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Patient Engagement [clear filter]
Monday, June 27
 

8:30am EDT

#106: Fostering a Partnership to Advance Innovation: Niche Service Leads to Breakthrough in Patient Recruitment and Retention Challenges
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Patient recruitment and retention remains the Achilles heel of clinical trials. An innovative service model involving traveling nurses to conduct at-home or alternate site study visits has gained traction over the past years. While only a handful of global providers of ambulant care services are available, sponsors of all sizes and locations have been forming partnerships with these organizations to accelerate their development timelines by fostering patient-centric services to enhance patient recruitment and retention. We will explore how a large pharmaceutical company is driving innovation through its corporate silos. We will also explore how this innovative ambulant care service model was incorporated into specific studies and how the resulting benefits benefited all stakeholders including patient, investigator, sponsor, and consumer.

Learning Objectives

Identify three keys factors when selecting strategic partners; Articulate the cornerstones to a successful partnership; Describe the hurdles when changing culture and advancing innovation.

Chair

Gail Adinamis

Speaker

Breaking Through Corporate Silos to Promote Innovation
Denisa McKnight, MSc

Panelist
Matt Dobson



Chair
avatar for Gail Adinamis

Gail Adinamis

CEO, GlobalCare Clinical Trials, LLC
Ms Adinamis has >35 yrs of global clinical trials experience including tenures at Abbott and Astellas. She established & headed clinical trials divisions for 3 national home infusion companies then started an independent ambulant care service company for clinical trials in 2004 where... Read More →

Speakers
avatar for Matt Dobson

Matt Dobson

Patient Recruitment Strategist, Roche Products Ltd.
Matt has 20 years Pharma experience, working in small, med and large size pharma companies working on Phase II & III trials across a variety of different disease areas. Starting his career as a CRA he went on to hold positions in Clinical Operations Management, Feasibility and Patient... Read More →
avatar for Denisa McKnight

Denisa McKnight

Patient Engagement and Media, Roche Products Limited
Denisa McKnight has >10 yrs of experience in the pharma industry covering a broad range of areas, including all lifecycles of clinical development, research and academia. She currently works at Roche where she is leading Patient Engagement & Media global category implementing innovative... Read More →


Monday June 27, 2016 8:30am - 9:30am EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 03: Innov Part Model-Outsourcing, Forum

8:30am EDT

#101: Opportunities for Improving Informed Consent of Clinical Research Volunteers
Limited Capacity seats available

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Learn about new strategies for improving the informed consent process. Recommendations and tools for re-focusing on the informed consent process will be provided. Examples, opportunities and future directions related to use of eConsent will be shared. Finally, the challenges and solutions for consenting adult and pediatric patients in antibacterial clinical trials will be discussed.

Learning Objectives

Describe recommendations for improving the informed consent process in clinical research; Discuss the TransCelerate eConsent project including benefits for research volunteers as the industry moves from paper to eConsent; Recognize actions that can be taken to encourage site eConsent adoption and proactively address issues that commonly surface during eConsent site implementation; Identify opportunities for improving consent in challenging situations.

Chair

Jennifer Lentz

Speaker

Transforming Informed Consent: Initiatives of the Clinical Trials Transformation Initiative and TransCelerate BioPharma, Inc.
Jennifer Lentz

Engaging Investigators and Site Staff in Adoption and Implementation of e-Consent: A World View
Susan Brink, DrPH

Applicable Lessons Learned from the CTTI Antibacterial Drug Development Program
Pamela Tenaerts



Chair
JL

Jennifer Lentz

Consultant, Global Informed Business Lead, Eli Lilly and Company
Jennifer Lentz has been the Global Informed Consent Business Lead at Eli Lilly and Company for the last 4 years. She has been involved in consent projects with Clinical Trials Transformation Initiative, Transcelerate, and Innovative Medicines Initiatives. Prior to joining Lilly, Jennifer... Read More →

Speakers
avatar for Susan Brink

Susan Brink

Executive Vice President, e-Consent Products and Services, Enforme Interactive
Dr. Brink has been involved in creation of e-consent since 2003. As PI on a NIH SBIR grant to develop an electronic informed consent, she led the team in vision, guidance and research for SecureConsent. Her Enforme portfolio includes expansion of SecureConsent e-consent system into... Read More →
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Pamela Tenaerts is the Executive Director at the Clinical Trials Transformation Initiative (CTTI) where she works closely with the Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium

8:30am EDT

#103: Decision Tools to Drive Efficient Recruitment and Retention: Making Recruitment a Science
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this session, we will display a tool that helps integrate recruitment planning into the fabric of a trial’s operational design. We will also debate the most appropriate usage of the tool and how to integrate it into the planning process.

Learning Objectives

Describe a new tools developed by sponsors to determine the best recruitment strategy for any given protocol; Show the impact these tools have had on developing budgets and tactics for recruitment planning; Discuss the positives and potential pitfalls of using these tools.

Chair

James Kremidas

Speaker

Matchmaking: Systematizing Best Fit Tactics for Study Needs
Lewis Millen

The Art and Science of Site Level Recruitment Planning: Tools, Tactics, and Tips?
Beth D. Harper, MBA



Chair
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing... Read More →

Speakers
avatar for Beth Harper

Beth Harper

President, Clinical Performance Partners, Inc.
Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance management. She has passionately pursued solutions for optimizing protocols, enhancing patient recruitment and retention and improving sponsor... Read More →
avatar for Lewis Millen

Lewis Millen

Operational Intelligence Leader, Roche Products Limited


Monday June 27, 2016 8:30am - 9:45am EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am EDT

#119: Narrative Medicine: Innovative Techniques for Including the Voice of the Patient in Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop will introduce participants to the concept of narrative medicine and the skills and habits of reflective writing and listening in order to better recognize, receive, absorb, interpret, and honor stories of illness in a clinical setting.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Define narrative medicine; Explain how narrative competence is applied to nourish empathic health care professional-to-patient relationships; Apply the skills of close reading and reflective writing in a small group setting.

Chair

Jesus Rivera, MSc

Speaker

Facilitator
Lauralee Leonard



Chair
JR

Jesus Rivera

Senior Learning Manager, Bristol-Myers Squibb Company
Jesús is a seasoned learning and development professional with over 20 years experience diagnosing, planning and implementing training, organizational development and technology solutions that address the learning needs of global financial services and pharmaceutical organizatio... Read More →

Speakers
LL

Lauralee Leonard

Senior Scientific Writer, Bristol-Myers Squibb Company


Monday June 27, 2016 8:30am - 9:45am EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 16: Prof Development, Workshop

10:45am EDT

#125: Patient Recruitment in Rare Diseases: Ideas and Framework for Out-of-the-Box Exploration
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-520-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patient recruitment is a challenging activity, which becomes even more so in rare diseases where populations are small, patients are geographically dispersed, and eligible subjects may not be physically (or economically) capable of traveling to a trial site. Unfortunately, current recruiting methods (e.g., listing on trial and patient organization websites, relying on key opinion leaders and trial investigators, billboards) may be limited in reach, overly reliant on busy physicians, and too costly or cost-ineffective. It behooves clinical trialists in rare diseases to consider mechanisms beyond these standard approaches. The aim of this session is to catalyze unconventional thinking and to provide a framework to organize innovative recruitment ideas.

Learning Objectives

Discuss the challenges of patient recruitment in rare diseases; Compare conventional and out-of-the-box ideas for patient recruitment; Illustrate a framework for organizing innovative recruitment ideas.

Chair

Badri Rengarajan, MD

Speaker

Leveraging Claims Data for Targeted Recruitment
Donny Chen, MBA

Direct-to-Patient Digital Recruitment: A Targeted Approach to Recruitment Enrollment and Retention Problems
Bethany Bray

Bringing Clinical Trials to Patients: Leveraging Convergent Data Sources to Accelerate Recruitment
Scott Douglas Schliebner, MPH



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes... Read More →

Speakers
avatar for Bethany Bray

Bethany Bray

Chief Executive Officer, Co-Founder, AutoCruitment
Bethany Bray, Oncology and Neuroscience Researcher, Entrepreneur and Technologist, founded AutoCruitment (a technology-enabled digital patient recruitment platform) with a vision to utilize the power of the internet to address recruitment, enrollment and retention problems in clinical... Read More →
avatar for Donny Chen

Donny Chen

Senior Director, Medical Affairs Research Operations, PPD
Donny Chen, senior director of medical affairs research operations at PPD, has spent the last 18 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr. Chen graduated... Read More →
avatar for Scott Schliebner

Scott Schliebner

Senior Vice President, Center for Rare Diseases, PRA Health Sciences
Scott Schliebner is a clinical strategist with a 20+ year background in clinical development specializing in rare diseases and orphan drug development. His experience encompasses all trial phases; a broad variety of study designs; interventional and observational studies; across a... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session

10:45am EDT

#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-568-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interdisciplinary session will explain how, with increased patient engagement, both regulatory and health technology assessment agencies need to be able to assess and report on how patient input is being utilized and how it is informing the decision process.

Learning Objectives

Discuss how health technology assessment agencies and regulators engage with patients so that the assessment and decision making is utilizing patients’ viewpoints; Identify the challenges that agencies face to ensure that the patient’s viewpoints are embedded into their decision processes; Assess the types of parameters agencies are using to measure the impact patient engagement is having on their processes and decision making.

Chair

Neil McAuslane, PhD, MSc

Speaker

FDA Perspective
Theresa M. Mullin, PhD

Empowering Patients as Organizational Change Agents
Durhane Wong-Rieger, PhD, MA

HTA Perspective
Victoria Thomas, MSc



Chair
avatar for Neil McAuslane

Neil McAuslane

Director, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →

Speakers
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Victoria Thomas

Victoria Thomas

Head of Public Involvement, Public Involvement Programme, National Institute For Health and Care Excellence (NICE)
Victoria Thomas has run the Public Involvement Programme at NICE since 2009, and has been with the Programme since 2001. Following a degree in Art History, Victoria has worked exclusively in the public and voluntary sector, specialising in healthcare quality improvement activities... Read More →
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

8:00am EDT

#202: Changing Cultures to Advance Patient Engagement
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-614-L04-P; CME 1.50; IACET 1.50; RN 1.50

The importance of engaging patients in medical product development is a message that has reached the industry. Acting on that message to adopt and sustain meaningful practice requires organizational cultures that value and place high priority on patient focus. In this session, sponsor companies and patient organizations will share their experiences with building internal cultures that encourage the collective group and individuals to incorporate patient engagement into their everyday work. A diverse panel will discuss reframing the challenges of cultural change to achieve the best outcomes for patients in the health care process.

Learning Objectives

Explain the role of organizational culture in enabling meaningful patient engagement practices; Assess key motivators for organizations to adopt a patient-focused culture; Describe effective approaches to incorporating patient focus throughout the organization; Discuss ways to meet challenges that may prevent a fully patient-focused culture.

Chair

Kim McCleary

Speaker

Panelist
Lode Dewulf

Panelist
Andrea Stern Ferris

Panelist
Andrew J. Garvey

Panelist
Mary Stober Murray, MBA

Panelist
Durhane Wong-Rieger, PhD, MA



Chair
avatar for K. Kimberly McCleary

K. Kimberly McCleary

Managing Director, FasterCures, A Center of the Milken Institute
Kim leads the Patients Count: Science of Patient Input program through which FasterCures aims to improve health by expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. She has been involved in FasterCures... Read More →

Speakers
avatar for Lode Dewulf

Lode Dewulf

Vice President and Chief Patient Affairs Officer, UCB
Lode Dewulf has a passion for patient perspectives and understanding. As medical practitioner he deeply realized that good health education was at least as important as good medicines. in 1989 he joined the pharmaceutical industry, to provide good education on diseases and new treatments... Read More →
avatar for Andrea Ferris

Andrea Ferris

President and Chairman, LUNGevity Foundation
Andrea is the President and Chairman of LUNGevity. In her role as President of LUNGevity, Andrea is responsible for setting and executing the strategic direction of the organization and its science programs. Prior to LUNGevity, Andrea had a variety of management experiences. She worked... Read More →
avatar for Andrew Garvey

Andrew Garvey

Global Patient Advocacy Lead, GlaxoSmithKline
Andrew leads GSK’s global work with patient organizations (excluding the US). He is responsible for leading the work to develop collaborations with patient organizations to bring patient insight into GSK, improve the management of diseases and to strengthen the capabilities of patient... Read More →
avatar for Mary Murray

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and representative populations. Mary has co-chaired the... Read More →
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board... Read More →


Tuesday June 28, 2016 8:00am - 9:30am EDT
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

10:30am EDT

#222: Valuing the Clinical Trial Patient
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-566-L01-P; CME 1.00; IACET 1.00; RN 1.00

Increasingly, during clinical research development, decisions are made on how to make trials more patient centric, increase patient engagement, and how/when patients will receive their individual research results. In this session, a patient advocate will share perspectives on each of these elements of research design and execution and a bioethicist will share the bioethical considerations for providing individual clinical trial test results to patients. Finally, participants will also hear about a pharmaceutical company's challenges and lessons learned when they decided to thank their clinical trial patients in a national television advertisement.

Learning Objectives

Recognize an increased awareness of clinical trial patients desired benefits from participating in a research study; Describe bioethical considerations when determining whether to provide clinical trial patients with their individual trial test results; Discuss a sponsor company’s experience with thanking clinical trial patients in a television advertisement.

Chair

Jane Perlmutter

Speaker

Bioethical Considerations with the Return of Individual Research Results and Incidental Findings to Clinical Trial Research Participants
Sandra Prucka, MS

Panelist
Deborah Howe



Chair
avatar for Jane Perlmutter

Jane Perlmutter

Founder and President, Patient Advocate
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of... Read More →

Speakers
avatar for Deborah Howe

Deborah Howe

Associate Director, Vendor Alliance Lead, Bristol-Myers Squibb
Deborah Howe is an Associate Director in Vendor Alliance Management in Global Clinical Operations at Bristol-Myers Squibb. Deborah joined Bristol-Myers Squibb in 2005 and has held positions of increasing responsibility in the area of clinical trial enrollment and engagement. Deborah... Read More →
avatar for Sandra Prucka

Sandra Prucka

Innovation Lead, Eli Lilly and Company
Before coming to Eli Lilly and Company in 2009 I was a clinical genetic counselor and Director of Genetic Counseling Services at the University of Alabama at Birmingham. I have been in the Tailored Therapeutics group at Lilly for 7 years. During this time I completed an internship... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT-GCP, Forum

2:00pm EDT

#236: Expanded Access: Ethical, Regulatory, and Policy Challenges and Considerations
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-522-L04-P; CME 1.25; IACET 1.25; RN 1.25

The legislative and regulatory landscapes for expanded access to investigational therapies are evolving due in part to public attention. This session will examine strategies proposed by stakeholders to address ethical, regulatory, and policy considerations.

Learning Objectives

Recognize FDA requirements for expanded access and the current regulatory, political, and social environment; Identify challenges faced by stakeholders from ethical, regulatory, and policy perspectives; Describe industry best practices for managing expanded access programs.

Chair

Kim M. Quaintance-Lunn

Speaker

Is There a Better Way? An Industry Perspective
Sandra A. Morris, PhD, PMP

The Ethics of Compassionate Use
Alison Bateman-House



Chair
avatar for Kim Quaintance-Lunn

Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, Regulatory Affairs Americas, Bayer U.S. LLC, United States
Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, Regulatory Affairs Americas, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy and... Read More →

Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, Dept of Population Health, NYU Langone Health, United States
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair, with Arthur Caplan PhD, of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies... Read More →
avatar for Sandra Morris

Sandra Morris

Vice President, Strategy Realization, Johnson & Johnson
Dr. Morris is currently VP, Strategy Realization for the J&J CMO. Prior to joining J&J, Dr. Morris spent 18 years at Merck where she was VP, Global Project Management. Dr. Morris received her PhD in Organic Chemistry and completed postdoctoral research in biochemistry.


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Session

2:00pm EDT

#243: Patient Involvement Today and Tomorrow: What’s in It for Patients?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-563-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patient engagement (PE) is the latest catch phrase in health care. But how can stakeholders apply it in a meaningful way? This forum will draw a picture of the PE landscape and trends and articulate a path forward to high value patient outcomes.

Learning Objectives

Identify the current patient engagement landscape by providing an overview of initiatives underway that are focused on meaningful patient involvement; Discuss general trends in patient engagement with respect to patient involvement through the research to care continuum, highlighting predictions for how this may impact future efforts; Examine the current and future impact of patient engagement efforts on patients’ life goals, quality of life, and desired clinical outcomes.

Chair

Marc M. Boutin, JD

Speaker

Panelist
Lode Dewulf

Panelist
Anton Hoos

Panelist
Graeme Johnston, CPA

Panelist
Isabelle Moulon, MD

Panelist
Theresa M. Mullin, PhD

Panelist
Bettina Ryll



Chair
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →

Speakers
avatar for Lode Dewulf

Lode Dewulf

Vice President and Chief Patient Affairs Officer, UCB
Lode Dewulf has a passion for patient perspectives and understanding. As medical practitioner he deeply realized that good health education was at least as important as good medicines. in 1989 he joined the pharmaceutical industry, to provide good education on diseases and new treatments... Read More →
avatar for Anton Hoos

Anton Hoos

Vice President and Medical Director, Europe, Amgen GmbH
Tony Hoos currently serves as the Chief of Medical for Amgen in Europe, which includes all therapeutic areas as well as all medical departments in Europe. Tony has been passionate about patient involvement in the development and life cycle of medicines for many years. He has worked... Read More →
avatar for Graeme Johnston

Graeme Johnston

Patient and Member of the Advisory Board of PFMD
Graeme (63) is a retired partner of PWC in London, UK. He had cancer in 2001 and was diagnosed with Rheumatoid Arthritis in 2006. He retired in 2009. Since then he has been active in health and patient advocacy initiatives at a local and national level in the UK. When the PFMD initiative... Read More →
avatar for Isabelle Moulon

Isabelle Moulon

Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Bettina Ryll

Bettina Ryll

Chair ESMO Patient Advocates Working Group (PAWG), Melanoma Patients
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Forum

4:00pm EDT

#263: Patient Centricity in Clinical Trials
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-536-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are increasingly empowered with an awareness of their conditions and treatment options. The internet and search engines have provided patients with unprecedented access to information previously only held by health professionals. With this knowledge, patients often seek a level of interaction, explanations and general engagement in regular care that can be challenging. This session will discuss methods and strategies for the management of activities and communications involving patients in clinical trials.

Learning Objectives

Describe the challenges and opportunities when establishing greater patient centricity in clinical trials; Discuss how technologies will assist in the distributed management and monitoring of patient engagement including how such oversight will aid in improving compliance and data quality; Recognize the opportunities for direct-to-patient activities in clinical trials.

Chair

Doug Bain

Speaker

Applying Process Management to Support Site and Patient Engagement in Clinical Trials
Doug Bain

Enhancing Patient-Centered Research: Combining Technology with Other Direct-to-Patient Contact Strategies
Chris Watson, PhD

Patient-Centricity and Real-Time Data Monitoring
Bruno Gagnon, MPharm



Chair
DB

Doug Bain

Chief Technology Officer, eClinicalHealth Ltd
Doug Bain, Founder and Co-CEO & CTO of eClinicalHealth Ltd,, has been involved in the development, deployment and optimization of eClinical technologies since 1996. eClinicalHealth provides the high performance cloud driven clinical trial solutions - Clinpal - for end-to-end clinical... Read More →

Speakers
avatar for Bruno Gagnon

Bruno Gagnon

Executive Consultant, Clinical Operations, Myokardia, Inc.
Bruno is a Clinical Operations Opinion Leader with over 24 years of experience in clinical trial management. His consulting practice has a focus on building capabilities in clinical trial execution. Bruno develops solution for his biotech clients around site selection, optimization... Read More →
avatar for Chris Watson

Chris Watson

Director of Product Strategy - Digital Patient, ERT
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 19 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 10 years, Chris has been translating... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#266: Perspectives on Expanded Access to Investigational New Drugs
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-545-L01-P; CME 1.25; IACET 1.25; RN 1.25

Expanded access is the use of an investigational drug outside of a clinical trial or study. This forum will provide an opportunity to hear perspectives from regulators, industry, and patients on the use of expanded access in drug development.

Learning Objectives

Describe the different types of expanded access investigational new drugs; Explain why a sponsor might consider expanded access in their drug development programs; Recognize the patient's role and perspective on expanded access programs.

Chair

Kevin Bugin, MS, RAC

Speaker

Introduction and FDA Regulator Perspective
Jonathan P. Jarow, PhD

Industry Perspective on Expanded Access
Kenneth I. Moch, MBA

Patient Advocacy and Expanded Access
Robert Erwin

Industry Perspective on Expanded Access
Anne B. Cropp, PharmD



Chair
avatar for Kevin Bugin

Kevin Bugin

Director of Special Programs, Office of New Drugs, CDER, FDA
Kevin Bugin works for the FDA in the Office of New Drugs as the Director of Special Programs, leading various internally driven initiatives for the enhancement of the new drugs regulatory program. Prior to joining the FDA, Kevin Bugin worked in both industry and government in multiple... Read More →

Speakers
avatar for Anne Cropp

Anne Cropp

Vice President, Pfizer Inc
Anne Cropp has led the strategic planning and clinical development of several compounds in Cardiovascular and Metabolic diseases, Phases 2-4. Anne has led many business process improvements and has led several initiatives across the spectrum of clinical trial planning, design and... Read More →
avatar for Robert Erwin

Robert Erwin

President, Marti Nelson Cancer Foundation
Robert L. Erwin is co-founder and President of the Marti Nelson Cancer Foundation, a cancer patient advocacy organization with a focus on access to experimental medicine. He has served as a member of the Cancer Policy Forum of the Institute of Medicine, a member of the Research Committee... Read More →
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology... Read More →
avatar for Kenneth Moch

Kenneth Moch

Managing Partner, Salutramed Group, LLC
Mr. Moch is Managing Partner of The Salutramed Group, a strategic/operational advisor to life science companies. He has been co-founder or CEO of 4 firms developing therapies for life-threatening diseases and most recently was CEO of Chimerix. In August 2014, Mr. Moch and Arthur Caplan... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

4:00pm EDT

#276: Using Input from Patient Communities to Develop PRO Instruments
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-592-L04-P; CME 1.25; IACET 1.25; RN 1.25

Capturing quality of life via patient-reported outcomes (PROs) is critical to understanding the patient experience in the course of disease and treatment. This information can improve clinical care and the development of new therapies. Conventional approaches to developing PRO instruments rely heavily on input of leading physicians and cursory or indirect input from patients. Capturing more granular and direct input from patients on outcomes related to social impact, emotional impact, daily functional living, coping, disease and treatment burden, and satisfaction with therapies would be useful to building and validating a PRO instrument. In particular, online platforms for patient communities stand to accelerate and optimize collection of this input.

Learning Objectives

Describe the process for developing patient-reported outcome (PRO) instruments; Identify the challenges of developing PRO instruments; Explain the benefits and risks of using data and input from patient communities (including those online); Discuss alternate methods to develop PRO tools.

Chair

Badri Rengarajan, MD

Speaker

Engaging Online Communities to Understand Patient Experiences
Chad Gwaltney, PhD

Developing a Disease-Specific PRO Tool from a Patient-Centric Research Network
Badri Rengarajan, MD

Regulatory Perspective
Elektra Johanna Papadopoulos



Chair
avatar for Badri Rengarajan

Badri Rengarajan

Medical Affairs Lead, ASPIRE Unit, Actelion
15 years’ experience across medical affairs, product development strategy and new product planning, regulatory affairs, business development, strategy: Former Board President, International Pemphigus and Pemphigoid Foundation (rare disease foundation); Senior Medical Director, Archimedes... Read More →

Speakers
avatar for Chad Gwaltney

Chad Gwaltney

Principal Consultant, Gwaltney Consulting
Dr. Gwaltney’s work focuses on the development of innovative methods to measure patient-centered outcomes in clinical trials. He has published numerous articles and book chapters addressing how the patient’s perspective can be examined to better understand product efficacy and... Read More →
avatar for Elektra Papadopoulos

Elektra Papadopoulos

Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER, FDA, United States
Dr. Papadopoulos serves as the Deputy Director (acting) of the Division of Clinical Outcome Assessment in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The Division provides consultation to CDER’s Review Divisions as well as other FDA Centers on... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 17: Rare/Orphan Diseases, Session
 
Wednesday, June 29
 

10:30am EDT

#308: Patient Recruitment Workshop: Survey Results and Practical Application
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-16-519-L01-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will incorporate the patient engagement survey results from the Tufts Center for the Study of Drug Development, a large group discussion, and small group breakouts to develop practical solutions for pediatric, rare disease, oncology, and other clinical studies.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Discuss the findings of the latest Tufts CSDD patient engagement surveys; Identify obstacles and opportunities to improve patient engagement in clinical trials; Propose at least three solutions which address patient engagement needs.

Chair

Robin F Marcus

Speaker

Facilitator
Stella Stergiopoulos



Chair
avatar for Robin Marcus

Robin Marcus

SVP Business Development & Strategic Initiatives, GlobalCare Clinical Trials
Robin is Sr. Vice President with GlobalCare Clinical Trials. In the past 25 years she has become known as an innovative healthcare executive focused on launching new products and services. Her talents have been leveraged with companies of all sizes including Caremark, Mediware & Home... Read More →

Speakers
avatar for Stella Stergiopoulos

Stella Stergiopoulos

Research Fellow, Tufts Center for the Study of Drug Development
Ms. Stella Stergiopoulos leads multi-sponsored research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Workshop

10:30am EDT

#316: What’s Your Preference? The Emerging Importance of Patient Preference Elicitation
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-553-L01-P; CME 1.25; IACET 1.25; RN 1.25

Patient engagement in the development of medicinal products is a high interest topic with rapidly evolving methodological work. This session will articulate the needs and interests of patients, industry, and regulators.

Learning Objectives

Discuss the importance, context, approaches to and appropriate use of patient preferences, particularly in benefit-risk evaluation, across the product life cycle; Evaluate and propose solutions to regulatory and methodological challenges for patient engagement and the assessment of patient preferences.

Chair

Rebecca A. Noel

Speaker

Regulatory Perspective
Isabelle Moulon, MD

Patient Perspective
Andrea Stern Ferris

Industry Perspective
Bennett Levitan



Chair
avatar for Rebecca Noel

Rebecca Noel

Global Benefit-Risk Lead, Global Patient Safety, Eli Lilly and Company
Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly. Since joining Lilly, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally via the PhRMA... Read More →

Speakers
avatar for Andrea Ferris

Andrea Ferris

President and Chairman, LUNGevity Foundation
Andrea is the President and Chairman of LUNGevity. In her role as President of LUNGevity, Andrea is responsible for setting and executing the strategic direction of the organization and its science programs. Prior to LUNGevity, Andrea had a variety of management experiences. She worked... Read More →
avatar for Bennett Levitan

Bennett Levitan

Senior Director, Benefit-Risk Assessment, Global R&D Epidemiology, Janssen Research & Development, LLC
Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and his team has led numerous clinical teams in benefit-risk assessments and patient preference studies. He co-led... Read More →
avatar for Isabelle Moulon

Isabelle Moulon

Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

2:00pm EDT

#333: Hearing the Patient Voice in Pharma and What Patients Want You to Know
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-517-L04-P; CME 1.25; IACET 1.25; RN 1.25

Are you considering creating a position for a director of patient engagement but have no idea where to start? Or do you just want to know more about what patients think about your drugs and what they want you to know? Learn how to do it from industry executives who have spent their time learning about patients and putting programs in place to advance advocacy efforts. They will also share real-world examples of pharma programs and experiences involving the patient voice.

Learning Objectives

Explain why it is important to have a director of patient engagement; Describe how to create the position, what the primary responsibilities should be, what the biggest challenges are in creating it, including how to overcome them; Discuss how to determine what patients think of your drug and efforts, what they are saying about it, and what they want you to know.

Chair

Ed Miseta, MBA

Speaker

Panelist
Roslyn F Schneider

Panelist
Beverly L Harrison

Panelist
Eric J. Peacock, MBA



Chair
avatar for Ed Miseta

Ed Miseta

Editor, Life Science Connect
Ed is the chief editor for the website Clinical Leader and a contributing editor to Life Science Leader magazine. He covers the latest trends, challenges, innovations, and best practices in the conduct of clinical trials. He has a BS in Business Economics and an MBA, both from The... Read More →

Speakers
avatar for Beverly Harrison

Beverly Harrison

Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
Leading the Patient Support Group @ Janssen R&D (a J&J Co.), reporting directly to the Chief Medical Officer, Beverly focuses on developing strategies for patients’ needs by working with internal/external stakeholders & engaging patient advocacy organizations. She is a R&D & nonprofit... Read More →
avatar for Eric Peacock

Eric Peacock

Co-founder and Chief Executive Officer, MyHealthTeams
Eric Peacock is the CEO of MyHealthTeams. Eric cofounded MyHealthTeams with the belief that if you are diagnosed with a chronic condition, it should be easy to find the best people around to help you. To date MyHealthTeams has launched social networks in 24 different chronic conditions... Read More →
avatar for Roslyn Schneider

Roslyn Schneider

Global Patient Affairs Lead, Pfizer Inc
Roz leads Global Patient Affairs at Pfizer, a hub of patient centricity, driving integration of patient experiences and perspectives across the company and the product lifecycle. She held roles in Medical Affairs, Medical Strategy and Medicine Development for twelve years at Pfizer... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am EDT

#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

The usage of wearables can be a challenge in the regulated and traditionally risk adverse pharmaceutical industry. This session reviews a case study of utilizing wearables from planning, to IRB, to final report in a large pharma clinical sub-study.

Learning Objectives

Describe the importance of reviewing standard processes when inserting wearables into a clinical trial; Discuss the support structure necessary for combining traditional clinical research with emerging technologies; Demonstrate an understanding of the change management necessary to run a successful wearables trial.

Chair

John H. Bunch

Speaker

Internet of Medical Things (IoMT) and Clinical Development: Challenges and Opportunities
Yury Rozenman

How to Get From Unknown Unknowns to Known Unknowns
Tilo Hache, MBA



Chair
avatar for John Bunch

John Bunch

Senior Innovation Project Manager, PPD
John Bunch is a PMP, Six Sigma, and Proci certified project manager now focused on pharmaceutical and CRO innovation projects intended to positively impact patient trial experience, improve data frequency and reliability, and bend the cost time curve for drug development. Mr. Bunch... Read More →

Speakers
avatar for Tilo Hache

Tilo Hache

Work Stream Leader Mobile Patient Data, Novartis Pharma AG
Tilo's career career started in Roche, developing and implementing large corporate IT platforms for more than 50'000 employees. Since 2003, he had positions with increasing responsibility in Novartis IT and Sourcing, for example to operate the global Personal Computer environment... Read More →
avatar for Yury Rozenman

Yury Rozenman

Director, Business Development, Qualcomm Life
Yury Rozenman leads Qualcomm Life pharmaceutical business development organization. Yury has considerable experience of working in and consulting to the pharmaceutical industry, strategic studies, new product and business development and manufacturing across the healthcare and life... Read More →


Thursday June 30, 2016 10:45am - 11:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA