pharma-chem-congress-toxicology-congress-2018-keynote

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S e p t e m b e r 1 0 - 1 1 , 2 0 1 8 | D u b l i n , I r e l a n d
Pharma Chem Congress 2018 & Toxicology Congress 2018
Note:
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alliedacademies
TOXICOLOGY AND PHARMACOLOGY
PHARMACEUTICAL CHEMISTRY & DRUG DISCOVERY
&
Global Congress on
International Conference on
Joint Event on
Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
Robert P Bianchi, Asian J Biomed Pharmaceut Sci 2018, Volume 8 | DOI: 10.4066/2249-622X-C2-004
GOVERNMENT AND INDUSTRY
RESPONSE TO THE US OPIOID EPIDEMIC
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
percent of the world’s populations but consumes 81 percent 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. FDA is also responsible for advancing the
public health by helping to speed innovations that make medicines more
effective, safer, and more affordable and by helping the public get the accurate,
science-based information they need to use medicines and foods to maintain
and improve their health. 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 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The FDA also issued draft guidance for industry in March 2016 (finalized
November 2017) 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.
Biography
Robert P Bianchi is currently the President and
Chief of Scientific and Technical Affairs at the
Prescription Drug Research Center, Bradenton,
FL. He is a retired laboratory Director for the
Drug Enforcement Administration after 34 years
of federal service, where he held increasingly
responsible positions as an Analytical Chemist for
the FDA and DEA to the Chief of DEA’s Laboratory
Operations Section. He was also Director of the
DEA Special Testing and Research Laboratory
where extractability experiments were conducted
more than 20 years ago. Since 2005 he has
been working with the pharmaceutical industry
and FDA on developing in vitro protocols to
evaluate abuse deterrent formulations and has
been actively involved in sharing his experience
with the regulatory, treatment, pharmaceutical
abuse and law enforcement community. He has
provided drug related consultations to more
than 30 organizations/companies concerned
about OTC and prescription drug abuse and has
made numerous presentations to the regulatory,
treatment, pharmaceutical, abuse and law
enforcement communities.
Robert P Bianchi
Prescription Drug Research Center, USA