Founder and Principal Consultant

Brett brings 25 years of experience in small-molecule drug product development and manufacturing, combining deep hands-on technical expertise with nearly two decades of leadership experience across pharmaceutical companies, emerging biotechs, and contract development and manufacturing organizations.

He began his pharmaceutical career at Pfizer, where he developed the Phase I tablet formulation for Xeljanz®, and subsequently expanded his expertise in oral drug product and modified-release development at Shire, Bilcare, and Xcelience. Working in both large pharmaceutical organizations and smaller CDMO environments gave him experience solving technically demanding formulation and process-development challenges under widely varying timelines, resource constraints, and business conditions.

Over the course of his career, Brett progressed from bench scientist into technical and organizational leadership roles while remaining closely engaged with the science of drug product development. He has led formulation development, process development, clinical manufacturing, technology transfer, and outsourced development programs spanning preclinical development through Phase III.

His career has also given him extensive experience on both sides of the sponsor–CDMO relationship. At Thermo Fisher Scientific, he led a department of more than 25 formulation scientists, managers, and technical professionals responsible for oral solid dosage-form development and clinical manufacturing from Phase I through Phase III. In sponsor-side roles with companies including Epizyme, Flatley Discovery Lab, SIGA Technologies, Vividion Therapeutics, and Cerevance, he directed networks of CDMOs and consultants supporting clinical programs in the United States and international markets.

At Epizyme, Brett helped accelerate the development and scale-up of tazemetostat, including leading transfer of the tablet manufacturing process from Japan to the United States; the product was subsequently commercialized as Tazverik®. Most recently, as Vice President of Technical Operations at Cerevance, he led CMC activities across Phase I–III programs while continuing to apply his drug product expertise to complex formulation, solubility, bioavailability, and manufacturing challenges.

Through Virtuoso CMC Consulting, Brett brings together technical depth, broad development perspective, practical judgment, and extensive outsourcing experience to help pharmaceutical companies navigate complex drug product development programs and make sound, phase-appropriate decisions.

Selected Highlights

25 Years in Small-Molecule Development
Formulation, process development, clinical manufacturing, scale-up, technology transfer, and CMC leadership from early development through Phase III.

Sponsor + CDMO Perspective
Nearly two decades working with or for CDMOs, including technical due diligence, partner selection, RFPs, proposal and pricing evaluation, and active program oversight.

Complex Drug Product Expertise
Immediate- and modified-release oral dosage forms, poorly soluble compounds, enabling technologies, gastroretentive systems, controlled release, and challenging formulation/process problems.

Technical + Organizational Leadership
Experience ranging from hands-on formulation science to leadership of multidisciplinary internal teams, external consultants, global CDMO networks, and Phase I–III CMC programs.

Education

Cornell University
MBA With Distinction

Johns Hopkins University
MS Biotechnology

University of Delaware
BS Chemical Engineering, Honors
BA French

Detailed résumé and additional experience available upon request.

Discover how the Virtuoso approach can support your drug product development needs.