Sarah Tannehill-Gregg

Toxicology oversight of Legacy GBT portfolio within the Hematology Research Unit and Global Product Development. Development and implementation of the nonclinical safety strategy for projects from idea to loss of exclusivity, to deliver on therapeutic area portfolio goals and stage-gate transitions. Nonclinical SME on regulatory strategy, dossier preparation and responses to regulatory queries. ⏩ INITIATIVES AND IMPACTS » Supported the rapid acquisition and ongoing integration of Global Blood Therapeutics by Pfizer, including identification and transfer of key clinical documents, touchpoint for nonclinical strategic and regulatory project knowledge, and effective transition of projects to a large matrixed team environment.

Company acquired; deal closed October 2022 Overall responsibility for toxicology activities, overseeing the quality, timeliness, and budget adherence of deliverables to support advancement of compounds to development and to progress development candidates to registration. Supervision, mentoring, and training of project toxicologist and the Nonclinical Operations team. Project leader for 1 marketed project, 1 phase 2/3 program, and 2 research stage programs. ⏩ INITIATIVES AND IMPACTS » Supported the rapid acquisition and integration of Global Blood Therapeutics by Pfizer, including identification and transfer of key nonclinical documents, touchpoint for nonclinical strategic and regulatory project knowledge, and effective transition of projects to a large matrixed team environment. » Led effort to educate research project teams on best practices for early stage projects from a toxicology perspective » Strategic oversight and scientific expertise contributed to the decision to terminate a program prior to IND-enabling studies based on the toxicity profile

The title change to Senior Director aligned best with my role as a global DSRE strategic lead for 70 programs in the oncology portfolio and therapeutic lead with significant global visibility, influence, and strategic oversight. I also served as interim DSRE head of marketed products with 400+ compounds. SCOPE: Provide scientifically accurate, efficient, and timely safety assessments, and identify potential liabilities to inform clinical trial design. In essence, the “final word” on interpretation and messaging of oncology nonclinical drug safety and toxicity data internally and to global regulatory bodies. Contributed to strategic, financially impactful decisions on program advancement. Part of the Preclinical and Translational Sciences organization. Active member on 4 leadership teams. ⏩ INITIATIVES AND IMPACTS » Fast-tracked SARS-CoV-2 initiatives including: clinical protocol amendments; data to support dosing non-oncology patients with oncology compound; analysis of SARS-CoV-2 in vitro and in vivo data. » Strengthened preclinical safety assessments and regulatory filings for cell therapy programs by devising a cross-functional, global in vivo safety study responsibility matrix. » Improved approaches to cell therapy programs throughout US and Japan by creating new lead role.

Led global DSRE oncology profile of programs from First in Human (FIH) to throughout the clinical life cycle. The 70+ programs ranged from small molecules to biologics of various modalities and from pre-project start to post-marketing. I worked closely with drug discovery and therapeutic area units on goal setting, strategy, resource allocation, and candidate drug development. When named TAL for oncology, there was transient overlap between this role and my prior position managing development toxicologists. ⏩ INITIATIVES AND IMPACTS » Noted and rectified toxicity inaccuracies in partner documentation prior to IND filing with FDA. » Recognized with award for contributions to the safety package and quality of the submission.

I led, mentored, and provided career development to 9 staff, all development toxicologists with varied experience; reviewed and approved protocols and reports for drug safety studies, toxicology lab investigations, and regulatory submissions of nonclinical packages; and administered tox lab budget. Delivered expert advice and leadership for immunotoxicology safety assessments across therapeutic areas and guidance on testing strategies for biologics and antibody drug conjugates. ⏩ INITIATIVES AND IMPACTS » Activated development of 12 scientific and 7 operational guides geared towards standardization of nonclinical safety assessments.

This was an opportunity to learn new modalities leaving the small molecule world for biotechnology. As in all my roles, I interpreted nonclinical pathology and toxicology data and promoted awareness of the “3 R’s” (reduce, replace, refine) for use of animals in pharmacology and toxicology studies. ⏩ INITIATIVES AND IMPACTS » Identified an error in peer-reviewed pathology data of late-stage compound and activated pathology working group, resulting in removal of toxicity liability and compound having more favorable profile than competitors. » Tightened regulatory report writing for studies done internally and at contract research organizations. » Performed program-level survey advocating for in vitro and ex vivo studies and animal welfare conscious study selection and design aimed at reducing, refining, and replacing animal use in drug development.