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Current Issues in Policy and Law [clear filter]
Sunday, June 26
 

8:30am EDT

#20: The Sunshine Act: Understanding the Essentials of Compliance
Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

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

As part of the Affordable Care Act of 2010, the Sunshine Act was enacted. This law is designed to inject greater transparency for the public to understand the relationship between pharmaceutical and medical device companies and the physicians and teaching hospitals that are most likely prescribing their products. The Sunshine Act imposes a duty on “applicable manufacturers” of “covered” drugs and devices to both track and disclose not only payments made to physicians and teaching hospitals in the form of consulting fees, honoraria, etc., but also any other provision of an item or service that has a value to such recipients, including meals, trips, research equipment, etc. And, annually all such payments need to be submitted to a website maintained by the Center for Medicare and Medicaid Services (CMS) for public review.

This tutorial will explore in detail the Sunshine Act’s requirements, including any potential exemptions, and also the unique way that the Sunshine Act deals with research-related payments, which overlaps in part with the separate provisions in 21 CFR Part 54 that FDA imposes for the disclosure of financial interests held by clinical investigators. The basics of the system and process for submitting the required disclosures to the CMS “Open Payments” database and suggestions on how to implement processes at their companies to ensure compliance with the Act’s requirements will be discussed.

Who should attend?

This tutorial is designed for all personnel responsible for ensuring compliance with the Sunshine Act.

Learning Objectives

• Discuss how the Sunshine Act is structured;
• Identify key definitions that impact duties under the Sunshine Act, including when a product is “covered” so as to potentially render the manufacturer responsible for disclosing payments;
• Identify the many different types of payments or provision of other things of value that must be tracked and disclosed under the Sunshine Act.


Speakers
avatar for Michael Swit

Michael Swit

Senior Director, Legal, Regulatory, Illumina, Inc.
Michael A. Swit, Esq., has solved vital FDA legal issues since 1984, with a focus on drug and device challenges. Before joining Illumina as its senior regulatory counsel in December 2014, he was a Special Counsel in the FDA Law Practice at Duane Morris, a global law firm. He also... Read More →


Sunday June 26, 2016 8:30am - 12:00pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 10: Pub Pol-HealthCare Compl-Law, Tutorial

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
 

8:30am EDT

#102: Digital Health Debate
Limited Capacity seats available

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

The Digital Debate will bring together expert representatives from sponsor, site, CRO and marketing perspectives to debate the merits of digital media for patient recruitment and retention. We will discuss the challenges and optimal scenarios for utilizing digital channels to recruit patients.

Learning Objectives

Discuss insights from sponsors, CROs, and sites on their past and planned use of digital media for patient recruitment; Describe the challenges faced in implementing digital media for patient recruitment; Address issues in coordinating digital media campaigns among the entities and in integrating digital with traditional campaigns; Identify possible methods to overcome organizational barriers to effectively implement digital campaigns for patient recruitment.

Chair

Nariman Nasser

Speaker

Move from Pilot to Platform: Four Strategies to Enable Digital Health Approaches to Scale in Research Programs
John Reites

mHealth in Clinical Research and Development: Is It All Hype?
Brett Villagrand

Site Perspective
Joshua R. Korzenik, MD



Chair
avatar for Nariman Nasser

Nariman Nasser

Digital Strategist, Operational Intelligence and Innovation, Roche
Nariman Nasser is Digital Strategist of Operational Intelligence and Innovation at Roche/Genentech. She previously was the Senior Director of Participant Recruitment & Study Management Services at UCSF's Clinical & Translational Science Institute. Ms. Nasser’s prior experience also... Read More →

Speakers
JK

Joshua Korzenik

Director, Crohn's and Colitis Center, Brigham and Women's Hospital
avatar for John Reites

John Reites

Senior Director, Head of Digital Health Acceleration, Quintiles Inc.
As the Head of Digital Health Acceleration, John Reites is focused on partnering and executing digital health innovation programs with biopharmaceutical companies, established innovators, start-ups and VC firms. Mr. Reites is a speaker and author of various publications, providing... Read More →
avatar for Brett Villagrand

Brett Villagrand

Principal, Carethings
Brett’s passion is for how innovation in technology can impact outcomes for patients. Most of his career was with Pharmaceutical companies Novartis and Genentech in product development and marketing roles. Until recently, was hired as an industry subject matter expert at Oracle... Read More →


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

8:30am EDT

#108: Drug/In Vitro Diagnostic Device Advertising and Promotion: Unapproved Combination Product or Awareness?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-526-L01-P; CME 1.25; IACET 1.25; RN 1.25

In vitro diagnostic devices are important tools intended for use in the diagnosis of disease or other conditions, including a determination of the state of health. Based on a diagnosis, it seems reasonable for a company to recommend an appropriate prescription drug treatment. This session reviews the basics of advertising and promotion for devices and prescription drugs in the context of intended use and approved indications. Taking the substantial evidence requirements and recent 1st Amendment challenges into consideration, the panelists will provide a systematic assessment of scenarios when company may or may not co-promote or recommend a prescription treatment based on a diagnostic outcome.

Learning Objectives

Identify valuable insights into the regulatory and legal boundaries of advertising and promotion of a device with a prescription drug when these tactics go beyond the approved intended use/indication, and when this may be viewed as an unapproved new combination device/drug product.

Chair

Kimberly Belsky, MS

Speaker

Panelist
Alan G. Minsk, JD

Panelist
Minnie Baylor-Henry, JD, RPh



Chair
avatar for Kimberly Belsky

Kimberly Belsky

Senior Director, Regulatory Affairs, Regulatory Intelligence, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals... Read More →

Speakers
avatar for Minnie Baylor-Henry

Minnie Baylor-Henry

President, B-Henry & Associates
President of B-Henry & Associates, a consulting firm focused on providing regulatory and compliance strategy services to life sciences companies. Prior to assuming her current role in early 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s... Read More →
avatar for Alan Minsk

Alan Minsk

Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP
Alan G. Minsk is a partner in the Food and Drug and Government and Regulatory Practices. Mr. Minsk was recognized in chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv-Mkting, Forum
 
Tuesday, June 28
 

10:30am EDT

#221: Envision the Future: How Big Data and Artificial Intelligence Change Our Regulatory Environment
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-555-L04-P; CME 1.25; IACET 1.25; RN 1.25

The complexity of the regulatory environment is growing rapidly in light of new technologies for disease surveillance, diagnostics, and medication. This session will focus on future knowledge and predictions in intelligence with an impact on the regulatory world.

Learning Objectives

Recognize the complexity of the future regulatory environment in light of new technologies; Identify challenges and opportunities in the field of digital data for disease surveillance, personalized medicines and individual stakeholder engagement through innovative tools; Evaluate future knowledge against new technologies.

Chair

Joseph C. Scheeren, PharmD

Speaker

Current Status of Big Data Use in the Health Care Sector: View from the Market
Luke D. Dunlap, MSc

Big Data Being Part of FDA eHealth Policy: Viewpoint of the Regulator
Robert M. Califf, MD

Challenges of Big Data in the Regulatory Environment from the Legal Point of View
Denise Esposito, JD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
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 →
LD

Luke Dunlap

Senior Principal, Real World Evidence Solutions, IMS Health
avatar for Denise Esposito

Denise Esposito

Partner, Covington & Burling LLP


Tuesday June 28, 2016 10:30am - 11:45am EDT
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session

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

#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.

Chair

Karin Van Baelen, PharmD

Speaker

FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc



Chair
avatar for Karin Van Baelen

Karin Van Baelen

Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those... Read More →

Speakers
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 Sean Tunis

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMTP)
Sean Tunis, MD, MSc, is Founder and Senior Strategic Advisor of the Center for Medical Technology Policy, an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that promote high value innovation by improving the quality, relevance... Read More →
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum

2:00pm EDT

#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, we will discuss open-label, delayed-start studies and open-label extension studies that are conducted to evaluate safety and efficacy. A statistician will describe delayed-start study designs and an epidemiologist will discuss when such studies are needed, and the interpretation of study findings. An ethicist will identify the ethical aspects of these study designs and their conduct.

Learning Objectives

Explain the objectives of open-label, long-term extension studies; Describe the role and design of delayed-start studies and single-arm extension studies in the evaluation of efficacy and safety; Discuss ethical considerations when designing and conducting open-label, long-term extension studies.

Chair

Lisa A Kammerman, PhD, MS

Speaker

Delayed-Start Study Design and Analyses for Demonstrating Disease Modification
Scott Andersen, MS

Bioethics of Open-Label Extension Studies
Robert M Nelson

When, if Ever, Open-Label Extension Studies Are Needed and Appropriate (and What Are the Alternatives)?
Jesse Aaron Berlin, DrSc



Chair
LK

Lisa Kammerman

Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she... Read More →

Speakers
SA

Scott Andersen

Principal Research Scientist, Eli Lilly and Company
Scott has been a statistician designing and analyzing neuroscience clinical trials for nearly 20 years. While most of his research has focused on depression and schizophrenia disease states, Scott has spent the last five years working on Alzheimer's Disease. In 2015, Scott co-authored... Read More →
avatar for Jesse Berlin

Jesse Berlin

Vice President and Global Head of Epidemiology, Johnson & Johnson
Jesse Berlin is Vice President of Epidemiology at Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He joined J&J over 11 years ago after spending 15 years at University of Pennsylvania, where he was a Professor of Biostatistics. He has authored... Read More →
avatar for Robert Nelson

Robert Nelson

Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric Therapeutics, OC, FDA
Robert “Skip” Nelson, M.D., M.Div., Ph.D. is currently the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. Prior to joining FDA full-time in 2009, he was Professor of Anesthesiology... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum

4:00pm EDT

#261: Marketing After Amarin and Pacira
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-529-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA regulation of off-label communications by industry sponsors has been under extraordinary scrutiny the past several years, especially since the Supreme Court decision in IMS v. Sorrell and the federal appeals court decision in US v. Caronia. The issue came to a head in the federal district court in New York city last summer that resulted in the decision against FDA in Amarin v. FDA and a similar challenge by Pacira Pharma against FDA. Meanwhile, the FDA has promised regulatory guidances on aspects of off-label communication policy and the US House of Representatives has passed related legislation. This session will review and assess the regulatory importance of these events, including any late breaking news from Congress, the Courts, and the FDA.

Learning Objectives

Identify many of the details of the Amarin and Pacira cases including how they may effect ongoing decision making in Congress, the courts, and FDA; Describe existing and emerging guidance from FDA and how it may change regulatory policy.

Chair

John Kamp

Speaker

Life After Amarin and Pacira: Understanding Off-Label Promotion in 2016
Alexander Varond, JD

Panelist
Jeffrey K. Francer

Panelist
Kellie B. Combs, JD



Chair
avatar for John Kamp

John Kamp

Executive Director, Coalition For Healthcare Communication
Dr. John F. Kamp is Executive Director of the Coalition for Healthcare Communication, a medical marketing trade association with offices in New York City and Washington, DC. He is also Consulting Counsel with the law firm Wiley Rein LLP, and is a widely respected advocate for First... Read More →

Speakers
avatar for Kellie Combs

Kellie Combs

Partner, Ropes & Gray LLP
Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She serves... Read More →
avatar for Jeffrey Francer

Jeffrey Francer

Vice President and Senior Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jeff Francer is Assistant General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he provides advice and advocacy to the Association and its member companies on FDA regulatory and policy matters.
avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv-Mkting, Session

4:00pm EDT

#268: Emerging Biopharma Therapeutic Modalities: Scientific and Policy Implications
Limited Capacity seats available

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

This forum will examine three emerging scientific platforms with potential to drive the next wave of therapeutic innovation. Participants will be presented with how to evaluate new platforms, recognize the hurdles and consider what regulatory pathways and policies are needed to bring these new therapies to patients.

Learning Objectives

Discuss three emerging therapeutic modalities and what aspects make them particularly useful as new therapies; Define the characteristics of each modality that present the most significant near-term challenges and inflection points for greater therapeutic utilization; Recognize what policies are needed to ensure development and delivery of these innovations as new therapeutics.

Chair

Adam Hacker, PhD

Speaker

Microbiome: What Is It and Why Do We Need to Prepare for It?
Adam Hacker, PhD

Regenerative Medicine: How Adaptive Biomedical Innovation Can Support Development of Cell and GeneTherapy Products
Anne-Virginie L. Eggimann, MS

Responding to Global Health Emergencies: A Regulatory Perspective
Luciana Borio, MD



Chair
avatar for Adam Hacker

Adam Hacker

Vice President, Head of Vaccines & Microbiome, Global Regulatory Affairs, Janssen Pharmaceuticals (johnson & Johnson)
Adam Hacker was appointed VP Head of Vaccines & microbiome for Global Regulatory Affairs at Janssen Pharmaceuticals (Johnson & Johnson company) in June 2015. As Head of Vaccines he is responsible for driving regulatory strategy with a focus on the accelerated development of Janssen’s... 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 Anne-Virginie Eggimann

Anne-Virginie Eggimann

Senior Vice President, Regulatory Science, bluebird bio, Inc.
Anne-Virginie joined bluebird bio in 2011 to lead global regulatory strategy and create innovative pathways to accelerate the development of bluebird bio’s gene therapy products. Previously, AV was an Executive Director at Voisin Consulting, leading rare diseases, oncology, and... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol-HealthCare Compl-Law, Session
 
Wednesday, June 29
 

10:30am EDT

#318: Changes to Common Rule Likely Affecting FDA-Governed Research
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: CME 1.00; IACET 1.00; RN 1.00

Although the Common Rule for research does not govern FDA governed clinical investigations, the proposed changes likely will eek over into FDA governed research. This session explores those proposed changes and their expected effects.

Learning Objectives

List key proposed changes to the Common Rule for Research; Contrast changes to FDA's requirements; Hypothesize how changes will affect FDA governed research.

Chair

David Vulcano

Speaker

Industry Perspective
David Vulcano

Industry Perspective
Neil McCullough



Chair
avatar for David Vulcano

David Vulcano

Vice President, Clinical Research Compliance and Integrity, HCA Healthcare, United States
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →

Speakers
NM

Neil McCullough

Executive Vice President, Clinical Quality Compliance, ICON Clinical Research
Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Session |   Trk 01: Clinical Operations, Session

2:00pm EDT

#345: Are State Consumer Fraud Lawsuits Encroaching on FDA’s Regulatory Authority?
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-564-L03-P; CME 1.25; IACET 1.25; RN 1.25

FDA, under the Food, Drug and Cosmetics Act (FDCA), has clear authority over, among other things: (1) the content and format of prescription drug labeling and promotional materials, (2) compliance with current prescription drug, device, and product manufacturing practices, and (3) product withdrawals from the market. Yet, each of these matters has been the subject of recent litigation filed by State Attorneys General under a theory that alleged violations of these federal laws can be brought in state court using broad, generalized state law causes of action, such as state unfair and deceptive practices acts. This forum will discuss how state court juries have been presented with questions that historically have been decided by FDA, such as whether FDA-approved labeling is false, or whether a FDCA violation warrants a warning letter or even more significant actions or penalties. In addition, the consent decrees resulting from these lawsuits can give states FDA-like regulatory authority over health care companies, prospectively.

Learning Objectives

Identify the implications of state involvement in issues historically reserved for FDA on the public health, industry, and the Agency itself.

Chair

Lisa M Dwyer, JD

Speaker

Panelist
JB Van Hollen, JD

Panelist
Sheldon Bradshaw, JD



Chair
avatar for Lisa Dwyer

Lisa Dwyer

Partner, Member of the FDA and Life Sciences Group, King & Spalding
Lisa has more than 15 years experience working with legal and policy matters involving all FDA-regulated products. From 2010-2015, she served in the Commissioner’s Office at FDA as a Senior Policy Advisor, in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner... Read More →

Speakers
avatar for Sheldon Bradshaw

Sheldon Bradshaw

Partner, FDA and Life Sciences Practice; Former Chief Counsel, FDA, King & Spalding
Bradshaw’s practice focuses on providing legal and regulatory assistance to both large multinational corporations and small growth companies regarding products regulated by the FDA. Prior to joining Hunton & Williams in 2007, Bradshaw served as FDA’s Chief Counsel from 2005 to... Read More →
avatar for JB Van Hollen

JB Van Hollen

Former State Attorney General for Wisconsin, Van Hollen Consulting, LLC
Prior to becoming Attorney General for the State of Wisconsin, JB was appointed United States Attorney for Wisconsin’s Western District in 2002 where he served until 2005. He also served as a District Attorney in both Ashland and Bayfield Counties subsequent to serving as both an... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#372: Impact of the European Medicines Agency’s Medical Literature Monitoring Service on Pharmacovigilance Processes
Limited Capacity seats available

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

On July 1, 2015, the European Medicines Agency initiated the monitoring of medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances and entering the relevant information into the EudraVigilance database. One of the key objectives of this initiative is to prevent duplication of cases reported by multiple marketing authorization holders (MAHs) for the same active substance through worldwide literature searches. Other intended benefits are to enhance the efficiency of adverse reactions reporting, improve data quality, contribute to resource savings, simplify processes, and support signal detection activities. This session will discuss the need for MAHs to assess the impact of this initiative on their existing process of literature safety report identification, case processing, and expedited reporting.

Learning Objectives

Identify the salient features of the European Medicine Agency's (EMA) medical literature monitoring (MLM) service; Assess the impact on existing global literature search, case processing, and expedited reporting; Identify measures required to align existing pharmacovigilance processes consequent to the implementation of EMA’s MLM service.

Chair

Vineet Kacker, PhD

Speaker

EMA Medical Literature Monitoring Service: Impact on EU Pharmacovigilance
Vineet Kacker, PhD

Authority-Based Medical Literature Monitoring in the EU: Impact on US and Global Pharmacovigilance
Leonardo Ebeling



Chair
avatar for Vineet Kacker

Vineet Kacker

Managing Director and Co-founder, APCER Life Sciences
Dr. Vineet Kacker is a Pharmacologist having completed his PH.D in 1997 from All India Institute of Medical Sciences in India. After more than 15 years in Academia, he switched his interests to Pharmaceutical Industry in 2000 and since then he has worked in Regulatory and Pharmacovigilance... Read More →

Speakers
LE

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Forum

4:00pm EDT

#366: Infectious Disease Containment and Lessons Learned
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-565-L01-P; CME 1.25; IACET 1.25; RN 1.25

This session will bring together industry, health scientists, and regulators to discuss scientific, regulatory, and other issues related to advancing preparedness for Ebola vaccine development based on the previous year’s experience.

Learning Objectives

Identify important scientific lessons learned from the Ebola outbreak of 2014 and the vaccine development process; Identify scientific and regulatory issues to address future Ebola vaccine development.

Chair

Jinjie Hu, PhD

Speaker

How Can We Develop Medicinal Products for Emerging Disease?
Junko Sato

Regulatory Response and Pathways for Licensure of Ebola Virus Vaccines: FDA Perspective
Sara Gagneten, PhD

Ethical Perspective
Walter Straus



Chair
JH

Jinjie Hu

co-chair of FDAAA International Network committee; Senior Consultant, Biologics Consulting Group
Dr. Hu received her Ph.D. in Comparative Pathology from UC, Davis, followed by postdoctoral fellowship at the NIAID, NIH. She worked at FDA for almost 12 years where she is recognized as the IVD expert on FDA regulation and QSR requirement. She chaired many review committees for 510... Read More →

Speakers
avatar for Sara Gagneten

Sara Gagneten

Associate Div Director, Policy, Office of Vaccines Research and Review, CBER, FDA
Dr. Gagneten completed her graduate studies at the Uniformed Services University for the Health Sciences (USUHS) in Maryland and conducted research in virology and genetic recombination before joining the Office of Vaccines Research and Review (OVRR) at CBER, FDA. Currently she is... Read More →
avatar for Junko Sato

Junko Sato

Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She... Read More →
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 10: Pub Pol/HealthCare Compl/Law, Session
 
Thursday, June 30
 

10:45am EDT

#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-560-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the current status of new treatment, prevention and diagnostic modalities, genetic testing in medical therapies offers promising potential, and public interest is extremely high. What regulations do we need in a convergent regulatory environment?

Learning Objectives

Recognize the huge impact of genetic testing in health care; Identify challenges and opportunities that exist in the current regulatory environment; Realize that many questions about patient rights and privacy still need to be resolved; Conceive the legal framework and the impact it has in today's health care environment.

Chair

Joseph C. Scheeren, PharmD

Speaker

Patient Perspective
Sue Friedman, DVM

Industry Perspective
Morten Sogaard, PhD

Regulator Perspective
Robert Schuck, PharmD, PhD



Chair
avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →

Speakers
SF

Sue Friedman

Executive Director and Founder, Facing Our Risk of Cancer Empowered (FORCE)
Dr. Friedman was a practicing veterinarian in 1996 when she was diagnosed at age 33 with breast cancer and later learned she carried a BRCA2 mutation. She founded the nonprofit organization Facing Our Risk of Cancer Empowered (FORCE) in 1999 to improve the lives of people affected... Read More →
avatar for Robert Schuck

Robert Schuck

Clinical Pharmacologist, Genomics and Targeted Therapy, OTS, CDER, FDA
Robert Schuck, Pharm.D., Ph.D. is a Clinical Pharmacologist in the Genomics and Targeted Therapy Group at the FDA. In his current position, Dr. Schuck contributes to regulatory review of investigational new drug (IND), new drug (NDA), and biologic licensing (BLA) applications to effectively... Read More →
MS

Morten Sogaard

Vice President and Head, Enterprise Scientific Technology Operations, Pfizer Inc
Morten has been with Pfizer since 2009 and is VP, Enterprise-wide Scientific Technology Operations and a member of Pfizer’s R&D leadership team . He oversees technology investment and Pfizer’s human genetics, computational biomedicine, diagnostics and bio-banking organizations... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session