Mackenzie Quirk, PharmD, MS, RPh Curia Global/ACPHS/FDA OPMA Clinical Development Fellow Alma Mater: Albany College of Pharmacy (ACPHS)
Meet Mackenzie, a Curia Global/ACPHS/FDA OPMA Pre-Clinical/Clinical Development Fellow and one of the current leads of our VIP Case Competition National Fellows Council Committee.
What fellowship project are you most proud of so far?
The development of MIC assay for a client that had no previous FDA precedent.
What is the most exciting place you've traveled?
Monterey, CA
What is your favorite hobby?
I love to exercise!
Finish this sentence: The greatest movie of all time is...
Aliyah Balogun, PharmD Johnson & Johnson Global Regulatory Affairs Fellow Alma Mater: Florida A&M University
Meet Aliyah, a Johnson & Johnson Global Regulatory Affairs Fellow and one of the current members of our Professional Programming National Fellows Council Committee.
What fellowship project are you most proud of so far?
Patient Focused Drug Development. I feel proud of this project because it allows me to make a tangible impact on improving the lives of patients. By advocating for patient input and working to ensure that drugs are developed with their needs in mind, I am helping to bridge the gap between regulatory requirements and patient needs.
What is the most exciting place you've traveled?
Zanzibar, Tanzania
What is your favorite hobby?
International traveling
Finish this sentence: The greatest movie of all time is...
Carley Yawn, PharmD IPhO/Clinical Education AllianceHealthcare Education and Outcomes Research Fellow University of Georgia College of Pharmacy
Meet Carley, an IPhO/Clinical Education Alliance Fellow and one of the current leads of our VIP Case Competition National Fellows Council Committee.
What fellowship project are you most proud of so far?
I would say it's our ACCP Visual Abstract. The ACCP Visual Abstract Challenge is an opportunity for postgraduate trainees, including residents, fellows, and full-time graduate students to blend their ability to evaluate primary literature with the art of creatively communicating key research components through visual representations. In our digital age, visually representing research can significantly enhance its impact, making complex information more accessible and engaging.
I’m particularly proud of this project as it perfectly aligns with my dual passions for creating visually appealing content and for clear, innovative scientific communication. My background includes working in the marketing department of InpharmD, an AI-driven startup dedicated to providing clinical pharmacists with drug information answers. The Visual Abstract Challenge honed my skills in making scientific content both easily digestible and aesthetically pleasing.
What is the most exciting place you've traveled?
Alaska
What is your favorite hobby?
Thrifting vintage home decor.
Finish this sentence: The greatest movie of all time is...
Megan Griffin, PharmD, NFC Diversity and Representation Co-Lead, sits down with Collins Asamoah, PharmD, MS, RPh to learn more about his Fellowship journey thus far.
University of North Carolina at Chapel Hill & United Therapeutics
When I started pharmacy school at Massachusetts College of Pharmacy and Health Sciences (MCPHS) – Boston, I was intrigued by various career pathways that a pharmacist can pursue after graduation. I attended multiple networking events and spoke with fellows, residents and pharmacists working in various fields, hoping to find my niche. Outside of the regular pharmacy curriculum, I also pursued additional coursework, including Business certificates with Harvard Business School, Precision Medicine certificate with Harvard Medical School and Clinical Research certificate with Boston College. The additional coursework certificates, along with research projects and professional organization activities, have shaped my interest in pursuing a post-graduate fellowship.
What project are you most proud of so far in your fellowship?
I am most proud of my involvement in creating a publications and scientific platform for a medical device we are looking to develop for Social Anxiety Disorder. Being able to be a co-author and a Scientific Communications lead on the development of this product’s scientific story is extremely impactful and important experience relating to the beginning of a product’s life cycle. It is exciting to get involved on a project from the beginning and it sheds a light on all the research and exchange of information it takes to understand the utility of pharmaceutical products.
Why did you choose to pursue a fellowship in Regulatory Affairs?
In my humble opinion, I believe that Regulatory Affairs is one of the few professions that plays such a critical role throughout the entire development and commercialization of medicines. The role of a Regulatory professional is the crucial link not only between the company and its products, but also for health authorities and of course our patients! Without Regulatory, life-saving drugs would not be able to get on the market and reach our patients. The broad high-level perspective on drug development from pre-clinical testing to NDA submissions all the way to commercial and drug marketing is very attractive to me, especially ensuring that the product moves forward and reaches our patients globally. I have a very detail and solution-oriented mindset as well as strong communication skills. My skillset perfectly aligned with this functional area since Regulatory is a very creative yet strategic field and contains a lot of cross-functional collaboration, as well as communication via health authorities very frequently.
Morgan Loh, PharmD Global Regulatory Affairs First-Year Fellow Alexion, AstraZeneca Rare Disease
Can you give a brief overview of your fellowship and its structure and value within your company?
The Global Regulatory Affairs fellowship at Alexion through MCPHS University is structured to give its fellows hands-on experience with a variety of regulatory specialties across several different therapeutic areas. There are three 6-month core rotations, which include Development Strategy, Chemistry, Manufacturing, and Controls (CMC), and Global Advertising and Promotional Compliance. In addition, the fellow can choose an elective, 6-month rotation within Regulatory Affairs, in areas such as Regulatory Labeling and Regulatory Intelligence. This allows the fellow to not only tailor their experience but also build a strong foundation as a well-rounded regulatory professional. The PharmD fellows at Alexion are widely seen as valuable assets, as we get to transfer our clinical and technical expertise to the biopharmaceutical industry setting.
Vivi Le, PharmD Pharmaceutical Marketing Fellow - Copywriter RevHealth
Can you give a brief overview of your fellowship and its structure and value within your company?
Pharmaceutical marketing Fellows at RevHealth have the opportunity to rotate between two main areas: content development and account services. Content development works internally to develop promotional/educational materials, translate scientific data to digestible messages, and help create concepts/campaign ideation for our clients. Account services is the client-facing role in which they work externally with the clients to develop strategic plans, formulate key competitive insights, and oversee development of marketing materials with cross-functional teams through promotional review. The PharmD Fellows at RevHealth are regarded as valuable additions to the team as we have the clinical expertise to ensure all messaging is scientifically sound.
What is your current day-to-day role like at your company?
My current day-to-day role consists of attending various cross-functional meetings, both internally and externally, and collaborating on the authoring and maintenance of regulatory documents. The types of meetings I attend include global/regional labeling, maintenance of IND and/or NDA applications, regulatory strategy, regulatory intelligence, and regulatory operations. I also assist in the interpretation of FDA regulations and guidelines to ensure that published materials are compliant with the FDA.
Megan Kirkpatrick, PharmD Visiting Scientist Fellow, US Value and Access Eli Lilly and Company
What is your current day-to-day role like at your company?
I support value development and frameworks on our value excellence team for Lilly USA. My work focuses on preparing strategies for engagement with ICER (Institute for Clinical and Economic Review) for our portfolio and involvement in active ICER assessments.
Aisha Choudhry, PharmD Global Regulatory Affairs and Ad/Promo Sanofi/Rutgers Second Year Fellow
What is your current day to day role like at your company?
Every week looks different for me! For my strategy role, I was meeting with my regulatory colleagues and project team to discuss project development and ensure submission documents are on track. For my advertising and promotion role, I am in Joint Review Committee calls that include members of various functional areas, and we review promotional materials and comments that were made. Between meetings I work on my projects, which can include writing and editing FDA submissions, reviewing promotional material, and working on my leadership committees.
Elizabeth Wilks, PharmD Hospital Business Unit, Global Medical Affairs Pfizer/Rutgers Second Year Fellow
Tell us about your current day-to-day responsibilities.
My role is very project focused. I work across four different portfolios in the Hospital Business Unit (anti-infectives, surgical hemostats, immunoglobulins, and sterile injectables) which allows me to work on products across all life cycles. Recently, I have been working on a launch which has led me to help create several medical education materials for healthcare providers. I have also been supporting several educational lectures regarding a product and disease state for our field medical colleagues.
Brian Arana-Madriz, PharmD Global Regulatory Affairs Fellow Alexion, AstraZeneca Rare Disease
Tell us about your current day-to-day responsibilities.
The beauty about Regulatory Affairs and pharma in general, is that no day is the same. You have to adapt as timelines tend to be fluid and objectives often change along with them. This is why adaptability is highly sought after in candidates pursuing a fellowship.
Kyle Noonan, PharmD Health Outcomes and Market Access Fellow AmerisourceBergen Xcenda
Can you give a brief overview of your functional area and its structure and value within your company?
Briefly, Health Outcomes centers around how a drug impacts patient outcomes, such as hospitalization or mortality. Market Access often uses these outcomes in addition to clinical data to tell the value story of a certain medication. Each of these takes many forms, but both are important aspects of the late development and commercialization phase of a drug, when speaking with a payer audience.
Within Xcenda, this places me under the Value and Access Strategy team.
Alexander Fletcher, PharmD, RPh, MBA US Cardiovascular Medical Science Liaison (MSL) Fellow Bristol Myers Squibb
Can you give a brief overview of your functional area and its structure and value within your company?
The Cardiovascular MSL team helps to execute upon the medical strategy created by the Home Office Medical team. The MSLs engage with thought leaders to provide educational value to the provider, support the commercial sales team, and to generate medical product related insights.
Cassie Goodman, PharmD First-year US Public Affairs & Patient Advocacy Fellow Sanofi/MCPHS
Tell us about your current day-to-day responsibilities in your fellowship role.
My current day-to-day routine is meeting with patient advocacy groups and internal team members to bridge the conversations from the patient perspective to the industry teams.
Throughout my day, I also work on innovative projects to work with patient advocacy groups, deliver scientific exchange, and report the work happening externally to our internal teams.
Nardeen Perko, PharmD Alma Mater: Albany College of Pharmacy & Health Sciences (ACPHS) Scientific Communications Fellow, Medical Affairs Edwards Lifesciences / Keck Graduate Institute (KGI)
What interested you in industry and how did you prepare for your interviews?
I wanted a position that offered diverse responsibilities. I did not have the predilection for a static, one-track career and instead, I wanted the fluidity of having different tasks and intertwined problems for me to solve. I knew that a fellowship would propel my professional development at the pace I wanted to grow.
Kevin Darko, PharmD Alma Mater: The University of Tennessee Fellowship Sponsor Company/Affiliation: UCB/IPhO Fellowship Duration: 2 Years (2022—2024) UCB Function/Discipline: Global Regulatory Affairs IPhO Function/Discipline: Fellow Co-Lead, Diversity & Representation National Initiative
Why did you choose Regulatory Affairs as your functional area?
When I started pharmacy school, I knew that my goal was to pursue a career within the pharmaceutical industry, due to my experience working in a drug synthesis lab for two years during my undergraduate education at Bowie State University. However, my decision to pursue a career in Regulatory Affairs was made during my third year of pharmacy school when I enrolled in the Duke Office of Regulatory Affairs training program. I gained an in-depth look into the drug development process, FDA meetings, and how FDA drug regulation impacts drug development strategy applied in clinical studies. Seeing firsthand how collaborative Regulatory Affairs was as a functional area, and how Regulatory Affairs professionals were involved during every step of the drug development process, truly solidified my decision as I’m an individual who must see how all the pieces come together to lead to great results. Regulatory is also an enriching career path because it’s our job to ensure we can stay compliant with regulations and provide safe and effective products for patient use worldwide. One of my top priorities in life is to do impactful work, and Regulatory is a career field filled with impact!
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