Archives: Speakers

Leticia has over 23 years of industry experience managing several research projects and clinical studies in various roles. She started her career in Pharma at Biogen, working collaboratively in an integrated monoclonal antibody research team and then moving to development in clinical operations, where she managed numerous phase I-III clinical trials in diverse therapeutic areas including, gastroenterology, immunology, neurology, and neuropathic pain.

She continued her career at Merck/EMD Serono where she provided strategic and operational expertise in the planning and conduct of several Phase I-III clinical studies in oncology and immuno-oncology, which led to the FDA accelerated approval of BAVENCIO® in merkel cell carcinoma and in urothelial carcinoma. Later she served as a Chief of Staff to the Sr. VP and Head of Development in Oncology, where she partnered with executive sponsors to identify and promote projects that are of strategic importance to the company and translating the function strategy into operational plans.
After many years in big Pharma, Leticia continued her career at various biotech companies: first at Kiniksa Pharmaceuticals, where she was responsible for various programs with high complexity in rare diseases, consisting of numerous global clinical trials in 10 different indications. Followed by Black Diamond Therapeutics, a biotech company addressing the significant unmet need for novel precision oncology therapies for patients with genetically defined cancers. In her last role, Leticia served as the Clinical Operations Lead at Nimbus Therapeutics, a biotech company working on the development of a HPK1 inhibitor in solid tumors.

Leticia also serves as an IRB Member at Yale University and is the Chair and President of the Association of Clinical Research Professionals (ACRP) – New England Chapter.
Leticia earned her Bachelor’s Degree in Biomedical Laboratory and Clinical Sciences from the School of Medicine at Boston University, followed by a Master’s Degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences in Boston.

Matt Birmingham is a seasoned operations leader with over 24 years of experience managing clinical and commercial operations in the biologics and cell and gene therapy (CGT) industries. His career includes extensive experience leading teams and operations at Genentech where he oversaw quality engineering and validation of computerized systems and laboratory equipment, clinical and commercial production planning and commercial product distribution and logistics for high-value biologics and small-molecule products.  Matt has spent the last 10 years playing pivotal roles in building and strengthening supply chains for leading CGT companies, contributing to the successful launch of four commercial CGT products. As Senior Director of Supply Chain and External Manufacturing at Prime Medicine, Matt leads all clinical manufacturing and supply chain operations for autologous cell and in vivo gene therapies.

Matt holds an MBA from the University of Maryland, a Bachelor of Science in Business Administration from the University of Vermont, and is APICS Certified in Production and Inventory Management.

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Stacey Oppenheimer is in the Clinical Imaging group at Pfizer in Cambridge, MA, where she is the Head of Vendor Oversight and Sourcing for Pfizer’s clinical trials with imaging.  In this role, she specializes in alliance management, issue resolution, auditing and providing scientific guidance for clinical study teams.  Prior to this role, she was an imaging lab head at Pfizer in the Drug Metabolism and Medicinal Chemistry Departments. She has a PhD in Chemistry from Vanderbilt University and an MBA from Northeastern University.

Yolanda is the Vice-President of Clinical Operations at Accutar Biotechnology. She brings along 17 years of experience in Clinical Development, with focus on both Clinical Operations and Clinical Project Management. Her areas of expertise include strategic operations planning at the compound-level; first-in-human study planning & adaptive execution in therapeutic areas of oncology and ophthalmology. Leadership with cross-functional teams has included the development and implementation of governance and operational strategy, optimizing processes and building dynamic teams to exceed business objectives. Prior to joining Accutar, she held various positions at Bayer in the US and a number of countries within Asia. This attributes to her extensive knowledge of bridging-strategy between the two continents.

Helen Chalk is a Clinical Development leader who has worked in Clinical and Program Management roles across the pharmaceutical, biotechnology and CRO sectors for over 25 years.  She has a breadth of global industry experience including oversight of Phase 1-4 clinical trials, medical affairs and global managed access programs in indications including oncology, autoimmune disorders, respiratory disorders, cardiovascular and infectious diseases.  Fueled by opportunities to build effective, cohesive teams and processes, Helen enjoys the challenges and daily risk management required to develop drugs and bring them to market.

Beyond work, Helen loves to travel with her family and spend time with her two dogs.  Helen relishes any opportunity to ride horses and to volunteer in a therapeutic riding program in Norfolk, MA.