Lynda Berne, Consultant, Commercial and Business Strategy

Lynda Berne is founder of BAL Pharma Consulting, LLC, a Princeton, NJ Management Consulting firm providing Commercial and Business Strategy and Valuation to Specialty Pharma and Biotech. The U.S. and European client base consists of companies in a range of therapeutic areas, including anti-bacterials, critical care, immunology, GI, nephrology, and pain. Lynda has over 18 years in senior and executive commercial roles in pharma, including 13 years at Bristol-Myers Squibb where she held the role of Vice President, Infectious Disease Marketing, managing a $600M business unit and providing leadership in the launch of Tequin (IV/oral gatifloxacin), which set a new prescription record for the quinolone class. Other senior commercial positions held include: Vice President, Managed Health Care Sales, Bristol-Myers Squibb, General Manager, Hospital/CV Portfolio, a $1B business unit, Abbott International, and Executive Director, Gastroenterology/Nephrology Marketing, a $200M business unit, Shire Pharmaceuticals. Lynda has a BS in Nursing from Indiana University, an MS in Nursing from DePaul University and an MBA from Northwestern University, Kellogg Graduate School of Management.

James S. MacDonald, Ph.D., Consultant, Toxicology

Until his retirement in 2008, James MacDonald was Executive Vice President, Preclinical Development, at Schering- Plough Research Institute. Over a 15 year period at Schering-Plough, Dr. MacDonald was responsible for directing activities surrounding the movement of new potential therapeutic entities from discovery research into and through the development process. This role encompassed all therapeutic areas as well as licensing and acquisition programs. Several hundred compounds were evaluated during this tenure, with dozens entering clinical trials, several currently marketed globally, and many more continuing in development. His direct line responsibility during this tenure was for the toxicology and drug metabolism groups which built on his previous experience at Merck. In this earlier role, Dr. MacDonald spent 17 years Merck Research Laboratories, ending as Executive Director of Toxicology, and had extensive experience with many important, currently marketed medicines. Dr. MacDonald received a Ph.D. in toxicology from the University of Cincinatti and completed a post-doctoral fellowship at Vanderbilt University.

Robert J. McCormack, Ph.D., Consultant, Regulatory

Dr. McCormack is a Regulatory professional with more than 25 years’ experience in the pharmaceutical sector. Currently a Consultant in Regulatory Affairs and Quality Assurance, Dr. McCormack provides strategic planning for clinical development, FDA meetings, IND, and NDA/BLA filings, planning, preparation and/or review of regulatory submissions including INDs, Type 2 DMFs, CMC Technical Data Sections for INDs, ANDA’s and NDA’s, preparation of FDA meeting dossiers, represents clients at FDA meetings, and performs due diligence activities related to the in licensing of various compounds for development. Dr. McCormack was previously Vice President, Regulatory Affairs and Quality and Vice President, Development, at Cubist Pharmaceuticals, a successful antibiotic company recently acquired by Merck & Co., Inc. for over $9B.

Catherine Strader Ph.D., Consultant, Drug Development

Dr. Strader is an accomplished scientific and business leader with experience in building and heading successful biopharmaceutical R&D organisations. She is an experienced CSO and research executive with strategic and operational responsibility for global pharmaceutical drug discovery and early development and is an advisor to biotech and start-up companies in building portfolios and successfully guiding programmes from discovery through IND and beyond. Catherine held senior leadership positions, including Vice President, External Basic Research, Senior Vice President, Science and Technology, Chief Scientific Officer and Executive Vice President, Discovery Research at Schering Plough Corporation and Merck & Co., Inc. Dr. Strader gained a BS in Chemistry from the University of Virginia, received a Ph.-D. in Chemistry from California Institute of Technology and was a Howard Hughes Fellow in the Lefkowicz Laboratory at Duke University.

Mark VanArendonk, Ph.D., Consultant, Chemistry, Manufacturing and Controls

Mark VanArendonk has more than 30 years of pharmaceutical experience and specializes in CMC drug development. Through 2013, he was Merck Vice President for Analytical Chemistry in Development and Supply. In this role he was responsible for late-stage development programs from Phase IIB through registration, launch and commercialization. Mark served as a founding partner of Garden State Pharmatech, LLC from 2014-2017 and President Vermeer Pharma, LLC beginning in 2018. As an independent consultant, Mark supports small and medium-sized companies in early and late development. Most recently he led the CMC team supporting the registration of delafloxacin. Over his “big pharma” career, through various mergers and acquisitions, Mark has worked at Upjohn, Pharmacia and Upjohn, Pharmacia, and Pfizer, holding positions of increasing functional and geographical responsibility in analytical R&D, quality assurance and CMC.