ICD2 is known for bringing together national and international scientists from academia, the pharmaceutical industry, the biotechnology industry and regulatory agencies for the opportunity to learn of and discuss new initiatives for finding a better way to develop new drugs and improve the quality of existing drug products. Ample time is provided for questions and discussion, to expand upon particular points of interest throughout the conference. The conference includes and FDA panel discussion that provides conference participants the opportunity to direct questions and comments to the panel of FDA members for thought and discussion.
|Dates||February 22 & 23, 2016|
|Location||Omni at Barton Creek, Austin, TX|
|Start Time||Programming begins at 1:00 PM CT on February 22|
|Ending||Last session will conclude around 8:00 PM CT on February 23|
|Lunch & Breaks||All inclusive with registration|
|Lodging||Omni at Barton Creek, Austin, TX|
|Nearest Airport||Austin-Bergstrom International Airport • AUS|
|Registration Fee||See Registration Page|
The goal of ICD2 is to update participants on the national and international initiatives affecting the development of safe and effective pharmaceutical drug products. By the end of the program, the attendee will develop an appreciation and in-depth understanding of the continuous scientific and regulatory efforts to improve the quality of pharmaceutical products and their impact on pharmaceutical care.
What is ICD2?
ICD2 is known for bringing together national and international scientists from academia, the pharmaceutical industry, the biotechnology industry and regulatory agencies for the opportunity to learn of and discuss new initiatives for finding a better way to develop new drugs and improve the quality of existing drug products.
"The tremendous strengths of the ICD2 is the fact that you have top people from the FDA, top people from industry, top people from other organizations, the legal groups, academic institutions all getting together and really trying to hash out some of the major challenges that the industry and the environment is dealing with and find ways to move forward."
Kenneth I. Kaitin, Ph.D.
Professor and Director, Tufts Center for the Study of Drug Development, Tufts University
The conference includes an FDA panel discussion that provides conference participants the opportunity to direct questions and comments to the panel of FDA members for thought and discussion.
"I have found it one of the most impactful conferences that I attend."
Janet Woodcock, M.D.
Director of the Center for Drug Evaluation and Research, US Food and Drug Administration
Ample time is provided for questions and discussion, to expand upon particular points of interest throughout the conference.
"The ICD2 is an incredibly intimate setting which allows dialogue on cutting edge topics with not only senior scientists and policy makers at the FDA, but academicians and other senior scientists and executives from industry, the opportunity to exchange that dialogue and discuss those topics in not only a small, intimate conference setting, but also over three meals a day, is really a unique opportunity. It’s not a typical conference."
Joanne Palmisano, M.D., FACP
Vice President, Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.
ICD2 was designed to fit the demands of today's top drug development professionals. The conference boasts 20+ presenters and panelists in one and a half days. Presentations and discussion will run through the evening hours on both days, resulting in a format that allows for travel time on Monday morning and early departure on Wednesday. Rates include program, meals, breaks, and accommodations resulting in one of the best values in drug development meetings at this level.
"If there’s any person who’s involved in any way with or wants to know about regulatory issues that are facing the industry, they ought to be at this meeting."
Gerald J. Yakatan, Ph.D.
Founder & Chairman, IriSys, Inc.
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.
In 1973, 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 the Waxman-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.
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.
History by Dr. Salmon Stravchansky, 2012
Past notable speakers have included (with titles at the time of appearance):
(COMING SOON – Complete list of past speakers)
|The University of Texas at Austin College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.|
|Comments to: UTPharmacyCE@austin.utexas.edu
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