Leadership

Matthew Weinberg

Chief Executive Officer

Matthew Weinberg is responsible for oversight of all client efforts, as well as the firm’s strategic growth. His client efforts focus on providing strategic and operational assistance to technically-oriented entities in areas such as research and development (R&D), regulatory affairs, and quality assurance. Mr. Weinberg’s assignments have included strategic development of new products, testimony on the management and economics of scientific enterprises, contract issues, and product development.

Mr. Weinberg holds a Bachelor of Science in Administration and Management Science with a double major in Economics and a Master of Science in Industrial Administration, both from Carnegie-Mellon University. Prior to joining The Weinberg Group, Mr. Weinberg was an assistant vice president with Marine Midland Banks, N.A. and a national account executive with AT&T Long Lines.

Mr. Weinberg serves on the board of the Charles E. Smith Jewish Day School and The Jewish Community Center of Greater Washington and is a fellow of the Wexner Heritage Foundation. He also created and continues to lead Building STEPS—a non-profit organization providing inner city children in low to middle income families throughout the Baltimore, MD, area with the opportunity to explore career possibilities in science through a program of internships. Mr. Weinberg spends his spare time training for and completing marathons and triathlons, and with his family, who still love him even though he never let them get a dog.

Jeff Antos

Vice President, Business Development

Jeff Antos has experience in marketing, manufacturing, product development, and clinical research. He is an experienced life science veteran who has led numerous projects for a variety of pharmaceutical and biotechnology companies, including R&D transformation, product portfolio analysis and US market entry strategy. Mr. Antos’ patent and copyright activities include inventions in medical and information technology. He is an author and speaker on leading topics, and has been a frequent session chair and speaker at the Drug Information Association’s annual meeting. In addition, he has served as a pharma/biotech industry expert for Standard and Poor’s.

Mr. Antos has led consulting engagements for more than 20 years, holding executive positions at Parexel International, Stanford Research International, Wood-Mackenzie and CSC-Index. He earned a B.S. in Mechanical Engineering at Union College, where he conducted artificial heart valve research, and attended Albany Medical College. On weekends, Mr. Antos likes to sail, golf, and bike (either pedal or 103 cubic inch powered).

Steve Jensen

Senior Vice President, Head of Regulatory Consulting

Mr. Jensen has over 22 years of pharmaceutical industry experience primarily focused on drug development and product approvals. Mr. Jensen has extensive experience within the analgesic space particularly working with FDA’s Division of Anesthesia, Analgesia, and Addiction Products. Most recently, while functioning as the Sr. Vice President, Regulatory Affairs at Iroko Pharmaceuticals, Mr. Jensen oversaw the NDA approval and commercial launch of Zorvolex® (acute pain and OA) as well as the NDA approval of Tivorbex™ (acute pain). Mr. Jensen’s responsibility within The Weinberg Group includes oversight of the regulatory consulting practice and strategic project support.

Robert Roth, M.D., Ph.D. 

Vice President and Worldwide Medical Director

Dr. Bob Roth provides consultation in all phases of research, development, and marketing of FDA-regulated drugs, biologics, and medical devices. He provides expert support on projects concerning strategic issues, clinical evaluation, data management and analysis, development of product support documents, regulatory support, and litigation support. Prior to joining The Weinberg Group, Dr. Roth was the Director of Medical Research at Life Science Economics and held academic positions as an Assistant Professor in Residence (Laboratory Medicine) and Research Associate Pathologist (Department of Pathology) at the University of California, San Francisco.

Dr. Roth holds a Bachelor of Science in Biology from Bucknell University, a Ph.D. in Biochemistry from the Baylor College of Medicine, and an M.D. from the University of Texas Medical Branch. Dr. Roth spends his free time hiking through the California redwoods and playing pool at the local billiard hall, no hustling allowed.

Nita U. Patel, Ph.D.

Vice President, Global Regulatory Issues and Head of CMC

Dr. Nita Patel is responsible for CMC and global pharmaceutical regulatory issues. Dr. Patel has over 30 years of research and professional experience in R&D and pharmaceutical development. She has extensive hands-on global regulatory and quality experience with INDs/CTAs, License Applications (BLA/NDAs), life cycle management, regulatory agency meetings and inspections, change control, compliance (GLPs, GCPs, GMPs), and advertising and promotional regulatory management. Dr. Patel has in-depth knowledge of product development, project management, partnering, due diligence (product and company), auditing (GMP, GLP, GCP), and risk management company strategies. Prior to joining The Weinberg Group, Dr. Patel has held multiple senior level executive positions including Senior Vice President of Operations at Artisan Pharma, Vice President of Regulatory Affairs and CQA at GenVec, and Project Director of Regulatory Affairs at MedImmune.

Dr. Patel holds a Bachelor of Science in Biochemistry from Queen Elizabeth College, London and a Ph.D. in Molecular Biology and Yeast Genetics from University College, London. She is currently member of RAPs, PDA and serves on the board of Biosciences; Health Sciences and Medicines Cluster Advisory Board (CAB) at Montgomery College, Maryland. Dr. Patel is passionate about gardening and volunteering her time to children in need as a Court Appointed Special Advocate (CASA) for children representative.

Nicholas Fleischer, R.Ph., Ph.D. 

Vice President, Clinical Pharmacology and Biopharmaceutics

Dr. Nick Fleischer specializes in clinical pharmacology, pharmacokinetics, bioequivalence, biopharmaceutics and clinical pharmacy and provides scientific and strategic support to clients in all stages of drug development. He is recognized as a leading expert in the FDA’s drug approval process with special emphasis on the utilization of the 505(B)(2) NDA and the ANDA pathways. Prior to joining The Weinberg Group, Dr. Fleischer held several senior positions at the United States Food and Drug Administration, the most recent being Director of the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research. He also served as the Deputy Chief, Assistant Chief, and Director of Quality Control in the Pharmacy Department of the U.S. Public Health Service Hospital, Staten Island, NY.

Dr. Fleischer holds a Bachelor of Science in Pharmacy from the Massachusetts College of Pharmacy, a Master of Science in Hospital Pharmacy Administration from the Arnold and Marie Schwartz College of Pharmacy of Long Island University, and a Ph.D. in Pharmacology from the Uniformed Services University of the Health Sciences. He is a registered pharmacist and maintains an active pharmacist licenses in Massachusetts. Dr. Fleischer serves on the editorial board of the Journal of Generic Medicines and upholds professional affiliations with the American Association of Pharmaceutical Scientists, American Society for Clinical Pharmacology and Therapeutics, Commissioned Officers Association of the USPHS, Massachusetts College of Pharmacy Alumni Association, Military Officers Association of America, and the Rho Chi Pharmaceutical Honor Society. Dr. Fleischer spends his spare time playing competitive soccer, baseball and softball. He has competed in several international soccer tournaments.

Carrie Rabe, Ph.D

Senior Consultant

Dr. Carrie Rabe provides strategic product development and regulatory guidance on a variety of FDA-regulated products. Dr. Rabe has over 20 years of experience in the review of clinical, pharmacological, and toxicological issues pertaining to pharmaceuticals, biologics, combination products, dietary supplements, and food and cosmetic ingredients. During her tenure at The Weinberg Group, Dr. Rabe has developed regulatory strategies (including orphan designation and expedited program requests) and prepared preclinical and clinical development programs, product defense strategies and performed due diligence assessments. In addition, she has prepared in-depth critical reviews for industry clients on health effects of products that are the subject of regulatory, legal, or public scrutiny.
Dr. Rabe holds a Bachelor of Arts in Biochemistry from Colgate University and a Ph.D. in Pharmacology from Georgetown University.

Marla Scarola, M.S. 

Senior Consultant

Marla Scarola’s work involves managing projects related to the development, regulation, and litigation of foods, pharmaceuticals, and medical devices. She has experience in drug and device development and regulation in the United States and Europe. Ms. Scarola has managed regulatory submissions including original and supplemental NDAs and has assisted many clients in meetings and negotiations with the FDA.

Ms. Scarola holds a Bachelor of Science in Biology with a concentration in Vertebrate Physiology from Pennsylvania State University and a Master of Science in Biotechnology from Johns Hopkins University. She is a member of the Regulatory Affairs Professional Society (RAPS). In her free time, Ms. Scarola enjoys doing CrossFit and taking snowboarding and surfing vacations with her family.