Combination Products Conference

Transcription

1 Combination Products Conference October Sheraton Silver Spring Hotel Silver Spring, MD PROGRAM CHAIR Rachel SW Turow, JD, MPH Executive Counsel - Regulatory Law Teva Pharmaceuticals Ltd. PROGRAM COMMITTEE David Amor, MSBE, CQA Vice President, Quality and Regulatory Pear Therapeutics Ryan McGowan Associate Director, Combination Products AstraZeneca Kirsten H. Paulson Senior Director, Global CMC Medical Devices Pfizer Inc Nancy Stade, JD Partner Sidley Austin LLP James Wabby Executive Director, Regulatory Affairs Allergan John Barlow Weiner, JD Associate Director for Policy FDA Bill Zeruld, MBA Business Development - Digital Strategy Otsuka America Pharmaceuticals, Inc. Overview The Combination Products Conference will examine the recent and ongoing changes in the regulatory ecosystem for combination product development and approval, including new FDA guidances, implementation status of PDUFA VI commitments around combination products, FDA collaborative decision-making models and the maturation of internal alignment at the agency, global regulatory changes, including the EU Medical Device Regulation implementation roadmap, and the direction of global alignment efforts. In-depth treatment of digital and ehealth issues, as well as complex generics and their impact on innovator product policy and business perspectives will be featured. Highlights Short Course on how the new EU Medical Device Regulation approaches combination products In-depth discussions on new, revised, and draft guidances related to combination products Interactive sessions to learn from key stakeholders from regulatory agencies and industry on challenges and opportunities in combination product development Hear from FDA leaders from CDER, CBER, CDRH, the Office of Combination Products, and the Oncology Center of Excellence Target Audience Senior-level professionals and decision-makers involved in: Biopharmaceutical, Device, and Combination Product R&D and Development Regulatory Affairs Policy Clinical Research Consulting, Legal, Government Affairs CMC Quality Assurance and Control Business Development #Combo18 DIAglobal.org 800 Enterprise Road Suite 200 Horsham, PA USA As of October 2, 2018

2 Schedule At-A-Glance SHORT COURSE WEDNESDAY, OCTOBER 10 ROOM 12:30-5:00PM Short Course Registration Elm 1 & II Foyer 1:30-5:00PM Short Course: How the MDR will Affect Combination Products Elm 1 & II DAY ONE THURSDAY, OCTOBER 11 ROOM 7:30AM-5:30PM Registration Cypress Foyer 7:30-8:15AM Continental Breakfast and Networking Hawthorn 8:15-8:30AM Welcome and Opening Remarks Cypress Ballroom 8:30-9:00AM Keynote Address Cypress Ballroom 9:00-9:45AM Session 1: FDA Update Cypress Ballroom 9:45-10:15AM 10:15-11:45AM Session 2: Complex Generic Combination Products Regulatory Policy Considerations 11:45AM-1:15PM Luncheon and Networking Magnolia Ballroom 1:15-2:00PM Session 3: Combination Products Lifecycle Management Issues Today Cypress Ballroom 2:00-2:45PM Session 4: Combination Product Regulatory Submissions: Considerations for Product Development 2:45-3:15PM Hawthorn 3:15-4:00PM Session 5: Innovator's Perspective Cypress Ballroom 4:00-4:45PM Session 6: Requests, Disputes, and Appeals: A Process Primer for Combination Product Applicants Cypress Ballroom Cypress Ballroom Cypress Ballroom 4:45-5:45PM Networking Reception Magnolia Ballroom DAY TWO FRIDAY, OCTOBER 12 ROOM 7:30AM-5:00PM Registration Cypress Foyer 7:15-8:15AM Continental Breakfast and Networking Cypress Ballroom 8:15-8:30AM Welcome to Day Two Cypress Ballroom 8:30-9:00AM Day Two Keynote Address Cypress Ballroom 9:00-10:30AM FDA Panel Cypress Ballroom 10:30-11:00AM Hawthorn 11:00-11:45AM Session 7: Global Regulatory Changes and Emerging Markets Cypress Ballroom 11:45AM-1:15PM Luncheon and Networking Magnolia Ballroom 1:15-2:45PM Session 8: Connected Combination Products Cypress Ballroom 2:45-3:15PM Hawthorn 3:15-4:00PM Session 9: Devices Referencing Drugs: Post-Market Considerations Cypress Ballroom 4:00-4:45PM Session 10: Aligning Drug- and Device-led Combination Product Policy Cypress Ballroom 4:45PM Closing Remarks Cypress Ballroom 2

3 Learning Objectives At the conclusion of this conference, participants should be able to: Discuss recently issued guidances and regulations as well as internal FDA changes affecting combination products List examples of challenges faced in the development of complex generic combination products Outline best practices of handling adverse effects, usability, and complaints throughout the drug-device lifecycle Explain key considerations in determining the appropriate regulatory submission path for a combination product Identify how the agency is collaborating with industry to encourage innovation Describe the importance of compliance with the EU MDR and specific provisions on combination products Recognize the characteristics of an appropriate Quality Management System for a connected combination product manufacturer Describe the top issues affecting both drug and device led combination products Continuing Education Credits DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This session is designated for up to contact hours or continuing education units (CEUs). Type of Activity: Knowledge Participants are able to receive an ACPE statement of credit for daily attendance. No partial daily credit will be awarded. DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA s My Transcript within 45-days post activity. If ACPE credit is not requested by November 24, 2018, the CEU request will not be transmitted through to the CPE Monitor. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-profile, please visit DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET). As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer up to 1.5 CEUs for this conference. Participants must complete the entire conference in order to be able to receive an IACET statement of credit. No partial credit will be awarded. If you would like to receive a statement of credit for the day(s) that you attended the conference, you must sign in each day at the DIA registration desk upon arrival, complete the program evaluation and complete the online credit request process through My Transcript. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests beginning Monday, October 22, To view DIA s Grievance Policy, visit DIAglobal.org/CE Continuing Education Credit Allocation Short Course: How the MDR will Affect Combination Products: Pharmacy 3 Contact Hours or.3 CEUs, UAN: L04-P Conference Day One: Pharmacy 5.75 Contact Hours or.575 CEUs, UAN: L04-P Conference Day Two: Pharmacy 6 Contact Hours or.6 CEUs, UAN: L04-P ACPE CREDIT REQUESTS MUST BE SUBMITTED BY NOVEMBER 24, 2018 TO ACCESS MY TRANSCRIPT Visit DIAglobal.org Sign In with your DIA User ID and Password Select the Welcome Menu in the upper right hand corner (where your name appears) Select My Account from the menu Select My Transcripts then Manage My Transcripts ACCESS PRESENTATIONS Visit DIAglobal.org Sign In with your DIA User ID and Password Select the Welcome Menu in the upper right hand corner (where your name appears) Select My Account from the menu Choose My Presentation Please Note: DIA User ID and Password are needed to access presentations. If you have forgotten your DIA User ID and Password, or this is your first time logging into the DIA website, please use our Login Reminder. *Presentations will be available for six months post conference. 3

4 SHORT COURSE WEDNESDAY, OCTOBER 10 12:30-5:00PM 1:30-5:00PM Registration Short Course: How the MDR will Affect Combination Products Instructors Ian Pearson, Associate, Jones Day Colleen Heisey, Partner, Jones Day This Short Course will provide an overview on how the new EU Medical Device Regulation approaches combination products combining medical devices and pharmaceuticals, in particular highlighting the differences to the current legislation and the additional challenges for manufacturers. Learning Objectives At the conclusion of this short course, participants should be able to: Become familiar with the classification methodology for combination products under the EU MDR Understand the new requirements for combination products under the EU MDR DAY ONE THURSDAY, OCTOBER 11 7:30AM-5:30PM 7:30-8:15AM 8:15-8:30AM Registration Continental Breakfast and Networking Welcome and Opening Remarks Representative Invited 8:30-9:00AM Keynote Address Keynote Speaker Thinh X. Nguyen, Director, Office of Combination Products, OSMP, OC, FDA 9:00-9:45AM Session 1: FDA Update John Barlow Weiner, JD, Associate Director, Policy and Product Classification Officer, Office of Combination Products, Office of the Commissioner, FDA FDA regulation of combination products has seen huge advances in recent years. Both PDUFA VI and 21st Century Cures have included programmatic changes for combination products, and FDA has been busy issuing guidances and regulations as well as implementing organizational changes to aid in the review of combination products. The Office of Combination Products will give an update on all of these aspects and forecast some future issues we might see addressed under the new FDA Commissioner. John Barlow Weiner, JD, Associate Director, Policy and Product Classification Officer, Office of Combination Products, Office of the Commissioner, FDA 9:45-10:15AM 4

5 10:15-11:45AM Session 2: Complex Generic Combination Products Regulatory Policy Considerations Rachel SW Turow, JD, MPH, Executive Counsel, Regulatory Law, Teva Pharmaceuticals Ltd. Building on the progress of DIA s Complex Drug-Device Generic Combination Products meeting, this session will address regulatory policy issues raised by the review and approval of complex generic combination products. Specifically, we will look at how FDA defines sameness with respect to device functionality; human factors requirements; and other policy considerations. Cory A. Wohlbach, Senior Director, Regulatory Affairs, TEVA Pharmaceuticals United States of America Inc Lesley DeRenzo, MA, MS, Regulatory Counsel, OMPT, OGD, CDER, FDA 11:45AM-1:15PM 1:15-2:00PM Luncheon and Networking Session 3: Combination Products Lifecycle Management Issues Today James Wabby, Executive Director, Regulatory Affairs Devices and Combination Products, Allergan This session will discuss the importance of promoting a culture of compliance to build a compliant lifecycle management infrastructure around combination products to ensure appropriate cgxps and Quality System regulations are enforced throughout the franchise. Open discussions and dialogue will be included. Alan Stevens, Branch Chief, General Hospital Devices Branch, ODE, DAGRID, CDRH Vijay Kumar Damodaran, Advisor/Director, Global Quality, Eli Lilly & Company 2:00-2:45PM Session 4: Combination Product Regulatory Submissions: Considerations for Product Development David Amor, MSBE, CQA, Vice President, Quality and Regulatory, Pear Therapeutics Regulatory submissions for combination products have evolved significantly in the past decade. From determination of modes of action to assessing requirements for combination product submissions, manufacturers have been forced to understand how two constituent products with their own submission requirements can be merged into a comprehensive regulatory filing. This session will review considerations for manufacturers in preparing combination product regulatory submissions, and will include specific casestudies that illustrate key concepts. Sugato De, MS, Principal Consultant, PAREXEL International Kevin Bardonner, Research Scientist, Regulatory Affairs, Eli Lilly Suzette Roan, Senior Director, Regulatory Affairs, Devices and Combination Products, Sanofi US 2:45-3:15PM 3:15-4:00PM Session 5: Innovator's Perspective Bill Zeruld, MBA, Business Development - Digital Strategy, Otsuka America Pharmaceuticals, Inc. There is tremendous buzz around novel combination product solutions leveraging digital technologies and other approaches. This session will spotlight the opportunities and challenges for such innovative solution providers in navigating the regulatory pathway. Hear from industry pioneers in a panel discussion that will highlight how their efforts in collaboration with the Agency are helping identify new approaches that will ultimately support and encourage ongoing innovation. Yuri Maricich, Chief Medical Officer and Head of Clinical Development, Pear Therapeutics Kevin Wurch, Director, Program Management, Otsuka Pharmaceutical Development & Commercialization Darin Oppenheimer, Executive Director, Drug Device Center of Excellence, Merck & Co. 5

6 4:00-4:45PM Session 6: Requests, Disputes, and Appeals: A Process Primer for Combination Product Applicants Nancy K. Stade, JD, Partner, Sidley Austin LLP This session will address regulatory and strategic considerations in interacting with FDA before and during the pre-market review of an application for a combination product. Nancy K. Stade, JD, Partner, Sidley Austin LLP 4:45-5:45PM Networking Reception DAY TWO FRIDAY, OCTOBER 12 7:30AM-5:00PM 7:15-8:15AM 8:15-8:30AM Registration Continental Breakfast and Networking Welcome to Day Two Representative Invited 8:30-9:00AM Day Two Keynote Address Keynote Speaker Scooter Plowman MD, MBA, MHSA, Medical Director, Proteus Digital Health, Inc. 9:00-10:30AM FDA Panel John Barlow Weiner, JD, Associate Director, Policy and Product Classification Officer, Office of Combination Products, Office of the Commissioner, FDA Medical Product Center, Office of Combination Products, and Oncology Center of Excellence leadership will discuss plans, priorities, and challenges for combination products, enhancing coordination and collaboration more broadly, and the future face of FDA as the Agency addresses increasingly complex, cross-cutting medical products. Panelists Kristina Lauritsen, Combination Products Review Advisor, CDER, FDA James Bertram, Policy Analyst, CDRH, FDA Sheryl L. Lard Whiteford, PhD, Associate Director for Quality Assurance, Ombudsman, CBER, FDA Melissa B. Burns, MS, Senior Program Manager, Office of Combination Products, FDA 10:30-11:00AM 11:00-11:45AM Session 7: Global Regulatory Changes and Emerging Markets Session Co-Chairs Ryan McGowan, Associate Director, Combination Products, AstraZeneca Kirsten Paulson, Senior Director, Global CMC Medical Devices, Pfizer, Inc New regulations and polices are emerging within key international markets and it is essential that companies understand expectations to ensure successful marketing and change management strategies for combination products. This session will cover the new EU Medical Device Regulation and its impact on combination products as well as an overview of international combination product regulation within emerging markets. 6

7 EU Medical Device Regulation and Impact on Combination Products Sarah H. Stec, Senior Counsel, Regulatory Law, Johnson & Johnson Combination Product Regulation in Emerging Markets Ola Oyinloye, Associate Director - Medical Devices and Combination Products, AstraZeneca 11:45AM-1:15PM 1:15-2:45PM Luncheon and Networking Session 8: Connected Combination Products David Amor, MSBE, CQA, Vice President, Quality and Regulatory, Pear Therapeutics With the advent of digital health upon us, combination product manufacturers have been working hard to integrate connected capabilities to their products. From talking auto-injectors to dose-counting inhalers, combination products with a digital health component will continue to empower providers and patients by providing data and actionable insights. This session will review regulatory and quality considerations for connected combination products while reviewing several case studies and examples. Tina Murphy PhD, RAC, Senior Global Program Regulatory Manager, Regulatory Affairs Innovation, Novartis Pharmaceuticals Corporation 2:45-3:15PM 3:15-4:00PM Session 9: Devices Referencing Drugs: Post-Market Considerations Nancy K. Stade, JD, Partner, Sidley Austin LLP This panel will examine challenges in post-market oversight of DRDs, identify how FDA has addressed such challenges in the past, and explore whether and under what circumstances FDA can exert sufficent oversight over DRDs to warrant the creation of a pathway. Panelists Kirk Seward, PhD, Co-Founder, President, Chief Science and Technology Officer, Mercator Medical Christy Foreman, Senior Consultant, Biologics Consulting Philip Desjardins, JD, Vice President, Johnson & Johnson 4:00-4:45PM Session 10: Aligning Drug- and Device-led Combination Product Policy Rachel SW Turow, JD, MPH, Executive Counsel, Regulatory Law, Teva Pharmaceuticals Ltd. This panel will discuss the challenges the Office of Combination Products faces in creating cohesive policy in an area with stakeholders that have very different priorities. We will also discuss how this affects efforts at FDA to align policy across centers and combination product types. Panelists Kate Cook, JD, Executive Vice President, Drugs and Biological Products, Greenleaf Health LLC David B. Clissold, JD, Director, Hyman, Phelps & McNamara, P.C. Kimberly A. Trautman, MS, Executive Vice President, Medical Device International Services, NSF Medical Devices, NSF International 4:45PM Closing Remarks Representative Invited Summary of Takeaways and Calls to Action 7