October 14: Primer
October 15-16: Conference
Combination products, comprised of a drug, generic, or biologic and device, are a rapidly growing segment of the biopharmaceutical and device industry. The convergence of innovative medicines such as advanced cell and molecular biological products (Advanced Therapeutic Medicinal Products or ATMPs), materials science advances, and the development of digital therapies and applications, is driving a rapid expansion of novel applications to better meet patient needs.
The use of combination products in these novel therapies has a growing impact on regulatory and development science. Many regulatory challenges arise as new product types intersect with previously distinct development and approval pathways. The good news is that recent and ongoing improvements in the regulatory framework and process are leading to better access to new combination products for patients. But development challenges and regulatory questions continue to emerge as combination product sciences advance.
DIA’s Combination Products Conference is a premier forum where industry and regulators dialog on today’s best answers to key questions:
- How can new and emerging regulatory tools be used to best advance combination product development and approval?
- How can the regulatory framework for combination products be continuously improved?
- How can new technologies and novel approaches be used to realize opportunities in the developmental of new therapies to meet patient needs?
Who should attend?
Senior Level Professionals and Decision-makers involved in:
- Biopharmaceutical, Generics, Biosimilars, Device, and Combination Product R&D and Development
- Business Development
- Clinical Research
- Legal, Government Affairs
- Quality Assurance and Control
- Regulatory Affairs, Regulatory Operations
- Research and Development
At the conclusion of this forum, participants should be able to:
- Define combination product and identify steps taken for uncertainty of approval
- Describe the current state of the global regulation of combination products
- Discuss the chemistry, manufacturing, and control (CMC) challenges, pitfalls, and best practices that sponsors should consider when submitting a combination product for FDA review
- Explain the post-market safety management process for a combination product
- Analyze regulatory expectations and industry challenges in complying with Article 117
- Identify expectations of the evolving regulatory landscape and challenges of on-body injectors
- Describe current FDA regulatory thinking and related guidance associated with digital combination products and concepts related
- Identify the role human factor engineering plays in combination product development and the design controls process
James Wabby, MHS • Executive Director, Regulatory Affairs, Emerging Technologies and CMC - Device
AbbVie, United States
Karthik Balasubramanian, PhD, MS • Director, Combination Products and Semisolids, Generic CPD
Teva Pharmaceuticals, United States
Khaudeja Bano, DrMed, MD, MS • Executive Medical Director, Combination Product Safety Head
Amgen, United States
John Barlow Weiner, JD • Associate Director for Policy, Office of Combination Products, OC/OCPP
FDA, United States
Jonathan Amaya-Hodges • Associate Director, Regulatory Affairs
Biogen, United States
Chin-Wei Soo, DrSc • Global Regulatory Head, PTR Devices and Combination Products
Genentech, A Member of the Roche Group, United States
Demetra Macheras, MBA • Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, Inc., United States
Darin Seth Oppenheimer, DrSc • Executive Director, Device & Digital Health Solutions
Merck & Co., Inc., United States
Primer: APPs/Digital Health in Combination Products - QMS and Risk Management Opportunities and Challenges