17–18 NovemberManchester, UK

Programme

Programme

Introducing the BOS Manchester 2020 Programme

The scope of BOS Manchester 2020 will be pharmaceutical Discovery Outsourcing and pharmaceutical CMC outsourcing (primarily development phase). Both small molecules and biologics are included in this scope. To reflect this focus area and consistent with 2019 the programme will include 3 work streams as follows:
Track 1 will focus on Discovery Outsourcing; Track 2 will focus on Small Molecule CMC Outsourcing; Track 3 will focus on Biologics CMC Outsourcing.

Within these 3 work streams we will look to encompass the following themes and topics: Outsourcing Business Process, to encompass the procurement element of your role: Technical Operations, to explore the technical elements of outsourcing discovery R&D, Drug Substance Outsourcing, Analytical Development Outsourcing, Drug Product Outsourcing for Biologics and Small Molecules: Outsourcing Case Studies, building on the Technical Operations sessions, demonstrating outsourcing approaches to real life scenarios: Poster Presentations, to support your Technology and Services Scouting, the objective of these sessions is to showcase new technologies and services shaping the industry.

Our programme for 2020 will be published later this year, in the interim please find details of our programme from our 2019 event (BOS Basel 2019).

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Day 1 - 19th June 2019

Time Discovery Outsourcing
08:00 - 09:00 Registration & Partnering
09:00 - 10:30 Outsourcing Process & Strategy
Chair: Dr Hayley Binch, Head of Medicinal Chemistry, F. Hoffmann-La Roche Ltd
09:00
Drug discovery: collaborations between CROs and the pharmaceutical industry
Dr Vicky Steadman, Business Line Leader - Integrated Drug Discovery

Drug discovery: Collaborations between CROs and the Pharmaceutical Industry

The role of CROs in supporting the drug discovery industry has evolved from providing pairs of hands to carry out certain simple pre-designated tasks to provide solutions to customer’s challenges and now are evolving further to provide innovation in the form of project ideas. Collaborative partnerships on integrated drug discovery projects are now common in the drug discovery landscape. This presentation will cover the advantages of outsourcing, business models, integrated outsourcing vs using many specialist providers, trends in the outsourcing environment and strategic alliances between CROs.

photo of Dr Vicky Steadman
About the speaker

Vicky carried out a PhD and post-doc in total synthesis of macrocyclic natural products at Cambridge University with Prof Ian Paterson and at U Penn with Prof Amos B. Smith, III. Her industrial career initiated at Merck (Terling’s Park) working on neuroscience targets. She then moved to GlaxoSmithKline (Harlow) focussing on anti-infectives and anti-inflammatories. Upon joining Selcia in 2008, she rose from Senior Scientist to Director of Discovery. Upon Selcia’s acquisition by Eurofins in 2017, she has become general manager of Eurofins Discovery and additionally taken on a global role as Business Line Leader of Integrated Drug Discovery Services at Eurofins Discovery. Vicky has a strong track record in innovative medicinal chemistry, and has delivered multiple pre-clinical candidates for customers. She is named on around 30 papers and patents and is a Fellow of the Royal Society of Chemistry.

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09:30
Confirmed title: On-boarding new technologies into existing discovery outsourcing partnerships
Dr Christoph Rosenbohm, Head of Discovery Ops

Dr. Christoph Rosenbohm will speak about the opportunities and challenges encountered when a “mature” technology in a well-established CMO partnership needs to change. New compounds that need to be made as custom manufacturing are entering the partnership and the established compounds LNA phosphoramidites are becoming commodities with other vendors entering into the supplier landscape.

photo of Dr Christoph Rosenbohm
About the speaker

Head of Discovery Operations, RNA Molecule Research (RMR) Pharma Research and Early Discovery (pRED) Roche Innovation Center Copenhagen (RICC)

As Head of Discovery Operations, RMR Christoph is responsible for leading the Oligonucleotides synthesis, Pharmacology, and Screening Operations teams and as a member of the RMR-LT he participates in defining and setting the strategy for RMR.

Christoph holds a Master of Science and a Ph.D. in Organic Chemistry from the University of Southern Denmark (the lab of Prof. Jesper Wengel - one of the inventors of LNA). After his PhD, Christoph worked as a post-doctoral fellow at the Danish Technical Univerisity. In addition Christoph holds an executive MBA in Technology, Market and Organisation from Copenhagen Business School.

Christoph started his biotech career in Cureon as chemist with the task of synthesizing the LNA monomers. The company was later merged with Pantheco A/S to create Santaris Pharma A/S in 2003, where he become group leader for the chemistry team. Later the group was joined with CMC, Bioinformatics, PK and Pharmacolgy to form the Research Operation Department for which he became the director. A position he held until the acquisition by Roche in 2014.

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10:00
Confirmed title: Effective supplier relationship development through the Supplier Relationship Mapping
Alessandro Fazio, Non Clinical Outsourcing Manager

Effective Supplier Relationship development though the Supplier Relationship Mapping.

Supplier Relationship Mapping is a process involving a number of different tools and techniques, that can provide Pharma R&D with competitive advantages through the analysis, management and leverage of their relationships with R&D service providers. Both Pharma R&D and Outsourcing departments should develop a structured understanding of the status quo, deeply investigating the nature of current relationships that exist within and between Pharma R&D organizations and their service providers.

Supplier Relationship Mapping relies on five core concepts: (i) Balance of power; (ii) Supplier preferencing; (iii) Supplier constituency mapping; (iv) Reverse marketing; (v) Relationship management. Supplier Relationship Mapping should be run together with Portfolio Analysis, a tool to help Pharma R&D identifying appropriate strategic options and tactical actions based on two of the most critical aspects of R&D services’ market: (a) Market difficulty/risk, and (b) Relative value/profit impact.

The combination of understanding Pharma R&D position from service providers’ viewpoint and understanding service providers’ position vis à vis the marketplace, enhances Pharma R&D strategic decision-making process, thus leading to a well-chosen outsourcing approach

photo of Alessandro Fazio
About the speaker

Alessandro Fazio works as R&D Outsourcing Manager (Non-Clinical) at Chiesi Farmaceutici Spa since 2017 (Parma, Italy). He is mainly responsible for managing the outsourcing activities within the Preclinical area (drug discovery, medicinal chemistry, toxicology, pharmacology and DMPK) and the CMC area for biologics (protein, enzyme and cell culture). Alessandro holds a PhD in Systems Biology from the Technical University of Denmark and he worked as Optimization Scientist for enzyme production at Novozymes A/S and as Innovation Project Manager for Commercial Development at Chr Hansen A/S (both positions in Copenhagen, Denmark).

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10:30 - 11:00 Coffee & Partnering
11:00 - 12:00 BOS Events Poster
Chair: Duncan Judd, CEO, Awridian
11:00
Confirmed title: Non-clinical in vitro ADME Tox services by SOLVO - transporters and more
Roelof de Wilde, Director of Sales

About the speaker

Roelof de Wilde received his MSc degree in Molecular Biology and Biotechnology from the University of Groningen, the Netherlands. He started his professional career as Study Director at SOLVO Biotechnology, Budapest, Hungary, where his main responsibilities were conducting contract-based research in the lab on drug - membrane transporter interactions. Following this, from 2012 to 2016 he served clients in North-American territory as Study Manager, during which he was responsible for close to 200 contract research studies. During this period he also designed a series of data analysis and interpretation templates, to streamline internal data processing as well as helped implementing new techniques to study transporter interactions in SOLVO’s labs (hepatocyte uptake and B-clear® assays). In 2016 his responsibilities increased in a new role as Head of the North-American team, moving into a more business oriented position. After a short transition period as Head of the European team he was promoted to Director of Sales in the end of 2017, becoming responsible for both the European and Asian-Pacific business development. Backed up by his strong technical background and experience working with clients in the pharmaceutical industry globally, he is currently managing a team of several Study- and Account Managers.

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11:10
Fast track in drug discovery
Dr. Thomas Fessard, CEO

photo of Dr. Thomas Fessard
About the speaker

Thomas studied chemistry in France (ENSC, Montpellier) and the UK (UMIST, Manchester) and obtained a PhD degree from the university of Nottingham, UK.

After research appointments at the School of Pharmacy in Nottingham and ETH Zürich, Thomas joined Lipideon Biotechnology AG in 2007. As Head of the Drug Discovery and Chemistry, he lead a multi-disciplinary team that discovered a candidate for pre-clinical investigation (Non-Systemic Cholesterol Absorption Inhibitor).

In 2011, Thomas co-founded SpiroChem AG, Swiss fine chemicals company and serves as CEO of the company.

Thomas has several years of experience in the management of R&D projects, including medicinal chemistry, design of innovative building blocks for drug discovery and development of new process routes.

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11:20
The development of a set of novel small molecule inhibitors of the Kv1.3 ion channel
Dr Robert Kirby, Head of CRO Services

About the speaker

Dr Robert Kirby, Head of CRO Services, will be substituting Andy Southan.

Andy has over 25 years’ experience in life science research, including 14 years in the CRO sector. In 1991 he received his PhD in Pharmacology from the University of London (UK), investigating the effects of anaesthetics and high pressure on CNS potassium channels. Following a move to industry Andy worked as a brain slice electrophysiologist supporting ion channel-based CNS programmes at Wyeth (UK), before moving to Imperial College London where he published the first patch-clamp recordings from cerebellar inhibitory nerve terminals. At CeNeS Pharmaceuticals he performed CRO services (hERG, nAChR) and internal research on HCN and two-pore channels. He subsequently established the electrophysiology laboratory for Ionix Pharmaceuticals, a company focused on identifying novel pain therapeutics, where he worked on Nav, Cav and mechanosenstive ion channels. Before joining Metrion, Andy spent 12 years in leadership roles at BioFocus and Charles River managing stand-alone projects, multi-year collaborations and fully integrated drug discovery programmes.

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11:30
Artificial intelligence applied to biotech
Dr Fred Jordan, CEO

AlpVision is providing solutions based on Artificial Intelligence to improve every aspects of research in biotech. For instance, we are currently working on following topics:

- Prediction of chemical reactions yields for the synthesis of small molecules.

- Prediction of performance of medical devices

- Automatic analysis of microscope images, in particular for cell culture (confluence, counting, etc)

About the speaker

Dr. Fred Jordan is co-founder of AlpVision and has served as CEO since June 2001. He is the author of numerous scientific publications and patents. Dr. Jordan has work experience in the United States and in France. In 1999, he received his PhD from the Swiss Technology Institute (EPFL) - Signal Processing Institute (ITS) in Lausanne.





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11:40
Capture Compound Mass Spectrometry®: on- and off-target deconvolution
Dr Tammy Ladduwahetty, Group Leader

Capture Compound Mass Spectrometry (CCMS) is an unbiased, proteome-wide approach for the identification of specific-binding protein targets for small molecules and peptides. The technology combines medicinal chemistry and in vitro pharmacology, coupled to high resolution proteomics mass spectrometry to isolate and identify target proteins that are responsible for an observed biological response. This technology can be used in a variety of contexts from target de-convolution and drug re-purposing to identification of off-target activities. Example case studies where CCMS technology have been used in-house are presented. The first involves target deconvolution for hits from a phenotypic assay and the second illustrates the use of CCMS to determine the hepatotoxicity causing off-target of the catechol-O-methyl transferase (COMT) inhibitor tolcapone.

About the speaker

Tammy Ladduwahetty is a Group Leader in Medicinal Chemistry at the Charles River Early Discovery site in the UK. During her >10 years at Charles River she has led medicinal chemistry and library design teams and worked on a number of target classes including GPCRs, ion channels, kinases and nuclear hormone receptors. She has experience in a range of therapeutic areas from CNS disease to antimalarials. After obtaining her Ph.D. from the University of Pennsylvania and spending a post-doctoral year at Cambridge University, Tammy joined Merck Sharp and Dohme in the UK. During her eighteen year career there she was a key contributor to a number of clinical candidates, including the NK1 antagonist Emend which is on the market for CINV. She is the co-author of over 60 patents and papers.

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11:50
Digitalisation of research outsourcing - driving faster science
Mr Tom Dexter, VP Europe

Digitalisation of business processes and drug development is a trend that will not be going away anytime soon. See how the worlds best pharma and Biotech companies have transformationally digitalised their research outsourcing processes and gain great insight into the art of the possible. Current outsourcing processes are laborious and antiquated (think Blockbuster Video). Now see how you can turn your research outsourcing into simple, fast, on-demand services....BE MORE NETFLIX

photo of Mr Tom Dexter
About the speaker

Tom has spent 20 years in strategic procurement roles in various large corporations. He has been with Scientist.com since 2017, but his connection to the company goes back more than 5 years, when he was leading the AstraZeneca Global Research Procurement team. At AstraZeneca, Tom led the strategic development and successful implementation of digitalisation strategy involving the Scientist.com marketplace across the global business. His current role is to develop new customer relationships and support partners in their strategic program development by leveraging his years of industry experience. Tom holds a MSc in Global Supply Chain Management from Southampton University.

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12:00 - 13:30 Lunch & Partnering
13:30 - 15:30 Technical Operations Outsourcing – Target ID & Validation to Hit Identification.
13:30
Discovery of new targets for rare diseases - developing new therapies to cure ALS
Dr Inez de Greef-van der Sandt, CEO, Treeway & Partner, 3D-PharmXchange

Inez de Greef, CEO, will speak about the discovery pipeline of Treeway. Inez will speak about the long history of GDNF and how Treeway is developing an AAV5-GDNF gene therapy for the indication ALS. In addition, she will present Project Mine, a genetic research project to identify new ALS targets and Treeway’s current target validation programme.

photo of Dr Inez de Greef-van der Sandt
About the speaker

Inez is a pharmaceutical professional with extensive experience within the pharma and biotech industry. In-depth knowledge of the different elements of drug development and the interfaces between them. As partner and co-founder of 3D-PharmXchange she is responsible for the strategy and management of 3D-PharmXchange. In 2013 she was appointed as CEO for our client Treeway, a biotechnology company with a mission to develop therapies to cure ALS.

Her interests are in the strategic aspects and the valuation of drug and companion diagnostic development projects, as well as the potential for collaboration and synergy in this development space between big pharma and smaller biotech companies. She has a passion for driving results that truly impact critical decisions through leadership and/or participation in multidisciplinary efforts at the interface between science and business.

Prior to founding 3D-PharmXchange, she was Director Clinical Development and Chief Operating Officer of Kinesis Pharma. She also worked for several years as consultant and project manager on clinical and PK-PD projects in several therapeutic areas.

At Tibotec-Virco, she managed the clinical pharmacology program for their successfully approved HIV protease inhibitor Prezistra and follow-up compounds. At Leiden Advanced Experts on PK and PD (LAP&P) she was responsible for modeling & simulation projects and project management.

Inez studied Medical Biology at the University of Amsterdam, The Netherlands, and obtained her PhD at the department of Pharmacology from the LACDR at Leiden University, The Netherlands.

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14:00
Confirmed title: Innovation in hit and lead identification at AstraZeneca
Dr Garry Pairaudeau, Head of Hit Discovery

photo of Dr Garry Pairaudeau
About the speaker

Garry Pairaudeauis currently Head of Hit Discovery at AstraZeneca; the group comprising HTS, Comp Chem, Virtual screening and DEL is responsible for generating high quality starting points for AstraZeneca. In addition, the group works extensively with academic centres of excellence through open innovation and strategic collaborations with groups such as MRC, CRUK, Life Arc and many others to help support academic drug discovery.

Garry also chairs the Global Chemistry Leadership team in AstraZeneca responsible for chemistry strategy and has been particularly active in building Automation and Machine learning capabilities in addition to continuing to lead AZ Discovery chemistry outsourcing.



Garry obtained his PhD in chemistry from the University of Southampton in 1991, followed by post-doctoral work at UC Irvine California. He joined AstraZeneca in 1994 as a medicinal chemist and was part of the chemistry team that discovered Brilinta. He has experience leading projects through all phases of Drug Discovery contributing to multiple clinical candidates in the respiratory, inflammation and CV areas. He has a long standing interest in lead generation, hit identification and diversity screening. Prior to taking up his current position in 2012 he was Director of Chemistry for the cardiovascular group at Alderley Park.

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14:30
Developing and implementing collaborative strategies in discovery to harness innovation
Dr Silvia Fonquerna, Head of Research Alliances

photo of Dr Silvia Fonquerna
About the speaker

PhD from University of Barcelona and Post-doc at University of Sheffield with Prof V. Aggarwal.

Joined Almirall in 1998 as a member of the starting Combinatorial Chemistry Group. From 2000 to 2008 worked as chemistry program leader working on a variety of targets including GPCRs, enzymes, chemokines and ion channels in the Respiratory therapeutic area. Since 2009 promoted to Medicinal Chemistry Head of Section and Inhalation Team Leader of a multidisciplinary group devoted to the design of inhaled drugs. Since 2015 involved in Idea Generation Groups for developing incremental innovation and repositioning projects.

Worked in several strategic collaborative programs and in 2018 promoted to Head of Research Alliances of a group responsible for running collaborations with other Biotechs, CROs and academic groups, obtain public funding and coordinate open innovation initiatives.

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15:00
How to fast-track healthcare innovation in the Basel region.
Dr Leonildo Delgado, Manager, Innovation & Sourcing

photo of Dr Leonildo Delgado
About the speaker

Dr. Delgado joined BaseLaunch in 2018 as Manager Innovation & Sourcing. He is responsible for scouting early-stage therapeutic innovation across continental Europe and also for supporting portfolio companies in important operational activities such as: de-risking science, team building, fundraising and connecting to Pharma and Venture Capital investors.

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15:15
Expanding the target space for drug discovery: target identification and validation at Evotec
Dr Eberhard Krauss, Group Leader

About the speaker

Dr. Eberhard Krauß is Group Leader in the In Vitro Biology department at the Evotec site in Toulouse, France, overseeing a number of internal and external projects in oncology as well as various technology platforms such as ex vivo culture, single cell RNAseq, CRISPR and high-content imaging. One of his current responsibilities is leadership of several target identification and validation activities. In 2014, Eberhard co-founded and implemented VIB Discovery Sciences enabling to translate basic research outcomes into early drug discovery programmes. Previously, he has been supporting scientists and teams during various positions in industry (Tibotec/Janssen) and academia in technology selection, target identification & validation, development particularly of physiologically more relevant cell-based assays, screening, and drug discovery (oncology, infectious diseases, CNS). In 2003-2008, he was setting-up and heading the central high-content screening labs at the Max Planck Institute in Dresden, Germany. Before, he held responsible positions for 6 years in biotech industry at Cenix BioScience (Germany) and Cyclacel (Scotland, UK) dealing with RNA interference (RNAi) and drug discovery, respectively.

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15:30 - 16:00 Coffee & Partnering
16:00 - 17:30 Outsourcing Case Studies
Chair: Prof. Dr. Brian Cox, Professor of Pharmaceutical Chemistry. Co-Director and Co-Founder , Sussex University & Photodiversity Ltd
16:00
Discovery and development of Bicycles, a brand new class of chemically synthesised medicines and the role played by CROs
Dr Paul Beswick, Director of UK Chemistry & IP



photo of Dr Paul Beswick
About the speaker

PhD from Imperial College. Joined Glaxo in 1984 and stayed until 2009 worked on a variety of targets including ion channels, GPCRs, nuclear receptors and enzymes. During the GSK era worked in the Neurology area as a department head in Medicinal Chemistry largely focussed on pain programmes.

Left GSK in 2008 and joined Almirall in Barcelona as Head of Chemistry where the focus was on respiratory projects and inhaled delivery and in 2013 returned to the UK to join the Drug Discovery Group at the University of Sussex with the responsibility of developing collaborations with both academic groups and industry and raised 12.5M in funding to support the group’s activities.

Started working with Bicycle in 2016 as a consultant while still at Sussex and joined as Director of Chemistry in October 2018

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16:20
Confirmed title: Pushing the boundaries of biology: utilising an external research network to develop new assays for malaria drug discovery
Dr Brice Campo, Director, Discovery Department

photo of Dr Brice Campo
About the speaker

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.



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16:40
Confirmed title: Medicinal chemistry on the way to new frontiers – from "do it all yourself" to a highly integrated mode of action
Dr Werngard Czechtizky, Senior Director, Head Medicinal Chemistry, IMED RIA

photo of Dr Werngard Czechtizky
About the speaker

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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17:00
Early form screening strategies to accelerate candidate selection
Professor Chris Frampton, JM Scientific Adviser

photo of Professor Chris Frampton
About the speaker

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

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17:30 - 19:30 Drinks Reception
Time Discovery Outsourcing
08:00 - 09:00 Registration & Partnering
09:00 - 10:30 Outsourcing Process & Strategy
Chair: Dr Anna Matranga, Business Consultant, AMC Alliances & Consulting SASU
09:00
Choosing the right CMOs: models for strategic sourcing, outsourcing and selection of CMOs.
Filipe Duarte, Senior Category Manager

photo of Filipe Duarte
About the speaker

Filipe Duarte joined Novo Nordisk in 2017 as Senior Category Manager in Strategic Sourcing. His background in organic chemistry (PhD from Nova University of Lisbon) and R&D experience supports him on the selection and management of CMOs for commercial production of biologic APIs, intermediates and complex materials. He is also responsible for implementing ethical sourcing standards in the supply chain.

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09:30
Building a robust, risk-based, supplier qualification process
Gabriele Sassi, Non Clinical Outsourcing Manager (CMC)

When companies began outsourcing and globalizing the supply chain in the 1980’s and 1990’s, they did so without understanding the risks suppliers posed. Companies have begun implementing vendor management systems to assess and mitigate vendor risks to the supply chain.

But how to address this to the management of R&D service providers?

An extensive Qualification Process developed by R&D Outsourcing Management of Chiesi Farmaceutici. The process is aimed to risk reduction/avoidance with external suppliers of Corporate R&D and is divided into specific clusters assessing business and financial aspects, technical capabilities, quality requirements including important criteria on a sustainable supply chain and procurement.

photo of Gabriele Sassi
About the speaker

Gabriele Sassi joined Chiesi Farmaceutici in 2010 and currently works as Non Clinical Outsourcing Manager in R&D Outsourcing Management, responsible for outsourcing R&D core activities for CMC such as Analytical Development, Clinical Trial Supplies and Drug Product / Drug Substance Manufacturing activities. Gabriele is mostly involved in establishing and managing the relationship with CROs and CMOs and the consequential contract management: this implies an intense knowledge of Procurement and Outsourcing processes that mainly refer to Supplier Selection and Qualification, Contract Awarding & Contract Management and Supplier Relationship Management. Gabriele has 9 years’ experience with procurement / outsourcing areas, starting his career in Procurement Department for Indirect Spend Categories (IT software, Laboratory Chemicals & Equipment).



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10:00
Confirmed title: CMO flexibility re-designed
Mr Felix Faupel, Head of Contract Manufacturing

Contract Manufacturing as a business is constantly evolving and there are several key factors to consider when partnering with a CMO. Firstly, clients look for CMO that shares their vision and passion, and therefore open and effective communications are crucial for success. Secondly, automation and digitalization are increasingly shaping this industry, and companies operating in the CMO arena need to demonstrate their capabilities together with their state-of-the-art technology to ensure quality and competitive pricing. However, competitive pricing alone is not enough; flexibility and a personalized customer approach are vital. Flexibility is not just about being able to change operations and adapt them when problems occur, it is about being proactive to consistently prevent problems while still being able to meet customer’s needs. This is why Acino Contract Manufacturing provides its customers with creative solutions that help them achieve their projects in a timely manner: by balancing both external and internal needs, being responsive, addressing concerns promptly, and ensuring transparency and trust. Finally, the best relationships are the easy ones, however they require work and we are happy to share our insights during our presentation.

About the speaker

Felix Faupel has been working with Acino for over 2 years, starting as Global Key Account Manager for Acino’s Contract Manufacturing business he was appointed as Associate Director of Contract Manufacturing in June 2018 and as Head of Contract Manufacturing in January 2019. In his role within Acino, Felix aims at reviving Acino’s Contract Manufacturing with new projects and customers, but also to shape the business with internal structural and process optimizations. Prior to his role at Acino, Felix was working as Business Development Manager in the pharma and medtech segment for the French consultancy Altran and as Business Development Manager for the API CMO Bachem. With his educational background in chemistry and business studies (University of Zurich), Felix developed a passion to reduce complexities that emerge within the interfaces of technical and commercial relationships in a B2B environment. With this goal in mind, flexibility as a CMO is only one aspect in a range of optimization possibilities a CMO can work on to develop their business further, but it is one of the most visible attributes pharma companies can detect easily. Felix will share his experience of the last two years with Acino and how an organization can be sharpened to work agile, flexible and thus customer satisfying.

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10:15
Selection, development and scale-up of sustainable manufacturing processes for active pharmaceutical ingredients.
Dr Peter Poechlauer, Innovation Manager, API

The synthesis routes employed in drug discovery to generate new pharmaceutical leads are designed for diversity, whereas the manufacturing processes of drug candidates chosen for development and launch have to be designed for efficiency, consistent product quality and to be sustainable. This may require modifications to the existing synthesis up to a redesign using advanced technologies in the fields of chemistry, process technology and analytics. The presentation will highlight criteria for synthesis route selection, process development and options to employ advanced technologies such as continuous manufacturing and online analytics to develop safe and sustainable manufacturing processes for high-quality products.

photo of Dr Peter Poechlauer
About the speaker

Dr Poechlauer joined the Thermo Fisher Scientific Linz site in 1990 and has more than 25 years of experience in pharmaceutical research and development. He has developed several large- scale biocatalytic processes for fine chemicals and led European research projects on biocatalysis and sustainable oxidation chemistry. In addition, he led process technology and introduced process intensification and microreactor technology in the company.

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10:30 - 11:00 Coffee & Partnering
11:00 - 12:00 BOS Outsourcing Showcase – Poster Presentations showcasing innovation and excellence in Small Molecule CMC Services & Technologies.
Chair: Dr David Elder, Principal Consultant, David P Elder Consulting
11:00
Development and manufacture of highly potent API drug products throughout the clinical phases
Mr Wesley Herridge, Senior Pharmaceutical Development Manager

About the speaker

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11:10
SK biotek Ireland: Current capabilities to develop, optimize and manufacture highly potent APIs
Mr Colm Duffy, R&D Products Portfolio Manager

About the speaker

Colm Duffy R&D Products Portfolio Manager SK biotek Ireland Colm joined the Swords Campus in 2013 as an R&D, progressing to R&D Team Lead in 2015 and Products Portfolio Manager in 2017. Colm has a PhD in Synthetic Organic Chemistry from University College Dublin and previously carried out post-Doctoral research for the Medical Research Council at the Laboratory of Molecular Biology in Cambridge. In his current role, Colm leads a team of chemists responsible for supporting commercial manufacture of existing products and supports the Marketing team by assessing new opportunities.

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11:20
Continuous technology improvement: key partnership to meet your outsourcing needs
Simone Manzini, Business Development Manager, Custom Synthesis

Procos S.p.A. is a CDMO active since 1945 and wholly owned by the multinational Japanese trading company CBC Co. Ltd. Group. The Company is focused to the development, scale-up and manufacturing of Active Pharmaceutical Ingredients (API’s) and has continuously expanded its technology portfolio in the last ten years in order to match customer needs. The approaches are mainly through business opportunity and customer partnership. The first case can be referred to the recent implementation of the High potent API facility. This cutting-edge new unit had been built up to respond to the current market needs and CDMO opportunities within the HPAPI field. The second approach is more peculiar to specific customer needs highlighting Procos approach on exclusive basis business that goes beyond the single project, going to establish partnerships. As showcase, an example will be presented following this last one, in which an established customer proposed flow chemistry project to Procos. That technology has not been available yet, at that time. In order to respond to this need, the new technology has been quickly implemented, according to the client direction and requirements, allowing the process success in the shortest time possible.

photo of Simone Manzini
About the speaker

Simone Manzini Joint Procos in 2016 and currently works as Business Development Manager, Custom Synthesis, taking care more than 15 projects as project manager, expanding company business and collaborations in US and Europe area and evaluating new technological opportunities to expand Procos capability portfolio. Graduated at University of Pavia in 2010, Simone obtained his PhD in organometallic chemistry and catalysis in 2014 at the University of Saint Andrews where, during that time, he has been awarded to JSPS fellowship for short time experience at University of Tokyo, followed by post-doctoral work in process chemistry at CaRLa, BASF and University of Heidelberg joint laboratory, before start working at Procos as process chemist and then, move to into the current role.

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11:30
An integrated drug development approach: accelerating the path from drug candidates to clinical trials
Dr Nathalie Huther, Business Development Manager Europe

There is a significant market need for an integrated drug development approach using a single site with an intensive technology focus. The Arcinova model ensures secure delivery of technically complex projects with a focus on velocity and scalability. Rapid delivery of high-quality results is a key differentiator and aligns with the emerging pharma fundraising model, focused on getting to first in human fast. A key focus is on continued investment in technology as enablers for the compression of delivery times. The talk will give an overview of Arcinova’s differentiating CDMO model, the rich site history and world class technical capability.

photo of Dr Nathalie Huther
About the speaker

Nathalie is responsible for European Sales and Business Development for Arcinova, a UK based CDMO. Nathalie holds BSc and MSc degrees in Chemistry from the University of Strasbourg (France) and a PhD in Organic Chemistry from the University of York. She started her career as a synthetic and process chemist in drug discovery and development. For the last 12 years, she has held various management positions in both tactical and strategic marketing and, more recently, in sales and business development, promoting services and products addressing the needs of the pharmaceutical and biotech markets in Europe, the Middle East and Africa. Previous employers include Sigma-Aldrich, Excelsyn, AstraZeneca and Pharmorphix (now owned by Johnson Matthey).

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11:40
Development and scale-up of continuous flow processes for the manufacture of active pharmaceutical ingredients
Dr Peter Poechlauer, Innovation Manager, API

photo of Dr Peter Poechlauer
About the speaker

Dr Poechlauer joined the Thermo Fisher Scientific Linz site in 1990 and has more than 25 years of experience in pharmaceutical research and development. He has developed several large- scale biocatalytic processes for fine chemicals and led European research projects on biocatalysis and sustainable oxidation chemistry. In addition, he led process technology and introduced process intensification and microreactor technology in the company.

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11:50
Rational design of enabling platforms: from API to amorphous solid dispersion based tablets
Dr Paulo Lino, Scientist

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About the speaker

Paulo Lino has a Master’s degree in Pharmaceutical Sciences by Universidade Lusófona, has completed a Ph.D in Pharmaceutical Technology at the Faculty of Pharmacy, Universidade de Lisboa and subsequently a Post-Doc between the same institution and Dr. von Hauner Children's Hospital at Ludwig-Maximilians-University spanning complex biopharmaceutical formulation/engineering, freeze-drying and particulate polymeric drug delivery systems. In 2017 Paulo joined Hovione at the Drug Product Development group as a Scientist and has been involved in projects that range Multivariate Formulation Screening and Development up to the Tech-transfer and Scale up of Solubility Enhancement and Particle Engineering projects aimed at developing Science Driven solutions towards the Drug Development challenge at hand.

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12:00 - 13:30 Lunch & Partnering
13:30 - 15:30 Technical Operations Outsourcing – Early Phase, Small Molecule
Chair: Dr Paul Madeley, CEO, Synth-Isis Ltd
13:30
Confirmed title: Lean delivery of a sulfoximine-based inverse RORyt agonist for topical administration
Dr Craig Harris, Scientific Advisor - API Synthesis & Chemical Development

As part of a continuous improvement program at Galderma, we have been exploring ways to accelerate DMTA (Design-Make-Test-Analyse) cycle times and deliver our project milestones more rapidly from lead generation into early development. As the Make part invariably takes the most time, we have been intensely focusing our efforts on how to be more efficient and reactive in drug discovery synthesis through better de-risking our route design and frontloading the synthesis process by streamlining our reagent sourcing through our CROs partnerships. This presentation highlights the actions we put in place for our RORyt target and focuses on the evolution of our route design from our first linear medicinal chemistry route to the optimized racemic route used to deliver 100 g quantities of our lead sulfoximine-based RORyt inverse agonist in a near seamless transition.

photo of Dr Craig Harris
About the speaker

Craig currently leads the discovery and development synthesis for Galderma, the pharmaceutical branch of Nestlé Skin Health, operating out of the offices of the Entre-Deux-Villes site, Switzerland. During his 6 years at Galderma, Craig drove both internal and external synthesis (CRO) teams to deliver 10 development candidates on a variety of targets linked to skin diseases such as psoriasis, acne, skin cancer, atopic dermatitis and in the aesthetic and corrective field on the Sophia Antipolis site in France. Prior to joining Galderma, Craig held a similar role at AstraZeneca, driving the synthesis for the Oncology iMed in Reims, France where he contributed to many discovery programs including 3 clinical candidates as well as to several continuous improvement projects.

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14:00
Confirmed title: Evolving a large pharma approach to externalisation for small molecule product development
Katrine Bonner, Key Account Director, Externalisation Centre of Excellence

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About the speaker

Katrine is a Key Account Director with Externalisation Centre of Excellence for Pharmaceutical Development & Supply at GSK. She has 25 years’ experience in the Pharmaceutical Industry, starting as Formulation Scientist at GSK, working within Project Management and Business Development roles for Contract Development Organisations providing small molecule Formulation, Analytical and Clinical trial supplies services. As well as a supplier of speciality excipients for modified release technologies and film coating where building and maintaining customer-supplier relationships and working as a product development partner was key to both customer and supplier business success. Returning to GSK in 2016 and leading the Technical team supporting the production of ViiV HIV and Novartis Oncology product portfolios at the Ware site for Global Product Supply before coming back to the realms of R&D outsourcing.

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14:30
Confirmed title: Pharmaceutical development pathways for poorly soluble small molecules and opportunities for CDMO innovation
Dr Alexandre Gil, Head of External Development - Small Molecules / Oral Delivery Platform

photo of Dr Alexandre Gil
About the speaker

Head of External Development - Small Molecules / Oral Delivery Platform

Expert in Pharmaceutical development with more than 15 years of experience in pharmaceutical sciences in a broad business area covering generic, OTC, veterinary and Rx with missions all along the value chain (from preclinical to launch). From 1999 to 2007 progressing from pharmaceutical research at Pierre Fabre (Consumer Health Care and prescription medicines), Ethypharm (Drug Delivery company) and Virbac (Animal Health).

Joined Sanofi in 2007 and since then have had increasing responsibilities within the pharmaceutical sciences department and recently moved in the Business Excellence organization of CMC in charge of the External Development department for Small Molecules / Oral Delivery Platform.

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15:00
The Importance of Understanding the Solid Form Landscape of an API During Early Product Development.
Mr Jonathan Loughrey, Head of Screening Services

During development, understanding the polymorphic landscape of an active pharmaceutical ingredient (API) is of utmost importance to ensure that the most stable form is reproducibly prepared and no batch-to-batch variability in solubility, dissolution rate, stability, crystallinity, or particle size is encountered. Water plays a key part in understanding the polymorphism of an API due to its presence in excipients, the atmosphere, or mode of administration. Within a product, water can prompt dissolution of soluble components, increase interactions between API and excipients, or induce API-specific phase transitions. Due to these risks, the impact of water should be fully understood in all aspects of drug development and manufacturing. Cambrex Edinburgh will present methods to locate and understand hydrated forms and describe the impact they have on downstream processing.

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About the speaker

Dr Jonathan Loughrey, Head of Screening Services, is based in Edinburgh and oversees the Solid Form Screening group who provide high quality polymorph, salt, co-crystal, and early crystallisation screening studies for a global client base. Jonathan’s career started at Abbott Life Sciences (The Netherlands) where he was a process solid form specialist. After obtaining a Ph.D. in Chemistry (University of Leeds) and numerous postdoctoral positions within the UK and USA, he joined Solid Form Solutions (now Cambrex) as a crystallisation scientist to develop scaleable process crystallisations for small molecules and peptides. Over the past five years, Jonathan has moved to oversee the Solid Form Screening group and now provides clear advice on solid form control for a given API during drug substance and drug product development

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15:15
A top class European partner for high potent APIs development and manufacturing from early phase to commercialization.
Mr Giorgio Bertolini, SVP R&D

Olon SpA has a rich technical heritage with highly skill researchers and engineers using modern technologies within qualified laboratories and assets.

From its HP APIs sites located in North Italy qualified by the most relevant worldwide Medicinal agencies and thank to multiple collaborations with best European institutes, OLON SpA is the right partner to provide value and top services to Pharmaceutical companies expecting an agile, versatile and affordable partner capable to bring their HP API to the highest standards on regulated markets in an optimized time frame with no compromise on quality.

photo of Mr Giorgio Bertolini
About the speaker

Giorgio Bertolini studied chemistry at University of Milan with a thesis on Stereoselective Electrophilic amination and Aldol condensation in the Labs of Prof. Cesare Gennari. Then he moved to Polytechnic of Milan to complete his education at the Specialization School of Organic Synthetic Chemistry. He subsequently undertook postdoctoral research with Professor Barry M Trost at the Stanford University. Here he worked on a selective modification of steroids.

In 1987 Giorgio joined the research laboratories of Zambon where he started is industrial carrier as Medicinal Chemist in lead generation, hit identification and optimization. After 12 years in Med Chem he moved as Process Chemistry Director of the Italian sites of Clariant Life Science Molecules Business Unit. After 20 years of experience in Process Chemistry in different Companies he is currently Senior Vice President Research & Development in Olon Group. Giorgio is now responsible of all the innovation activities of the group for both fermentative and chemical processes with particular focus on recombinant peptides, high potent API, continuous processes and hazardous chemical. He is author of more than 100 of patents and publications.

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15:30 - 16:00 Coffee & Partnering
16:00 - 17:30 Outsourcing Case Studies
Chair: Dr Frederik Barfoed Beck, Senior Outsourcing Manager, Zealand Pharma
16:00
Building an external manufacturing network for orphan drug development
Bianca Matthee, Vice President Manufacturing & Pharmaceutics

photo of Bianca Matthee
About the speaker

Bianca Matthee holds a PharmD degree from the University of Utrecht. She started her career as formulation scientist at Organon BioSciences and has developed into a manufacturing leader in biotech/pharmaceutical R&D. She has >12 yrs of experience in Chemistry, Manufacturing & Control (CMC) of adenoviral vaccine products and oligonucleotide products, having worked for Merck (Schering Plough, Organon BioSciences) and Johnson & Johnson (Crucell) in different roles including formulation scientist, production manager and CMC Director. Since 2013 she heads up the CMC department at ProQR Therapeutics where she has built the CMC team and manufacturing capabilities from scratch including vendor management, in house facilities, interacting with regulatory authorities and delivering supplies for clinical programs. All of the clinical products she is involved developing are based on oligonucleotides developed for (ultra)orphan indications mainly in ophthalmology and dermatology and are in preclinical, early stage and late stage clinical trials.

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16:20
Balancing timelines and ingenuity. A journey through case studies of life at a Premier CDMO.
Dr Jeorg Jung, Senior Director Custom Synthesis

About the speaker

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16:40
Flexibility and agility in collaboration with CDMOs in view of product development and launch
Dr Rudolf Hausmann, VP Technical Development & Operations

During development, launch and commercialization, there are a number of time-critical and cost-driving technical development & manufacturing steps which impact the progress and costs of the overall development program throughout all clinical phases and regulatory processes up to commercialization of a pharmaceutical product. This presentation is illustrating where critical technical development & manufacturing activities impact the overall timelines and ultimately "speed to market" and provides some examples with the focus on collaboration of small to medium size Pharma companies with contract development & manufacturing organisations (CDMO).

photo of Dr Rudolf Hausmann
About the speaker

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.

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17:00
Confirmed joint title: Innovation through partnership in process development and manufacture
Dr Georg Wuitschik, Senior Scientist
Dr Youchu Wang, Head of Process R&D, Changzhou Site

Youchou Wang (STA Pharma) and Georg Wuitschik (Roche) will talk about their successful collaboration on RG7907, a drug candidate currently being developed against Hepatitis B. The presentation will focus on what strengths both partners brought to the table and what were the guiding principles for this collaboration.

photo of Dr Georg Wuitschik
About the speaker

Dr. Wuitschik is a senior scientist in Process Chemistry at Roche. He has worked on a number of early- as well as late-stage small molecule projects after joining Roche in 2011. His work, through external as well as internal resources, cover API process R&D, drug substance manufacturing, and support of regulatory filings.

Dr. Wuitschik received his diploma from Technical University of Munich with a master thesis under supervision of Prof. Barry M. Trost, and Ph.D. from ETH Zurich under the supervision of Prof. Erick M. Carreira under the title Oxetanes in Medicinal Chemistry, followed by a postdoc in the group of Prof. Steve V. Ley at Cambridge University.

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photo of Dr Youchu Wang
About the speaker

Head of Process R&D, WuXi STA Changzhou Site

Ph.D. in Organic Chemistry, expert in Chemical Development with more than 18 years of experience in Pharmaceutical Industry

Youchu is an organic chemist by training. He started his career in Chemical Development at Wyeth (now Pfizer) in 2002 after postdoctoral research in the synthesis of a Natural Product-Bisbenzylisoquinoline. From 2002 to 2008, worked in Chemical Development at Wyeth (now Pfizer) as Process Chemist. In August 2008, joined WuXi STA, a global leading outsourcing company. Currently responsible for Process R&D, WuXi STA Changzhou site, a new integrated CDMO site that includes R&D, Pilot Plant and Commercial Plant in small molecules, peptides and oligonucleotides areas, with a team of more than 400 process chemists.

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17:30 - 19:30 Drinks Reception
Time Discovery Outsourcing
08:00 - 09:00 Registration & Partnering
09:00 - 10:30 Outsourcing Process & Strategy
Chair: Dr Anna Matranga, Business Consultant, AMC Alliances & Consulting SASU
09:00
Choosing the right CMOs: models for strategic sourcing, outsourcing and selection of CMOs.
Filipe Duarte, Senior Category Manager

photo of Filipe Duarte
About the speaker

Filipe Duarte joined Novo Nordisk in 2017 as Senior Category Manager in Strategic Sourcing. His background in organic chemistry (PhD from Nova University of Lisbon) and R&D experience supports him on the selection and management of CMOs for commercial production of biologic APIs, intermediates and complex materials. He is also responsible for implementing ethical sourcing standards in the supply chain.

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09:30
Building a robust, risk-based, supplier qualification process
Gabriele Sassi, Non Clinical Outsourcing Manager (CMC)

When companies began outsourcing and globalizing the supply chain in the 1980’s and 1990’s, they did so without understanding the risks suppliers posed. Companies have begun implementing vendor management systems to assess and mitigate vendor risks to the supply chain.

But how to address this to the management of R&D service providers?

An extensive Qualification Process developed by R&D Outsourcing Management of Chiesi Farmaceutici. The process is aimed to risk reduction/avoidance with external suppliers of Corporate R&D and is divided into specific clusters assessing business and financial aspects, technical capabilities, quality requirements including important criteria on a sustainable supply chain and procurement.

photo of Gabriele Sassi
About the speaker

Gabriele Sassi joined Chiesi Farmaceutici in 2010 and currently works as Non Clinical Outsourcing Manager in R&D Outsourcing Management, responsible for outsourcing R&D core activities for CMC such as Analytical Development, Clinical Trial Supplies and Drug Product / Drug Substance Manufacturing activities. Gabriele is mostly involved in establishing and managing the relationship with CROs and CMOs and the consequential contract management: this implies an intense knowledge of Procurement and Outsourcing processes that mainly refer to Supplier Selection and Qualification, Contract Awarding & Contract Management and Supplier Relationship Management. Gabriele has 9 years’ experience with procurement / outsourcing areas, starting his career in Procurement Department for Indirect Spend Categories (IT software, Laboratory Chemicals & Equipment).



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10:00
Confirmed title: CMO flexibility re-designed
Mr Felix Faupel, Head of Contract Manufacturing

Contract Manufacturing as a business is constantly evolving and there are several key factors to consider when partnering with a CMO. Firstly, clients look for CMO that shares their vision and passion, and therefore open and effective communications are crucial for success. Secondly, automation and digitalization are increasingly shaping this industry, and companies operating in the CMO arena need to demonstrate their capabilities together with their state-of-the-art technology to ensure quality and competitive pricing. However, competitive pricing alone is not enough; flexibility and a personalized customer approach are vital. Flexibility is not just about being able to change operations and adapt them when problems occur, it is about being proactive to consistently prevent problems while still being able to meet customer’s needs. This is why Acino Contract Manufacturing provides its customers with creative solutions that help them achieve their projects in a timely manner: by balancing both external and internal needs, being responsive, addressing concerns promptly, and ensuring transparency and trust. Finally, the best relationships are the easy ones, however they require work and we are happy to share our insights during our presentation.

About the speaker

Felix Faupel has been working with Acino for over 2 years, starting as Global Key Account Manager for Acino’s Contract Manufacturing business he was appointed as Associate Director of Contract Manufacturing in June 2018 and as Head of Contract Manufacturing in January 2019. In his role within Acino, Felix aims at reviving Acino’s Contract Manufacturing with new projects and customers, but also to shape the business with internal structural and process optimizations. Prior to his role at Acino, Felix was working as Business Development Manager in the pharma and medtech segment for the French consultancy Altran and as Business Development Manager for the API CMO Bachem. With his educational background in chemistry and business studies (University of Zurich), Felix developed a passion to reduce complexities that emerge within the interfaces of technical and commercial relationships in a B2B environment. With this goal in mind, flexibility as a CMO is only one aspect in a range of optimization possibilities a CMO can work on to develop their business further, but it is one of the most visible attributes pharma companies can detect easily. Felix will share his experience of the last two years with Acino and how an organization can be sharpened to work agile, flexible and thus customer satisfying.

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10:15
Selection, development and scale-up of sustainable manufacturing processes for active pharmaceutical ingredients.
Dr Peter Poechlauer, Innovation Manager, API

The synthesis routes employed in drug discovery to generate new pharmaceutical leads are designed for diversity, whereas the manufacturing processes of drug candidates chosen for development and launch have to be designed for efficiency, consistent product quality and to be sustainable. This may require modifications to the existing synthesis up to a redesign using advanced technologies in the fields of chemistry, process technology and analytics. The presentation will highlight criteria for synthesis route selection, process development and options to employ advanced technologies such as continuous manufacturing and online analytics to develop safe and sustainable manufacturing processes for high-quality products.

photo of Dr Peter Poechlauer
About the speaker

Dr Poechlauer joined the Thermo Fisher Scientific Linz site in 1990 and has more than 25 years of experience in pharmaceutical research and development. He has developed several large- scale biocatalytic processes for fine chemicals and led European research projects on biocatalysis and sustainable oxidation chemistry. In addition, he led process technology and introduced process intensification and microreactor technology in the company.

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10:30 - 11:00 Coffee & Partnering
11:00 - 12:00 BOS Outsourcing Showcase – Poster Presentations showcasing innovation and excellence in Biologics CMC Services & Technologies
11:00
Empowering enzymes for pharmaceutical applications
Dr Yves Dudal, Lead Director

At INOFEA, we empower enzymes for high-performance pharmaceutical applications using our unique patented enzzen® technology. It immobilizes any enzyme or enzyme cocktail of interest onto silica microparticles and shields it into a soft organo-silica layer. The shield stabilizes the enzyme, maintaining its activity under harsh conditions. These enzzen®-enzymes are the perfect tool for the pharmaceutical industry, providing robustness to highly specific enzymes for added-value applications and compounds. Pharma companies, CROs, and CMOs can benefit from this technology in applications such as bioanalysis, bioconjugation, post-translational modification of proteins, quantitative release of biomarkers from biological matrices, etc. The technology is highly versatile and the shield can be tailor-made to provide enzyme stability in the given application. INOFEA has successfully completed joint development work with various partners from the industry.

photo of Dr Yves Dudal
About the speaker

Biotech engineer by training (National Institute for Applied Sciences, INSA Toulouse, France) and received his PhD in chemical engineering from Polytechnique Montréal, Canada in 2000. Yves has worked 8 years as academic researcher in Montpellier, France, leading to the foundation of his first start-up company in 2010, which was taken over by a European group in 2015. He co-founded INOFEA in Basel back in 2014, was the CEO for 5 years, and is now the Lead Director.

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11:10
Application of MVDA, raman spectroscopy and process control to enhance bioprocess understanding and promote bioprocess optimization
Mr Mark Sheehan, Research Scientist

In recent years, there has been a growing necessity to increase the speed, efficacy and information content associated to the development and scale-up of biopharmaceutical processes, particularly given the regulatory authorities current shift in philosophy towards quality-by-design (QbD) (FDA Q8(R2) Pharmaceutical Development). This QbD requirement for increased process understanding by increasing process knowledge can speed the technical transfer from development into manufacturing, deliver a more optimised, robust process with higher titres and greater reproducibility and aid in troubleshooting and root-cause analysis of deviations during production. Process Analytical Technology (PAT) and modelling enable a more fundamental understanding of how bioprocesses work and what influences their efficiency. PAT can also be used comprehensively in bioprocessing to help manufacturers exercise greater control over operations and simplify the process to ensure the process works within a defined Design Space; a region around a golden batch for acceptable variance to ensure the quality target product profile (QTPP) is met. Within this research a combination of process analytical technology (Raman Spectroscopy) and data analytics (MVDA) were used to improve the process performance of a Chinese Hamster Ovary (CHO) mammalian cell bioprocess, by optimising the bioreactor feed profile by moving from a traditional bolus to a PAT-enabled continuous feeding strategy in order to prevent nutrient depletion and deliver a stable macro-environment for the cells. Glucose, Glutamate, Lactate, Ammonia, Osmolality and biomass concentrations in the CHO mammalian cell culture were determined online using Raman spectroscopy coupled with validated chemometric models. The application of a PAT-enabled optimisation routine resulted in an approximate 40 % decrease in ammonia production and an approximate 30 % increase in protein production in comparison to the traditional bolus fed-batch process through feedback control of continuous feeds related to glucose concentration and cell density.

photo of Mr Mark Sheehan
About the speaker

Mark Sheehan studied for his undergraduate degree in Industrial Chemistry in the University of Limerick. For the following 11 years, Mark proceeded to work in various roles in both the pharmaceutical and biopharmaceutical industry, choosing to focus specifically on analytics and instrumentation. Later, Mark studied for his Master’s in Biopharmaceutical Engineering from University College Dublin, which led to the start of his PhD research using process analytical technology and data analytics for process improvements. As part of this programme, Mark focuses on the development of in-house capabilities for APC Ltd. to be provided to client companies as a solution for process refinement and troubleshooting

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11:20
This is not just fill finish: insight from a C(D)MO perspective
Mrs Carole Delauney, Director Business Development

After a long and expensive process to develop Drug Substances, biotech companies want to quickly move to First-in-Human and then reach Proof of Concept stage, at which time they often out-license their project to be able to fund future development in view of market reach. The added value of Fill Finish is often regarded as a simple development step, but it is actually extremely complex in nature. Enough development time for Fill Finish partners selection and technology transfer is usually not planned, and too little time is spent on primary packaging selection, which can be detrimental when stabilities issues are discovered late in the process. The establishment of a strong Fill Finish partners network early in the process could save time and money in Drug Product development projects.

photo of Mrs Carole Delauney
About the speaker

Carole Delauney has 18+ years expertise in the field of Contract (Development) Manufacturing Organizations in which she is acting as a highly technically skilled commercial person looking for specific solutions adapted to the outsourcing needs of pharmaceutical and biotechnology.

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11:30
Onwards, to a fully integrated CDMO offering
Dr Barry Shortt, Senior Director Global Market Intelligence

About the speaker

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11:40
Speed matters – validated manufacturing cell line in 8 weeks
Iris Bodenmann, Cell Line Development Engineer

About the speaker

Iris went to the University of Lausanne where she achieved a bachelor degree in Biology. Iris then went to study Applied Sciences (major in Biotechnologies) at the engineer school HESSO Valais (Sion) where she achieved an additional bachelor degree. Iris then started to work at Selexis and has been there since 2015. Iris started in the CLD department, became in charge of the cloning team, then moved to the R&D team and became in charge of the Beacon evaluation and implementation at Selexis.



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12:00 - 13:30 Lunch & Partnering
13:30 - 15:30 Technical Operations Outsourcing – Early Phase, Biologics.
Chair: Prof. Dr. Tudor Arvinte, Chairman & CEO, Therapeomics Inc
13:30
Optimised CMO partnerships to expedite early stage development of bispecific antibodies.
Dr Martin Hangler, CMC Project Manager

About the speaker

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14:00
Confirmed title: Creating a robust analytical development strategy powered by external partnerships
Dr Thomas Wegge, Senior Director of Analytical Sciences

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About the speaker

Dr Thomas Wegge has been working in biotech and pharmaceutical industry for close to 20 years and is currently Senior Director of Analytical Sciences at Ascendis Pharma where his department is developing bioanalytical and CMC methods. Prior to Ascendis Pharma he hold positions at Roche and Complex Biosystems. He was part of the team that created the TransCon technology and has participitated in the development of several TransCon products. Thomas has a diploma degree in chemistry from the University of Dortmund and a PhD from the Philipps University of Marburg.

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14:30
Confirmed title: Challenge and strategy for successful ADC external manufacture
Kyle Blair, Global Category Manager, Biologics

The manufacture of Antibody-Drug Conjugates presents unique challenges for outsourcing. Concerns around high containment, multiple supply chain nodes, limited pool of commercial suppliers, and uncertainties around early stage material demand all need to be addressed. Kyle will present one approach for using those challenges to inform the CMO selection process that has been successfully employed by AstraZeneca. He will also identify key elements of partnership with the selected CMO that can enhance chances for success.

photo of Kyle Blair
About the speaker

Kyle began his career in Discovery Chemistry at Pfizer working on all the major classes of antibacterial agents. During his time at Pfizer Kyle earned a Master’s degree in Organic Chemistry from the University of Connecticut.

Beginning in 2002, Kyle joined the outsourcing arm of Pharmaceutical Development at Pfizer. After several years managing FTE collaborations in support of Discovery programs, he joined the late stage development group to manage contract manufacturing relationships in support of key late stage assets, notably Xeljanz and Xalkori.

Since 2011 Kyle has been part of the AstraZeneca Operations Procurement organization supporting external manufacture of biologics drug substance and drug product. In addition to Antibody-Drug Conjugates, Kyle currently supports external partnerships covering a broad spectrum of biopharmaceuticals including oncolytic virus, plasmid DNA, messenger RNA, monoclonal antibodies and fragments, microbial expression products, and peptides.



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15:00
Security of supply: Choose a dedicated analytical partner to ease CMC capacity constraints
Dr. Ray Sexton, BDM

Biopharmaceutical manufacturing quality is only as robust as the associated CMC analytics. An ever-growing pipeline of therapies plus increasing regulatory demands is causing capacity issues for all analytical labs - so what can Solvias do to ensure your analytical program delivers on time? The traditional transactional outsourcing model is evolving - the era of short notice, on-demand testing is rapidly becoming a thing of the past. Successful delivery programs now rely heavily on close partnerships between sponsor and analytical provider. To ensure development programs stay on track, Sponsors must now engage with their dedicated analytical partner long before manufacture to establish robust methods, set specifications, reserve capacity and prepare CMC ready documentation. Solvias supports our partners with a 100% consultative relationship featuring professional Project Management, Technical expertise and Regulatory support. The Solvias Solution provides the complete portfolio of GMP analytical techniques in a single hub, this one-stop-shop approach delivers every component of Protein characterisation, Comparability & Stability to address Quality, Identity, Sequence, Higher order structure, Post translational modifications, Process & Product related impurities and Potency.

photo of Dr. Ray Sexton
About the speaker

Dr Sexton is a Biopharma Sales manager at the Swiss Analytical Laboratory, Solvias AG, specialising in the analysis of Biotherapeutics, Monoclonal antibodies and 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 throughout the UK, Ireland & Scandinavia. Our aim is to provide the complete analytical CMC service from characterisation to QC release and to differentiate based on unrivalled expertise, capabilities & service within a single hub.

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15:15
Spray drying: a versatile processing technology to stabilise biologics, improve bioavailability whilst controlling particle size
Mr Andrew Naylor, R&D Director

Spray drying is a fast-growing technology in the pharmaceutical industry for producing dry powder formulations. It is gaining momentum over other established techniques, such as freeze-drying, due to the faster processing times, ease of scale up and the semi-continuous manufacturing processes. During spray drying, a dry powder is formed when a liquid feed is atomised and rapidly dried in a hot air stream. Particles from 1-50 µm can be easily produced, and particle properties engineered for the desired applications, including nasal, pulmonary and oral drug delivery. Spray drying has been used to improve the stability of biologics, such as virosomes, proteins and enzymes, without any loss of activity, which can eliminate the need for cold-chain storage. For MACIVIVA, a Horizon 2020 project, virosomes have been spray dried into a powder for vaccination by the nasal route. The powder shows greatly superior stability to the liquid product when stored frozen or at 40°C/75%RH, and when delivered to rats via an APTAR nasal spray device provoke an immune response comparable to that induced by sub-cutaneous delivery. Oral bioavailability of poorly-soluble APIs can be increased by spray drying with polymers. In collaboration with Xenogesis and Axis Bio Services, spray drying raloxifene with PVP K-12 resulted in a 7-fold increase in oral bioavailability in a preclinical study. Spray drying can also be used for particle engineering, to optimise particle size, morphology, and encapsulate particles. Pulmonary drug delivery requires 1 - 5 µm particles, but these are notoriously difficult to collect on scale up. Upperton have successfully applied fluid energy milling to spray dried powders to overcome this challenge achieving aerodynamic performance and fine particle fraction ideal for pulmonary delivery. These case studies illustrate the versatility of spray drying as a formulation technology, producing dry powder formulations of APIs for effective drug delivery.

About the speaker

Dr Naylor works as R&D Director for Upperton Pharma Solutions. He has over 17 years’ experience in the field of formulation development, characterisation & processing. He was appointed as R&D Director for Upperton Ltd in August 2015 and is responsible for directing all of the company’s research and development activities. Before joining Upperton Dr Naylor worked for Critical Pharmaceuticals for 9 years as Head of Process Development. He completed his PhD in 2006 at the University of Nottingham under the supervision of Professor Steve Howdle studying the reactive blending of polymers using supercritical carbon dioxide. He has also sat on several Royal Society of Chemistry special interest group committees supporting the areas polymer and materials.

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15:30
Spray drying: a versatile processing technology to stabilise biologics, improve bioavailability whilst controlling particle size
Mr Andrew Naylor, R&D Director

Spray drying is a fast-growing technology in the pharmaceutical industry for producing dry powder formulations. It is gaining momentum over other established techniques, such as freeze-drying, due to the faster processing times, ease of scale up and the semi-continuous manufacturing processes. During spray drying, a dry powder is formed when a liquid feed is atomised and rapidly dried in a hot air stream. Particles from 1-50 µm can be easily produced, and particle properties engineered for the desired applications, including nasal, pulmonary and oral drug delivery. Spray drying has been used to improve the stability of biologics, such as virosomes, proteins and enzymes, without any loss of activity, which can eliminate the need for cold-chain storage. For MACIVIVA, a Horizon 2020 project, virosomes have been spray dried into a powder for vaccination by the nasal route. The powder shows greatly superior stability to the liquid product when stored frozen or at 40°C/75%RH, and when delivered to rats via an APTAR nasal spray device provoke an immune response comparable to that induced by sub-cutaneous delivery. Oral bioavailability of poorly-soluble APIs can be increased by spray drying with polymers. In collaboration with Xenogesis and Axis Bio Services, spray drying raloxifene with PVP K-12 resulted in a 7-fold increase in oral bioavailability in a preclinical study. Spray drying can also be used for particle engineering, to optimise particle size, morphology, and encapsulate particles. Pulmonary drug delivery requires 1 - 5 µm particles, but these are notoriously difficult to collect on scale up. Upperton have successfully applied fluid energy milling to spray dried powders to overcome this challenge achieving aerodynamic performance and fine particle fraction ideal for pulmonary delivery. These case studies illustrate the versatility of spray drying as a formulation technology, producing dry powder formulations of APIs for effective drug delivery.

About the speaker

Dr Naylor works as R&D Director for Upperton Pharma Solutions. He has over 17 years’ experience in the field of formulation development, characterisation & processing. He was appointed as R&D Director for Upperton Ltd in August 2015 and is responsible for directing all of the company’s research and development activities. Before joining Upperton Dr Naylor worked for Critical Pharmaceuticals for 9 years as Head of Process Development. He completed his PhD in 2006 at the University of Nottingham under the supervision of Professor Steve Howdle studying the reactive blending of polymers using supercritical carbon dioxide. He has also sat on several Royal Society of Chemistry special interest group committees supporting the areas polymer and materials.

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16:00 - 17:30 Outsourcing Case Studies.
Chair: Dr Karlheinz Landauer, Managing Director, QBDC GmbH
16:00
Confirmed title: Logistics as a major player in the supply of personalized therapeutic cancer pDNA vaccines
Dr Mette Husbyn, Chief Technology Officer

photo of Dr Mette Husbyn
About the speaker

Dr Husbyn completed her PhD at University of Oslo, Norway within the area of peptide synthesis and the testing of complex peptide domains and derivatives as anticoagulants.

She has worked within R&D of the Pharmaceutical and Biotech industry for over 20 years and has extensive experience within CMC from early discovery until filing of NDA/MAA.

She held a variety of positions at GEHC ranging from scientist, project manager and department manager, before she joined a small Norwegian Immunotherapy company in 2012 and took on the role as Head of CMC.

In October 2017 she started at Vaccibody as CTO and was introduced to the world of individualized therapeutic DNA cancer vaccines and the logistics challenges associated with this concept.

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16:20
Strategies towards optimized and flexible facilities for vaccine and biotherapeutic manufacturing
Sebastian Pungel, Programme Manager

The world is facing an under-supply of some key vaccines and biotherapeutics due to poor synergies between growing market demands and aging production models. In this light, Univercells has developed a proof of concept of a vaccine manufacturing platform aiming at increasing availability and affordability of vaccines - the NevoLineTM system. This simulated continuous and automated platform integrates both USP1 and DSP2 processes and is encapsulated into an isolator, making it a self-contained production unit (6m²). The technology relies on a single-use, high-density fixed-bed bioreactor operated in perfusion chained with downstream filtration, clarification and polishing steps to (a) decrease batch time, (b) reduce equipment utilization, (c) optimize utilities consumption and (d) intensify operations. By optimizing single-use technologies we are able to drastically reduce CAPEX3 , CoGs4 and footprint and increase production capacity. Such manufacturing platform can easily be implemented into flexible facilities with simplified infrastructure, increasing adaptability in production and capacity for record time-to-market.

photo of Sebastian Pungel
About the speaker

Sebastian joined Univercells (Belgium, Germany) in 2017 as a Program Manager for recombinant proteins and was leading multidisciplinary project teams to ensure successful delivery of the project’s objectives. Today, Sebastian is responsible of science and innovation. He is in charge of evaluating technologies across all Univercells businesses covering all aspects of manufacturing technologies for producing drug substance, drug product of therapeutic proteins and vaccines as well as analytical and equipment development.

Sebastian Püngel graduated with a Bachelor degree from University of Applied Sciences Emden (Emden, Germany) followed by a Master degree from Beuth University of Applied Sciences Berlin (Berlin, Germany) with a focus on cell culture technology and recombinant protein production.

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16:40
Zelluna manufacturing strategy case study
Dr Arjan Roozen, Chief Technology Officer

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About the speaker

Chief Technical Officer

Arjan Roozen joined Zelluna Immunotherapy in April 2018 and is responsible Zelluna’s Manufacturing and Development strategy. Arjan has extensive experience in GMP manufacturing in the EU and US. The supply chain management from raw materials, GMP cell manufacturing for clinical and commercial supplies. Prior to joining Zelluna, Arjan served as VP GMP Solutions & Manufacturing at Cellectis, where he headed up the team responsible for the sourcing of the critical raw materials as well as the manufacturing of the gene modified cell therapy products. Additionally, he has previous valuable experience from the CDMO Pharmacell, recently acquired by Lonza, responsible for its operational activities. Arjan has a degree in microbiology with specialization in molecular microbiology.

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17:00
Hookipa's supercharged immunotherapeutics: sourcing and project managing a complex network of external CROs and CMOs
Dr Andreas Aspoeck, Head of External Manufacturing

photo of Dr Andreas Aspoeck
About the speaker

Andreas Aspöck is Head of External Manufacturing at Hookipa Biotech in Vienna, Austria. Hookipa Biotech is a clinical stage biopharmaceutical company developing prophylactic and therapeutic treatments based on viral vector platforms. These arenavirus-based treatments are novel treatments (ATMP) and there are some challenges around the manufacturing process, as every biotechnology company experiences.

As Head of External Manufacturing Andreas is responsible for the aligning all aspects of the manufacturing strategy with the company pipeline. This includes the supplier selection, scheduling and supervising the manufacturing campaigns.

Andreas started at Hookipa Biotech in 2012 as a Scientist in the Up-Stream Department (UPS), and later became Head of UPS to drive the development of the upstream processes.

From 2008 to 2012 Andreas worked at AVIR Green Hills Biotech, a biopharmaceutical company focusing in developing an attenuated Influenza vaccine. At AVIR Green Hills Biotech he assisted the Head of Manufacturing and PD in the manufacturing campaign and led later the Up-Stream Development.

Andreas finished his studies in life science with a master degree at the University of Applied Life Sciences in Vienna.

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17:30 - 19:30 Drinks Reception
Time Discovery Outsourcing
08:00 - 09:00 Refreshments & Partnering
09:00 - 11:00 Lead Generation to Lead Optimisation
Chair: Dr Neil Press, Director, Global Discovery Chemistry, Novartis Pharma AG
09:00
Premium CRO impact in Agritech: from patent exemplification to process optimization and pilot synthesis.
Dr Florian Guignard, R&D Associate Scientist
Dr. Thomas Fessard, CEO







About the speaker

Dr. Florian Guignard has an education in Chemical and Bio Engineering from EPFL (Bsc.) and ETHZ (MSc.), followed by a PhD in Physical Chemistry from the Adolphe Merkle Institute, University of Fribourg. His academic work focused on atypical colloidal suspension and self-assembly.

He now works as a R&D Associate Scientist for AgroSustain, where he is in charge of the product development and formulation.



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photo of Dr Florian Guignard
About the speaker

Thomas studied chemistry in France (ENSC, Montpellier) and the UK (UMIST, Manchester) and obtained a PhD degree from the university of Nottingham, UK.

After research appointments at the School of Pharmacy in Nottingham and ETH Zürich, Thomas joined Lipideon Biotechnology AG in 2007. As Head of the Drug Discovery and Chemistry, he lead a multi-disciplinary team that discovered a candidate for pre-clinical investigation (Non-Systemic Cholesterol Absorption Inhibitor).

In 2011, Thomas co-founded SpiroChem AG, Swiss fine chemicals company and serves as CEO of the company.

Thomas has several years of experience in the management of R&D projects, including medicinal chemistry, design of innovative building blocks for drug discovery and development of new process routes.

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09:30
Joint presentation: Unleashing the potential of biotech through collaborative discovery
Dr Paul Beswick, Director of UK Chemistry & IP
Dr Dave Madge, Vice President, Research Services Division



photo of Dr Paul Beswick
About the speaker

PhD from Imperial College. Joined Glaxo in 1984 and stayed until 2009 worked on a variety of targets including ion channels, GPCRs, nuclear receptors and enzymes. During the GSK era worked in the Neurology area as a department head in Medicinal Chemistry largely focussed on pain programmes.

Left GSK in 2008 and joined Almirall in Barcelona as Head of Chemistry where the focus was on respiratory projects and inhaled delivery and in 2013 returned to the UK to join the Drug Discovery Group at the University of Sussex with the responsibility of developing collaborations with both academic groups and industry and raised 12.5M in funding to support the group’s activities.

Started working with Bicycle in 2016 as a consultant while still at Sussex and joined as Director of Chemistry in October 2018

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About the speaker

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 leading global pharmaceutical and medical device open-access capability and technology platform company.

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10:00
Integrating internal and external expertise and capabilities to drive successful drug discovery and development in a small biotech
Dr Steve Collingwood, Head of Chemistry

photo of Dr Steve Collingwood
About the speaker

Dr Steve Collingwood obtained his first degree in chemistry from the University of Durham and his PhD in organic chemistry from the University of Newcastle. After postdoctoral research at the University of Oxford, he joined the central research laboratories of Ciba Geigy, which later became Novartis. In 1997 he joined the Novartis respiratory disease team. During his time there, he led the chemistry on multiple respiratory projects, delivering several clinical candidates and contributing to two successful human proof of concept studies. In 2006 his contributions were recognised with a Novartis Leading Scientist award. He later became Director of Respiratory Medicinal Chemistry and a member of the Novartis Respiratory Disease Area Board. In 2014 he joined Janssen as Head of Chemistry for the respiratory research activities at its Respivert subsidiary, where he led a new research project and oversaw the inhaled DMPK strategy and Respivert IP portfolio. Throughout his time in respiratory research Steve has a particular interest in the design of novel inhaled medicines. He is an author of over 70 patents and publications.

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10:30
Phase-appropriate solid form screening in early development
Mr Matteo Seregni, Business Development Director

photo of Mr Matteo Seregni
About the speaker

Dynamic business developer, with a strong entrepreneurship spirit, management skills and a particular interest in STEM disciplines. Experience in various sectors (Life Sciences, IT, Oil & Gas, Energy, Automotive, Food), fluently quadrilingual (English, Dutch, Italian and French). Always looking for opportunities to create added value and develop business in a sales & marketing environment: my dream is to disruptively innovate an industry, always whilst meeting and exceeding customer needs and expectations.

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10:45
Confirmed title: Unique nanonisation technology for poorly soluble APIs by Nanoform
Dr Niklas Sandler, Chief Technology Officer

Our multi-patented and scalable Controlled Expansion of Supercritical Solutions (CESSᵀᴹ ) technology produces nanonized ‘designed-for-purpose’ API particles. This enables poorly soluble molecules in the pharmaceutical pipeline to progress into clinical development by increasing their rate of dissolution and improving their bioavailability. Our unique nanonizationᵀᴹ technology also provides novel opportunities in diverse value enhancing drug delivery applications. We work together with pharma and biotech partners globally to enhance molecules’ formulation performance through our best-in-class nanonizationᵀᴹservices. Nanoform’s platform technology can give failed drug molecules a second chance and gives an unique path to develop nanoparticles from early phase development onwards. The patented technology is based on supercritical CO2. The drug solution is expanded through a controlled process to produce pure drug nanoparticles. The process is more controlled than conventional supercritical technologies, and it produces smaller and more uniformly sized particles. This presentation will give an introduction Nanoforms technology and show the capabilities in small scale screening in early stage development and GMP manufacture of nanoparticles.

photo of Dr Niklas Sandler
About the speaker

Chief Technology Officer at Nanoform Finland Ltd. since January 2019 leading the R&D and QC activities with a focus on further developing the company’s innovative manufacturing technology. Nanoform offers new technological and business advantages for the pharmaceutical industry. The company has developed a proprietary technology called Controlled Expansion of Supercritical Solutions (CESSTM) that allows nanonization of drug substances. Dr Sandler has a PhD from the University of Helsinki and he has worked in various roles both in the pharmaceutical industry and academia. He has more than 20-years of experience in pharmaceutical technology with the focus on manufacturing technologies, material science and process analytical technologies. He has run numerous academic and industrial R&D and commercialisation projects in the field successfully. He has been invited speaker in various international conferences and published more than 100 peer reviewed articles in international high-quality journals throughout the years.

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11:00 - 11:30 Refreshments & Partnering
11:30 - 12:30
Bridging capability gaps in drug discovery in fibrotic disease: A workshop approach to identifying capability gaps and initiate collaborations to bridge these gaps.
Chair: Dr Simon Cruwys, Co-founder and Director, TherapeutAix
Chair: Bob Humphries, Director, Project Strategy
Chair: Dr Darcey Black, Director, Translational
Chair: Lyn Rosenbrier Ribeiro, Expert Network Lead
Chair: Dr Jane Escott, Director, Respiratory External innovation

photo of Dr Simon Cruwys
About the speaker

Simon Cruwys is Director of Pharmacology, TherapeutAix UG. Prior to the founding of TherapeutAix in 2018, Simon was Head of the Innovative Medicines Unit, Grünenthal Innovation. In this role, Simon led a team responsible for in-licensing molecules and delivering them to Clinical proof of concept. He has over 30 years experience in academic and industry research. As a project leader, he has a track record of delivery from Lead Identification through to clinical validation. Prior to Grünenthal, Simon worked for AstraZeneca where he was lead for both small molecule and antibody projects.

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photo of Bob Humphries
About the speaker

Bob Humphries, BSc
A pharmacologist with 30+ years of pharma experience, including partnered early development projects and successful out-licensing, Bob led teams in discovery and early progression of the anti-thrombotics, Brilinta and Cangrelor. As VP Inhaled Projects, AstraZeneca, he led strategic and delivery activities for in-house and partnered projects. Bob is co-founder of the inhalation consultancy, Adhale, a Director of VisionRealisation, Oncotherics and Platelet Solutions, and Scientific Advisor to a number of companies and academic groups.

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photo of Dr Darcey Black
About the speaker

Formerly, Head, External Innovation in the Innovative Medicines Unit, Grünenthal Innovation, Aachen, DE. He has over 30 years’ experience in pre- and early clinical drug discovery working in all aspects from target ID and validation, LO and translational studies in early clinical development, in several therapeutic areas. Prior to joining Grünenthal, he worked for Merck (formerly Organon/Schering-Plough) in senior project and line management roles, and previously at Pfizer, UK and Glaxo (now GSK) in the UK and CH.

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photo of Dr Jane Escott
About the speaker

Jane Escott is a Director in the Early RIA, R&D BioPharmaceuticals group in AstraZeneca leading licensing evaluations and collaborations in respiratory diseases. Previously, Jane established a variety of ‘Open innovation’ initiatives and was the Alliance manager for the MRC ‘Asset Sharing’ initiative. Jane has a PhD in Pharmacology from King’s College, London and over 15 years of R&D experience in the pharmaceutical industry. By following the science, Jane has progressed compounds from preclinical to early clinical development in a number of disease areas including respiratory, inflammatory and oncology. More recently, Jane has championed the repositioning of deprioritized compounds into new disease indications through the generation of novel biology internally and through external collaborations with disease experts. As a keen advocate for diversity and inclusivity in the workplace, Jane actively supports diversity initiatives in AstraZeneca.

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12:30 - 14:00 Lunch & Partnering
14:00 - 15:30 Innovator & Sponsor Showcasing Outsourcing Case Studies
Chair: Dr Alexander Bausch, CEO, Strekin
14:00
Confirmed joint title: Fragment based drug discovery partnership for an early phase biotech
Dr Kamal Azzaoui, CEO & Co-founder
Dr Thomas Fessard, CEO

photo of Dr Kamal Azzaoui
About the speaker

Dr. Kamal Azzaoui received his PhD in computational chemistry from the University of Orléans (France) followed by 2 postdocs at McGill University (Montréal) and Georgetown University (Washington DC).

Dr. Azzaoui worked for 2 years for a flavor and fragrance mid-size company as a senior computational chemist (Givaudan, Zurich, CH) and 15 years at Novartis as a laboratory head in charge of data analysis, data modeling and drug design using machine learning, cheminformatics and molecular modeling tools. He left Novartis in 2017 to co-found Saverna Therapeutics AG (www.saverna.com). He is finishing a master for advanced science (MAS) program of the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) at the University of Bern. He has contributed to many drug discovery projects in term of data analysis, machine learning, medicinal chemistry and cheminformatics support. He also pioneered in developing machine learning models for the prediction of adverse effects and safety of novel drugs. He was a partner in the European Innovative Medicine Initiative (IMI OpenPhact) consortium. He is a consultant for Axxelis and co-founder/ CSO for VentureFlow (www.ventureflow.ch).

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photo of Dr Thomas Fessard
About the speaker

Thomas studied chemistry in France (ENSC, Montpellier) and the UK (UMIST, Manchester) and obtained a PhD degree from the university of Nottingham, UK.

After research appointments at the School of Pharmacy in Nottingham and ETH Zürich, Thomas joined Lipideon Biotechnology AG in 2007. As Head of the Drug Discovery and Chemistry, he lead a multi-disciplinary team that discovered a candidate for pre-clinical investigation (Non-Systemic Cholesterol Absorption Inhibitor).

In 2011, Thomas co-founded SpiroChem AG, Swiss fine chemicals company and serves as CEO of the company.

Thomas has several years of experience in the management of R&D projects, including medicinal chemistry, design of innovative building blocks for drug discovery and development of new process routes.

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14:30
Outsourcing strategies for the development of biosimilars
Norbert Bleich, COO and CMO

photo of Norbert Bleich
About the speaker

Norbert comes with Diploma degree in chemistry gained at the university of Freiburg and 25 years of experience at Quintiles (1993), Novartis (1998), Hoffmann-La Roche (2008), and Boehringer Ingelheim (2017).

He had leading positions in Pharma Development and Corporate functions, which included heading functions like Global Services implementing R&D hubs in Japan, China, and India, medical writing including document and submission management with responsibility for more than 200 Development projects and 10 NME submissions during this period, and portfolio governance for both the Clinical portfolio as well as Innovation and Efficiency in Development, and Portfolio Management of the Merial Animal Health integration into Boehringer Ingelheim.

As a successful entrepreneur, Norbert recently (co)-founded Versameb AG, a regenerative medicine start-up, kicking off the company as CEO.

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15:00
Joint presentation with Lee Smith: Collaboration between biotech, consultant & CRO to drive a vaccine’s development
Prof. Dr. Tudor Arvinte, Chairman & CEO
Dr Lee Smith, Principal Consultant, Managing Director

photo of Prof. Dr. Tudor Arvinte
About the speaker

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.

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About the speaker

Dr. Lee Smith's experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.

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15:30 - 17:00 Conference Close & Drinks Reception
Time Discovery Outsourcing
08:00 - 09:00 Refreshments & Partnering
09:00 - 11:00 Technical Operations Outsourcing – Late Phase, Small Molecule
Chair: Dr Yogeshwar Bachhav, Associate Director Pharmaceutical Development, AiCuris GmbH
09:00
Confirmed title: Utilising biocatalysis and the external workbench to deliver the Roche small molecule pipeline
Dr Dennis Wetzl, Scientist, Process Chemistry & Catalysis

About the speaker

Dr. Wetzl works in the Catalysis section of the Process chemistry department at Roche, with a focus on biocatalytic transformations for chiral API intermediates. He has worked on several reaction steps in small molecule projects in different clinical phases after joining Roche in 2014. Dr. Wetzl studied chemistry at the Universities of Stuttgart and Tuebingen with a diploma thesis and Ph.D. under supervision of Prof. Bernhard Hauer at the University of Stuttgart focusing on biocatalysis. He then joined Roche in 2014 for a postdoc position with the focus on imine reductases as an emerging new synthetic tool. Since 2016, he is working at Roche as a Research Scientist for biocatalysis.

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09:30
Confirmed title: The Onpattro story: the development and commercialization of a siRNA therapeutic leveraging an outsourcing model
Dr Charlie Hitscherich, Head of Clinical Supply & External Manufacturing

About the speaker

Dr Hitscherich has been working in industry for close to 20 years. He is currently the Head of Clinical Supply Chain & External Manufacturing at Alnylam Pharmaceuticals. Prior to joining Alnylam he had positions at Biogen, Bristol Myers and Wyeth. He has participated in the development and commercialization of numerous parenteral products. Dr Hitscherich received his BS in Chemical Engineering from Penn State University, MBA from Northeastern University, and his PhD in Biochemical Engineering from the University of Iowa.

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10:00
Confirmed title: Optimised formulation strategies: development of an oral formulation of Edaravone for ALS
Dr Ronald van der Geest, Partner, 3D-PharmXchange & CDO, Treeway

Ronald van der Geest, Chief Development Officer will speak about the development of TW001, Treeway’s lead product, being a clinical-stage oral treatment for ALS. Edaravone, the active ingredient of TW001, is a compound for which it was said to be not possible to develop an oral formulation. Ronald will explain how Treeway succeeded nonetheless, driven by their unique patient driven development approach and will lead the audience through the early stages of the development of their first pilot formulation, including early in vitro studies, animal PK trials and subsequent clinical trials. He will also speak about the reason why Treeway selected this compound and the associated importance of biomarker development in ALS.

photo of Dr Ronald van der Geest
About the speaker

Ronald is one of the founders of 3D-PharmXchange. Next to his role as general partner, he holds roles as CDO and is Treeway’s CDO since 2013. He is an advisor for various regional and strategic development programs in the life sciences and involved in the establishment of a number of early start-up companies. Ronald led the development of Glybera™ for uniQure, the 1st approved genetherapy product in the western world and holds strategic knowledge in the areas of translational development, orphan drugs, individualized medicines and biomarker-based development. Prior to co-founding 3D-PharmXchange Ronald was COO and CDO at Kinesis Pharma, responsible for business development and multidisciplinary drug development, leading the team project leaders. During this time he held advisory board positions and interim management positions for clients, supporting them in fund raising, drug development and corporate strategy. Prior to that he worked for various companies, including Tibotec where he was, amongst others, Compound Development Leader for Prezista®.

He is a PhD-level clinical pharmacologist and drug delivery expert by training (Leiden University and UC San Francisco) and started his career in this area at Johnson & Johnson, Belgium.

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10:30
Confirmed title: High potent API manufacturing at FAREVA
Dr Christian Miksch, Director Sales API

Dr. Christian Miksch, Sales Director API, will speak about the capabilities of Fareva to manufacture high potent APIs from small scale to large scale.

photo of Dr Christian Miksch
About the speaker

Christian Miksch is currently Director Sales API at Fareva; the group is a top 5 CDMO globally with 35 production sites around the world focusing on drug substance and drug product development and manufacturing. 4 API sites in Germany & France and 13 DP sites in Europe & USA can offer a wide range of capabilities. Special expertise has been developed in the field of HPAPIs, sterile APIs and steroids. Christian obtained his PhD in organic chemistry from the University of Munich (LMU) in 2001. His career started with his own Biotech company, which developed anti-cancer APIs. 2005 Christian has joined DSM as lab head and developed API manufacturing processes. Starting in 2006 he worked for Pfizer Center Source in Germany as Project and Validation manager. He has joined the Sales team in 2011, when the production site has been sold to Fareva. Since then he is responsible for exclusive business and generic API business for all API manufacturing sites in the EMEA region.

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10:45
Confirmed title: Diazomethane: embracing hazardous chemistry at scale and through the utilisation of flow chemistry
Dr Dan Stark, Development Chemist

Dr Dan Stark will be presenting Sterling Pharma Solutions capabilities for the scale-up and manufacture of complex and hazardous synthesis. Showcased through Sterling’s current work on diazomethane and the utilisation of modern flow chemistry technologies in API manufacture.

photo of Dr Dan Stark
About the speaker

Dr Dan Stark completed a PhD in organic chemistry and synthetic methodology, under the supervision of Professor Andrew Smith, at the University of St Andrews. Dan then moved into industry with roles at Almac and Syngenta, working on projects ranging from lead generation discovery to kilo-scale manufacture. In 2017, Dan took up his current position at Sterling Pharma Solutions’ UK-based headquarters as a development chemist working in process R&D.

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11:00 - 11:30 Refreshments & Partnering
11:30 - 12:30 Creating the conditions to enable win/win, sustainable outsourcing relationships. In this session we ask the speakers to share their perspectives on how to create effective outsourcing partnerships.
Chair: Dr Anna Matranga, Business Consultant, AMC Alliances & Consulting SASU
11:30
Confirmed title: Developing a supplier governance model as part of an integrated supplier relationship strategy
Dr Andrea Calenne, Senior Manager Global Strategic Sourcing

photo of Dr Andrea Calenne
About the speaker

Employed as Senior Manager External Manufacturing at Biogen International, Andrea is supplier relationship manager for the outsourced manufacture of injectable products (Biologicals and Oligonucleotides).

Over the past 15 years Andrea worked in multiple QA and External Manufacturing roles for CSL Behring, Bayer Healthcare and Biogen, managing a relevant number of manufacturing sites and a product portfolio including plasma derivatives, biologicals, as well as non-sterile pharmaceuticals distributed globally.

Starting his career in Corporate Quality Management within a Japanese automotive company (Bridgestone), Andrea developed his professional identity in an environment where outsourcing is key to product compliance as well as to the performance of the supply process.

Andrea holds a M.Sc. in Organic Chemistry from University La Sapienza in Rome, after graduation he completed a Master in Intellectual Property at the Italian Patent and Trade Mark Office. Andrea speaks Italian, English, French, Spanish and German.

Born 1972 in Rome (Italy) Andrea lives in Switzerland with his family since 2005. Andrea is Italian and Swiss national.

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11:50
Confirmed title: David and Goliath? Building successful and sustainable collaborations with CMOs - the view from a non-profit SME
Dr Joan Herbert, Director Business Development

photo of Dr Joan Herbert
About the speaker

I joined MMV in 2009 when I saw a unique opportunity to apply novel and exciting science to solve some real problems which will not only stop people from dying or becoming sick but can also turn their lives around and enable them to escape from poverty. I have almost nineteen years of experience in drug discovery and development gained in the biotechnology and contract research sectors and including six years at MMV. Prior to joining MMV, I held positions in business development with Paragon Biomedical, Synarc Inc., and PPD in Cambridge, UK and before that I worked as a research and senior scientist at Cambridge Antibody Technology. I have a Ph.D. in Immunology from the University of London and a B.Sc. in Biochemistry from the University of Glasgow. In 2014, I enrolled for a master’s degree in biomedical ethics and healthcare with the University of Leeds.

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12:10
Creating the conditions to enable win/win, sustainable outsourcing relationships
,

About the speaker

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12:30 - 14:00 Lunch & Partnering
14:00 - 15:30 Innovator & Sponsor Showcasing Outsourcing Case Studies
Chair: Dr Alexander Bausch, CEO, Strekin
14:00
Confirmed joint title: Fragment based drug discovery partnership for an early phase biotech
Dr Kamal Azzaoui, CEO & Co-founder
Dr Thomas Fessard, CEO

photo of Dr Kamal Azzaoui
About the speaker

Dr. Kamal Azzaoui received his PhD in computational chemistry from the University of Orléans (France) followed by 2 postdocs at McGill University (Montréal) and Georgetown University (Washington DC).

Dr. Azzaoui worked for 2 years for a flavor and fragrance mid-size company as a senior computational chemist (Givaudan, Zurich, CH) and 15 years at Novartis as a laboratory head in charge of data analysis, data modeling and drug design using machine learning, cheminformatics and molecular modeling tools. He left Novartis in 2017 to co-found Saverna Therapeutics AG (www.saverna.com). He is finishing a master for advanced science (MAS) program of the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) at the University of Bern. He has contributed to many drug discovery projects in term of data analysis, machine learning, medicinal chemistry and cheminformatics support. He also pioneered in developing machine learning models for the prediction of adverse effects and safety of novel drugs. He was a partner in the European Innovative Medicine Initiative (IMI OpenPhact) consortium. He is a consultant for Axxelis and co-founder/ CSO for VentureFlow (www.ventureflow.ch).

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photo of Dr Thomas Fessard
About the speaker

Thomas studied chemistry in France (ENSC, Montpellier) and the UK (UMIST, Manchester) and obtained a PhD degree from the university of Nottingham, UK.

After research appointments at the School of Pharmacy in Nottingham and ETH Zürich, Thomas joined Lipideon Biotechnology AG in 2007. As Head of the Drug Discovery and Chemistry, he lead a multi-disciplinary team that discovered a candidate for pre-clinical investigation (Non-Systemic Cholesterol Absorption Inhibitor).

In 2011, Thomas co-founded SpiroChem AG, Swiss fine chemicals company and serves as CEO of the company.

Thomas has several years of experience in the management of R&D projects, including medicinal chemistry, design of innovative building blocks for drug discovery and development of new process routes.

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14:30
Outsourcing strategies for the development of biosimilars
Norbert Bleich, COO and CMO

photo of Norbert Bleich
About the speaker

Norbert comes with Diploma degree in chemistry gained at the university of Freiburg and 25 years of experience at Quintiles (1993), Novartis (1998), Hoffmann-La Roche (2008), and Boehringer Ingelheim (2017).

He had leading positions in Pharma Development and Corporate functions, which included heading functions like Global Services implementing R&D hubs in Japan, China, and India, medical writing including document and submission management with responsibility for more than 200 Development projects and 10 NME submissions during this period, and portfolio governance for both the Clinical portfolio as well as Innovation and Efficiency in Development, and Portfolio Management of the Merial Animal Health integration into Boehringer Ingelheim.

As a successful entrepreneur, Norbert recently (co)-founded Versameb AG, a regenerative medicine start-up, kicking off the company as CEO.

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15:00
Joint presentation with Lee Smith: Collaboration between biotech, consultant & CRO to drive a vaccine’s development
Prof. Dr. Tudor Arvinte, Chairman & CEO
Dr Lee Smith, Principal Consultant, Managing Director

photo of Prof. Dr. Tudor Arvinte
About the speaker

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.

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photo of Dr Lee Smith
About the speaker

Dr. Lee Smith's experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.

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15:30 - 17:00 Conference Close & Drinks Reception
Time Discovery Outsourcing
08:00 - 09:00 Refreshments & Partnering
09:00 - 11:00 Technical Operations Outsourcing - Late Phase, Biologics
Chair: Prof Rolf G Werner, Professor for Industrial Biotechnology, University of Tübingen
09:00
Confirmed title: Creating a framework for effective CMO selection for late phase biopharmaceutical drug substance production
Dr Karlheinz Landauer, Managing Director

CDMO selection for outsource-seekers is often unstructured and based solely on factual knowledge like company size, track records, available infrastructure, because this information is computable and comparable. However, the best candidates are not those with an impressive track record, reasonable pricing or the right number of bioreactors, but also those with which the outsourcer feels most comfortable, those that radiate a sense of reliability and competence.

In my presentation, I will speak about our way to make outsourcing more structured, and, thus, more sustainable and scientific. In questionnaires, we consider both factual knowledge and personal/subjective impressions, and fill them into a comprehensive scoring system, which allows a more accurate comparison of candidates. Our approach is based on Quality by Design considerations, starting with superficial screening that goes more and more in-depth while the number of CDMOs continuously decreases, until less than a handful of promising candidates are left.

photo of Dr Karlheinz Landauer
About the speaker

Dr Karlheinz Landauer is an expert in Biotechnology with a PhD and MSc title in Applied Microbiology and 18+ 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.

After his PhD in 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.

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09:30
Integrated matrix assisted enzymatic antibody drug conjugation
Prof. Dr. Dr. Rolf G. Werner, Science & Technology Committee

Bullet Points are: Site directed antibody and protein scaffolds drug conjugation Site directed isotope labelling for tumor imaging and radiotherapy Key factors for bioconjugation Continuous DSP integrated bioconjugation Stable linker with limited off target toxicity and broader therapeutic window Potent HER 2 selective cytotoxicity Business model for CDMO services

photo of Prof. Dr. Dr. Rolf G. Werner
About the speaker

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, conceptual design of biopharmaceutical plants and he is Chairman of the Advisory Board in a number of different companies. 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.

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10:00
Confirmed title: Biologics outsourcing: preparing for launch readiness with your CMO partner
Dr Ulrich Rümenapp, Head of Launch Preparation and Co-ordination, Biological Development

This presentation will include the following:

• The benefits and risks of outsourcing

• Special challenges with the outsourcing of biologics and new therapeutic modalities

• Best practices for selecting and managing your supplier

• The journey from contracting through partnering, tech transfer and GMP manufacture to launch readiness, incl. sufficient quality oversight



photo of Dr Ulrich Rümenapp
About the speaker

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.

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10:30
Freeflex®: fill and finish service in innovative IV-bag for global supply
Dr Benedikt Reichart, Business Development Manager

Freeflex®: Fill & Finish Service in innovative IV-bag for global supply

Highest quality PVC-free freeflex bags are the leading-edge container technology of today for IV bag pharmaceuticals. Freeflex bags are convenient and safe for use in a broad field of application from standard infusion to drug reconstitution. Fresenius Kabi offers its proprietary bag technology as well as fill and finish services for all markets around the world. Supporting our customers from product development to commercial manufacturing is our duty and pleasure.

photo of Dr Benedikt Reichart
About the speaker

Benedikt acts as the first point of contact for pharmaceutical companies planning the outsourcing of manufacturing of sterile pharmaceuticals at Fresenius Kabi’s manufacturing sites in Europe and Asia. Benedikt joined Fresenius Kabi as a Management Trainee after completing his PhD in Organic Chemistry from the Karl-Franzens University of Graz, Austria in 2014. He afterwards covered the role of executive assistant at Fresenius Kabi focusing on pharmaceutical manufacturing, global investments, strategy roll-out, capacity and supply chain management.

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10:45
An agnostic approach of applying PAT and mathematical modelling to support process knowledge enhancement
Dr Nicola Barison, Biologics Technical Lead

This presentation will focus on: -The application of in-line PAT tools such as Raman spectroscopy and laser-based particle characterisation technologies to support real-time monitoring of upstream and downstream bioprocesses. -Advanced process control complemented by PAT to support bioprocess optimisation. -Process scale-up and unit operation characterisation support using Computational Fluid Dynamics (CFD) tools.

photo of Dr Nicola Barison
About the speaker

Dr. Barison completed his Bacherlor’s degree in pharmaceutical biotechnologya and subsequent PhD in protein crystallography at the University of Padua in Italy. Following this, he was a postdoctoral fellow at Max Planck Institute for Infection Biology in Berlin for 3 years before joining Cobra Biologics. During his 5 years at Cobra Biologics, Dr. Barison progressed from a Senior Downstream Development Scientist role to becoming Principal Downstream Development Scientist. Dr. Barison currently holds the position of Biologics Technical Lead at APC Ltd. in Dublin where he utilizes his experience in process development of a large range of Biologics (Proteins, Viral Vectors, Plasmid DNA, Phages) to solve complex process-related issues affecting the global market.

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11:00 - 11:30 Refreshments & Partnering
11:30 - 12:30 Creating the conditions to enable win/win, sustainable outsourcing relationships. In this session we ask the speakers to share their perspectives on how to create effective outsourcing partnerships.
Chair: Dr Anna Matranga, Business Consultant, AMC Alliances & Consulting SASU
11:30
Confirmed title: Developing a supplier governance model as part of an integrated supplier relationship strategy
Dr Andrea Calenne, Senior Manager Global Strategic Sourcing

photo of Dr Andrea Calenne
About the speaker

Employed as Senior Manager External Manufacturing at Biogen International, Andrea is supplier relationship manager for the outsourced manufacture of injectable products (Biologicals and Oligonucleotides).

Over the past 15 years Andrea worked in multiple QA and External Manufacturing roles for CSL Behring, Bayer Healthcare and Biogen, managing a relevant number of manufacturing sites and a product portfolio including plasma derivatives, biologicals, as well as non-sterile pharmaceuticals distributed globally.

Starting his career in Corporate Quality Management within a Japanese automotive company (Bridgestone), Andrea developed his professional identity in an environment where outsourcing is key to product compliance as well as to the performance of the supply process.

Andrea holds a M.Sc. in Organic Chemistry from University La Sapienza in Rome, after graduation he completed a Master in Intellectual Property at the Italian Patent and Trade Mark Office. Andrea speaks Italian, English, French, Spanish and German.

Born 1972 in Rome (Italy) Andrea lives in Switzerland with his family since 2005. Andrea is Italian and Swiss national.

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11:50
Confirmed title: David and Goliath? Building successful and sustainable collaborations with CMOs - the view from a non-profit SME
Dr Joan Herbert, Director Business Development

photo of Dr Joan Herbert
About the speaker

I joined MMV in 2009 when I saw a unique opportunity to apply novel and exciting science to solve some real problems which will not only stop people from dying or becoming sick but can also turn their lives around and enable them to escape from poverty. I have almost nineteen years of experience in drug discovery and development gained in the biotechnology and contract research sectors and including six years at MMV. Prior to joining MMV, I held positions in business development with Paragon Biomedical, Synarc Inc., and PPD in Cambridge, UK and before that I worked as a research and senior scientist at Cambridge Antibody Technology. I have a Ph.D. in Immunology from the University of London and a B.Sc. in Biochemistry from the University of Glasgow. In 2014, I enrolled for a master’s degree in biomedical ethics and healthcare with the University of Leeds.

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12:10

,

About the speaker

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12:30 - 14:00 Lunch & Partnering
14:00 - 15:30 Innovator & Sponsor Showcasing Outsourcing Case Studies
Chair: Dr Alexander Bausch, CEO, Strekin
14:00
Confirmed joint title: Fragment based drug discovery partnership for an early phase biotech
Dr Kamal Azzaoui, CEO & Co-founder
Dr Thomas Fessard, CEO

photo of Dr Kamal Azzaoui
About the speaker

Dr. Kamal Azzaoui received his PhD in computational chemistry from the University of Orléans (France) followed by 2 postdocs at McGill University (Montréal) and Georgetown University (Washington DC).

Dr. Azzaoui worked for 2 years for a flavor and fragrance mid-size company as a senior computational chemist (Givaudan, Zurich, CH) and 15 years at Novartis as a laboratory head in charge of data analysis, data modeling and drug design using machine learning, cheminformatics and molecular modeling tools. He left Novartis in 2017 to co-found Saverna Therapeutics AG (www.saverna.com). He is finishing a master for advanced science (MAS) program of the Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) at the University of Bern. He has contributed to many drug discovery projects in term of data analysis, machine learning, medicinal chemistry and cheminformatics support. He also pioneered in developing machine learning models for the prediction of adverse effects and safety of novel drugs. He was a partner in the European Innovative Medicine Initiative (IMI OpenPhact) consortium. He is a consultant for Axxelis and co-founder/ CSO for VentureFlow (www.ventureflow.ch).

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photo of Dr Thomas Fessard
About the speaker

Thomas studied chemistry in France (ENSC, Montpellier) and the UK (UMIST, Manchester) and obtained a PhD degree from the university of Nottingham, UK.

After research appointments at the School of Pharmacy in Nottingham and ETH Zürich, Thomas joined Lipideon Biotechnology AG in 2007. As Head of the Drug Discovery and Chemistry, he lead a multi-disciplinary team that discovered a candidate for pre-clinical investigation (Non-Systemic Cholesterol Absorption Inhibitor).

In 2011, Thomas co-founded SpiroChem AG, Swiss fine chemicals company and serves as CEO of the company.

Thomas has several years of experience in the management of R&D projects, including medicinal chemistry, design of innovative building blocks for drug discovery and development of new process routes.

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14:30
Outsourcing strategies for the development of biosimilars
Norbert Bleich, COO and CMO

photo of Norbert Bleich
About the speaker

Norbert comes with Diploma degree in chemistry gained at the university of Freiburg and 25 years of experience at Quintiles (1993), Novartis (1998), Hoffmann-La Roche (2008), and Boehringer Ingelheim (2017).

He had leading positions in Pharma Development and Corporate functions, which included heading functions like Global Services implementing R&D hubs in Japan, China, and India, medical writing including document and submission management with responsibility for more than 200 Development projects and 10 NME submissions during this period, and portfolio governance for both the Clinical portfolio as well as Innovation and Efficiency in Development, and Portfolio Management of the Merial Animal Health integration into Boehringer Ingelheim.

As a successful entrepreneur, Norbert recently (co)-founded Versameb AG, a regenerative medicine start-up, kicking off the company as CEO.

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15:00
Joint presentation with Lee Smith: Collaboration between biotech, consultant & CRO to drive a vaccine’s development
Prof. Dr. Tudor Arvinte, Chairman & CEO
Dr Lee Smith, Principal Consultant, Managing Director

photo of Prof. Dr. Tudor Arvinte
About the speaker

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.

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photo of Dr Lee Smith
About the speaker

Dr. Lee Smith's experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.

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15:30 - 17:00 Conference Close & Drinks Reception