BeiGene, FDA, ACPHS Announce Pharmacovigilance Fellowship

By Matthew Pillar, Editor, Bioprocess Online

Albany College of Pharmacy and Health Sciences, BeiGene, and the FDA are setting a new standard for collaborative cultivation of next-gen life sciences talent by breaking down barriers between academia, industry, and the Agency. We go inside their innovative Fellowship model.

Sabrina Hayden and Vincent Wysocki are about to kick off a two-year odyssey that, when it’s all said and done, is likely to make them very, very employable.

The two Pharm.D. graduates were recently chosen for a new Pharmacovigilance Fellowship spearheaded by a trifecta of organizations that will collectively provide them a deep learning opportunity like no other. At the conclusion of their journey, Fellows Hayden and Wysocki, both of whom beat out a field of more than 40 national applicants, will boast the benefits of:

• Four months of study at Albany College of Pharmacy and Health Sciences (ACPHS), under the guidance of College Professor Patrick Meek. 
• Eight months working within the four walls of the FDA’s Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology, working side-by-side with Deputy Director of Regulatory Science Staff Suranjan De and Director of Regulatory Science Staff Amarilys Vega, M.D., M.P.H.
• One full year of on-the job training at BeiGene, overseen by Chief Safety Officer and SVP John Freeman and VP of ICSR Case Management, Medical Review, Aggregate Safety Reporting & Signal Management C.J. Delgra, M.D., one of the preceptors. 

The new Fellowship—and importantly, the academic, industry, and regulatory synergy behind it—offers a case study in collaboration among the three most important institutions in life sciences talent cultivation. I was grateful for the opportunity to sit down with Freeman and Drs. Greg Dewey (ACPHS President), Vega, and Delgra to learn about the unique Fellowship, and the three organizations’ intentions to ensure the initiative creates an impact well beyond bolstering the careers of its inaugural Fellows.

What’s A Pharm.D., If Not A Pharmacist?

To explain the genesis of the new Fellowship, Dr. Dewey introduces yet another character to the story: Lindsay Wagner, a former ACPHS student who earned her Pharm.D. from ACPHS back in 2009. Dr. Wagner, he says, is exemplary of the potential of the Pharm.D. degree beyond the typical. Rather than seek employment as a community  pharmacist, Dr. Wagner leaned into her own Fellowship at the FDA and took a post there after graduating ACPHS. She’s now a Board-Certified Pharmacotherapy Specialist, a U.S. Public Health Service Pharmacist, and Branch Chief at the FDA’s Divisions of Drug Information.

“Here at the College, we’re taking the initiative to facilitate Pharm.D. graduates’ entry into the pharmaceutical industry. We see that as a very robust career path for them, particularly as some other sectors of pharmacy come under job market stress,” he says. “Lindsay is an example of a Pharm.D. that did well charting an alternate path, and she was instrumental in our early talks with the Agency about launching the new Fellowship.”

Those early talks bolted down two critical pieces of the puzzle and revealed the third: a corporate presence. That’s where BeiGene stepped in. “What Dr. Dewey describes is a solution looking for an opportunity, and we were keen to provide the opportunity,” says BeiGene’s Freeman. “I’ve worked in drug safety for more than 35 years and across four very large organizations, and in that capacity, I've had the fortune or misfortune of bringing on board about a thousand professionals into those companies. It's always been a challenge to ensure that we can identify and develop talent.” The initiative, he says, aligns with BeiGene’s needs for pharmacovigilance talent as the company continues a steep global growth trajectory. “It’s a shared responsibility across healthcare professionals, academics, industry, and regulators to play a role in this continuum of activity from patient to report, and this opportunity fit well within that ecosystem to ensure that we could help orientate contributions to that environment.”

What’s more, Freeman says BeiGene is as keen to tap into the annual crop of some 15,000 Pharm.D. graduates as it is to hire talented M.D.s. “The work my teams do requires a multi-disciplinary approach. Pharmacovigilance is a hybrid of medical, statistical, regulatory, and pharmacological science,” he explains. “We employ M.D.s, Ph.D.s, R.N.s, and more. We need them all to be well-versed across all those disciplines. And frankly, I think Pharm.D.s can offer the perfect solution because they bring a deep underlying understanding of the science and a practical mindset to the data. Data is our currency and Pharm.D.s often do a better job than M.D.s in terms of translating scientific data to operational outcomes.” 

Shaping Outcomes: What Pharmacovigilance Fellows Can Expect

During their year working full-time at BeiGene, Hayden and Wysocki will rotate throughout Freeman’s organization under Dr. Delgra’s and other preceptors’ mentorship. “The Fellows will work on specific pharmacovigilance projects in the context of our development and post-market spaces and will be given the opportunity to observe and potentially participate in some milestones,” says Dr. Delgra. Much of that work will depend on the company’s clinical pipeline milestones during the Fellows’ rotations. They are likely to have exposure to candidates at various submission stages across multiple global regulatory agencies. They’ll play an active role in global safety information management and reporting requirements. Additional work will include safety data acquisition, IT and health informatics, regulatory and safety reporting, inspection readiness signal detection and validation, risk assessment, and risk communication, all within BeiGene’s systems-based approach to improving medication use safety.  The fellow will also have an opportunity to work on a longitudinal project that they will work on at each of the three sites along with their preceptors over the 2 years. 

Over the course of their eight months at the FDA, Dr. Vega says the Fellows will have a hands-on experience with the regulatory aspects of drug safety, much like the fellows in the ORISE Fellowship program. Her office is responsible for monitoring and evaluating the safety profiles of drugs available to American consumers. “I was a fellow myself, so I understand the value in an opportunity to learn about the regulatory aspects of drug safety within the FDA. It’s not easy to understand if you’re not present,” she says. “The fellows will have the opportunity to explore different perspectives throughout the program through work on projects related to medication errors, pharmacovigilance informatics, pharmacoepidemiology, and more.” Dr. Vega says the students will also play an active role in the management of the influx of adverse event reports and safety data coming to FDA reviewers, helping the agency to explore new data visualization and artificial intelligence strategies to process these large quantities of data.

The Fellows’ time at ACPHS will look much like that of a postdoctoral fellow. Dr. Dewey says they’ll conduct pharmacovigilance research with a biostatistician on the college’s faculty and be given the opportunity to teach classes as well. “Pharmacovigilance is a field that's in dire need of talent, and one that offers a whole range of career opportunities and subspecialties,” he says. “In pharmacy education, we're seeing increased popularity of residencies and fellowships that offer a deeper dive into specialty areas. The depth of knowledge they afford is becoming a requirement of preparation for these complex and sophisticated fields.”

Fellowship Outcomes: Highly Employable “Seeds” In The Industry

Without question, inaugural Fellows Hayden and Wysocki will emerge from their 24-month adventures with an incredibly high degree of employability. What pharma company wouldn’t want a young, talented professional whose spent a year at BeiGene, studied at one of the oldest pharmacological institutions in the world, and had eight months of first-hand exposure to one of FDA’s premier regulatory science programs? Similarly, the institutional participants will benefit from the experience as well. Freeman even quips that he’ll benefit personally. “These are the life sciences professionals that will be looking out for the medicines people like me will be consuming in our old age. I have a vested interest in their education,” he quips.

On a more serious note, Freeman and Dr. Dewey agree that the goal of the Fellowship is to make waves beyond the impact it has on the individual careers of these two initial Fellows. “Our goal is to regularize the paths to the pharmaceutical industry for Pharm.D. graduates, and to drive their success in the pharmaceutical industry,” he says.

“In these two Fellows, we're planting two seeds,” adds Freeman. “The fundamental question is what becomes of those two. Hopefully, they will emerge as significant leaders in this space who can then continue to exponentially propagate learning opportunities.”

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