Principal Consulting Partners

Robert A. Falconer
CMC Regulatory Management
Rob is the founder and principal consultant of ALFA Associates. He brings over 30 years' progressive experience in the areas of Rx and OTC drug development, including management of regulatory, manufacturing, quality, and technical services functions in companies ranging from virtual startups to large multinational firms. Prior appointments included VP, Technical Operations for Insmed Inc.; VP Technical Operations for Shire Pharmaceuticals US; Senior Director of Regulatory & Technical Affairs for Shire Richwood, Inc.; and VP, Regulatory & Technical Affairs for Medicopharma, Inc.

Chester M. Trzaski
Supply Chain Management
Chet has 35 years in the pharmaceutical industry, serving his last 25 years in the contract manufacturing and packaging area of the business. His experience includes hands-on expertise in the production of most dosage forms such as injectables, tablets, capsules, creams, lotions, liquids, and gels. Chet has held production management positions ranging from high-volume products such as Alka Selzer to small batches of radioactive labeled injectables. He has served in management positions from production supervisor to COO and executive vp pharmaceutical production operations for an array of companies involved in commercial, as well as clinical, manufacturing and packaging. Chet’s career spans the range of pharmaceutical manufacturing from large, fully-integrated companies to several entrepreneurial companies that were in various stages from startup through IPO. His management training and experience have led him to positions in labor relations and contract negotiations in the union environment. Chet's career has been progressive in nature, all of which has been mostly hands-on experience. Chet has a B.S. in microbiology and 20 hours of credit toward an MBA.

Terry Leuchars, MBA
Program and Business Management
Terry has more than 27 years' experience providing project management services for small to large-scale projects in the private, federal, and state sectors. Project management services have included leading or managing complex integrated programs, independent unique projects, the development of other project managers, and training services for project personnel. Terry has managed programs that span a large variety of specialties and complexities, including information system conversions, business reengineering efforts, company mergers, testing and qualification programs, new product development, and implementations across a diverse set of industries. For the past 8 years Terry has supported pharmaceutical companies in managing the successful clinical development and commercial launch of several drugs. He holds an MBA from the University of Santa Clara and a teaching credential from San Jose State University. He has taught project management professional (PMP) classes for the Project Management Institute (PMI) in Sacramento, CA.