Meeting the Challenges of Developing New Anticancer Therapies

Meeting the Challenges of Developing New Anticancer Therapies
September 17, 2012 · 9:00 am to 1:00 pm
India International Center

Internationally renowned cancer researcher, Dr. H. Kim Lyerly of Duke University will discuss methods of developing new anticancer therapies in India and the U.S. for worldwide distribution. This one-half day event will discuss strategic planning, clinical trial initiatives, translational research, and regulatory elements of the drug development process.

Attendees will be 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. This workshop has been highly praised for its innovative approach to drug development while providing unique access opportunities for cancer researchers to top regulatory officials.

Fee: A 100 USD registration fee will be assessed to industry participants. There is no fee to attend for ABLE members or government employees. For more information, Email Mary Ruemker. Register now while seats are still available at Please note that 50% of the 40 seats available are reserved for the Indian government sector until September 10th. Also kindly note that walk-ins are not permitted.

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.

The oncology community and the pharmaceutical industry have been shifting the focus of clinical research towards performing trials in emerging markets due to the benefits such as lower overall costs, faster recruitment timelines and enthusiastic patient populations. Another significant trend has been for high risk/high innovative research and development to take place in small start-ups, and not exclusively in the larger multi-national pharmaceutical companies.

Therefore, the oncology community would benefit in supporting the efficient testing of innovative products developed in smaller start-ups around the world. It is the intent of this workshop to develop strategies to clarify the opportunities for entering the U.S. market by obtaining USFDA approval, which should foster opportunities for the best ideas from the most innovative laboratories around the world to have an impact on cancer.

This half-day event will deliver an overview of the annual USFDA workshop, and provide some case study presentations. It will provide a forum for Indian regulators and drug developers from India on the critical issues in which will provide them with a solid strategy and game plan for acquiring the knowledge of issues such as optimization of trials, legal compliance, site selection and engagement, investigator and study nurse training, and patient recruitment approaches.

India International Centre
Seminar Hall No.3 i (New Conference Block)
40, Max Mueller Marg
Lodhi Estate
New Delhi 110 003
+91 11 2461 9431

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.

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.

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.

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