Meet selected specialists from DEP’s global network. We assemble additional expertise around each program’s needs.
External solid-state expert
Robert Wenslow, Ph.D.
Robert is an external solid-state expert, bringing experience in solid-state NMR, drug characterization, and crystallization development.
Relevant to: Solid-state characterization and crystallization questions.
Related support: Scientific solid-form support
External expert in process chemistry and API development
David Hughes, Ph.D.
Dave brings extensive experience in small-molecule process chemistry and active pharmaceutical ingredient (API) development, from early development through registration and commercial launch. His expertise includes synthesis route design and optimization, process development, technology transfer, and assessment of potentially genotoxic impurities.
Relevant to: API development strategy, synthesis and manufacturing challenges, process optimization, and impurity assessment.
Related support: Drug substance & process development
External expert in nonclinical development and toxicology
Michael J. Schlosser, Ph.D., D.A.B.T.
Mike brings experience in drug discovery and development, toxicology, bioanalysis, and research strategy, including work with small-molecule programs. His background includes scientific leadership, regulatory applications, and development due diligence.
Relevant to: Nonclinical development strategy, toxicology questions, and evaluation of research plans.
Related support: Nonclinical development & toxicology
Physical chemistry & solid-state science
Jeff Brum, Ph.D.
Physical properties and solid-state analysis, methods development, and CDMO management.
Relevant to: Assessment and focused solid-form questions.
Related support: Scientific solid-form support · Developability Assessment
Chemistry & patent law
Elisabeth Healey, Ph.D., J.D.
Research design, technology protection and transfer, and commercialization.
Relevant to: Scientific and legal interfaces for IP/patent support, subject to an appropriate engagement with qualified external patent counsel.
Related support: Solid-form science & IP coordination
Analytical development & quality control
Lavanya Kokkula, M.S.
Analytical methods, validation, troubleshooting, and quality control.
Relevant to: Analytical readiness and focused technical review.
Related support: Analytical development
CMC development
James McElvain, Ph.D.
CMC organization development and small-molecule progression through clinical development and commercialization.
Relevant to: Integrated CMC planning and development leadership.
Related support: Development coordination
Process, transfer & manufacturing
Joe Ninosky, M.S.
Process and analytical development, scale-up, technology transfer, and external provider management.
Relevant to: Provider coordination and manufacturing transitions.
Related support: Manufacturing & transfer
Program & alliance management
Swati Prasad, Ph.D., MBA
Cross-functional planning, program leadership, and alliance management across development stages.
Relevant to: Program integration and coordination.
Related support: Development coordination
Drug product & formulation
Larry Rosen, Ph.D.
Small-molecule drug product development, fixed-dose combinations, and formulation bridging.
Relevant to: Formulation strategy and drug product planning.
Related support: Formulation support
