Prof. Alan Liss
Founder, CEO, GXP farma, LLC – Mentoring & Consulting, USA
Title: Animal Models, Animal Rule, Human Medicines: The Pathway to Protecting Humans from Radiation Sickness
Abstract:
Acute Radiation Syndrome (ARS), or radiation sickness, occurs in humans after whole-body exposure to large doses of ionizing radiation delivered over a short period of time. Data from epidemiologic studies of human populations exposed to these levels of exposure may come from atomic energy plant accidents, use of nuclear weapons and even from cancer therapy treatments. Research bettering the understanding of the effects of radiation exposure in humans has revealed a number of potential targets to protect, mitigate or treat damage caused by radiation. However, moving from the laboratory to an approved medicine has been difficult. I will present data and examples of how potential ARS drugs are being considered by drug regulatory authorities. directly affecting the survival of irradiated humans is requires a variety of factors not seen during the development of traditional drugs. Knowledge of the unique ARS drug pathway should also prove useful to basic and applied radiation researchers to better design their experiments. This will facilitate taking promising drug candidates from the bench top to the patient’s palms.
Biography:
Dr.
Alan Liss has over 30 years of successful experience in the areas of drug
development and biotechnology. He has focused on establishing and maintaining
high quality pharmaceutical project management systems - directing teams of
scientists and support staff to improve manufacturing quality and efficiency,
and GXP regulatory compliance.
Alan
retired in late 2014 as the Director of the Public Health and Security Action
Team Program of the US Food and Drug Administration Commissioner’s Medical Countermeasures
Initiative in Washington, DC. This team
was essential in the US FDA approval process of several drugs that can be used
to treat acute radiation syndrome patients. Prior to that position, he
organized the creation of the Regulatory and Quality Division for the
Biomedical Advanced Research and Development Authority (BARDA) of the US
Government’s Department of HHS/ASPR.
Alan
has worked in private industry as Senior Director, Biotechnology and Project
Management for Duramed Research, Inc. (a Division of Teva/Barr Pharmaceuticals, Inc.); Vice
President, Product Development for Antex Biologics, Inc.; Site Director,
Quality Assurance and Quality Control for Wyeth Pharmaceuticals Inc.; Senior
Director of Quality Assurance and Regulatory Affairs for Aventis Bio-Services,
Inc.; and Director of Quality Assurance and Quality Control for the Institute
of Molecular Biology.
Dr.
Liss founded GXP farma, LLC (www.GXPfarma.com),
an independent consulting group which focuses on moving drug development
programs forward. His team has created strategic quality and regulatory plans
for drug and biologics development and a novel business-oriented approach to
facilitate the execution of these plans. He has also developed a series of
focused auditsdesigned to support potential mergers and acquisitions as well as
to prepare for inspections by regulatory authorities.
Alan
has authored over 60 scientific publications and has presented numerous
lectures on quality, compliance, medical countermeasures, vaccines and other
specialty manufacturing issues both nationally and internationally.
Dr.
Liss received a B.S. degree in Genetics from the University of California,
Berkeley, and a Ph.D. in Microbiology and Immunology from the University of
Rochester School of Medicine and Dentistry.