Leadership team

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 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., 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., 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.

Ms. Gina Ross, is Director of Regulatory Publishing Services at Beckloff Associates, Inc. (BAI), and has more than 10 years of experience in regulatory publishing and document management for the pharmaceutical industry.

Joining BAI in 1998, Ms. Ross started by managing the document preparation department and began researching how to implement electronic document management and electronic submission capabilities within BAI. In 2002, she identified an electronic document management system and actively participated in the validation and implementation. BAI submitted its first electronic submission (eCTD) in December 2004. Since that time, Gina has overseen the submission of multiple electronic submissions, including original submissions, amendments, annual reports, and supplements, and the implementation and validation of eCTD software. Recently, she has managed the submission of several original eCTDs to the Office of Generic Drugs (OGD) and to various divisions within FDA. She has also given numerous presentations on CTD and eCTD implementation.

Ms. Ross has a B.S.B.A in Business Administration from Rockhurst College in Kansas City and has been trained on the following systems: Submission Accelerator eCTD with CoreDossier, Publishing with CoreDossier, ISI ToolBos Pharma (Certified), MASTER Control Systems Administration, Electronic Document Management (DIA), Implementation of Structured Product Labeling (SPL), Practical Implementation of eCTD (DIA), Practical Implementation of the Comment Technical Document (DIA), and Biotechnology – Electronic IND Submissions and Global Issues (DIA)

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 know as Covidien).

Mr. Kavlick holds a Masters in Business Administration from Baker University and a B.S. in Biology from Emporia State University.