Howard Stock

With over 20 years of experience in the Pharma industry, I have extensive experience in IND-enabling toxicology study management for both small and large molecule therapies. My experience includes: * Study design * CRO selection * Protocol development * On-site monitoring * QC’ing study data * Report review and finalization Additionally, I have a solid background in vendor management and reviewing documents for health authority submissions.

• Study Director for in-house studies and Study Monitor for studies conducted at external laboratories • Aid governmental and commercial clients in designing and implementing toxicology and safety pharmacology studies for small molecules in Neuroscience, Metabolic, and Infectious Disease therapy areas. • Plan and coordinate acute and chronic non-GLP and GLP toxicology studies for small molecules • Provide scientific interpretation of toxicology results for reporting to senior management and Sponsor agencies • Communicate and present results to attending Sponsor agencies • Ensure that studies are completed within budget and time restrictions • Generate and edit study reports/protocols • Generated and received 9 million dollar funding proposal from National Institute on Drug Abuse • Member of the Predictive Safety Testing Consortium: Nephrotoxicity Working Group

• Toxicology representative on discovery (pre-GLP), IND-enabling (GLP), and clinical (Ph 1) programs, resulted in reaching internal milestones • Designed and implemented toxicology studies for Oncology, Inflammation and Neuroscience targets • Developed target liability assessments for discovery stage programs • Reviewed, analyzed, and provided critical evaluation of scientific data and results and presented to program teams and senior management • Provided written and verbal updates of project results as appropriate, allowing achievement of internal milestones • Interfaced with cross-functional groups (PK/DM, Chemistry, CMC) • Wrote, reviewed, and revised study reports/protocols • Drafted toxicology sections of annual updates for small and large molecule IB’s and IND’s • Served on various department teams to better design CRO study reports, assess fetal exposure of large molecules, and compare clinical and pre-clinical test article exposure levels • Participated in due diligence activities and assessed the safety profile of possible new drug candidates

Acted as Study Director for in-house studies and Study Monitor for studies conducted at CROs Trained in Good Laboratory Practices Extensive experience designing, implementing, and coordinating toxicology and safety pharmacology studies for small and large molecules in CNS, virology, and inflammation therapy areas Investigated and coordinated primate male and female fertility studies and enhanced peri/post natal toxicology studies for large molecules Investigated and coordinated rodent, dog, and primate acute and chronic non-GLP and GLP toxicology studies for small and large molecules Scientific interpretation of toxicology results for reporting to senior management, global safety department and project teams Communication and presentation of results to global company management Authored/contributed to the preparation of regulatory documents such as Investigational New Drug Application (IND), and Investigators Brochures (IB) Ensured timely reporting of studies Led working group of study directors and study monitors to coordinate data integration, report timelines, and resolution of study issues

Developed and validated behavioral assays for depression- and anxiety- like behaviors Behavioral pharmacologist representative on three lead optimization programs Led multi-site team responsible for identifying novel drug targets for depression Negotiated and implemented contracts with various external organizations with responsibility for monitoring contracts, reviewing data, and reporting findings Generated summary data reports on lead molecules for inclusion in Investigator's Brochures. Led a group of three direct reports Proficient in computer programming (Graphic State and Med-PC behavioral software

Performed rodent cocaine self-administrations studies. Responsibilities included experimental design, catheter implantation, and data analysis Characterized the potential therapeutic effects of GABAB receptor agonists in self-administration paradigms

Obtained VA career development award for two years full-time VA employment Member of VA Internal Animal Care and Use Committee Examined the effects of olfactory bulbectomy on cocaine sensitization Presented findings at local and national meetings