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Speaker Profiles - Discovery/Early Development Track

Dr Christoph Rosenbohm, Head of Discovery Ops,
Roche Innovation Center Copenhagen
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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.

Dr Garry Pairaudeau, Head of Hit Discovery,
AstraZeneca
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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.

Dr Paul Beswick, Director of UK Chemistry & IP,
Bicycle Therapeutics
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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

Dr Vicky Steadman, General Manager,
Eurofins Selcia
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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 Selcia Drug Discovery and additionally taken on a global role as Business Line Leader of Integrated Drug Discovery Services at Eurofins Pharma Discovery Services. 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.

Dr Brice Campo, Director, Discovery Department,
Medicines for Malaria Venture
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Brice is a Director Drug Discovery at Medicines for Malaria Venture (MMV). He leads drug discovery activities in the context of individual projects and pharmacology platforms. As Director Drug Discovery, Brice provides scientific advices and leadership to portfolio of drug discovery activities projects and pharmacology platforms. He works with partners from both academia and industry in order to deliver pertinent and optimal biological test cascades as well as safe and efficacious pre-clinical candidate which will be part of the next generation of anti-malarials. Brice has a particular interest in molecules and biological assays that tackle the liver stage of the parasite and more precisely the hypnozoites reservoir in order to find the new drugs that will help eradicate Malaria.

He joined MMV in November 2011, bringing with him more than 14 years of experience in drug discovery, gained primarily with the Genomic Institute of the Novartis Foundation (GNF) and Addex Pharmaceuticals S.A. He has broad experience in molecular pharmacology and drug discovery in several disease areas such as Neuroscience, Metabolic Disease and Inflammation, and has successfully led and contributed to teams at all stages of drug discovery. Brice holds a PhD in Neuroscience and Immunology from the University of Sheffield (UK) and has published a significant number of scientific papers and patent applications.

 

Dr Silvia Fonquerna, Head of Research Alliances,
Almirall
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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.

Dave Madge, Vice President, Research Services Division,
Wuxi AppTec Inc
Dr Inez de Greef-van der Sandt, CEO, Treeway & Partner, 3D-PharmXchange,
Treeway & 3D-PharmXchange
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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. 

Read Abstract...

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.

Featured Profile
Dr Steve Collingwood, Head of Chemistry,
Enterprise Therapeutics Ltd.
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Head of Chemistry
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.

Dr Neil Press, Director, Global Discovery Chemistry,
Novartis Pharma AG
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Dr Press studied undergraduate chemistry at Imperial College, London, staying on to complete his PhD research on ‘macrocyclic stereocontrol’ in the labs of Prof Don Craig. He subsequently undertook postdoctoral research with Professor Phil Magnus at the University of Texas in Austin. Here he worked on a total synthesis of calicheamicinone, a potent anti-tumour compound with a particularly elegant mode of action.

In 1995 Neil joined the central research laboratories of Ciba-Geigy, Macclesfield, and subsequently moved to the Novartis Horsham research centre after the merger with Sandoz. Neil has worked as a medicinal chemist for 23 years, having led multiple projects from early phase through to clinical compounds. He is currently a Director in Novartis global discovery chemistry and is based in Basel where he leads a medicinal chemistry team. Neil’s current interests are in finding new, inventive ways to enable and expedite the target and drug discovery process through chemistry, computation and multidisciplinary collaboration.

Tim, Collins,
Test Labs
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Dr Paul Beswick, Director of UK Chemistry & IP,
Bicycle Therapeutics
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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

Speaker Profiles - Small Molecule Stream

Dr Charlie Hitscherich, Head of Clinical Supply & External Manufacturing,
Alnylam Pharmaceuticals
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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.

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

Dr Alexandre Gil, Head of External Development - Small Molecules / Oral Delivery Platform,
Sanofi
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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.

Dr Craig Harris, Senior Expert Scientist API Synthesis,
Galderma
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As the lead for both discovery and development synthesis, Craig is responsible for driving the synthesis from lead generation all the way through to cGMP manufacture for Galderma S.A., Entre-Deux-Villes, Switzerland. After receiving his B.Sc. and Ph.D. from the University of Manchester in 1997, Craig was taken on by AstraZeneca as Senior Process Chemist at Macclesfield, U.K. In 2000, after a short secondment at Alderley Park working in the Oncology iMed, Craig transferred to the Reims site in France and continued to support the Oncology iMed contributing to many programs including the clinical candidates AZD1845, AZD4769 and AZD8835. In 2012, AstraZeneca closed the research facility in Reims and, after a short spell at Adocia (Lyon, France), Craig was recruited to lead the research synthesis for Galderma, a dermatology-focused pharma company in Sophia-Antipolis, France. In 2014, he was promoted to Senior Expert Scientist and became responsible for the synthesis support strategy to both the discovery medicinal chemistry and aesthetic and corrective project portfolio. During his time 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 site. In 2017, after Nestlé’s decision to stop active research and development activities on the Sophia-Antipolis site in France, Craig was chosen to lead the synthesis going forwards for Galderma S.A., now adopting a virtual R&D model in Switzerland.

Bianca Matthee, Vice President Manufacturing & Pharmaceutics,
ProQR
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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.

Dr Ronald van der Geest, Partner, 3D-PharmXchange & CDO, Treeway,
3D-PharmXchange & Treeway
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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.

Read Abstract...

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.

Featured Profile
Dr Youchu Wang, Head of Process R&D, Changzhou Site ,
STA Pharmaceuticals, a WuXi AppTec Company
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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

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.

Dr Georg Wuitschik, Senior Scientist,
F. Hoffmann-La Roche Ltd
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Dr. Wuitschik leads a laboratory 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.

Katrine Bonner, Key Account Director, Externalisation Centre of Excellence,
GSK
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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.

 

Dr Dennis Wetzl, Scientist, Process Chemistry & Catalysis,
F. Hoffmann-La Roche Ltd
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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.
Dr Christian Miksch, Director Sales API,
Fareva S.A. Service Comptabilite
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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 oncology 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.

Read Abstract...

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

Mr Felix Faupel, Head of Contract Manufacturing,
Acino International
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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.

Mr Alessio Piccoli, Business Development Manager,
SK Holdings
Dr. Ray Sexton, BDM,
Solvias AG
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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.

Read Abstract...

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.

Mr David O'Connell, Director of Scientific Affairs,
PCI Pharma Services

Speaker Profiles - Biologics Stream

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

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

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

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

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

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

Read Abstract...

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

 

Dr Andreas Aspoeck, Head of External Manufacturing,
Hookipa Biotech AG
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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.

Dr Christian Cimander, Director, CMC,
Genmab A/S
Dr Thomas Wegge, Senior Director of Analytical Sciences,
Ascendis Pharma GmbH
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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.

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

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

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

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

 

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

Sebastian Pungel, Programme Manager,
Univercells
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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.

Dr Mette Husbyn, Chief Technology Officer,
Vaccibody
Read Abstract...

Confirmed presentation title:  Logistics as a major player in the supply of personalized therapeutic cancer pDNA vaccines

Speaker Profiles - Session Chair

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

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

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

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

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

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

Dr Anna Matranga, Business Consultant,
AMC Alliances & Consulting SASU
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PhD, MBA, CA-AM

AMC is a British/Italian national based in France. She has worked in international leadership roles for the pharmaceutical industry over the last 25+ years working for Eli Lilly (Erl Wood, UK), Allergan (Sophia Antipolis, France), Galderma (Sophia Antipolis, France) & at Ipsen Innovation (Paris, France). She has also worked in Baden-Baden, Germany.

She started her consultancy practice in 2016. She provides business strategy to operations support to pharma/biotech/CROs/academia in alliance management, B2B matchmaking, outsourcing/ procurement, contract management and operational excellence. She also provides group and/or 1:1 training/coaching in effective communication, leadership, management of cultural diversity, effective negotiations, how to manage the risk in your service contracts, vendor quality management and how to optimize the Sponsor/Partner/Supplier relationship. These are conducted in English and French (and some Italian when needed!). She is a part-time lecturer at several business schools.

She holds a PhD in microbiology (from Bristol University) and an MBA in general management/finance (from Henley Management College) and has obtained certification in alliance management (from ASAP). She has strong experience in alliance/relationship management, leadership, project management, procurement/negotiation, training, and performance management. AMC is an alumni member at the universities of Trent, Bristol and Henley management college as well as a member of SIETAR. She is a regular industry speaker at pharma conferences.

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

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

Dr Hayley Binch, Head of Medicinal Chemistry,
F. Hoffmann-La Roche Ltd
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Hayley Binch is Head of Medicinal Chemistry, Basel at Hoffman-La Roche. Prior to her current role, Hayley worked Vertex Pharmaceuticals at both the San Diego and Oxford sites, where she worked on a number of kinases and pain targets as well as Cystic Fibrosis. Hayley completed her her PhD at the University of Bristol with Professor Tim Gallagher, followed by postdoctoral research positions at the University of Hamburg in the area of synthetic and enzymatic methodology for complex carbohydrate assembly and at Kings College London in the area of nucleophilic additions to asymmetric vinylphosphonamidates.

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

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

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

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

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

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

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

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

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

Prof. Dr. Tudor Arvinte, Chairman & CEO,
Therapeomics Inc
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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.

Dr Simon Cruwys, Co-founder and Director,
TherapeutAix

Speaker Profiles - Plenary

Dr Andrea Calenne, Senior Manager External Manufacturing,
Biogen
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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.

 

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

Dr Helge Tippmann, Senior Category Manager,
Novo Nordisk A/S
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Helge Tippmann joined Novo Nordisk in 2013 and currently works as Senior Category Manager in Strategic Sourcing, responsible for outsourcing of API, intermediates and complex materials. Helge has been responsible for different direct spend categories, has a strong negotiation background and has extensive experience with implementing ethical sourcing standards in the supply chain. Helge has over a decade experience with outsourcing for global pharmaceutical companies and has been working within the Biotech field for 17 years in different positions in Specialist and Manager Roles. 

 

 

Gabriele Sassi, Non Clinical Outsourcing Manager (CMC),
CHIESI FARMACEUTICI SPA
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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).

 

Dr Joan Herbert, Director Business Development,
Medicines for Malaria Venture
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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.

Dr Karsten Marx, CMC & Supply Chain Manager,
Polyphor
Prof. Dr. Tudor Arvinte, Chairman & CEO,
Therapeomics Inc
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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.

Dr Lee Smith, Principal Consultant, Managing Director,
GreyRigge Associates

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