Clinical trials and partnerships-an overview

EPP News Bureau - Mumbai

IBC Life Sciences organised a three-day conference on ‘Drug Discovery to Clinical Trials- Global partnering and New Science’. The conference gave an overview of the big Asian opportunity in drug discovery, with an in-depth focus on India as an emerging clinical trials offshoring destination.

The Chairperson’s welcome and opening remarks were given by Nailesh Bhatt, Managing Director of Proximare, USA.

As pharmaceutical and biotechnology companies continue to explore new geographic opportunities to expand their pipelines of products and create business efficiencies, the importance of Asia-Pacific market is growing. The quality of science and capabilities in drug discovery vary widely between India, China, Japan, Taiwan and Singapore. This diversity was discussed in the first segment of the first day seminar.

Nailesh Bhatt provided an overview of India from an economic, political and business opportunity viewpoint. The topic of his seminar was ‘The Complete Landscape of the Indian Pharmaceutical Research and Contract Services Environment’. He focussed on the pharma and biotech landscape from discovery and chemistry services to clinical research and manufacturing.

Zhi Yang, the General Partner of BioVeda Capital talked on An Overview of the Pharma/Biotech Landscape in China’. Yang presented an outline of the drug development landscape in China, strength in R&D, manufacturing, clinical trials and emerging areas of opportunity. The role of start-up companies and university based research in the market was discussed.

A talk on ‘Asian Contract Pharma Market: The Landscape’ was given by Nitin Naik, the Principal Consultant, Healthcare Asia Pacific, Frost & Sullivan, Singapore.

He claims that the contribution of USA and Europe to global pharmaceutical market is excepted to decline by 2010. Market saturation, declining population size and increasing cost of drug development and manufacturing were some of the given explanations. He also pointed out that pharmaceutical R&D expenditure in Asia is growing faster than in US and Europe. According to the statistics he offered, the global contract research market is estimated at $10 billion in 2004. 40 to 50 percent of global clinical trials market will be outsourced to developing countries by 2010.

The constraints of outsourcing to Asia are regulatory hurdles and red tapism, competition for trained CRAs, lack of uniform clinical practice protocols and low entry barriers resulting in mushrooming of small CROs and subsequent price war. The key drivers are large patient pools, high disease incidence, higher life expectancy, data approval by international regulatory authorities and fast growing pharma markets.

Satish C Tripathi, Director of Worldwide Regulatory Strategy provided an insight on ‘The Global Regulatory Environment in the US, Europe and Asia: Challenges and Opportunities’. He provided an insight on International Conference on Harmonization (ICH) which is aimed at improving the process for developing and registering by harmonisation. Dr Sadhna Joglekar, Senior Medical Advisor, Regulatory Affairs of Pfizer spoke on ‘Overview of Regulations pertaining to Clinical Research in Asia’.

The second session had various speakers talking on Intellectual Property Rights in Asia.

Gowree Gokhle, Senior Member, IPR and Pharma Team of Nitish Desai associates gave addressed on the ‘New Patent Regime in India: The Changing Pharma Scenario’. The presentation discussed the new patent regimes and its potential impact on Indian companies and foreign companies doing business in India. The protection of intellectual property rights in India which was one of the biggest concerns of global pharmaceutical companies seeking to enter India in the past has changes rapidly to adapt to a post-TRIPS and WTO scenario. Gokhle says that there are well-established statutory, administrative and judicial frameworks, to safeguard intellectual property rights in India.

Steven R Ludwig, Director of Sterne, Kessler, Goldstein & Fox, PLLC spoke on ‘Patent Problems arising out of Global Drug Development’. The talk focussed on issues like infringement of drug discovery patents, royalties, damage exemptions for clinical trials and statutes blocking importation of products.

Zaka Imam, Deputy Director and Head of TIILP Division, Central Drug Research Institute presented the process of discovery to development of new pharmaceutical drugs in India and the utilisation of new technologies in the product patent regime.

Some interesting case studies were prersented in the conference. Jitendra Patel, Director of Global Discovery Alliances, AstraZeneca R&D spoke on ‘Successful Global partnering with Pharma: Business and Cross-Cultural Issues’. The presentation explored effective strategies for deal making and alliance management with special reference to cross-cultural issues.

Mae Shield, Head of Global Partnerships, Novartis Institute for Tropical Diseases (NITD), spoke on ‘Globalisation of R&D through Effective Partnerships’. She gave an insight into the unique mission and operating model of NITD.

‘Global Partnerships of Nicholas Piramal: Case Studies and Lessons Learned’ was the topic on which Swati Piramal, Director, Strategic Alliances and Communications of Nicholas Piramal India Limited. In the times when global innovator pharma and biotech companies are looking at opportunities, she discussed case studies of partnerships, the lessons learnt, the challenges and obstacles faced in the lookout for international partners.

katyanaidu@expressindia.com