Matthew 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. Mr. Weinberg’s assignments have included strategic development of new products, testimony of the management and economics of scientific enterprises, contract issues, and product development.
Steve Jensen provides oversight of our regulatory consulting practice and offers strategic project support. Mr. Jensen has over 22 years of pharmaceutical industry experience focused on drug development and product approvals, including the management of multiple FDA submissions and numerous successful meetings with the Agency. Prior to joining The Weinberg Group, he held executive roles at Iroko, Verus, and SkyePharma.
Jeff Antos has experience in marketing, manufacturing, product development, and clinical research. 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’ patent and copyright activities include inventions in medical and information technology. Mr. Antos has led consulting engagements for more than 20 years, and has held executive positions at Parexel International, Stanford Research International, Wood-Mackenzie, and CSC-Index.
Dr. Robert Roth provides consultation in all phases of the research, development, and marketing of FDA-regulated drugs, biologics, and medical devices. He has led and provided support on projects involving strategic issues, clinical evaluation, data management and analysis, development of product support documents, and regulatory and litigation support. Dr. Roth has extensive experience in the management of drug safety and surveillance activities for pharmaceutical clients as well as post marketing analyses of safety data and/or data to support expansion of marketing claims
Dr. Nick Fleischer provides scientific and strategic support to clients in all stages of drug development. Dr. Fleischer specializes in biopharmaceutics, pharmacokinetics, and clinical pharmacology. 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).
Dr. Nita Patel has over 30 years of research and professional experience in R&D and the pharmaceutical environment. 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, and GMPs), and advertising and promotional regulatory management. Dr. Patel also has experience in product development, project management, partnering, due diligence (product and company), auditing (GMP, GLP, and GCP), and risk management company strategies..
Dr. Carrie Rabe provides consulting services to industry and counsel on a variety of FDA regulated products. She has over 20 years’ 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. 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.
Marla Scarola’s work involves technical support for issues related to the development, regulation, and litigation of foods, pharmaceuticals, and medical devices. Ms. Scarola has experience in drug and device development and regulation in the United States and Europe. She has assisted in the development of regulatory strategies, as well as the preparation and quality assurance reviews of regulatory submissions in both the United States and Europe. Additionally, she has conducted on-site audits to evaluate the quality of bio analytical and clinical data in accordance with FDA criteria. She has experience in litigation support in the form of expert witness identification, medical record review, and assisting in the development of scientifically-sound legal strategies.
Daniel Solorio provides regulatory and quality strategic support to clients. He has over 20 years of experience in the pharmaceutical industry spanning the clinical R&D spectrum, leading both registration and commercial activities across multiple therapeutic areas. He has led high-performance operations teams through both early and late phase development activities, including multiple clinical trial programs, quality and compliance, NDA submissions, product approvals, launches, and post marketing efforts. Mr. Solorio also has experience in medical affairs activities, including scientific communication, publication planning, HCP/KOL interaction, and speaking and presenting at scientific conferences and advisory board meetings.
Dr. Bryce Whited provides consultation in all phases of the development, approval, and marketing of medical devices and combination products. He has extensive hands-on experience in U.S. regulatory submissions (IDE, PMA, 510(k), de novo, and HUD/HDE), change control, risk management, nonclinical testing, and clinical trial design. Prior to joining The Weinberg Group, he was a lead scientific reviewer at the Food and Drug Administration (FDA), and held senior regulatory positions at Biotronik and Contego Medical.
Dr. Oh consults on the clinical and regulatory development of vaccines, biologics and small molecules. He has handled global development programs across various therapeutic areas, including autoimmune diseases, respiratory diseases, infectious diseases, cancer, CNS, and rare/orphan diseases. Dr. Oh has effectively managed multiple submissions to U.S., European, and Asian regulatory authorities. His vast knowledge acquired through his medical, academic, and industry posts provides Dr. Oh with the unique expertise to guide the company’s clients in all phases of clinical development as well as the implementation of successful regulatory strategies.
Dr. LeBlanc-Rivera has over 18 years of Pharmaceutical experience with specific concentration in generics, handling product launches, market re-introductions, life cycle maintenance and drug shortage mitigation strategies. She has successfully managed the compilation, review, and maintenance of ANDA, DMF, and NDA submissions. Her previous experience as an FDA CMC reviewer (biologics and small molecule generic drugs) has provided her with the knowledge to minimize the number of FDA deficiencies received by a company. Dr. LeBlanc-Rivera’s role within The Weinberg Group includes providing regulatory support to its clients.
Deborah Formelio is responsible for leading the firm’s efforts in all quality and auditing projects, which vary between small- and large-scale auditing programs. She manages auditor selection, reviews and approves all audit reports, and conducts audits alongside the team. In addition to her expertise as a Clinical Quality Auditor, Deborah is skilled in the areas of project/operations management, GCP compliance, process and SOP development, pharmaceutical/CRO experience, regulatory oversight, and process improvement.
John LoPiccolo has over 31 years of pharmaceutical, biotech, medical device, consumer products, and nutraceutical industry management experience primarily focused on operations and GMP compliance. He has extensive experience in operations, GMP, compliance, and validation. Mr. LoPiccolo has experience in managing several Quality Systems Remediation projects and FDA Consent Decrees. Mr. LoPiccolo’s responsibility within The Weinberg Group consists of the oversight of the GMP Services consulting practice and strategic project support. Prior to joining The Weinberg Group, he spent seven years working under direct contracts with various pharmaceutical and manufacturing companies performing quality system review, remediation, implementation, and audits.
Mr. Scicchitano has over 20 years of experience in the pharmaceutical industry. He has developed regulatory risk assessment strategies, program budgets, resource allocation, and timing of toxicology studies in relation to regulatory and clinical milestones. He has also been responsible for GLP toxicology study designs, dose selection, study initiation, monitoring, and data review. He has experience interpreting and reporting nonclinical studies (GLP and non-GLP) and providing toxicology study designs (in vitro and in vivo) to support individual drug development plans. Marshall has been involved with due diligence and in-licensing activities as well as regulatory submissions and interactions. He also has a strong mechanistic/investigative toxicology background and experience supporting a variety of projects from many therapeutic areas. In addition, Marshall has a solid understanding of nonclinical regulatory guidelines and the requirements and processes needed to advance drugs from lead ID/optimization through nonclinical testing in support of clinical development.
Ayesha Adil’s work 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. She provides support in responding to various legislative challenges to consumer and industrial products. She is responsible for expert investigation and identification for consultation and witness purposes. In addition, Ms. Adil is responsible for the management, dissemination, and review of scientific literature. She also routinely performs activities to assure the quality and accuracy of technical reports and data tabulations. Ayesha Adil’s work 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. She provides support in responding to various legislative challenges to consumer and industrial products. She is responsible for expert investigation and identification for consultation and witness purposes. In addition, Ms. Adil is responsible for the management, dissemination, and review of scientific literature. She also routinely performs activities to assure the quality and accuracy of technical reports and data tabulations.
Zachary Mietus examines issues related to the development, regulation, and litigation of foods, drugs, and medical devices. He assists in the coordination and compilation of regulatory submissions and provides support in the generation of product specific regulatory strategies. Additionally, he is responsible for the management, dissemination, and review of scientific literature and develops technical reports for submission to regulatory authorities.