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US, Indian biotech firms find common ground on key issues at BIO event

Source : FnB News
Sept 18, 2012

The 3rd annual BIO India conference, organised by Biotechnology Industry Organisation (BIO) in partnership with Association of Biotechnology Led Enterprises (ABLE) saw the industry body addressing key issues in tandem with major industry players. At BIO India International Conference 2012, views were expressed on public policies that are intended to bring about innovation, collaboration and investment in the biotech sector, particularly strong intellectual property (IP) protections and regulatory mechanisms.

The industry captains, led by Kiran Mazumdar-Shaw, chairman and managing director, Biocon, H Thomas Watkins, former president & CEO, Human Genome Sciences, Inc, along with industry organisation heads, Alan Eisenberg, executive vice-president, Emerging Companies and Business Development, BIO, and P M Murali, president, ABLE, lay threadbare issues like strong intellectual property as well as patent enforcement, a strong tax and regulatory system, strong support for R&D, streamlined safety and efficacy testing and approval process.

The participants agreed that they do not believe that the compulsory licensing of innovative products or technology generally is an effective means of promoting access or affordability of healthcare. Moreover, it undermines incentives for companies and individuals to innovate in India, since it creates uncertainty about receiving economic returns for their innovations, they said. Indiscriminate use of compulsory licenses would thus jeopardise India's goal of developing a research oriented biotechnology industry, and is unsound policy, according to participants.

All participants agreed that the issuance of India's Guidelines on Similar Biologics is a step in the right direction. "The guidelines recognise the scientific and regulatory complexities presented by the development and manufacture of biologic medicines. What follows next is industry collaboration in the implementation of these guidelines in a manner that continues to protect patient safety and ensure continued research and development of new cures and treatments," said Eisenberg. However, he pointed out that India needs to recognise scientific differences between small molecule therapeutics and biologics. The US industry represented by BIO urged the Government of India to include substantial non-patent data exclusivity in its policy and respect intellectual property and other legal rights. All participants agreed that there is scope for continued discussion and collaboration on these key issues.

The two-day conference will offer opportunity for large and small biotech companies to gather in one place and engage in partnering discussions with biotech leaders from around the world. On Wednesday, a fireside chat on the future of development and production of vaccines in India was held and featured Cyrus Poonawalla as a panel list.

A session titled 'Commercialising Stem Cell Therapies and Regenerative Medicine' was held recently. B N Manohar, managing director and CEO, Stempeutics Research Pvt. Ltd.; Virender S Sangwan, associate director, L V Prasad Eye Institute (LVPEI), and Chandra Viswanathan, head of regenerative medicines group, Reliance Life Sciences were the panel lists. A keynote and plenary luncheon on 'Strategies for Success: India's Global Role in Innovation' also took place the same day. Achin Gupta, director, strategic planning, Abbott Laboratories; Phil Kearney, director, external scientific affairs, worldwide licensing, Merck; Chaitanya Saxena, CEO, Shantani Proteome Analytics; Renu Swarup, adviser, Department of Biotechnology, Ministry of Science & Technology, Government of India, and Holly Vineyard, deputy assistant secretary, Africa, the Middle East, and South Asia, US Department of Commerce, International Trade Administration were the panellists.


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