Lynn Gold, Ph.D., has honed her career working across disciplines.
By Mark Crawford
With a doctorate in organic photochemistry and more than 25 years of experience in the pharmaceutical industry, Lynn Gold has pretty much done it all—basic drug discovery, synthesis, drug formulation development, analytical method development and validation, microbiological method development, clinical trial manufacture and logistics, process scale-up and technical transfer to production, and troubleshooting production issues, quality control, and regulatory registrations.
She is vice president of Scientific and Regulatory Affairs for Camargo Pharmaceutical Services, a drug development company based in Blue Ash, Ohio. Gold is primarily responsible for facilitating client/sponsor interactions with regulatory agencies (usually the Food and Drug Administration [FDA]) on quality development issues, as well as maintaining the quality module for the regulatory submission.
She has also been highly active in the Regulatory Sciences section since she joined the American Association of Pharmaceutical Sciences (AAPS) in 2012. Positions include chair-elect (2016), vice chair (2015), secretary/treasurer (2014), cochair Chemistry, Manufacturing, and Controls focus group (2012–2013). Gold is also involved in several special AAPS projects, including developing the Regulatory Sciences 101 ecourse. “It has been very rewarding to produce high-quality work with such a dedicated team of scientific professionals," she says. “I always learn something new—a new approach to an old problem, or a new way to interpret a guidance document.”
As if these responsibilities are not enough to keep her busy, Gold also recently prepared a book chapter titled “Regulatory Aspects at the Drug Discovery Interface” for an AAPS book, Translating Molecules into Medicine—Cross-Functional Integration at the Drug Discovery-Development Interface.
“I enjoy the challenge of reaching different audiences,” says Gold. “This book is much more focused on the early stages of development, rather than the end stages of product development. Regulatory sciences are often considered as a late-development-stage function; however, a good development program considers regulatory challenges in the up-front planning stages. We are still in the process of finalizing chapters, which will include relevant drug development examples, as well as regulatory approaches.”
LEADERSHIP = COMMUNICATION
Gold has held leadership positions throughout her career and believes good leadership starts with communication, which she admits can be hard for scientists. As a result, she is always looking for new ways to interact with people. “It can be a challenge to build a rapport with scientists,” she says. “It is important to have flexibility in your style to account for a variety of personalities. Building trust can be a slow process, so it may require multiple discussions before real exchange starts to occur.”
Scientists are often most comfortable using tools such as laboratory equipment, experiments, analyses, results, and data-driven reports to convey their ideas. As important as these are, Gold believes effective communication is the most powerful tool scientists can use for exchanging ideas and building mutual respect among members of the community. Communication skills also include listening and providing encouragement, feedback, and follow-up.
One way to build communication and leadership skills is by becoming an active member of AAPS, which provides opportunities to write articles, participate on programming teams, moderate sessions at meetings, develop webinars and elearning courses, and join other initiatives that require face-to-face interactions or collaborations. Gold encourages scientists to learn more about who they will be working with in these situations, and what their interests are, to deepen their perspectives and maximize the collaborative output.
For Gold, the most exciting part of effective communication is the way it ignites new ideas. “Over my career I have learned that the most rewarding discoveries and developments involve multiple disciplines, often with unexpected rewards,” she says. “For example, almost all scientific project teams are multidisciplinary. I once worked with a nonclinical laboratory to support a study that would be the pivotal program for supporting a new drug application. We managed to design the protocol, get FDA concurrence, execute the protocol, and get the product approved. It took a multidisciplinary team of analytical chemists, quality control scientists, statisticians, and regulatory scientists to make it all work.”
FUTURE PLANS
Gold feels extremely fortunate to have participated in every aspect of a drug development program leading up to commercialization. Much of her experience has been in technology transfer from the bench to the pilot scale and from the pilot to the commercial scale. This work also included developing analytical methods and validating all aspects of the program. Her favorite role is imagining what the product will be when it is commercialized and the key parameters that will be required for the development program.
As a life-long learner, contributor, and problem-solver, Gold is especially fascinated by scientific, regulatory, and commercial interfaces. “There is always the possibility to learn something unexpected, and to find ways to apply these new learnings to my day-to-day problems,” she says. “I particularly enjoy interacting with scientists from other disciplines, including toxicologists, pharmacokineticists, pharmacists, engineers, and other chemists.”
Supporting students—especially women—who are interested in careers in pharmaceutical sciences interfacing with regulatory sciences is another passion for Gold. “I enjoy discussing career possibilities in regulatory sciences with students,” she says. “I have spoken to the AAPS student chapter at Campbell University about what I do at Camargo and about not limiting your options until you find the discipline that sparks your interest.”
For younger scientists or graduate students still seeking their path, Gold emphasizes there is no rush—the pharmaceutical industry consists of a variety of disciplines, each with many career paths to consider. She recommends that students follow the science that excites them the most, explore it across as many disciplines as possible, and then determine what value they can add to the field. “Working with a mentor in an area of interest is a great way to find out what skills you may need to gain that type of position,” Gold advises.
Finding people who care about what you want to accomplish—and provide valuable advice and even mentorship as well—can be found in organizations like AAPS. Gold indicates that volunteering for AAPS greatly expanded her scientific community with thought leaders from various disciplines. “Working in this environment reminds me how large and how small the world is, and keeps me from focusing only on what is of interest to me every day,” she states. There are so many excellent scientists involved in AAPS, all wanting to learn and explore the boundaries of science to support the development of effective and available new medicines for the patients. It energizes me to work with these individuals in this dedicated pharmaceutical sciences community.”
Mark Crawford, a freelance writer based in Madison, Wis., specializes in science and technology.