Michael Beckloff
President
Michael C. Beckloff is President of Beckloff Associates, Inc. (BAI). Mr. Beckloff has over 30 years of experience with global drug development and regulatory affairs.
Founded in 1976, BAI has an established tradition of assisting pharmaceutical and biotechnology clients in bringing new products to market. Mr. Beckloff leads a team of scientists and project managers with extensive international regulatory experience. They have successfully supported worldwide drug development across a broad range of therapeutic categories and have worked with virtually all types of product formulations. The staff at BAI is particularly skilled in specialized projects that require unique development and regulatory strategies.
Mr. Beckloff earned his B.S. degree in cellular biology from the University of Kansas and is a member of the International Society for Pharmaceutical Engineering (ISPE), the American Association of Pharmaceutical Scientists (AAPS), Drug Information Association (DIA), the Regulatory Affairs Professionals (RAPS), and the Parenteral Drug Association (PDA).
Miguel A. de Soto-Perera, Ph.D.
Vice President, Pharmaceutical Sciences
Miguel de Soto-Perera, Ph.D., is Vice President of Pharmaceutical Sciences at Beckloff Associates, Inc. (BAI), and has more than 28 years of experience in the pharmaceutical industry.
In his current position at BAI, Dr. de Soto-Perera is responsible for all the managerial, business, and technical aspects of the Chemistry, Manufacturing, and Control (CMC) and Compliance Groups, which includes personnel in Overland Park, KS and San Diego, CA.
Before joining BAI in 1995, Dr. de Soto-Perera was with the Dow Chemical Company (later to become Merrell Dow Pharmaceuticals, and subsequently Marion Merrell Dow, Inc.) where he was responsible for the development and validation of analytical methods for drug substances, drug products, biological fluids, feed matrices, and dosing solutions for animal studies. He also held managerial positions in Quality Control and Quality Operations (including Quality Assurance) in the United States and Europe.
Dr. de Soto-Perera holds a Doctorate in Electroanalytical Chemistry, and a Master’s Degree in Analytical Chemistry, both from the University of Massachusetts at Amherst. He is fluent in Spanish and conversant in French and Italian. Dr. de Soto-Perera also has extensive teaching experience at the undergraduate and graduate levels, and is a regular lecturer at Regulatory Workshops offered by BAI both domestically and internationally.
Diane M. Beatty, Ph.D.
Vice President, Pharmaceutical Sciences
Diane M. Beatty, Ph.D., is Vice President of Pharmaceutical Sciences at Beckloff Associates, Inc. (BAI), and has more than 15 years of experience in the formulation of scientific and regulatory strategies for drug, biologic, and device development programs.
At BAI, Dr. Beatty is responsible for all the managerial, business, and technical aspects of the Regulatory Affairs and Product Development Group, which includes personnel in Overland Park, KS, Research Triangle, NC, and San Diego, CA. Dr. Beatty has experience with development and technical writing for analgesia, anti-infection, neurology, psychiatry, dermatology, infectious diseases, oncology, rheumatology, endocrinology, special pathogens, over-the-counter, and nutraceutical products.
Prior to joining BAI in 1998, Dr. Beatty held a Product Manager position with Molecular Probes, Inc. in Eugene, Oregon. Before Molecular Probes she was with the Division of Molecular Biology and Biochemistry, School of Biological Sciences, University of Missouri-Kansas City; Kansas City, Missouri, where she was responsible for management and coordination of laboratory personnel and research activities in the fields of anatomy, biochemistry, cell biology, physiology, pharmacology, neuroendocrinology, molecular biology, and analytical instrumentation.
Dr. Beatty holds a Doctorate in Chemistry/Biochemistry, and a B.S. in Biology, with a Minor in Chemistry, both from the University of Missouri-Kansas City, Kansas City, Missouri. Dr. Beatty is a regular lecturer at Regulatory Workshops offered by BAI.
Gary Hindman, Ph.D., MBA
Vice President, Pharmaceutical Sciences
Gary Hindman, Ph.D., is Vice President of Pharmaceutical Sciences at Beckloff Associates, Inc. (BAI), and has over 30 years of experience in the formulation of scientific and regulatory strategies, product development, and quality systems for drug, biologic, device development programs (human and animal health).
At BAI, Dr. Hindman is responsible for all the managerial, business, and technical aspects of the Pharmaceutical Development group, which includes personnel in Overland Park, KS. Dr. Hindman has experience with global regulatory affairs and quality aspects of drug and device development (human and animal health). Dr. Hindman is a regular lecturer at Regulatory Workshops offered by BAI.
Prior to joining BAI in 2001, Dr. Hindman was the President of the Ivy Laboratories Division of Ivy Animal Health in Lenexa, KS. Before this position, Dr. Hindman held several other director and manager level positions with Ivy Animal Health and Veterinary Laboratories, Inc.
Dr. Hindman holds a Doctorate in Analytical Chemistry from Louisiana State University and a Masters in Business Administration from Baker University.
Rick Friederich
Vice President Finance
Greg Onyszchuk, Ph.D.
Director, Managing Consultant, Regulatory Publishing Services
Greg Onyszchuk, Ph.D., is Director, Managing Consultant, Regulatory Publishing Services at Beckloff Associates, Inc. (BAI), and has more than 23 years of experience in telecommunications, imaging, content management and life sciences.
In his current position at BAI, Dr. Onyszchuk directs the Regulatory Publishing Services group, with responsibility for strategy, business development, marketing, sales and operations.
Before joining BAI in 2008, Dr. Onyszchuk was with the Neurosurgery Department at the University of Kansas Medical Center (KUMC), in a research role related to the safety of medical devices for Parkinson’s Disease patients. Earlier in his career, Dr. Onyszchuk held general management, business development, operations, marketing and technology positions in broadband media and telecommunications companies in the United States and Canada.
Dr. Onyszchuk holds a Doctorate in Physiology and Neuroscience from the University of Kansas Medical Center, a Master’s degree from the University of Quebec at Montreal, and a Bachelor’s of Electrical Engineering from McGill University. He is fluent in French. Dr. Onyszchuk has extensive experience with brain imaging, traumatic brain injury, brain aging, and the cellular mechanisms of neurodegeneration and neuroinflammation. Dr. Onyszchuk is a member of the Society for Neuroscience and a member of the Institute of Electrical and Electronics Engineers.
Christopher Kavlick, MBA
Director, Business and Project Development
Christopher Kavlick, M.B.A., is Director of Business and Project Development at Beckloff Associates, Inc. (BAI), and has over 15 years of experience in business development and general drug development.
At BAI, Mr. Kavlick is responsible for the contracts, proposals and marketing functions and has primary responsibility for new business development for U.S. and Europe.
Prior to joining BAI in 2005, Mr. Kavlick was an Account Manager for Cardinal Health, Pharmaceutical Technologies and Services. Throughout his career, Mr. Kavlick has also held manager and technical positions with Quintiles, Oread, and Mallinckrodt Chemical (now known as Covidien).
Mr. Kavlick holds a Masters in Business Administration from Baker University and a B.S. in Biology from Emporia State University.