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Sunday, June 26
 

9:00am EDT

#41: A Rare Disease Program Case Study: Strategies for Successful Outcomes
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-16-507-L01-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials.  Register today for this tutorial.

Working through a multifaceted case study, this one-day, intensive tutorial will address heads-on the unique challenges associated with the development of rare disease therapies. Successful outcomes are a direct result of early planning, design and engagement with patients, patient advocacy groups, treating physicians, specialists, and regulators.

This interactive case study will emphasize how “spending” time in early planning assures appropriate study outcome measures, timely enrollment of clinical trials, and successful regulatory interactions which affect the bottom line and improve the potential for developing therapies for rare disease patients faster.

Who should attend?

This tutorial is designed for professionals working with rare disease therapies including by not exclusive to researchers from academia and industry, senior managers, regulatory affairs specialists, clinical trialists, government officials and investors focused on the future of rare disease and orphan product development.

Learning Objectives

• Examine rare disease clinical and regulatory program issues and challenges;
• Discuss special considerations for study endpoint identification and development;
• Distinguish differences between working with FDA on the development of rare disease therapies as compared to more common diseases;
• Develop ideas for educating, building visibility and understanding of a rare disease programs with key stakeholders.


Speakers
avatar for Ronald Bartek

Ronald Bartek

Co-Founder/Founding President, Friedreich's Ataxia Research Alliance (FARA)
Co-founder/President, FARA, Board of Directors, NORD; NIH/NINDS National Advisory Council; partner/president, government affairs firm; 20 yrs federal service in defense, foreign policy & intelligence; U.S. Delegation to Intermediate-Range Nuclear Forces (INF) Treaty talks, Geneva... Read More →
avatar for Linda Deal

Linda Deal

Head of Patient-Centered Outcomes Measurement, Pfizer Inc.
Linda currently serves as PCOA Lead working across Pfizer’s therapeutic categories addressing efforts to develop, validate and use COAs as endpoints for providing evidence of medical treatment benefit differentiation, labeling and value. Linda has served patients and the pharmaceutical... Read More →
avatar for Jessica Foley

Jessica Foley

Head of Regulatory Services, NovusLife, LLC
Jessica is a senior regulatory professional and consultant with 10 years of experience in the global biopharmaceutical industry. She provides strategic product development and approval strategies to pharmaceutical and biotechnology companies with a focus on investigational therapies... Read More →
avatar for Jonathan Goldsmith

Jonathan Goldsmith

Associate Director for Rare Diseases, Office of New Drugs, CDER, FDA
Dr. Goldsmith is Associate Director for Rare Diseases in the Office of New Drugs/CDER/FDA. Prior to federal service, he was a tenured professor in academia and focused on clinical drug development in regulated industry, at NHLBI/NIH and at orphan disease foundations. He earned his... Read More →
avatar for David Schubert

David Schubert

Vice President of Regulatory and Quality, Stealth BioTherapeutics
David Schubert is the Vice President of Regulatory and Quality at Stealth BioTherapeutics Inc. Previously, Mr. Schubert held positions at MediVector Inc., Logical Therapeutics Inc., Coley Pharmaceutical Group, Genzyme and Cubist Pharmaceuticals. Mr. Schubert has over 30 years of experience... Read More →


Sunday June 26, 2016 9:00am - 5:00pm EDT
112AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
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

#114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-604-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are the experts in their disease and its impact, and across the research enterprise, stakeholders are working to identify how to best leverage this expertise to enhance trial design, conduct, and overall relevance to patients. This session will provide patient, regulator, and industry perspectives on how this goal can be achieved. Speakers will review key FDA, Clinical Trials Transformation Initiative, and sponsor initiatives designed to bring the patient into the conversation as trials are designed, implemented, and their results reviewed. Presenters will discuss challenges faced and offer ideas on how these challenges may be proactively addressed.

Learning Objectives

Discuss key FDA initiatives related to patient engagement and how these may better incorporate the patient perspective into all stages of drug development; State a patient perspective on how patients could be better engaged in trial design and recruitment and learn about a project to facilitate patient engagement and recruitment.

Chair

Jonca C. Bull, MD

Speaker

Patient Perspective
Jane Perlmutter

Patient Centric Trial Design: It's More Than Just the Trial
Joseph Kim

FDA Perspective
Elektra Johanna Papadopoulos



Chair
avatar for Jonca Bull

Jonca Bull

Assistant Commissioner for Minority Health, Office of the Commissioner, FDA
Dr. Bull worked at the FDA from 1994 to 2006. She served as Director of Clinical Regulatory Policy at Genentech and as Vice President for US Regulatory Policy at Novartis, returning to FDA in 2012 to serve in the Office of the Commissioner as Assistant Commissioner for Minority H... Read More →

Speakers
avatar for Joseph Kim

Joseph Kim

Senior Advisor, Clinical Innovation, Eli Lilly and Company
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on innovative patient engagement solutions. He has spent over 17 years in the Pharma industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing... 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 →
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 →


Monday June 27, 2016 8:30am - 9:45am EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT/GCP, Session

8:30am EDT

#115: Clinically Relevant Specifications: Translating Voice of the Patient Into Quality Attributes of the Product
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-605-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical relevance has re-emerged within recent discussions in both the quality and regulatory arenas, with specific focus on patient expectations, clinically relevant specifications, residual uncertainty, and benefit-risk based decision making. Translating highly technical information into the pertinent patient-centric frame requires an intricate balance. This session highlights multiple opportunities for collaboration and communication, with the end goal of improving medicines, ensuring their availability, and assuring their use in accordance with patient needs.

Learning Objectives

Share common experiences regarding the establishment of clinically relevant specifications; Identify areas for future discussion with regard to clinical relevance in the quality arena; Discuss specific cases that illustrate establishment and/or challenges establishing clinically relevant specifications.

Chair

Richard T. Lostritto

Speaker

Paving the Road Toward Setting Clinically Relevant Drug Product Specifications: The Relevance of Biopredictive Dissolution Testing
Sandra Suarez Sharp, PhD

Industry Perspective
Ganapathy Mohan, PhD

FDA Perspective
Laurie Graham



Chair
RL

Richard Lostritto

Acting Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
Richard (Rik) Lostritto currently serves as a Division Director In FDA's ONDQA. Prior to this, he served in the FDA as a Team Leader, and Chemsitry Reviewer.

Speakers
LG

Laurie Graham

Acting Director, DIPAP, OPPQ, OPQ, CDER, FDA
Ms. Graham is the Acting Directorof the Division of Internal Policies and Programs (DIPAP), which leads the development and evaluation of OPQ internal policy documents.
avatar for Ganapathy Mohan

Ganapathy Mohan

Head of External Affairs (Quality), Merck & Co., Inc., United States
Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015. Prior to joining... Read More →
SS

Sandra Suarez Sharp

Biopharmaceutics Lead (Acting), DB Branch III, ODNP, OPQ, CDER, FDA
Dr. Sandra Suarez-Sharp joined the Office of Clinical Pharmacology (OCP) at the FDA, in September 1999. Currently, she works at the Office of New Drug Products/Division of Biopharmaceutics (FDA/OPQ/ONDP) as a Master Biopharmaceutics Reviewer/Biopharmaceutics Lead (acting) supporting... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session

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

4:30pm EDT

#153: BBK Innovation Theater: Reimagining the Patient Experience Through mHealth Technologies
Limited Capacity filling up

Component Type: Session
Level: Intermediate

mHealth remains one of the most talked about trends in clinical R&D. Yet despite many successes across life sciences and health care, industry-wide adoption lags. Patient-centric strategies are critical to any study’s success, and few efforts are more patient-centric than providing tools to improve patient engagement and enable efficient data collection and sharing. This presentation will offer advice on mHealth engagement strategies and share insights gleaned from real use cases.

Chair

BBK Worldwide


Chair
BW

BBK Worldwide

BBK Worldwide

Monday June 27, 2016 4:30pm - 5:00pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

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

10:30am EDT

#208: Measuring Return on Engagement: An Interim Report on the DIA-Tufts CSDD Metrics Study
Limited Capacity seats available

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

The patient centricity movement has generated substantial activity within both the public and private sectors, but to date no quantitative data have been gathered on the adoption and impact of specific patient-centric initiatives implemented by pharmaceutical and biotechnology companies to support processes within the medical product life cycle. Similarly, no effort has been made to harmonize the patient centricity principles and draft guidance recommendations developed by public and public-private consortia with industry drug development practice and policy. DIA, in collaboration with Tufts Center for the Study of Drug Development (CSDD), have undertaken a comprehensive study to address these critical needs. In this forum, the Tufts CSDD-DIA team, along with industry representatives participating in the study, will describe the study objectives and approach as well as work to date. In addition, they will share interim observations and insights from preliminary data that have been gathered and analyzed.

Learning Objectives

Discuss current outcomes and effectiveness of patient engagement in the medical product life cycle; Identify the benefits of standard metrics to advance the practice of meaningful patient engagement in medical product development and approval processes; Describe the objectives and approach of the DIA-Tufts CSDD study; Discuss observations of the study based on data collected to date, including patient engagement practice, metrics in use, and barriers to robust patient engagement programs.

Chair

Mary Jo Lamberti
Elizabeth Lincoln, MA

Speaker

Panelist
Kathleen A. Foley, PhD

Panelist
John Manganaro

Panelist
Jeffrey W. Sherman, MD, FACP

Panelist
Ellen Coleman



Chair
avatar for Mary Jo Lamberti

Mary Jo Lamberti

Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
Mary Jo Lamberti is on the faculty at Tufts University and is Associate Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She leads multi-company sponsored research studies and has extensive experience conducting research on biopharmaceutical... Read More →
avatar for Elizabeth Lincoln

Elizabeth Lincoln

Global Director of Engagement, DIA
Prior to DIA, Elizabeth spent 12 years in Human Capital consulting at Accenture and five years at Career Concepts, Inc. She has worked across industries and for Fortune 100 as well as small, family-owned businesses in human resources and organization development. Since joining DIA... Read More →

Speakers
avatar for Ellen Coleman

Ellen Coleman

President and CEO, VOZ Advisors
As president and CEO, Ellen Coleman leads VOZ Advisors and is responsible for all aspects of the overall firm path and direction. Ellen brings considerable experience in working with patients with life-threatening and chronic illnesses giving her a view of the entire patient experience... Read More →
avatar for Kathleen Foley

Kathleen Foley

Senior Director, Pfizer Inc.
Kathleen A. Foley is a senior director and the Patient Centered Metrics Lead in the Global Health and Value Innovation Center at Pfizer, where she is responsible for the development of metrics contributing to the science of patient input. Dr. Foley has a master’s degree from the... Read More →
JM

John Manganaro

Deputy Director, Regulatory Policy and Intelligence, Bayer HealthCare Pharmaceuticals
John has over 20 years in the pharmaceutical industry in Medical and Regulatory Affairs. He has extensive experience with various topics ranging from medical information, safety, compliance, product quality, intelligence research and regulatory issues. John is currently Deputy Director... Read More →
avatar for Jeffrey Sherman

Jeffrey Sherman

Chief Medical Officer and Executive Vice President, Research and Development, Horizon Pharma, Inc.
Jeff has more than 20 years of experience in the pharmaceutical industry. He is President of the Drug Information Association (DIA) and a member of the Board of Directors. He also served as chairperson of the DIA 2008 Annual Meeting and received an Outstanding Service Award in 20... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Forum

12:00pm EDT

#230: Quintiles Innovation Theater: Transforming Patient Recruitment Through Site and Patient Engagement
Limited Capacity filling up

Component Type: Session
Level: Intermediate

Transforming patient recruitment requires operating with patients in mind from start to finish for better outcomes. Generating awareness and trust is an imperative first step. Then getting patients involved in program and protocol design pre-recruitment also effects study execution. It is also imperative to support sites through proper tools, training, and support. Learn how we’re using innovative solutions and partnerships to transform the way patients impact study success.

Chair

Quintiles Transnational


Chair
avatar for QuintilesIMS

QuintilesIMS

Quintiles Transnational

Tuesday June 28, 2016 12:00pm - 12:30pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

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

#262: Solving Challenges and Employing Best Practices in Medical Information Contact Centers
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

The medical information sector is growing and changing significantly due to rising health care costs, population growth in emerging markets, advances in technology, changing product landscapes, and regulatory pressures. As the demand for medical information increases globally, medical information organizations need to be trusted partners in guiding health care professionals and consumers in obtaining high quality, authoritative, science-based information. This session will discuss how these centers, which serve as crucial lifelines between patient, health care provider, and life sciences companies, are facing increased challenges as well as demands to adjust to changing consumer communication trends and needs.

Learning Objectives

Discuss some of the biggest challenges facing medical information contact centers; Identify which specialized languages and skills are growing in demand; Describe how future trends will impact the flow of information and how companies will need to adjust.

Chair

Chris O'Shaughnessy

Speaker

Industry Point of View
Dominick L. Albano

Industry Point of View
Elke M. Blaetz



Chair
avatar for Chris O'Shaughnessy

Chris O'Shaughnessy

Vice President, Sales, C3i Healthcare Connections
Chris O'Shaugnessy R. PH has nearly 20 years of experience in the pharmaceutical industry in varying roles. Today, Chris serves as the Vice President of Sales at C3i Healthcare Connections where he leads a team in developing strategic multi-channel contact solutions to meet the needs... Read More →

Speakers
avatar for Dominick Albano

Dominick Albano

Vice President, Global Medical Information, Pfizer Inc
Dominick Albano is Vice President, Global Medical Information at Pfizer. He also serves as President on the Board of Directors for phactMI, (Pharma Collaboration for Transparent Medical Information). He has more than 20 years of experience in the pharmaceutical industry. Dr. Albano... Read More →
EB

Elke Blaetz

Regional Medical Information Lead, North America, Shire PLC
Has spent most of her career pursuing excellence in the practice of medical information, fulfilling every department role from front-line telephone agent, medical writer of standard response documents, dossier development, systems validation, employee training, line management, compliance... Read More →


Tuesday June 28, 2016 4:00pm - 5:00pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 06: Med Comm/Wrtg/MSL, Session

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

#267: FDA Institutes/Centers of Excellence: A Step Toward Patient Focused Drug Development?
Limited Capacity seats available

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

The historic structure of FDA is oriented around the products it regulates. Today, the treatment of many diseases involves numerous different technologies and interventions centered on providing optimal care for the patient, and a patient-centered orientation to reflect the current multimodal approach to patient care is being proposed. Cross-center Institutes of Excellence could help FDA to further advance the promotion of human health. These institutes could foster increased intellectual collaboration and a consistent FDA approach by forming teams of Agency staff with cutting-edge expertise in the treatment and prevention of specific types of diseases. Consolidating disease-oriented activities at FDA may help reduce redundancies within the current FDA Centers and better consolidate core competencies to focus on scientific advancement within the Agency and streamline processes for the review of products to treat high impact disease areas. The benefits of such a restructuring will be explored and discussed by a panel of experts.

Learning Objectives

Describe how the proposed reorganization could affect drug development and review by FDA; Discuss whether the proposed reorganization could benefit patients; Explain path forward and potential challenges associated with the proposed reorganization.

Chair

Margaret A. Anderson, MA

Speaker

Panelist
Wade Ackerman, JD

Panelist
Steven K. Galson

Panelist
Eric H. Rubin, MD

Panelist
Ellen Sigal, PhD



Chair
avatar for Margaret Anderson

Margaret Anderson

Executive Director, FasterCures, A Center of the Milken Institute
Margaret Anderson is the executive director of FasterCures, a Washington, DC-based center of the Milken Institute, which is driven by a singular goal – to save lives by speeding up and improving the medical research system. FasterCures focuses on spurring cross-sector collaboration... Read More →

Speakers
avatar for Wade Ackerman

Wade Ackerman

Former Senior FDA Counsel for the Senate HELP Committee, NA
Wade Ackerman recently served as Senior FDA Counsel for Ranking Member Patty Murray on the US Senate Committee on Health, Education, Labor and Pensions (HELP) where he handled issues related to pharmaceuticals, medical devices, animal products, cosmetics, and other FDA-related areas... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
avatar for Steven Galson

Steven Galson

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc.
Dr. Steven Galson is Senior Vice President - Global Regulatory Affairs & Safety at Amgen. Prior to Amgen, Galson spent more than 20 years in government service, including two years as acting Surgeon General of the United States. He also served as director of FDA’s Center for Drug... Read More →
ER

Eric Rubin

Vice President and Therapeutic Area Head, Merck Research Laboratories
ES

Ellen Sigal

Chairperson and Founder, Friends of Cancer Research
Dr. Ellen Sigal has been a devoted patient advocate and stanch supporter of cancer research. She founded Friends of Cancer Research in 1996 to mark the anniversary of the National Cancer Act. Friends is a cancer research think tank and advocacy organization based in the Washington... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, 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

12:40pm EDT

#332A: Salesforce Innovation Theater: Connect to Your Patients, Providers, and Partners in a Whole New Way with the Salesforce Platform
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Life science leaders are shifting towards the patient and using the Salesforce platform to drive this transformation. Hear inspiring stories of how Salesforce’s pharmaceutical, medical device, and CRO customers have connected with patients, providers, and partners to build personalized relationships at scale. See a live demo of Salesforce Health Cloud, the platform delivering a complete view of the patient journey, improving patient acquisition, patient services, therapy adherence, and more.

Chair

Salesforce


Chair
Wednesday June 29, 2016 12:40pm - 1:10pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

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