Jane Harrelson Email and Phone Number

• Leader for the Smart Trials project, a cross-functional, multi-year innovation project aimed at transforming long-term clinical trials through integration of emerging mobile health technologies, driving more informed, real-time quality decisions related to the conduct, analysis and interpretation of clinical studies• Completed three technology evaluation clinical pilots designed to evaluate technologies to accurately collect dosing information to reduce PK/PD variability, enrich exposure/response data, and drive improved clinical trial decisions and outcomes through enhanced data sets. Initiated implementation of strategy within Merck’s project portfolio.• Developed effective collaborations across Merck divisions to connect groups involved in related activities to drive a comprehensive mobile health strategy for Merck.

•Provide leadership and strategic direction for preclinical DMPK staff at West Point, Boston and Rome (~110 staff), responsible for discovery and development of small molecules, therapeutic proteins, peptides and siRNAs.•Co-led the design and implementation of Global DMPK bringing together multiple groups from six sites into a single organization. Currently leading efforts to ensure the successful realization of the Global organization, including the DMPK Networks.•Executive Black Belt and sponsor of Merck Sigma Black and Green Belt projects for process improvements within DMPK.

• Provided leadership and strategic direction for ~100 multidisciplinary staff responsible for preclinical evaluation of DMPK in support of both Discovery and Development programs.• Responsible for ensuring the preparation of high quality ADME information for worldwide registration.• Responsible for preparing annual and long-range plans for facilities, resources and budget.• Developed strategic vision and co-led the design and implementation of Global DMPK which brought together multiple groups from six sites worldwide into a single organization. Subsequently responsible for preclinical discovery and development activities at West Point, Boston and Rome.• Initiated and sponsored multiple Sigma projects to improve efficiency of DMPK workflows, resulting in decreased cycle times. Contributed to Global DMPK sourcing strategy.• Led initiatives to integrate and harmonize DMPK groups following the Merck/Schering-Plough merger; designed preclinical organization, initiated and sponsored workstreams, developed implementation and communication plans.

• Provided local leadership and strategic direction for the multi-disciplinary DMPK site, primarily supporting Metabolic and Viral Diseases Discovery and Development programs. • Responsible for ensuring the preparation of high quality ADME information for worldwide registration.• Responsible for local site facilities and logistics of site operation.

• Led and directed department of 140 scientists. Responsible for providing bioanalytical, drug metabolism and pharmacokinetic data, and intellectual input, for projects throughout the discovery, development and post-marketing phases. • Established department responsible for providing bioanalytical, drug metabolism and pharmacokinetic data for the Metabolic/Rheumatic Diseases, Anticancer and Antiviral therapeutic areas. • Responsible for strategic investment in mass spectrometry, development of high-throughput techniques for in vitro and in vivo studies, with subsequent increase in productivity over a 3-year period.

• Led a team of scientists responsible for studying the metabolism and disposition of Burroughs Wellcome discovery and development projects• Completed preclinical and clinical studies and reports for Mivacron, Nuromax, and Nimbex (neuromuscular blockers) IND, NDA and European submissions. Project team member. • Directed preclinical research and prepared reports for IND submissions for 1370U87 (monoamine oxidase-A inhibitor), 403U76 (serotonin reuptake inhibitor), and 534U87 (anticonvulsant).• Represented BW at FDA meetings, advisory committee and NDA meetings. Authored over 90 internal reports.• Directed program to develop in vitro drug metabolism systems, utilizing microsomes, liver slices and cDNAs, to study species variation, P450 isozymes, drug interactions, and predict genetic polymorphism and in vivo pharmacokinetic parameters in humans.

• Directly impacted the drug discovery process by collaborating with research groups to correlate metabolism and disposition of pre-development compounds with biological activity and toxicity. This lead to the formation of the Discovery Support group within Drug Metabolism at DuPont. • Contributed towards the discovery and selection of diarylimidazole angiotensin II receptor antagonists (Losartan).