The ASCPT Member Spotlight is a forum to recognize and thank a member of ASCPT who has supported the Society's endeavors. We also highlight the Member of the Month, along with two other members, in each issue of Clinical Pharmacology & Therapeutics. We hope you will enjoy learning about fellow members and as always, encourage your participation in Society events and activities.
Captain E. Dennis Bashaw, PharmD: January Member Spotlight
Previous Members of the Month
|ASCPT is proud to recognize Captain E. Dennis Bashaw, PharmD as the January 2017 Member of the Month.
Captain E. Dennis Bashaw, PharmD, Director, Division of Clinical Pharmacology-3, Food and Drug Administration, Silver Spring, MD
Captain Bashaw’s involvement with ASCPT goes back almost 25 years. CAPT Bashaw joined the US Public Health Service Commissioned Corps in 1987 and was assigned as a pharmacokineticist in the Division of Biopharmaceutics at the FDA. He explains that “we did not call ourselves clinical pharmacologists at the time as we were primarily focused on biopharmaceutics issues.” He goes on to explain that this was before the American Board of Clinical Pharmacology was established and at a time when he and his colleagues were still hand writing the first drafts of reviews and having typists enter them into mainframe word processors.
In 1992, he was selected to be one of the founding members of the Pilot Drug Evaluation Staff (PDES) in the FDA. This was a new group in the FDA that was formed by the then Center of Drug Evaluation and Research Director, Dr. Carl Peck. Dr. Peck wanted a review division or staff that he could use as a testbed for review and innovation in drug review. Dr. Peck wanted to take drug review out of the purview of individual review elements and work towards a blended review, where the different disciplines (statistics, chemistry, biopharmaceutics, and medical) actually talked with each other rather than simply exchange reviews at the end of a review cycle. He explains that the norm at the time was that the different groups did not interact much. The PDES sought to encourage interaction by sitting down together as an entire unit in one physical space. CAPT Bashaw believes that this decision to “co-locate” the staff was a key element in the development of clinical pharmacology at the FDA.
When he joined ASCPT it was a small organization by today’s standards. However, at the time some colleagues at the FDA including Dr. Peck were believers in its value and its potential. Dr. John Harter, the day-to-day director of the PDES, was a great promoter of ASCPT and in the integration of dose response and data mining to enhance drug safety and efficacy. Dr. Harter was a big supporter of ASCPT and strongly encouraged attendance at the Annual Meeting and membership in ASCPT.
CAPT Bashaw has a little trouble measuring how ASCPT has impacted his career. He feels that he has “grown-up” professionally in ASCPT and he finds it difficult to separate the evolution of ASCPT, the science of clinical pharmacology, and his professional evolution. He doubts that the science of clinical pharmacology would have evolved as quickly as it has without ASCPT. As for the personal impact he has this to say: “without ASCPT and its impact on the field I doubt that I could have achieved as much as I have. It is trite to quote Newton, but his statement rings true regarding ones career, ‘if I have seen further, it is by standing on the shoulders of giants.’” For CAPT Bashaw, these “giants” are Drs. Peck, Harter, and ASCPT.
The Annual Meeting is CAPT Bashaw’s most valued aspect of membership. He views the journals as top notch, but he prefers the face-to-face discussion, debate, and the robust discussions that happen in both the meeting rooms and informally after the sessions. At the ASCPT 2016 Annual Meeting, he ran across some colleagues that he had not seen in a few years and had a great time exchanging input on research programs that have yet to bear fruit in publication or even grant submission. The ability to affect or provide input at these early stages are what all scientists want to do and the meeting provides that platform.
As for the younger generation of researchers and scientists, CAPT Bashaw encourages not holding back. He explains that too many people stand around waiting for someone else to do or say something. When one is starting out frequently one feels that he/she should let the more experience speak first, but this is a mistake. Younger members need to seek out opportunities on committees or as meeting speakers. They need to challenge the current processes and the current methods. Science is not static, and neither is ASCPT. In order to continue as a relevant organization and as a platform for thought leaders, then all types of members need to participate in ASCPT’s shaping. He goes on to say: “following those who came before is nice, but it does not grow the science into new and unique areas.” According to CAPT Bashaw, ASCPT has been a force for change within the profession over the last fifty years, but one needs to look ahead to the next fifty years. All fields of science are changing due to the revolution in information processing and the sheer bulk of new things to know. ASCPT has to develop the role more of how to adapt to these changes and new or younger members are the key to maintaining relevancy.
CAPT Bashaw explains that “you never know where things will take you.” About twenty years ago, he was promoted to be a team leader for a team that included dermatology products. At that time little PK work was done on dermatology products for a number of reasons, mostly however due to poor study designs. He developed over the years a study design called the Maximal Usage Trial to streamline the evaluation of topical dermatologic products. Recently this methodology has been applied to the development of new sunscreens to combat the rising rates of melanoma and other sun exposure related skin cancers. The importance of determining the degree of systemic availability is highlighted by the recognition of new manifestations of toxicity such as endocrine disruption with bisphenol A. Considering that sunscreens can be found in more and more products and that as clinicians we are recommending the preventive use of sunscreens on a routine basis, the establishment of safe exposure levels has been a key area of research over the last few years and will continue to be so under the direction of the Sunscreen Innovation Act that was passed by Congress in 2014. While seemingly not an area for clinical pharmacology, once one begins to understand the potential magnitude of the issue and the need for informed risk-benefit determinations, the role of clinical pharmacology as a major player in these evaluations becomes clear. This has been a particularly rewarding program to be involved with as it will ultimately “touch” every person in the United States.
CAPT Bashaw has been a member of ASCPT since 1997.
Thank you, CAPT Bashaw, for your continued commitment to ASCPT and the discipline of clinical pharmacology and translational medicine.