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Monday, September 13
 

9:00am EDT

Promotional Review Morning Workshop - Mock Product Group Activity
In this interactive discussion, attendees will be broken up into small groups which will each be given a unique mock-product and market landscape. These mini committees will be assigned with the task of developing a series of communications through a marketing, medical, regulatory, and legal lens. Attendees will then all come back together, and each group will present their collateral for review and feedback.

Speakers
avatar for Howard Dorfman

Howard Dorfman

Distinguished Visiting Practitioner and Adjunct Professor, Seton Hall University School of Law
Howard L. Dorfman is an Adjunct Professor and Distinguished Practitioner in Residence at Seton Hall Law School where he has taught courses on FDA Regulations, Health Law and Healthcare Compliance and is Founder of H.L. Dorfman Pharmaceutical Consulting, LLC, which provides compliance... Read More →


Monday September 13, 2021 9:00am - 12:00pm EDT

1:00pm EDT

Medical Affairs Afternoon Workshop – Am I doing this right? An Industry Workshop on Compliance
The Pharmaceutical Industry has an ethical obligation to provide fair-balanced scientific information and education about their products, not only to the health care community but to the patients receiving the treatments. PhRMA guidelines provide the guardrails that ensure all are operating with integrity and upholding high ethical standards. There are company variations regarding compliance guidelines, however, at their core, compliant methodologies and guidances are consistent across the pharmaceutical industry.

This workshop will provide discussions on Medical Science Liaison, Manager, Headquarter, and Commercial interactions; and will include a review of the guidelines across the product lifecycle. Understanding compliance is not straightforward, but knowing the basics will provide confidence in performing daily activities. During an interactive discussion, you will have the opportunity to discuss scenarios in a safe space with industry peers and learn to be more comfortable when talking about and asking questions about compliance.


Speakers
avatar for Howard Dorfman

Howard Dorfman

Distinguished Visiting Practitioner and Adjunct Professor, Seton Hall University School of Law
Howard L. Dorfman is an Adjunct Professor and Distinguished Practitioner in Residence at Seton Hall Law School where he has taught courses on FDA Regulations, Health Law and Healthcare Compliance and is Founder of H.L. Dorfman Pharmaceutical Consulting, LLC, which provides compliance... Read More →
avatar for Jaclyn Quilantan

Jaclyn Quilantan

Medical Science Liaison, Kala Pharmaceuticals
Jaclyn is a Medical Science Liaison at Kala Pharmaceuticals. She completed her B.S. in Biology from St. Mary’s University in San Antonio, and her Ph.D. in Biomedical Sciences from the University of North Texas Health Science Center in Fort Worth. After completing her Ph.D. she assumed... Read More →


Monday September 13, 2021 1:00pm - 4:00pm EDT
 
Tuesday, September 14
 

7:30am EDT

Networking Breakfast and Registration
Tuesday September 14, 2021 7:30am - 8:30am EDT

8:30am EDT

Chairperson’s Opening Remarks
Speakers
avatar for Gary M. Wieczorek, BSCHE, MBA

Gary M. Wieczorek, BSCHE, MBA

Director, Regulatory Affairs, U.S. Advertising and Promotion, AbbVie


Tuesday September 14, 2021 8:30am - 8:45am EDT

8:45am EDT

Keynote Presentation: Risk: It’s not a game. How to put handles on assessing and communicating risks in promotional materials
Speakers
avatar for Larry Herring

Larry Herring

Senior Director of Regulatory Affairs, Advertising & Promotion, Merz North America
Larry Herring’s career in healthcare and pharma spans 20+ years and he has held many diverse roles, giving him unique insight into the PRC process. From advertising and promotion review to generic product development and field clinical education, Larry’s expertise has made him... Read More →


Tuesday September 14, 2021 8:45am - 9:15am EDT

9:15am EDT

Building a Promotional Review Process in Small Pharma: “Making the Dream Work” for Your Company’s First Launch
  • The Builders: Heads of Review & Marketing Ops – the promotion review Dynamic Duo
  • The Foundation: Cross-functional relationships – internally within review team and externally with Commercial organization, vendors, other departments
  • The Framework: SOPs and Work Instructions, Ops Manual, review/approval/retention system, meetings, lexicon
  • Executing Organizational Excellence – streamlining to build to process and efficiencies
  • Planning & Execution for Launch…and Beyond

Speakers
avatar for Sunena Wadhwa

Sunena Wadhwa

Director of Marketing Operations, Aurinia Pharmaceuticals
Sunena has over 20 years of experience in pharmaceutical and healthcare operations. She has worked in various organizations from start-up to mid to large sized pharma. While she has led Marketing Operations specifically for over 5 years, she brings a rounded skillset from functions... Read More →


Tuesday September 14, 2021 9:15am - 9:45am EDT

9:45am EDT

Networking Break
Tuesday September 14, 2021 9:45am - 10:15am EDT

10:15am EDT

Panel: Utilizing Metrics & KPI’s to Measure Promotional Review Success
Moderators
avatar for Gary M. Wieczorek, BSCHE, MBA

Gary M. Wieczorek, BSCHE, MBA

Director, Regulatory Affairs, U.S. Advertising and Promotion, AbbVie

Speakers
avatar for Nan Clarke

Nan Clarke

Governance Manager, US Marketing Operations, AbbVie
Nan has been with AbbVie for nine years in roles of increasing in responsibility related to the material review process. Currently Nan is managing the transformation of AbbVie’s PRC Governance structure to maximize agility and transparency. In earlier roles at AbbVie Nan acted as... Read More →
avatar for Viral Desai

Viral Desai

Lead, MAP Strategy & Operations Team, Novartis
avatar for Michael Corrao

Michael Corrao

Project Manager, AbbVie
Project Manager supporting users of the Electronic Review System (Veeva PromoMats) and all reporting on the Material Review Process.
avatar for Georgina Lee

Georgina Lee

Senior Director, Regulatory Affairs Advertising & Promotion and Labeling, Acceleron Pharma
Georgina Lee is currently the Head of Regulatory Advertising and Promotion and Labeling at Acceleron Pharmaceuticals Inc. Over the past 9 years, her focus in industry has been to develop labeling for small molecules and biologics, including the management of REMS materials, and to... Read More →


Tuesday September 14, 2021 10:15am - 11:00am EDT

11:00am EDT

Panel: Soft Skills & Team Building Exercises
Moderators
avatar for Ana Rasack, MBA

Ana Rasack, MBA

Promotional Advertising, Lead - CooperSurgical, Inc., CooperSurgical, Inc.
I, Ana Rasack have an abundance of Advertising and Promotions experience from both Pharma and Medical Device platforms.I bring knowledge, expertise, and a great variety of stories to the table.I am one part Leader, one part Collaborator, one part Mediator, and one part Student; still... Read More →

Speakers
avatar for Lauren Fedinec

Lauren Fedinec

Senior Director, Marketing Operations, Bausch Health Companies, Inc.
Lauren Fedinec joined Bausch Health in February of 2019 to lead the PRC process across the Rx, Device and OTC businesses of Bausch Health.  In January of 2021, she was promoted to lead a newly formed Marketing Operations organization which is comprised of the PRC process as well... Read More →
avatar for Christi Bruce

Christi Bruce

Head, Promotional Excellence & Standards for Advertising & Promotion, Sanofi
Christi joined Sanofi in 2006 and has held several roles increasing in responsibility during her time with the company. She has been responsible for the U.S. Advertising and Promotion process since 2009. Currently, she is head of the Promotional Excellence & Standards group in the... Read More →
avatar for Leeann Bonaventura

Leeann Bonaventura

Director, Promotional Regulatory Affairs, AstraZeneca
I am a biotech profession with over 10 years in the pharmaceutical and biotech industry with the last 8 years in Promotional Regulatory Affairs (PRA).  I am currently a Director of Promotional Regulatory Affairs at AstraZeneca supporting our oncology portfolio.  Therapeutic areas... Read More →


Tuesday September 14, 2021 11:00am - 11:45am EDT

11:45am EDT

Lunch Break
Tuesday September 14, 2021 11:45am - 1:00pm EDT

1:00pm EDT

Triaging Errors in Promotional Material (aka CAPA)
  • Explore organizational norms and structures related to addressing errors in released marketing materials. 
  • Learn about one framework for assessing impact (risk) and commensurate action. 
  • Your turn!  Assess impact on real world scenarios. 
  • Take away some key ideas to discuss with your organization. 

Speakers
avatar for Nan Clarke

Nan Clarke

Governance Manager, US Marketing Operations, AbbVie
Nan has been with AbbVie for nine years in roles of increasing in responsibility related to the material review process. Currently Nan is managing the transformation of AbbVie’s PRC Governance structure to maximize agility and transparency. In earlier roles at AbbVie Nan acted as... Read More →


Tuesday September 14, 2021 1:00pm - 1:30pm EDT

1:30pm EDT

Ensure Quality in your Promotional Review Processes
  • How to save time and money
  • Learn how to prioritize KPIs in your Review Processes
  • How to measure progress and success
  • Shorten the Review Rounds by Delivering Quality Pieces

Speakers
avatar for Christi Bruce

Christi Bruce

Head, Promotional Excellence & Standards for Advertising & Promotion, Sanofi
Christi joined Sanofi in 2006 and has held several roles increasing in responsibility during her time with the company. She has been responsible for the U.S. Advertising and Promotion process since 2009. Currently, she is head of the Promotional Excellence & Standards group in the... Read More →


Tuesday September 14, 2021 1:30pm - 2:00pm EDT

2:00pm EDT

Networking Break
Tuesday September 14, 2021 2:00pm - 2:30pm EDT

2:30pm EDT

Social Media/Mobile DTC Case Study
  • Promotional labeling requirements for social media
  • Compare social media post examples from company account vs. spokesperson account
  • Content and execution considerations for using a spokesperson in product-branded social media ads

Speakers
avatar for Josephine Secnik

Josephine Secnik

Director, Regulatory Affairs, Eli Lilly and Company


Tuesday September 14, 2021 2:30pm - 3:00pm EDT

3:00pm EDT

How the Pandemic has Changed the Future of Promotion
  • Which new trends will stick, and which will pass?
  • You need to be adaptable and ready to quickly change your strategy
  • How do you carry the learnings from the pandemic into a post-pandemic world?

Speakers
avatar for Erin Bell

Erin Bell

Senior Commercial Counsel, Zealand Pharma US, Inc.
Erin is currently at Zealand Pharma US, Inc. where she supports the needs of the US Commercial organization in all aspects of its first launched product, Zegalogue. Erin joined Pear Therapeutics, Inc., a digital health company, where she served as Assistant General Counsel. At Pear... Read More →


Tuesday September 14, 2021 3:00pm - 3:30pm EDT

3:30pm EDT

Interactive Group Discussion
  • A collaborative group activity that will allow attendees to work together to answer a set of questions highlighting major aspects of promotional review operations.
  • Questions to be shared on the conference date

Speakers
avatar for Gary M. Wieczorek, BSCHE, MBA

Gary M. Wieczorek, BSCHE, MBA

Director, Regulatory Affairs, U.S. Advertising and Promotion, AbbVie


Tuesday September 14, 2021 3:30pm - 4:30pm EDT

5:30pm EDT

Cocktail Networking Reception
Tuesday September 14, 2021 5:30pm - 6:30pm EDT
 
Wednesday, September 15
 

8:00am EDT

Breakfast
Wednesday September 15, 2021 8:00am - 9:00am EDT

9:00am EDT

Chairperson’s Opening Remarks
Speakers
avatar for Gary M. Wieczorek, BSCHE, MBA

Gary M. Wieczorek, BSCHE, MBA

Director, Regulatory Affairs, U.S. Advertising and Promotion, AbbVie


Wednesday September 15, 2021 9:00am - 9:15am EDT

9:15am EDT

Panel: Reviewing Promotional Materials on New, Evolving Platforms: A Conversation between Regulatory, Legal, Marketing, and Medical
Moderators
avatar for Moulakshi Roychowdhury, Pharm.D., J.D.

Moulakshi Roychowdhury, Pharm.D., J.D.

Executive Director of Regulatory Affairs, US Advertising & Promotion, Allergan Aesthetics, an AbbVie Company

Speakers
avatar for Marybeth Toscano

Marybeth Toscano

Director, Advertising and Promotion Compliance, Alexion Pharmaceuticals
Marybeth Toscano, PharmD, RPh, RAC is a Director of Global Advertising and Promotion Compliance at Alexion, Astra Zeneca Rare Disease.  She has over 10 years of advertising and promotion experience, in pharmaceutical industry and with the FDA, Office of Prescription Drug Promotion... Read More →
avatar for Elizabeth Kim

Elizabeth Kim

Deputy General Counsel, Mitsubishi Tanabe Pharma
Elizabeth H. Kim is Deputy General Counsel of Mitsubishi Tanabe Pharma companies in North America. She is a former law firm partner and has supported dozens of promotional review committees as both a legal and regulatory reviewer.
avatar for Bonnie Perkins

Bonnie Perkins

Lead, Patient Engagement and Marketing, US Commercial, Alexion Pharmaceuticals
Bonnie Perkins, MBA, has been in pharmaceuticals for over 20 years. She has worked at Biogen, Sanofi Genzyme, Ironwood, and is currently at Alexion Pharmaceuticals. Bonnie has worked in US, international, and global commercial roles in multiple sclerosis, hemophilia, IBS-C, myasthenia... Read More →
avatar for Timothy Roberts

Timothy Roberts

Vice President, Chief Compliance Officer, Amneal Pharmaceuticals


Wednesday September 15, 2021 9:15am - 10:00am EDT

10:00am EDT

Panel: Unbranded Marketing Campaigns
Moderators
avatar for William L. Aprea

William L. Aprea

Head of Healthcare Compliance, Phathom Pharmaceuticals
Bill Aprea serves as the Head of Healthcare Compliance at Phathom Pharmaceuticals, a late clinical-stage biopharma company committed to improving the lives of patients suffering from acid-related gastrointestinal (GI) disorders.  His experience as an attorney within the biopharma... Read More →

Speakers
avatar for Leeann Bonaventura

Leeann Bonaventura

Director, Promotional Regulatory Affairs, AstraZeneca
I am a biotech profession with over 10 years in the pharmaceutical and biotech industry with the last 8 years in Promotional Regulatory Affairs (PRA).  I am currently a Director of Promotional Regulatory Affairs at AstraZeneca supporting our oncology portfolio.  Therapeutic areas... Read More →
avatar for Peena Patel

Peena Patel

Head of Legal, US, HutchMed
Peena K. Patel, Head of Legal - US at HUTCHMED International Corporation, has over fourteen years of experience within the pharmaceutical industry.  Prior to HUTCHMED, she was at Bristol Myers Squibb, through the acquisition of Celgene, where she served as the lead counsel for the... Read More →
avatar for Nikki Pedersen

Nikki Pedersen

Manager, Regulatory Advertising & Promotion, Horizon Therapeutics
Nikki is a Manager, Regulatory Advertising & Promotion at Horizon Therapeutics. Prior to joining Horizon in 2020, Nikki completed a Regulatory Pharmaceutical Fellowship in Drug Advertising and Promotion. Throughout the two-year fellowship, Nikki worked at Purdue University, Johnson... Read More →


Wednesday September 15, 2021 10:00am - 10:45am EDT

10:45am EDT

Networking Break
Wednesday September 15, 2021 10:45am - 11:15am EDT

11:15am EDT

Panel: Strategies for Approaching Payors: HEOR and FDAMA 114
Moderators
avatar for Linda Pollitz

Linda Pollitz

Executive Director, Regulatory Affairs, Advertising & Promotional Labeling, Alkermes
Linda Pollitz has been working in regulatory affairs for 25 years, with a focus on Advertising and Promotion since 2001. She is currently Executive Director of Regulatory Affairs, Advertising and Promotional Labeling at Alkermes. Her regulatory experience includes preparation of US... Read More →

Speakers
avatar for Scott McConnell

Scott McConnell

Vice President Medical Affairs, Chiasma
Scott graduated with a Pharm.D. from Creighton University. He then completed a one-year Pharmacotherapy Residency and a two-year Infectious Diseases Fellowship. He served on faculty at both the University of Arkansas and Creighton University Pharmacy Schools, teaching infectious diseases... Read More →
avatar for Keren Tenenbaum

Keren Tenenbaum

General Counsel, Vice President of Legal & Compliance - U.S., Vifor Pharma
avatar for Elizabeth Mulkey

Elizabeth Mulkey

FDA/Life Sciences Associate, Goodwin
Elizabeth Mulkey is a senior associate in Goodwin’s Technology and Life Sciences groups and a member of the firm’s FDA regulatory practice. She counsels pharmaceutical, biologic, medical device, digital health, and consumer product companies on FDA regulatory compliance issues... Read More →


Wednesday September 15, 2021 11:15am - 12:00pm EDT

12:00pm EDT

Lunch Break
Wednesday September 15, 2021 12:00pm - 1:00pm EDT

1:00pm EDT

Legal Case Study: False & Misleading Information
Speakers
avatar for Howard Dorfman

Howard Dorfman

Distinguished Visiting Practitioner and Adjunct Professor, Seton Hall University School of Law
Howard L. Dorfman is an Adjunct Professor and Distinguished Practitioner in Residence at Seton Hall Law School where he has taught courses on FDA Regulations, Health Law and Healthcare Compliance and is Founder of H.L. Dorfman Pharmaceutical Consulting, LLC, which provides compliance... Read More →


Wednesday September 15, 2021 1:00pm - 1:30pm EDT

1:30pm EDT

Panel: Uniting Your MLR Team with your Legal Team
Moderators
avatar for Linda Kollmar

Linda Kollmar

Executive Director, Global Medical Affairs, Oncology, Merck
Linda Kollmar, MD, FACC is an Executive Director at Merck in Global Medical Affairs, Oncology. She leads the Medical Consult and Review Physician team and is the Patient Advocate Lead for Medical Affairs - Oncology. Her physician team reviews all of Merck’s Oncology promotional... Read More →

Speakers
avatar for Rachel Henderson

Rachel Henderson

Director/Team Leader, Office of Promotion and Advertising Review, Merck
Rachel Henderson has over 22 years of experience in the pharmaceutical industry.  For the last 13 years, she has focused on providing regulatory guidance and education on promotional materials in support of pharmaceutical and biological products in many therapeutic areas.  Rachel... Read More →
avatar for Tessie Kenney

Tessie Kenney

Counsel, Merck
Tessie Kenney has over 15 years of experience in the pharmaceutical industry as both in-house and outside counsel.  She currently serves as Counsel at Merck where she has supported multiple therapeutic areas including oncology, specialty, and chronic care.  Tessie’s work focuses... Read More →
avatar for Kavita Singh Vazirani

Kavita Singh Vazirani

Principal Consultant, Opus Regulatory
Kavita Vazirani is a Principal Regulatory Affairs Consultant with Opus Regulatory Inc. with over 12 years of successful experience in the pharmaceutical industry. In her most recent position, she was a Hematology-Oncology Medical Science Liaison covering the Hematology portfolio at... Read More →
avatar for Elizabeth Lipp

Elizabeth Lipp

Change Management Consultant with Apex Systems, Janssen Pharmaceuticals
Elizabeth Lipp has spent the last 10 years coordinating and running MLR meetings for a variety of pharmaceutical companies. Her background includes writing and editing training materials for pharmaceutical sales and scientific and medical writing and reporting for Genetic Engineering... Read More →


Wednesday September 15, 2021 1:30pm - 2:15pm EDT