Cross-functional expertise supporting CAV-121

Jace Sanders, MBA, has been with CSA BioTech since 2012. He earned an MBA from Utah State University in 2003 and has worked in finance and business development since. He has been instrumental in the development, management, and funding of dozens of small businesses. Jace is married with five children and volunteers with the Boy Scouts of America.

Doug Paul, PharmD, PhD, brings more than 25 years of biopharmaceutical and medical device commercialization experience, with deep expertise in rare disease therapeutics. As a founding Partner of Medical Marketing Economics, he led engagements across more than 150 orphan therapies and more than 100 rare conditions. His experience includes launch strategy, pricing and reimbursement, forecasting, and product acquisition assessments.

Michelle Higgin, PhD, is a development and regulatory strategist with experience across all phases of drug development. She has supported the virtual biotech model for more than 15 years, conducted numerous health authority meetings, and opened 40+ INDs, IMPDs, CTAs, and NDAs across the US, Europe, and Australia.

Jessica Beaver, PhD, is a pharmaceutical industry executive with more than 20 years of R&D experience. Her expertise spans clinical pharmacology, translational medicine, regulatory strategy, quality systems, compliance, program leadership, alliance management, and FDA interactions across CDER, CDRH, and CBER.

Thomas Richardson, PhD, is a senior medicinal chemistry and drug development consultant with experience from lead generation through pre-IND candidate selection. His CMC expertise includes process research, API and drug product manufacturing, clinical supply, vendor management, regulatory writing, impurity characterization, and stability and forced degradation studies.

Lindsey Brinton, PhD, is a program manager with broad expertise in target identification, validation, and therapeutic development across small molecules, biologics, bioconjugates, and immunomodulatory agents. Her background includes translational bioinformatics, pharmacology, experimental design, cross-functional team management, and IND-enabling programs.

Alyssa Galley is a Senior Consultant with PharmaDirections and Project Manager for CSA BioTech. She brings extensive clinical development and operational leadership experience, including sponsor-side roles in Alzheimer's disease research at Cognito Therapeutics and the DIAN group at Washington University in St. Louis, as well as operations leadership at EMA Wellness.

Samir Tabash, PhD, has more than 18 years of pharmaceutical industry experience with focused CMC expertise. His formulation work includes injectable, tablet, capsule, oral, and topical dosage forms, and he has authored CMC sections for regulatory documents while managing drug development and manufacturing CMOs in North America, Europe, and Asia.

Jasmina Jankicevic, MD, MSc, CCRP, is a dermatology and medical aesthetics clinical development leader specializing in drug and device development. She has driven strategy and execution for more than 350 clinical studies across more than 30 indications, with experience in regulatory strategy, product launches, lifecycle management, and clinical development for common and rare skin diseases.