Dr. Rümenapp studied chemistry and holds a Ph.D. in biosciences. He worked several years in academic research in the field of signal transduction and as an assistant teacher in the field of general pharmacology.

Today, Dr. Rümenapp area of expertise is the set-up and management of external relationships for the development and supply of bio-pharmaceutical products. He has more than 15 years of experience in the bio-pharmaceutical industry.

To correspond with Dr. Rümenapp, please contact him at ulrich.ruemenapp@bayer.com.

Read Abstract...

Confirmed presentation title: Outsourcing late stage CMC development and bio-manufacturing for fast track projects with accelerated timeline – the challenges and needs.  Ensuring your external collaboration is fit for purpose.

Outline

  • Drivers for accelerated CMC development
  • Pathways open for expedited regulatory review and approval
  • Considerations for CMC development and regulatory submission
  • Challenges & risks
  • Example case

Abstract

Accelerated programs to expedite the development and approval of innovative drugs for indications of high unmet medical need (supported by e.g. Breakthrough Therapy Designation of US FDA or the EMA Priority Medicines, PRIME scheme) raise numerous challenges to CMC developers and manufacturers incl. their outsourcing partners.  Common goal of the pharmaceutical / biotech industry, patients and regulatory health authorities is early access for patients to these drugs – of course with product quality and compliance uncompromised, and with sustainable supply.  CMC development incl. any outsourcing and technology transfer needs to keep pace with much faster clinical development, causing the need for a well thought through development plan and strategy towards initial submission and for life-cycle management.  In the presentation, the drivers, approaches and risks & mitigations related to such accelerated projects, esp. when outsourcing bio-manufacturing, will be reviewed.

Dr Vincent Turula, Director, External Supply Biotherapeutics,
Pfizer
Read Profile...

Vincent Turula is currently in the Portfolio & Project Management, External Supply and Outsourcing function in the Pfizer Biotherapeutics pharmaceutical sciences organization. Responsibilities include the establishment and management of strategic vendor relationships for the production of clinical trial drug substance and drug product for antibody drug conjugates (ADCs), monoclonal antibodies, adjuvants, vaccines, nanoparticle drug delivery and general Biotherapeutics. In this role he oversees CMO technical evaluations and audits, management of contracts, technology transfer and business relationships.  Additional accountabilities concern evaluating the manufacture of potential in licensed biological therapeutics assets.  

Prior to this role and while in the Wyeth Vaccine Development organization he led a group of scientists responsible for the generation of in process, release and stability assays as well as executed product characterization in support of regulatory filings (IND/BLA). Vaccines included the Prevenar franchise, meningococcal serogroup B (Trumenba) and Staphylococcal aureus vaccines. He has also worked at Baxter International, North American Vaccine and Bristol Myers Squibb in similar capacities.

Vincent has a Ph.D. in chemistry from the University of Georgia, MBA Biosciences Management from North Carolina State University and Bachelors of Science from the College of New Jersey.

Read Abstract...

Confirmed presentation title:  CMO considerations and technology transfer in support of a dynamic biologics portfolio

Abstract:  Pfizer possesses a diverse biologics portfolio with sustained growth from both internal discovery efforts as well as from business development activity.   Acquisitions, in-licensing of individual assets or innovative technology platforms enables Pfizer to supplement its pipeline, but places burden onto the CMC development organization which is responsible for internalization and adaption of new technologies.  In most cases, this must be done quickly to maintain timelines and progress clinical trials.  In such a dynamic situation, Pfizer has become adept at the intake process and has enhanced its absorptive capacity.   Critical to successful intake, during due diligence, External Supply (aka Outsourcing) makes an evaluation of the reliability of manufacture and controls at the asset’s contractor(s).  The evaluation includes analysis of outsourcing effectiveness, testing, and importantly process maturity in preparation for technology transfer.   A judicious risk-based process has evolved that allows decisions to be made, such as whether to fully internalize, proceed in a collaboration or alliance, versus allowing current manufacturing and testing to continue.  We will discuss representative case studies of the internalization and technology transfer of biological therapeutics at various stages of clinical development, from preclinical, up to and including late stage, post-proof of concept.

Prof Rolf Werner, Professor for Industrial Biotech,
University of Tübingen
Read Profile...

Prof. Dr. Dr. Rolf G. Werner is Honorary Senator of University of Tuebingen and teaching Industrial Biotechnology. After his promotion at University Tuebingen he spent more than 3 years in academia at Max Planck Institute for Molecular Genetics, Berlin, Germany and Massachusetts Institute for Technology, Cambridge, USA and has more than 35 years experiences in industry at Boehringer Ingelheim in top leading positions. He was responsible for the development and registration of the first, genetically engineered, protein therapeutic from mammalian cell culture: tissue plasminogen activator for myocardial infarction and stroke. More than 20 therapeutic proteins and monoclonal antibodies have been developed, manufactured and regulatory approved under his responsibility. Under his supervision, processes for viral therapeutics and vaccines have been developed. He is consulting biopharmaceutical, viral therapeutic and vaccine companies in Europe and Asia in all aspects of research and production technologies. His achievements are recognized by the Prize of the City of Vienna, Austria, for outstanding scientific work as well as from the Hangzhou Government, China, as Hangzhou Qian Jiang Distinguished Expert in Biotechnology.

Read Abstract...

Confirmed presentation title:  Manufacturability of viral therapeutics - an emerging field for CDMOs

Abstract:  Advanced Therapeutic Medical Products (ATMP) are emerging to the market. The first ATMP’s have been approved, a number of ATMP’s are under regulatory review, clinical trials and early stage development. In most cases the innovative research organization developing ATMP’s, has no GMP facility, vaccine manufacturer have no sophisticated downstream processing required for highly purified ATMP’s, the biotech industry, mainly involved in therapeutic antibody manufacturing, don’t like viruses in the plant and shareholders would like to avoid financial investment risk. As a result acquisition or outsourcing are the solutions.


Selection criteria for CDMO’s for manufacturing of viral vectors for ATMP’s should be amongst others: Track record in virology for handling a broad spectrum of viruses and viral vectors, representative panel of adherent and suspension host cells for viral propagation, high throughput media screening for cell growth, transfection and high titer virus production, MVB/WVB and MCB/WCB establishment and characterization, fermentation technologies for adherent and suspension culture, harvest technologies based on centrifugation, filtration and acoustic wave as well as DSP with affinity chromatography, AIEX, CIEX and sterile filtration. Stabilizing formulations should be provided to allow stability for liquid or freeze dried drug product of more than 24 month. A qualified spectrum of analytical methods should addressing purity, empty and full capsides, aggregates, HCP HCD and efficiency. The plant should operate under BSL 2-3, cGMP in adequate scale for clinical and commercial material. A one stop shop is preferred. Labor Dr. Merk & Kollegen can provide such services.

Dr Andreas Herrmann, CEO,
Valerius Biopharma
Read Profile...

Dr. Andreas Herrmann has 25 years of experience in biopharmaceutical and biosimilar development.

From 2013-2016, Dr. Herrmann built up Alvotech, a leading biosimilars company based in Iceland with a four product pipeline and 14,000 sqm manufacturing plant and made two successful acquisitions and other strategic initiatives.

Between 2003-2013, Dr. Herrmann (co-)founded seven different biotech companies including Celonic (CMO), Baliopharm (innovator company for autoimmune diseases, oncology), Synimmune (bispecific antibodies, oncology), ICAAN (Aesthetic Navigation), Icelandic Natura (Topica), and Probiocon (Consulting).

In 1996, Dr. Herrmann co-founded Cardion AG where he was heading the R&D department
until 2003.

He received his PhD in biochemistry in the field of neurobiology at the University of Cologne and worked as an associate professor in the department of cardiovascular physiology at the University of Düsseldorf (1995-1997).

Read Abstract...

Confirmed presentation title:  "Implementing an effective manufacturing strategy for biosimilars"

Dr Aiala Lorente-Trigos , CMC Manager,
Novimmune
Read Profile...

Aiala Lorente-Trigos is CMC Manager at Novimmune, a biopharmaceutical company based in Geneva (Switzerland) and dedicated to the discovery and development of therapeutic monoclonal antibodies against immune related diseases and cancer. She joined the company in 2012, after 8 years of experience as research scientist in the cancer research field.  As CMC Manager in the Bioprocess R&D department, she has been responsible for the coordination of the internal CMC activities of different projects in the pipeline as well as the management of the outsourced activities. These include cell line, process and assay development, drug substance and drug product manufacture, quality control, stability studies and IMP release to support preclinical and clinical studies.

 

Read Abstract...

Confirmed presentation title:  "Preparing for potential commercialisation: managing fill and finish process validation in collaboration with your CMO partner"

Abstract:  Novimmune is a company dedicated to the discovery and development of therapeutic monoclonal antibodies against immune related diseases and cancer. For one monoclonal antibody product, Novimmune has recently undertook process validation activities in partnership with a fill & finish manufacturer.  This presentation will share our experience and lessons learned in order to manage process validation activities as well when performing such complex activities in partnership with a CMO. 

Dr Einar Jonsbu, Director Biopharmaceutical CMC Development,
Targovax
Read Profile...

Einar Jonsbu holds the position Director Biopharmaceutical CMC Development in Targovax and have been in the company since January 2016. Einar Jonsbu has a PhD in Biotechnology and has been working in several biotech and pharma companies within biopharmaceutical development and manufacturing throughout the last 20 years.

Read Abstract...

Confirmed  presentation title: "Small virtual biotech company: CMC outsourcing for antigen-specific cancer immunotherapy"

Dr Jo Vercammen, Director Operational Excellence,
Eurofins Amatsi
Read Profile...

Dr Jo Vercammen is Director Operational Excellence at Eurofins Amatsigroup (CDMO) with extensive knowledge on formulation development of biologics. He is responsible for helping clients with the early formulation development of their compound and making development plans.

Before joining Eurofins Amatsigroup, Jo gained experience at Ablynx in the discovery and CMC department. He contributed to the pre-formulation and formulation platform of the company by setting up different screening tools.

Background & Experience:
since 2018 Director Operational Excellence at Eurofins Amatsigroup (Ghent, Belgium)
2016-2017: Biopharmaceutical Development Manager at Amatsigroup (Ghent, Belgium)
2013-2016: Analytical Sciences Manager at SEPS Pharma (Ghent, Belgium)
2009-2013: CMC Teamleader at Ablynx (Ghent, Belgium)
2007-2009: Screening discovery teamleader at Ablynx (Ghent, Belgium)
2004-2007: PostDoc at KULeuven on Fluorescence Correlation spectroscopy in living cells
1999-2004: PhD in Biochemistry (KULeuven, Belgium)
https://www.linkedin.com/in/jo-vercammen-8b5a465

Read Abstract...

Confirmed presentation title:  "Formulation and development of biologics for oral drug delivery"

Abstract:  Although oral delivery is still the most preferred route of administration due to the ease of administration and high patient compliance, the number of marketed biopharmaceuticals for oral intake is still limited. An observation that is especially attributed to the poor absorption and stability of biomacromolecules across the GI tract. Consequently, the bioavailability of biologics after oral intake is often low. To date, pharmaceutical companies have generally preferred parenteral administration of biopharmaceuticals over the oral one. As biopharmaceuticals are gaining increasing attention as future medicines for numerous unmet medical needs, oral administration of biologics poses a major challenge for the pharmaceutical industry. Also, the need for future microbiome therapeutics will require oral or topical delivery of these products. Hence, by applying the same technologies used for small molecules, development of solid formulations for biologics can be achieved. During this talk, we will highlight the advantages or disadvantages as well as the restrictions of oral delivery for biologics. Furthermore, different formulation strategies for a wide variety of biologics will be presented. Both, the protective mechanisms (pH and time dependent coating or microbially triggered systems) and the analysis of the resulting formulations will be discussed.

Professor Rolf G Werner, Professor Industrial Biotechnology,
University of Tübingen
Read Profile...

Prof Dr Rolf G Werner is Honorary Senator of University of Tuebingen and teaching Industrial Biotechnology. After his promotion at University Tuebingen he spent more than 3 years in academia at Max Planck Institute for Molecular Genetics, Berlin, Germany and Massachusetts Institute for Technology, Cambridge, USA and has more than 35 years experiences in industry at Boehringer Ingelheim in top leading positions. He was responsible for the development and registration of the first, genetically engineered, protein therapeutic from mammalian cell culture: tissue plasminogen activator for myocardial infarction and stroke. More than 20 therapeutic proteins and monoclonal antibodies have been developed, manufactured and regulatory approved under his responsibility. Under his supervision, processes for viral therapeutics and vaccines have been developed. He is Chairman of the Sunshine Guojian Advisory Board and is consulting biopharmaceutical, viral therapeutic and vaccine companies in Europe and Asia in all aspects of research and production technologies. His achievements are recognized by the Prize of the City of Vienna, Austria, for outstanding scientific work as well as from the Hangzhou Government, China, as Hangzhou Qian Jiang Distinguished Expert in Biotechnology.

Read Abstract...

Confirmed 10-minute presentation title:  "3 S Guojian an integrated global player and leading CDMO for biologics"

Abstract:  Sunshine Guojian, a member of 3SBio Group, is an integrated global CDMO headquartered in Shanghai, China with comprehensive geographical coverage in Europe and North America and well established commercial manufacturing sites. For process development a full value chain from cell line development, media optimization, scale up to 300 L in SSB and 200 L SUB, DSP with proprietary low cost protein A, AIEX and CIEX chromatography, formulation and fill & finish for preclinical and clinical trial material including glycoprotein analytical characterization.

For commercial GMP manufacturing a total capacity of 38,000 L with different suites of 2x2,500 L and 6x5,000 L wv Sartorius and Bioengineering bioreactors are in operation with corresponding downstream processing from GE Healthcare and Merck-Millipore. For fill & finish, filling lines from Bausch & Strobel, IMA Life and Optima with up to 300 2R vial per minute and 4,500 PFS per hour as well a lyophilization capacity with up to 15m2 are available. A broad spectrum of analytical methods from SDS page to LC-MS/MS is applied for determination of quality, potency, biosimilarity and safety of the produced biologics for the release testing.

In addition to biologics, the site in North America, Therapure, also provide plasma fractionation for therapeutic proteins. Sirton in Italy support fill & finish services for European customers.

Mrs Elise Mous, Director Sales & Marketing/Business Development,
Capua Bioservices
Read Profile...

Elise Mous joined Capua BioServices in 2015 as Director Sales & Marketing / Business Development to further strengthen and develop Capua BioServices’ positioning as a microbial CDMO. She started her career at DSM in 2004, followed by Patheon in 2014 and during the past 8 years build up international business development experience in the field of custom research, development and manufacturing services. Elise holds a MSc degree in Managerial Sciences next to a BSc degree in Chemistry/Biotechnology.

Read Abstract...

Confirmed presentation title:  "Recent examples in outsourcing of microbial process development and manufacturing"

Abstract:  Capua BioServices is a global provider of services for microbial custom development and manufacturing for the Pharma and Food industry. Microbial fermentation has its opportunities and challenges for biopharmaceutical manufacturing: from lab to pilot to commercial scale. During this short presentation, Capua BioServices would like to highlight recent successes from outsourcing of microbial projects.

Dr Nripen Singh, Associate Director, Manufacturing Sciences and Technology,
Bristol-Myers Squibb
Read Profile...

Nripen is an Associate Director in Manufacturing Sciences and Technology group within Global Product Supply organization in Cruiserath, Ireland at Bristol-Myers Squibb. He leads a team of downstream scientists to provide process improvements and identify new technologies for current and next generation products. Nripen first joined BMS in 2014 and led process development, characterization, technology transfer and commercial support work of mid to late stage biologics within Biologics Development Organization in Devens, MA. Nripen was also responsible for developing next generation manufacturing platform using concepts of continuous processing to increase specific productivity. Prior to joining BMS, Nripen worked for Merck Millipore for 5 years where he led a team of engineers for the development of chromatography and clarification products, including resins, depth filters, and membrane filters for protein purification.

Nripen received his B.S. from Panjab University in 2002, and his PhD from the Clemson University in 2007, both in Chemical Engineering. He has co-authored over 30 publications, book chapters and patents. He is in the editorial board of mAbs Journal and serves as the guest editor for Current Opinion in Biotechnology and reviewer for several top-tier journals.

Read Abstract...

Presentation title:  "Integration of hybrid models for next generation manufacturing of biologics into clinical and commercial facilities"

Pearl Fong, Senior Vice-president,
Mycenax
Read Profile...

Pearl has worked over 15 years in the biotechnology industries to serve both operating and consulting roles for more than 30 biomedical projects. As Director of Project development, she operates in CMC, project management, project oversight, regulatory consulting and business development fields.  Pearl’s educational credentials include a Bachelor of Nutrition and Health Science and a Master in Molecular Biology and Biotechnology. She has brought the very first biological medicinal product from preclinical to NDA approval in Taiwan.

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Confirmed presentation title:  "A cutting-edge improvement for biologics manufacturing."

Prof. Dr. Tudor Arvinte, Chairman & CEO,
Therapeomics Inc/University of Geneva
Read Profile...

Tudor Arvinte studied physics at University of Jassy, Romania, and received his Ph.D. in biophysics from University of Düsseldorf, Germany. He held numerous research positions in Europe and the USA at: Max-Planck Institute, Germany; C.N.R.S., France; Cornell University, New York; Texas A&M University; Ciba-Geigy U.K., Novartis, Switzerland. T. Arvinte worked with more than 200 biopharmaceuticals, three of his formulations reached the market, has over 90 publications and 15 patents. He is Titular Professor at Geneva University and CEO of Therapeomic, Inc. Basel Switzerland, a contract research biotech company focused on the characterization and formulation of biopharmaceuticals.

Read Abstract...

Confirmed presentation title:  "Importance of formulation and orthogonal methods for the success of new protein drugs and biosimilars"

Dr Ray Sexton, Business Development Manager Biopharma,
Solvias
Read Profile...

Dr Sexton is a Biopharma Sales manager for the Swiss Contract research organisation, Solvias AG, specialising in the analysis of biotherapeutics such as Monoclonal antibodies and their biosimilars. Based in the UK Ray has over 20 years’ experience in Biopharmaceuticals, spending many years at BioReliance (now Merck KGa) in Key Account roles developing customised Biosafety testing solutions for clients throughout UK, Ireland & Scandinavia.

Solvias Biopharma performs a wide range of Protein characterisation, Comparability, Stability and Method Development & Validation studies. For over 20 years Solvias has supported a wide range of clients including major global players, virtual companies and contract manufacturing organisations collecting an enviable level of experience and expertise along the way. Drop by booth 39 to learn more about the Solvias Solution.

Read Abstract...

Confirmed presentation title:  "Deliver products faster with the Solvias solution"

Abstract: The pressure to produce robust analytical data increases year on year. Ever increasing Regulatory & Industry expectations alongside a growing pipeline of Monoclonal and Biosimilar candidates places huge demands on CMC control strategies.

The Solvias Solution consistently delivers successful Protein characterisation, Stability and Comparability studies. The Solvias solution comprises a centralised Analytical laboratory stocked with all necessary techniques, industry Expert support and professional Project Management. This unique hub concept means all analysis is performed in-house under the same Quality system, thus allowing optimal laboratory scheduling to deliver the fastest possible outcome. Project management ensures communication excellence while a team of experts are on hand to address all your study design, troubleshooting and data interpretation needs.

Dr Márcio Temtem, Director, PD & Pharmaceutical Development,
Hovione
Read Profile...

Joined Hovione in 2008 and has been since involved in the development of the Particle Design and Drug Product Business of the company. In the role of a scientist, group Leader or manager, Marcio has been involved in the development of multiple commercial and late stage programs in the field of solubility enhancement, particularly in the area of amorphous solid dispersions by spray drying, taste masking by spray congealing, microfluidization assisted processes and jet milling.

Márcio is currently Director, PD & Pharmaceutical Development at Hovione leading the R&D efforts in the field of particle engineering, oral solid dosage forms and inhalation.

Márcio is PhD in Chemical Engineering with several papers and patents published in topics such as Green Chemistry, Controlled Release, Inhalation, Drug Product, Particle Engineering and Solubility enhancement.

Read Abstract...

Confirmed presentation title:  "Spray drying - a viable alternative to biopharmaceuticals"

Dr Marcus Mreyen, Director Business Development,
Protagen Protein Services GmbH, Germany
Read Profile...

Marcus Mreyen is an expert for peptide and protein analytics with a focus on mass spectrometric techniques. He holds a PhD in chemistry and spent two years in Australia where he worked in the protein analytical field at Macquarie University and at the Australian Proteome Analysis Facility (APAF). Starting at Protagen in 2000 he successfully worked as a Project Manager and supported multiple customer projects in the various fields of protein characterization. He transferred and deepened his technical understanding during a time working for Shimadzu, one of the worldwide leading analytical instrument providers, as a Product Manager for Mass Spectrometry and Life Science products. During this time he assist customers in pharma and biotech in Europe and Russia, before returning to Protagen Protein Services as a Director for Business Development.

Since then he has given support for a large variety of international companies in their Biosimilar or NBE developments from early phases of development to Phase 3 as well as to GMP release and stability testing.

Read Abstract...

Confirmed presentation title:  "Process-related impurities – how to control host cell proteins"

Dr Jogi Amit, Associate Director, Head, Biologics Manufacturing Operation,
Syngene International Ltd
Read Profile...

Jogi Amit is an Associate Director at Syngene International Ltd and heads Biologics Manufacturing Operation. He has been in industry over 17 years in contract research and manufacturing OF biopharmaceutical products, evolved by leading roles in upstream development, Manufacturing Science And Technology (MSAT) and Manufacturing Operations. He has been with Syngene last 9 years and led manufacturing operations to obtain European Union GMP certification. He has experienced more than 25 molecules (proteins and mAbs) in development programs and more than 15 molecules in manufacturing for different phase of clinical supply. Prior to Syngene, he has worked at Magene Life Sciences, Claris Life Sciences and Cadila Healthcare ltd. By training a Bioprocess technologist, Amit has pursued Ph.D in Microbiology and author of many publications and a book chapter.

Read Abstract...

Confirmed presentation title:  "Biopharma manufacturing facility design and operations, integrated with advanced analytics; from a CMO perspective"

Dr Ravi Krovidi, Lead Investigator, Biologics,
Syngene International
Read Profile...

Roles and responsibilities: Head Advanced Analytics

Education: Ph. D. in Mass Spectrometry and Proteomics – Max Planck institute, Germany

Industrial Experience: 16 years of industrial experience (USA, India)

Relevant Experience:
Led teams in creating biosimilarity assessment sections of dossiers for several biosimilars
Expertise in advanced protein analytics as per ICH Q6B guidelines, scientific partnering from early inception to completion
Expertise in developing and validating client specific methods
Published and presented at various Indian and international conferences

Read Abstract...

Confirmed presentation title:  "Role of advanced analytics - mass spectrometry in Monoclonal Antibody (mAb) stability assessment"

Dr Carole Mainguet, Senior Site Manager,
F.Hoffmann-La Roche Ltd
Read Profile...
Dr Carole Mainguet, Senior Site Manager, F.Hoffmann-La Roche Ltd
 
Experience: After an internship at Sanofi, I joined Novartis Biotech center in Huningue (France) in 2001. I worked there 7 years on the implementation of a commercial product + several tech transfers for PhIII clinical supply. Then I moved to Sandoz (Slovenia) for 2 year in order to support another tech transfer. Last experience before Roche is Merck-Serono (Vevey-Switzerland) 2 years in production as process engineer to support the continuous improvement of one commercial line, as part of the lean production systems implementation.
Current experience: I joined F. Hoffmann-La Roche 5 years ago as CMO manager in development activities. My role is to support the selection/Implementation activities at CMOs as well as project management, to supply the clinical phases 1 to 3.

Speaker Profiles - Session Chair

Dr Alain Bernard, Director,
Independent Biopharma Advisor
Read Profile...

Dr Alain Bernard is an independent consultant, general manager of ABConsulting. He was formerly Vice-President, Biopharmaceutical Process Sciences at UCB, overseeing process developments for new chemical and new biological entities as well as for life-cycle management of marketed products. He joined UCB in 2006, from Serono where he was Director of Process Development.  He had joined Serono in 1998 and was formerly responsible for the biotechnology department in the R&D function. Prior to that move, he had been working at the Glaxo-Wellcome Institute of Molecular Biology. He holds a PhD in biochemical engineering and worked both in the US and Europe on process/product development and reactor design for a variety of biotechnological processes. He has authored or co-authored many publications in biotechnology.

Read Abstract...

Chairman of Technical operations outsourcing - early phase module, CMC Outsourcing Biologics track

Dr Guido Koch, COO,
Topadur Pharma AG
Read Profile...

Dr Guido Koch holds the position of the COO at Topadur Pharma AG, a Swiss Biotech company focusing on the discovery and development of innovative medication for the treatment of severe wounds. Until January 2018, Guido was a Director in Global Discovery Chemistry at Novartis Institutes for Biomedical Research in Basel. The focus of his research team was to enable challenging chemistry and apply innovative synthesis design for fast and high quality lead optimization. In this role he was a member of the Global Discovery Chemistry leadership team. During his career at Novartis in different functions, Guido has contributed to drug discovery and development in different phases starting from target ID up to early clinical trials in man. In addition, Guido has been responsible for building and maintaining the Global Discovery Chemistry University relations network in Europe. Guido received his Diploma in Chemistry and Biochemistry from ETH Zürich in 1991 and a PhD in Chemistry from the University of Basel in 1996. After a postdoc at California Institute of Technology he joined Novartis in 1997 in Process R&D before moving into drug discovery chemistry in 2001.

Read Abstract...

Session chair of Outsourcing process and strategy module

Dr Sergio Lociuro, CSO,
BioVersys AG
Read Profile...

Sergio received his Laurea degree in Chemistry at the University of Rome, Italy in 1981 and, after a two-year postdoctoral fellowship at the Italian Research National Countil, he moved t o UNB, Canada, where he received his Ph.D in 1987. In the same year he started his career in the pharmaceutical industry as a medicinal chemist.  In his almost 30 years experience in major pharmaceutical companies and SMEs, Sergio has held positions such as Director of Medicinal Chemistry and International Project Leader in GSK, Head of Peptide Epitope Mimetics in Polyphor Ltd and Head of Research and Scientific Communication in Arpida AG and has been part of the Board of Directors of Arpida A/S. Founder of THOT consulting Sagl, a Swiss consulting firm providing services in the Research and Development of anti-infectives and pharmaceutical drugs in general, he has lately held the position of CSO in C10 Pharma and Adenium Biotech, two Scandinavian biotech companies. His background spans from early drug discovery to late preclinical development. He has conducted Phase I clinical studies, participated in late clinical studies and in discussions with both the US FDA and EMA.

Read Abstract...

Session chair of the Technical operations outsourcing - target ID and validation to hit identification module

Dr Rudolf Hausmann, VP Technical Development & Operations,
Santhera Pharmaceuticals
Read Profile...

Rudolf Hausmann, originally from Kiel Germany, studied Pharmacy before his Ph.D. in Immunology. He has also a degree in Pharmaceutical Medicine from Basel University.

His career in the Pharmaceutical Industry started at Hoffmann La-Roche in Basel/Switzerland and he held different positions in Galenical Production, Formulation Development and Project Leadership. He worked on numerous development projects from pre-Phase-I up to launch.

2005 he started at Santhera Pharmaceuticals, a Biotech company near Basel, Switzerland, which is focussed on Development and Commercialization of new medicines against Neuromuscular Diseases. In his position as Head Technical Development & Operations he is responsible for Technical Development from Phase-I to Phase-III and commercial manufacturing & supply. He is also involved BD&L activities and has additional responsibilities as Project Leader.

Read Abstract...

Session chair of Outsourcing case studies - contract giver and contract acceptor showcase of effective outsourcing case studies module

Dr Brian Cox, Professor of Chemistry, and Director,
University of Sussex, and Photodiversity
Read Profile...

Brian has had a highly successful career in drug discovery in industry with GSK and Novartis. Brian has a BSc in Pharmacy and PhD from the University of Manchester where he worked on novel antifungal agents. This was followed by Post Doctoral study at the University looking at novel opioid-like analgesics, then a two-year industrial Post Doctoral position at Schering Plough in New Jersey focussed on the total synthesis of the marine natural products Pseudopterosins.

Brian then spent 12 years at Glaxo/GlaxoWellcome/GSK working in many different disease areas (CNS, respiratory, cardiovascular, GI and antibacterials). Moving to Novartis (Horsham) in 2002 he became Head of Chemistry with the site specialising in respiratory and GI research, as well as acting as an expertise hub for automated synthesis for the Novartis chemistry organisation (Global Discovery Chemistry). He developed a keen interest in the modulation of ion channels as a target class and the design of inhaled medicines, which he is now a recognised expert in.

Brian moved to the University of Sussex (November 2014), where he is now Professor of Pharmaceutical Chemistry growing a medicinal chemistry platform underpinned by extensive automated synthesis capability. His group’s focus is the application of high throughput automated synthesis in hit and lead optimisation and the synthesis of novel archive diversity enhancement libraries. Along with Professor Kevin Booker-Milburn, he is co-founder and co-director of Photodiversity Ltd, a start-up company from the Universities of Sussex and Bristol which specialises in the use of Photochemistry to produce novel sp3 rich fragment and diversity libraries for screening against Pharmaceutical and agrochemical biological targets.

He is a Fellow of the Royal Pharmaceutical Society of Great Britain and registered pharmacist, Fellow of the Royal Society of Chemistry, chartered Chemist and chartered scientist. He is a member of the Royal Society of Chemistry’s Chemistry organic and Medicinal Chemistry Sector committee. He is associated with a number of marketed compounds and multiple late stage clinical candidates and is a champion of diversity and inclusion (D&I).

Read Abstract...

Session chair of the Technical operations outsourcing – lead generation to lead optimization module

Dr Alexander Bausch, CEO, Founder,
Strekin AG
Read Profile...

In August 2014 I founded and lead Strekin as CEO. Strekin is a Biotech company developing drugs in the area of stress related pathways after a scientific cross disease area assessment in new indications.

Since January 2013 I am working as independent consultant supporting Venture Capital Funds in investment decisions as well as small biotech companies in strategic drug development/business plan questions. I can build on more 20 years experience in pharmaceutical research, development, and strategic marketing with more than 10 years as cross functional project leader. In this time I successfully led projects from phase 00 to phase 3 in several indications.

Prior to this role I gained 10 years experience in technical research and technical project leadership finally as head of solid dosage Form development at Hoffmann La Roche in Basel. I have expertise in formulation research, aerosol development, as well as powder technology.

Read Abstract...

Session chair of Technical operations outsourcing – late phase module

Dr Matthew Konneh, Director,
Konnsult Life Sciences Ltd.
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Matthew is founder and Lead Consultant of  Konnsult Lifescience Ltd, a UK based consultancy providing strategic and business development services to preclinical pharmacology and early clinical development CROs, and enables accelerated access to niche service providers for the global pharma-biotech industry. Matthew is based in London and has worked in in pre-clinical pharmacology (Novartis), clinical research ( Parexel, Biotrial) and strategic consultancy (Accenture) in the pharma industry for the past 20 years. He holds a PhD inPharmacology and an MBA. 

Dr Laura Millichamp , Consultant, Regulatory & CMC,
Independent Consultant
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Dr Laura Millichamp is the Founder of InsideReg, a Swiss Regulatory Affairs Consultancy specialising in CMC and regulatory strategy.

Laura has a PhD in hydrogels, and started her career with over 7 years experience as a Pharmaceutical Assessor at the MHRA. This position gives her a unique insight into the workings of the European Regulatory Authorities, gained through her assessment of Marketing Authorisation and variation applications submitted through all procedures (Centralised, DCP, MRP, National). She worked on all product types, across many therapeutic areas, and has provided scientific advice on behalf of the MHRA and CHMP. Laura also has direct experience of presentation at UK Expert Committees (CHM and CPS), and successful influencing within both Regulatory Agencies and the Pharmaceutical Industry.

Following the MHRA, Laura moved to PAREXEL International as a Senior Consultant, and later VCLS as a Director of CMC, where she advised companies of all sizes: from start ups to top ten pharma, and at all stages of product development: from proof of concept to post-marketing activities.

Dr Paul Madeley, Managing Director,
Synth-Isis Ltd
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Paul Madeley, Ph.D., is an organic chemist with over thirty years’ experience of chemical synthesis. He has worked for three large companies (Boots, Courtaulds and Abbott Laboratories) and two biotech companies (British Biotech and OSI Pharmaceuticals) before setting up his consultancy company, Synth-Isis Ltd. Dr. Madeley has worked on over one hundred projects, comprising more than six hundred individual reaction steps; at scales ranging from a few grams to several metric tonnes.

In 1995, having worked as a pilot plant manager for five years with Abbott Laboratories, Dr. Madeley moved to virtual pharma and has been responsible for outsourcing more than two hundred manufacturing contracts. This involved development of template agreements and site visits for technical appraisal of potential manufacturers. He has visited more than fifty manufacturing sites in Europe and the US. He has acted as the CMC technical lead for a number of due diligence meetings on behalf of clients on more than twenty occasions; in which he presented the technical package for the API to potential investors. He has also undertaken due diligence examinations of potential in-licensing opportunities. Since setting up Synth-Isis Ltd in 2004, Dr. Madeley has worked with over twenty small biotech and emerging pharma companies, together with a number of service companies, and has prepared the chemistry sections of seventeen IMPDs and three INDs. This has included technical oversight of manufacture of the APIs.

Duncan Judd, CEO,
Awridian Ltd
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Duncan is an enthusiastic and accomplished medicinal chemist with extensive outsourcing experience, a 40-year proven track record with a Blue-Chip Pharmaceutical Company, and is the founder of Awridian Ltd.

Duncan has made significant contributions to numerous drug discovery projects, and is cited on many patents and publications including research areas such as prostaglandin agonists, histamine H2, opioids, angiotensin II and CCR3 receptor antagonists. He has been pivotal numerous lead generation projects gaining a unique insight into project and compound tractability. He has extensive outsourcing experience including projects to enhance screening collections, where he engaged with external partners to design, and synthesise appropriate compounds in a cost effective and timely manner. Duncan has recently published and presented on Open Innovation in Drug Discovery for which he is a strong advocate. He was a founder member of the DiscoverAssist™ Panel at the Stevenage Bioscience Catalyst.

Duncan formed his consultancy company (Awridian Ltd) in 2012, and is currently working with a range of international companies and UK academics.

Dr Chris Hill, Executive Director of Chemistry & DMPK in Early Discovery,
Charles River Laboratories
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Christopher Hill is currently Head of Chemistry & DMPK in Early Discovery at Charles River. Prior to that he ran his own consulting company after retiring from Merck, where he was VP and Head of Discovery Chemistry. Earlier responsibilities at Merck included Global Chemistry Head and Site Head at Rahway, Site Head at Kenilworth, NJ and Site Head at Boston. Before moving to the US, he was Site Head at Schering-Plough's Newhouse facility in Scotland (2007-2010).

Earlier roles included Senior Vice President and Site Director for Organon Research, Executive Director of Medicinal Chemistry at Organon and Director of Chemistry at Roche. Chris received his BSc in chemistry from the University of Manchester and his PhD from the University of Manchester Institute of Science and Technology. He undertook postdoctoral research in synthetic methodology at the CNRS, Gif-sur-Yvette, France before joining the medicinal chemistry department at Roche in 1985.

Dr Amer Alghabban, Managing Director,
GXP Compliance & Training Partners Limited
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Amer Alghabban joined Karyopharm in August 2015 as Vice President, GxP Quality Assurance, Compliance and Training, bringing with him over 25 years of experience in the pharmaceutical industry. Prior to joining Karyopharm, he was the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies and academic institutions to achieve compliance with GCP, GVP and GLP. Prior to that, he was Director, Global Head of Quality Assurance & Audit Management at Merck Serono.​ Earlier in his career, Mr. Alghabban was the Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK. He has an innovative methodology is​ ​recognized internationally as evidenced by the fact that he is an invited speaker at over 74​ ​ international conferences and academic institutions world-wide.

Dr Karlheinz Landauer, Managing Director,
Quality Biotech Development & Cells
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Dr Karlheinz Landauer is an expert in Biotechnology with a PhD and an MSc title in Applied Microbiology with 15+ years of work experience. He has specialized on cell line engineering, up-stream process development, scale-up and tech transfer strategies, GMP operations and was a program manager of an NBE (=new biological entity).

After his PhD in the field of animal cell culture medium development, he took several jobs in the above-mentioned fields with increasing responsibilities, when in 2011 he eventually was Head Manufacturing and COO at Celonic AG in Basel.

In 2016, he has founded his own company QBDC, with its core focus on consultancy for biotech companies in CMC matters, process development, tech transfer & scale-up, facility layout & design, project management, and QM & QA.

At QBDC, he is driving the company towards high quality standards and problem-solving communication strategies. For QBDC’s customers, he is an easily accessible, goal-oriented technical solution provider.

 

  • 05/2017 to date: Managing Director, Quality Operations Saudi Biotechnology Manufacturing Company, Riyadh, Kingdom of Saudi Arabia
  • 01/2016 to date: Managing Director at QBDC GmbH, Nusshof, Switzerland.
  • 12/2007 to 12/2015: Director R&D, in 01/2011 promoted to COO and Head Manufacturing at Celonic AG, Basel, Switzerland.
  • 11/2006 to 10/2007: Assistant Senior Manager at Celltrion Inc, Incheon, South Korea.
  • 12/2002 to 06/2006: Post-Doc, later Deputy Head of Manufacturing, eventually promoted to Head Manufacturing at Igeneon, Krebs-Immunotherapie Research and Development GmbH, Vienna, Austria.

Speaker Profiles - Plenary

Dr Jeremy Parker, Principal Scientist, New Modalities and Tissue Targeting,
AstraZeneca
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Jeremy Parker obtained a Chemistry BSc from Imperial College, then moved to the University of Oxford, completing a DPhil with Professor Sir Jack Baldwin. After a brief period with Laporte Fine Chemicals at Southampton, he joined AstraZeneca in 1999.  He has held numerous roles in Process Chemistry, Analytical Chemistry and External Sourcing including Team Manager Roles within Process Chemistry and Analytical Chemistry.  He is currently AstraZeneca’s Principal Scientist for New Modalities and Tissue Targeting, leading the chemistry activities on the development and commercialisation a range of new therapeutic modalities including Antibody Drug Conjugates, Dendrimer Drug Conjugates and Polymer Drug Conjugates.  His interests include contemporary synthetic methodology, route selection, linker chemistry and the synthesis of a wide range of New Therapeutic Modalities.

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Confirmed presentation title: "Making magic bullets:  development and manufacture of antibody-drug conjugates"

The preparation of Antibody Drug Conjugates (ADCs) presents significant challenges, requiring the preparation of specific antibodies and cytotoxic small-molecule payloads; conjugation of the two species and finally fill-finish.  These projects pose significant development and manufacturing challenges, and typically require close collaboration with a range of CMOs.  This talk presents key learning obtained by AstraZeneca/MedImmune in their ADC program which includes a Biparatopic HER2-Targeting Antibody Drug Conjugate currently in Phase I clinical trials.

Richard Pompe, Director Global Outsourcing CMC,
Ipsen
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Richard has worked in the pharmaceutical industry for 20+ years working for a number of Pharmaceutical companies as a CRO. He holds a BSc in Neuroscience and an MBA as well as is MCIPS certified. He has been working in purchasing and strategic outsourcing since 2005 including developing and driving global procurement strategies for both direct and in direct categories as well as implementing various tactical, preferred provider, functional/tactical partner alliances with responsibilities for strategic supplier implementation, delivery of budgetary savings and oversight and operational delivery. He currently heads up Direct Purchasing at Ipsen.

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Confirmed joint presentation title (with Anita Bugajewska):  "Integrating a CDMO strategy in complex manufacturing environment"

Lidia Cappellina, Head of R&D Outsourcing Management,
Chiesi Farmaceutici SpA
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Lidia is the Head of Outsourcing Management for Chiesi Corporate R&D. She has 23 years’ experience in the pharmaceutical industry, started in 1992 in GSK Italy where she covered the role of Head of Licensing and License Management Department  and subsequently she become the Head of Procurement. She moved in Astra Zeneca Italy in 2003 with the role of Strategic Business Development & Planning Director, and joined Chiesi with the current role in 2009. Lidia has an extensive business development, commercial and procurement / outsourcing areas experience, with in-depth knowledge of large and medium pharma commercial and R&D processes and needs, and consolidated skills in outsourcing and business development strategies, asset evaluation & prioritisation, deal making, alliance management, P&L optimisation processes, at affiliate and corporate level.

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Confirmed presentation title:  "Analyze from a methodological perspective SAP “purchase to pay” cycle in CMC R&D for continuous improvement purposes"

Joint presentation with Massimo Giossi, In/Outsourcing Governance and Neo & Special Care Technical Leadership Head.

Massimo Giossi, In/Outsourcing Governance and Neo & Special Care Technical Leadership Head,
Chiesi Farmaceutici SpA
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Massimo is the Head of CMC Operations for Chiesi Group. He has 30 years’ experience in the pharmaceutical industry, started in 1988 in Chiesi S.p.A. where he covered the roles of Pharmacology Scientist. He moved to Project Management in 2007  assuming the role of Project Managers Director in 2008. In 2010 he joined  Chemistry Manufacturing and Control where he took the direction of Technical Project Leaders and Budget and Purchase Administration. Currently he is in charge of Operations Department  leading  Logistic and GMP Documentation Management and Resource management.  Massimo  graduated in Pharmacy with a specialization in Molecular Pharmacology.

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Confirmed presentation title:  "Analyze from a methodological perspective SAP “purchase to pay” cycle in CMC R&D for continuous improvement purposes"

Joint presentation with Lidia Cappellina, Head of R&D Outsourcing Management, Chiesi Farmaceutici SpA

Sean Ramsden, Director, Business Management,
Patheon
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Sean Ramsden is a Director of Business Management for Thermo Fisher Scientific.  Sean is based at the Swindon, UK site, which specializes in designing, building and validating novel processes in bespoke ‘condo’ manufacturing suites.  

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Confirmed presentation title:  "From complexity to flexibility: manufacturing unique drug products"

Abstract:  

Drug development and commercialization continues to be challenging, often resulting in increased pressure on budgets and timelines. In addition the growth of complex product formulations and manufacturing processes increasingly requires unique solutions. The ‘Condominium’ model provides a runway from development to commercialization for complex products. Building a facility for a standard process has challenges, however building for a complex process requires special expertise and experience to meet the challenges head on to create robust processes, reduce overall cost and ensure important new products are available to patients.

Dr Xiaona Jing, Director Global CMC & Pharmaceutical Development,
NBE-Therapeutics Ltd
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Xiaona Jing is experienced in managing biopharmaceutical CMC development projects from early clinical to the commercial stage, at small and large international pharmaceutical companies, with focus on innovative oncology products such as antibody and ADC.

She is currently heading the CMC and Pharmaceutical Development of NBE-Therapeutics, a Basel based biotech focusing on next-generation ADC, which is based on three key technology platforms enabling ADC development: (i) antibody discovery Transpo-mAbTM Display technology, (ii) site-specific toxin payload conjugation by sortase enzymes (SMAC-technology), and (iii) ultra-potent, anthracycline-based toxin platform

The current focus is to establish and optimize the GMP manufacturing platform, to enable the clinical validation of NBE's novel ADC technology in lead program, to build the global supply chain for Tox and phase I and beyond.

Previously, Xiaona was leading early phase pharmaceutical development and drug product manufacturing in Genmab. Afterward, she was working on late to commercial phase biologics development & supplies in Roche, while she was also engaged in China Regulatory Policy External Interactions Steering Committee to support China strategic initiatives.

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Provisional presentation title:  "Can enzymes make the magic in manufacturing the magic bullet?"

Dr Edith Norrant, Researcher, Innovations Technology Sciences,
Université Libre de Bruxelles
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Having a PhD at ENSIC-CNRS (Nancy) and HDR at Toulouse University, in Chemical Engineering, I worked for 7 years as National Researcher in CNRS. I developed new tools to study the Three phase Gas/liquid/Solid industrial reactors. Then I worked in different private companies Rhône Poulenc, Rhodia, Pierre Fabre and UCB Biopharma
In these different companies, I managed research up to the Industrialization for chemical and pharmaceutical compounds I supported manufacturing plants over the world (France, UK, USA, Brazil, Argentina)
During this period, I introduced new technologies such as microwave, photoreactions, electro-synthesis, micro- mixing, CPC, PAT, new continuous dryer, and new continuous chemistry process at laboratory scale and on industrial plants. Since 2009, I am Innovation/Technology/Sciences Director at UCB Biopharma, in order to introduce new methodology, new technology for the development and the industrialization of all new chemical and biological pharmaceutical process (DS, DP, Analytical methods), and to introduce innovation in existing manufacturing plants with the support of academia.

Since Feb 2018, I am researcher at ULB (University Libre of Brussels) in order to create the start-up LEGOMEDIC, a company which will supply innovative tools with operating conditions to develop continuous & mobile chemical and biological process for biopharmaceutical companies.

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Confirmed presentation title:  "The pharmaceutical world of tomorrow: how to get a personalized medication … only by innovative solutions in technology and by innovative way of working"

Abstract:  Due to regulatory constraints and business, it is important to develop innovative solutions:

- by taking account all the evolution of new technology (AI/ML, Genetic therapies, …

- by working differently, that means we must work in a multidisciplinary team composed with experts over the world… from academia and private companies…

 

LEGOMEDIC project has been created and started in Jan 2013. The team was composed with 7 universities in different countries with 4 private companies: the objective was to develop continuous & mobile chemical and biological process. We have developed a holistic approach, that means to design new equipment with optimization of operating conditions to get a full continuous flexible process to manufacture new API (chemical and biological compounds) from raw material, in safety way, at high quality, at low cost (Huge Reduction of OPEX and CAPEX).

Results after 5 years: It has been submitted 8 patents during the last 2 years and 3 patents must be submitted during this year.

During this period, we have developed a full continuous process to manufacture Brivaracetam, an antiepileptic drug. It has been increased the global yield by 2 with a huge reduction of cost between the batch process and the continuous process. For example, one of the steps, takes 3 days in batch process, and can be reduced to 30mn in continuous process.

Acronym of LEGOMEDIC :

In French:  Les   Générations Outils Milli/micro Equipements pour le   Développement et Industrialisation de Composés Chimiques/Biologiques.

In English:The LEap Generation of tOols Milli/micro   Equipment for the Development and Industrialization

Alina Bugajewska-Waller, Specialist, BioProcess Sciences Project Co-ordinator,
Ipsen
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After graduating in 2005 with MSc degree in Biotechnology from Adam Mickiewicz University in Poznań, Poland, Alina started her career as a researcher at ProImmune Ltd., an innovative immunology based company, before moving to an exciting position within pharmaceutical industry at Ipsen Biopharm Ltd in 2013. Alina initially worked with high potency molecules as part of the biopharmaceutical programme before moving from benchwork to leading external projects within the Biologics Pharmaceutical Development department.

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Confirmed joint presentation title (with Richard Pompe):  "Integrating a CDMO strategy in complex manufacturing environment"

Elmar Zurbriggen, Executive VP, Head Biopharma,
Solvias AG
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Elmar Zurbriggen is Executive Vice President and Head of Biopharmaceuticals.

He started his career at Lonza Biotech in controlling, moving to roles with increasing responsibility in operations and sales & marketing located in the Czech republic, the US and Switzerland. In 2001 Elmar moved into Medical Technology (Orthopaedics) starting with Stratec Medical, followed by Synthes and up until recently with Johnson & Johnson. He was member of various European and Global Management Boards and held senior roles in Product & Market Development as well as Sales & Marketing.

Elmar has a degree in Biotechnology from the ETH in Zurich and a business degree from the HSG in St. Gallen, Switzerland.

Neil Jones, Director Business Development Europe, Oral Drug Delivery,
Catalent Pharma Solutions
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After graduating for the University of Bristol, with a degree in Chemistry, Neil joined Sigma-Aldrich as a Production and Development Chemist, working on the production of synthetic organic compounds.

In 1998 he joined Hoechst Marion Roussel as a Scientific Officer in their QC laboratory and was responsible for leading a team testing and relasing API and starting materials for the manufacture of a wide variety of different Pharmaceutical dosage forms.

Following acquisition of the Swindon facility by Patheon, Neil moved through various roles, with increasing seniority, in Production, Production Management, Business Services, Marketing and Sales, finishing his time at Patheon as the Senior Director of Business Management for the five European finished product facilities.

In November 2016 Neil joined Catalent Pharma Solutions, with responsibility for the European Sales team responsible for Development and Analytical Services.

Neil’s current role is Director of Business Development Europe, managing a team selling Catalent’s Oral Drug Delivery technologies and capabilities.

Neil is based in the UK, close to Catalent’s Zydis® Orally Dissolving Tablet Technology Facility in Swindon.

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