Adam Silverstein

Background

About Adam Silverstein

Nonclinical Development leader with extensive experience in all aspects of global pharmaceutical development from discovery through nonclinical regulatory toxicology and post-marketing support. Big picture thinker active in business development for evaluating partnerships, products and technologies to enhance pipeline and portfolio development. Approach to science is rooted in pharmacology, which allows critical thinking about the complex relationships between the multiple physiological systems and signal transduction pathways that govern a drug’s behavior. Successful execution of nonclinical/preclinical pharmacology and toxicology drug development programs through NDA, MAA and 510(k) submissions and post-marketing support. Drug/biologic approvals include Tyvaso (US), IV Remodulin (EU), Treprost (Japan), Orenitram (US), and Unituxin (US, EU, Canada, Japan). Cleared devices include Low Potassium Dextran Solution with Tris Diluent (US). Direct experience with small molecule, biologic, and cell therapy global development programs. Led due diligence initiatives, a pharm/tox team, a protein expression group and various preclinical drug discovery project teams. A core team member of senior, lead subject matter experts selected to be the decision making body on projects.Collaborative leader who can enable and motivate team to perform. Open, honest communicator who motivates through enthusiasm, recognition, and ability to establish rapport and trust. Straightforward, lead-by-example style.Specialties: Preclinical/Nonclinical Pharmacology and Toxicology Programs to Support Regulatory Filings, Writing Regulatory Submissions, Protein and Small Molecule Therapeutics, Managing Relationships with CRO and Academic Partners, In-Licensing and Due Diligence Activities, Protein Chemistry, Molecular Biology, Pharmacology, Cell Biology, Signal Transduction, Protein Expression, Assay Development, Problem Solving, Critical Thinking, Project/Group Leadership