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Environmental Factor, January 2012

NIEHS postdocs learn the value of options at NC biotech career day

By Ian Thomas

Jonathan Stocker

Stocker said of the long and expensive process of drug development, “It’s hard, but very exciting.” (Photo courtesy of Steve McCaw)

Emily Zhou, Ph.D.

NIEHS postdoctoral fellow Emily Zhou, Ph.D., took advantage of the morning break to network with Schuller and learn more about careers in regulatory affairs. (Photo courtesy of Steve McCaw)

Andy Seipel, Ph.D.

Meanwhile, NIEHS postdoc Andy Seipel, Ph.D., used his break to talk with colleagues from other institutions. According to Parthasarathi, the workshop attracted Ph.D.s from as far away as East Carolina University. (Photo courtesy of Steve McCaw)

Dominique Pifat, Ph.D. and Leo DiNapoli, Ph.D.

The panelists talked about their circuitous career paths and how they’ve become comfortable with change. Shown above are Pifat, right, and DiNapoli. (Photo courtesy of Steve McCaw)

NIEHS postdocs joined dozens of their colleagues at the North Carolina Biotechnology Center (http://www.ncbiotech.org/)  (NCBC) Dec. 9 for the third installment of the organization’s career series, titled “Science Industry Careers: Discovery to Product Development.” Held at NCBC’s main facility in Research Triangle Park, the event exposed attendees to a range of industry career paths, available to scientists who hold a Ph.D.

“Science and pharmacology are no different than any other field when it comes to the job market,” said Drew Applefield, Ph.D., (http://www.ncbiotech.org/author/drew-applefield-phd)  a business and technology development associate with NCBC and the event’s moderator. “With that in mind, we wanted to give new scientists entering these fields a chance to explore their options, both in and out of research, as well as a chance to network with actual members of the industry.”

Spanning the majority of the day, the event consisted of three primary segments. The first featured a discussion of the drug development process, while the second addressed the role of regulatory affairs. Finally, the day concluded with a panel discussion and a resume review session.

According to several attendees, the workshop added to their understanding of career options. “I learned a lot today, particularly with regard to the drug development process and the regulations that deal with it,” said NIEHS trainee Emily Zhou, Ph.D.

A complex process

Led off by Jonathan Stocker, the associate director of clinical development for ClinPharm Consulting, the morning began with a step-by step-breakdown of the New Drug Application (NDA) development process. Stocker discussed the pre-clinical, or discovery stage, the clinical stage, featuring the three phases of clinical trials, the FDA evaluation stage, and finally the post-approval, or commercialization stage. 

“Moving an NDA from the bench top, through lead optimization into the clinical stage alone is a long and complicated process that takes many years,” said Stocker, who focused much of his presentation on the pre-clinical and clinical stages. “Making this process happen requires a wide range of people from both the academic and entrepreneurial arenas. So it really behooves new scientists to become familiar with both.”

Regulating an industry

In the second session, attendees were versed in the world of pharmaceutical regulatory affairs. As described by Charity-Anne Schuller, Ph.D., associate director of regulatory affairs for PPD Inc., this field involves reading, understanding, and interpreting of laws surrounding drug development, so as to insure proper compliance on the part of manufacturers.

“Ultimately, the role of the FDA is to protect the public health by passing laws that assure the safety, efficacy, and security of the medical products on the market,” said Schuller, an adjunct professor with Campbell University’s clinical research program. “That requires a fluent understanding of a lot of complex topics which means that we, as regulatory specialists, can often times find ourselves wearing a lot of different hats within the companies we work for.”

Shifting gears

The NC Biotech career day concluded with a panel of four members, each of whom began their careers as research scientists before eventually moving into industry. Throughout the hour, panelists took turns answering questions from the audience, while sharing their respective experiences and insights about the field. While their stories may have differed, their advice to attendees was unanimous.

“Always know your options,” said Amber Barnes, Ph.D., a panelist and senior medical writer who began her career as an oncology researcher. “Not everyone is cut out to spend their entire career working from the bench, and if you decide to shift gears, like I did, it’s up to you to arm yourself with the tools you’ll need to make that transition.”

The Ph.D. career workshop series was organized by Shobha Parthasarathi, Ph.D., technology development director of the BCNC Business and Technology Development Program and head of the Center's Industrial Fellowship Program (IFP). The first two sessions focused on “Life Science Industry Careers: Bench to Boardroom” and “Agencies and Research Institutes.”

(Ian Thomas is a public affairs specialist in the NIEHS Office of Communications and Public Liaison and a regular contributor to the Environmental Factor.)


Amber Barnes, Ph.D.

Barnes, who seems to flourish in the shifting environment of the private sector, told the audience, “Don’t feel that you’re making a decision for the rest of your life.” (Photo courtesy of Steve McCaw)


Bob Black, Ph.D.

Black, an engineer who now works in medical device development for a small firm, has also worked in academia and for a large corporation. He described his career as a random walk. (Photo courtesy of Steve McCaw)


Career Day Panelists

  • Amber Barnes, Ph.D.
    • Senior Medical Writer, Pharmanet/i3
  • Bob Black, Ph.D.
    • Vice President, Scion NeuroStim
  • Dominique Pifat, Ph.D.
    • Senior Consultant, Biologics Consulting Group
  • Leo DiNapoli, Ph.D.
    • Associate Director for Regulatory Affairs, Cato Research


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