CURRICULUM VITAE: Dr. SANDY EISEN
I studied medicine at Cambridge University and at St Bartholomew's Hospital Medical School, London and qualified as a doctor in 1980. I am a fully registered UK Physician with a current GMC licence to practice, and postgraduate qualifications in surgery (Fellowship of the Royal college of Surgeons of London) and pharmaceutical medicine (MFPM London).
Following 9 years’ experience in the clinical practice of medicine and surgery, I have now had more than 20 years’ experience working in the pharmaceutical industry and in pharmaceutical regulation. This includes time as a UK and EU regulator at the (MCA) MHRA and EMA, working on all types of products, including medical devices, and in all therapeutic areas. During this period I acquired a detailed knowledge and understanding of EU pharmaceutical legislation and procedures, including those for new and generic products, biologicals and vaccines, and medical devices.
This experience provided a sound basis for my industry career, firstly as a consultant at PAREXEL International advising over 50 companies on their development plans and providing regulatory troubleshooting for all types of products including NCEs, biologicals anddevices in both Europe and the US. Most recently I worked as Chief Medical Officer for Teva Pharmaceuticals Europe for the past 5 years with overarching responsibility for all medical affairs and clinical issues, after joining Teva in 2005 as VP with responsibility for EU regulatory, portfolio and medical affairs. At Teva I worked on innovative products, biosimilars and generics, covering all regulatory affairs including PIP applications.
In 2011 I left Teva to set up my company Frontline Pharma Consulting Ltd which provides regulatory, clinical and strategic advice to a wide variety of client companies.
Gonville and Caius College, Cambridge University Bachelor’s Degree (BA) in Medical Sciences 1977
Cambridge University Medical Qualification (MB BChir) 1980
Royal College of Surgeons London Postgraduate Surgical Qualification (FRCS) 1985
Royal Colleges of Physicians of the United Kingdom Postgraduate Diploma in Pharmaceutical Medicine (MFPM) 1991
SCHOLARSHIPS AND PRIZES
Gonville and Caius Scholarship awarded for First Class Honours 1975
Knott Surgical Prize, St. Bartholomew's Hospital Medical College 1978
Royal College of Surgeons, London, Second Place in UK, Duke-Elder Prize in Ophthalmology 1980
Previous Appointment: Chief Medical Officer, TEVA Europe, 2006 – 2011
- Teva Pharmaceuticals is a top 20 Pharmaceutical Company, and currently the global leader in generic pharmaceutical products, as well as a growing innovative company in both conventional medicines and biologicals (including biosimilars).
I joined Teva Europe in 2005 as Vice President responsible primarily for regulatory and medical affairs, reporting to the CEO of Teva Europe. In 2006 I was appointed Chief Medical Officer for Teva Europe with responsibility for all medical affairs including drug safety, all medical standards, and all medical aspects of clinical research within Teva Pharmaceuticals Europe, and reporting to the President and CEO of Teva Pharmaceuticals Europe.
- Over the period 2005 to 2011 Teva has been an extremely successful company undergoing tremendous organisational change and incredible growth to which I have made a major contribution. When I joined in 2005 Teva had about 13,000 staff and a turnover of about $5bn. The equivalents at the time I left were a headcount of 40,000 and turnover of $16bn. In Europe over this period the turnover rose from about $1bn to about $4bn. Throughout this period I was a member of the European Management Team, the top level decision-making body of the European Company, with direct involvement in all Teva Europe management decisions. My experience at Teva has covered:
· Provision of top level regulatory and medical strategic advice for all products, including Copaxone and other innovative medicines, biosimilar products, and medical devices covering the effects of current legislation and guidelines, and the interface with other governmental affairs areas, such as health economics outcomes and pricing and reimbursement, that impact on these products
· Clinical development strategy and operations and regulatory affairs / ongoing medical issues for innovative medicines, including Copaxone and Azilect, and other innovative medicines and advanced therapy products. This has included successful variations to extend the licensed indications of Copaxone within the EU, and oversight of all promotional materials for all products in Europe.
- Development / regulatory approval and ongoing medical issues, including drug safety, for all generic medicines, including respiratory products and branded generics in all therapeutic areas and product classes. This has included several PIP applications.
- Strategy, development planning and regulatory advice on approval and ongoing medical issues for biotechnology products, including biosimilars. Teva’s first biosimilar product, TevaGrastim, received EU approval during 2008 and I was personally responsible for all medical aspects of this development, including the CHMP appeal and the final EC regulatory approval.
- I have represented Teva at many EU and international, scientific and regulatory meetings, including ICH where I have been a participant in several expert working groups. I have represented Teva at the EBG (European Biotechnology Group) of the EGA since 2005. During the period 2006-8 I was elected vice-chairman of this group, and from 2008 until March 2011 I chaired this trade association body, having been elected to the position of chairman in 2008.
- Medical due diligence, medical aspects of regulatory compliance, and medical reorganisations relating to Teva's acquisitions (which included those of Ivax (2006 $7.4bn) and Barr/Pliva (2008, $7.5bn)
Vice President – Portfolio and Scientific Affairs, TEVA Europe, 2005 – 2006
In this post I was responsible for all Portfolio, Regulatory and Scientific/Medical affairs in Teva Pharmaceuticals Europe, reporting to the President of TEVA Europe. This position included responsibility for generic, innovative, and biotech/biosimilar products, and covered direct/indirect reports with over 100 staff.
Clinical Vice President, PAREXEL Consulting, Uxbridge, UK, 2004 – 2005
Responsible for Clinical leadership worldwide for PAREXEL Consulting Group working through the London, Paris, Berlin, Freiberg and US offices of PAREXEL Consulting with a group of about 100 regulatory professionals responsible for all aspects of regulatory affairs and drug development consulting worldwide.
Provision of advice and consultancy on all aspects of clinical data and regulatory affairs, including preparation and review of clinical development plans at all stages of clinical development, and in all therapeutic areas for all types of products, including biotechnology products, biosimilars, vaccines and devices, including preparation and review of clinical dossiers. Advice in relation to appeals procedures, and other interactions with regulatory authorities, including informal scientific advice in the EU, and pre-IND, IND, pre-NDA and NDA meetings with the FDA, and strategic advice on general and specific regulatory topics including pricing issues.
Principal Consultant, PAREXEL Worldwide Regulatory Affairs Group, 2002 – 2004
Providing Clinical Leadership for the London Office of the WRA Group of 25 staff.
Senior Medical Officer, Medicines Control Agency (MHRA) London 1989 - 2002
Dossier review and preparation of reports / assessments for regulatory advisory bodies such as the Committee on Safety of Medicines (CSM) and the Committee for Proprietary Medicinal Products (CPMP – now the CHMP). Assessment of product licence applications decisions on the grant or refusal of such applications without reference to expert committees.
Provided medical advice on policy matters, preparation of briefings for ministers and replies to parliamentary questions, and responses to queries from industry and the press. Negotiations and advice to the pharmaceutical industry on regulatory strategy and clinical development plans.
Senior Medical Assessor, New Drugs Unit, MCA (MHRA) 1994 – 2002.
Responsible for clinical assessment of UK national applications and EU applications (Centralised and Mutual Recognition) for New Chemical Entities and New Active Substances in all therapeutic areas, including biological applications and vaccines. I specialised in CNS, assessing most applications for MS, Alzheimer’s, pain and other neurology/psychiatric products, and contributed to the development of CHMP guidelines in this therapeutic area, although I continued to work across all therapeutic areas as before.
I attended the CPMP and its working parties and groups as an expert, and became very familiar with the working procedures of these bodies and the European Medicines Agency (EMA).
Medical Assessor to the Committee on Dental and Surgical Materials, 1990-93 (Appointed Principal Assessor to the Committee in 1992)
Assessment of applications to the CDSM covering products such as surgical implants, sutures and dressings, ophthalmic products, and including actions for these products.
Medical Assessor to the Review of Medicines, MCA (MHRA), London, 1989-91
Review of medicines, and support for the CRM covering all therapeutic areas.
Full-time accredited posts in Medical and Surgical Training in UK Hospitals 1980 - 1989
Full Registration as UK Medical Practitioner since 1980 (Reg. No. 2635903)
Lecturing experience in a variety of settings on many aspects of regulatory affairs and clinical research. Teaching on clinical topics within many international Regulatory Affairs courses 1993-2007, teaching for the University of Cardiff, Diploma in Pharmaceutical Medicine Course, WHO courses for regulators, and lectures at DIA and TOPRA meetings.
Mobile telephone (main contact number): +44 7921 495663, or +44 208 3648426 office