AAPS Global Leader Award recipient Vinod Shah displayed leadership abilities from the start.
By Mark Crawford
After 30 years with the U.S. Food and Drug Administration (FDA), Vinod P. Shah, Ph.D., retired as a senior research scientist in the Office of Pharmaceutical Sciences in 2005. Shah worked for several FDA divisions during his career with the agency and developed regulatory guidance documents for the pharmaceutical industry, including dissolution, scale-up and postapproval changes (SUPAC), bioanalysis, bioequivalence, biopharmaceutics, and topical drugs.
Shah is well known for his passion and commitment to advance the development of quality drugs and therapies in developing countries. In collaboration with the American Association of Pharmaceutical Scientists (AAPS) and the International Pharmaceutical Federation (FIP), Shah launched outreach programs to conduct workshops and conferences on bioequivalence and dissolution around the world to provide educational training to improve drug product quality. He has organized workshops in Australia, Brazil, China, Chile, Croatia, Egypt, Greece, Hungary, India, Jordan, Korea, Latin America, Mexico, Philippines, Portugal, Romania, South Africa, Taiwan, Thailand, Turkey, and Vietnam. Some dissolution workshops were hands-on events to provide practical know-how for product testing. His tireless efforts to expand the availability of high-quality drug products have benefited patients around the world.
After leaving FDA, Shah joined NDA Partners as an expert consultant in 2016.
Topical Drug Products
Shah has a longtime interest in topical drug products. As an independent scientist, he recently proposed a practical and science-based approach for simplifying the regulatory pathway for complex generic topical drug products termed “Topical Drug Classification System” (TCS).
“Determination of bioequivalence is the biggest barrier to the approval of generic topical dermatological drug products,” Shah says. “TCS was developed using SUPAC-SS principles, Q1, Q2, Q3, and in vitro release similarity measurements. The in vitro similarity can provide biowaiver for certain generic topical drug products.”
Similar to the well-established Biopharmaceutics Classification System for oral drug products, Shah’s TCS will facilitate generic topical drug development and approval, reduce regulatory burden, and assure product quality.
Exemplifying Leadership
Shah’s supervisors recognized his leadership abilities early in his career. When he was a postdoctoral fellow at the University of California-San Francisco, Jerome Skelly, Ph.D., of FDA met Shah during a training session for pharmacokinetics. He was impressed by Shah’s ability to manage multiple projects, as well as his productive relationships with other employees in the lab. Skelly invited Shah to come to FDA, meet other managers and scientists there, and apply for a position. Shah accepted the job of technical coordinator and steadily advanced through higher positions, including branch chief and associate director at FDA. Other key leadership roles outside FDA included scientific secretary for FIP and various AAPS positions, including president in 2003.
“Each job position in my career has been unique and helped me develop my leadership and communication skills,” says Shah.
Shah believes the key leadership qualities are vision, mission, communication, optimism, and having the ability to motivate and excite others. This also requires long-term patience and dedication, careful use of resources, and the ability to foster collaboration among cross-disciplinary groups.
“Good leaders thoroughly understand an issue and develop a plan to resolve it through consensus building, taking everyone into confidence, and being a team builder-leader,” he says. “They should be able to interact well with their coworkers, disseminate information clearly, and delegate authority and other responsibilities wisely.”
Shah indicates that good scientists should have a thorough understanding of the problem and what they want to achieve, analyze the pros and cons of various approaches to find the solution, face the research challenges that will invariably present themselves, and not be frightened or discouraged by some failures or criticism by “big shots.” This is especially true for recent graduates and young scientists, who may feel rushed or pressured to select a specialty.
“Pharmaceutical science is a very broad field that encompasses many health-related disciplines, starting from drug discovery to drug development and through drug regulations and patient treatment,” says Shah. “It is easy to get confused about the best path to follow. It is important to take the time needed to explore subdisciplines and build the career that will satisfy your curiosity and desire. Mentorship can also help in this regard, especially when interacting in a project together.”
Improving Lives
Shah’s education and training, vision, determination, and communication skills have allowed him to do “good science” and create products that have benefited international health.
Having this kind of global impact requires consummate leadership skills and the ability to collaborate with others and build support for a mission or goal. His significant and long-lasting research contributions to the pharmaceutical sciences field, and working tirelessly with regulatory, standard-setting, and academic communities in the U.S. and abroad, have been instrumental for improving drug
product quality.
“Dr. Shah’s leadership and efforts in organizing and conducting international workshops have had a significant and broad impact in the availability of high-quality drug products, and benefit to patients,” states Leslie Z. Benet, Ph.D., professor of bioengineering and therapeutic sciences at University of California-San Francisco and a founder of AAPS. “His tireless efforts have garnered good will for AAPS and FIP globally and improved drug therapies for patients in need.”
Volunteering with AAPS
Shah is a sustaining member of AAPS and enjoyed serving as AAPS president in 2003. Under his leadership, AAPS finalized its vision, mission, and values statements and expanded regulatory science workshops to improve drug product quality. An AAPS Fellow, Shah has also received the AAPS Presidential Citation, Distinguished Service Award, Pharmaceutical Sciences World Congress Research Achievement Award, Distinguished Pharmaceutical Scientist Award, and most recently the 2018 AAPS Global Leader Award. You can see him accept his Global Leader Award at http://bit.ly/AAPSShah.
“AAPS has had a very significant impact on my career,” says Shah. “Using AAPS as a neutral platform, I have planned, developed, organized, and implemented several regulatory science workshops to address complex scientific issues of great importance to FDA and regulated industry. I launched a joint AAPS/FIP outreach program to run bioequivalence and dissolution workshops in developing countries globally. Being involved with AAPS from the day of its inception and having served in various capacities over the years have greatly influenced my career and my leadership skills. Perhaps most important of all, I have been able to work with, and learn from, some of the best scientists in the field—many of whom have become life-long friends.”
Mark Crawford is a science and technology freelance writer based in Madison, Wis.