A FREE Webinar from Medical Device Daily and BioWorld
Through Sponsorship by Novella Clinical
Novel combination products, which pair a medical device with a biologic or a device with a drug, offer new and innovative diagnostic and treatment options for patients and are becoming more prevalent. According to the Institute of Medicine, an estimated 30 percent of pharmaceutical research and development currently focuses on combination products.
Register for this FREE webinar to learn from our expert panelists how to avoid the regulatory nightmare that can result in the pursuit of innovative solutions through combination products.
When a product under review is classified as a device, drug, or biologic, FDA regulations provide clear guidance on which of the three centers (Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and Center for Drug Evaluation and Research) will conduct the evaluation. However, when a product relies on different modes of action (even when comprised of previously cleared components) the agency's process for determining the regulatory path to be followed is not always predictable.
During this FREE webinar Medical Device Daily’s Washington Editor, Mark McCarty will moderate a discussion with experts David Novotny and Cynthia Pritchard, PhD from Novella Clinical and Kristin Neff from TARIS Biomedical as they explain the regulatory challenges surrounding combination products and provide you with strategies and recommendations for avoiding costly mistakes. Register today!
Key Learning Points:
- Learn how combination products are defined by FDA
- Explore strategies to obtain the preferred Request for Designation (RFD) response and the process steps
- Identify clinical requirements, timing and implications for sponsors
- Learn when to engage a CRO partner
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About Our Panelists:
Mark McCarty, Washington Editor, Medical Device Daily
Mark has served as the Washington editor for Medical Device Daily since March 2006. He has covered FDA’s regulation of the medical device industry from both a regulatory review and compliance/enforcement aspects, but has also routinely reviewed Medicare reimbursement. Mark’s portfolio at Medical Device Daily includes coverage of medical device advisory committees, congressional hearings and medical specialty society meetings. Among the subjects he has covered are patent law and patent reform legislation, medical liability law, healthcare reform and the science of cardiovascular disease. Mark has also led strategic discussions of AHC Media’s medical device publication portfolio and has assembled several publication proposals. As the editor of the Oncology Extra feature appearing weekly in Medical Device Daily, he has also extensively covered cancer treatments and diagnostics. Previously Mark served as the managing editor for two publications by the Washington Information Source, Inspection Monitor and Warning Letter Bulletin, and was a contributing writer for WIS’s Validation Times.
Kristin Neff, Senior Director of Clinical Operations, TARIS Biomedical
Kristin has spent the majority of her career at the intersection of project management and clinical operations in pharmaceutical, biotech and medical device organizations. Her most recent experiences have been leading clinical development/operations at smaller start-up companies including HeartWare, ConforMIS and most recently as the Senior Director of Clinical Operations at TARIS Biomedical. At TARIS, she is equally involved in strategic clinical development, oversight of clinical study operations and program management of the development programs. Kristin has degrees in Electrical Engineering from University of Massachusetts and Biomedical Engineering from Boston University.
David Novotny, Vice President, Medical Device & Diagnostics, Novella Clinical
David provides leadership, operational and strategic oversight for Novella’s medical device division, and has been involved in medical device and pharmaceutical research for over 13 years including overseeing US clinical operations for a medical device manufacturer specializing in wound care products and electrical delivery systems. He has direct experience with various product regulatory designations in the US and Europe, Class II and Class III FDA submissions and approvals, BIMO inspections and strategic planning for medical device and diagnostic manufacturers. His combination products experience includes strategic regulatory planning; management of feasibility through post-approval clinical trials for diabetes insulin pumps, implantable cardiac devices, drug eluting stents, surgical sealant compounds and various compounds for wound care closure indication. David holds a BS in Physiology from University of Iowa.
Cynthia Pritchard, PhD, Senior Regulatory Specialist, Novella Clinical
Dr. Pritchard has over 30 years in the medical device/diagnostic/biologics industry, and has brought more than 30 Class II and Class III products from research into development through clinical trials and manufacturing to market launch. She has a strong Regulatory and Quality Assurance background, with extensive experience in FDA/ICH/ISO regulations, clinical project management, design control, and documentation, and has written over 30 successful submissions to CDRH and CBER divisions of the FDA and to European regulatory agencies. Dr. Pritchard obtained a BS in microbiology at the University of South Florida, a PhD in virology/molecular biology at Virginia Tech, and was a Damon Runyon Postdoctoral Fellow in biochemistry at Harvard Medical School.
About Our Sponsor:
Novella Clinical is a full service clinical research organization (CRO) dedicated to the medical device industry offering a comprehensive suite of services. Our approach provides medtech companies both personalized regulatory consulting – critical in the early development phase – as well as expert global study execution.
