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5 Ways to Build Your Pharma Career

William Soliman, PhD, BCMAS

William Soliman, PhD, BCMAS

President, Chief Executive Officer
Accreditation Council for Medical Affairs

1. Solutions Not Problems

Don’t have enough experience? Feel like your career path is limited? Think about how you’re going to solve the problem versus the problem itself. Don’t dwell on the issue. Take action.

2. Do What it Takes to Be Successful

Not everyone is willing to put in the time & effort to become successful in their professional life. Are you willing to go the extra mile? To demonstrate that you’re a hard worker who is committed to excellence in their profession? If so, you are already at an advantage. And others will notice.

3. Figure Out What Matters to You

Each of us are motivated by different things. For some, it’s money, for others it’s appreciation and recognition and for others it’s work-life balance. Determine what matters to you and go after it.

4. Don't Get Distracted

In today’s world, it’s easy to get distracted by ‘noise.’ To achieve your goals, you need to stay focused. Think of the best athletes in the world. They are laser focused during the game. They know what their objective is and they stay focused and consistent in their efforts.

5. Become a Subject Matter Expert

In pharma, becoming a subject matter expert in particular therapeutic areas can pay off in dividends. Are you an expert in pharmacoeconomics or clinical trial design? If not, become one! This can really help to distinguish you when applying for new roles or being considered for that next promotion.

An Interview With Antoine Daher, MS

Antoine Daher, MS

Antoine Daher, MS

President, Febrararas
President, Casa dos Raros
Vice-president, Clinical Research Alliance of Brazil

1. Tell us a little about your professional background?

Born in Beirut (Lebanon) on 31st March of 1975, Antoine Daher is a Brazilian businessman who dedicate his life to the Rare Diseases’ cause. He speaks Arabic, French, English and Portuguese and has a Master in Political and Administrative Science with an extension in Political Science. In 2012, he got involved with advocacy, when he discovered that his son has the Hunter Syndrome (MPS II), a metabolic innate error. Founder and president of Casa Hunter, Toni – as he is usually called – has been dedicating his life to help Brazilians with the rare diseases. With a strong presence in the —- Parliament, he fights for public health policies and laws that grants a better life for people with rare diseases. Since January/2019, Antoine Daher is the president of Febrararas, The Brazilian Federation of Rare Diseases Associations. He is also a member of the Rare Diseases Commission at the Federal Council of Medicine in Brazil (since 2015); vice-president of Clinical Research Alliance of Brazil and president of Casa dos Raros (The House of the Rares).

2. Why did you decide to join the ACMA board?

ACMA’s goal is totally related with Casa Hunter’s mission. As a president of NGO focused on Rare Diseases, we are extremely concerned about establishing benchmarks of excellence in training for the life sciences and healthcare industries.

3. What are 3 predictions you have for the pharmaceutical industry in the next 10 years?

  • Gene Therapy (pharmacogenomics)

  • New drugs focused on childhood diseases

  • Research into tackling auto-immune problems

4. What would you tell companies considering to Board Certify their medical affairs organizations?

Medical Affairs involves a group of activities of high value and high competence: technical knowledge, communication abilities, emotional intelligence… In order to certify a good teamwork level, you must submit them to training. Besides that, a certification from a recognized organization, can cut steps and get an important time in a competitive era.

5. What do you enjoy doing (hobbies, etc..) in your spare time?

Cooking and traveling.

Accredited Medical Affairs/MSL Professional Development in the Pharmaceutical Industry: Trends & Future Outlook

Donna White, CCEP

Donna White, CCEP

As Medical Affairs continues to grow within the pharmaceutical industry, providing proper training and continued professional development is critical. Traditionally, pharmaceutical companies either:

  1. Develop their own internal training or 
  2. Work with third-party vendors to build training programs for them.

While this can help onboard new hires, there are several limitations to this traditional approach.

Limitations to the traditional pharmaceutical industry Medical Affairs training process

  1. It is a ‘one & done,’ focusing primarily on proper on boarding for new hires.  There is no plan put in place to assess continued professional development.
  2. Vendors are NOT accredited training providers. What that means is that they do not meet any type of standards when it comes to learning design, process, technology or proper assessments.
  3. Non-accredited training does not lead to a qualification or any credits awarded.
  4. Traditional training is not externally recognized outside the company which limits employee motivation and development.
  5. Traditional training is not externally recognized outside the company which limits employee motivation and development.
  6. Traditional training typically requires a minimum level of knowledge is met does little to assess assess progress over time.
  7. Because non-accredited training doesn’t have to meet any type of external measures of quality or assessment, it poses a risk to pharmaceutical companies if they are audited.
  8. Finally, today’s training often lacks consistency across US & Global Medical Affairs organizations creating gaps and putting certain teams at a disadvantage.

Accreditation Matters

The Accreditation Council for Medical Affairs (ACMA) is the only accredited provider of professional development & certification for Medical Affairs & sales professionals working across the pharmaceutical, biotechnology, medical device and diagnostic industries.  Accreditation indicates that you have met and/or surpassed industry standards for training & certification

Light Bulb

The ACMA is accredited by the International Association for Continuing Education & Training (IACET/ANSI). The ACMA is also a member organization with the Institute for Credentialing Excellence and, through its partnership with Scientia CME, is a joint provider of Continuing Medical Education (CME) & Continuing Education (CE) for physicians, pharmacists, and other healthcare professionals. This level of accreditation indicates that the ACMA offers the highest quality of training and certification. The robust quality management system, innovative learning design, optimized pedagogical techniques and proper learner support are key elements to ACMA’s success.

Regulators & Accreditation

Using an accredited provider of training for your pharmaceutical company helps to safeguard and minimize risk for your organization. This becomes particularly important when concerns arise over:

  1. The competence of your team members
  2. Issues related to Ethics
  3. Concerns over quality systems and operations
  4. Issues with Compliance

Industry Trends

The ACMA continues to partner with companies who are raising the bar for their organization by offering accredited training & certification programs. There are several benefits afforded to both the company and employees. By partnering with the ACMA, pharmaceutical companies can ensure that all individuals who successfully meet ACMA standards will receive a certificate of competence, which is accredited and recognized in the US & internationally.

Moreover, several studies have shown that certification:

  1. Improves employee motivation and performance
  2. Increases team morale
  3. Ensures that a minimum level of competency is set across the organization.

This helps establish consistency, provides peace of mind and improves the chances for more effective & compliant engagement with key opinion leaders (KOLs). As a matter of fact, the ACMA surveyed over 1000 KOLs.  Over 87% of those KOLs indicated that partnering with pharmaceutical industry professionals with an accredited certification would help them feel an increased sense of trust and credibility.

As we reflect on the opioid crisis and other issues that have plagued the pharmaceutical industry in recent years, it is critical that Compliance, Medical and Commercial work together to raise the bar for their organizations. Doing so is not only the right thing to do for their company, but more importantly, we owe it to the patients and healthcare organizations we serve.

BCMAS 101: The Basics

FORMAT:

  • Self-Paced, Online, 20 modules, Case Studies, Industry Glossary and Downloadable Resources

COST:

  • $1999 USD

Time it Takes to Complete:

  • Average is 2 months

Who Should Enroll?

  • Physicians, Pharmacists, PhD professionals
  • Medical Science Liaisons
  • Medical Affairs Professionals
  • Med Info Professionals
  • Medical Communication Professionals
  • Medical Education Professionals
  • Clinical Development Professionals

Is it Accredited?

  • Yes. BCMAS is the only Accredited Med Affairs/MSL program in the world.

An Interview With Barbara Troupin, MD, MBA

Barbara Troupin, MD, MBA

Barbara Troupin, MD, MBA

Chief Medical Officer at ERX Pharmaceuticals

1. Tell us a little about your professional background?

I am trained as a family physician and practiced for about 18 months before I realized full time clinical medicine in a tightly controlled managed care setting wasn’t the best long-term fit for me. Started at a late phase clinical trial center as a sub-investigator, and later as PI when the center director retired – and ran 150+ late phase clinical trials across multiple therapeutic areas in about 5 years with a staff of 20+ coordinators, educators, lab and technical personnel. Loved the multi-disciplinary environment. Started a US site for a European CRO doing high complexity metabolic studies for 2 years before transitioning into industry. Started in Clinical Development and followed my first drug to market, starting and building the Medical Affairs organization. We built late, as an organization that had never taken a product to market, and it became very clear how building earlier would have added much more value and momentum. I’ve enjoyed building from micro companies to small entities and have started or built out medical affairs earlier at every company since then to many great successes.

2. Why did you decide to join the ACMA board?

I truly believe in the value of Medical Affairs, and how the perspective of digging deep on the science and understanding the perspectives of multiple stakeholders really elevates the work we do in this industry. Building an organizational culture that embraces Medical Affairs creates value from early development, regulatory engagements, patient-focus, market access strategy, corporate branding, and employee engagement and retention. Supporting ACMA is an important mission, and as the industry has suffered reputational loss, I think a stronger role for medical affairs internally and externally can continue to raise the bar across the industry.

3. What are 3 predictions you have for the pharmaceutical industry in the next 10 years?

1) The definition of value will evolve even more rapidly – beyond clinical definitions, addressing targeted and individual patient needs, providing payer value, and context within the health care system as a whole.

2) Incorporation of technology to increase efficiency and value across discovery, development, regulatory processes, and getting therapies in to the hands of patients.

3) What does it mean to be transformational? We are still in an environment where there are “hot areas” and ignored areas, and there are many unmet medical needs still in need of good science and effective and safe therapies – we need to do better meeting more patients’ needs.

4. What would you tell companies considering to Board Certify their medical affairs organizations?

Investing in Medical Affairs certification is investing in your company as a whole. Often your Medical Affairs experts are the individuals on the front line – they define your reputation for skill, knowledge, and professionalism to your key stakeholders and ultimate customers. They carry your companies brand and the success of your operations in many ways. Arming them with high quality skills and continued professional development means that they can best do their jobs in service of your corporate objectives.

5. What do you enjoy doing (hobbies, etc..) in your spare time?

I am an avid traveler and enjoy exploring new places, cultures, food, and people. Have traveled to more than 100 countries to date, with so much left to see. And I enjoy cooking, live music, pilates and time with friends and family.

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