(Westbury, NY – July 11, 2022) – Frances Zipp, President and CEO of Lachman Consultant Services, Inc. (Lachman Consultants), a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, announced today that CAPT Martin H. Shimer, II joined the firm as Executive Director, Regulatory, effective July 11, 2022. In this role, Mr. Shimer will assist clients with regulatory submissions and strategy, communications with FDA, and navigating the approval process while offering guidance on issues related to therapeutic equivalence, patent certifications, 180-day exclusivity, the Competitive Generic Therapy pathway, New Drug Application exclusivities, regulatory requirements for ANDAs and more.
Prior to joining Lachman, Mr. Shimer enjoyed a 22-year tenure with the FDA, where he held several senior-level positions, most recently as Deputy Director of the Division of Legal and Regulatory Support in the Office of Generic Drug Policy (OGD). In this capacity, Mr. Shimer led the Patent and Exclusivity Team (PET) and other key staff, implemented new statutory requirements, actively resolved complex regulatory issues related to Abbreviated New Drug Applications (ANDA), and played a key role in the development of the Drug Competition Action Plan (DCAP) and other groundbreaking programs. His time with the FDA also included roles as Senior Supervisory Regulatory Management Officer, Deputy Director; Supervisory Regulatory Management Officer, Branch Chief; and Senior Regulatory Management Officer. During his time with the FDA, Mr. Shimer actively supported a range of important public health initiatives, both domestically and abroad.
“We are honored to welcome Mr. Shimer to our team,” said Ms. Zipp. “Highly regarded and widely recognized for his tremendous work with the FDA over the last two decades, Mr. Shimer brings an unmatched wealth of experience and specialized regulatory expertise to the Lachman team.”
“I am eager to join a tremendous team of thought leaders who are making a marked impact on the industry,” said Mr. Shimer. “I look forward to applying my knowledge and background to strengthen Lachman’s Regulatory Affairs practice, with the ultimate goal of bringing simple, workable solutions to clients’ regulatory problems or issues.”
A licensed pharmacist since 1993, Mr. Shimer spent the early part of his career working in Community Pharmacy. He has been the recipient of dozens of awards and commendations, including the Food & Drug Law Institute Distinguished Service and Leadership Award, FDA’s Center Director’s Special Citation, FDA’s Commissioner’s Special Citation, as well as the Public Health Service (PHS) Commendation Medal, the PHS Citation Medal, the PHS Achievement Medal, and many more. He has also authored and co-authored several presentations, publications, and book chapters.