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Sunday, June 26
 

1:00pm EDT

#34: Ethical Issues in Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

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

This tutorial will provide an overview of the various ethical considerations associated with conducting clinical trials, including the history of ethical principles - Nuremburg Conventions, Declaration of Helsinki, The Belmont Report, and ICH. Topics will include obtaining ethics committee and regulatory authority clearance, subject informed consent, investigator conflict-of-interest, issues of fraud, authorship, and ensuring subject safety and well-being. In addition, consideration will be given to conducting studies in emerging economy populations where fair distribution of risks and benefits come into play. It will become evident, through case examples, that these issues are not always black-and-white, and that the situation in which these issues are considered result in many shades of gray.

Who should attend?

This tutorial is designed for pharmaceutical company clinical operations staff, clinical trial site investigators and study coordinators, ethicists, regulators and regulatory affairs staff.

Learning Objectives

• Discuss the foundations of ethics;
• Explain how ethical decisions may be influenced by context and experience;
• Discuss the viewpoint of the clinical study subject when educating clinical study site staff about ethical considerations.


Speakers
avatar for Art Gertel

Art Gertel

President and Principal Consultant, MedSciCom, LLC, United States
Dr. Gertel has more than 40 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm EDT
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 08: Reg Affairs, Tutorial
 
Monday, June 27
 

1:30pm EDT

#149: EMA's Publication Policy 0070: Best Practices for Implementation
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

In this session, we will share experiences and discuss best practices and solutions to challenges that sponsors are facing with EMA Policy 0070. EMA has provided general guidance but has not been prescriptive. They have also emphasized that this will be a learning process for both EMA and industry with an opportunity to provide feedback along the way. In this session, there will be a brief overview, followed by break-out discussions in small groups. Questions to be discussed include:

• What steps are sponsors taking to ensure that their approach and rationale are consistent from document to document? How may this feedback be shared with EMA to ensure consistency in what is accepted?

• How are companies approaching the anonymization of case narratives?

• How can organizations best write documents bearing in mind downstream CCI and patient de-identifying redaction (without using expensive vendors)? How are organizations managing their internal governance?

• How are companies handling the review of Informed Consent Forms for ‘older’ CSRs that are in scope of Policy 0070?

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Describe steps sponsors are taking to ensure their approach and rationale are consistent from document to document; Identify approaches sponsors are using to anonymize case narratives; Discuss how companies are handing the review of Informed Consent Forms for legacy clinical trials.

Chair

Robert Paarlberg, MS

Speaker

Facilitator
Helle M Gawrylewski, MA



Chair
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB... Read More →

Speakers
avatar for Helle Gawrylewski

Helle Gawrylewski

Senior Director, Medical Writing and Alliance Management, Janssen Research & Development, LLC
Head Med Affairs Writing/ MW Alliances, previously director of Early Development and multiple therapeutic area writing at J&J for 17yrs. 2-term MW SIAC Chair, and CDISC Protocol Rep/Glossary Group from 2001. Held positions of increasing responsibility in MW and management for 40... Read More →


Monday June 27, 2016 1:30pm - 2:15pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop
 
Tuesday, June 28
 

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
 
Wednesday, June 29
 

8:00am EDT

#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 EDT
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

10:45am EDT

#328: The Ethics of “Big Data” Biomedical Science
Limited Capacity seats available

Component Type: Workshop
Level: Basic

Drug developers, regulators, and payers are increasingly relying on large, linked, and networked databases to discover and test new therapies; inform regulatory and funding decisions; monitor therapies in practice and fine tune therapeutic approaches. The use of such “big data” resources is scientifically exciting but raises a number of ethical issues relating to participant consent and confidentiality; ownership, and benefit sharing; and effects on clinical trials, regulatory and funding processes, and the physician-patient relationship. This session will include an exercise to explore the ethical issues raised by biomedical research that uses “big data” resources.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Recognize that there are many different kinds of “big data” with many different applications in public health and biomedicine; Discuss the key ethical issues arising from research involving “big data,” including consent, confidentiality, ownership, benefit sharing, and effects on clinical trials, regulatory and funding processes and the physician-patient relationship; Express whether, when and how “big data” research should be conducted so it is ethically sound.

Chair

Wendy Louise Lipworth


Chair
avatar for Wendy Lipworth

Wendy Lipworth

Senior Research Fellow, Centre for Values, Ethics and the Law in Medicine, University of Sydney
Dr Wendy Lipworth is a medically trained bioethicist and qualitative social researcher from the Centre for Values, Ethics and the Law in Medicine, University of Sydney, Australia. Her program of research focuses on the ethics and politics of biomedical innovation, with a particular... Read More →

Wednesday June 29, 2016 10:45am - 11:45am EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop