medical & scientific communications 2015 annual forum...3 pharmacy credit breakdown core...

DIA Global Center: Washington, DC, USA | Basel, Switzerland | Beijing, China Horsham, PA, USA | Mumbai, India | Tokyo, JapanDIAGlobal.org

800 Enterprise Road Suite 200 Horsham, PA 19044 USA

OVERVIEW

This is a must-attend annual forum for Medical Communication, Medical Information, Medical Science Liaisons, and Medical Writing Professionals. The cross-functional general session and five breakout tracks encompass all areas including medical information, medical science liaison, medical communications, medical call center, and medical writing, so you can gain further expertise and networking opportunities in your own area as well as different functional areas. Nowhere else can you network with all these professionals in one location. This content is developed to meet the needs of those who work in pharmaceutical based medical scientific communications by including three central tracks covering:

• Medical Communications

• Medical Writing Regulatory and Publication

• Medical Science Liaisons

FORUM HIGHLIGHTS:

• Three Central Tracks: Medical Communications, Medical Writing Regulatory and Publication, and Medical Science Liaisons

• Five Breakout Tracks Focused on Medical Information, Medical Science Liaisons, Medical Call Centers, and Medical Writing (Regulatory and Publication)

• Presentation of Best Practices via Podium Pearls and Posters

• Presentation of Original Research from Fellows and Residents in Specifically Focused Forum for Fellows and Residents in Training

• Special Resident, Fellow, and Preceptor Sessions (new this year)

• Exhibit Hall with 30 Exhibiting Companies

Medical & Scientific Communications 2015 Annual Forum

PROGRAM CO-CHAIRS:Eileen Girten, MSPrincipal Medical WriterinVentiv Health Clinical

Craig Klinger, RPhConsultant Medical Liaison Strategy and Capabilities - Trainer Lilly USA, LLC

Darryl L’Heureux, PhD, MSPharm, MScPrincipal WriterMedSciTech Writing

Carrie C. Murray, PhD, NPDirectorGlobal Brand ManagerBayer

Mary Sendi, PharmDDirector -Team Lead Cardiovascular & General MedicinePfizer Medical InformationPfizer, Inc.

Jim Wilkinson, PhDExecutive DirectorGlobal Scientific AffairsAmgen, Inc.

PROGRAM COMMITTEE:Vickee Altman, MEd, BSN, RNMSA National MSL ManagerRoche Diagnostics

Maureen L. Baldwin, MSN, RNAssociate DirectorMedical Customer InterfaceMedical InformationPfizer, Inc.

Ian BancroftOwnerTardis Medical Consultancy

J. Lynn Bass, PharmDDirector, Medical AffairsJazz Pharmaceuticals

Poonam A. Bordoloi, PharmD Senior ManagerMedical Information ServicesInternal Medicine and BioSurgerySanofi US

David Bowers, PharmDDirector, Medical CommunicationsPPD

Ivy Chang, PharmDAssociate Director Medical CommunicationsGenentech, Inc., A Member of the Roche Group

Christine Dale, MS, MBAIndependent Contract WriterXWrite, LLC

Pete Fairfield, MBAScientific Communications ConsultantEli Lilly and Company

Pete Guillot, MBA, RACPresidentCenter First Consulting, LLC

Kevin Henderson, PharmD, MBA Medical Science LiaisonGenentech, Inc., A Member of the Roche Group

Jihwon Im, PharmDPrincipal ScientistManaged Care Medical Medical CommunicationsGenentech, Inc., A Member of the Roche Group

Leena Jindia, MS, PharmDDirector, Medical InformationJanssen Scientific Affairs

Matt Joyce, PhDManager, Medical LiaisonsLilly USA, LLC

Monica Kwarcinski, PharmDExecutive Director, Medical ServicesPurdue Pharma LP

Juan C. Nadal, MDVice PresidentMedical CommunicationsMedical AffairsBayer Healthcare Pharmaceuticals

Valerie Perentesis, PharmDSenior Director Pharmacovigilance Evaluation, Reporting and SystemsJanssen Research & Development, LLC

Julia Petses, PharmDDirectorMedical Information ServicesOncologySanofi U.S.

Timothy E. Poe, PharmDDirectorTEP Consulting, LLC

Beth A. PriceExecutive Vice PresidentThe Medical Affairs Company

Jane Stephenson, PhD, MBADirectorMedical WritingBoehringer Ingelheim Pharmaceuticals, Inc.

Carri Taylor, MBAManager Medical WritinginVentiv Health Clinical

Rebecca A. Vermeulen, RPhSenior Director, BioOncology Medical Science Liaisons Genentech, Inc., A Member of the Roche Group

Robin WhitsellPresidentWhitsell Innovations, Inc.

Ann Winter-Vann, PhDSenior Medical Writer and ConsultantWhitsell Innovations, Inc.

Core Curriculum: March 15 | Tutorials (AM): March 16 Forum: March 16-18

Renaissance Glendale Hotel and Spa | Glendale, AZ

As of March 10, 2015

This program has been developed in collaboration with the Medical Communications, Medical Writing, and Medical Science Liaison Communities.

http://DIAGlobal.org

http://www.diahome.org/en-US/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=3694319&EventType=Meeting&utm_source=Program&utm_medium=Banner&utm_campaign=15006_OnlineProgram

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CONTINUING EDUCATION CREDITS

DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 23.5 contact hours or 2.35 continuing education units (CEU’s).

ACPE CREDIT REQUESTS MUST BE SUBMITTED BY THURSDAY, APRIL 30, 2015DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. If ACPE credit is not requested by Thursday, April 30, 2015, the CEU request will not be transmitted through to the CPE Monitor. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

Corexcel is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.Corexcel designates this activity for a maximum of 26 contact hours.

DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer up to 2.6 CEUs for this program. Participants must attend the entire program, core curriculum, tutorial, conference, if applicable, in order to

be able to receive an IACET statement of credit. No partial credit will be awarded. If you would like to receive a statement of credit, you must attend the forum, core curriculum, and/or tutorials, if applicable, scan your name badge at each session, core curriculum and/or tutorial you attend, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.DIAGlobal.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, April 1, 2015.

Please Note: If you do not scan your badge at each session you attend, you will not be able to request continuing education credits for that portion of the program.

It is DIA’s policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Speaker disclosures will be included in the course materials.

CONTINUING EDUCATION CREDIT ALLOCATION

CORE CURRICULUM:Pharmacy 6.75 contact hours or .675 CEUs; Nursing 6.75 contact hours; IACET .7 CEUs

TUTORIALS:AMWA Workshop - Fundamentals of Ethics and Practical Applications: Nursing 3.5 contact hours; IACET .4 CEU

Medical Communications: Compliance in 2015: Pharmacy 3.25 contact hours or .325 CEUs; Nursing 3.25 contact hours; IACET .3 CEUs

Medical Science Liaison Tutorial – The Basics for Success: Nursing 3.25 contact hours; IACET .3 CEUs

FORUM: Pharmacy up to 13.5 contact hours or 1.35 CEUs; Nursing up to 16 contact hours; IACET 1.6 CEUs

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Thank You to Our Media Partners!


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Pharmacy Credit Breakdown

Core Curriculum6.75 contact hours or .675 CEUs, 0286-0000-15-024-L04-P, Knowledge

Tutorials

Medical Communications: Compliance in 2015: 3.25 contact hours or .325 CEUs, 0286-0000-15-025-L04-P, Knowledge

Forum

Session 2A-B: Overview of Recent FDA Guidances Relevant to Medical Communications: 1.5 contact hours or .15 CEUs, 0286-0000-15-028-L04-P, Knowledge

Session 2C-D: Demonstrating Value through Health Economics and Outcomes Research: 1.5 contact hours or .15 CEUs, 0286-0000-15-029-L04-P, Knowledge

Session 2E: The New Face of Health Care: 1.5 contact hours or .15 CEUs, 0286-0000-15-057-L04-P, Knowledge

Session 3A-B: The Use of Technology for Innovative Solutions in Medical Communications: 1.5 contact hours or .15 CEUs, 0286-0000-15-031-L04-P, Knowledge

Session 3C: Pediatric Drug Development: The Good, The Bad, The Necessary: 1.5 contact hours or .15 CEUs, 0286-0000-15-032-L01-P, Knowledge

Session 3E: Safety and Risk Mitigation and the MSL: 1.5 contact hours or .15 CEUs, 0286-0000-15-033-L04-P, Knowledge

Session 4A-B: Hot Topics: Insights Across Medical Communications: 1.5 contact hours or .15 CEUs, 0286-0000-15-034-L04-P, Knowledge

Session 4E: National Physician Payment Transparency Program – How Does This Impact MSL Relationships: 1.5 contact hours or .15 CEUs, 0286-0000-15-035-L03-P, Knowledge

Session 5A-B: Driving Value of Medical Information through Actionable Customer Insights and Exceptional Services: 1.5 contact hours or .15 CEUs, 0286-0000-15-036-L04-P, Knowledge

Session 6A: Medical Communications in the Evolving Payer Landscape: Demonstrating Product Value and Outcomes to Payers: 1.5 contact hours or .15 CEUs, 0286-0000-15-037-L04-P, Knowledge

Session 6C: Topics of Special Interest for Regulatory Writers: 1.5 contact hours or .15 CEUs, 0286-0000-15-038-L04-P, Knowledge

Session 6E: The Shift in the Provision of Medical Information to Health Care Professionals - Are We at the Precipice of Change?: 1.5 contact hours or .15 CEUs, 0286-0000-15-047-L04-P, Knowledge

Session 7A: PhACTs & Collaborations: 1.5 contact hours or .15 CEUs, 0286-0000-15-039-L04-P, Knowledge

Session 7C: Safety is at the Core: Impact of Core RMP on Labeling and PBRERs: 1.5 contact hours or .15 CEUs, 0286-0000-15-040-L04-P, Knowledge

Session 7E: The Complex World of Integrated Health Care Systems: 1.5 contact hours or .15 CEUs, 0286-0000-15-041-L04-P, Knowledge

Session 8D: Who Owns Social Media? The FDA, Pharma, and the Medical Community Look for Answers: 1.5 contact hours or .15 CEUs, 0286-0000-15-042-L04-P, Application

Session 10B: Current Compliance Landscape (Enforcement, Sunshine Act and CIA’s) As they Relate to Medical Affairs (Med Comm and MSL) Activities: 1.5 contact hours or .15 CEUs, 0286-0000-15-044-L04-P, Knowledge

Session 10E: MSL Technology Session: 1.5 contact hours or .15 CEUs, 0286-0000-15-045-L04-P, Knowledge

Session 11A: Promotional Review Committees – Medical Communications as a Successful Team Member: 1.5 contact hours or .15 CEUs, 0286-0000-15-046-L04-P, Knowledge

Continuing pharmacy education credits are NOT AVAILABLE for the following tutorial/sessions:

• Tutorials: Fundamentals of Ethics and Practical Applications and Medical Science Liaison Tutorial – The Basics for Success

• Sessions: Welcome and Opening Remarks; Opening Plenary - Session 1; DIA Publication Sessions; 3D; 4C-D; Special Resident, Fellow, and Preceptor Sessions, 5C; 5E; 6B; 6D; Resident and Fellow Poster Reception; 7B; 7D; 8A-B; 8C; 8E; 9; 10A; 10C; 10D; 11B; 11C-D; 11E

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of DIA. Speakers, agenda, and CE information are subject to change without notice. Recording of any DIA educational material in any type of media, is prohibited without prior written consent from DIA.

View DIA’s Grievance Policy, at www.DIAGlobal.org/CE.

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Follow #DIAMSC for Updates @DrugInfoAssn

http://www.DIAGlobal.org/CE


https://twitter.com/DrugInfoAssn

https://www.linkedin.com/company/dia

https://www.youtube.com/user/DrugInfoAssoc

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http://instagram.com/druginfoassn/

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SUNDAY, MARCH 15

8:30am-4:45pm CORE CURRICULUM

CHAIR:

Jihwon Im, PharmDPrincipal ScientistManaged Care Medical CommunicationsGenentech, Inc., A Member of the Roche Group

SPEAKERS:

Wynter Balcerski, PharmDSenior ManagerOncology Medical Information ServicesSanofi U.S.

Michael Cuozzo, PharmDSenior Medical DirectorMedical Affairs and Medical Information ServicesIncyte Corporation

Kristin Goettner, PharmDAssociate Director Medical Information & ServicesJanssen Scientific Affairs, LLC

Ellen Guthrie, BS Pharm, PharmDMedical Information Specialist (Oncology)Med CommunicationsAstraZeneca

Margaret May, MLS, AHIPLiterature Research AnalystUS Medical Affairs Genentech, Inc., A Member of the Roche Group

Jennifer Totten, PharmDSenior Scientific Communications SpecialistActavis

This activity is specifically designed to meet the needs of individuals new to biopharmaceutical industry-based Medical Communications. Attendees will discuss skill sets that provide value to both internal and external customers. Those who have been in their functional role for less than one year would gain the most from attending.

Core Curriculum Learning Objectives:

At the conclusion of this activity, participants should be able to:

• Describe how the regulatory environment influences Medical Communications practice

• Identify critical steps that a Medical Communications professional should take when receiving an unsolicited inquiry, including evaluating the available data and sources of information

• Describe the important elements of writing a concise and clear standard response letter

• Recognize key biomedical literature resources for answering medical information inquiries including strategies and techniques for finding literature to answer medical information questions

• Discuss medical information roles and responsibilities at medical congresses

• Recognize the differences and similarities between the roles of Medical Communications and Medical Science Liaisons including ways to share information and resources and share best practices and ideas for collaboration to enhance productivity and value for both organizations

• Discuss ways that Medical Communications professionals can support the needs of managed care customers and understand the background, content, and purpose of the AMCP Formulary Dossier

• Describe the distinct scientific value that Medical Communications provides on promotional review committees

8:30-11:30am CORE CURRICULUM – SESSION 1

8:30–9:00am WELCOME AND INTRODUCTIONS

Jihwon Im, PharmD

Following opening remarks, the Core Curriculum speakers will introduce themselves to the attendees and provide descriptions of their career paths leading to their current roles in Medical Communications. The speakers will then describe their current responsibilities, allowing the audience to begin to see similarities and differences in the practice of Medical Communications across the industry.

9:00–10:15am AN INTRODUCTION TO THE US REGULATORY ENVIRONMENT AND MEDICAL COMMUNICATIONS PRACTICES

Kristin Goettner, PharmD

This session describes how the US regulatory environment impacts Medical Communications within the pharmaceutical industry. An introduction to key concepts in Medical Communications practice based on FDA statutes, regulations, policies and guidance will be provided. In addition, useful regulatory resources that are accessible in the public domain will be shared.

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10:15–10:30am REFRESHMENT BREAK

10:30–11:00am BEST PRACTICES FOR HANDLING MEDICAL INQUIRIES

Michael Cuozzo, PharmD

This session identifies the critical steps that a Medical Communications professional should take when receiving an inquiry, evaluating the sources of information/data available when preparing a response, and the importance of fair balance and documenting responses.

11:00–11:30am UNSOLICITED REQUEST CASE SCENARIO ROUNDTABLE DISCUSSIONS

11:30am–12:30pm LUNCH

12:30-4:15pm CORE CURRICULUM – SESSION 2 AND 3

These two sessions will delve deeper into the challenging aspects of six different areas of our industry practices. This includes activities such as literature searching and medical writing. Topics will also include scientific congress support, collaborations with Medical Science Liaisons, AMCP formulary dossier communications, and promotional review.

12:30–2:15PM SESSION 2

1. 30 Literature Searching Tips in 30 Minutes

Margaret May, MLS, AHIP

2. Tips for Effective Medical Writing

Ellen Guthrie, BS Pharm, PharmD

3. Medical Congress Planning and Medical Information Booth Support

Wynter Balcerski, PharmD

2:15–2:30pm REFRESHMENT BREAK

2:30–4:15pm SESSION 3

1. Medical Communications and Medical Science Liaisons: Opportunities for Collaboration

Jennifer Totten, PharmD

2. AMCP Dossier and the Managed Care Perspective

Jennifer Totten, PharmD

3. Promotional Review Committee Overview

Jihwon Im, PharmD

4:15-4:45pm Q&A WITH CORE CURRICULUM SPEAKERS

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1:15-5:00pm PREFORUM TUTORIAL

TUTORIAL #4

AMWA Workshop - Fundamentals of Ethics and Practical Applications (RR) [4020]

FACULTY:

Art Gertel, PhDPresident and Principal ConsultantMedSciCom, LLC

Ethical considerations associated with conducting clinical research will be explored in this workshop intended for medical writers, editors, and researchers with some experience reviewing, analyzing, and communicating data-regulated therapeutic development activities. The workshop will consist of short presentations on relevant ethical issues with respect to therapeutic (drug, device, vaccine) clinical trials, and group discussions on major ethical considerations of some case studies. Topics include the importance of ethics in good clinical practice (GCP), the informed consent process and the challenges that may arise in developing countries, the infrastructure of ethics committees, and data safety monitoring committees. Throughout, the workshop will focus on the central ethical issue in clinical study conduct: to ensure subject safety and well-being. Precourse Review Materials will be distributed prior to the tutorial/workshop. NOTE: This workshop or Ethics of Communicating Regulated Drug Development Activities is required to complete the Regulatory and Research specialty certificate.

TUTORIAL LEARNING OBJECTIVES:

At the conclusion of this tutorial, participants should be able to:

• Discuss the foundations of ethics

• Explain how ethical decisions may be influenced by context and experience

• Discuss the viewpoint of the clinical study subject in educating clinical study staff as to ethical considerations

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Join the Global Community

Join a DIA community to exchange knowledge,

network with professional colleagues, and share

best practices. DIA communities are essential in

developing programming for offerings, cultivating

content, and connecting with other volunteers.

Find out more at DIAGlobal.org/Community


http://DIAGlobal.org/Community

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MONDAY, MARCH 16

7:30-8:30am REGISTRATION AND CONTINENTAL BREAKFAST

8:30am-12:00pm PREFORUM TUTORIALS

TUTORIAL #1

Medical Communications: Compliance in 2015CHAIR:

Monica Kwarcinski, PharmDExecutive DirectorMedical ServicesPurdue Pharma, L.P.

SPEAKERS:

Mark A. DeWyngaert, PhD, MBAManaging DirectorHuron Consulting Group

Monica Kwarcinski, PharmDExecutive DirectorMedical ServicesPurdue Pharma, LP

The compliance obligations within the pharmaceutical industry continue to increase each year. Now more than ever it is critical that Medical Communication departments have policies and procedures that address such things as medical inquiry and response documentation, staff training, and monitoring / audit programs. Whether you have been in Medical Communications for a few months or a few decades this tutorial will provide an overview of what policies, procedures and programs Medical Communications departments should consider implementing to help ensure compliance and mitigate risk. This will be an interactive tutorial with opportunity for discussion and questions from the audience.

LEARNING OBJECTIVES:


• Discuss compliance hot topics in Medical Communications such as medical inquiry documentation, response development and documentation, Sunshine Act reprint reporting requirements, staff training, and sales force facilitated inquiries

• Describe what policies and procedures the Office of Inspector General (OIG ) is requiring Medical Communications departments to have in place based on recent Corporate Integrity Agreements (CIA)

• Identify the factors to consider when developing, implementing, and maintaining QA, compliance, and training programs

• Describe how to mitigate risk in Medical Communications

DIAGlobal.org

Download the Free DIA Global App Today!

To download, search for “DIA Global” in your app store.

Access the MSC 2015 App:• Sign in with the Email Address You Registered

for MSC 2015• Click on the Events Icon• Select Medical and Scientific Communications

2015 Annual Forum

The DIA Global app is designed to enhance your meeting experience and provide valuable information in one place. Create your session agenda, network with Attendees and Exhibitors, and connect to DIA resources, social media channels, member communities, and more.

Download the Free DIA Global App Today!The DIA Global app is designed to enhance your meeting experience and provide valuable information in one place. Create your session agenda, network with Attendees and Exhibitors, and connect to DIA resources, social media channels, member communities, and more.

Access the MSC 2015 App:• Sign in with the Email Address You Registered for MSC 2015• Click on the Events Icon• Select Medical and Scientific Communications 2015 Annual Forum

To download, search for “DIA Global” in your app store.



TUTORIAL #2

Medical Science Liaison Tutorial – The Basics for SuccessCHAIR:


SPEAKERS:

J. Lynn Bass, PharmDDirectorMedical AffairsJazz Pharmaceuticals

Robin L. Winter-Sperry, MDPresident and Chief Executive OfficerScientific Advantage LLC

Kevin Appareti, MBASenior DirectorGlobal Medical Science LiaisonPhilips Healthcare

Rebecca A. Vermeulen, RPhSenior DirectorBioOncology Medical Science LiaisonsGenentech, Inc., A Member of the Roche Group

This tutorial will help new and experienced MSLs learn the basic needs to be a successful MSL. Topics covered will include:

1. Thought leader identification techniques and relationship development skills

2. How to build strong internal partnerships and communicate effectively to exchange information

3. Basic business acumen ranging from geographic management, adapting to customer social styles, appropriate communication (internally and externally), working with sales colleagues, and managing daily administrative tasks



• Describe the current challenges MSLs face when starting a career as a MSL

• Examine best practices to be a successful MSL, ranging from identification of thought leaders, to partnering with internal business colleagues

• Discuss how to implement techniques to better manage a career as a MSL in the field

12:00-1:00pm LUNCH BREAK

**Please note: Lunch is not provided by DIA.

DIAGlobal.org 8







For more information, contact:

Jessica McGrory 215.442.6182 [email protected]

Linda Belmont 215.293.5818 [email protected]

Learn more at DIAGlobal.org/

AccelMSC

Medical & Scientific Communications Accelerated Professional DevelopmentDIA’s Medical & Scientific Communications Accelerated Certificate Program is designed to develop the skills used by professionals and experts working in the Medical Communications, Medical Writing, Medical Liaison, Medical Information, and Medical Call Center environment. This accelerated certificate program is a valuable educational platform to enhance your skills and demonstrate your commitment to lifelong learning.

Benefits of this Program:

• Accelerated pathway to complete the certificate program in 2015

• A certificate upon completion of the program requirements by December 31, 2015

• Customize your package with the choice of face-to-face meetings, training courses, and online learning to best meet your needs

• Flexible scheduling with multiple offerings per year

Package includes the DIA Medical & Scientific Communications 2015 Annual Forum and the

DIA 2015 51ST Annual Meeting as options towards completion of the program

This Accelerated Certificate Program will provide the fundamental skills you need to excel at your job.

Package Price: $2,500

NEW

FROM DIA

9DIAGlobal.org

1:00-1:30pm WELCOME AND OPENING REMARKS

Susan A. CantrellSenior Vice President and Managing DIrectorDIA Americas

PROGRAM CO-CHAIRS:

Jim Wilkinson, PhDExecutive DirectorGlobal Scientific AffairsAmgen, Inc.



1:30–3:00pm OPENING PLENARY – SESSION 1

Keynote Presentation (Remote)

The Voice of the Patient

Patricia FurlongFounding President and CEOParent Project Muscular Dystrophy

3:00–3:30pm REFRESHMENT BREAK/EXHIBITS

http://DIAGlobal.org/AccelMSC




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3:30–5:00pm BREAKOUT SESSIONS 2

MEDICAL COMMUNICATIONS TRACK 2A-B

Overview of Recent FDA Guidances Relevant to Medical Communications

CHAIR:

Monica Kwarcinski, PharmDExecutive DirectorMedical ServicesPurdue Pharma L.P.

Over the last few years FDA has issued several draft guidances that are relevant to the practice of medical communications within industry. While these guidances are still draft they do provide FDA’s current thinking on topics such as dissemination of reprints on off-label uses or new risk information for approved drugs, responding to unsolicited requests for off-label uses of approved drugs or devices and correcting misinformation found in social media. This session will provide an overview of recent FDA guidances as well as an update on anticipated guidances on scientific exchange and dissemination of health care economic information.


At the conclusion of this session, participants should be able to:

• Explain where to access the most current information about FDA guidances

• Describe recent FDA guidances relevant to industry medical communications

• Describe what guidances FDA is planning on developing in 2015 that impact the practice of industry medical communications

SPEAKERS:

Monica Kwarcinski, PharmDExecutive DirectorMedical ServicesPurdue Pharma L.P.

Robin Whitsell President Whitsell Innovations, Inc.

MEDICAL WRITING REGULATORY AND PUBLICATION TRACKS 2C-D

Demonstrating Value through Health Economics and Outcomes Research

CHAIR:


Recent changes to the reimbursement landscape around the world have elevated the importance of Health Economics and Outcomes Research (HEOR) within the pharmaceutical industry. As a result of new demands from payers and Population-Based Decision Makers (PBDMs), market access considerations are now seen as integral to drug development from its earliest stages and throughout its life cycle. One example of these changes is the creation of new payment models in the United States that incentivize quality and value rather than quantity of services. In addition to clinical attributes such as safety and efficacy, payers and PBDMs increasingly require evidence supporting the real-world use of a drug, including patient experience, medication adherence, comparative effectiveness, and cost implications. The combination of clinical and real-world attributes represents the value proposition of a new technology. Throughout industry, HEOR is responsible for designing, executing, and disseminating research that provides insight into these questions. The reimbursement dossier is a single document that communicates the value proposition of a new medicine to relevant stakeholders. It is essential for medical communicators working on any HEOR-related work to understand the role of that work within the context of the value proposition. Furthermore, communicators must have a basic understanding of methodologies unique to real-world data generation and economic modeling.



• Recognize the evolution of HEOR in drug development and changing roles

• Identify value-based components of HEOR

• Discuss how to apply methodologies relevant to real-world data generation methodologies relevant to real-world data generation

• Compare different economic evaluations and cost-effectiveness

SPEAKERS:


Matthew MonbergDirectorOutcomes ResearchMerck and Company

Tom Lang, MAPrincipalTom Lang Communications & Training International

To the right is the key for all breakout sessions throughout the entire forum. Please note that you are free to attend breakout sessions in any track based upon your level of interest and the topics that are offered.

Breakouts A and B - Medical Communications TrackBreakouts C and D - Medical Writing Regulatory and Publication TracksBreakout E - Medical Science Liaisons Track

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MEDICAL SCIENCE LIAISONS TRACK 2E

The New Face of Health Care

CHAIR:

Vickee Altman, MEd, BSN, RNMSA National MSL ManagerRoche Diagnostics

The basics of health care have not changed: right diagnosis, right treatment, right time. This reflects an early concept of “personalized care” recognizing that “one size does NOT fit all” when managing patient care. Today the face of health care continues to evolve including increasing expectations that patients will have access to the “right” diagnostic and treatment strategies at the most efficient cost, all while finding a way to improve overall health economics. The goal is to assure that every eligible patient is identified and is tested by the appropriate diagnostic test leading to selection and administration of the correct pharmaceutical or other intervention at a per capita cost that is sustainable.

The question, “How does this evolving new face of health care impact the MSL?”

The speakers will explore the following specific areas related to this question:

• Multispecialty Care & Delivery Increases Key Stakeholders

• Expanding Definition from Individual to Organizations and from Clinicians to Administrators

• Informatics Driving Integration Across Modalities

• Molecular Imaging Biomarkers for Clinical Trials and Patient Management

• Power, “Where Does It Sit?”

• Risk, “How Is It Shifting?”

• Impact on KOL Access and Engagement Strategies



• Identify how the evolving face of health care impacts the role of a Medical Scientific Liaison

• Discuss and differentiate the expanding definition from individual to organizations and from clinicians to administrators in today’s personalized health care environment

• Appraise the potential future shift in “risk” related to multidisciplinary care and an increase in key stakeholders

• Summarize the impact on KOL engagements and develop an engagement strategy

SPEAKERS:

Kevin Apparetti, MBASenior DirectorGlobal MSL for the Office of Medical and Health AffairsPhilips Healthcare

LisaAnn TrembathAssociate Director Clinical Imaging OperationsAvid Radiopharmaceuticals, Inc.

Earn CMPP credits for attending select sessions*! This is your opportunity to attain additional credits towards your CMPP recertification. Please be sure to visit www.ismpp.org/recertification for a full list of pre-approved activities. *Sessions reviewed and determined credit-eligible by ISMPP

5:00-6:00pm NETWORKING RECEPTION/EXHIBITS






http://www.ismpp.org/recertification

http://www.ismpp.org/recertification

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TUESDAY, MARCH 17, 2015

7:30-8:30am REGISTRATION/CONTINENTAL BREAKFAST/EXHIBITS

8:00–8:30am DIA PUBLICATIONS SESSION

Add “published author” to your accomplishments! Judy Connors, Associate Director of Editorial Services and Managing Editor of DIA’s official peer-reviewed journal, Therapeutic Innovation & Regulatory Science (TIRS) along with TIRS Associate Editor, MaryAnn Foote,

PhD, will discuss the submission and peer-review process for this publication. Other publication opportunities with DIA, including article submission to our association news magazine, the Global Forum and content development for the DIA website will also be discussed.

51ST Annual MeetingJ U N E 1 4 – 1 8 | W A S H I N G T O N , D C

DIA 2015

| Develop | Innovate | Advance

2015 PROGRAM CO-CHAIRS:

Christopher P. Austin, MDDirector, National Center for Advancing Translational SciencesNational Institutes of Health (NIH)

Michael Rosenblatt, MDExecutive Vice President and Chief Medical OfficerMerck & Co., Inc.

Tailored Offerings Related to YouThe DIA 2015 51st Annual Meeting gives you a rare opportunity to join a global network of life sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients. As one of the 7,000+ attendees, you will have unprecedented access to industry’s key thought leaders and high-profile officials from a variety of global and regional government and regulatory agencies in a neutral, noncommercial setting.

DIA 2015 51st Annual Meeting is packed with 245+ educational offerings across 20 tracks on today’s hottest topics.

Follow #DIA2015 For Real-time Updates

• Accountable Care Organizations and Integrated Health Care

• Communicating Pharmaceutical Risks and Benefits: Why Is It So Hard and How Can We Do Better?

• Efficient Authoring of Submission Documents

• Engaging Patients and Health Care Professionals Through Social Media and Big Data Systems

• Globalization of Field Medical Science Liaison: How to Take it to the Next Level

• How Collective Insights of Medical Affairs Customer-Facing Teams Work to Inform Strategy

• Leadership and Process in Medical Writing

• New Approaches to Submission Components

• Returning Results to Study Participants: Health Literacy and Effective Language

• The Future of Clinical Trial Data Sharing

• Tool is a Good Four-Letter Word

• #20: The Sunshine Act: Understanding the Essentials of Compliance

• #22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing

Make the Advance Attendee List by registering before May 8

GROUP DISCOUNTS! Register 10 individuals and another person can attend for FREE.

ANNUAL MEETING AT-A-GLANCE

It’s a Meeting of the Minds

Visit DIAGlobal.org/DIA2015 for more information and registration details.

4 Days.20 Tracks.

245+EducationalO�erings.

450+Exhibitors.

7,000+Attendees.

http://DIAGlobal.org/DIA2015

13

8:30–10:00am BREAKOUT SESSIONS 3


The Use of Technology for Innovative Solutions in Medical Communications

CHAIR:

Jim R. Wilkinson, PhD Executive DirectorGlobal Scientific AffairsAmgen, Inc

Innovation is critical to the health of any organization. Technology has driven innovation and growth and is an invaluable tool for the practice of Medical Communications, but it is only part of the process of developing innovative solutions. In this session, we will present a framework for the practice of innovation in a highly-regulated environment and how to move from evaluation to adoption and integration. We will provide specific examples of innovative, technology-driven solutions in the field of Medical Communications that either succeeded or failed, and discuss factors leading to each outcome. We will also describe technologies that have the potential to elevate the practice of Medical Communications. Finally, we will discuss how to learn from failures, as well as, leverage successes to ultimately become a more effective innovator.



• Identify the value of technology, in the context of existing enterprise solutions and business processes, to effectively integrate innovative solutions that benefit the whole organization

• Describe the practice of innovation in a highly-regulated environment and how to move from evaluation to adoption and implementation and then to integration

• Evaluate specific examples of the implementation technology-driven solutions in the field of Medical Communications that support internal, as well as external customers

• Appraise the differences between disruptive and supportive innovation and recognize failures to ultimately become a more effective innovator.

SPEAKERS:

Peter Baumeister, PhDSenior Manager Global Scientific CommunicationsAmgen, Inc.

Krupa ParanjpeAssociate DirectorMedical InformationPfizer, Inc.

MEDICAL WRITING REGULATORY TRACK 3C

Pediatric Drug Development: The Good, The Bad, The Necessary

CHAIR:


Pediatric Investigation Plans (PIP) ensure that the necessary data are obtained through studies in children to support the authorization of pediatric medicines. The normal development of any medicine requires that studies be performed to ensure its quality, safety, and efficacy in subjects. PIPs must include elements that are similar or different from adults (disease state, safety and efficacy), a robust dose selection strategy, formulation plans, studies with clear end points and other specific elements tailored to the pediatric population. These pediatric investigation plans are dynamic documents which may change over the course of product development and include modifications in study design and timeline implementation. Without evidence-based information and appropriate pharmaceutical formulations to support administration of many medicines in children, pediatricians may elect to use off-label or unauthorized products, which can result in unnecessary and unwanted side effects or little efficacy.



• Identify the required elements of pediatric investigation plans in Europe and US

• Discuss the historical, ethical, and legal framework of pediatric investigation

• Identify best practices in pediatric plan development to overcome obstacles in product development

SPEAKERS:


Sarah Duban, MASenior ManagerMedical WritingAbbVie Inc.

Hernando Patino, MDSenior Medical DirectorChild Health Innovation Leadership DepartmentJanssen Research & Development, LLC



14


MEDICAL WRITING PUBLICATION TRACK 3D

Proposed Rulemaking for FDAAA Section 801

CHAIR:

Eileen Girten, MSPrincipal Medical WriterinVentiv Health Clinical

In January 2015, a Notice of Proposed Rulemaking was published by the US Department of Health and Human Services relating to the registration and publication of results of clinical trials. A proposed change to the Food and Drug Administration Amendments Act of 2007 (FDAAA), if implemented, would require summary results of other trials, including the release of results of unapproved products.



• Describe the key aspects of the proposed rulemaking for the FDAAA Section 801

• Discuss how these proposed changes will affect Medical Writers

• Identify challenges and discuss best practices for reporting clinical trial results

SPEAKERS:

Scott PattonAssociate ManagerMedical Writing Document Quality and DisclosuresGilead Sciences, Inc.

Barbara Godlew, RN, BAPresidentThe FAIRE Company, LLC


Safety and Risk Mitigation and the MSL

CHAIR:


During this session we will explore Risk Evaluation and Mitigation Strategies (REMS) and how MSLs contribute to pharmacovigilance initiatives. The following questions will be explored by a panel of experts:

• What is REMS and why are they important for MSLs?

• How are MSLs involved and what value does MSL involvement bring?

• What type of training is required to make REMS effective?

• How is MSL involvement documented and shared internally?

• What are best practices in partnerships between MSLs and pharmacovigilance teams?



• Describe what REMS are and the expectations for pharmaceutical/biotech companies

• Examine implications for MSLs in participation in REMS programs

• Discuss solutions for partnerships between field based medical teams and pharmacovigilance

SPEAKERS:


Kathleen Gondek, PhDVice PresidentUS Medical Science Liaisons and Medical Affairs OperationsBayer

Kimberly Johnson, PharmDConsultant Medical Liaison Strategy and CapabilitiesEli Lilly and Company






15

8:30–10:00am SPECIAL RESIDENT, FELLOW AND PRECEPTOR SESSIONS

Providing Feedback to Residents and Fellows

CHAIR:

Evelyn Hermes-DeSantis, PharmDClinical ProfessorErnest Mario School of PharmacyRutgers, The State University of New Jersey

This session will focus on how, when, and why to provide feedback to residents and fellows. In addition, there will be a presentation on a research project one of the fellows has been working on concerning feedback on presentations.



• Identify common bias associated with giving and receiving feedback

• Discuss methods used to overcome barrier and properly give and receive feedback

• Demonstrate giving and receiving feedback through case examples

SPEAKERS:


Emily A. Prince, PharmDPost-Doctoral FellowBristol-Myers Squibb/Rutgers University

10:00–10:30am REFRESHMENT BREAK/EXHIBITS

DIA’s Medical Communications eLearning Certificate Program

ModulesCrisis Management

Database Management

Literature Evaluation

Literature Searching

Medical Inquiries

Medical Writing

Product Labeling

Regulatory Issues

Statistics for Medical Communications Professionals

Enroll today at DIAGlobal.org/MedComm-eLearning

Save Now!Buy all 9 modules and save up to $490Group Discounts and Licensing Now AvailableContact [email protected] for information.

You will have one year to complete the program while receiving continuing education credits and a certificate upon completion. Use these self-paced modules to meet your individual or organization’s training needs.

http://DIAGlobal.org/MedComm-eLearning

16


10:30am–12:00pm BREAKOUT SESSIONS 4


Hot Topics: Insights Across Medical Communications

CHAIR:

Poonam A. Bordoloi, PharmDSenior ManagerMedical Information ServicesInternal Medicine and BioSurgerySanofi US

This interactive session will review several hot topics of interest to Medical Information (MI) professionals. MI groups gather and share customer insights to shape medical information strategy and medical planning to address customer informational needs. After gathering this information, how do you identify areas of improvement and how do you implement a program with internal partners to improve the overall quality of information delivered to the customer?

Acquisition of new products and/or new business units continues across the pharmaceutical industry. Support of new products requires integrating people, processes, and technologies. How does this affect the contact center and what steps are required to ensure customer contacts, people, and best practices transition smoothly? Our panel will discuss examples and scenarios through recent experiences.

In this time of Corporate Integrity Agreements (CIAs) and increased compliance, it is important to discuss audit inspection readiness? Are MI groups changing the way they do business and if so, how are they preparing for complex audits? Are you keeping up with compliance as changes occur to your operations and regulatory environment, and more importantly, are you ready for your next audit? We are sure this topic will generate some great dialogue.

Each of these 3 topics will focus on Medical Communications and how companies are handling the above hot topics. During this session, you will have the opportunity to hear from a distinguished panel of experienced Medical Communications professionals and have the opportunity to share best practices. You are invited to attend and participate in a lively discussion that will leave you with great ideas to think about and implement in your company.



• Define key elements as it relates to insights gathered from call and case monitoring data to improve the quality and value of information provided to external customers and internal partners

• Compare and contrast successful customer insights and how it may relate back to value

• Evaluate and improve your organization’s performance and quality in the aftermath of mergers and acquisitions by following best practices in integrating the people, processes and technologies that support Medical Information

• Assess level of compliance and useful preparation techniques to control your business in case of an audit

SPEAKERS:

Stacey M. Fung, PharmDAssociate DirectorMedical CommunicationsGenentech, Inc., A Member of the Roche Group

Donato SilvestriDeputy DirectorCompliance and OperationsBayer HealthCare Pharmaceuticals

Pete Guillot, MBA, RACPresidentCenterfirst








17

MEDICAL WRITING REGULATORY AND PUBLICATION TRACK 4C-D

Transparency in Medical Writing: How Does the EU Clinical Trial Regulation Impact Medical Writers?

CHAIR:


The European Union (EU) Clinical Trial Regulation, which becomes effective in 2016, is going to change how clinical trials are conducted and reported. A major consequence of this regulation is the creation of study participant summaries for clinical trial results. This session will focus on the summaries and other sections of the EU Clinical Trial Regulation as they apply to medical writing.



• Describe key aspects and specific changes of the EU Clinical Trial Regulation as they apply to medical writing

• Identify challenges for medical writing as a result of the EU Clinical Trial Regulation

• Describe the challenges and opportunities identified in returning results to participants of clinical trials

• Discuss best practices for clinical trial disclosure

SPEAKERS:

Barbara Godlew, RN, BAPresidentThe FAIRE Company, LLC

Deborah E. CollyarPresidentPatient Advocates In Research


National Physician Payment Transparency Program - How Does This Impact MSL Relationships

CHAIR:


During this session we will explore the National Physician Payment Transparency Program and how MSLs have been impacted. This panel discussion, with audience participation, will explore how companies have interpreted and implemented the law. We will also discuss how this law has impacted the MSL / Thought Leader relationship.



• Evaluate the National Physician Payment Transparency Program and the guidelines for reporting transfer of value and who is considered a “covered recipient”

• Discuss how MSL / Thought Leader relationships have been impacted by the National Physician Transparency Program

• Describe ways in which MSLs can be an effective partner and still meet transparency guidance’s

SPEAKERS:

David UllmarConsultantGlobal TransparencyEli Lilly & Company

Kathleen Guindon, RN, MS, DMSenior Medical Science LiaisonGenentech, Inc., A Member of the Roche Group

Sheryl TindellConsultant Medical LiaisonLilly USA, LLC

INTERESTED IN NETWORKING? Join 34,000+ of your peers on DIA’s LinkedIn Group. Search DrugInfoAssn to join.

https://www.linkedin.com/company/dia?utm_source=Program&utm_medium=Banner&utm_content=LinkedIn_7&utm_campaign=15006_OnlineProgram

18


10:30am–12:00pm SPECIAL RESIDENT, FELLOW AND PRECEPTOR SESSIONS

How to Impart Wisdom – Teaching Best Practices

CHAIR:


This session will focus on various activities that preceptors could utilize to enhance the resident/fellow training program. Activities that will be discussed include besides the “on-the-job” training, including case-based problem solving activities, interaction with other practitioners, learning from other industries, wins and losses.



• Identify strategies in incorporating learning into daily work/practice

• Identify teaching style and explain how teaching styles affect different styles of learners

• Discuss methods of applying teaching styles in different ways in order to help residents/fellows with different learning styles succeed

SPEAKERS:

Jennifer L. Riggins, PharmDAdvisorGlobal Medical Channels and eCapabilitiesEli Lilly and Company

Chandni Patel, PharmDSenior Medical Information Therapeutic ManagerClinical Development, Medical & Regulatory AffairsNovo Nordisk Inc.

Dannis Chang, PharmDUS Medical Affairs - Bio-OncologyMedical Communications ScientistGenentech Inc., A Member of the Roche Group

12:00–1:30pm LUNCH/EXHIBITS

12:00–1:30pm RESIDENT/FELLOW & PRECEPTOR LUNCH; A TIME FOR REFLECTION

*Resident, Fellow, and Preceptor Development Session

This is a special session for Residents and Fellows only.

No fee required to attend. Will be held in separate room during lunch.

CHAIR:

Alicia Alexander Cadogan, RPh, PharmDDirector Oncology Medical InformationPfizer, Inc.

This will be a focused talk on utilizing reflection to assist with self-directed life long learning. As any successful individual will tell you, it is taking a moment to reflect on where you are and where you want to go that allows you get to the place of your dreams. As pharmacy students are taught how to write a reflection in school, many are not taught the application of reflection in their careers. This session will take that opportunity to explore this important skill set.

LEARNING OBJECTIVES


• Discuss how to assess a resident or fellow’s competencies gained during the training program

• Identify the roles and responsibilities of program’s preceptors

• Identify best practices for the preceptor – trainee relationship that optimize educational outcomes

• Recognize how DIA can strengthen and cultivate preceptor – trainee relationships through partnership

SPEAKERS:








19




Driving Value of Medical Information through Actionable Customer Insights and Exceptional Services

CHAIR:

Leena Jindia, MS, PharmDDirectorMedical InformationJanssen Scientific Affairs, LLC

Medical Information (MI) departments are implementing innovative strategies to demonstrate value-added services to internal and external customers. This interactive session will provide an overview of how MI can measure and communicate the value of MI department. The session will describe new value opportunities built upon technical and leadership competencies and share examples of such projects. In addition, through Voice of Customer (VoC) analysis, MI departments have tremendous opportunity to drive value by uncovering customer insights (data gaps, potential future product development areas, and unmet customer needs). This session will cover the importance and process for VoC analysis.



• Discuss how Medical Information can demonstrate its value for external and internal customers

• Identify the process Medical Information can take to innovate its role and identify new value opportunities

• Describe the importance/rationale for conducting Voice of Customer analyses on the medical information request database to identify customer insights

• Explain how a VoC analysis and generation of actionable customer insights help drive the value of Medical Information

SPEAKERS:

Poonam A. Bordoloi, PharmD Senior ManagerMedical Information ServicesInternal Medicine and BioSurgerySanofi US

Chandni Patel, PharmDSenior Medical Information Therapeutic ManagerNovo Nordisk Inc

Jennifer Kern Sliwa, PharmD, BCPPDirector, Medical InformationJanssen Scientific Affairs, LLC


Watson vs Homo sapiens: Artificial Intelligence in MW

CHAIR:


A variety of software tools exist to aid the writer: word processors, structured authoring systems, and now artificial intelligence (AI). Learn from real-life examples how artificial intelligence software was used to create tables for documents, generate text, update data, decrease document generation time, and allow the writer to concentrate on value-added analysis. This will be an interactive session with opportunity for discussion and questions from the audience.



• Explain the application of AI in generating and updating in-text tables

• Describe how AI-generated text and data updates contribute to document development

• Construct the use of AI-generated text and tables across documents

SPEAKERS:


Susan CousounisGlobal Head Oncology Medical WritingGlaxoSmithKline

Dominic De Bellis, PhDSenior Associate DirectorUS Medical WritingBoehringer Ingelheim Pharmaceuticals, Inc.

Panel Discussion and Q&A








20



The MSL and Clinical Trials

CHAIR:

Matt Joyce, PhDManagerMedical LiaisonsLilly USA, LLC

This session will focus on the MSL facilitation of study collaborations and clinical trials during all phases of the product’s life cycle. Opportunities for MSLs include: identifying potential trial sites, working with investigators, providing internal assistance with study protocol development, and the dissemination of results.



• Describe how MSLs are partnering with clinical trial sites during all phases of product development

• Explore how MSLs can help foster clinical trial partnerships between internal business colleagues and investigators

• Discuss solutions on how MSLs can be an effective partner in clinical trials

• Explain how MSLs can add value to clinical development programs at multiple points along a product’s life cycle

SPEAKERS:

David A. Jencen, PhDPrincipalJencen Field Medical Consulting, LLC

Matt Joyce, PhDManagerMedical LiaisonsLilly USA, LLC

Michelle Cho, PharmD, AAHIVEAssociate Field DirectorMedical Science LiaisonsJanssen Scientific Affairs, LLC

1:30–3:00pm SPECIAL RESIDENT, FELLOW AND PRECEPTOR SESSIONS

Emotional Intelligence

CHAIR:


This session will emphasis the training necessities of emotional intelligence to the new-to-pharma residents/fellows and employees. Leadership training, team building, meeting facilitation, conflict resolution, negotiating, business etiquette, and management styles are all highlighted in this session.



• Define emotional intelligence and the potential impact it has on communications in the workplace

• Self evaluate the four types of personality areas that define workplace communications

• Identify potential valued communication techniques based on the profiles of individual coworkers

SPEAKER:

Michael Toscani, PharmDResearch ProfessorDirector, Institute for Pharmaceutical Industry FellowshipsErnest Mario School of PharmacyRutgers, The State University of New Jersey







21



MEDICAL COMMUNICATIONS TRACK 6A

Medical Communications in the Evolving Payer Landscape: Demonstrating Product Value and Outcomes to Payers

CHAIR:

Julia Petses, PharmD Director Medical Information Services OncologySanofi U.S.

The US health care system has been evolving over time and recently underwent a large transformation due to the Affordable Care Act. It has moved away from fee-for service, volume based care and moved toward pay-for-performance and value-based care. The intent is to maximize value for patients by improving quality of care and achieving the best outcomes at the lowest cost. As the health care landscape has changed to a value-based model, the medical information needs of payers (i.e., private insurance, Center for Medicare and Medicaid Services, health care systems, accountable care organizations, etc.) have changed to require information beyond the AMCP dossier. Medical communications departments will need to understand what the informational needs are for different payers, how to partner with them to generate and compile relevant data, and how to deliver it most effectively. This interactive session will provide medical information, health outcomes liaison and payer perspectives on fulfilling the medical information needs of this customer type.



• Describe different types of medical information created specifically for payers and formulary decision makers

• Explain the role of outcomes liaisons including how they partner with customers to generate health outcomes data

• Discuss ways to effectively present product value to a payer

SPEAKERS:

Eleonora Ford, PhDDirectorPayer & Formulary Medical InformationAmgen, Inc.

Thu-Mai Duong, PharmDRegional Outcomes LiaisonSanofi US

Scott Taylor, RPh, MBA Director Geisinger Health System

MEDICAL COMMUNICATIONS TRACK 6B

Contact Center Workforce Management

CHAIR:

Maureen L. Baldwin RN, MSNAssociate Director Medical Customer InterfaceMedical InformationPfizer, Inc.

The medical information call center is the “voice” of your company. Workforce management includes all of the activities needed to maintain a productive workforce. During this session several strategies and best practices will be discussed. Some topics to include: finding the right call center agent, staffing types, alternate service channels, forecasting, and tools for scheduling and reporting. The speakers will also provide examples from their professional experiences. We also encourage you to share your best practices and questions.



• Define contact center terminology and discuss concepts used

• Recognize the key strategies of forecasting inquiries including scheduling staff in order to maximize staff availability to consumers and health care professionals

• Describe how to integrate web, chat, and other media into the contact center

• Discuss tools used for scheduling and reporting

SPEAKERS:

Michael BoudreauConsultant – Business Integrator for The Lilly Answers CenterEli Lilly and Company

Paul BiedenbachDirector, OperationsPPD






22


Topics of Special Interest for Regulatory Writers

CHAIR:


We have three presentations on current “hot topics” for regulatory writers: REMS Assessment Reports, Health Technology Assessments, and Benefit-Risk Assessment of Medicines. These are rapidly emerging areas needing writing support and may be new to most regulatory writers.



• Examine three assessment types in understanding their purpose and overall structure

• Discuss the emerging areas in need of writing support

SPEAKERS:


Eleni Samaras Allen, PharmDSenior ManagerGlobal Medical WritingAmgen, Inc.

Lawrence Liberti, MSc, RPh, RACExecutive DirectorCentre For Innovation In Regulatory Science (CIRS)


Strategic Publication Planning

Pete Fairfield, MBAConsultantOncologyGlobal Scientific CommunicationsEli Lilly and Company

This session will delve into making strategic decisions with publication planning. The speakers will offer the audience an overview of strategic publication planning, best practices to consider, and what the future holds in terms of opportunity and challenges. The speakers will provide perspectives from both agency and pharma companies.



• Recognize contemporary challenges for strategic publication planning

• Discuss best practices to incorporate in strategic decisions regarding publication planning

SPEAKERS:

Bethany Fox, PhDConsultantNeuroscience Global Scientific CommunicationsEli Lilly and Company

Kim Pepitone, CMPPScientific DirectorCactus Communications

Keri Poi, PhDConsultantCV/Acute CareGlobal Scientific CommunicationsEli Lilly and Company

LOOKING FOR THE UP-TO-THE-MINUTE NEWS AND INFORMATION FROM DIA? Follow DIA on Twitter by searching DrugInfoAssn to stay informed.

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23



The Shift in the Provision of Medical Information to Health Care Professionals—Are We At The Precipice of Change?

CHAIR:


This session will educate professionals in the pharmaceutical, biotech, and device industries on the shifting landscape around the education of health care providers. The current regulatory environment, the changing drivers of health care, and the transformation of medical discussions from a focus on science to a focus on the economics of the science will be discussed.



• Describe the current challenges and restrictions of disseminating medical information to health care professionals

• Examine the evolving dissemination of medical information from both a legal and public policy perspective scientific and economic focus

SPEAKERS:


Kevin Apparetti, MBASenior DirectorGlobal MSL for the Office of Medical and Health AffairsPhilips Healthcare

Monica Kwarcinski, PharmDExecutive DirectorMedical ServicesPurdue Pharma, L.P.

5:00-6:00pm RESIDENT AND FELLOW POSTER RECEPTION

CHAIRPERSON:


The residents and fellows will display their projects and will be eager to discuss their work with you. Please take advantage of this opportunity to learn from their research, share your perspective on their work, and discuss the results and impact on our business with them. Projects will cover a wide range of topics and represent many pharmaceutical companies. One project will be selected as the winner for having the biggest potential impact on how we practice Medical Communications.

6:30pm DINNER ON THE TOWN

Sign up for dinner with your colleagues at your choice of several restaurants.

(All restaurants will be within walking distance of the Renaissance Glendale Hotel and Spa; dinner cost is on your own.)

LOCATIONS:

Soleil Restaurant

Located within the Renaissance Glendale Hotel and Spa, Soleil features an open layout, large portions, and a menu featuring contemporary American cuisine.

The Shout House

Two pianists play rock & roll tunes from the ‘50s to now at this high-energy bar with food choices from American bar classics to gourmet fare.

Saddle Ranch Chop House

Their concept is “Rock Meets Western” with a large outdoor patio with stone campfire pits in addition to serving home-style cooking with down-home hospitality.






24

WEDNESDAY, MARCH 18

7:00-8:00am REGISTRATION/EXHIBITS/CONTINENTAL BREAKFAST

8:00–9:30am BREAKOUT SESSIONS 7


PhACTs & Collaborations

CHAIR: Mary Sendi, PharmDDirector -Team LeadCardiovascular & General MedicinePfizer Medical InformationPfizer, Inc.

Collaboration between medical information executives is increasing as they look to create a shared voice to elevate and raise awareness of the value of the function. As an industry, Medical Information faces many challenges and these challenges are similar across companies. Medical Information teams have tried to address these challenges as individual companies with some success. But what if we could do more collectively? This session will introduce the collective vision and an approach of charting a new path forward into the future of Medical Information discussing the following topics:

• What are the internal and external challenges facing Medical Information?

• How do HCPs prefer to seek and obtain/ receive Medical Information?

• Who has the best medical information?

• How can Medical Information groups collectively address the challenges and opportunities posed by the changing environment?



• Recognize the need to enable compliant access and utilization of medical information in an evolving health care environment

• Discuss the current landscape of how health care professionals seek and obtain medical information

• Describe how commonly used compendia and online medical references may not be the best option for obtaining drug information because they may contain significant omissions or erroneous information

• Discuss PhaCT MI cross-industry collaboration efforts focused on creating a shared voice to raise awareness of the value of the medical information function

SPEAKERS:

Tiziana Fox, PharmDSenior DirectorMedical InformationJanssen Scientific Affairs, LLC

Suzana Giffin, PharmDExecutive DirectorGlobal Scientific CommunicationsAmgen, Inc.

Chandni Patel, PharmDSenior Medical Information Therapeutic ManagerNovo Nordisk Inc.

Patrick Reilly, MScVice PresidentMedical Contact, Content, and InsightsBristol-Myers Squibb

Dominick Albano, PharmD, MBARegional Director Medical InformationPfizer, Inc.

PANEL:

D. Stuart Sowder, PharmD, JD, MBAVice PresidentExternal Medical CommunicationsPfizer, Inc.

Thomas Faria, PharmD, MScExecutive DirectorGlobal Medical InformationCelgene Corporation

Jennifer L. Riggins, PharmDAdvisorGlobal Medical Channels and eCapabilitiesEli Lilly and Company

Christine GilmourVice PresidentKnowledge Enhancement Medical UnitUS Medical Affairs Genentech, Inc., A Member of the Roche Group



25


Managing Call Center Quality for Improved Performance and Compliance

CHAIR:

Pete Guillot, MBA, RACPresidentCenterfirst

Effectively managing our call centers, and managing our vendor partners who often times help run our centers, is integral to the ongoing success of today’s Medical Information organization. Helping to ensure our centers and our partners are operating in alignment with expectations, industry best practices, and regulatory requirements is the responsibility of Medical Information leaders. During this session, tenured Medical Information leaders will share their experience in using specific strategies and tactics for managing call centers and vendor partners. The strategies include Process Improvements, Global Quality Monitoring Processes and Standards, Periodic Quality Assessments, and others. Case studies will be shared during the session.



• Discuss how to develop a program for monitoring a call center for regulatory compliance, customer service best practices, and adherence to company standards

• Recognize ways to utilize results of quality monitoring to develop actions plans for improving call center performance

• Describe how to lead a process improvement program that can result in improved quality and efficiency of call center (s)

• Conduct an assessment of a call center vendor(s) and make recommendations to improve quality in support of a product launch and ongoing operations

SPEAKERS:

Sara Doshi, PharmDDirectorStrategy and Operations Global Medical InformationEli Lilly and Company

Joanne GibsonDirectorMedical Customer Interface - Europe/Middle East/Africa Pfizer, Inc.

Praveena Raman, MSc, MSAssociate DirectorMedical InformationXenoPort


Safety is at the Core: Impact of Core RMP on Labeling and PBRERs

CHAIR:

Valerie Perentesis, PharmDSenior Director Pharmacovigilance Evaluation, Reporting and SystemsJanssen Research & Development, LLC

A key responsibility that pharmaceutical companies bear when marketing a drug product is to increase knowledge about the safety of the product, identify effective ways to manage risks, and evaluate the risk-benefit profile of the product on a routine basis. This responsibility is growing as the landscape of pharmacovigilance continues to evolve and the pressure has rightfully increased for companies to be more transparent, more proactive, and more sophisticated with regard to patient safety. In today’s environment of increased public scrutiny, high standards in good pharmacovigilance practices, regulatory hurdles, and the complexity of more information from more places, companies need to strategically manage all aspects of safety. The Risk Management Plan and Periodic Benefit Risk Evaluation Report (PBRER) are core strategic documents that enable a company to help fulfill their rigorous safety obligations and communicate the appropriate benefit risk message of the product. This session will provide different perspectives on how to develop and align these documents from a unified position.



• Summarize regulatory guidelines on risk management plans and periodic benefit risk evaluation reports

• Identify different approaches to creating core risk management plans including how to account for regional differences

• Describe the connections between risk management plans and periodic benefit risk evaluation reports

• Identify potential concerns and solutions when leveraging a core risk management plan in the PBRER

SPEAKERS:

Dessislava Dimitrova, MD, PhDSenior Director Head of Risk Management Center of ExcellenceGlobal Medical OrganizationJanssen Research and Development, LLC

Natalie Gearhart, Pharm DDirectorPharmacovigilance Evaluation and ReportingGlobal Medical SafetyJanssen Research and Development, LLC

Ana Aymes, RPh, PharmDAssociate Director (Manager)Global Aggregate Reporting and DocumentationBristol-Myers Squibb

26



Publication Reviews to Achieve Quality

CHAIR:


This session will share a pharmaceutical company manuscript, abstract, and poster publication quality review process. Details that make up the quality review elements as well as strategic thinking behind the process will be presented, along with associated pros and cons. Four different quality review segments will be addressed: writing, medical/scientific, statistics, and data integrity. The session will end with a panel discussion with topic experts that will allow for robust audience Q&A, participation, and sharing of ideas and concerns.



• Identify key components of publication development process leading to quality disclosures

• Explain expectations for author, editor, and contributor reviewer contributions

• Discuss the strategic delivery and importance of different review types, including writing, medical, statistics, and data integrity quality reviews

SPEAKERS:

David B. Clemow, PhDSenior Clinical Research ScientistEli Lilly and Company

Pete Fairfield, MBAConsultantBiometrics Business OperationsEli Lilly and Company

Scott PattonAssociate Manager Medical Writing Document Quality and Disclosures Gilead Sciences, Inc.




The Complex World of Integrated Health Care Systems

CHAIR:

Rebecca A. Vermeulen, RPhSenior DirectorBioOncology Medical Science LiaisonsGenentech, Inc., A Member of the Roche Group

This session will focus on the future of quality standards and implications for pharmaceutical companies to be involved as a part of solutions and support decision-making that impacts the care of patients. In particular how field based medical teams (i.e. MSLs, MCLs) can work with quality organizations and clinical practice settings to serve as a trusted resource as quality standards, clinical practice guidelines and risk based patient treatment models are being implemented.



• Describe what quality standards are and the expectations for health care practitioners

• Examine implications for implementing quality standards and the care of patients

• Discuss solutions for engaging field based medical teams within the industry

SPEAKERS:

Michael Dubroff, MDSenior Director Managed Care LiaisonsGenentech, Inc., A Member of the Roche Group

Stephen Dodge, PharmD, MBAExecutive Director Health Systems US Medical AffairsMerck & Co., Inc.

9:30–10:00am REFRESHMENT BREAK/EXHIBITS






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10:00-11:30am BREAKOUT SESSIONS 8


Podium Pearls

CHAIR:


In this session, Medical Communications Professionals were invited to present their successes, challenges, and “pearls of wisdom” on various topics through podium presentations. Six presentation topics were selected from submitted abstracts for this unique opportunity to share podium pearls.

Insight from Customer Unmet Needs: The Role of Medical Information

Lucia Fantini, Pharm DGlobal Medical Information Tech LeadACE RegionEli Lilly and Company

Best Practices for Continuous Improvement of Medical Information Websites

Dominick Albano, PharmD, MBARegional Director Medical InformationPfizer, Inc.

UCBCares™ Mindset: Transforming Medical and Customer Facing Expertise Around the Customer vs. the Function

Christi C Marsh, Pharm D, RPhDirectorNA MI&Comms and UCBCares™UCB, Inc.

Immediate Response to Provider Medical Information Inquiries via Sales Representative-facilitated Videoconference Technology

Krupa ParanjpeAssociate DirectorMedical InformationPfizer, Inc.

FDA’s Recommendations for Statements Regarding Latex Content in Injectable Products: Benchmarking Medical Information Responses

Iris Tam, Pharm DDirectorManaged Care Medical Communications Genentech, A Member of the Roche Group

A dedicated compliance role within Medical Information

Yvanne Colinet, MBACompliance SpecialistMedical ServicesPurdue Pharma L.P.


Quality Documents: From Draft to Finalization

CHAIR:

Ann M. Winter-Vann, PhDSenior Medical Writer and ConsultantWhitsell Innovations, Inc.

Quality regulatory documents don’t just happen; they are the result of careful planning that starts before the first words are drafted. Effective templates provide the correct structure for a document and prompt the authoring team to include relevant content that is well organized and easy to understand. With a solid template in hand, the lead writer drafts the document, working closely with the authoring team to define the important messages and clearly communicate the data. Finally, the Quality Control specialist ensures that the data are accurately presented and that the document follows a consistent style. In this session, we will present strategies and best practices for designing and using templates, drafting and reviewing documents, and performing Quality Control checks to ensure consistent quality in regulatory documents.



• Describe how to design and use effective template documents

• Discuss ways to implement strategies to maintain quality while working with a team of contributors to write and review regulatory documents

• Assess the accurate presentation of data and consistent use of style in a regulatory document

SPEAKERS:


Ann M. Winter-Vann, PhDSenior Medical Writer and ConsultantWhitsell Innovations, Inc.

Cathy SerranoManagerMedical Writing OperationsVERTEX Pharmaceuticals



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Who Owns Social Media? The FDA, Pharma, and the Medical Community Look for Answers

CHAIR:


Social media differs from standard media in that it can be a two-way communication with a specific audience, rather than an information push. Challenges are many but the solutions have, so far, been few and far between. This presentation will delve into the applicability of social media to the life sciences, the history of the FDA guidance documents, and the trends and best practices for social media use, including a case study that looks at how medical publications and social media are forging new ground and re-defining the space scientific exchange and promotion.



• Describe the ramifications for social media including its applicability to the life sciences

• Outline the current FDA guidance documents and how they have been interpreted and implemented

• Discuss some core challenges in applying social media in the medical publication space

SPEAKERS:


Alison Woo Corporate Digital and Social Media Strategy, LeadBristol-Myers Squibb


MSLs and Customer Access – Getting Access and Demonstrating Value

CHAIR:

Beth A. PriceExecutive Vice PresidentBusiness DevelopmentThe Medical Affairs Company

Understanding the barriers and getting access to KOLs, institutions, payers, ACOs and community practices has continued to present challenges within our industry, yet MSLs have maintained their ability to demonstrate their clinical utility and value through targeted clinical data discussions and educational support activities. These activities have clearly differentiated the MSL’s and their organization’s value to these stakeholders and importantly, enabled them to engage with stakeholders and health care professional audiences that may be unaccessible to their commercial industry colleagues.

The first part of this session will focus on trends in access restriction and what the factors/drivers may entail including those specialties which are considered more restrictive. A unique field medical program case study will be shared and how this unique program has ensured that health care professional audiences within this restricted access system are receiving timely, fair-balanced, compliant and thorough clinical data educational support and services.

The second part of this session will focus on institutional access & credentialing and restricted access. Strategies and best practices for accessing customers with limited time will be discussed alongside the clinical and educational activities that MSLs can provide. Training programs and resources in support of these activities will also be shared as well as documentation and portal systems used to manage these activities.

The final component to this session will be the discussion of methods and metrics useful for demonstrating the MSL and MSL teams’ value to their organizations. Examples of specific activities aligned by stakeholder audiences will be discussed and how the MSLs established both initial and long-term value. Strategies for compliantly disseminating and vetting KOL clinical insights and competitive intelligence amongst internal constituents will also be shared.



• Demonstrate an understanding of causative reasons resulting in restricted access for MSLs

• List various restriction criteria and information required of MSLs to gain access

• Identify at least two methods used by institutions for tracking MSL access

• Discuss technical and soft skills training topics critical for MSLs to be successful in providing clinical services/activities to restricted access customers

• Recite different restrictions used with DoD and VA institutions

• Describe methods and metrics that MSL’s can use to demonstrate value

SPEAKERS:

Beth A. PriceExecutive Vice PresidentBusiness DevelopmentThe Medical Affairs Company

Norm Enriquez, PharmDVice PresidentBusiness DevelopmentThe Medical Affairs Company

David A. Price, PhDConsultant – Medical Liaison Strategy & CapabilitiesUS MedicalLilly USA, LLC

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11:30am-1:00pm LUNCHEON/PROFESSIONAL POSTER SESSION 9

Poster Pearls

CHAIR:


This session will offer a unique opportunity for any Medical Communications practitioner (e.g., information specialist, medical liaison, manager) to share their successes, challenges, and “pearls of wisdom” on various Medical Communications topics through poster presentations.

Medical Science Liaisons Track Posters

CHAIRS:



In this session, Medical Science Liaison Professionals were invited to present their successes, challenges, and “pearls of wisdom” on various topics through podium presentations. Presentation topics were selected from submitted abstracts for this unique opportunity to share podium pearls.

12:30–1:00pm DIA PUBLICATIONS SESSION

Add “published author” to your accomplishments! Judy Connors, Associate Director of Editorial Services and Managing Editor of DIA’s official peer-reviewed journal, Therapeutic Innovation & Regulatory Science (TIRS) along with TIRS Associate Editor, MaryAnn Foote, PhD, will discuss the submission and peer-review process for this publication. Other publication opportunities with DIA, including article submission to our association news magazine, the Global Forum and content development for the DIA website will also be discussed.

1:00-2:30pm BREAKOUT SESSIONS 10


Globalization: Medical Information Perspectives from Around the World

CHAIR:

David Bowers, PharmDDirectorMedical CommunicationsPPD

This will be a truly global session with expert speakers from Europe, Latin America, the US and Asia. Participants in this session will hear benchmarking data from large global companies about where these companies are in their globalization process. Speakers will present their region’s perspective and challenges in delivering medical information. For example, regional differences in staffing, compliance requirements, languages, and cultures will be discussed. The format will include presentations, panel discussion, and audience participation.



• Describe standards for globalization that are being adopted within medical information contact centers

• Discuss specific challenges for medical information regions around the world

• Recognize strategies used by other pharmaceutical companies to successfully globalize processes and resources

SPEAKERS:

Viviane M. Arid de LimaMedical Information Area Lead Central & South America Pfizer Brazil

Shin Keol (SK) KimGMI Tech LeadMedical Information Strategy and OperationsGMILilly Korea Ltd.

Lillian Auberson, PhDMedical Information LeadRegion Europe F. Hoffmann-La Roche Ltd.

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Current Compliance Landscape (Enforcement, Sunshine Act and CIA’s) As they Relate to Medical Affairs (Med Comm and MSL) Activities

CHAIR:

Juan C. Nadal, MDVice PresidentMedical CommunicationsMedical AffairsBayer Healthcare Pharmaceuticals

Medical Affairs personnel are continuously dealing with increasing changes in compliance related issues. This interactive session will include experts in each of the three topics who will discuss the importance of effective Compliance Practices in our daily jobs. The focus will be in several areas of interest to Medical Information (MI) and MSL professionals.

Current Enforcement Landscape:

In 2014 there were several enforcement initiatives which have had either direct or indirect implications for Medical Affairs personnel. Are you aware of these enforcement initiatives and are you up to date with compliance functions as changes occur to your operations and regulatory environment?

The Sunshine Act:

The Sunshine Act, a part of the Health Care reform bill was adopted in 2010, but was not fully implemented until 2013, when CMS released the final regulations for the Act. Is your organization complying with the Sunshine Act’s mandates?

How are other Pharmaceutical Companies complying with the mandates for the Sunshine Act? What have we learned from the four months of 2013 data published on September 30, 2014?

CIA’s:

With many Corporate Integrity Agreements (CIAs) either having come to an end of their term or about to, it is important to

consider post-CIA compliance and to discuss how that may impact your respective role and departments responsibilities. How are Medical Affairs (Medical Information / Medical Communications/ Medical Science Liaison) groups changing their approach. Is your organization covering all of the responsibilities for post-CIA compliance? We are sure this topic will generate some great interest and dialogue.

These three topics will focus on Medical Communications and how companies are addressing the above hot topics. During this session, you will have the opportunity to hear from a distinguished panel of experienced professionals and have the opportunity to share best practices. You are invited to attend and participate in a lively discussion that will leave you with great ideas to think about and possibly implement within your company.



• Discuss the importance of effective compliance in assessing the level of Compliance including audit Readiness at your respective organization

• Describe the current Regulatory Environment as it pertains to Medical Communications and Medical Science Liaisons

SPEAKERS:

Cliff Safron, JDPrincipalLife Sciences Regulatory Enforcement & ComplianceKPMG LLP

Lawrence Platkin, JDVice PresidentHead of Compliance Center of ExcellenceBayer Corporation

Thomas SullivanPresidentRockpointe Corporation

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Global Strategies for Global Submissions

CHAIR:


Increasingly submissions are planned across multiple geographies simultaneously, creating a burden on resource-constrained teams and their medical writers. This session will engage the audience with best practices based on successful complex submissions and lessons learned from less-than-successful submissions. It will focus on coordinated planning and preparation of briefing packages. We will present a case study of a large, global submission and share perils and pearls. Come with questions and stories to share.



• Articulate the importance of strategic planning and identify and sequence steps towards successful completion

• Differentiate the best approaches for briefing packages submitted to various global regulatory authorities

• Discuss the lessons learned from a large global submission based upon a case study presented

SPEAKERS:


Sarah Duban, MA Senior ManagerMedical WritingAbbVie Inc.

Dominic De Bellis, PhDSenior Associate DirectorUS Medical WritingBoehringer Ingelheim Pharmaceuticals, Inc.


Management in Medical Writing/ Technical Communications

CHAIR:

Carri Taylor, MBAAssociate DirectorMedical WritinginVentiv Health Clinical

This session will be geared towards managers of Medical Writing/Technical Communications. The focus will include recruiting/onboarding, career progression for managers, challenges managing people, employee development and retention, and metrics.



• Discuss best practices for recruiting and onboarding top talent across the industry

• Identify goals and objectives to build a successful career ladder as a manager

• Discuss challenges managers face when managing staff

• Describe ways to develop and retain top talent

• Examine metrics that are associated with Medical Writing competencies and translate them into actual work

SPEAKERS:

Cynthia Fuller, PhDAssociate DirectorMedical WritinginVentiv Health Clinical







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MSL Technology Session

CHAIR:

Kevin Henderson, PharmD, MBA Medical Science LiaisonGenentech, Inc., A Member of the Roche Group

The MSL technology session is a broad-based overview of various technology applications and programs currently utilized by pharmaceutical/biotechnology companies. MSL representatives from these companies will review these tools in terms of how they are utilized to support the MSL function. Highlights of these presentations will involve interactive discussions with the presenters on real-world experiences with these applications, including what worked well and also lessons learned.



• Describe various means of utilizing technology to support and execute MSL core responsibilities and field-based activities

• Discuss the future direction of business process technology development within the pharmaceutical/biotechnology industry and its application to the MSL role

SPEAKERS:

Lori Mouser, PharmDAssociate Director BioOncology MSLGenentech, Inc., A Member of the Roche Group

Paul Latimer, PhDMedical Science LiaisonGenentech, Inc., A Member of the Roche Group

Kimberly Boothe, PharmD, MHADirectorMedical Science LiaisonsBayer Healthcare Pharmaceuticals

Kevin Chan, PharmDRutgers Postdoctoral FellowBayer Healthcare Pharmaceuticals

Gary Takher, PharmD, MBARegional Medical LiaisonSanofi US


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3:00-4:30pm BREAKOUT SESSIONS 11 (AND CLOSING REMARKS)


Promotional Review Committees – Medical Communications as a Successful Team Member

CHAIR:

Ivy Chang, PharmDAssociate Director Medical CommunicationsGenentech, Inc., A Member of the Roche Group

Promotional review committees (PRCs) ensure that a company’s advertising and promotional materials and activities meet regulatory, legal, and scientific requirements, and internal policies and guidelines. This session will discuss the latest FDA Notices of Violation and Warning Letters for promotional materials to highlight areas of promotional risk; the levels of evidence to consider when reviewing promotional materials; and tips and best practices for medical information/communications to become an effective and valued member of promotional review committees. Discussions will also highlight ‘soft skills’ needed to be a successful committee member.



• Discuss the areas of risk when making promotional claims

• Determine acceptability of references used to support promotional claims

• Examine the importance of ensuring that promotional claims are adequately supported by substantial evidence

• Describe tips and best practices for becoming an effective and valued member of the promotional review committee

SPEAKERS:

Lois Jessen, PharmDDirector US Pharmaceuticals Law and Promotion ComplianceOtsuka Pharmaceutical Development and Commercialization, Inc

Kristen Goettner, PharmDAssociate DirectorMedical InformationJanssen

Leslie McKay, PharmDContent Medical Information SpecialistMed Communications, Inc


Leading and Learning: A Career Journey

CHAIR:

Timothy Poe, PharmDDirectorTEP Consulting, LLC

Has your career changed since graduating school, do you want it to? How do you plan for your road to success? This session will explore elements of a career journey, including primary elements of career development, setting goals, networking, and understanding various options, such as career ladders and lattices. Methods to manage and assist in career development of others will be discussed. This will be an interactive session where the audience will be asked to participate by sharing experiences and best practices.



• Describe the Primary elements of career development

• Discuss how to set reasonable career goals while understanding and managing potential barriers and limitations

• Discuss how to leverage networking to improve career development opportunities

• Describe your career path in terms of ladder/lattice/matrix and understand if your current path is consistent with future goals

• Describe methods to manage/assist in career development for others

SPEAKERS:

Tim Fish, RN, MBA, DNP DirectorGlobal Medical AffairsBaxter









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Essential Medical Writing Resources: Remembered, Forgotten, New, and Necessary

CHAIR:


What resources do you remember? What resources have you forgotten? What resources do you need to know about to stay on the cutting-edge of medical writing? As a medical writer, it is important to stay current on topics that impact our work. During this session, you will have the opportunity to learn about tools and resources available for medical writers.



• Identify resources for regulatory and publications writing

• Discuss how these resources can help medical writers

SPEAKER:



Global MSLs, Corporate Perspectives and Partnership Support

CHAIR:

Ian BancroftOwnerTardis Medical Consultancy

This session will focus on the globalization of the MSL – and concentrate on the MSL’s growing role as the face of the pharmaceutical industry to physicians and other providers of health care internationally. The panel includes leaders and provider who are innovators and drivers of best practices worldwide.



• Describe the core global MSL role and how to partner with pharma colleagues and providers

• Discuss that MSLs are a critical interface globally and why

• Develop plans for creating and growing your MSL teams to support new medicine introductions worldwide

SPEAKERS:

Jeffrey Wojtowicz, PharmD, BCPSVice President Global Medical Affairs FunctionsTakeda

Abbey Wojtowicz, PhDMSLTakeda

Yasmin Walker, MScDirector – Head of Talent Acquisition MCCS GmbH Ltd

Ruth Kaiser, RN, BSNDirector Clinical OperationsPublicis Touchpoint Solutions

4:30pm CONFERENCE ADJOURNED

Save the Date!Medical & Scientific Communications 2016 Annual ForumCore Curriculum: March 20, 2016

Tutorials and Conference: March 21-23, 2016

Gaylord Palms Resort & Convention Center | Kissimmee, FL