25 Aug Boston Biomedical Associates Announces Former FDA Reviewer Joins Boston Biomedical Associates
MARLBOROUGH, MA – Boston Biomedical Associates (BBA), a strategic clinical and regulatory consultancy and full-service contract research organization (CRO) serving the medical device and biopharmaceutical industries, today announced an appointment to the company’s senior regulatory team.
Megan M. Shackelford, former Biomedical Engineer/Scientific Reviewer of the Division of Reproductive, Gastro-Renal and Urological Devices at the Food and Drug Administration (FDA), has joined the company as a Principal of Regulatory Affairs in its Consulting Services Group.
In her new role at Boston Biomedical Associates, Ms. Shackelford will assist the firm’s more than 100 clients in developing strategies for obtaining market authorization for new technologies. She will also work with the firm’s regulatory and clinical operations staff and in the design of clinical trials to support device clearances and approvals and with regard to medical device advisory panel meetings.
Ms. Shackelford joins the firm following 6-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. Ms. Shackelford reviewed a wide range of devices submitted to the Gastroenterology and Renal Device Branches from 2007 to 2014, including biliary stents, esophageal stents, colonic stents, surgical plication devices, dialysis technologies, enteral feeding devices, ostomy devices, and weight loss devices. After leaving the FDA in 2014, 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.
“We welcome Ms. Shackelford to our company and we are certain she will provide highly valued insight and assistance to our clients navigating the FDA premarket processes for new technologies. Megan’s proven track record of successful interactions with industry and her regulatory expertise make her an excellent addition to the BBA team”, said Lauren Baker, CEO of Boston Biomedical Associates. “Megan’s appointment reflects our ongoing commitment to utilize experience and expertise, to advance our client’s unique medical technology through the ever changing global regulatory approval process.”
“Joining the team at BBA provides me the opportunity to bring my experiences, and the perspectives I developed at the FDA, to companies developing new medical technology”, said Megan Shackelford. “I am excited to join the Consulting Services team at BBA and leverage my experience to help our clients find innovative and straight forward regulatory strategies and solutions to advance their product through the regulatory review process,” she added.
While at the FDA Ms. Shackelford worked with industry representatives and regulatory consultants to meet regulatory requirements for the design of medical devices, including bench and animal testing as well as clinical studies. In addition, she participated in the Obesity Device Working Group, with members of the Office of Device Evaluation and the Office of Surveillance and Biometrics, tasked with determining the best clinical, statistical, and regulatory approaches for determining the safety and effectiveness of obesity devices. A key outcome of this working group was the FDA Patient Preference Survey, which assessed the amount of risk that the patients would be willing to assume for a certain amount of benefit. She also served as the Executive Secretary for the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. In this capacity she worked within the FDA to plan, organize and staff physicians on advisory panel meetings.
Boston Biomedical Associates (BBA) is a clinical and regulatory consultancy and full-service contract research organization (CRO) serving the medical device and biotech industries. BBA was founded in 2000 by Lauren Baker, PhD, PE. The BBA team is comprised of experts with global regulatory and clinical trial experience. For over 15 years and more than 100 Sponsors, BBA has improved the efficiency of clinical development through innovative methodology, processes and technology. BBA offers broad-ranging capabilities in product development from initial design and first in human, through large pivotal trials and post-market studies. BBA’s experts operate globally and service a wide range of therapeutic areas.