BIO’s stated mission is ‘to be the champion of biotechnology and the advocate for its member organisations—both large and small.’ What are the key advocacy issues impacting the sector and what have been BIO’s initiatives on these fronts?
| James C Greenwood |
BIO’s overall goals in India are to foster collaborations between the US and Indian industry in all areas relating to biotechnology. To help facilitate this collaboration BIO looks at a variety of factors including R&D potential, protections for biotechnology innovations and regulatory mechanisms. In terms of R&D potential, BIO along with the Association of Biotechnology Led Enterprises (ABLE), have co-hosted the BIO India International Partnering Conference. The Conference, which this year will be held in Mumbai, brings together US and Indian business and thought leaders in the area of biotech for partnering. In addition, we have watched closely as India’s Department of Biotechnology in conjunction with the Drug Controller General of India (DCGI) has issued guidelines for the approval of similar biologics. Indeed, we worked with our Indian industry colleagues to provide comments. We believe the guidelines are a step in the right direction and we are continuing to work with our industry colleagues as these guidelines are implemented to provide additional input into the process. Our industry is eager to work with the Indian government and our Indian counterparts to help India achieve its public health goals. We believe we are quite well equipped in terms of technology, expertise and innovative capacity.
We also watched with concern as the Indian Patent Office issued a compulsory license to Natco Pharma on a Bayer cancer drug recently. The majority of our members, those that we are hoping to bring with us to India for the BIO India Conference, are small and medium sized enterprises that have breakthrough technologies ripe for development.
These companies truly rely on their patents to attract partners for the development of potential cures. The possibility that their patents may at some point down the road by compulsorily licensed, gives many of these companies pause. Currently, the decision is on appeal and we are watching to see its ultimate outcome.
As President and CEO of BIO, how do you see BIO’s engagement with biotech companies in emerging countries?
BIO represents the entire biotech ecosystem and emerging markets can play an integral role in each phase of a biotech product’s development. For example, BIO’s companies are interested in collaborating with India’s scientists to push the boundaries of science and translate that science into new biotech products.
BIO companies are also seeking partners to manufacture and distribute biotech products in markets like India and around the world. BIO’s role is to facilitate this broad engagement and ensure governments around the world create a positive policy and legal environment for biotech.
As a former Congressman from Pennsylvania, you have played an role in shaping policy in the US in this sector. What are your views on the tug of war between originators/ innovators and governments who are under pressure to provide safe and effective treatments for patients?
Our nation and our world face significant problems; and it is now more clear than ever that the biotech industry represents our best hope to cure disease, feed the hungry, discover newer and cleaner forms of energy, and provide protection from pandemic and bio-terror threats. Government policies and the economic environment should support and encourage innovation to ensure that patients receive safe and effective treatments.
In the US, healthcare is a major political issue with ‘Obamacare’ becoming a rallying points for both Republicans as well as of course the Democrats. Do you think this extra attention benefits the healthcare sector? Or do you think it harms the sector because it forces politicians to take stances which may turn out to be unsustainable in the long run?
In the US, a lot of attention is being devoted to healthcare right now as our industry strives to create a policy environment that supports and encourages innovation and, ultimately, enables the industry to deliver cures and treatments to patients.
Similar to the US, India has a burgeoning biotech sector, and the Indian government has invested billions into biotech research. India’s biotech and pharma space is world class, and the number and type of collaborations between Indian and US or EU companies has grown rapidly in the past few years.
During this period of tremendous growth in both the Indian economy and its healthcare sector, it is a critical time to capitalise on the biotech opportunities available within India. Launching the BIO India International Partnering Conference builds on a tremendous amount of existing activity led by Indian companies.
In countries like India, accessibility is a twin concern with affordability. What is BIO’s take on this issue?
BIO’s Options for Increasing Access to Medicines in the Developing World (www.bio.org/advocacy/letters/options-increasing-access-medicines-developing-world) clearly outlines our position on this issue. In the letter it states, “BIO’s members believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are not mutually exclusive.”
BIO Ventures for Global Health (BVGH) and BIO recently collaborated on a new report on the biotech sector’s contributions to neglected disease product development across drugs, vaccines, and diagnostics. Biotechnology: Bringing Innovation to Neglected Disease R&D(www.bvgh.org/ Biopharmaceutical-Solutions/Data-Center/BVGH-Reports/2012-Biotech-Report.aspx) describes the overall biotech business model and identifies some of the challenges facing biotech engagement in global health product development. Millions of lives could be saved through faster and more efficient R&D. It is critical to target our resources and R&D efforts to provide the greatest benefit to the world’s poor.
The report found that biotech companies participating in neglected disease R&D represent engagement of less than five per cent of the total number of biotech companies focused on health research and development. Despite the large proportion of neglected disease pipeline products with biotech company participation, the 134 active companies identified represent a small proportion of the nearly 3,000 biotech companies worldwide. These data suggest biotech companies are an underutilised resource for neglected disease R&D. Furthermore, large pharma companies participating in neglected disease R&D represent engagement of approximately 65 per cent of the total number of large, innovator pharma companies.
What are the special features/ new attractions at the third annual BIO India International Conference to be held September 12-13 at the Grand Hyatt in Mumbai, India?
As the non-profit trade association that represents the biotech industry, BIO is pleased to bring the BIO India International Conference back to India in an effort to further create and drive business development and collaborations through investor and partnering conferences. BIO has partnered with the ABLE, as well as leading investment banks and venture capital firms.
In addition to high-level keynote speakers and educational India-focused panels, the event offers networking opportunities, company presentations, and the BIO One-on-One Partnering system. Through this conference and ongoing advocacy efforts, BIO aims to help the industry flourish within India’s borders and help patients and citizens benefit from the promise of biotech.
Confirmed keynote speakers for BIO India include Sam Pitroda, Advisor to the Prime Minister of India on Public Information Infrastructure & Innovations and H Thomas Watkins, Former CEO, Human Genome Sciences, a GlaxoSmithKline Company.
Dr Cyrus Poonawalla, Founder, Chairman, and Managing Director, Serum Institute of India will discuss Vaccine Development in India during a Fireside Chat on September 12.
Other sessions at BIO India include a session on Commercialising Stem Cell Therapies and Regenerative Medicine, on the second day which will discuss India’s progress in stem cells and gene therapies, the increasing use of these technologies to treat a host of diseases and look at what types of collaborations and funding are fuelling the space in India. Companies at the forefront of the field will share their business strategies and discuss the commercial and regulatory issues involved with developing these specific treatments at the national and international level. Panelists include BN Manohar, CEO, Stempeutics Research and Dr Chandra Viswanathan, Head of Regenerative Medicine, Reliance Life Sciences
The keynote and plenary luncheon session will be on Strategies for Success: India’s Global Role in Innovation, which will deliberate how while India’s healthcare market is vastly different from Western markets, the country is quickly establishing itself as a global leader in the life sciences.
Moderated by Rashmi Barbhaiya, CEO and MD, Advinus Therapeutics and with panelists including Phil Kearney, Director, External Scientific Affairs, Worldwide Licensing, Merck the panel will feature a candid discussion of India’s global role in biotech innovation and the mechanisms engaged to ensure success. Some of the queries that will be addressed include strategies employed by multinational biopharma companies to bolster innovation in India, what kind of policies can help foster this continued innovation and how both Western and local companies can leverage these to ensure success. The panel will also look at what role public-private partnerships play in facilitating funding for innovation.