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

Elisabeth Mortimer, MSc, MBA

Elisabeth has been working as a regulatory toxicologist with the pharmaceutical industry for over 20 years.  She began her career with 8 years at Glaxo (UK/USA) following which she joined Novo Nordisk in Copenhagen where she was responsible for a number of their small molecule diabetes candidates, most notably PPARs.  Following a further 4 years in business development for a French CRO, she then returned to the UK to spend a further 7 years working for a drug development consultancy.   In her consultancy role, she worked with a wide range of companies and was responsible for preclinical strategy and implementation as well as leading the European team of toxicologists and serving as a Project Director in a diverse variety of therapeutic areas. In 2010, she joined Pfizer in Sandwich as a Research Fellow and head of the Study Director group.  In 2011, following the Sandwich site closure; she joined Neusentis (Pfizer’s pain research unit) in Cambridge where she is currently Director of Toxicology.  Elisabeth holds a BSc (York) in Biology, an MSc (Surrey) in applied toxicology and an MBA in Life Sciences from the Open University. She is a registered toxicologist and currently serves as a member of the ABPI preclinical drug safety subgroup.

Matt is currently CEO of Isomerase Therapeutics Ltd., a drug discovery and development company based in Cambridge, UK, with particular expertise in optimised microbial natural products. His previous role was Director of IP and Project Management at Biotica Technology Ltd., where he was for over 10 years, with responsibilities that included management of all outsourced discovery and development activities.

Hugh is currently Head of Pharmacology at TPP Global Development, a virtual drug discovery company based in Edinburgh. Following 12 years in academic research in the UK & US he worked at Organon/Merck, Newhouse from 2001 to 2010 as Neurobiology Section Head, he managed a team of scientists (32FTE) working on psychiatry, neurology and pain projects and an equal resource allocated to outsourced activities. Also active on a range of teams from Neuroscience Lead Finding through Lead Optimisation to Early Clinical Development programmes, Hugh was a member of the pre-clinical team responsible for supporting Asenapine’s (Saphris/Sycrest) registration by the FDA & EMEA. He holds an Honorary Professorship at the University of St Andrews is a serving member of BAP Council

Prof. Dr. Eckhard Ottow is currently Vice President and Head of Global External Innovation & Alliances inside Global Drug Discovery of Bayer HealthCare. Together with his team he is responsible for sourcing, development and execution of external innovations and alliances for GDD. Before assuming his current position in October 2012, Dr. Ottow served as Head of Medicinal Chemistry Berlin for more than 10 years. He received his Ph.D. degree in chemistry from Hanover University, Germany, in 1982, conducted thereafter postdoctoral research at the University of Berkeley, California and started out his scientific industrial career in working on steroidal projects in the Gynecology Therapy area of Schering AG in 1982. Today he overlooks more than 30 years of pharmaceutical industry experience. In 2002 he was appointed honorary professor at the Technical University Berlin and teaches currently at the Free and Technical University in Berlin. In addition, he is since 2011 member and since 2013 Vice President of the board of the German Chemical Society (GDCh).

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.

Mr. Jocelyn Saget holds a MSc. in Chemistry and has been working for over 12 years in the pharmaceutical and biopharmaceutical contract research and manufacturing industry. He has been working for CARBOGEN AMCIS since 2009 as Business Development Manager. Jocelyn Saget has expertise in all aspects of CMC support to the emerging Biopharmaceutical industry.

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.

Ton Vries has been Syncom´s CEO since 2000 when he succeeded Prof. Hans Wynberg, founder of Syncom.  Since 1991 Ton has worked in various roles of increasing responsibility in Syncom as Director of Research, Group Leader and Research Chemist. He has been involved in many different aspects of Syncom business including scientific development, chiral technologies, business development and business strategy.

Ton obtained his MSc in 1988 and received his PhD in Organic Chemistry in the field of chiral resolutions in 1996 from the University of Groningen, The Netherlands.

Ian is a biochemist who after initially working in Applied Research, Regulatory and Formulation and Development  groups for SmithKline Beecham moved into project management. Ian has more than 20 years of project and programme management experience spanning  programme and project management for all phases of product development. This has been gained within varied organisational structures spanning large pharmaceutical company, pharmaceutical service companies, contract research organisations and the virtual pharmaceutical biotech environment. He now works for Destiny Pharma Ltd., a clinical phase UK based biotech company.

Ian is currently Head of Project Leadership at Acacia Pharma Ltd, a virtual company focussed upon cancer supportive care. Ian joined Acacia from Sosei R&D where he was Development Group Head and was responsible for leading several programmes through to commercialisation, including AD237 for COPD and AD923 for cancer breakthrough pain.  He gained B. Pharm and PhD degrees from the University of Nottingham, and has significant global development experience gained with a range of pharmaceutical companies, including Reckitt and Colman, Ethical Pharmaceuticals, Quadrant Healthcare, Arakis and Sosei. 

Joachim is VP of Medicinal Chemistry at Syngene / Bangalore since 01/08/2013, having for the previous 11 years held several positions at the Danish ion channel drug discovery specialist Neurosearch and its management buyout follow up company Aniona, of which he was a VP and co-founder. During his tenure at Neurosearch, Joachim was responsible for project managing several ion channel DD programs, most notably the discovery/design and development of several new series of IK potassium channel blockers as novel anti-inflammatories for use in IBD. Apart from that he was Head of Medicinal Chemistry and Director for External Chemistry, a capacity in which he ran several outsourced chemistry ventures at European and Asian CROs, including a successful 9 year collaboration with Syngene, where he has just taken up his new post.

Prior to that Joachim obtained his BSc (Imperial College) and PhD (Cambridge) and held posts in Brazil (University of Brasilia and Universidade Federal de Pernambuco) and Sandoz Pharma (then Novartis) (Basel)

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.

Diane is a versatile and adaptable leader with a comprehensive knowledge of clinical development and outsourcing of clinical trials. Diane’s career spans over 20 years and across all continents. She started with Glaxo Laboratories (GSK) in 1980 and developed through several Big Pharma, BioTechs, and CROs in roles of increasing seniority until she recently joined Fujifilm Kyowa Kirin Biologicals (FKB) as Director of Clinical Operations in their UK offices. FKB is a new start-up  company working on a portfolio of biosimilars.

Peter MacLennan has many years of research experience both in academia and pharmaceutical industry. He has been with ORION Clinical Services since 2001 where he is responsible for Business Development, the company’s German Business Unit and the Data Management/Statistics team.  Before joining ORION he worked for other CROs in business and operational roles and prior to that spent several years in the pharmaceutical industry with responsibilities in clinical development, selection and management of CROs and medico-marketing activities. He began his career in academic research with a PhD in Biochemistry at Dundee University and was a Lecturer at Liverpool University.

Amer completed his M.Sc in Pharmacology at BradfordUniversity, Postgraduate studies in Medical Sciences at University College Hospital, Diploma in Biological Sciences from Salford University and Postgraduate Certificate in Clinical Research from Surrey University.

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 at Arpida 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).

Dr Penelope (Penny) Ward is founder and Director of PWG Consulting (Biopharma) Ltd. She qualified in medicine from University Hospital London entering the pharmaceutical industry as a clinical research physician in 1991, after a clinical career in academic medicine and obstetrics and gynaecology. She has enjoyed an extensive industry career, including senior roles in both large pharma and small biotech companies. Her experience encompasses translational medicine, early and late stage clinical development, medical affairs, OTC switch and pharmacovigilance. Her work has resulted in the launch of several innovative medicines, small molecule and biologics, now used for the treatment of infection, inflammatory disorders, osteoporosis, neurological conditions, cancer and sexual and reproductive disorders. 

Mark has over 20 years of experience in the global Pharma R&D industry. During this time he has gained experience in large multinational pharma, mid-cap US biotech, and private VC/PE backed organisations. He is currently Managing Director of Quotient Clinical, where he has led the development of disruptive services and technology platforms to help clients (both large and medium/small sized pharma) to transform their drug development processes. Before Quotient, Mark was Chief Business Officer for a UK biotech, focused on novel therapeutics for respiratory disorders. Prior to that Mark worked for Incyte, a Californian biotech, and in the earlier stages of his career, a number of positions of increasing responsibility in Pharma R&D, initially for Sandoz (now Novartis) based in Basel, Swtizerland and then Zeneca (now AstraZeneca) based in Manchester, England.

Mark attended Leicester University from which he holds a BSc (Hons) degree in Biological Sciences, and the University of Edinburgh where he earned his PhD in Biochemistry.

Martin Westcott is a Business Development Manager at LGC, a leading provider of analytical testing services for the Pharmaceutical and Biotech industries.

Martin has a BSc (Hons) in Chemistry, and has been working within the CRO environment for 15 years. He has extensive experience in analytical testing, ranging across the full spectrum of products both in development and also on the market. Prior to moving into Business Development, Martin’s previous roles were within the laboratory both as an Analytical Chemist and as an Analytical Projects Manager.

LGC have a great deal of experience in the testing of Pharmaceutical products throughout the various phases of product development, with a wide variety of clients from virtual companies to international names in the Pharma, Healthcare and Household sectors. Following the acquisition of Quotient Bioanalytical Sciences in December 2012, LGC are also now a leading provider of analytical services to the Biotech sector.

Outside of work, Martin is a proud father to 4 young children. He is also a keen all-round sportsman, mostly playing football or running. Martin completed the Marathon des Sables in 2008.

Jon began work at a small biotech (Microscience, later acquired by Emergent Biosolutions) supporting new vaccine construction activities.  After 4 years in various molecular biology technical roles he moved into the project management team.  Here, he led projects in challenging disease areas across Asia as well as North and South America.  Primarily the focus was on combating human infectious disease - HIV, Anthrax, Plague, Hepatitis B, Chlamydia, Clostridium difficile and Highly Pathogenic Avian Influenza.   Most experience is in programs involving the design and development of vaccines using live bacterial or viral vectors.
After leaving Emergent in 2011, Jon worked briefly as a contractor before taking up a position at University College London as a Translational Project Manager.  This role provides project management expertise to steer academic development programmes towards practical endpoints.  This frequently includes management of collaborations and external service providers to provide services to GxP, consulting, prototype development etc. Jon holds a BSc (Bath) in Applied Biology, a PhD (Warwick) in Molecular Biology and holds an Association for Project Management APMP qualification.

Sarah Deeley is a biomedical scientist with nearly a decade experience in clinical research working in small and large biotechnology companies and currently at Shire Pharmaceuticals. Sarah is a senior clinical scientist, and is responsible for the planning, implementation, execution and management of clinical research studies, phases II - IV. Her role involves managing the outsourcing of clinical trial studies (interventional / non interventional) to contract research organisations (CROs), including supervision of the outsourced study from start up to completion to ensure that set objectives, timelines and milestones are achieved on time according to standard operating procedures, international regulations, set quality and budget.

Sandra has worked in the biopharmaceutical industry for nearly 17 years.  She began her career in the UK with 7 years in business development for Contract Research Organisations Syne qua non and PRA International.  Sandra then worked for 9 years in Switzerland in various strategic sourcing roles for Roche and Novartis.  She has worked in different outsourcing models for clinical development and medical affairs with increasing areas of responsibility.  In 2013 she set up her own outsourcing consultancy based in Switzerland which provides contracts and sourcing advice to biotech, device and pharmaceutical companies in Europe.  Sandra holds a BSc (Hons) Surrey University (UK), a Marketing Management Diploma (Australia) and is a member of Pharmaceutical Contracts Management Group, Swiss Association for Pharmaceutical Professionals and Chartered Institute of Purchasing. 

Dr Phil Jones

Phil received his PhD from the University of Manchester and studied at Imperial College with Professor S V Ley.  In 1986 Phil joined Roche Discovery Welwyn, UK as a medicinal chemistry team leader, then project leader and departmental head. In 2001, Phil joined Organon and in 2003 became Executive Director with responsibility for the chemistry group at Newhouse, Scotland which became part of Schering-Plough Research Institute in 2007 and MSD in 2009. In 2010 and 2011 Phil was acting site head of the Newhouse facility managing the closure of the site and leading the successful search for a new owner. During 2012 Phil was a member of the consortium which was awarded funding for the IMI European Lead Factory and in 2013 he was appointed Director of the European Screening Centre at Newhouse. Phil was elected a Fellow of the Royal Society of Chemistry in 2005 and is an author on over 50 scientific papers and patents.

Steve Greentree is currently the Director GlobalPortfolio Management for biologics at Mylan GmbH in Zurich Switzerland. His responsibilities include portfolio,program and project management for the range of biosimilar products in Mylan's development pipeline. As a relative newcomer to the field of biosimilars he is particularly interested in the development and application of standard portfolio and program management methods to support this business model. In this position he applies the knowledge and expertise gained from more than 25 years spent in a variety of drug development positions in the pharmaceutical and biotechnology industry.

Sharon Grimster has 30 years’ experience in development of biological and small molecule pharmaceuticals. Her career began in Guys Hospital London, where she developed new analytical methods for clinical research.  Sharon then spent 18 years at Celltech in a number of management roles in research, manufacturing and project management.  She subsequently joined the senior management team at  Antisoma, to lead project management, manufacturing, quality, regulatory, and business operations. In 2011, Sharon joined the senior management team at F-star to lead the development of bispecific antibodies generated from F-star’s modular antibody technology platform. Sharon’s experience covers a range of therapeutic areas, including oncology, respiratory and autoimmune diseases.

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.

Keith Rodgers is managing director of Inspirexe Limited, a business strategy consultancy which serves the full range of organisations from small early stage to large blue chip including academic and not-for-profit organisations.

Keith is also currently the Chair of the Pharmaceutical Industry Project Management Group (PIPMG)

He is an accomplished director, senior executive, senior consultant, business coach and project management professional with a background which includes the pharmaceutical, biotechnology, diagnostic, device, engineering, and packaging sectors including 20 years with Wellcome and GlaxoWellcome.

Inspirexe provides inspiration in the areas of strategy, vision, change, leadership, project management, programme management, board & executive leadership and facilitation. Keith has
  Provided strategic consulting to organisations
  Delivered complex projects both within budget and to tight time scales and has delivered project turnarounds
  Provided business coaching for high tech, high growth organisations
  Led international teams to scope and plan business critical change projects
  Chaired steering committees
  Worked with a wide variety of organizations including large blue chip (GlaxoWellcome, Astra Zeneca), medium (Cambridge Antibody Technology, Xenova), small sized and not for profit organizations
  Delivered presentations, workshops and chaired sessions at international conferences including pharmaceutical, clinical, device, portfolio & project management

Keith holds an MBA, MSc, PMP , Diploma in Company Direction, and honours degree. Keith is also a Chartered Scientist, Chartered Chemist and current or recent member of a number of professional associations (including Member Project Management Institute, Member Royal Society of Chemistry, Chartered Institute of Marketing, Fellow Royal Society of Medicine, Member Institute of Directors,). He is well networked globally in a number of sectors including Pharmaceutical, biotech, technology, engineering, device & clinical.

Dr Simon Cruwys has recently taken up the role of Head of Inflammation Pharmacology at Grunenthal R&D. He was previously a Team Leader in Bioscience at AstraZeneca R&D Charnwood. His team provided in vitro and in vivo pre-clinical support for a number of projects within the Respiratory and Inflammation area. As a Project Leader, he co-ordinated the progression of candidate drugs from early Discovery through to early stage Development (First Time in Man).

He has also been responsible for a number of successful collaborations with both academic and industry partners and in the outsourcing of specific studies to support candidate drug progression. In addition, Simon has been involved in the assessment of a large number of in-licensing opportunities. These activities will continue in his new role with Grunenthal.

Mary has over 15 years of experience in discovery and development within large pharma and small biotech environments. In the last few years she has held project management and leadership roles at three different biotechs as they venture from discovery based companies into pre-clinical and clinical development, often using a virtual development team model. Mary has experience in outsourcing and managing all aspects of early development. Prior to this she worked at as a biologist and project leader in the Neurology department at GSK for 9  years. Mary has worked on small molecule, antibody, viral vector and synthetic peptide therapeutics in neurological and anti-infective disease areas. She has a DPhil from Oxford University.

Lan is the global head of clinical outsourcing for Eisai and has over 15 years industry experience, including knowledge of both preclinical and clinical outsourcing. Lan joined Eisai in 2005 to set up the European clinical outsourcing and contracting function where his group was responsible for outsourcing a wide range of clinical services. Now as head of the global team he is responsible for global sourcing and supplier management activities including the implementation of strategic and tactical solutions.  Prior to joining Eisai he was part of the AstraZeneca clinical outsourcing group and he has also worked for several biotechnology companies. Lan has a PhD from the National Institute for Medical Research in London and is also the Vice Chair of the Pharmaceutical Contract Management Group (PCMG).

John Macdonald joined ICON in 2012 to take up the newly-created position of Vice President, Global Strategic Sales, with a remit to establish and further develop ICON’s strategic alliances. He began his career in clinical research with Merck, Sharp & Dohme, and later Syntex Pharmaceuticals, gaining experience in a wide variety of therapeutic areas. Following a move to business development  18 years ago, he has held positions of increasing responsibility within some of the world’s largest CROs including Quintiles, PPD, Kendle and INC Research. He holds an honours degree in Biochemistry from the University of Edinburgh.

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.

Sharmela Thevarajaha is an Associate at Fasken Martineau LLP and a member of the Technology, Intellectual Property and Life Sciences practice groups.

Sharmela handles commercial, intellectual property and information technology work. Her experience includes drafting commercial agreements, conducting due diligence investigations for mergers and acquisitions and advising on the protection and enforcement of all aspects of intellectual property rights.

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.