Day 1 :
Prescription Drug Research Center, USA
Time : 09:30-10:00
Robert P Bianchi is the President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center in Bradenton, Florida. Previously, he has spent 34 years in federal service as a Chemist at the FDA and DEA, including as Chief of the DEA’s Laboratory Operations Section, and the Director of the DEA Special Testing and Research Laboratory, where in-vitro studies were done more than 20 years ago. For the last decade, he has participated dozens of category 1 studies on abuse-deterrent opioid formulations, appeared as a panelist and presenter at abuse deterrent formulation and prescription drug abuse professional meetings. He has provided drug related consultations to more than thirty organizations/companies concerned about OTC and prescription drug abuse and has made numerous presentations to the treatment, pharmaceutical and law enforcement communities.
Prescription drug abuse has been declared an epidemic in America by the Centers for Disease Control and Prevention. According to the National Safety Council “Prescription Nation 2016”, the United States makes up 4.6% of the world’s populations but consumes 81% of the world supply of oxycodone. The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs while assuring patient access. This is a responsibility shared with the pharmaceutical industry, treatment facilities, educational institutions, and Federal, state and local law enforcement agencies. Toward that end, the FDA issued Guidance for Industry in April 2015 under the title, "Abuse-Deterrent Opioids-Evaluation and Labeling", which contains the following statement:"The goal of the laboratory-based studies, Category 1, should be to evaluate the ease with which the potentially abuse-deterrent properties of a formulation can be defeated or compromised". The FDA also issued draft guidance for industry in March 2016 the “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products”. This presentation will discuss abuse deterrent technology currently approved or in development and the required in vitro studies designed to evaluate extractability or tamperability. The FDA position on abuse deterrent delivery systems and the history of abuse deterrent opioid development will also be discussed. Studies on the efficacy of a new formulation to deter abuse will also be discussed.
ExtLe Solutions Ltd., UK
Shane P Smith is the Managing Director of ExtLe Solutions Limited, a company based in Cambridge in UK. He has over 30 years of experience in Industrial Analytical Chemistry, with well over half of that time spent in the Pharmaceutical sector. From 2004, he has worked for GlaxoSmithKline’s world class extractables and leachables team at Stevenage in the UK, managing projects for global cross-site project teams, and having ultimate responsibility for extractables and leachables sections of regulatory files submitted to agencies in North America, Europe and other territories. He has left GlaxoSmithKline in early 2016 to pursue a career as an Independent Consultant.
The subject of extractables and leachables has become an increasingly hot topic within regulatory agencies over recent years, especially with the increase of single use technologies in the manufacture of API/BDS and drug products. In addition, new guidance documents and pharmacopeial updates are driving the need for a thorough understanding of how extractables and leachables may affect the quality and efficacy of a drug product. This presentation will discuss key issues to consider whilst developing and executing a scientifically robust, and cost/resource effective GMP extractables and leachables strategy.