Who We Are

Formulation Scientists with Extensive Backgrounds in Pharmaceutical Development

Meet our team

Mike Radomsky, PhD

Dr. Radomsky received his PhD in chemical engineering in 1991 from The Johns Hopkins University and has a nearly 25 year uninterrupted career in the pharmaceutical industry.  He has served in a number of technical roles at both big pharma and small startup pharmaceutical and biotech companies.  He has held technical positions at Syntex/Roche, Orquest, Epicyte, Arc Engineering, Boehringer-Ingelheim and most recently had a role as a founder and Vice President of Technical Operations at Oncogenerix/DARA Biosciences.  He provides expertise in the chemistry, manufacturing, and controls for a wide variety of pharmaceutical products and has led product approvals and manufacturing efforts at contract manufacturing organizations (CMOs) around the world.  His expertise has led to demonstrated success in advancing generic and innovator product pipelines to product approval and launch, utilizing CMOs and CROs for virtual development and manufacturing, and leading large and small groups of cross functional scientists.   Dr. Radomsky has established a broad based knowledge of the FDA regulations of pharmaceutical products and a strong history in the development of intellectual property including a number of formulation and drug delivery patents.  He has been consulting on and off in the industry since 2001.

Cynthia L. Stevenson, PhD

Dr. Stevenson is an independent pharmaceutical consultant providing all aspects of CMC development for large and small molecule drug candidates, including portfolio planning, formulation, analytical, regulatory CMC (pre-IND thru CTD, PAI) and program management.  This experience covers a wide spectrum of drug delivery experience in controlled release orals, transdermal, inhalation, parenterals and implants.  Dr. Stevenson has provided executive management and strategic planning from her leadership experience including three successful drug approvals and seven drug candidates in clinical trials.  Dr. Stevenson was Vice President of Pharmaceutics at On Demand Therapeutics developing an ocular implant for macular degeneration.  Previously, Dr. Stevenson was Senior Director of Product Development at Ethos, developing peptidomimetics.  Dr. Stevenson was Director of Drug Development at Nektar Therapeutics, where she had multiple roles in the development of insulin for pulmonary delivery (Exubera).  She was Associate Director of Formulation Development at Alza Corporation (now J&J), where she was a co-inventor of novel formulations for the Duros implant, and provided leadership for the approval of the leuprolide implant (Viadur).  She has also held scientific positions at Glaxo Research Institute (now GSK) and The Upjohn Company (now Pfizer).  She received her B.A. in Chemistry at Colorado College, and her M.S. and Ph.D. in Pharmaceutical Chemistry at The University of Kansas.  Dr. Stevenson has authored over ~95 peer reviewed publications, presentations and patents.

David B. Bennett, PhD

Dr.Bennett is an independent pharmaceutical consultant experienced in all aspects of CMC development, including formulation design, manufacturing process development and validation, analytical method development and validation, and regulatory CMC (IND, NDA, post-approval updates, and PAI).  Dr. Bennett received his PhD in pharmaceutical chemistry from the University of Utah and has 25 years of post-graduate industry experience covering a broad spectrum of product designs, including dispersed systems (colloids, suspensions, aerosols), controlled release (transdermal patches, parenteral depots and implants), aerosols (dry powder, nebulized solutions), and drug-device combination products (inhalers, pre-filled syringes, materials qualification).  Dr. Bennett has provided senior management and technical leadership to small and large organizations and enabled advancement of development programs to commercial readiness, including two successful US drug approvals, two EU drug approvals, and numerous drug candidates in clinical trials.  Previously, Dr. Bennett was Senior Director of Pharmaceutical Sciences at Neurogesx, Senior Director Product Development at Nektar Therapeutics, and also held a variety of technical positions at Syntex/Roche and SmithKline Beecham (now GSK).  Dr. Bennett has authored more than 25 peer reviewed publications, presentations and patents in the fields of formulation design, solid state characterization, and novel compositions of matter.  He has been consulting to the pharmaceutical industry since 2007.

Casey Loveland

Ms. Loveland received her BA in communications from the University of San Diego in 2002.  Casey is our virtual office manager and provides office support with her well-developed organizational skills.