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Monday, June 27
 

10:45am EDT

#129: Delivering Value Through Medical Information Metrics
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-530-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000193; RN 1.25

As the pharmaceutical environment becomes increasingly demanding, it is essential for companies to have a clear understanding of their customer needs in order to both anticipate and adequately address them. Speakers will illustrate the value of capturing and reporting environmental insights (medical information inquiries) to help identify customer needs. We will examine different insights that can be gained, based on real examples encountered. Speakers will also demonstrate one approach to collating and presenting qualitative functional metrics for medical information to internal leadership. Such reporting and analysis of insights and metrics can demonstrate the value of medical information to the medical affairs function and strategic planning process.

Learning Objectives

Discuss how tracking medical information inquiries can identify environmental insights and trends; Illustrate the value of gathering and communicating qualitative functional medical information metrics to stakeholders; Describe the potential contribution of medical information insights and metrics to strategic and operational planning.


Chair

Sara Doshi, PharmD

Speaker

Delivering Value Through Medical Information Metrics
Dipti Tankala, PharmD, RPh

Effective and Efficient Use of Customer Interactions Data to Anticipate Customer Needs Through Text Analytic Metrics
Edward J. Brauer, PharmD

Tools for Data Insights in Medical Information
Zachary Furqueron, MBA



Chair
avatar for Sara Doshi

Sara Doshi

Director, Medical Information Strategy and Capabilities, GMI, Eli Lilly and Company
Sara graduated with her PharmD from Butler University and then completed the Purdue University/Eli Lilly and Company Drug Information Residency. She then accepted a role with Global Medical Information (GMI) at Lilly. Sara spent several years supporting numerous products/therapeutic... Read More →

Speakers
avatar for Edward Brauer

Edward Brauer

US ML/RML Strategy and Capabilities Fellow, Lilly USA, LLC
Edward Brauer received his PharmD degree from the University of Southern California in 2015 and received his undergraduate degree in Chemistry from Fresno State in 2010. Currently Edward is a US MSL/RML Strategy and Capabilities Fellow within the US Medical Affairs department at Eli... Read More →
ZF

Zachary Furqueron

Director/Team Leader, Analytics and Reporting Group, External Medical Comm, Pfizer Inc
Zachary has over 20 years of experience at Pfizer, and currently serves as the Director, Team Leader of the Analytics and Reporting group within the company’s Medical Division. In this role he oversees the analytics and reporting activities on behalf of several external-facing functions... Read More →
avatar for Dipti Tankala

Dipti Tankala

Associate Medical Information Manager, Astellas Pharma Canada Inc.
Dipti received her Bachelors of Science in Pharmacy and Doctor of Pharmacy Degree from the University of Toronto in 2013. She went on to complete a specialty Industrial Pharmacy Residency in Medical Information at Eli Lilly Canada for and won the 2014 Residency Award. Currently, Dipti... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am EDT

#213: FDA Enforcement Update: Advertising and Promotion
Limited Capacity seats available

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-527-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA enforcement actions and policy guidances need to be understood by every company because they reflect FDA's priorities and concerns in regulating advertising and promotion. In this forum, FDA representatives will examine the latest agency enforcement actions and policies and what they mean.

Learning Objectives

Describe the latest FDA enforcement actions and policy initiatives in the area of advertising and promotion; Explain what the enforcement actions reflect about FDA policies and priorities.

Chair

Philomena McArthur, JD

Speaker

CDER Perspective
Thomas W. Abrams

CBER Perspective
Lisa L. Stockbridge, PhD



Chair
avatar for Philomena McArthur

Philomena McArthur

Vice President Global Policies, Procedures & Training, Healthcare Compliance & P, Johnson & Johnson International
Philomena McArthur's diversified experience spans 25 yrs. She currently oversees the Regulatory Advertising & Promotion Dept. in Health Care Compliance supporting the Janssen Pharmaceutical companies of Johnson & Johnson, for whom she has worked for 10 yrs. Philomena has held a variety... Read More →

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. He joined FDA as a reviewer in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical... Read More →
avatar for Lisa Stockbridge

Lisa Stockbridge

Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA
Dr. Stockbridge is chief of the Advertising and Promotional Labeling Branch in CBER’s Office of Compliance and Biologics Quality. Her team reviews promotional labeling and advertising, proprietary names, and product labeling. With over 15 years of experience in both CDER’s DDMAC... Read More →


Tuesday June 28, 2016 10:30am - 11:30am EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv/Mkting, Forum

2:00pm EDT

#238: Prescription Drug Marketing Regulatory Primer
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-16-528-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interactive workshop will provide a basic introduction to the regulation of prescription drug advertising and promotion. It will cover such important information as fair balance, required claim support, comparative claims, preapproval activities, and medical conventions.

Learning Objectives

Discuss important environmental forces and agencies impacting the regulation of prescription drug promotion; Apply advertising and promotional regulations to advertising/marketing materials; Explain the importance of reviewing FDA regulatory letters as they apply to these regulatory decisions.

Chair

Lucy Rose, MBA

Speaker

FDA Perspective
Thomas W. Abrams



Chair
avatar for Lucy Rose

Lucy Rose

President, Lucy Rose and Associates, LLC

Speakers
avatar for Thomas Abrams

Thomas Abrams

Director, Office of Prescription Drug Promotion, OMP, CDER, FDA
Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. He joined FDA as a reviewer in DDMAC. Prior to joining FDA, Mr. Abrams worked in pharmaceutical... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 05: Reg of Prod Adv/Mkting, Session

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