<p>Biotech Outsourcing Strategies <em>cmc</em> 2013:</p>

Maarten van Geffen’s career in the industry spans nearly 25 years, with substantial experience in pharmaceutical product development and regulatory affairs. Maarten was previously Director of Product Development at Shire-Movetis NV, where he was responsible for the pharmaceutical development of the GI early and late phase products and was the CMC lead for due diligence of early phase and late phase small and large molecule products. While at the Company, Maarten also played a pivotal role in the strategic development of commercial and pipeline products as well as carrying out quality control on dossiers and interacting with regulatory authorities. Prior to working at Shire-Movetis NV, Mr. van Geffen held several positions as Director of CMC Regulatory Affairs at Barrier Therapeutic NV, Centocor BV, and Janssen Research Foundation, where he was involved in managing and executing product development and regulatory approval. Before initiating his career in the industry Mr. Van Geffen was assessor of quality part pharmaceutical dossiers for the Dutch Health and Environmental agency. Mr. van Geffen received an MSc in Biology from the University of Utrecht, the Netherlands.

Dr. Frederik Beck has 20 years of experience from pharmaceutical and biotech companies. He is the CMC outsourcing manager at Zealand Pharma and has held this position for the past two years. 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.

Spoorthi Dharmayat is a Principal Scientist at LGC specialising in solid-state chemistry and characterisation of small organic molecules. Prior to joining LGC in October 2012, Spoorthi worked at Pfizer Global Research and Development as a Materials Scientist supporting the development of medicines from discovery to commercial manufacture. Spoorthi holds PhD and MEng degrees in Chemical Engineering from the University of Leeds.

I have been at Shire since Nov 2007 joining from AZ and the Fine Chemicals industry prior to that.  Originally a bench chemist after my PhD (Thesis title Regioselective Electrophilic Aromatic Substitutions over Solid-Support Catalysts) and development manufacture process chemist (scale-up lab to plant) before turning to procurement of API’s (Commercial and Development) and Raw Materials/Key Intermediates.

At Shire widened my categories/area of responsibility to API, Finished Dose, Packaging and Testing globally for Shire Specialty Pharma.  Shire SP is 100% outsourced in all these activities for branded product manufacture and I head up the team that has accountability for that supply base and all procurement/supplier relationship mgt activities from contract negotiations and daily oversight to strategic sourcing and long term vision supporting Global Supply Chain goals such as supply base partnering and consolidation.  I also personally support M&A activities that relate to Shire due diligences on commercialised products and some late stage development products.

Dr. Alexander Strätz is Sales Manager at Switzerland-based CARBOGEN AMCIS, a Dishman Group Company.  He holds a Ph.D. in metallorganic chemistry from the University of Cologne, where he focused on developing new platinum complexes as precursor for chemical vapor deposition (CVD) processes.

Alexander’s strong functional expertise on GMP production and validation of APIs and intermediates is further built on more than 10 years working within the pharmaceutical and chemical industry. Prior to joining CARBOGEN AMCIS, Alexander worked as a Business Development Manager for the Group Novasep SAS where he gained hands-on experience on custom development and manufacturing of APIs and Highly Potent APIs (HPAPIs) and chromatography. Previous assignments also include several positions in the sales Organization of Acros Organics (Thermo Fisher Scientific).

In his role as Sales Manager at CARBOGEN AMCIS, Alexander is responsible for business development in Scandinavia, The Netherlands and Eastern Europe and focuses on the coordination of CMC activities related to API and HPAPIs development and manufacturing on customers’ behalf.

Katrine Thor Andersen, Sr. Consultant and Owner, PharmAcross Consulting. 

Delivers R&D Outsourcing Management services to pharma clients. Services range from advising on outsourcing strategy, vendor evaluation and selection to negotiation and drafting of contracts. Katrine has worked with various aspects of drug development for fourteen years. Eight years as formulation scientist and technical project manager involving external partners developing oral, SC, inhalable drug products at Bristol Myers Squibb Co. and Novo Nordisk. Three years as R&D Outsourcing Manager at LEO Pharma covering the CMC, pre-clinical and clinical activities. Katrine has earned a Cand.Pharm degree from University of Copenhagen in 1999, an MSc in QA/RA from Temple University in 2004 and is a certified LEAN project manager.

Dr. Paul Deutsch currently heads the Chemical Process Research & Development (CPR&D) department within BioPharmaceutical Process Development group (CMC development function) at UCB Pharma. Major activities within CPR&D include chemical route selection, process development and scaleup for material supplies for all NCEs in UCB’s portfolio, technology transfer and validation of processes, as well as major process lifecycle management initiatives. 

Paul received his BS in Chemistry from Lehigh University (Bethlehem PA, USA) and a PhD in Chemistry from University of Rochester (Rochester NY, USA).  He subsequently spent 13 years performing, coordinating and managing process development and scale-up activities for active pharmaceutical ingredients at several CMOs – Lonza, Aerojet Fine Chemicals, and Cambrex. This included efforts working with many big and medium pharma companies as well as startups, and ranging from tox supplies to clinical supplies to launch, for both innovator and generic molecules. 

Dr. Deutsch then added 8 years experience within pharma companies, initially working as Director API development and Manufacturing at DOV Pharmaceutical, where he was involved with all GMP API activities, before moving to UCB.

Mr Sören Olsson has been with Cambrex for 34 years. Over this period, he has held the position as Manager R&D Analysis for 15 years and Project Leader Strategic Projects for two years. Since 2003, Sören has been the Director R&D New Products with primary responsibility for project management. Prior work experience includes time with Billerud as a Chemical Engineer.

David Lindholm is Nordic Business Manager at Recipharm. He has more than 10 years experience from the CDMO business, including formulation development, project management and business development.

David’s expertise lies within GMP production of finished dosage forms and he has a broad knowledge in pharmaceutical development, tech transfer, relationship management and commercial contracts.

In his role as Business Manager at Recipharm, David is responsible for business development in the Nordic countries related to commercial manufacturing. He also acts at account manager for key customers.

David earned a Master of Chemical Engineering in 2000 from Lund University.

Jean-Paul Hermet holds a Master’s degree in engineering from the University of Marseille, France, and a Ph.D. in organic chemistry from the University of York, UK. Jean-Paul started as a process development chemist in the pharmaceutical industry, working on setting-up new process for APIs and NCEs.

Jean-Paul joined Bachem in 2008, where he puts his experience to good use by helping pharma and biotech companies developing their small molecules NCEs. 

Marcel Hogerheide earned his Ph.D. in the area of organometallic chemistry. After initially working in the area of hybrid coatings, he has held various Sales and Business Development positions with service providers to the Pharmaceutical industry for the last 13 years. He joined Hovione in 2011 as Sr. Business Development Manager, with a focus on new business development in Europe and Japan.

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.

Henrik Næsted, Ph.D, Head of Manufacturing, Symphogen A/S.

Henrik Næsted is head of Manufacturing at Symphogen A/S. He completed his first degree and Ph.D. at the University of Copenhagen Denmark. Several years in industry and academia followed in both analytical and manufacturing development roles in addition to heading the Rozrolimupab program at Symphogen - a polyclonal antibody product consisting of 25 unique antibodies. He is now heading the Manufacturing team at Symphogen where the main emphasis is on the development of upstream and downstream processes, ensuring manufacturing strategies of single batch antibody mixtures using the Sympress™ technology platform.

Dr. Ulrich Rümenapp, Head of Biotech Projects, Contract Manufacturing Biotech, Bayer Pharma AG

Dr. Rümenapp is based in Berlin, Germany and working within the Product Supply Biotech division of Bayer Pharma AG, where he is responsible for external manufacturing cooperations in the field of biotechnological APIs and finished products.

In his current position as Head of Biotech Projects in Contract Manufacturing, he provides expertise in team leadership, manufacturing processes, and project management to both current and planned external cooperations, with the goal to ensure reliability in supply, quality, and economy of costs.

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 for small molecules 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 management of external relationships for the manufacture and supply of bio-pharmaceutical products and outsourcing CMC activities. He has more than 10 years of experience in the bio-pharmaceutical industry.

To correspond with Dr. Rümenapp, please contact him at: [email protected]

Amer completed his M.Sc in Pharmacology atBradfordUniversity, Postgraduate studies in Medical Sciences atUniversityCollegeHospital, Diploma in Biological Sciences fromSalfordUniversityand Postgraduate Certificate in Clinical Research fromSurreyUniversity.

Amer is a frequently invited speaker at international congresses and has presented and chaired at over 30 international congresses. He has over 22 years’ track record in the pharmaceutical industry (Clinical Development, Quality Assurance, Pharmacovigilance, Medical Information, & Medical Communications). For some time, he was the Assistant Editor for 11 Medical & Pharmaceutical journals. He contributed further to these disciplines by writing “The Pharmaceutical Medicine Dictionary” in April 2001 and “The Dictionary of Pharmacovigilance” in May 2004. He is currently writing his 3rd book, Dictionary of Clinical & Pharmaceutical Development.

Amer is currently the Director, Global Head of Quality Assurance & Audit Management at Merck Serono,Geneva,Switzerland. Prior to his current position he was the Global Head of GxP Quality Assurance atArpida Ag.,Switzerland. His previous positions include: Senior International Clinical Quality Assurance Auditor at Novartis Pharma Headquarters in Switzerland and he was the first Pharmacovigilance Compliance Coordinator of the Medicines and Healthcare products Regulatory Agency (MHRA) where he participated as part of the inspection team of the very first MHRA pharmacovigilance inspection of pharmaceutical companies.

In these roles, Amer conducted a vast number of audits including a spectrum of GCP, Pharmacovigilance, Clinical Laboratories, GLP, GCLP, GMP, Vendor, Protocol, Clinical Study Reports, Due Diligence, Fraud investigation and Databases audits. He is certified as a Lead Auditor by the International Register of Certified Auditors.

He served as an Executive Committee Member of International Society of Pharmacovigilance (ISoP) and the Good Pharmacovigilance Practice Committee of the British Association of Research Quality Assurance (BARQA), and is a member of the Society of Pharmaceutical Medicine, Associate of the Institute of Quality Assurance (IQA), DIA, Member of the Association of Clinical Research Professional (ACRP), and the Organization for Professions in the Regulatory Affairs (OPRA).

Allan Hey has extensive experience with outsourced biopharmaceutical development, both as a provider of services and a client.  After a PhD and post-doctoral work in protein purification and analysis, he worked for 12 years with an Australian company, BresaGen, which offered contract process development and manufacturing services.   Since moving to Denmark in 2008, he has held the positions of CMO Manager at Lundbeck, and Senior CMC Project Manager at Takeda (formerly Nycomed).  Both of these companies outsource much or all of their biopharmaceutical development and manufacturing work. 

Peter graduated from the University of Manchester Institute of Science and Technology with a degree in Biochemistry in 2001. He worked as a Protein Biochemist at GlaxoSmithKline and AstraZeneca before joining Syntaxin as a Senior Scientist in 2007. Subsequently Peter took on a Group Leader role, managing the process development and technical transfer of candidate molecules from Syntaxin’s pipeline. Peter is currently the Group Leader for the Molecular Biology and BioManufacturing groups at Syntaxin.

Edward van Wezel, Managing Partner BioGeneration Ventures Edward has extensive international expertise in small and large pharma and biotech companies. Edward currently serves on the the boards of Arcarios, NovioGendix, Progentix Orthobiology, Acerta Pharma and Cristal Delivery. He served on the board of BioCeros that was sold in 2011. Edward started his industrial career as process engineer for Chiron Inc. and working for Johnson & Johnson as project manager. At J&J he was responsible as CMC project manager for several small molecule and biologics development projects. In addition he was involved in several in-licensing activities in the oncology franchise. Since 2000 he gained experience in small start-up and early stage companies in the Netherlands. He was director business development at Pepscan Systems and managing director of a semi-virtual company Macrozyme. At Macrozyme Edward was responsible for the complete pre-clinical development of a new chemical entity that under his responsibility was successfully partnered with Genzyme Inc. in 2005.

Ola (M.Sc. Biological engineering) holds the position as Head of Operations at the Cobra Biologicals site in Matfors, Sweden. He is responsible for the operation of the sites microbial large scale production facility and the aseptic  fill/finish plant. He joined the company in 2010 coming from AstraZeneca where he worked as a Senior Scientist in the field of large scale target expression in mammalian cell systems. Ola has 10 years of experience from the Pharma and Biotech industry spanning from early development to commercial production.

Magnus Gustafsson’s background is of a scientific kind rather than in business development and he holds a PhD in medical protein science from Karolinska Institute and has an engineering degree from the Royal Institute of Technology, Stockholm. Today he works as Business Manager selling Cobras services including monoclonal antibodies, other recombinant proteins, DNA, virus and fill&finish including lyophilization and packaging  to Cobra’s customers in Northern Europe.

Cobra Biologics has 160 employees, three GMP sites and has over the last 15 years supplied more than 320 batches to more than 100 customers located in 19 different countries on all continents of the world (except for Antarctica).

I graduated at the Technical University of Braunschweig with a degree in Biotechnology in 2005. I obtained my Ph.D at the Medical University in Hannover in the field of oncology and cell biology. Here I identified a formerly unknown protein which is playing an important role in cell cycle control and potentially in the formation of cancer (Thesis title: The SCF–FBXW5 E3-ubiquitin ligase is regulated by PLK4 and targets HsSAS-6 to control centrosome duplication). In 2011 I started my career at Boehringer Ingelheim as a postdoc working on the evaluation and characterization of new techniques/host cells for cell line development. Changing one year later to the position of a Scientific Expert Bioassay gave me the opportunity to broaden my knowledge especially in the field of assay development and new bioassay formats.

Jesper Valbjorn joined Genmab A/S in 2006. He is heading CMC Operations with responsibility for the CMC activities in Genmabs projects from early phase to late phase validated commercial scale. Additionally the unit is responsible for the clinical drug supply logistics and preparation of CMC sections for regulatory filings.

Jesper Valbjørn has 15 years of experience within CMC development in the biopharma industry with positions as project manager, line manager and scientist at H. Lundbeck, Statens Serum Institut and Novo Nordisk.

Jesper Valbjørn holds a MSc in Plant Biochemistry and is inventor of patents in the field of analytical science and process science.

Christoph Rosenbohm is responsible for managing the company’s chemistry activities including in-house synthesis of both novel analogues and oligonucleotides, synthesis of non GMP and GMP material at CMO, analytical chemistry and project management.

He is author and co-author of than 30 scientific publications and patents. M. Sc. and Ph.D. in chemistry were obtained from the University of Southern Denmark with Prof. Jesper Wengel – one of the inventors of LNA - as supervisor. In addition he is an MBA graduate of the Copenhagen Business School.

Mr. Breault is a retained advisor to innovative companies providing value-added services to the Pharma industry, and serves as Chairman of the Advisory Board of the Procurement Leaders Network.  He is a career Productivity, Supply Chain, Sourcing and Procurement executive with strategic and operational experience in the Pharmaceuticals, Electronics, and Aviation industries. He is an acknowledged expert in the field of Global Procurement, Productivity and Offshoring/Outsourcing, and has led several Procurement & Supply Chain restructuring efforts focused at maximizing the return on investment in supply chain and procurement resources.

Mr. Breault is a sought after speaker and industry opinion leader in his field of interest. Previously he was Chief Procurement Officer, Novartis Pharmaceuticals, Basel, Switzerland, Senior Vice-President, Aventis Pharmaceuticals in Frankfurt, Germany, and held several positions at F. Hoffman La Roche in the US.

In his capacity as VP R&D, Site Manager at Egalet Ltd, Denmark, Karsten Lindhardt is responsible for the operational management of all R&D functions in the company and serves as a general manager of the Danish branch. During his more than 15 years of experience in various R&D functions in academia, biotech and pharmaceutical companies he has received hands on experience in drug development and in handling the interaction between Organization/Project Culture/Risk Management/Value optimization. Earlier, he has been Senior Director of Portfolio and Alliance Management at Egalet Ltd. where he came from a position as Senior Clinical Project Manager at Curalogic a/s, Denmark. Before that he was Project Director in Prosidion, UK, that successfully developed NCEs from Discovery to c-PoC. He has been responsible for various R&D management functions performed through a virtual organization including ensuring candidate selection, API upscaling (mg scale to multiple kg scale), pharmaceutical development, pre-clinical, Phase I-III clinical trials, executive management and execution of exit strategies. He has been deeply involved in out-licensing activities, creating business plans and managed to make deals and build relations with various pharmaceutical companies of variable sizes. He has also worked in Clinical Pharmacology in Ferring Pharmaceuticals and Novo Nordisk a/s.

Dr Hans Lindner is Head of External Technology & Innovation in Bayer Pharma. This function is overseeing all external pharmaceutical development activities including technology scouting and contracting.

Hans is a pharmacist by training with a doctorate degree in pharmaceutical technology. He served in various positions in pharmaceutical industry, starting as formulation scientist at Arzneimittelwerk Dresden GmbH in 1994 in Germany. He joined Ferring Pharmaceuticals in 1996, where he gradually took over positions with rising responsibility, ultimately leading the consolidated pharmaceutical development function in Copenhagen. In 2004, Hans moved to Schwarz Pharma, Germany, as head of pharmaceutical development. After the merger with UCB S.A. in 2007, he took over Drug Product Development & Industrialisation in Belgium. Hans joined Bayer Pharma in 2008, initially leading global pharmaceutical development until he took over his current role in 2012.

Hans is member of the editorial board of the European Journal of Pharmaceutics and Biopharmaceutics, member of various professional associations and past vice president of the European Association Pharma Biotechnology (EAPB).

Dr. Rümenapp is based in Berlin, Germany and working within the Product Supply Biotech division of Bayer Pharma AG, where he is responsible for external manufacturing cooperations in the field of biotechnological APIs and finished products. 

In his current position as Head of Biotech Projects in Contract Manufacturing, he provides expertise in team leadership, manufacturing processes, and project management to both current and planned external cooperations, with the goal to ensure reliability in supply, quality, and economy of costs. 

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 for small molecules and biologics.

Marcel Hogerheide earned his Ph.D. in the area of organometallic chemistry. After initially working in the area of hybrid coatings, he has held various Sales and Business Development positions with service providers to the Pharmaceutical industry for the last 13 years. He joined Hovione in 2011 as Sr. Business Development Manager, with a focus on new business development in Europe and Japan.

Roger Joby Bsc. CSi CertMgmt MAPM

An international project management consultant and educator in Project Management, with over 40 years experience in the pharmaceutical sector. Roger has worked for both Pharmaceutical companies in project management and outsourcing, and in CROs as head of clinical operations and in a number of senior positions in contracts and proposal departments.

Roger has also taken an active role in project management research collaborating with Professor David Bryde Liverpool JM University as well as being an active member of the planning and project control special interest group of the Association for Project Management(APM).

Over the last decade Roger has worked with a number of sponsor and supplier companies including MedImmune, AstraZenica, Boehringer Ingelheim, NovoNordisk, Solvay, Misubushi, Ono Pharma, Quintiles, Harrisons, CroMedica, and Bio Products Laboratory.

Antonina Nijran is Senior Associate at Fasken Martineau LLP and a member of the Technology and Intellectual Property and Life Sciences practice groups.

Antonina advises on a wide range of commercial, intellectual property and transactional matters and undertakes commercial work for a variety of corporate clients, including advising on agency, distribution and franchise arrangements, licensing deals, services agreements, including consultancy arrangements, sale and purchase terms, website terms of use, assignment and novation agreements and confidentiality agreements.

As a key member of the Life Sciences team, Antonina advises a variety of pharmaceutical and biotech companies in the life sciences sector including advising on negotiating and drafting licensing arrangements, development deals, research and development collaborations, manufacture and supply arrangements, distribution agreements, material transfer agreements and quality and pharmacovigilance agreements.

Antonina has experience in advising on a variety of matters in the technology sector, including, website and software development projects, software licencing and maintenance agreements, master services agreements, reseller agreements and escrow agreements.

Antonina also advises clients in different industry sectors on privacy and data protection issues, including transfer of personal data outside the EEA, data transfer agreements, preparation of data protection registrations and questionnaires for data protection audits and drafting data protection sections of staff handbooks and privacy policies.

Francesca advises clients on a wide range of intellectual property, information technology, regulatory and transactional matters in the life sciences sector. Her pharmaceutical industry experience is wide ranging and includes both in-house to pharmaceutical companies and as an external legal adviser.

She has spent a considerable period of time seconded to the contracting and outsourcing development team of large global pharmaceutical client companies and continues to support one of the firm’s such clients in this capacity. This has heightened her strong focus on speedy client-centric delivery aligned with practical and business focused solutions. In her current secondment role, Francesca provides full legal support to the Procurement Function. She also assists the Compliance Officer on the implementation of compliance programmes and compliance training. She is responsible for all contracting activity in respect of consultancy requests relating to Clinical Operations, Regulatory, PV and QA and also provides legal support to Facilities, IT and HR.

Francesca has experience in representing commercial clients on a broad range of intellectual property matters including trademarks, copyright, confidentiality and licensing. She frequently advises on a range of technology related contracts including IT and outsourcing contracts and technology procurements. Her experience also includes drafting commercial agreements and conducting due diligence investigations for mergers and acquisitions.

Francesca has experience advising on preparing and negotiating confidentiality agreements, material release agreements, a range of clinical trial related agreements and documents, consultancy agreements, supply and distribution agreements, research and development agreements, licensing agreements, collaboration agreements, contract manufacture and technical agreements and other general commercial documents. She also has experience advising on issues relating to data protection/privacy, general outsourcing, ABPI Code of Practice requirements, confidentiality, ownership and publication of data arising from clinical trials and risk management such as limitation of liability, indemnities and insurance.