THURSDAY 23 MARCH 2006
ASIA-PACIFIC PHARMA SEMINAR
This page is maintained for historic reference only
Organised by: Global Outsourcing Review and Asia-Pacific Technology Network
Location: Chatham House, 10 St James' Square, London SW1Y 4LE: (Nearest Tube Stations: Piccadilly Circus or Green Park)
Time: 17.00 - 19.30 pm (followed by reception)
Chair: Dr Stephen Bentley, ASB Associates & Harrison Clinical Research
Speakers: Paul Hudson, Head, Central Laboratory, Charles River Laboratories, Scotland Specialised Assays for Multicentre Clinical Trials
Dr Colin Wyatt, Director of Business Development, Imperial College London Bridging the Gap between Industry and Academia
Dr Nermeen Varawalla, Vice President, Business Development International, PRA International, UK How to Utilise the Clinical Development Opportunities in India
Sponsors: Charles River Laboratories
Clinphone.com
Global Outsourcing Review
Harrison Clinical Research -
Imperial College London
Japan Airlines
JETRO London -
MDS Pharma Services
Pharmaceutical Profiles
Background
The Asia Pacific Pharma Evening Seminars provide a good opportunity to keep abreast of pharmaceutical and biotechnology developments, particularly regarding Asia-Pacific. Starting at 5.00pm, each Seminar has two or three speakers followed by lively discussion. After the talks at 7.15pm, sushi and wine are served which provides an excellent opportunity to interact with UK and Japanese pharmaceutical company personnel and others interested in these sectors.
Paul Hudson, Head, Central Laboratory, Charles River Laboratories, Scotland
Pharmaceutical companies must maximise the value they obtain from studies in their development programmes. For this reason there is increasing interest in laboratory biomarkers. Selection of the most appropriate assays may be challenging. This presentation explores the issues that may arise during project planning, including analytical methods and validation, scientific community acceptance, investigation site systems, logistics and data interpretation. Paul Hudson is a biomedical scientist with more than 25 years experience in the pharmaceutical industry. After working in regulatory affairs and quality assurance for Syntex he joined Inveresk, latterly Charles River Laboratories, in the 1980's as manager of clinical pathology. He is now responsible for the Central laboratory which supplies safety, efficacy and pharmacodynamic analyses for preclinical and clinical development programme
Dr Colin Wyatt, Director of Business Development, Imperial College London
Imperial College London is one of the world's leading research intensive universities and has a mature and effective Business Development model. 13% of its research revenue comes from industrial sources, compared with 6% for the UK as a whole. This paper describes Imperial's approach to identifying and creating global research collaborations and commercialising the results. It shows how appropriate structures and practices can increase the probability of success and illustrates different collaborative models by reference to a number of case studies, with a particular emphasis on SE Asia and the Indian subcontinent. Colin is Director of Business Development for Imperial College London, one of the world's leading research intensive universities. He is responsible for Imperial's research collaborations with industry. He and his team are Imperial's interface to business and are responsible for identifying, creating and managing strategic research relationships with global industry partners across Imperial's medical, scientific and technological areas of expertise. Originally a medical physiologist, Colin has worked in the commercial Life Sciences sector for over twenty five years, both for pharmaceutical companies and as a management consultant to most of the major pharmaceutical and biotechnology companies. Most recently, Colin was Vice President of Cambridge Pharma Consultancy and Head of the European R&D Practice at Cap Gemini Ernst & Young.
Dr Nermeen Varawalla, Vice President, Business Development International, PRA International,
India's compelling attractions for the global clinical development are based on (i) its large, English speaking, cost effective graduate work force (ii) numerous patients with diseases of the industrialised and developing world (iii) proven track record in providing outsourced IT services to world beating standards. These attractions are now well accepted by the global pharmaceutical industry. Furthermore events over the past year such as India's first uneventful FDA audit, streamlining of the regulatory approvals process and demonstration that India is intent on upholding international Intellectual Property standards have effectively addressed sponsor concerns. As a result multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India. The country's nascent CRO industry composed of local CROs, Indian subsidiaries of global CROs and niche data management providers is experiencing an annual growth rate close to 100%. Thus although there remain challenges there are numerous approaches for sponsors seeking to access the opportunities in India. Dr Nermeen Varawalla leads the international business development effort for Asia and South America at PRA International - a global CRO with 2500 employees, covering 68 countries in all six continents. Nermeen has a strong interest in the utilisation of emerging world countries for global clinical trials and is establishing PRA's capabilities in Mumbai and Pune, India. Prior to joining PRA, Nermeen was the founder of PerinClinical, a niche India focused CRO. Before that she worked with Accenture's Health & Life Sciences Business Consulting Practice in London in the area of drug development. Nermeen received her medical training at the KEM group of hospitals, Mumbai, India. She was awarded the Rhodes Research Fellowship to the University of Oxford where she conducted her doctoral research in Molecular Genetics. Nermeen practised as a specialist at two of the UK's leading NHS Hospitals. She then obtained her MBA at INSEAD.
7.15 pm to 9.00pm Wine, canapés and sushi refreshments
FUTURE MEETING DATES 13th July (has been changed)
28tth September
29th November (has been changed)
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