ALBANY, NY – The Albany College of Pharmacy and Health Sciences (ACPHS) is pleased to announce two new two-year fellowships in pharmacovigilance and medication safety with BeiGene, a global research-based biotechnology company, and the U.S. Food & Drug Administration’s (FDA) Office of Surveillance and Epidemiology.
One fellow will first work full-time for one year at BeiGene at either their Emeryville or San Mateo, California location or Ridgefield Park, New Jersey location. Then the fellow will spend four months at ACPHS doing a series of field-based experiences in institutional pharmacy settings. Finally, during the last eight months, the fellow will work at the FDA’s Office of Surveillance and Epidemiology in Silver Spring, Maryland. The second fellow will reverse this order, beginning at the FDA, transitioning to ACPHS, and then completing the final year with BeiGene.
Our two inaugural fellows are Sabrina Hayden and Vincent Wysocki. Sabrina Hayden has more than three years of pharmaceutical and biotechnology industry related experience, including a rotation at the Dana Farber Cancer Institute, and is expected to graduate with her Doctor of Pharmacy degree from Massachusetts College of Pharmacy and Health Sciences this spring. Vincent Wysocki, who endeavors to apply his clinical knowledge doing pharmaceutical research, is currently a Clinical Informatics Research Intern at the University of Colorado and is expected to graduate with his Doctor of Pharmacy degree from that university this spring.
At the end of the two years, these fellows will have gained an extensive understanding of the importance of pharmacovigilance and medication safety across the drug development lifecycle by participating in functional core activities including safety data acquisition, adverse event case management and evaluation, information technology/health informatics, regulatory/safety reporting, inspection readiness, signal detection and validation, risk assessment, and risk communication. They will also have developed an understanding of a systems-based approach to improving medication-use safety with field-based experiences in institutional pharmacy settings and quality improvement projects.
“Our valued partnership with BeiGene and the FDA provides our two fellows with a unique and dynamic opportunity to draw upon our respective strengths and expertise to learn the diverse aspects of pharmacovigilance to support safe medication use,” said ACPHS President Greg Dewey.
“The practice of pharmacovigilance continues to evolve and with today’s heightened public interest in drug safety, we are very excited to collaborate with ACPHS and the FDA to develop the next generation of pharmacovigilance professionals,” said John Freeman, Chief Safety Officer at BeiGene.
“The program provides a unique and valuable experience by learning from and collaborating with scientists in industry, academia and government to understand the regulatory aspects of pharmacovigilance and enhance public health,” said Suranjan De, Deputy Director, Regulatory Science Staff, Office of Surveillance and Epidemiology at the FDA.
This partnership of a global pharmaceutical company with a regulatory agency and an academic institution will provide a rich and rewarding experience for the fellows by building on the three entity’s individual strengths to create a compelling learning environment that will span two years.
Albany College of Pharmacy and Health Sciences (ACPHS), founded in 1881, is a private, independent institution with a long tradition of academic and research excellence. The college’s mission is to educate the next generation of leaders to improve the health of our society. ACPHS was named the #1 value-added college in the country by the Wall Street Journal and the Brookings Institution.
BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 5,400+ employees around the world are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology medicines and market or plan to market additional oncology products in China licensed from Amgen Inc.; Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company; and EUSA Pharma. We have also entered a collaboration with Novartis Pharma AG for Novartis to develop and commercialize our anti-PD-1 inhibitor in North America, Europe, and Japan. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.
FDA Office of Surveillance and Epidemiology (OSE) monitors and evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. OSE maintains a system of post-marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. OSE evaluates more than two million adverse event reports submitted every year to FDA's MedWatch program. Staff in the Office of Surveillance and Epidemiology use this information to identify drug safety concerns and recommend actions to improve product safety and protect the public health.