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05: Patient Engagement [clear filter]
Monday, June 24
 

11:00am

#120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.

Learning Objectives

Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Chair

Sissi Pham, PharmD

Speaker

FDA Perspective
Sheila Ryan, MPH, RAC

Panelist
Chris Leo Pashos, PhD

Panelist
Mitchell Higashi, PhD

Panelist
Denise Sanchez, JD, MPH, MS



Speakers
avatar for Mitchell Higashi

Mitchell Higashi

Vice President, Health Economics and Outcomes Research, Bristol-Myers Squibb
Mitch is the Vice President of HEOR at Bristol-Myers Squibb. Prior to joining BMS, he was the Chief Economist for GE Healthcare, where he led global efforts in health economics, pricing, reimbursement, and health policy. Mitch is a published author, including JAMA, and his work in... Read More →
avatar for Chris Pashos

Chris Pashos

Vice President, Global Evidence Strategy, AbbVie Inc.
Dr. Pashos oversees AbbVie’s Real-World Evidence Generation and Patient Centric Research Center of Excellence, demonstrating the value of medicines in addressing needs perceived by regulators, health technology assessment agencies & payers, the medical community and patients. He... Read More →
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →
SR

Sheila Ryan

Acting Director, Division of Supply Chain Integrity, Fda/cder/Office Of Compliance/Office of Drug Security, Integrity and Response
Sheila Ryan, PharmD, MPH, RAC is currently the Acting Director of the Division of Supply Chain Integrity in the Office of Drug Security, Integrity and Response within CDER's Office of Compliance at FDA. She has over 15 years of FDA regulatory experience, including over 10 years in... Read More →
avatar for Denise Sanchez

Denise Sanchez

Executive Director, Regulatory Affairs Advertising and Promotion, Allergan
Denise joined Allergan with 15 years of combined industry, government and law firm experience. Prior industry roles include Regulatory overview of commercial promotion and practices at Ironwood Pharmaceuticals, Celgene Corporation, and Cubist Pharmaceuticals. While at the law firm... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#161: Making Trials Work for Special Populations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session discusses a variety of ways to address patient needs that help recruit and retain special populations in clinical trials.

Learning Objectives

Identify useful guidelines and regulations regarding special populations in various countries; Discuss useful models of patient engagement that focus on special populations; Discuss case studies that show how some clinical trials have attracted special groups of patients.

Chair

Deborah E. Collyar

Speaker

Therapeutic Needs of Older Patients in the Era of Mobile Health
Dinah Duarte, MSc

Implementation of a Peer Advocate Model to Optimize Trial Enrollment, Diversity, and Retention
Caroline Donovan, MPH

Site Awareness and Best Practices for Inclusion of Diverse Populations in Research
Diana Foster, BSN, PhD, MSN



Speakers
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis in 1990. She founded the Patient Advocates in Research (PAIR) international network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →
avatar for Caroline Donovan

Caroline Donovan

Manager of Patient Engagement, LuCIN, Lupus Therapeutics, LLC
Caroline Donovan, MPH is the Manager, Patient Engagement for Lupus Therapeutics, an affiliate of Lupus Research Alliance. She is responsible for the development and implementation of a peer education program in which prospective lupus clinical trial patients are matched with a trained... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Diana Foster

Diana Foster

CEO, Society For Clinical Research Sites
Dr. Foster serves as a consultant to the Society for Clinical Research Sites as the Vice President of Strategy and Development. In her role she is responsible for building relationships with industry that help amplify the voice of the clinical research site. She has been integrally... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

9:30am

#224 RT: Round Table Discussion: Enhancing Patient-Focused Outcome Assessment in Medical Product Development
Component Type: Session
Level: Basic

Round table discussion tied to session #158: Enhancing Patient-Focused Outcome Assessment in Medical Product Development (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Elektra Papadopoulos, Telba Irony, Michelle Tarver.

Chair

Emuella Flood


Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#236: Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-608-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will explore and discuss agency-wide patient engagement programs and initiatives that provide patient stakeholders (patients, caregivers and advocates) opportunities to engage with FDA and participate in regulatory discussions that inform medical product development and review.

Learning Objectives

Describe how FDA has established organizational components to ensure patients are a priority; Describe avenues for patient stakeholders to engage with the agency; Explain key initiatives where patient stakeholders can share their experiences to help inform medical product development; Discuss the value of patient stakeholder participation.

Chair

Samir Shaikh, MBA

Speaker

FDA Perspective
Patroula Smpokou, MD

Patient Perspective
Debbie Drell

Patient Perspective
Sabina A. Kineen



Speakers
avatar for Debbie Drell

Debbie Drell

Director of Membership, National Organization for Rare Disorders (NORD)
Debbie joined the National Organization for Rare Disorders (NORD) in 2017 with more than 18 years of nonprofit experience in public health education, awareness and advocacy. Most recently, she worked for the Pulmonary Hypertension Association, a NORD member organization. Debbie says... Read More →
avatar for Sabina Kineen

Sabina Kineen

Fabry Disease, Patient Advocate
Diagnosed with Fabry Disease in her early teens, Sabina provides a unique perspective as both a patient and caregiver. Over the years, she has shared her experiences living with a rare genetic condition, as well as helping manage the complicated and multi-faceted healthcare needs... Read More →
PS

Patroula Smpokou

Clinical Team Leader, Office of New Drugs, CDER, FDA
Patroula Smpokou, MD, FACMG is a clinical team leader (lead physician) in the Division of Gastroenterology and Inborn Errors Products (DGIEP) at FDA’s Center for Drug Evaluation and Research where she is involved in the regulation of products intended for the treatment of rare genetic... Read More →
avatar for Samir Shaikh

Samir Shaikh

Deputy Director, Patient Affairs Staff, Office of the Commissioner, FDA
Samir Shaikh works at the U.S. Food and Drug Administration (FDA) and serves as the Deputy Director for the Patient Affairs Staff (PAS) in the Office of the Commissioner. PAS leads and enhances patient engagement activities across the medical product Centers—facilitating dialogue... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#235: Walking the Talk: Using Home Nursing as a Patient-Centric Service in Clinical Trials - From Multiple Perspectives
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session examines the use of home trial support services from the perspectives of the study sponsor, CRO partner and the potential patient participant. During this session we will discuss the logistics of home trial support, its benefits and pitfalls, when it is most appropriate to use and the patient perception of the service and how it may affect their willingness to participate.

Learning Objectives

Describe the benefits of use of home nursing (specifically, home trial support) in clinical trials from the sponsor, CRO and patient perspectives; Identify barriers to implementation of home trial support; Discuss scenarios where the greatest return on investment for home trial support is realized.

Chair

Ellyn Getz

Speaker

Academic Perspective
Ellyn Getz

Industry Perspective
Todd McGrath

Study Sponsor Perspective
Nour Ziyadeh, MS

Patient Perspective
Mary Koestler

CRO Perspective
Kelly Franchetti, RN



Speakers
MK

Mary Koestler

Assistant Professor, Clinical Trials Adminstrator, Memory and Aging Center, University of California San Francisco
avatar for Nour Ziyadeh

Nour Ziyadeh

Clinical Trial Oversight Lead, Alnylam Pharmaceuticals
Nour Ziyadeh is a Clinical Trial Oversight Lead ensuring compliance for Alnylam’s outsourced clinical trials. She has 15 + years of industry experience including third party auditing for the FDA, CRO , SMO and Pharma. She has held roles including Clinical Research Coordinator, Clinical... Read More →
avatar for Kelly Franchetti

Kelly Franchetti

RN, CCRN, CEN Vice President, Global Head Patient Insights & Engagement, ICON plc.
Kelly has a diverse background comprised of nursing, advocacy & clinical research. She is also the mother of a child with a rare disease. This gives her a unique 360 degree view of patients’ & caregiver’s perspectives in the realm of disease management, treatment and burden. As... Read More →
avatar for Ellyn Getz

Ellyn Getz

Associate Director, Development and Community Engagement, CISCRP
Ellyn Getz is the Associate Director of Development and Community Engagement at CISCRP. She is responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential... Read More →
TM

Todd McGrath

Vice President Operations A/O, Medical Research Network
Todd has over 15 years' experience in the clinical trial and life science industry; beginning his career in pharmaceutical and biotech consulting and then holding operational positions at a clinical research organization. As Vice President Operations Americas Oceania at MRN, Todd... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#262: Measuring the Impact of Patient Engagement Activities in Medicines R&D: A Way to Sustain the Cultural Change?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-731-L04-P; CME 1.25; IACET 1.25; RN 1.25

Measuring the impact of patient engagement in medicines R&D provides a means of demonstrating effectiveness of the engagement and thus support for sustaining it. In this session, early results of IMI’s PARADIGM, other recent work on assessing value and measuring impact, and their role in supporting sustainability are discussed.

Learning Objectives

Describe the IMI PARADIGM Project’s overall goal and objectives for patient engagement (PE), high level project structure and methods, and early results related to measuring PE impact; Identify the benefits of assessing value and measuring impact of PE; Discuss the importance of PE sustainability and the role of metrics in supporting it.

Chair

Mathieu Boudes, PhD

Speaker

Panelist
Nicholas Brooke, MBA

Panelist
Debra Michaels, MS

Panelist
Lidewij Eva Vat, MS



Speakers
avatar for Mathieu Boudes

Mathieu Boudes

PARADIGM Coordinator, European Patients' Forum
Mathieu Boudes, PhD, joined the European Patients’ Forum (EPF) in 2018 as coordinator of the PARADIGM project, a public-private partnership financed by the Innovative Medicines Initiative and co-led by EPF and EFPIA (European Federation of Pharmaceutical Industries and Associations... Read More →
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), The Synergist.org
Nicholas Brooke is Founder of The Synergist, a collaboration platform incubator that brings key players together with the express aim of solving significant societal problems through collective action. Under Nicholas’ leadership, The Synergist acts as a backbone, providing vision... Read More →
avatar for Debra Michaels

Debra Michaels

Associate Director, Scientific Programs & Patient Engagement Lead, DIA
In her content-focused role at DIA, Debra Michaels provides guidance on educational content strategy and development across the DIA Americas portfolio of educational programs as well as subject matter expertise in selected areas. She is the lead for DIA’s Patient Engagement thought... Read More →
avatar for Jaye Bea Smalley

Jaye Bea Smalley

Director, Global I and I Patient Advocacy and Life Cycle Management, Celgene Corporation
Jaye Bea joined Celgene as Global Director, Patient Advocacy and Life Cycle Management, Inflammation & Immunology in March 2018. Her twenty-five-year career in health care includes extensive experience in the public and private sector focused on advancing the needs and interests of... Read More →
avatar for Lidewij Vat

Lidewij Vat

Researcher and Lecturer Meaningful and Sustainable Patient Engagement, Vrije Universiteit (VU)
Lidewij (Eva) Vat is a researcher and trainer in patient and public engagement. Her work focuses on creating partnerships between patients, professionals and researchers to drive meaningful innovation. Her research aims to better understand the key conditions needed for patient engagement... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:00pm

#272: Aligning Facilitated Regulatory and Access Pathways: Observations from the North American Experience
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-622-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session is for agencies, industry, and other organizations to present their observations around the types of facilitated pathways that are available in North America to speed access to medicines that address an unmet medical need.

Learning Objectives

Describe initiatives that the US and Canada has implemented to streamline the process for approval of and access to therapies that address unmet medical need (UMN); Illustrate opportunities and challenges with aligning regulatory and access pathways; Discuss if these pathways may have a broader remit than just for therapies for UMN.

Chair

Lawrence Eugene Liberti, PhD, RPh, RAC

Speaker

Market Access on the Two Sides of the Atlantic: Barriers and Opportunities
Maria Isabel Manley, LLM

Aligning Approval and Access: The US Experience
Sean Tunis, MD, MSc

Patient Perspective
Julie Eller



Speakers
avatar for Lawrence Liberti

Lawrence Liberti

Executive Director, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →
avatar for Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for Julie Eller

Julie Eller

Manager of Grassroots Advocacy, Arthritis Foundation
Julie leads a patient network of more than 100,000 patient Advocates as they share their story to effect change. Julie has had arthritis since she was seven years old and the Arthritis Foundation has helped her foster a passion for translating the patient experience into advocacy... Read More →
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

2:00pm

#372: Advancing Value and Access With Technology
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-695-L04-P; CME 1.25; IACET 1.25; RN 1.25

The purpose of this session is to describe advanced technologies being used to advance value and access through specific, real case examples, in terms of their use for contracting and value assessment. Speakers will describe the technology and use cases associated with blockchain, distributed networks and use of artificial intelligence in outcomes-based contracting among other technological advances.

Learning Objectives

Describe the use of technology to advance value and access; Discuss the use of specific technologies, including blockchain, artificial intelligence, and distributed networks.

Chair

Richard Gliklich, MD

Speaker

The Power of the New Healthcare Data Intelligence
Ian Rentsch, JD

Advancing Outcomes-Based Contracts with AI
Robert A. DiCicco, PharmD



Speakers
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
avatar for Ian Rentsch

Ian Rentsch

Chief Executive Officer, Clinerion
Ian Rentsch has over 23 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent... Read More →
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#384: Patient Preferences in Decision Making and the PREFER Project: Past, Present, and Future
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-703-L04-P; CME 1.25; IACET 1.25; RN 1.25

Speakers will present an historical overview of decision making, including PREFER’s place in that evolving landscape; the results from the ongoing PREFER project; and how patients and their representatives provide valuable insight into the project.

Learning Objectives

Discuss the evolution of decision making and the expanding role of patient preferences; Describe the aims and results of the PREFER project regarding when and how to integrate patient preferences into medical product decision making from diverse perspectives: industry, regulator, and patient; Identify the value gained by including patient representatives in study development.

Chair

Kristin E Bullok, PhD

Speaker

Benefit-Risk Evaluation with the Patient’s Perspective: Past, Present, and Future
Juhaeri Juhaeri, PhD

Patient Preference Studies: Why, When, and How
Rachael L. DiSantostefano

Patient Involvement in Preference Study Design: A Case Study
Jenny Sharpe, PhD



Speakers
avatar for Kristin Bullok

Kristin Bullok

Benefit-Risk Management Scientist, Global Patient Safety, Eli Lilly and Company
Kristin Bullok, PhD, is a research scientist in benefit-risk management at Eli Lilly and Company, Global Patient Safety. Since joining Lilly, she has years of combined experience in conducting structured benefit-risk assessments, consulting on patient preference trade-off studies... Read More →
avatar for Rachael DiSantostefano

Rachael DiSantostefano

Senior Director, Benefit Risk, Epidemiology, Janssen Research & Development, LLC
Rachael L. DiSantostefano, MS PhD, is a Senior Director of Benefit-Risk in the Epidemiology Department within Janssen Pharmaceuticals, R&D, LLC. She has 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes... Read More →
avatar for Juhaeri Juhaeri

Juhaeri Juhaeri

Vice President and Head, Epidemiology and Benefit-Risk Evaluation, Sanofi
Juhaeri Juhaeri, Ph.D., is Vice President and Head of Epidemiology and Benefit-Risk at Sanofi. Juhaeri is an Epidemiologist and Statistician with over 20 year experience in epidemiologic research in academia and in pharmaceutical industry. He joined Sanofi in 2001 where he established... Read More →
avatar for Jenny Sharpe

Jenny Sharpe

Research Communications Manager, Muscular Dystrophy UK
Jenny is Research Communications Manager for Muscular Dystrophy UK, a charity bringing together over 60 rare and ultra-rare muscle weakening and wasting conditions. She is primarily responsible for overseeing the charity’s communications about research. This involves translating... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA