Dr. Sam Lynch
Founder & CEO
Dr. Lynch has pursued a lifelong passion for bettering our lives through scientific discovery, translational medicine and individual service. His patented inventions and pioneering medical technologies have formed the basis of two biomedical companies. Working collaboratively with a team of leading scientists and surgeons around the world, he has led the development of multiple innovative medicines to improve healing of bone injuries and defects. The products he has developed have now been used to treat injuries in millions of patients.
Dr. Lynch has two doctorates, including one from Harvard Medical School, over 250 publications and patents, numerous grants from the National Institutes of Health (NIH) and numerous other awards and honors. His clinical and scientific focus is in the field of regenerative medicine.
In keeping with their commitment to giving back, LYNCH Biologics will contribute 10% of their profits to the not-for-profit foundation that Drs. Sam & Leslie started over a decade ago to promote STEM education and health care to the underserved in the U.S and internationally.
Read More about Sam Lynch.
General Manager & CCO
Mr. Kestler has nearly 25 years of global experience in the development and commercialization of medical devices, biologics and pharmaceuticals across the craniomaxillofacial and orthopedic markets. Immediately prior to joining Lynch Biologics, Mr. Kestler served as Chief Commercial Officer of OrthogenRx, a privately held leader in the viscosupplementation market. From 2006 through 2016, Mr. Kestler served in various positions of increasing responsibility at BioMimetic Therapeutics/Wright Medical having lead the BioMimetic Therapeutics business through a successful merger with Wright. While at Wright Medical, Mr. Kestler served as the Vice President of Commercial Operations for Biologics and then as Vice President of International Marketing and R&D. Previous to BioMimetic/Wright Medical, Mr. Kestler spent 4 years with Biora/Straumann, two years with BTI/Dentsply and five years at Luitpold/Osteohealth, a Division of Daiichi Sankyo.
Director of Marketing & Medical Education
Mrs. Bukowski has over 18 years of experience in the areas of Marketing, Medical Education and Product Development spanning two industries. Most notability with her work across injectable drugs, implantable medical devices, combination products, and tissue products.
Joining BioMimetic in 2007, Mrs. Bukowski supported the marketing of GEM 21S® leading up to the Canadian and Australian launch of AUGMATRIX® and AUGMENT® Bone Graft before transitioning to Wright Medical N.V. post acquisition up until 2018. While at Wright, Mrs. Bukowski took the lead as Downstream Marketing Manager of Global Biologics Marketing responsible for bolstering brand awareness for the global Biologics portfolio. Among her many career accomplishments, Mrs. Bukowski most notably points to her leadership as the creative force behind the U.S. AUGMENT® Bone Graft Launch 1,082 days after the first patient enrollment in the largest foot and ankle clinical trial to date. The journey from pre-clinical to commercialization with a product is a once in a lifetime career achievement, one might say, rHPDGF-BB is quite literally in her genes.
Prior to joining LYNCH Biologics LLC Mrs. Bukowski served as creative consultant in the neurosurgical, spine, advanced wound care and viscosupplementation arena. Her creative work included game-changing U.S. and global product launch plans with respect to 510k, class I, class II , and class III medical devices and combination products.
Earl has over 30 years of significant experience as an attorney and legal counsel provider to start-ups and publicly traded life sciences and medical device companies. Earl has previously served as General Counsel for LevitasBio, a start-up cell analytics company, OPX Biotechnologies, a start-up biotechnology clean tech company, BioMimetic Therapeutics, a publicly traded biotech company, and Spinal Dynamics, a start-up medical device company. In these roles, Earl advised on a wide range of legal issues, including matters related to intellectual property strategy, corporate governance, SEC filings, commercial transactions, mergers and acquisitions, corporate finance, litigation, and compliance programs. Earl has also previously been Counsel at Wilson Sonsini Goodrich & Rosati were his practiced focused on intellectual property counseling, and earlier in his career he served as an associate at several law firms including Weil, Gotshal & Manges, where his practice focused on intellectual property litigation. Earl earned his J.D. from Columbia University School of Law and he received a B.S. in chemical engineering from Massachusetts Institute of Technology.
Over the past 38 years Gil has been Is a former Lead Assessor for an international registrar, Senior Director of Global Quality and holder of 10 other positions in areas of quality control, quality assurance, laboratory management, analytical testing and development, and leader of learning and development in the Medical Device, Biologics, Pharmaceutical, and Chemical Industries. Gil has expertise with Internal Auditing, CAPA, Complaint Handling, Supply Chain Audits, Process Flow, Continuous Improvement, Validations, Training, and much more. Gil’s focus is to understand needs; coordinate plans, execute, and resolve issues that would meet requirements of QMS/Regulatory requirements.
Most recently, Gil has provided an Independent Contract Service for 21 CFR 210, 211, MDSAP, ISO 13485 and ISO 9001 gap analysis to 5 companies in 2017.
Kathy L. Remsen, MS, MBA, CTBS
Ms. Remsen has over 20 years of experience in the areas of Product Development, Quality Assurance, and Regulatory Affairs of injectable drugs, implantable medical devices, combination products, and tissue products.
Before becoming a consultant, Kathy was a Senior Program Manager of Regulatory Affairs at Medtronic Inc. where she was responsible for U.S. and global regulatory filings with respect to the company’s class I, class II , and class III medical devices and combination products. Kathy was also involved in the development and early-stage clinical testing of combination products and controlled-release drug depots. Kathy is co-inventor of 18 U.S. patents and several U.S. patents pending. Kathy holds a Bachelor’s degree in Chemistry from Rhodes College and a Master of Science degree in Organic Chemistry from Vanderbilt University.