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Monday, June 27
 

8:30am EDT

#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-526-L01-P; CME 1.25; IACET 1.25; RN 1.25

In vitro diagnostic devices are important tools intended for use in the diagnosis of disease or other conditions, including a determination of the state of health. Based on a diagnosis, it seems reasonable for a company to recommend an appropriate prescription drug treatment. This session reviews the basics of advertising and promotion for devices and prescription drugs in the context of intended use and approved indications. Taking the substantial evidence requirements and recent 1st Amendment challenges into consideration, the panelists will provide a systematic assessment of scenarios when company may or may not co-promote or recommend a prescription treatment based on a diagnostic outcome.

Learning Objectives

Identify valuable insights into the regulatory and legal boundaries of advertising and promotion of a device with a prescription drug when these tactics go beyond the approved intended use/indication, and when this may be viewed as an unapproved new combination device/drug product.

Chair

Kimberly Belsky, MS

Speaker

Panelist
Alan G. Minsk, JD

Panelist
Minnie Baylor-Henry, JD, RPh


Chair
avatar for Kimberly Belsky

Kimberly Belsky

Senior Director, Regulatory Affairs, Regulatory Intelligence, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals... Read More →

Speakers
avatar for Minnie Baylor-Henry

Minnie Baylor-Henry

President, B-Henry & Associates
President of B-Henry & Associates, a consulting firm focused on providing regulatory and compliance strategy services to life sciences companies. Prior to assuming her current role in early 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s... Read More →
avatar for Alan Minsk

Alan Minsk

Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP
Alan G. Minsk is a partner in the Food and Drug and Government and Regulatory Practices. Mr. Minsk was recognized in chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers... Read More →

Monday June 27, 2016 8:30am - 9:45am EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv-Mkting, Forum

10:45am EDT

#134: How Can We Utilize Mobile Health for Better Quality of Life and Medical Economy?
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-561-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this session, basic information on regulations of software as a medical device will be provided. Also, the expectation of mobile health devices in terms of quality of life and medical economy and challenges to develop such devices will be discussed.

Learning Objectives

Explain the regulations on software as a medical device including topics discussed in the International Medical Device Regulators Forum Standalone Medical Device Software Harmonization Working Group for the utilization of mobile health for enhancement of quality of life; Discuss the potential of mobile health in terms of reducing medical costs.

Chair

Madoka Murakami, PhD

Speaker

Academic Perspective
Hiroshi Hosoi

Industry Perspective
Nersi Nazari, PhD

FDA Perspective
Bakul Patel


Chair
MM

Madoka Murakami

Unit Chief, Division of Regulatory Cooperation, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)

Speakers
avatar for Hiroshi Hosoi

Hiroshi Hosoi

President, Nara Medical University
Hiroshi Hosoi, M.D., Ph.D. is a president of Nara Medical University in Japan. He is a doctor who specializes in Otorhinolaryngology. In 2004, he found a new sound conduction pathway “cartilage conduction,” which is different from the two previously known sound conduction pathways... Read More →
avatar for Nersi Nazari

Nersi Nazari

Chairman and Chief Executive Officer, Vital Connect, Inc.
Nersi is Chairman & CEO of VitalConnect, a medical device and healthcare solutions company applying advanced biosensor technology and surrounding data management systems to deliver an innovative platform that enables clinical-grade continuous monitoring of vital signs. He is a veteran... Read More →
avatar for Bakul Patel

Bakul Patel

Director, Digital Health Center of Excellence (DHCoE), CDRH, FDA, United States
BAKUL PATEL is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate... Read More →

Monday June 27, 2016 10:45am - 12:00pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices/InVitro/CombProd, Session
 
Wednesday, June 29
 

10:30am EDT

#317: Global Medical Device Development: Regulatory Concordance or Discordance?
Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-558-L04-P; CME 1.25; IACET 1.25; RN 1.25

Developing medical devices for a global environment is difficult, with regulatory authorities working to regulatory convergence not harmonization. Participants will explore the latest developments from the International Medical Device Regulators Forum and Asian Harmonization Working Party to guide global device development decision-making.

Learning Objectives

Describe the growing regulatory landscape for medical devices; Discuss how to apply the advancements toward a converged regulatory environment for necessary global regulatory support to create more streamlined global development plans.

Chair

Mary Ann Smith, MS, RPh

Speaker

Industry Perspective
Anthony D. Watson, MBA, MS

Health Canada Perspective
Nancy Shadeed


Chair
MA

Mary Ann Smith

DRA Policy Head of Medical Device and Combination Products, Novartis Pharmaceuticals Corporation
Mary Ann Smith is Regulatory Policy Director, Digital Medicine & Devices, with Novartis since 2009 focused on software as a medical device, technology applications and enabled clinical trials, combination products and regulatory strategy. Ms. Smith has regulatory experience at Nektar... Read More →

Speakers
NS

Nancy Shadeed

Special Advisor, International Programs Division, Health Canada
DIA
avatar for Anthony Watson

Anthony Watson

Associate Vice President, Regulatory Affairs - Devices, Sanofi US
Anthony Watson is the Head of Regulatory Affairs - Devices, for Sanofi, in Cambridge, Massachusetts. Before Sanofi, he was the Director of Regulatory Affairs, CMC, Combination Products at Biogen. Prior to Biogen, he was a Division Director responsible for drug delivery devices in... Read More →

Wednesday June 29, 2016 10:30am - 11:45am EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session

2:00pm EDT

#344: Companion Diagnostics: Driving New Business Models for Successful Outcomes
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This forum will identify critical issues and success factors in the evolving field of companion diagnostics, with a focus on addressing operational challenges and delivering benefits to patients through successful business partnerships.

Learning Objectives

Describe the evolving field of companion diagnostics; Identify best practices for successful collaborations between pharmaceutical and diagnostics companies.

Chair

Patrick Phillips

Speaker

Panelist
Robert Bilkovski

Panelist
Kelly R. Pitts, PhD


Chair
avatar for Patrick Phillips

Patrick Phillips

Chief Executive Officer, Health Decisions, Inc.
Dr. Phillips is an experienced and respected clinical development executive and industry leader. He is responsible for executive oversight and strategic leadership of Health Decisions. Before his appointment as CEO, Dr. Phillips served for over two years as Health Decisions’ Vice... Read More →

Speakers
avatar for Robert Bilkovski

Robert Bilkovski

Head, Medical and Clinical Affairs, Abbott Molecular
Following medical school (Rosalind Franklin Univ/Chicago Medical School), Dr. Bilkovski focused on research in sepsis and noninvasive hemodynamic management. After 5 years, he identified his zeal for entrepreneurship and pursued his MBA (Notre Dame). His primary focus has been in... Read More →
avatar for Kelly Pitts

Kelly Pitts

Vice President, Research & Development, Site Manager - Colorado Operations, Corgenix, Inc.
Kelly R. Pitts, PhD is Vice President of R&D at Corgenix, Inc., an IVD company specializing in cardiovascular, autoimmune, and companion diagnostics. He previously held leadership positions at Myogen, Gilead Sciences, and Amgen, focused on drug discovery, development, and commercialization... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Forum

4:00pm EDT

#365: Cross-Labeling of Drugs and Devices: How Can It Be Done?
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

Cross-labeling poses regulatory challenges. Device and drug labeling may mention another product, but the reference is not mirrored. This session will present the challenges faced by both FDA and regulated industry to properly align labels of drugs and devices intended to be used together.

Learning Objectives

Discuss the regulatory challenges of aligning the labels of drugs and devices approved for combined use under separate applications; Explore the possible regulatory solutions to better aligning labels for drugs and devices intended to be used together; Identify the challenges misaligned labeling presents for industry, patients, health care practitioners, and regulators.

Chair

Heidi F. Gertner

Speaker

Panelist
Lene Garde Sommer

Panelist
Diane Macculloch Johnson, MS

Panelist
John Barlow Weiner, JD


Chair
avatar for Heidi Gertner

Heidi Gertner

Partner, Hogan Lovells US LLP
Heidi Gertner is a partner at Hogan Lovells in their drug regulatory group. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at NIH. Heidi then worked at the FDA's Office of Chief... Read More →

Speakers
avatar for Diane Johnson

Diane Johnson

Senior Director, North American Regulatory Affairs Policy and Intelligence, Johnson & Johnson
Diane is responsible for providing key strategic direction and regulatory intelligence across the North America device sector. Supports shaping of growth plans by translating the impact of regulatory environmental changes/trends on Strategic Business Plans. 20yrs of experience in... Read More →
avatar for Lene Sommer

Lene Sommer

Vice President, RA Devices, Novo Nordisk A/S
VP of Regulatory Affairs Devices at Novo Nordisk A/S. Responsible for regulatory strategies for development of devices as well as maintenance of devices on the market. She has more than 18 years of experience in the world of pharmaceuticals (medical devices). She has wide experience... Read More →
avatar for John Weiner

John Weiner

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Forum

4:00pm EDT

#370: Pricing, Patient Access, and What’s Next for Today’s Biopharma and Devices
Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry leaders, public payers, policy makers and issue experts provide insights into today’s heated debate about drug pricing, patient access and the policy battles ahead. This forum will offer engaging presentations, moderated discussion, and participant Q&A.

Learning Objectives

Identify key issues affecting the treatment pricing and patient access landscape; Describe how to apply potential models for determining a treatment’s value; Discuss ways to integrate new ideas for communicating a product’s rationale for patients, treaters and payers.

Chair

Jane Horvath, MHA

Speaker

Panelist
Matt Salo

Panelist
Michael Gray, MBA

Panelist
John Hoffman, MBA


Chair
avatar for Jane Horvath

Jane Horvath

Market Access Lead, 3D Communications
Jane Horvath, MHSA, leads 3D's Market Access and Value Communications team. Jane brings nearly 25 years of experience in health policy and reimbursement. She was Merck’s Executive Director of Health Policy and Reimbursement for a decade, Deputy Director of the RWJF project at Johns... Read More →

Speakers
avatar for Michael Gray

Michael Gray

Vice President and Chief Operating Officer, The Resource Group, Ascension
Michael has executive oversight and thought leadership responsibility for the ongoing development, implementation, and management of The Resource Group’s Strategic Direction. He spent seven years as President and CEO of Mercy Resource Management Inc., with responsibilities for Corporate... Read More →
avatar for John Hoffman

John Hoffman

Senior Director, Health Policy, Advocacy and Quality, Johnson & Johnson
As the Senior Director, Health Policy, Advocacy & Quality for the Strategic Customer Group at J&J North American Pharmaceuticals, John's responsibilities include ensuring unencumbered access to all J&J NA Pharma products for patients and physicians. The Strategic Customer Group develops... Read More →
avatar for Matt Salo

Matt Salo

Executive Director, National Association of Medicaid Directors
Matt Salo was named Executive Director of the National Association of Medicaid Directors in February 2011. The association represents all 56 of the nation’s state and territorial Medicaid Directors, and provides them with a strong unified voice in national discussions as well as... Read More →

Wednesday June 29, 2016 4:00pm - 5:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 13: CER-Glob Health Econ, Forum
 
Thursday, June 30
 

10:45am EDT

#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment
Limited Capacity seats available
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-560-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the current status of new treatment, prevention and diagnostic modalities, genetic testing in medical therapies offers promising potential, and public interest is extremely high. What regulations do we need in a convergent regulatory environment?

Learning Objectives

Recognize the huge impact of genetic testing in health care; Identify challenges and opportunities that exist in the current regulatory environment; Realize that many questions about patient rights and privacy still need to be resolved; Conceive the legal framework and the impact it has in today's health care environment.

Chair

Joseph C. Scheeren, PharmD

Speaker

Patient Perspective
Sue Friedman, DVM

Industry Perspective
Morten Sogaard, PhD

Regulator Perspective
Robert Schuck, PharmD, PhD


Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
SF

Sue Friedman

Executive Director and Founder, Facing Our Risk of Cancer Empowered (FORCE)
Dr. Friedman was a practicing veterinarian in 1996 when she was diagnosed at age 33 with breast cancer and later learned she carried a BRCA2 mutation. She founded the nonprofit organization Facing Our Risk of Cancer Empowered (FORCE) in 1999 to improve the lives of people affected... Read More →
avatar for Robert Schuck

Robert Schuck

Clinical Pharmacologist, Genomics and Targeted Therapy, OTS, CDER, FDA
Robert Schuck, Pharm.D., Ph.D. is a Clinical Pharmacologist in the Genomics and Targeted Therapy Group at the FDA. In his current position, Dr. Schuck contributes to regulatory review of investigational new drug (IND), new drug (NDA), and biologic licensing (BLA) applications to effectively... Read More →
MS

Morten Sogaard

Vice President and Head, Enterprise Scientific Technology Operations, Pfizer Inc
Morten has been with Pfizer since 2009 and is VP, Enterprise-wide Scientific Technology Operations and a member of Pfizer’s R&D leadership team . He oversees technology investment and Pfizer’s human genetics, computational biomedicine, diagnostics and bio-banking organizations... Read More →

Thursday June 30, 2016 10:45am - 12:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session