Matthew Weinberg

Matthew Weinberg is Chief Executive Officer at The Weinberg Group. Mr. Weinberg guides all Strategic Issues Management client efforts with an emphasis on providing strategic and operational assistance to technically-oriented entities in areas such as Research and Development (R&D), Regulatory Affairs, and Quality Assurance. His assignments have included strategic development of new products, testimony of the management and economics of scientific enterprises, contract issues and product development.  CV  

Joel Falk

Joel Falk is an Executive Vice President at The Weinberg Group where he has global responsibility for all of the activities of the Product Regulation & Compliance group. At The Weinberg Group, Mr. Falk has been actively involved in managing programs geared toward the problem solving of health care product development issues for large and small firms. Mr. Falk has over 35 years of experience in the health care industry and has either led, or been instrumental in more than 20 major drug submissions in the United States and abroad.  CV  

Nicholas Fleischer, R.PH. Ph.D

Dr. Nicholas Fleischer is a Vice President at The Weinberg Group where he provides scientific and strategic support to clients in all stages of drug development. Dr. Fleischer specializes in biopharmaceutics, pharmacokinetics, and clinical pharmacy. Prior to joining The Weinberg Group, Dr. Fleischer held several positions at the United States Food and Drug Administration (FDA), the most recent being Director of the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER).  CV  

Robert Roth, M.D., Ph.D.

Dr. Robert Roth is a Vice President and Worldwide Medical Director at The Weinberg Group Inc. Dr. Roth provides consultation in all phases of the research, development and marketing of FDA-regulated drugs, biologics, and medical devices. He has provided support on projects concerning strategic issues, clinical evaluation, data management and analysis, development of product support documents, regulatory support and litigation support.  CV  

Jeff Antos

Jeff Antos is a Vice President at The Weinberg Group, with 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 U.S. market entry strategy. Mr. Antos has experience in leading consulting engagements for more than 20 years.

Steve Hunter

Steve Hunter is a Vice President at The Weinberg Group where he brings his many years of international business experience to assist various clients. Many of Mr. Hunter’s clients have developed a need for strategic assistance whether it be regulatory, compliance or tactical due diligence. In the past, Mr. Hunter has worked with many top pharma as well as top biotech organizations and resource challenged start –ups looking for strategic planning or simple human resource bandwidth assistance.

Amy Hansen

Amy Hansen is Director of Good Clinical Practice (GCP) Services at The Weinberg Group where she provides international project management and oversight for quality assurance audits to assess compliance with FDA Regulations, ICH Guidelines and other regulatory agencies. Ms. Hansen has experience in planning and coordinating GCP audits with appropriate resolution of observations, and providing training in FDA inspections. She specializes in auditing Electronic Data Capture (EDC) trials as well as Clinical Databases.

Stephanie Haley

Stephanie Haley is a Manager for GCP Services at The Weinberg Group Inc. Ms. Haley has global responsibility for Good Clinical Practice (GCP) consulting services to clients in the pharmaceutical, biotechnology and medical device industries and oversees the allocation of resources. She provides international project management and oversight for quality assurance audits to assess compliance with FDA Regulations, International Conference on Harmonization (ICH) Guidelines and other regulatory services.

Carrie Rabe, Ph.D.

Dr. Carrie Rabe is a Senior Consultant at The Weinberg Group Inc. Dr. Rabe provides consulting services to industry and counsel on a variety of FDA-regulated products and has extensive experience in the review of clinical, pharmacological and toxicological issues pertaining to human healthcare products. During her tenure at The Weinberg Group, she has developed regulatory strategies and prepared preclinical and clinical development programs, regulatory submissions, and product defense strategies for drugs, cosmetics, and foods/dietary supplements.

Tom Golojuch, M.S.

Tom Golojuch is a Senior Director at The Weinberg Group. Mr. Golojuch has been the principal investigator and author or has assisted in numerous projects for public and private clients. He has conducted toxicology, exposure, and risk assessments as well as regulatory analyses of many potentially hazardous materials, including inorganic substances, simple organic substances and more complex organic substances. He has applied the tools and techniques of hazard and exposure assessment, risk analysis, risk management, and impact assessment to solve client problems for products in all stages of their life cycles.

Kerry Roche, M.S.

Kerry Roche is a Senior Consultant at The Weinberg Group. Prior to joining The Weinberg Group, she was an associate at Booz, Allen & Hamilton Inc. She has 20 years of experience in providing program management and technical support to clients in the areas of foods and beverages, environmental sciences, toxicology, pharmaceuticals, and litigation support.

Theresa Allio, Ph.D.

Dr. Theresa Allio is a Senior Consultant at The Weinberg Group Inc. Dr. Allio provides consultation for FDA-regulated products in the development and post-marketing arenas. She has provided support on projects concerning strategic development, FDA submissions and meetings, and product defense.

Lauren Wind, M.P.H.

Lauren Wind is a Senior Consultant at The Weinberg Group. Ms. Wind provides technical support to industry and counsel regarding the development and regulation of pharmaceuticals, medical devices and biotechnology products. She has experience with drug development programs in various stages and has extensive experience in preparation of INDs, NDAs, pre-meeting briefing packages and other routine FDA submission documents.

Marla Scarola, M.S., RAC

Marla Scarola is a Senior Consultant at The Weinberg Group. Ms. Scarola’s work involves technical support for issues related to the development, regulation, and litigation of foods, pharmaceuticals and medical devices. Specifically, she has experience in litigation support in the form of expert witness identification, medical record review and helping to construct scientifically-sound legal strategies.

Ayesha Adil

Ayesha Adil is a Researcher at The Weinberg Group. Her work at The Weinberg Group involves issues related to the development, regulation, and litigation of foods, drugs, and medical devices. She assists in the coordination and compilation of regulatory submissions, provides support in responding to various legislative challenges to consumer and industrial products. Ms. Adil is also responsible for expert investigation and identification for consultation and witness purposes.