Career Possibilities: Clinical, Regulatory, and Development

See other events in this series
1/20: Career Possibilities Panel: New Commercial Strategy, Product Planning, Marketing
2/10: Career Possibilities Panel: Discovery, Research
3/24: Career Possibilities Panel: Portfolio Strategy, Project Management, Scientific Operations
4/14: Career Possibilities Panel: Medical Affairs-Comms, Publications, Medical Science Liaison
5/05: Career Possibilities Panel: Business Development and Intellectual Property

Erika Dahl, Consultant, Strategy & Program Leadership, Halloran Consulting Group

Erika leverages her biomedical research background to support clients in strategic planning for pre-clinical development, clinical trial operations, regulatory filings, program management, and quality assurance. Before joining Halloran, Erika led pre-clinical research projects focused on determining the role of G-protein coupled receptors and their role in cardiac biology. Erika has also led consulting projects that included competitive intelligence analysis, freedom to operate evaluation, due diligence reporting, and identification of commercialization strategies for new small molecule drugs, biologics, and devices. Erika earned her doctorate in Pharmacology from the University of Minnesota in Minneapolis, Minnesota. Her thesis project was focused on the underlying mechanisms of heart failure leading to the publication of two peer-reviewed papers. Erika earned her bachelor’s in arts degree in Biology at Augustana University in Sioux Falls, South Dakota. 

Gersham Dent, Senior Director of Clinical Imaging, Biogen

Gersham Dent is a Clinical Development executive with over 20 years of biopharmaceutical industry experience in Central Nervous System Research and Development. Prior to joining the pharmaceutical industry, she worked at several branches of the federal government. Her clinical research is primarily focused on developing new treatments for brain disorders. Gersham holds a Ph.D. in Neurobiology and a Master’s in Business Administration. She is a Senior Director in Research and Development at Biogen. Gersham’s team is responsible for late phase imaging in clinical trials. She enjoys the application of neuroscience and is passionate about developing new therapeutics for brain disorders.

Adrianne Monsef, Director, Program and Alliance Management at Pandion Therapeutics

Adrianne Monsef has ten years of broad cross-functional experience in the healthcare sector and the biotech startup space. Prior to joining Pandion Therapeutics in March of 2020, Adrianne worked in strategic product development at a topical drug delivery technology company and was a key author on multiple FDA submissions, an active participant in face-to-face FDA meetings (pre-IND, Type B, Type C) and lead the design, oversight and final data analyses for early and late stage clinical trials spanning the therapeutic areas of women’s health, urology, and pain. During this period of time, Adrianne was also closely involved in a number of business development initiatives, including supporting negotiation of the final license for two programs, presentation of asset value and competitive market assessment, and served as the program leader for the company’s flagship asset which advanced from pre-IND to Phase 2b during her tenure. Adrianne earned her bachelor of arts dual degree in Biology and Middle Eastern Studies with a minor in Chemistry at New York University in New York, NY.

Jana Subramanyam, VP of Regulatory, Allena

Regulatory Affairs professional with 20 years strategic experience with FDA, EMA and Health Canada regulations. Proven history of successful leadership of teams including multiple approvals (drugs, biologics & medical imaging agents). Strategic and operational oversight of regulatory activities; including Clinical, Preclinical & Manufacturing development, global Phase II & Phase III clinical trials, approval of products in the United States, Europe and Canada including strategic regulatory assessment of products for business development activities. Skilled liaison with proven leadership skills and experience interfacing with external organizations, regulatory agencies for US, Canada & EMA in support of Company submissions and Health Authority inspections (Pre-Approval and Pharmacovigilance). Strengths include providing strategic input to cross functional teams, management of departmental operations, project management related to submission activities, as well as leading and mentoring multi-functional teams. Exceptionally organized and articulate; possessing strong interpersonal skills and a flexible work style to effectively collaborate with individuals at all levels in a matrix environment.

Debi Tran, Sr. Director, Regulatory Affairs (Global Lead for Lumasiran), Alnylam Pharmaceuticals

Debi Tran has 19 years of broad regulatory experience, including 4 years at the FDA and USPHS, in addition to 15 years in pharmaceutical industry (Alnylam, Pfizer, Wyeth, Merck). Debi has global experience with early and late stage development programs across various therapeutic modalities (RNAi therapy, gene therapy, vaccines, small molecules) in multiple therapeutic areas including rare diseases. Debi has led global registration filings, PMR/PMC/labeling negotiations, IND/CTA submissions, global regulatory agency engagements, regulatory designation applications, policy development, and process improvement. Prior to joining regulatory strategy, Debi worked in regulatory advertising and promotion, reviewing promotional materials to ensure compliance with applicable regulations and guidances. She is currently a Senior Director, Regulatory Portfolio Lead at Alnylam with oversight and accountability for a portfolio of liver-targeted early candidates and mid to late stage programs, and management of a talented team of regulatory colleagues. Debi has a Doctorate of Pharmacy degree from the University of the Sciences in Philadelphia. She enjoys reading, cooking, nature walks, and spending time with her family (3 kids, husband and dog) at the beach.

Nadia Zakaria, Director of Translational Medicine, Novartis  

Nadia Zakaria obtained her medical degree from the University of Karachi, Pakistan and went on to obtain her PhD in Medicine with a focus on Limbal stem cell therapy from the University of Antwerp, Belgium. She is currently a Director/Translational Medicine Expert in Ophthalmology at Novartis Institutes for BioMedical Research (NIBR), Cambridge, Massachusetts, United States. She continues to hold Guest Professorship at the University of Antwerp where she formerly lead the Ophthalmology Research Team at The Centre for Cell Therapy and Regenerative Medicine, Antwerp University Hospital. She pioneered the 'no touch' surgical technique for limbal stem cell transplantation and was awarded the Jules Francois Award for her scientific research and important contribution to Ophthalmology. She has been awarded numerous grants and prizes among which is the prize for the most innovative research on regenerative medicine with cells and tissues by the Belgian Association for Bioindustries.

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