Frances Zipp, President & CEO of Lachman Consultants who provides expert guidance to the pharmaceutical, biologic and biotechnology industries. Ms. Zipp joined Lachman after a 30-year career in the industry, where she held significant positions of responsibility for Quality and GxP Compliance, including various positions in drug development, operations, quality and regulatory affairs. Ms. Zipp […]
David Petshaft, Esq., Chief Legal and Financial Officer of Lachman Consultants, and in this position oversees and manages the legal and financial affairs and activities of the firm. He also serves on the Board of Directors as the Treasurer/Secretary of the firm. His responsibilities include direct oversight and management of corporate activities relating to the […]
Ricki A. Chase, M.S., is Vice President at Lachman Consultants with over twenty-five years of experience in US FDA and similarly regulated industry. While Director of Investigations at FDA, Ms. Chase was responsible for domestic and international markets, inspections, investigations, sample collections, and critical emergency response programs for all FDA regulated commodities. She developed compliance […]
Linda Evans O’Connor, M.B.A., As Vice President at Lachman Consultants, Linda Evans O’Connor oversees and manages critical operational activities that include project oversight/management, work planning and workflow analysis, and quality assurance. Ms. O’Connor has a deep understanding of the pharmaceutical industry and delivers thought leadership on client projects. She maintains current industry / leading practices […]
David G. Lonza, is Vice President at Lachman Consultants. Mr. Lonza is a leader with significant regional and global management experience who understands the complexities involved in the international pharma industry. He has a successful track record building and directing organizations and is recognized as an exceptional leader with strong commitment to consensus management, team […]
John McShane, M.B.A., Vice President, Cell & Gene Therapy, Compliance and Business Development at Lachman Consultants, oversees and manages the Cell & Gene Therapy division within the Compliance Practice Group. An accomplished professional, Mr. McShane has extensive industry experience in international biopharmaceuticals, cell and gene therapy, and biotechnology. His distinguished career spans traditional pharmaceutical modalities […]
Keith A. Lamb, Ph.D. is an Executive Director at Lachman Consultants and a Quality and Chemistry Manufacturing and Controls (CMC) executive with a passion for innovation and delivery of novel medicines to patients. Committed to the combination of quality, science and a risk-based approach to ensure clear decision making and outcomes which benefit patients. Broad […]
Martin H. Shimer is an Executive Director at Lachman Consultants with over 20 years of experience at the US FDA. While Deputy Director of the Division of Legal and Regulatory Support at the FDA, Mr. Shimer was responsible for implementation of new statutory requirements and resolving complex issues (legal, scientific and/or regulatory) impacting ANDAs. He […]
Michelle Ryder, Executive Director at Lachman Consultants with 20+ years’ experience as a Regulatory professional in the pharmaceutical industry. With her expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong practical experience, she delivers strategic leadership to Lachman’s clients, including for ANDA, NDA, and IND, [505(j), 505(b)(1) and 505(b)(2)] applications as well as […]
John Darby, M.Sc., Senior Director in the Compliance practice at Lachman Consultants. Mr. Darby is a goal directed, results-focused executive professional with a strong, global background in quality assurance, compliance, audits, training, and remediation. His 18+ years of experience and keen insight contribute to his ability to identify issues and form innovative solutions and strategies […]