ABLE, DUKE and OSHL conduct workshop on

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ABLE, DUKE and OSHL conduct workshop on

Meeting the Challenges of Developing New Anticancer Therapies

New Delhi: September 17, 2012: Cancers are the leading cause of deaths in almost all countries and all public and private pharmaceutical and biotechnology research agencies and companies normally have anti-cancer therapies as one of their areas of interest. Cancer drugs constitute a significant portion of the one Trillion USD global pharmaceutical market.

The oncology community and the pharmaceutical industry have been shifting the focus of clinical research towards performing trials in emerging markets like India due to the positivessuch as faster recruitment timelines, patient populations who could benefit from trials with cutting edge therapeutics and also lower overall costs. As cancer therapies are often targeted on specific genomic mutations, the specific profiles of patients in India would also determine the optimal use of these therapies locally. Another significant trend has been that innovative research and development oftentakes place in smallerbiotechnology firms, and not exclusively in the larger multi-national pharmaceutical companies. Therefore, the oncology communitieswould benefit in supporting the efficient testing of innovative products locallyand thereby have early access to these innovations.

The Association of Biotechnology Led Enterprises (ABLE), the DUKE University and The

Open Source Health Laboratories (OSHL) organized a workshop on Meeting the

Challenges of Developing New Anticancer Therapies in New Delhi on September 17 th that attracted interest and participation from public agencies and private companies.

The workshop was led by internationally renowned cancer researcher, Dr. H. Kim Lyerly of

Duke University who discussed methods of developing new anticancer therapies in India and the U.S. for worldwide distribution. Strategic planning, clinical trial initiatives, translational research, and regulatory elements of the drug development process were discussed.

Attendees were provided with a broad overview of the annual USFDA workshop whose goal is to expedite the development and validation for new anticancer and cancer prevention agents.

Dr. Lyerly commented that, “Indian pharma and biotech companies and public institutions have researchers and facilities that are capable of researching and developing new anticancer drugs. The traditional Indian medicine systems too have several remedies but in order for them to be validated for global use they too need to go through the same procedure as any other chemical or biotech drug. The workshop will surely help in improving the drug development processes of anti-cancer drugs in India.”

Dr Vijay Chandru, CEO of Strand Life Sciences and EC member (ABLE) observed ‘We are grateful to Dr. Lyerly for having come all the way to offer his expert advice on these topics.

Drug Development is one of the most expensive aspects of getting drugs to the market. The prowess of researchers and regulators in Indiain this highly regulated space depends on timely knowledge of global standards and benchmarks and how to approach them. The

BioPharma sector in India is active in oncology therapeutics with global market aspirations and welcomes such interactions withthought leaders in development.

Charles Maynard, ED of OSHL commented "this workshop is one example of the types of international collaborations that OHSL seeks to initiate, nurture and develop. The speed with which global collaborative medical research is being launched continues to be enigmatic and therefore it is necessary for organizations such as OHSL to exist. From our vantage point, we can leverage a great deal of resources to facilitate the successful stewardship of these medical research projects. We have done it and therefore we understand what it takes! We look forward to a mutually beneficial and rewarding relationship with the various medical research communities and organizations in Asia such as ABLE as we do in other parts of the world."

About Speaker: H. Kim Lyerly, M.D

Dr. Lyerly is the George Barth Geller Professor of Cancer Research, Professor of Surgery, and Director of the Center of Applied Therapeutics at Duke University. He is an internationally recognized expert in cancer therapy and cancer immunotherapy and has published nearly 200 scientific articles and has edited 10 textbooks on surgery, cancer immunotherapy, and novel cancer therapies. In 2008, Dr. Lyerly was appointed to the

National Cancer Advisory Board (NCAB) by President George W. Bush and was named chair of the Cancer Centers sub-committee of the NCAB. Dr. Lyerly is a highly sought advisor and currently serves on the external advisory boards of several renowned U.S. cancer centers. He is the Honorary Director of the Comprehensive Cancer Center at Beijing

Shijitan Hospital, Capital Medical Center. He is currently a member of the Scientific Advisory

Board of Susan G. Komen for the Cure, a prominent U.S. breast cancer education and research organization. He has previously served as chairperson of the executive committee of the integration panel of the U.S. Congressionally Directed Medical Research Programs in

Breast Cancer.

About ABLE, OHSL and Duke University:

Association of Biotechnology Enterprises (ABLE) : ABLE is a national forum that represents the Indian biotechnology sector. Launched in April 2003, the primary objective of

ABLE is to accelerate the pace of growth of the biotechnology industry in India, through encouraging greater investment in the sector, providing a platform for domestic and overseas companies to explore collaborations and partnerships, partnering with the

Government of India in their biotechnology endeavors and forging stronger links between academia and industry. http://ableindia.in/

Open Health Systems Laboratory (OHSL) : OHSL was conceived to focus on building global team science consortia by leveraging the best biomedical informatics, information and communication technology to address the key questions of medical science and to provide a quicker and better global public health response. OHSL and its strategic partners undertake projects in life sciences, which are innovative, path breaking, and proof-of-concepts requiring cross-sector collaboration. OHSL was conceived with a focus on team science, leveraging

biomedical informatics and information technology for quicker and better global health response. http://www.ohsl.us/

Duke University : Duke University was founded in 1924 and is situated on 9,000 acres in

Durham, North Carolina, USA. It has a student body of nearly 15,000 undergraduate and graduate students, and consistently ranks among the very best institutions of higher education. Duke is comprised of 10 schools and colleges including schools of law, medicine, engineering, business, nursing and arts and sciences. Duke’s mission is to provide a superior education to its students, attending not only to their intellectual growth, but also to their development as adults committed to high ethical standards, and full participation as leaders in their communities. http://www.duke.edu

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For more information, please contact:

The PRactice

Mr. Farooque Shaikh - +91-9323671307

Mr. Aseem Das - +91-9311965186

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