Clinical Trials in Asia (APBiomed Seminar)

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Monday, 6 October 2008
(Hosted by Olswang)
(Co-organiser: Asia-Pacific Technology Network)
(Co-organiser: London Biotechnology Network)

Chair

• Tony Jones, Director of Biotechnology & Healthcare, London First/London Biotechnology Network

Speakers

• Dr Nermeen Varawalla, Vice President Scientific & Medical Affairs, PRA International
  • India and China
• John Kelly, Founder, Moffat Dickson
  • The situation in Malaysia and ASEAN
• Dr Stephen Bentley, Director, ASB Associates
  • The position in Japan

The big clinical trials players are increasingly moving into the Asia-Pacific, looking for time and cost efficiencies in drug development, at a time when the demand for clinical trial services continues to grow. They and the wider pharmaceutical industry are being forced to globalise as the pool of patients within Europe and the USA plateaus, and while they are required to broaden the genetic pool within which they carry out their trials. Additionally, fast growth in Asian pharma markets is attractive as pressure grows on profitability in traditional markets.

In this seminar we will look at the three key clinical development regions in Asia namely India, China and South East Asia, which offer many similar attractions, while posing some common issues with respect to the placement of international clinical trials.

Amongst the questions which this seminar may raise would be: -

• Is the attraction of Asia disease specific, or are there constraints on the kinds of trials which can be carried out there?
• What is the quality of the work out there?
• What are the ethical questions (Helsinki Accord)?
• At what point can local CROs safely be used?
• What are the policies of the FDA and EMEA towards such outsourcing? (.... and what are the qualities of local regulators?)
• To what extent do clinical trials help companies penetrate end pharma markets in these economies?
• As clinical trial outsourcing increases within the region, are there growing capacity constraints, and how adequate is the supply of trained personnel?

Location: Olswang, 90 High Holborn, London, WC1V 6XX (nearest tube station Holborn)
Timing: 17:30 - 1930 (Please arrive 15 minutes early to register)
Pricing:

• Free to Olswang clients and APTN annual subscribers
• £40 + VAT (Executives)
• £20 + VAT (Asian citizens/institutions, officials, executives from Small Companies)
• £10 + VAT (Academics),
• Free for the Media.

To Register: please send your details (name, institutional affiliation, email address, phone number) to biz@aptn.org