Adam Silverstein

Lead Nonclinical Development team, programs and activities by using pharmacology and toxicology principles to scientifically and strategically assess the mechanism, activity, and safety of UT products (small molecules, antibodies, cell therapies, and devices) during development and post-marketing activities. Nonclinical expert for due diligence evaluation of in-license candidates. Assess for scientific validity, regulatory strategy, timelines, cost, and opportunity. NDA approvals include Tyvaso and Orenitram. BLA approvals include Unituxin. MAA approvals include IV Remodulin and Unituxin. NDS approvals include Unituxin. 510(k)s cleared include Low Potassium Dextran Solution with Tris Diluent.

Led Nonclinical Development team, programs, strategy and activities for small molecules, antibodies, cell therapies, and devices. Nonclinical expert for due diligence evaluation of in-license candidates.

Established Preclinical Sciences department and responsible for strategy and execution of all nonclinical toxicology and pharmacology programs including pharmacology, toxicology, safety pharmacology and nonclinical ADME to support pharmaceutical development in diverse therapeutic areas (cardiovascular and infectious diseases and cancer). Serve as nonclinical expert on various drug development teams and to various external groups including contract research organizations, alliances, collaborators and regulatory agencies. Responsible for setting preclinical objectives for a specific project and evaluating their timing and conduct at outside labs, as well as ensuring performance and timely deliverables from preclinical consultants. Oversee selection and management of external vendors/consultants, budget and contract negotiation. Design/author, review and edit proposals, protocols and reports. Responsible for nonclinical sections of all US and European regulatory submissions and correspondence including IND/NDA/MAA/BLA/CTD/eCTD and Carcinogenicity proposals, IND updates, Investigator’s Brochures/IMPDs, PSURs/PBRERs/DSURs, product labeling, regulatory queries, etc. Nonclinical expert for due diligence evaluation of in-license candidates.

Led non-clinical toxicology and pharmacology programs to support cardiovascular and infectious diseases and cancer pharmaceutical development.

Volunteer position responsible for governing, managing, organizing and executing a youth sports league with over 1000 kids playing soccer and baseball.

Responsible for leading biology team and direct responsibility for developing biological assays and tools to enable novel biosensor technology. Responsible for managing projects for external contracts through assessing client needs and ensuring project goals and timelines are met.

Led a protein expression group and drug discovery project teams. HIV Vaccine Project Team Leader: Built and managed a multi-disciplinary, 15 person group over an 18 month period to drive results. Protein Expression Group Leader: Responsible for managing a small team and direct responsibility for recombinant expression and purification of HIV-1 envelope peptides and proteins. Cancer/Apoptosis Peptide Project Leader: Led and managed a small team responsible for design, implementation, and evaluation of peptides and assays for targeting cancer and apoptotic pathways. HIV Next Generation Peptide Project Core Team Member: Member of key decision-making group governing next generation gp41 fusion inhibitor peptide project. HIV Envelope Project Core Team Member / Molecular Screening Subgroup Member: Responsible for providing recombinant protein expression, bioinformatics, assay development, and molecular biology support for both fusion inhibitor screening efforts.

Awarded an NIH NRSA Fellowship to study the “Functional Roles of the Protein Phosphatase 2A Regulatory Subunits” UT Southwestern Career Forum Co-Chair, 2001-2003 UT Southwestern Postdoctoral Forum, Chairman, 2001-2003

• Co-founded and operated a graphic design and screen printing business that served the Vanderbilt University community. • Grew business from one design and direct sales to cornering the market by forming strategic partnerships to service over 30 different organizations including the Vanderbilt University Bookstore, Vanderbilt University Concerts, fraternities and sororities, and other student-life groups and events.

Thesis Title: Binding of Immunophilins, Protein Phosphatase 5, and p50cdc37 to hsp90 and hsp90-Chaperoned Signaling Proteins