James D. Wakefield Email & Phone Number

Needham, Massachusetts, Us

Cambridge, Ma, Us

During my time at Acceleron, I drove clinical pharmacology strategies for several drug development programs (one at the clinical stage and 2 at preclinical stage) and managed interactions with internal cross-functional teams, CROs, and regulatory agencies. Following are some of my contributions:✓ Educated and mentored early discovery project teams on how clinical pharmacologists translate preclinical data to inform clinical study designs and minimize drug development and regulatory approval risks. ✓ Enhanced teams’ collaboration during preclinical study dose and regimen selection, results interpretation, and root cause analysis of unexpected results. ✓ Devised and drove implementation of clinical pharmacology plan to use a combination of clinical studies, data mining, and modeling approaches to answer a list of questions required for regulatory filing and drug approval.✓ Modeled preclinical PK data, used simulated concentrations to assess PK/PD relationships, and modeled clinical PK data to select range of doses and dosing regimens that maintained equivalent circulating concentrations to efficacious ones in animal models while remaining below levels producing adverse effects in toxicology studies.✓ Outsourced and managed QSP modeling project to support clinical development program. Enabled to predict effects on disease progression, compare emerging phase 2 clinical results to expected biomarker changes and primary endpoint responses, update model, and use simulations to inform subsequent pivotal study elements.✓ Recognized with a Key Contributor Award in 2021 and a Team ACE Award in 2020, for facilitating development of regulatory and dose selection strategies, problem-solving contributions, exemplary collaboration, and team spirit.► Merck acquired Acceleron Pharma Inc. in November 2021.

Cambridge, Ma, Us

As a Director of Clinical Pharmacology at Cyclerion Therapeutics, I devised and implemented effective clinical pharmacology plans for 2 development programs.Following are some of my contributions:✓ Entrusted with increasing strategic responsibilities impacting clinical development direction, including selecting and designing clinical pharmacology studies to focus on and interpreting/presenting study results.✓ Contributed to the ongoing clinical development of 2 small molecules for cardiovascular/metabolic disease indications.✓ Wrote/reviewed PK summary for INDs, designed clinical pharmacology studies for phases 1/2, and developed reports. ✓ Represented Clinical Pharmacology department at meetings with the FDA; wrote and reviewed responses to FDA inquiries.► Cyclerion is a clinical-stage biopharmaceutical company harnessing the power of soluble guanylate cyclase (sGC) pharmacology to discover, develop, and commercialize breakthrough treatments for serious and orphan diseases.► Cyclerion was spun out of Ironwood Pharmaceuticals as an independent, publicly-traded company in April 2019.

Boston, Ma, Us

At Ironwood Pharmaceuticals (formerly Microbia), I managed DMPK and clinical pharmacology functions and personnel to support preclinical and clinical development.After receiving multiple promotions, I advanced from a scientist role in the DMPK department to a Director in the newly launched Clinical Pharmacology department. Throughout tenure, I played a crucial role in providing clinical pharmacology strategy for drug development programs, optimizing DMPK/ADME company capabilities, and selecting/managing CROs. I also wrote sections of regulatory reports for preclinical and clinical drug development, guided physicians on drug-drug interactions, and participated in FDA meetings. Following are some of my key initiatives and accomplishments:✓ Contributed to growing the DMPK department and partnered with co-worker to establish the first Clinical Pharmacology department at the company. ✓ Conducted preclinical studies to determine metabolic rate of Linzess in GI tract by LC/MS/MS analysis, and contributed to IND reports and NDA filing; Linzess was approved by the FDA in 2012 for treatment of IBS-C and CIC in adults.✓ Led personnel on planning/execution and outsourcing of ADME studies and pharmacokinetic analysis for clinical and preclinical studies. ✓ Supported preclinical stage and wrote reports for INDs of 4 small molecule drugs for hypercholesterolemia, pain, asthma, and MS. Served as primary reviewer of 3 PK summary sections and contributed to phases 1 and 2 for pain drug and phase 1 for asthma and MS drugs.✓ Wrote PK summary section for IND of an in-licensed anxiety drug candidate and contributed to a phase 1 study.

Us

I joined Praecis Pharmaceuticals when the company was in its infancy, initially contributing to analytical chemistry and biochemistry testing of drug candidates, and later managing ADME and clinical pharmacology study design and implementation.Throughout my tenure, I supported company expansion, the establishment of new departments and testing capabilities, and the advancement of drug candidates from preclinical stage through clinical trials.Following are some of my key initiatives and accomplishments:✓ Ran early drug formulation stability testing for peptide, which was FDA approved and marketed for prostate cancer treatment.✓ Led team of 4 scientists in establishing new pharmacodynamic ELISA assay to measure activity of non-Hodgkin's lymphoma drug compound in nonclinical pharmacology and toxicology studies for IND submission. ✓ Managed transfer and validation of pharmacodynamic ELISA assay to CRO in time for GLP sample analysis from Ph1 clinical study in patients with non-Hodgkin's lymphoma.✓ Conducted in vitro ADME assays, including intrinsic clearance, CYP profiling, plasma binding, and metabolite identification as part of structure-activity relationship (SAR) determinations to guide medicinal chemistry efforts.✓ Performed in vitro and in vivo metabolite profiling studies and wrote metabolite identification sections of IND application of Alzheimer’s drug candidate. Measured enzyme kinetics constants to evaluate drug-drug interactions.✓ Established high-throughput screen to test drug candidates for Alzheimer’s disease treatment, one of which progressed to clinical trials. Wrote reports for its IND application.

Master Of Science - Ms, Biotechnology

Bachelor Of Science - Bs, Biochemistry