Adrienne Clements-Egan, Ph.D. joined Larimar Therapeutics in June 2023 as Vice President, Bioanalytics and Developability after over 16 years of experience in biotherapeutics development. Dr. Clements-Egan began her biotherapeutics career at Centocor, R&D, a wholly owned subsidiary of Johnson and Johnson, where she developed and oversaw a protein biochemistry team within the bioanalytical department. She later progressed through positions of increasing scope and responsibility at Centocor (and later, Janssen) in the fields of immunogenicity and bioanalysis. She most recently served as a Senior Scientific Director of Bioanalysis, Target Engagement, and Receptor Occupancy assessments for Janssen. In this capacity, Dr. Clements-Egan oversaw a group of 40+ Janssen employees and additional flexstaff who executed internal and outsourced projects to provide bioanalytical solutions for Janssen’s biotherapeutic pipeline. Dr. Clements-Egan provided bioanalytical and Immunogenicity expertise to numerous novel biotherapeutic programs, including 5 approved therapeutic antibodies, 2 approved bispecifics, and one approved CAR-T cell therapy.
Dr. Clements-Egan has been an active member of the American Association of Pharmaceutical Sciences, where she served as a Steering Committee Member of The Therapeutic Protein Immunogenicity Focus Group, the chair of an eLearning committee for AAPS educational webinars, and the designer of a multi-lecture curriculum for the first AAPS e-course on Immunogenicity. Dr. Clements-Egan obtained her Ph.D. in Biochemistry and Molecular Biophysics at the University of Pennsylvania, where she studied protein structure-function relationships.
Gopi Shankar, PhD, MBA, FAAPS, joined Larimar Therapeutics in February, 2023 as Chief Development Officer bringing over 20 years of experience leading the development of novel biologics, most recently as Vice President and Global Head, Biologics Development Sciences at Janssen Research & Development (a pharmaceutical company of Johnson & Johnson, Inc.). In this role, Dr. Shankar led a global, 175-person R&D team that contributed to more than 60 combined investigational new drug (IND) application, biologics license application (BLA), and marketing authorization application (MAA) filings. He also previously worked as Senior Director and Head, Bioanalytical Sciences and Immunogenicity at Janssen Research & Development. Earlier in his career, Dr. Shankar worked as a Director, Immune Response Assessment and Research at Centocor R&D (a wholly-owned subsidiary of Johnson & Johnson), where he contributed to multiple regulatory approvals and spearheaded the publication of five multi-author white papers that formed the basis of U.S. Food and Drug Administration and European Medicines Agency guidance on clinical immunogenicity assessment and reporting.
Dr. Shankar is a Fellow and President-elect of the American Association of Pharmaceutical Scientists (AAPS) and was previously awarded the AAPS Distinguished Service Award. He also received several leadership and innovation awards, including two of Johnson & Johnson’s top recognitions – the Philip B. Hoffman Research Scientist Award and the SPARK Innovation Award. He has an Executive MBA from Drexel University, a Master of Science from Oklahoma State University, and a PhD from the University of Kentucky.
Mohamed Hamdani joined Larimar Therapeutics in March 2021 as the Vice President of Biostatistics and Data Management, bringing more than 22 years of experience in global drug development. Previously, he worked as Vice President of Biometrics at Apellis Pharmaceuticals. At Apellis, he built the biostatistics, statistical programming, and data management group, which was integral to the FDA approval of Empaveli® and the design of multiple Phase 2 and 3 clinical trials. Before joining Apellis, Mr. Hamdani spent over 11 years at Shire Pharmaceuticals, where he managed therapeutic areas and contributed to the filing of several new drug applications (NDAs) and supplemental NDAs, including those for Vyvanse® and Xiidra®. At Shire, he also managed the statistical group, which was responsible for supporting the medical affairs, market access, and business development teams. Earlier in his career, Mr. Hamdani held various positions at Kos/Abbott and P&G pharmaceuticals. Mr. Hamdani has an MS and ABD in Biostatistics from the School of Public Health at SUNY Albany, New York.
Rusty Clayton, DO, serves as the Scientific Advisory Board Chair for Larimar Therapeutics. Dr. Clayton has more than 15 years of executive experience in pharmaceutical, biologics and medical device development and commercialization as a consultant in clinical development, medical affairs and regulatory affairs. Prior to becoming a consultant, he was the chief medical officer at Alcresta Therapeutics, a medical device company. While at Alcresta, Dr. Clayton led clinical development and medical affairs, overseeing the design and execution of pivotal clinical studies as well as developing a medical affairs capability in support of a new product launch. Prior to Alcresta Therapeutics, he was the senior vice president of research and development at Discovery Labs, a pharmaceutical and medical device company, where he led the scientific and regulatory efforts leading to the marketing authorization of Discovery’s first product. Dr. Clayton is a board-certified pediatric pulmonologist who practiced at St. Christopher’s Hospital for Children and the Children’s Hospital of Philadelphia prior to beginning his career in the pharmaceutical, biologics and medical device industry. Dr. Clayton received his DO from the Philadelphia College of Osteopathic Medicine.
Frank Conway joined Larimar Therapeutics in July 2020 as Vice President and Controller. He brings more than 20 years’ experience as a financial executive in the life sciences and medical device fields. Mr. Conway has served as a Controller, Vice President of Finance, and Chief Financial Officer in entrepreneurial public and private environments, both commercial and pre-revenue. He most recently held the position of Vice President of Finance at TELA Bio and was part of the management team that took the company public. Other prior roles include: Corporate Controller at Orthovita, Inc. which was sold to Stryker; Manager of Financial Reporting and Analysis at Centocor; and Chief Financial Officer at Principia Pharmaceuticals, which was acquired by Human Genome Sciences, Inc. Mr. Conway began his career at Ernst & Young. He is a Certified Public Accountant and received his BS in business administration from Drexel University.
Michael Celano joined Larimar Therapeutics in June 2020, as Chief Financial Officer (CFO). He brings over 30 years’ experience as a life science business leader with a broad skill set including capital raising, creative financing structures, investor relations, business development, manufacturing, tax planning, SEC compliance, and general business activities. Since transitioning from his public accounting career, Mr. Celano spent more than 15 years as a Chief Operating Officer (COO), CFO and board member with a series of high-growth life science companies. He is currently the Chairman of the Board of Directors (previously the audit committee chair) of OraSure Technologies, a molecular tools and diagnostic company. Mr. Celano was also on the Board of Performance Health, a private equity funded consumer healthcare products company sold to Patterson Medical in a dual track IPO / business sale process. Most recently, he was the COO and previously the CFO of Recro Pharma, a specialty pharmaceutical company. Mr. Celano also served as CFO of Kensey Nash until its acquisition by DSM. Previously, he served as CFO for BioRexis, which was sold to Pfizer. Before joining BioRexis, Mr. Celano spent 24 years in public accounting, where he co-chaired Andersen’s U.S. Life Sciences Practice. After leaving Andersen, he held similar leadership positions with KPMG. Mr. Celano received his BS in accounting from St Joseph’s University.
Noreen Scherer is the Vice President of Clinical Operations at Chondrial Therapeutics, Inc. Previously, Ms. Scherer was Vice President of Clinical Operations at Alcobra, Inc. Before joining Alcobra, Ms. Scherer was at Shire Pharmaceuticals where she spent over 10 years managing clinical operations teams both in the U.S. and abroad, enhancing operational efficiency, overseeing the integration of acquired companies and assets and conducting due diligence. Earlier in her career, Ms. Scherer also held various positions at Wyeth in Clinical Research, Medical Affairs, and Medicinal Chemistry. Ms. Scherer received a Bachelor of Arts in Biology from La Salle University.
Keith Lynch joined Chondrial Therapeutics in October 2019 as the Vice President of Manufacturing and Supply Chain, bringing more than 19 years’ experience to the company. Previously, Mr. Lynch held leadership roles at a variety of pharmaceutical and biotechnology companies where he managed manufacturing and supply chain operations for multiple products at various stages of drug development. Most recently, Mr. Lynch held the position of Associate Director in the Global Technical Operations group supporting External Manufacturing at Merck and Co., Inc., where he supported the external manufacture of Keytruda® and Zinplava®. Prior to Merck, Mr. Lynch served as the Director of Manufacturing for Oncobiologics, Inc. (now Outlook Therapeutics, Inc.) a company that was focused on the development of biosimilar candidates of commercially available products like Humira® and Avastin®. Before joining Oncobiologics, he was a Director of Manufacturing at AppTec Laboratory Services, Inc. (now WuXi AppTec, Inc.) a contract development and manufacturing organization supporting companies in non-clinical and clinical development. Mr. Lynch began his career on the manufacturing floor at Immunomedics, Inc. and ImClone Systems, Inc. (now Eli Lilly and Co.) supporting the manufacture of CEA-Scan®, Leukoscan® and Erbitux®. Mr. Lynch graduated with a B.S.in Biology from Muhlenberg College, where his was president of his fraternity, Sigma Phi Epsilon.
Jennifer Spokes Johansson joined Larimar Therapeutics in December 2016, bringing more than 25 years of pharmaceutical legal, regulatory and compliance experience to the company. Ms. Johansson previously served as senior vice president, regulatory policy and counsel for Putney (acquired by Dechra), an early stage veterinary generics company. While at Putney from company initiation through exit, she was chair of the Generic Animal Drug Alliance and a member of the industry negotiation teams for the Animal Generic Drug User Fee Act and its reauthorization. Prior to Putney, Ms. Johansson served as vice president of regulatory affairs, as well as counsel, for Andrx (now Teva), a human drug company focused on generics and pharmaceutical delivery. Before joining Andrx, she was an associate in a leading food and drug regulatory practice at the law firm of Patton Boggs (now Squire Patton Boggs) in Washington, DC. Ms. Johansson started her career in laboratory research at the National Institutes of Health. Ms. Johansson graduated with an AB, cum laude with Distinction in Biology from Duke University and holds a JD, magna cum laude, from Boston University School of Law, where she was an editor of the Boston University Law Review. She is a member of the bars of Massachusetts and Washington, DC.
John Berman joined Larimar Therapeutics in January 2017 as Vice President of Finance and Operations, bringing more than 20 years’ experience to the company. Previously, Mr. Berman spent 14 years at Teva Pharmaceutical Industries where he held various positions of increasing responsibility. Most recently, Mr. Berman held the position of Senior Director of Corporate Alliance Management, where he worked closely for some of the largest brands in the Teva portfolio on both R&D and commercial alliances. Prior to that, he worked on the commercial side of the business where he led the finance team for the branded US Oncology Business, with revenue of nearly $1B. Mr. Berman also served in Teva’s R&D organization where he managed finance and business operations. Prior to joining Teva, John worked in financial planning and analysis at Cell Pathways, CDNow, Toll Brothers, and PricewaterhouseCoopers. Mr. Berman earned a BA in Economics from the College of Arts and Sciences at the University of Pennsylvania and an MBA from the Wharton School at the University of Pennsylvania. Mr. Berman is a Certified Public Accountant and holds the Chartered Financial Analyst designation.