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Trk 19: DIAmond [clear filter]
Tuesday, June 28
 

8:00am

#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
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

#203: Next Generation Collaborations: Transforming the Industry
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-609-L04-P; CME 1.50; IACET 1.50; RN 1.50

“Alone we can do so little; together we can do so much.” Harnessing the power of collaboration truly has the ability to alter the healthcare landscape as we know it today. What is the next generation of collaborations and what will be unique about them? What will change in our organizations in the future, and how will they be different from today? Is collaborative R&D going to become a reality for our industry? What roles will FDA and other stakeholders play? This forum will bring together a diverse panel representing some of the industry’s most influential and powerful organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health. Submit your questions in advance for the panelists to annualmeetingprogram@diaglobal.org; subject line: Next Gen Collaborations.

Learning Objectives

Review the role of collaborations to date in better aligning biopharmaceutical R&D with needs and constraints of an evolving health ecosystem; Discuss the impact of coming landscape changes on the industry of tomorrow and needs that new collaborations must address; Describe the stakeholders and innovative elements of the new and transformational collaborations that are emerging.

Chair

Dalvir Gill, PhD

Speaker

Panelist
Margaret A. Anderson, MA

Panelist
Christopher P. Austin, MD

Panelist
Jonathan P. Jarow, PhD

Panelist
C. David Nicholson, PhD

Panelist
Drew Schiller



Chair
avatar for Dalvir Gill

Dalvir Gill

Chief Executive Officer, TransCelerate BioPharma Inc.
Dalvir Gill has more than 25 years of drug development & leadership experience. Prior to his appointment as CEO of TransCelerate, he was the President of a major international CRO. Dr. Gill earned his BSc from the University of Hertfordshire and his PhD from the Royal Free Hospital... Read More →

Speakers
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 →
avatar for Christopher Austin

Christopher Austin

Director, National Center for Advancing Translational Sciences, National Institutes of Health (NIH)
Christopher P. Austin has served as director of the NCATS since 2012. Prior to this role, he was NCATS’ scientific director, focusing on translating basic science discoveries into new treatments and technologies to improve the efficiency of therapeutic/diagnostic development. He... 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 C. David Nicholson

C. David Nicholson

Executive Vice President, Brand R&D, Allergan
Dr. Nicholson joined Actavis as SVP, Global Brands R&D in August 2014. Previously, he served as Chief Technology Officer and EVP, R&D for Bayer CropScience from March 2012 to August 2014; VP of Licensing and Knowledge Management at Merck from 2009 to December 2011; and SVP, responsible... Read More →
avatar for Drew Schiller

Drew Schiller

Co-Founder and Chief Technology Officer, Validic
Drew Schiller co-founded Validic and serves as the CTO. At Validic, Drew leads the product and technology strategy, drives key initiatives, and works closely with senior executives at partner organizations to stay ahead of the technology curve. Drew sits on the Consumer Electronics... Read More →


Tuesday June 28, 2016 8:00am - 9:30am
Ballroom A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

#201: International Regulatory Convergence, Collaboration, and Cooperation
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.75; IACET 1.75; RN 1.75

Join senior leadership from international regulatory authorities to hear the latest on multi- and bilateral initiatives that avoid duplication and increase mutual reliance, their strategic governance, and their impact on industry.

Part 1 of this session will see the heads of three regulatory agencies provide updates on the challenges facing them as global regulators, both domestic and within the framework of international cooperative initiatives.

In Part 2, the panel will be joined by additional heads of regulatory authorities with leading roles in the International Coalition of Medicines Regulatory Authorities (ICMRA) and will provide an overview of the developing role of ICMRA and initiatives aimed at facilitating interactions, coordination, and convergence. It will also address ICMRA's current status of strategic collaboration in areas such as pharmacovigilance, crisis management and supply chain integrity (GMP and traceability).

The combined panel will look at existing initiatives to avoid duplication and increase mutual reliance between regulators, the need for strategic governance of these initiatives and their impact on industry and other stakeholder.

Learning Objectives

Identify the current framework of bilateral and multilateral international cooperation initiatives; Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

Chair

Emer Cooke, MBA

Speaker

Panelist
Emer Cooke, MBA

Panelist
Robert M. Califf, MD

Panelist
Tatsuya Kondo, MD, PhD

Panelist
Anil Arora

Panelist
Lorraine Nolan, PhD

Panelist
Jonathan Mogford

Panelist
John Skerritt, PhD

Panelist
Jarbas Barbosa, MD, PhD



Chair
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation... Read More →

Speakers
avatar for Anil Arora

Anil Arora

Chair of the ICMRA; Assistant Deputy Minister, Health Products and Food Branch, Health Canada
Mr. Arora has a breadth of experience in the private and public sectors. He has worked internationally-bilaterally, as well as with the UN and the OECD, including leading a multi-year program with the National Bureau of Statistics in the modernization of China’s statistical system... Read More →
avatar for Jarbas Barbosa

Jarbas Barbosa

Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems... Read More →
avatar for Robert Califf

Robert Califf

Commissioner, FDA
Robert M. Califf, MD, MACC, is the Food and Drug Administration's commissioner of food and drugs. As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public healt... Read More →
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
avatar for Jonathan Mogford

Jonathan Mogford

Director of Policy, Medicines and Healthcare products Regulatory Agency (MHRA),
avatar for Lorraine Nolan

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA)
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
avatar for John Skerritt

John Skerritt

Deputy Secretary for Health Products Regulation, Department of Health
Dr John Skerritt joined the Australian Department of Health in 2012 and is currently a Deputy Secretary and member of the executive team of the Department of Health. He was formerly the National Manager of the Therapeutic Goods Administration (TGA), until his role was expanded and... Read More →


Tuesday June 28, 2016 8:00am - 9:45am
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

8:00am

#301: The Future of Big Data
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

Just how BIG will Big Data be? Understanding how innovators plan to use it to disrupt drug development and advance new health care offerings across delivery systems will be HUGE for everyone involved in innovation.

Come hear from top thought-leaders about what innovations are in the pipeline that will both generate and harness BIG DATA. Learn how innovators will use Big Data to disrupt the health care system. This dynamic forward-focused session will bring together industry, technology innovators, academia, and government agencies to paint a colorful picture of how they will drive advances in health care founded on big data platforms.

Learning Objectives

Discuss how big data will impact innovation in health care; Describe the way academia, industry, government agencies, and technology innovators are advancing health care utilizing big data.

Chair

Nancy Bradish Myers, JD

Speaker

Panelist
Luciana Borio, MD

Panelist
Kara N. Dennis

Panelist
Michael J Doherty

Panelist
Brad Hirsch, MD

Panelist
Sally A. Howard, JD



Chair
avatar for Nancy Myers

Nancy Myers

President and Founder, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and... Read More →

Speakers
avatar for Luciana Borio

Luciana Borio

Acting Chief Scientist, Office of the Chief Scientist, OC, FDA
Dr. Luciana Borio is FDA’s acting chief scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership... Read More →
avatar for Kara Dennis

Kara Dennis

Managing Director, Mobile Health, Medidata Solutions Worldwide
As managing director of mobile health, Kara leads Medidata’s efforts to support mobile-enabled clinical trials and launched mobile health (mHealth) as a new business unit in 2015. Prior to this, Kara served as chief of staff to the company's CEO and president, and a vice president... Read More →
avatar for Michael Doherty

Michael Doherty

Head, Strategic Innovation, Pharma Dev; Exec Advisor, Foundation Medicine Inc., Hoffmann-La Roche Ltd.
Head of regulatory affairs at Roche and Genentech from 2002 to 2016. Currently head of strategic innovation at Roche and Executive adviser to Foundation Medicine.
avatar for Brad Hirsch

Brad Hirsch

Senior Medical Director, Flatiron Health
Dr. Hirsch is a practicing medical oncologist with Texas Oncology in Dallas. At Flatiron Health, he helps to lead multiple efforts including value based care initiatives, collaborations with life sciences companies, and the development of novel research capabilities. Prior he served... Read More →
avatar for Sally Howard

Sally Howard

Head of Regulatory Affairs and Policy, Human Longevity, Inc.
Has more than two decades of health policy and regulatory expertise, leads all efforts related to federal and state regulatory oversight. She comes from the FDA where she served most recently as Senior Advisor and Acting Chief of Staff to the FDA Commissioner. She also spent two years... Read More →


Wednesday June 29, 2016 8:00am - 9:30am
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

#302: Europe and the US: Making Outcomes-Based Health Care Possible
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-610-L04-P; CME 1.50; IACET 1.50; RN 1.50

Europe and the US are experimenting with ways to develop therapies based on their actual ‘real world’ performance. This session will discuss the benefits and challenges of outcomes-based health care, as well as the remaining barriers to implementation.

Learning Objectives

Describe the concept of outcomes-based health care; Define real world evidence, Adaptive Pathways, and Precision Medicine; Identify how we can use health data to improve the efficiency of clinical trials and research (better targeting, smaller trials, flexible models); Recognize the links between failures rates, trial sizes, and investments into new therapies.

Chair

Duane Schulthess, MBA

Speaker

European Approaches to Outcomes-Based Health Care
Hans-Georg Eichler

Engineering Outcomes: Driven Biomedical Innovation
Gigi Hirsch, MD

Big Data for Better Outcomes: Innovative Medicines Initiative - IMI Taking the Lead
Richard Bergström, MS

Measuring Outcomes and Performance
Steve Rosenberg



Chair
avatar for Duane Schulthess

Duane Schulthess

Managing Director, Vital Transformation
Duane is the Managing Director of Vital Transformation which consults to national health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He and his firm have developed many unique techniques and methods... Read More →

Speakers
avatar for Richard Bergström

Richard Bergström

Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the Director-General of LIF, the Swedish Association of the Pharmaceutical Industry, following... Read More →
avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at... Read More →
avatar for Gigi Hirsch

Gigi Hirsch

Executive Director, Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
Her current efforts are leading the New Drug Development Paradigms initiative (NEWDIGS), a “think and do tank” that is re-engineering pharmaceutical innovation to deliver new, better, affordable therapeutics to the right patients, faster. Within the broad strategic framework of... Read More →
avatar for Steve Rosenberg

Steve Rosenberg

Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle Health Sciences
Steve Rosenberg, Senior Vice President and General Manager of Oracle Health Sciences Global Business Unit, has over 30 years of experience leading development, services, support, and consulting, in addition to significant industry experience in life sciences and healthcare. Some of... Read More →


Wednesday June 29, 2016 8:00am - 9:30am
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:00am

#303: Value-Based Health Care Decision Making: The Quest for Smarter Spending
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

As demand increases for better management of health care costs while still providing the highest levels of care, the landscape is evolving into one assessed on value. All stakeholders – providers, payers, manufacturers, and ultimately patients – are interested in the impact this movement toward value has, including who is making or influencing access decisions and what information and evidence is being used to define value. In this session, you will hear perspectives from multiple stakeholders to better understand the challenges and implications brought by this new focus towards value, and uncover ideas of collaboration to realize smarter health care spending.

Learning Objectives

Review the global landscape of value-based health care decision making; Discuss the challenges facing health care stakeholders as they work to understand this new “value” assessment and what that means for future decisions and patient access; Identify evidence considerations for pharmaceutical research and development plans; Share ideas on stakeholder collaboration for optimal results.

Chair

Jennifer Snow, MPH

Speaker

Panelist
Ben Heywood, MBA

Panelist
Sarah Garner

Panelist
Richard J. Willke, PhD

Panelist
Newell McElwee



Chair
avatar for Jennifer Snow

Jennifer Snow

Director, Health Policy, Xcenda
Jennifer Snow, MPH, is a Director of Health Policy and keeps clients and stakeholders informed on the latest legislative and regulatory updates and their commercial impact. Her team analyzes the healthcare environment and provides strategic guidance on how to best navigate challenges... Read More →

Speakers
avatar for Sarah Garner

Sarah Garner

Associate Director – Science Policy and Research, National Institute for Health and Care Excellence (NICE)
Professor Sarah Garner is a pharmacist specialising in the interface between Health Technology Assessment (HTA) and regulation. Sarah is the Associate Director for Scientific Policy and Research at NICE and an honorary professor at UCL and Manchester University. She leads Work Packages... Read More →
avatar for Ben Heywood

Ben Heywood

President and Co-Founder, PatientsLikeMe
As President and Director of PatientsLikeMe, Benjamin Heywood is responsible for setting the company vision to improve healthcare and accelerate research, while directing its business growth strategy. Inspired by his brother Stephen’s battle with ALS, Heywood co-founded the company... Read More →
avatar for Newell McElwee

Newell McElwee

Assistant Vice President, Center for Observational and Real-world Evidence, Merck & Co., Inc.
Newell McElwee, PharmD, MSPH, is Executive Director of U.S. Outcomes Research, Merck & Co., Inc. Dr. McElwee serves an active role on many committees including the Steering Committee for the AHRQ Centers for Education, Research, & Training, the Advisory Board for the Institute for... Read More →
avatar for Richard Willke

Richard Willke

Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Dick became ISPOR’s first Chief Science Officer in 2016, where he develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Prior to ISPOR he worked for 25 years at Pfizer and its legacy companies, where he retired as a vice president... Read More →


Wednesday June 29, 2016 8:00am - 9:30am
Ballroom A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

9:00am

#401: EMA/FDA Question Time
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-611-L04-P; CME 1.50; IACET 1.50; RN 1.50

This forum will provide an opportunity for EMA and FDA leadership to explore at a roundtable discussion areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/FDA collaboration will explore topics such as innovation support to industry, use of real world data, patient involvement in the development, evaluation and post-authorization of medicines, and mutual reliance on GMP inspections.

The audience will be invited to submit questions of general interest. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions and topics of interest in advance to annualmeetingprogram@DIAglobal.org, and include “EMA/FDA Question Time” in the subject line.

Learning Objectives

Summarize key issues discussed by EMA and FDA; Identify regulatory hot topics; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy, and safety; Identify how to engage both agencies in the development of a medicine at the same time.

Chair

Sabine Haubenreisser
Sandra L. Kweder, MD, FACP

Speaker

Panelist
Emer Cooke, MBA

Panelist
Dara Corrigan, JD

Panelist
John K. Jenkins, MD

Panelist
Jordi Llinares Garcia

Panelist
Anabela Marcal, PharmD

Panelist
Heidi C. Marchand, PharmD

Panelist
Peter W. Marks

Panelist
Isabelle Moulon, MD



Chair
avatar for Sabine Haubenreisser

Sabine Haubenreisser

Liaison to the US FDA, European Medicines Agency, European Union
Sabine Haubenreisser, MSc, Ph.D., is a pharmacologist who joined the European Medicines Agency in 1997, where she held a variety of positions including scientific team leader and officer for external communications. In 2012 she was appointed EMA Liaison Official at the U.S. FDA in... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →

Speakers
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation... Read More →
avatar for Dara Corrigan

Dara Corrigan

Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Leads a 5,000-member workforce devoted to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. She joined FDA in 2010, serving as... Read More →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in... Read More →
avatar for John Jenkins

John Jenkins

Director, Office of New Drugs, CDER, FDA
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
avatar for Anabela Marcal

Anabela Marcal

Head of Committees and Inspections Department, European Medicines Agency (EMA),
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.
avatar for Heidi Marchand

Heidi Marchand

Assistant Commissioner, Office of Health and Constituent Affairs, OC, FDA
Heidi Christl Marchand, Pharm.D. is currently the Assistant Commissioner for Health and Constituent Affairs at FDA. She has held leadership positions in global regulatory affairs with Novartis, Pfizer and Amgen. Dr. Marchand leads FDA’s office responsible for engaging external stakeholders... Read More →
avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... 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 →


Thursday June 30, 2016 9:00am - 10:30am
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

9:00am

#402: Protocol Development Is a Team Sport
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-612-L04-P; CME 1.50; IACET 1.50; RN 1.50

From stating study objectives, participant criteria, endpoints and methods for data collection to establishing safety, the protocol is a key document for all stakeholders to ensure a successful clinical trial. The protocol defines the study design and provides the foundation for data collection that is used to evaluate clinically and statistically meaningful results of a study. It defines to a great extent what will be known about a drug or medical intervention, and is thus highly relevant to diverse stakeholders. During this session, the requirements and considerations for developing a successful and executable clinical trial protocol will be presented from the perspectives of sponsors, research sites, and patient representatives. The unique viewpoints will serve as the basis for a moderated discussion that analyzes the current process for protocol development, while suggesting approaches to more fully incorporate the patient voice into protocol design and implementation.

Learning Objectives

Discuss the requirements and considerations for developing a clinical trial protocol from the combined perspectives of the statistician, the clinical operations director, the patients, the medical officers and the regulators; Describe a process for protocol writing that is holistic rather than atomistic and involves collaborative as opposed to separate contributions; Identify ways to more fully and impactfully incorporate patient input into protocol design and implementation.

Chair

Richard Murray, DrMed, MD, FACP

Speaker

Panelist
Michael Krams

Panelist
Andy Lee, MA

Panelist
Christine Pierre, RN

Panelist
Steven Taylor, MBA



Chair
avatar for Richard Murray

Richard Murray

Vice President and Deputy Chief Medical Officer, Merck & Co., Inc.
Dr. Murray joined Merck & Co., Inc. in November 1994, and since August 2014 he has held the position of Vice President and Deputy Chief Medical Officer, managing a team of physician scientists supporting the scientific and medical needs for the Office of the CMO at Merck across all... Read More →

Speakers
avatar for Michael Krams

Michael Krams

Vice President, Global Head Quantitative Sciences, Janssen Pharmaceuticals, Inc.
Mike is a neurologist with a background in functional imaging. One of his early contributions was the ASTIN stroke study, illustrating how adaptive designs allow learning in real time and enable teams to make the correct decision at the earliest time point in the most efficient manner... Read More →
avatar for Andy Lee

Andy Lee

Senior Vice President, Head of Global Clinical Trial Operations, Merck & Co., Inc.
Andy heads Global Clinical Operations at Merck and is responsible for all global/regional clinical trials. Andy has over 17 years industry experience with interests in Human Subject Protection, Multiregional Studies, Quality and Compliance and finding more efficient ways to run clinical... Read More →
avatar for Christine Pierre

Christine Pierre

President, Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites, a global trade organization representing over 9,000 sites in 47 countries committed to providing sites a community and voice for site sustainability. Christine is an internationally recognized expert on the global... Read More →
avatar for Steven Taylor

Steven Taylor

Chief Executive Officer, Sjögren's Syndrome Foundation
Since joining the Foundation as its CEO in 2003, Steve has focused on making Sjögren’s syndrome a household name by increasing awareness among the general public and healthcare professionals. In addition, under Steve’s leadership, the SSF has launched two major initiatives around... Read More →


Thursday June 30, 2016 9:00am - 10:30am
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA