BS, MBA, RAC
President, BioMDg
Ms. Caron has over thirty years of progressive experience in basic research, regulatory affairs, clinical research and new business development in both the academic setting and in the medical device and pharmaceutical industry. Ms. Caron has successfully submitted multiple 510(k)’s, IDE’s, INDs, PMA’s, obtained an Orphan Designation for a gene therapy product and several medical devices, successfully submitted a COVID-19 EAU, and has successfully submitted several breakthrough designation requests and fast track designations. She has over 25 years of experience in biologics submissions, including embryonic stem cell therapy, and multiple autologous stem cell therapies, and allogeneic therapeutics for cardiovascular and neurological diseases. Over the past five years of practice, she has successfully submitted 12 INDs for therapies in clinical areas such as critical limb ischemia, heart failure, diabetic neuropathy, Alzheimer’s, weight loss, and ALS, and 1 IND for an embryonic stem cell product. Over the last 5 years, Ms. Caron has also successfully negotiated and obtained approval for 13 IDEs spanning therapeutic areas such as stroke, cardiac arrhythmia treatment, cardiac implants, neurosurgical implants, in vitro diagnostics, physical therapy devices, thrombectomy devices, and critical care devices.
Ms. Caron’s clients include both Fortune 500 companies and startups in the fundraising stages. Prior to consulting, Ms. Caron was Vice President of Regulatory Affairs and Quality Assurance at TheraCardia, a venture-backed startup company developing a paradigm shift emergency cardiac assist system for treating patients in cardiac arrest. Ms. Caron negotiated a reduction of clinical trial requirements (endpoint & enrollment requirements) for the device by two thirds and helped shape FDA’s policy for CPR devices. Ms. Caron also negotiated an agreement for Medicare Coverage with the medical device coverage group at CMS (formerly HCFA).
Prior to joining TheraCardia, Inc., Ms. Caron held several management positions at medical device companies including Biosense Webster, a Johnson & Johnson Company, Smith & Nephew’s Endoscopy Division, Codman, a Johnson & Johnson company and Johnson & Johnson Orthopedics. Before working in the medical device and pharmaceutical industry, Ms. Caron worked as a basic researcher at the Woods Hole Oceanographic Institution where she obtained grants from government agencies to fund original research, managed and administering them, designed and built novel chemical analyzers, and published four papers in peer reviewed journals (two-first author papers). Ms. Caron holds a BS from UCLA in Biology (emphasis in mathematics) and an MBA from Northeastern University’s High Technology MBA program (emphasis in biotechnology management).
For more information, please contact Ms. Caron at sigi@biomdg.com.