History of ICD2: International Industrial Pharmacy Conference (IIPC) to the International Conference on Drug Development (ICD2)
In 1962, Lee Frank Worrell, Dean of the College of Pharmacy at The University of Texas at Austin, envisioned the dissemination and discussion of scientific and regulatory initiatives to improve the manufacturing process of pharmaceutical drug products. This vision resulted in a yearly conference organized by the College of Pharmacy to bring pharmaceutical scientists, regulators from the Food and Drug Administration (FDA) and the Pharmaceutical Industry to Austin, Texas to discuss new initiatives to improve the quality of drug products sold in the United States and across the world. The Conference was labeled the International Industrial Pharmacy Conference (IIPC).
In 1966-67 Interim Dean Clarence Albers and the newly elected Dean Joseph Barnett Sprowls offered continued support of the Conference.
In 1968, at the famous Motel Villa Capri, the conference agenda was devoted to Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding and discussed the Regulations under the Federal, Food, Drug, and Cosmetic Act, Part 133, Title 21 of the Code of Federal Regulations.
In 1970, Interim Dean William Sheffield continued to support the vision of its predecessors.
In 1973, Dean James T. Doluisio recognized the importance of this Conference and made it an important initiative of the newly created Drug Dynamics Institute under the Directorship of Dr. Alfred Martin, its Associate Director, Robert V. Smith, its Biopharmaceutics Coordinator, Salomon Stavchansky and Bill Jobe, the newly appointed Director of Continuing Education. After considerable effort, the 13th IIPC Conference was reborn with the close cooperation of FDA. The theme of the Conference was New FDA Regulatory Guidelines Particle Technology. The FDA support was a result of the excellent relationship that Dean Doluisio established with the leadership of the FDA and leaders in the Pharmaceutical Industry. The support that we received from individuals such as Bernard Cabana, Jerome Skelly and others at the FDA was of immense help. In fact, Dr. Jerry Goyan, a pharmacist and friend of Dean Doluisio, was the first of several FDA Commissioners to participate.
In 1976, the Bioavailability and Bioequivalence regulations were first discussed at the conference. These regulations in conjunction with theWaxman-Hatch Act opened the door to generic versions of brand name products.
In 1987, Dr. Salmon Stravchansky became Scientific Chairman of the conference, a post he holds to this day. Under his leadership, the conference has continued to grow with a renew focus on innovation in drug development.
In 1998, Dean Steven W. Leslie lead the Planning Committee in evaluating and expanding the scope of the conference to reflect the growing international participation in the conference, leading to a name change of the conference to the International Conference on Drug Development ( ICD2). The result was an increase in topic and participation from drug development regulators, industry and scientist from around the world.
In 2005, Dr. Janet Woodcock, Director of the Center for Drugs Evaluation and Research at the FDA, Dr. Mark McCelland, then Commissioner of the FDA, later administrator for the Centers for Medicare and Medical Services, and a University of Texas alumnus, opened the conference discussing quality efficiency and transparency of the drug development process. In addition, he stressed the importance of improving access and affordability of pharmaceutical products. The ICD2 Conference also served as a forum to discuss another FDA initiative concerning how to Improve Efficiencies in Drug Development – cGMP’s for the 21st Century and Process Analytical Technologies.
In 2011, the conference served as a forum to discuss the challenges to perform comparative effectiveness studies to improve healthcare outcomes while curbing rising healthcare expenditures and still maintaining incentives for innovation.
In 2012, the FDA guidance policies to establish biosimilarity were initially discussed.
In 2013, a new format was introduced to reflect the changing environment of today’s drug development industry, with a wider scope of topics and speakers in a compressed program to meet today’s busy executives’ schedules.
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The mission of ICD2 continues to develop the most informative and up to date conference in the science and regulation of drug development. Our goal remains to create an informal forum for the exchange of ideas with the purpose of creating new scientific initiatives to improve the efficiencies of drug development. The College of Pharmacy believes that helping shape the drug development process is an important component of health care resulting in a strong national and international reputation.
More than fifteen countries have been represented at the meeting throughout its history. Representatives are usually in attendance from Mexico, Germany, England, France, Canada, Italy, and Japan.
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History by Dr. Salmon Stravchansky, 2012
Past notable speakers have included (with titles at the time of appearance):
- Dr. Jerry Goyan, Commissioner of the FDA
- Dr. McClellan, Commissioner of the FDA
- Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer and Director of the Center for Drugs Evaluation and Research at the FDA
- Dr. Andrew von Eschenbach, Director of the National Cancer Institute
- Steven Paul, Executive Vice President of Science and Technology and President, Lilly Research Laboratories
- Dr. Murray Lumpkin, Deputy Commissioner, International and Special Programs, FDA
- Brian Burns, Executive Director, Federal Affairs, Johnson & Johnson
- Kay Holcombe, Senior Health Policy Advisor, Genzyme Corporation
- Thomas Löngren, Executive Director, European Medicines Agency
- Garry Neil, Corporate Vice President, Johnson & Johnson
- Dr. John Leichleiter, CEO of Eli Lilly Laboratories
- James Greenwood, President and CEO of the Biotechnology Industry Association
- Bill Tauzin, President and CEO, PhRMA, Dr. Steve Galson, Director, FDA/CDER; Dr. Robert Temple, Associate Director for Medical Policy FDA
- Dr. Roger Williams, CEO of the United States Pharmacopeia
- Dr. Robert Baum, Executive Director, Pfizer Inc.
- Dr. Helen Winkle, Director of the Office of Pharmaceutical Sciences, FDA/CDER
- Dr. Moheb Nasr, Director of the Office of New Drug Quality Assessment, FDA/CDER
- Jacky Vonderscher, Vice President, Head Exploratory Development in Europe, Novartis Pharma AG
(COMING SOON – Complete list of past speakers)
