Our Leadership Team

At Boston Biomedical Associates, our experienced and dedicated employees give us a competitive advantage. With their extensive tenure in the medical device, In-vitro diagnostics, biotech and pharmaceutical industries, our Regulatory, Quality and Clinical experts develop unique and innovative solutions across every phase of development. Our commitment to quality has made us a key contributor to the development of hundreds of products for companies.

Our team members are recognized experts in clinical and regulatory consulting and clinical trial operations. Our experience in wide range of therapeutic areas provides unparalleled support to your company during every step of the product development lifecycle.

Our philosophy, “Success is achieved from teamwork and customer-focused service,” is a core belief with everyone at Boston Biomedical Associates.

Lauren S. Baker, PhD, PE

President and CEO

Dr. Baker is the President and CEO of Boston Biomedical Associates (BBA). She established BBA in 2000 after an extensive career of nearly 10 years running the corporate clinical research group for Boston Scientific. Prior to BSC, she was employed as a Research Assistant Professor at the University of Massachusetts Medical School where she worked in the Cardiac and Vascular Surgery Departments. She has served as a Professor in Mechanical Engineering at Worcester Polytechnic Institute and has established herself as a leader in clinical research in a variety of medical areas including cardiovascular, neurovascular, orthopedics, GI and GU. Dr. Baker is a licensed professional engineer and holds a BS in Chemical Engineering and a Masters and PhD in Mechanical Engineering with an emphasis in Biomedical Engineering. She has received her degrees from Worcester Polytechnic Institute and her research was performed in the Vascular Surgery Department at UMASS Medical School.

Tami Abudi

Co-CEO & Clinical Director

Ms. Abudi is a Co-Founder, Co-CEO and Clinical Director of BBA Ltd., a BBA LLC company. She and Dr. Lauren Baker co-founded the BBA Ltd office in Israel in March, 2017.  Ms Abudi joins BBA after an extensive career in clinical and regulatory affairs for over 22 years.  Prior to BBA, she worked as the Director of Clinical Affairs at Magenta Medical, an Israeli start-up developing a catheter system for treatment of Acute Decompensated Heart Failure (ADHF). In addition, she was the VP of Clinical and Regulatory Affairs at Cardiosonic, a consultant to the life sciences industry and served as VP Clinical Affairs at Becker VSG (Washington DC, USA) and as Sr. Associate, Clinical Affairs at Donawa Lifescience Consulting (Rome, Italy). During this time, she designed and managed the execution of clinical studies in support of the development and commercialization of medical device technologies. She also provided leadership for the development and execution of clinical/regulatory plans, in addition to the provision of clinical/regulatory intelligence, and expertise in translating regulatory requirements into practical work plans.  Ms. Abudi holds a Bachelor of Sciences degree from the Life Sciences faculty in Tel Aviv University, Israel.

Adi Richter

Co-CEO

Ms. Richter is the Co-CEO of BBA Ltd., a BBA LLC.  As an attorney, Ms. Richter specializes in legal matters associated with corporate and commercial issues, with a particular focus on hi-tech and biotech companies. Her extensive experience includes intellectual property law, clinical trial agreements with various research institutions, including hospitals in the US, Europe and Canada.  Prior to joining BBA Ltd., Ms. Richter was a senior corporate attorney at the law firm of Tulchinsky Stern Marciano Cohen Levitski & Co., specializing in providing comprehensive legal advice and services to clients involved in sophisticated corporate and commercial transactions, both in Israel and internationally.  Prior to that she was an attorney at the law firm of Tadmor & Co., practicing corporate and antitrust law.  While in the United States, she worked as an attorney at the law firm of Bingham McCutchen LLP which deals in trademark prosecution and corporation-wide intellectual property portfolios. Ms. Richter received her law degree from the Interdisciplinary Center in Herzliya in 1998 and a Masters in International Law from Boston University.  She is a member of both the Israeli and the New York Bar Associations.

Jake Martz, MBA

Chief Financial Officer

Mr. Martz is the Chief Financial Officer (CFO) at Boston Biomedical Associates (BBA). Before joining BBA, Mr. Martz was employed at Accounting Management Solutions providing interim CFO and Consulting Services to a variety of clients in both the Boston and New York regions. Prior to AMS he spent 13 years working for Boston Scientific in a variety of project management and senior finance roles including extensive international experience in Asia, Europe and South America. Mr. Martz has more than 30 years of diverse accounting and financial management experience with small, medium and large companies. Mr. Martz earned his Bachelor’s degree from Northern Kentucky University, and his Masters degree from Northeastern University in Boston.

Mack D. Rubley, PhD

Vice President, Consulting Services

Dr. Rubley is the Vice President of Consulting Services at Boston Biomedical Associates (BBA). He has over 15 years of leadership experience in clinical research. Previously, he served as the Director of Business Development at BBA, where his responsibilities included marketing, sales, proposal development and contracting with clients. Prior to joining BBA Dr. Rubley was an Associate Professor of Athletic Training in the School of Allied Health Sciences at UNLV for 10 years and the director of the Athletic Training Education Program form 2006-2011. His previous experience working as a clinician in sports medicine as a Certified Athletic Trainer and as a clinical researcher allows him to understand the nuances of executing a clinical study. During his time at UNLV he was a member of the UNLV Biomedical IRB and Director of the Athletic Training Research Laboratory. Dr. Rubley has published over 20 papers and 50 abstracts in Sports Medicine journals. He has presented internationally, nationally and locally at over 50 medical meetings on topics related to regulatory strategy, injury prevention, diagnosis, treatment and rehabilitation. As an established clinical scientist, Dr. Rubley understands the needs of executing appropriate clinical studies that are designed to suit Sponsor research question. He manages the Consulting Services group and the Business Development functions at BBA to ensure that projects are targeted with the optimal BBA team members. Dr. Rubley holds a BS and Masters in Kinesiology from the University of Colorado, and Pennsylvania State University, respectively and a PhD in Exercise Science and Wellness from Brigham Young University.

Marybeth Gamber

Principal, Consulting Services

Ms. Gamber is a Senior Regulatory Consultant at Boston Biomedical Associates (BBA). Ms. Gamber utilizes her extensive regulatory and quality systems experience to help develop preclinical, clinical, and strategic regulatory programs for our clients. Ms. Gamber joined the company in 2009 after working for over 11 years in Regulatory Affairs for Boston Scientific Corporation, Acumen Medical, Concentric Medical and Bacchus Vascular Inc. where she formulated and executed aggressive regulatory strategies for medical devices, as well as created and maintained quality systems meeting ISO 13485 and FDA QSR requirements. While serving in those roles, she established herself as an experienced and strategic Director of Regulatory Affairs. She has experience with regulatory submissions for a wide range of therapeutic areas to support product approvals in the United States and internationally in the European Union and Canada. She has experience in the medical device product development process as well as post market surveillance activities. In addition, Ms. Gamber has clinical experience including development of study protocols and other study related documents. She has executed site study start up activities, monitored clinical sites and continues to perform BIMO audits at clinical sites in preparation for FDA audits. Ms. Gamber’s therapeutic experiences include cardiovascular, peripheral vascular, neurovascular, gastroenterology and orthopedics. Ms. Gamber developed and implemented the plan and process for BBA to obtain ISO 13485:2003 certification. Ms. Gamber holds a Bachelor of Arts from Juniata College in English and is a member of the Regulatory Affairs Professional Society.

Mark Gosnell

Principal, Consulting Services

Mr. Gosnell is a Principal Consultant at Boston Biomedical Associates (BBA). Mr. Gosnell provides preclinical, clinical and regulatory consulting services to our clients in the medical device industry. Mr. Gosnell uses his 24 years of experience in cardiovascular disease and devices to provide client consultation in the areas of interventional cardiovascular/ neurovascular devices, mechanical circulatory support, electrophysiology, orthopedic implants, and obesity/gastrointestinal devices in clinical trials within and outside the US. Prior to joining BBA, he was VP of clinical affairs at OmniSonics Medical Technologies Inc., a Clinical Programs Manager and Senior Clinical Research Scientist at Boston Scientific Corporation. During his time at Boston Scientific, he was responsible for worldwide activities in the development of coronary, peripheral and drug-eluting stent technology. He worked to develop regulatory strategies to support new product approvals in the area of drug-device combination products. He has served on an AdvaMed task force for cardiovascular devices. Mr. Gosnell has co-authored eight papers and abstracts in the area of medical devices and holds a US patent with his colleagues for an ultrasonic probe used with a pharmacologic agent. He is a member of the American Association for the Advancement of Science, and the Society for Clinical Trials. Mr. Gosnell holds a BS in Zoology from the University of Wisconsin, Eau Claire.

Michelle A. Michela, MS

Principal, Consulting Services

Ms. Michela is Principal Consultant at Boston Biomedical Associates (BBA). Ms. Michela has more than 20 years of experience in medical devices, data management and analysis, and regulatory submissions in a variety of settings. As a founding member of BBA Ms. Michela has been instrumental in identifying the complex needs of clients and applying her experiences in clinical research, data analysis and management, and biostatistical consulting services to deliver high quality solutions. During her years at BBA, Ms Michela assembled a strong internal team of biostatisticians and programmers as well as strong working relationships with external consulting Statisticians to support specialized needs including Bayesian adaptive designs and Data Monitoring Committee support. Ms. Michela has a particular focus in clinical trial design and development and biostatistical analytical methods, including Bayesian and adaptive study designs, critical to evaluation of clinical data to support safety and efficacy of new medical devices across numerous therapeutic specialties. Additional areas of expertise include preparing regulatory submissions; managing Data Monitoring Committees and Clinical Events Committees, designing clinical trials and developing protocols, conducting literature review, designing case report forms, implementing web-based data management, and conducting software validation and statistical analyses for clinical summary reports. Prior to joining BBA Ms. Michela worked at Boston Scientific Corporation and Survival Technologies. Ms. Michela holds a BS in Biochemical Engineering from the University of Rochester and a MS in Physiology from Georgetown University.

Bonnie Weiner, MD, MSEC, MBA

Executive Director, Medical Affairs

Dr. Weiner is the Medical Director at Boston Biomedical Associates (BBA), a Professor of Medicine at University of Massachusetts Medical School, Director of the Cardiology Fellowship Program Division of Cardiology, Saint Vincent Hospital and President of Imaging Core Lab Services, LLC. Dr. Weiner has served as principal investigator/sub-investigator for studies in the specialty of cardiovascular medicine in numerous studies. She has published over 100 peer-reviewed manuscripts, over 100 abstracts accepted, presented at over 50 medical symposiums, and serves as a manuscript reviewer for many journals including the New England Journal of Medicine. Dr. Weiner oversees all medical aspects of the projects managed by BBA. Dr. Weiner holds a BA with Honors in Chemistry from Mills College and an MD from the University of Oregon Medical School, an MSEC and MBA from the University of Maryland.

Maria Francescon, MPH

Executive Director, Clinical and Safety Operations

Ms. Francescon is Executive Director of Clinical and Safety Operations at BBA. In this role Ms. Francescon oversees Clinical Project Management, Monitoring, Site Management and Safety services. Ms. Francescon and her experienced team provide BBA’s clients with quality clinical trial services and innovative processes designed to protect patient safety and uphold data integrity. Prior to joining BBA, she served as Senior Program Director of CEC and DMC services at Harvard Clinical Research Institute, an academic CRO, working with leading medical device and pharmaceutical clients for 10 years in various therapeutic areas, including interventional cardiology, neurology, endovascular, and peripheral vascular. She executed and led CEC and DMC services for 80 projects during her tenure at HCRI, including MD recruitment, charter development, and serving as the client liaison to maintain independence between the client and committees while working with clients to educate them on the importance and functionality of these committees in order to ensure data integrity. She grew the business in this area significantly and worked closely with internal colleagues and clients to ensure the delivery of quality and client service. Earlier in her career, she was employed with several health care consulting firms for 10 years where she worked and developed significant experience within project management and client services. Ms. Francescon earned her MPH from Boston University.

Mary LeGraw

Principal, Consulting Services

Ms. LeGraw is a Senior Regulatory Consultant at BBA. Ms. LeGraw, utilizes her extensive experiences gained during her 20+ years in regulatory affairs to provide strategic regulatory consulting for our clients. Ms. LeGraw has held senior postions at several companies where she oversaw IDE submissions, interactions with regulatory agencies, Notified Bodies, Competent Authorities and Authorized Representatives. In additions she has executed global regulatory strategies to obtain product approvals and clearances. Prior to joining BBA in 2015, Ms. LeGraw served as the VP of Global Regulatory Affairs for GI Dynamics, and in progressive regulatory roles for over 10 years at Tepha, Inc. In addition she has worked with OmniSonics Medical Technologies, Mitek Products (Ethicon, a J&J Company), and Boston Scientific. Some of the products she has worked on includes: Aortic Valve Replacement technology, technology utilized in women’s health and fertilization, a bioresorbable polymer made from rDNA technology for bone & tissue repair, acoustic energy for vascular occlusive disease, various medical devices for sports medicine & reconstruction surgery, interventional neuroradiology and cardiovascular devices. Ms. LeGraw holds a Bachelor of Arts in both Education and Psychology from the University of Massachusetts.

Joe Massaro, PhD

Senior Consultant, BioStatistics

Dr. Massaro is a Senior Consultant of Biostatistics at Boston Biomedical Associates.  Dr. Massaro provides study design and statistical analysis consulting to our clients developing new medical technologies and therapies.  He utilizes his over 25 years of experience in the design and statistical analysis of clinical trials to provide innovative and cost efficient trial design ideas for our clients, that meet regulatory standards for clinical studies conducted globally.  Dr. Massaro will maintain his position as Professor in the Department of Biostatistics at Boston University while working with BBA.  Dr. Massaro joins BBA following 14-years consulting with the Harvard Clinical Research Institute, where he served as a Managing Director, Biometrics and Data Management and more recently as the Director of Statistical Consulting.  Dr. Massaro has served as a member of Data Monitoring Committees, whose purpose is to review the data trends in safety and efficacy of a clinical trial to provide recommendations to study sponsors regarding continuation or stopping of a clinical trial.  While working in the industry, he has co-authored over 50 publications related to health care and clinical trial outcomes.  Many of the clinical trials he has supported have investigated new treatment paradigms for cardiovascular disease. Dr. Massaro is also a statistical investigator at the Framingham Heart Study, assessing risk factors for cardiovascular disease and dementia.  He is an accomplished public speaker having presented at many academic and industry conferences on statistical methods in clinical trials.  In addition, Dr. Massaro has been recognized for his excellence in the classroom with numerous excellence in teaching awards at Boston University.  Dr. Massaro holds a Bachelor of Arts degree in Mathematics from Boston College and both a Master of Arts and PhD degree from Boston University.

Megan M. Shackelford

Principal, Consulting Services

Ms. Shackelford is a Regulatory Consultant at BBA.  Ms. Shackelford supports our clients utilizing her experiences gained during a six-year career at FDA, where she served as a lead reviewer in the Office of Device Evaluation, reviewing premarket approval applications, 510(k) notices, de novo petitions, investigational device exemption applications, and associated pre-market submissions for hemodialysis, obesity, and gastroenterology devices.  After leaving the FDA, Ms. Shackelford served in a consulting role to medical device companies at Biologics Consulting Group in Alexandria, Virginia until July 2016.  In that role she advised medical device clients on regulatory matters including regulatory strategy, preclinical and clinical testing requirements, FDA submission preparation, FDA communication, and post-market regulatory requirements.  Ms. Shackelford holds a Bachelors of Science degree in Biomedical Engineering from Tulane University and a Master of Science degree in Biomedical Engineering from Texas A&M University.

Our dedicated team. Your unique goal.

Subscribe To Our Newsletter

Subscribe To Our Newsletter

Join our mailing list to receive the latest news and updates from our team

You have Successfully Subscribed!

MENU