WHITE PAPER: Medical Devices & Biologics Leader Board Certifies her Medical Affairs and MSL team.

Medical Device and Biologics Leader Board Certifies her Medical Affairs Team

Elio Evangelista, Editor

Elio Evangelista, Editor

Elio has several years of experience in medical affairs market research.

Imagine you’ve been hired to lead an organization of medical affairs professionals. They’re a small, but highly skilled team made up of people from diverse backgrounds and experience. As a leader, it’s important to be involved with and invest in your team’s professional development. But in medical affairs, what does that development look like?
After 20 years of medical affairs experience, many of which were in leadership roles at various organizations, Shabnam Vaezzadeh found herself able to get involved in her new team’s development. Vaezzadeh, the Vice President of Global Medical and Clinical Affairs at Organogenesis Inc., has made the decision to enroll her medical affairs team in the Board Certified Medical Affairs Specialist (BCMAS) program offered by the Accreditation Council for Medical Affairs (ACMA). And, furthermore, Vaezzadeh has decided that she will be going through the credentialing program alongside her team.

Accreditation for All
Organogenesis Holdings, Inc., headquartered in Canton, MA, is a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis’

medical affairs team, at present, consists of medical sciences, medical communication, along with health economics and outcomes research. As with other companies in this space, the size of medical affairs team is relatively small compared to the typical size in large pharmaceutical companies, possibly by a factor of ten. This necessitates some generalization of responsibilities and less specialization in certain areas of medical affairs.
But the medical affairs team’s size reflects neither its competency nor Vaezzadeh’s drive to develop it into a high-functioning organization. The BCMAS is one tool that will help the process. It was not necessarily Vaezzadeh’s first thought for the team’s professional development, but what she’d heard about the ACMA piqued her interest.
“I had noticed the LinkedIn posts by ACMA, and frankly I had thought that this was interesting for me to explore at some point,” Vaezzadeh said. “But it wasn’t until I met Will [Soliman] and Christine [Megalla] at a recent medical affairs conference that I understood their vision and commitment to shaping this as a well-recognized accredited program.”
The concept of a certification program for medical affairs personnel is not new. Several institutions now offer different

“My experience working for different companies, various therapeutic areas and stages of product lifecycle, makes me believe that one can’t take a cookie cutter approach to Medical Affairs. In each new situation, I base the strategy and tactics of my department on corporate strategies and the dynamics of the disease states and medical community we address."
Shabnam Vaezzadeh, MD
VP, Medical Affairs Organogenesis

credentialing programs for medical affairs executives. Will Soliman created the ACMA in 2015 with a vision to establish a standardized, international certification for medical affairs professionals. And, ideally, that standard would be recognized around the world and throughout the industry. After only four years, more than 4,000 medical affairs executives in 30 countries have received their BCMAS certification.
A common perception about continuing education for medical affairs professionals is that much of the available material and educational collateral is targeted at executives working in the pharmaceutical industry. And Vaezzadeh shared this perception of the BCMAS program at first. It wasn’t until she met some of the ACMA’s leaders, as well as other medical affairs executives who had gone through the credentialing program, that her views changed.
“During that [medical affairs conference], I spoke with a few other medical affairs leaders, one particularly who has certified

his team of 150 professionals at once in order to bring everyone on the same page,” Vaezzadeh said. “I later spoke with my team of medical science liaisons about this opportunity. The natural first impression was that most medical affairs programs, including this one, are primarily based on the pharmaceutical industry concepts. With an understanding that this might be the case, the knowledge that the principles are quite similar across the industry and the modules include some specific medical devices and diagnostics content, we decided to take it on.”
The decision to enroll her medical affairs team in the BCMAS certification program aligned with Vaezzadeh’s belief that leaders need to be involved in their teams’ professional development. Because her budget covers individual professional development, it was easy for Vaezzadeh to make the decision and to enroll her team in the BCMAS program.
“My team and I felt that going through the certification program as a group will

be beneficial” said Vaezzadeh. “Making this a reality made sense particularly at the beginning of the fiscal year, as our budget allocates some funds for individual development. With the expectation that we will find it worthwhile, we have discussed enrolling future team members down the road. I fully believe that with appropriate development, professionals are better equipped to fully perform in their roles and feel empowered to grow in their careers. This program should provide us with the assurance that across our team we have a robust, baseline understanding of medical affairs concepts and the applicable rules and regulations. From there we can confidently enhance competencies of team members in their areas of interest.”

Setting Expectations
The medical affairs team at Organogenesis is currently undergoing a growth phase. In the past, for example, its team consisted of two people. But the team has grown significantly since then, though it’s still considered small even compared to other, larger, medical device companies.
Small teams can only focus on so many goals. Currently, Organogenesis has medical science liaisons (MSLs) in the field, meeting customers face-to-face, explaining the science behind the company’s products and educating. All of these are extremely important assignments for the team.
“Our medical science liaisons are highly qualified for field interactions with the medical community, discussing disease


state, science and evidence of the products to address their safe and effective utilization leading to positive outcomes for the patients’ best interest”, Vaezzadeh said. “Each MSL also is trained and accountable to certain corporate level projects, such as pharmacovigilance, KOL management, educational grants review and so on.”
But Vaezzadeh wants her team members to be up to speed on the full spectrum of typical medical affairs responsibilities. And with the limited bandwidth that her team has to experience how other medical affairs functions operate, the BCMAS program fits the bill.
“Our company is growing rapidly. We will be expected to provide a deeper level of support across the organization, and we are truly excited to do so.”

Establishing a Common Language

The term ‘Medical Affairs’ is familiar throughout the life sciences industry, particularly in larger pharmaceutical, medical device or biotechnology companies. But what the function represents could vary across organizations. Startups and smaller companies may not have the bandwidth to employ full time medical affairs teams and fulfill the need through hiring consultants. “I have found that often, after I indicate my medical affairs title, it makes sense to describe what it entails as well,” said Vaezzadeh. “Clinical affairs generally is more universally understood.”

Organogenesis received its first FDA approval in 1998 and its USA sales and marketing organization formed in 2004. Like many young companies, the medical affairs organization doesn’t cover every aspect that it could. Currently, the medical affairs group is responsible for safety, publications, medical education grants, health economics and key opinion leader (KOL) development. It’s that final group, KOL development, that will primarily undergo the BCMAS program.
“Each individual will have 6 months to complete the 20 e-modules, pass the quizzes and accomplish certification” Vaezzadeh explained. “Within this period the team will adhere to internal milestones and checkpoints. We will have periodic conference calls to discuss the material amongst ourselves. Since we represent a diversity of clinical, academic and industry backgrounds, my expectation is that this exercise will provide us with a well

understood common language. We all have experienced that what one communicates can be interpreted differently according to the nomenclature and background of the audience. This is something we plan to proactively address.”
It’s that common language that the BCMAS provides that Vaezzadeh, and many others who have already obtained their credential, find immensely valuable. As Organogenesis continues to grow, and its medical affairs team grows with it, the understanding of what the medical organization can do is just as important as what it’s already doing.
“Based on our early exposure to the training materials, my team members have expressed their belief that the foundational information they are reviewing will be valuable. Check back with us in a year or two to find out how this may impact our approach moving forward.”

“Having built and reshaped medical affairs through many transitions, continuously optimizing my departments’ contributions to the business, has solidified my broad skillset and the agility to adapt my skills to best serve the needs of the companies I work for. I personally look forward to the BCMAS courses, as I understand they are designed to cover standardized broad range of medical affairs related topics, some of which may be reaffirmation, and some could provide me fresh perspective to utilize moving forward. "
Shabnam Vaezzadeh, MD
Vice President, Medical Affairs Organogenesis