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 24 & 25, 2014|
|Location||Omni at Barton Creek, Austin, TX|
|Start Time||Programming begins at 1:30 PM CT on February 24|
|Ending||Last session will conclude around 8:00 PM CT on February 25|
|Lunch & Breaks||All inclusve with registration|
|Lodging||Two nights stay at Omni at Barton Creek, Austin, TX included with registratoin|
|Nearest Airport||Austin-Bergstrom International Airport • AUS|
|Registration Fee||See Registration Page|
To offer the most informative and up to date conference in the science and regulation of global drug development
2014 Conference Theme:
Transformation of Drug Development – Challenges
And Opportunities Advancing Innovative Solutions to Meet Patient’s Medical Needs of Serious Conditions and Rare Diseases
2014 Conference Description:
For more than a century innovative pharmaceutical companies have translated basic science to bring new molecular entities (NME) to meet the medical needs of patients. These NME’s and improved delivery systems combined with better regulatory science have reduced the cost of the therapeutic management of many serious conditions and rare diseases. Despite the U.S.A pharmaceutical industry being the world’s best there is concern that the rate of patient focused drug development needs to be expedited to take advantages of the ongoing revolution in molecular pharmacology, genetics, molecular imaging, nanotechnologies, and other scientific advances.
A revolution in personalized therapeutics is ongoing. This has already resulted in better clinical outcomes and has reduced cost aided by the use of companion diagnostics to support evidence based treatment modalities. Despite all these advances expenditures in health care in the United States have reached approximately 16% of GNP and this increased cost, in the near future, will be challenging to sustain. Health expenditures per capita in the United States are 50% more than any other country, however, treatment of chronic diseases, life expectancy, and infant mortality are not at the top of the list.
Although patients and physicians are generally willing to accept greater risk and uncertainty about benefit, we have experienced a decrease in the rate of entry to market of new innovative drugs and therapeutic modalities to meet patient needs suffering from serious and rare diseases. The reasons for this slowdown are numerous; however, it raises new scientific and regulatory challenges and opportunities to continue the transformation of drug development to successfully bring innovative drugs to market.
The 2014 ICDD will attempt to answer several questions: What is the role of academia, industry, FDA, payers, and the patient in finding innovative ideas to accelerate drug development? Are innovative partnerships feasible to better integrate the health care system between and among academia, industry, payers, patient’s representatives, FDA and other government agencies to accelerate the development of new drugs, diagnostics, and new treatment modalities for patients?
This year’s conference is dedicated to explore how to find, advance and accelerate innovative solutions, clinical and non-clinical, to improve patient’s outcomes at a reduced cost without impacting drug discovery and development. ICDD is dedicated to advance scientific and regulatory solutions to expedite drug development to meet patient’s medical needs without compromising quality, safety, and efficacy of drugs and biologics.
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.
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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©2012 College of Pharmacy, The University of Texas at Austin