Medical Affairs and Scientific Communications ForumProject Linus, a non-profit organization whose mission is to provide love, a sense of security, warmth, and comfort to children who

Medical Affairs and Scientific Communications Forum Primer: March 17 | Short Courses: March 18 | Forum: March 18-20 Loews Sapphire Falls Resort | Orlando, FL

#MASC19 | DIAglobal.org800 Enterprise Road Suite 200 Horsham, PA 19044 USA As of March 8, 2019

OverviewCelebrating 30 years of excellence!

DIA’s Medical Affairs and Scientific Communications Forum is designed for medical affairs professionals, by medical affairs professionals. This forum provides a comprehensive understanding of the regulatory and compliance environment directly affecting the daily activities of medical affairs and scientific communication professionals.

Made up of multiple general sessions and breakouts sessions within three tracks covering medical communications, medical science liaisons, and medical writing, you can pick and choose which sessions to attend and create your own unique forum!

Highlights• Three educational tracks: Medical Communications, Medical

Science Liaisons, and Medical Writing (See page 5 for track descriptions)

• A primer course and four short course offerings to take place prior to the kickoff to the forum on March 17 and March 18

• Cross-functional general sessions dedicated to integrating work areas, addressing regulatory, policy, and medicine updates

• DIA’s Medical Science Liaison Community meet-up for members and those interested in learning more about the Community projects/member benefits

• DIA Fit – Start your mornings off with light instructed exercise to prepare for a full day of learning

• NEW: Community Service Project with Project Linus. Join us and become a blanketeer throughout the forum in the Grand Caribbean Foyer for a simple blanket project to make a difference in someone’s life. Let’s weave the thread and spread the warmth of DIA!

Who Should Attend Professionals involved in:

• Medical Communications

• Medical Writing

• Medical Science Liaisons

• Medical Information

• Medical Call Center Environment

• Regulatory Affairs

• Clinical Research

• Professional Education, Training, and Development

• Document Management/eSubmissions

PROGRAM CO-CHAIRS

Poonam Bordoloi, PharmDDirector, Medical Affairs Team Lead Merck & Co., Inc.

Ivy Chang, PharmDPrincipal Medical Science Director, Medical Affairs Genentech, Inc., A Member of the Roche Group

Ed Cunningham, PharmDSenior Director, Neurology Medical Science Liaison Team Lead Sunovion Pharmaceuticals, Inc.

David Price, PhDAdvisor, US Field Medical Lilly USA, LLC

David MeatsAssociate Director Midwest Operations, Medical Writing ManagerTrilogy Writing & Consulting

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

PROGRAM COMMITTEE

Kevin Appareti, MBASenior Director, Global Medical Science Liaison Philips HealthTech

Anne Arvizu, PharmD, FASCP, PCCCEO and Medical Affairs Advisor RxER Communications

J. Lynn Bass, PharmDSenior Director, MSLs and Lead, Global Field Medical Affairs Rakuten Aspyrian

Dan Benau, PhDDirector, Biomedical Writing Programs University of the Sciences

Donna Booth, PharmDSenior Director, US VEO Strategic Initiatives Lead GlaxoSmithKline

Kathryn Bucci, PharmDMedical Governance Lead Pfizer, Inc

Jacqueline Byun, PharmDManager, Medical Information Sanofi

Maureen Feeney, PharmD, MBA, RPhSenior Director, Head Global Medical Communications Takeda

Ruggero Galici, PhDAssociate Director, Medical Writing Pfizer Inc

Jennie Jacobson, PhDLead Medical Writer Fishawack Communications

Taleen Kalebjian, PharmDSenior Manager, Medical Information Gilead Sciences, Inc.

Craig Klinger, RPhGlobal MSL Trainer, The Office of Medical Professional Development Lilly USA, LLC

Stephanie KrupskiConsultant - Global Scientific Communications Eli Lilly and Company

Andrea MeyersVice President, Medical Writing Syneos Health

Lori Mouser, PharmDGlobal Head, Medical Science Liaisons Roche, Switzerland

Sarika Sood, MDSenior Director Global Medical Information Abbvie Inc.

Amy Van Sant, PharmD, MBAPresident, Medical Affairs Ashfield Healthcare LLC

Ellen Whipple, PharmDDirector of Medical Communications Med Communications, Inc.

Jim R. Wilkinson, PhDExecutive Director, Global Medical Affairs Amgen, Inc.

Robin Winter-Sperry, DrMed, MDHead, Global Field Based Medical Excellence Sanofi Genzyme

STAY CONNECTED!Connect to the Complimentary Forum WiFiNetwork: loews_confPassword: DIAMASC19

http://DIAglobal.org

http://www.diaglobal.org

DIAglobal.org 2Follow us @DrugInfoAssn #MASC19 for real-time updates

It is designed to enhance your meeting experience and provide valuable information in one place: agenda and speaker information, presentations, connect with attendees and exhibitors, participate in live session polling, and more! NEW to the App this year:

• Channels: Keep the conversation going by utilizing these new Track Channels for MASC. It’s a virtual discussion board for all the topics or questions you have regarding all the tracks at MASC. Select Channels on the App Menu to access all the track discussion boards.

• Evaluations: We value your feedback and are always looking to improve the MASC Forum. Access the evaluations by selecting General Information in the App Menu. From General Information select the Evaluations button.

Not sure about how to use the App? Join us before the Opening Session on Monday, March 18, at 12:40PM in Grand Caribbean 6 for a brief tutorial.

SAVE THE DATE!Medical Affairs and Scientific

Communications ForumMarch 23-25, 2020

Anaheim Marriott, Anaheim, CA

Register today by visiting

DIAglobal.org/MASC20

Download the DIA Global App!

Download today by searching “DIA Global” in your app store.


https://twitter.com/DrugInfoAssn

https://www.instagram.com/druginfoassn/

https://www.diaglobal.org/RSIDM20


Join DIA as we give back to our community! Help us “weave the thread” and provide blankets to those in need. DIA has paired up with Project Linus, a non-profit organization whose mission is to provide love, a sense of security, warmth, and comfort to children who are seriously ill, traumatized, or otherwise in need through the gifts of new, handmade blankets, lovingly made by volunteer “blanketeers”.

With chapters in all 50 states, Project Linus continues to grow. Blankets are collected locally and distributed to children in hospitals, shelters, social service agencies, or anywhere that a child might be in need of a big hug. The local Orlando chapter will be collecting the blankets we make here and distribute in the local community.

Join us and become a blanketeer throughout the forum in the Grand Caribbean Foyer for a simple blanket project to make a difference in someone’s life. Let’s weave the thread and spread the warmth of DIA!





Schedule At-A-Glance

Track* Key: Track 1: Medical Communications Track 2: Medical Writing Track 3: Medical Science Liaisons

*See track descriptions on page 5.

PRIMER | SUNDAY, MARCH 17 ROOM8:00AM-5:00PM Medical Communications Primer Registration and Breakfast *This course requires an additional registration fee. Grand Caribbean Foyer

8:30AM-5:00PM Medical Communications Primer: The Fundamentals of Medical Communications Grand Caribbean 1&2

DAY ONE | MONDAY, MARCH 18 ROOM8:00-8:30AM Short Course Registration and Breakfast *These courses require an additional registration fee. Grand Caribbean Foyer

8:30AM-12:00PM Short Course 1: Medical Communications: Compliance in 2019 Grand Caribbean 1 Short Course 2: Pubs Planning Grand Caribbean 2 Short Course 3: Effective Delivery of NDA and MAA Submission Packages Grand Caribbean 3 Short Course 4: Advertising and Promotional Content Review: A Medical Information Perspective Grand Caribbean 4

10:00AM-12:00PM MSL Community Round Table Grand Caribbean 8&9

11:00AM-5:35PM Forum Registration Grand Caribbean Foyer

12:40-1:00PM DIA Mobile App Tutorial Grand Caribbean 6

1:00-1:30PM Welcoming Remarks Grand Caribbean 6

1:30-2:30PM Session 1: Keynote Address Grand Caribbean 6

2:30-3:15PM Refreshment, Networking, and Exhibits Break Grand Caribbean 7

3:15-4:15PM Session 2: Breakout Sessions

Track 1: All Aboard the Globalization Train Grand Caribbean 6

Track 2A: No Need to Fear the Journal Editor Grand Caribbean 1&2

Track 2B: Health Canada – Regulatory Transparency and Openness Grand Caribbean 11&12

Track 3: Quadruple Aim Grand Caribbean 3-5


Track 1: The Future of Medical Affairs: The Voice of the Visionary Grand Caribbean 6

Track 2: Lay Language Process and Planning Grand Caribbean 1&2

Track 3: MSL Field Insights: Executing Three Rights (Right Audience, Right Time, Right Information), Without Going in Circles Grand Caribbean 3-5

5:35-6:45PM Networking Reception in the Exhibit Hall Outdoor Pavilion





DAY TWO | TUESDAY, MARCH 19 ROOM6:00-7:00AM DIA Fit Grand Caribbean 10

7:00AM-4:30PM Registration Grand Caribbean Foyer

7:00-8:00AM Networking Breakfast in the Exhibit Hall Grand Caribbean 7

8:00-8:15AM Remarks and Presentation of the Excellence in Service Award Grand Caribbean 6

8:15-9:05AM Session 4: Keynote Address: How to Communicate Information that Patients Need and Want Grand Caribbean 6

9:10-10:25AM Session 5: Breakout Sessions

Track 1/3: What’s Your Favorite Channel? Dialing up Individualized Communication…An Advisory Board with Customers Grand Caribbean 6

Track 2: EU GDPR and Medical Writing Grand Caribbean 1&2

10:25-11:10AM Refreshment, Networking, and Exhibits Break Grand Caribbean 7

11:10AM-12:25PM Session 6: Breakout Sessions

Track 1: Sewing Together HCPs and Pharma’s Opinion on Medical Information Scientific Response Documents Grand Caribbean 6

Track 2: Techniques, Technology, and Templates: New Approaches to Writing Clinical Study Reports Grand Caribbean 1&2

Track 3: Balancing the Importance of Global Alignment and Local Execution for the MSL Role Grand Caribbean 3-5

12:25-1:45PM Networking Luncheon in the Exhibit Hall Grand Caribbean 7

12:25-1:45PM Resident, Fellow, and Preceptor Luncheon and Professional Development Session: Difficult Conversations Grand Caribbean 10


Track 1A: The Three D’s of RWE Grand Caribbean 6

Track 1B: Is Your Contact Center Prepared for a Crisis? Grand Caribbean 11&12

Track 2: Medical Communication Data Visualization – New Ways of Presenting Clinical Data Grand Caribbean 1-2

Track 3: Thought Leader (TL) Identification, Tracking, and Engagement Best Practices Grand Caribbean 3-5



Track 1: Traversing Murky Waters Grand Caribbean 6

Track 2: ICMJE’s Data Sharing Requirements - Experience to Date Grand Caribbean 1&2

Track 3: Incorporating Proficiencies for Professional Development Grand Caribbean 3-5

4:30-6:00PM Resident and Fellow Poster Reception and Networking Grand Caribbean 7

6:30-9:00PM Dinner on the Town





DAY THREE | WEDNESDAY, MARCH 20 ROOM

6:00-7:00AM DIA Fit Grand Caribbean 10



8:00-9:30AM Session 9: Breakout Sessions

Track 1: Podium Pearls Grand Caribbean 6 Track 2: Automation Technologies in Medical Writing Grand Caribbean 1&2 Track 3: The Emerging Role of Medical Science Liaisons in Clinical Research Grand Caribbean 3-5

9:30-10:30AM Refreshment, Networking, and Exhibits Break - View Professional Posters Grand Caribbean 7

10:30-11:00AM Session 10: DIA Communities Update Grand Caribbean 6

11:00AM-12:00PM Session 11: Patient Centricity: Is it Just Lip Service? How to Get Everyone Focused on the Common Goal Grand Caribbean 6

12:00-12:15PM Remarks Grand Caribbean 6

12:15-1:30PM Networking, Luncheon, and Exhibits - View Professional Posters Grand Caribbean 7

1:30PM Forum Adjourns

Track 1: Medical Communications Grand Caribbean 6

“Weaving the Patient Thread”

Gain tangible insights via an executive-level interactive panel to discuss challenges facing small, medium, and large-sized companies. Further address solutions in how to build the right capacities and competencies required to meet the evolving needs of Medical Information. You’ll have the opportunity to listen to the voice of our customers in a new ad-board style format as they analyze medical content and communication channels. You will also learn how to apply these learnings to further refine content creation and dissemination to meet our evolving customer needs. The last session will weave in all three tracks to highlight how the patient voice impact activities and deliverables across medical affairs.

Track 2: Medical Writing Grand Caribbean 1&2

Independent industry experts will share the latest approaches in medical regulatory and publication writing. Topics discussed include artificial intelligence in clinical study reporting; the US, EU, and Canada regulatory policies; plain language processes; relationships with journal editors; data sharing and visualization; and implementation of common protocol templates. Attend this track to gain insight into the latest challenges and opportunities impacting Medical Writing!

Track 3: Medical Science Liaison Grand Caribbean 3-5

This track is appropriate for current or prospective Field Medical Professionals, including: Medical Science Liaisons (MSLs), MSL Supervisors, MSL Operations, and anyone else with interest in learning more about the issues impacting the Field Medical role. You will find a comprehensive and cohesive agenda that has been curated and peer-reviewed by recognized thought leaders from the global MSL community. The theme is, “Putting the Pieces of the MSL Value Puzzle Together.” The content is high-quality and non-biased – developed by MSLs for MSLs in the setting of DIA’s neutral, global forum. This is your opportunity to network with peers – and be – an MSL thought leader!





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Continuing EducationDIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for up to 20.25 contact hours or 2.025 continuing education units (CEU’s).If you are claiming ACPE credit for this forum you must:

• Complete a Verification of Attendance Form found in your folders

• Return it to the registration desk at the conclusion of the forum

• Access your DIA account and select My Transcript to claim your ACPE credit, available on April 10

DIA 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 Friday, May 1, 2019, 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.

Type of activity: Knowledge

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 CEUs for this program. Participants must attend the entire forum (primer, short courses, and forum 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 (primer and/or short courses if applicable), complete the “Verification of Attendance” form located in your forum folder, turn in your form to the registration desk at the conclusion of the forum, and claim CE via the online credit request process through DIA at My Transcript. 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 10.

Thank you to our media partner:

ACPE CREDIT REQUESTS MUST BE SUBMITTED BY FRIDAY, MAY 1, 2019

ACCESS PRESENTATIONS

• Visit DIAglobal.org• Sign In with your DIA User ID and Password• Select the Welcome Menu in the upper right hand corner

(where your name appears)• Select My Account from the menu

• Choose My Presentation

Please Note: DIA User ID and Password are needed to access presentations. If you have forgotten your DIA User ID and Password, or this is your first time logging into the DIA website, please use our Login Reminder. *Presentations will be available for six months post conference.

TO ACCESS MY TRANSCRIPT

• Visit DIAglobal.org

• Sign In with your DIA User ID and Password

• Select the Welcome Menu in the upper right hand corner (where your name appears)

• Select My Account from the menu

• Select My Transcripts then Manage My Transcripts





Continuing Education AllocationPrimer: The Fundamentals of Medical Communications: Pharmacy 7 contact hours or .7 CEUs, UAN: 0286-0000-19-025-L04-P; IACET .7 CEUs

Short Courses

Short Course 1: Medical Communications: Compliance in 2019: Pharmacy 3.25 contact hours or .325 CEUs, UAN: 0286-0000-19-026-L04-P; IACET .3 CEUs

Short Course 2: Pubs Planning: Pharmacy 3.25 contact hours or .325 CEUs, UAN: 0286-0000-19-027-L04-P; IACET .3 CEUs

Short Course 3: Effective Delivery of NDA and MAA Submission Packages: Pharmacy 3.25 contact hours or .325 CEUs, UAN: 0286-0000-19-028-L04-P; IACET .3 CEUs

Short Course 4: Advertising and Promotional Content Review: A Medical Information Perspective: Pharmacy 3.25 contact hours or .325 CEUs, UAN: 0286-0000-19-029-L04-P; IACET .3 CEUs

Forum IACET Credit: 1

Forum Pharmacy Credit Breakdown

Session 2 Track 1: All Aboard the Globalization Train: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-030-L04-P

Session 2 Track 2B: Health Canada – Regulatory Transparency and Openness: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-031-L04-P

Session 2 Track 3: Quadruple Aim: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-032-L04-P

Session 3 Track 1: The Future of Medical Affairs: The Voice of the Visionary: Pharmacy 1.25 contact hours or .125 CEUs, UAN: 0286-0000-19-033-L04-P

Session 3 Track 3: MSL Field Insights: Executing Three Rights (Right Audience, Right Time, Right Information), Without Going in Circles: Pharmacy 1.25 contact hours or .125 CEUs, UAN: 0286-0000-19-034-L04-P

Session 4: Keynote Address: How to Communicate Information that Patients Need and Want: Pharmacy .75 contact hours or .75 CEUs, UAN: 0286-0000-19-035-L04-P

Session 5 Track 1&3: What’s Your Favorite Channel? Dialing up Individualized Communication…An Advisory Board with Customers: Pharmacy 1.25 contact hours or .125 CEUs, UAN: 0286-0000-19-036-L04-P

Session 5 Track 2: EU GDPR and Medical Writing: Pharmacy 1.25 contact hours or .125 CEUs, UAN: 0286-0000-19-037-L04-P

Session 6 Track 1: Sewing Together HCPs and Pharma’s Opinion on Medical Information Scientific Response Documents: Pharmacy 1.25 contact hours or .125 CEUs, UAN: 0286-0000-19-038-L04-P

Session 6 Track 2: Techniques, Technology and Templates: New Approaches to Writing Clinical Study Reports: Pharmacy 1.25 contact hours or .125 CEUs, UAN: 0286-0000-19-039-L04-P

Session 6 Track 3: Balancing the Importance of Global Alignment and Local Execution for the MSL Role: Pharmacy 1.25 contact hours or .125 CEUs, UAN: 0286-0000-19-040-L04-P

Session 7 Track 1A: The Three D’s of RWE: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-041-L04-P

Session 7 Track 1B: Is Your Contact Center Prepared for a Crisis?: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-042-L04-P

Session 7 Track 2: Medical Communication Data Visualization- New Ways Of Presenting Clinical Data: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-043-L04-P

Session 7 Track 3: Thought Leader (TL) Identification and Tracking Best Practices: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-044-L04-P

Session 8 Track 1: Traversing Murky Waters: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-045-L04-P

Session 8 Track 2: ICMJE’s Data Sharing Requirements - Experience to Date: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-046-L04-P

Session 8 Track 3: Incorporating Proficiencies for Professional Development: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-047-L04-P

Session 9 Track 1: Podium Pearls: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-19-048-L04-P

Session 9 Track 2: Automation Technologies in Medical Writing: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-19-049-L04-P

Session 9 Track 3: The Emerging Role of Medical Science Liaisons in Clinical Research: Pharmacy 1.5 contact hours or .15 CEUs, UAN: 0286-0000-19-050-L04-P

Session 11: Patient Centricity: Is it Just Lip Service? How to Get Everyone Focused on the Common Goal: Pharmacy 1 contact hour or .1 CEUs, UAN: 0286-0000-19-051-L04-P

Sessions Not Available for Pharmacy Credits

MSL Community Round TableDIA Mobile App TutorialWelcoming RemarksSession 1: Keynote Address: Overcoming a Misunderstood Illness: A Story of Hope, Resilience, and Modern MedicineSession 2 Track 2A: No Need to Fear the Journal EditorSession 3 Track 2: Lay Language Process and PlanningFellow and Resident Professional Development SessionPoster ReceptionSession 10: DIA Communities Update





PRIMER | SUNDAY, MARCH 17 ROOM

8:00AM-5:00PM Medical Communications Primer Registration and Breakfast *This course requires an additional registration fee. Grand Caribbean Foyer

8:30AM-5:00PM Medical Communications Primer: The Fundamentals of Medical Communications Grand Caribbean 1&2

Session ChairKristin Goettner, PharmD, Senior Director, Medical Information and Knowledge Integration, Janssen Scientific Affairs, LLC

Instructors: Shelby Biagi, PharmD, Site Engagement Manager, UCB Biosciences Inc.

Emily Costerison, PharmD, Principal Medical Science Director, Genentech, Inc.

Payal Desai, PharmD, Associate Director, Medical Information-CV, Janssen Scientific Affairs, LLC

Jennifer Park, PharmD, Global Medical Information Content Manager, Sanofi

Ankur Shah, PharmD, Director, US Medical Information, Incyte Corporation

Ellen Whipple, PharmD, Director of Medical Communications, Med Communications, Inc.

This primer will address many of the common responsibilities of medical communications staff and dig deeper into challenging aspects of each role. This activity is specifically designed to meet the needs of individuals new to biopharmaceutical industry-based medical communications. Many times, their understanding is limited to only their own companies’ SOPs and “way of doing things.” In this activity, attendees will learn and discuss important skill sets that provide value to both internal and external customers and compare these across companies. These include activities such as identifying the critical steps that a medical communications professional should take when receiving an inquiry, evaluating the sources of information/data, and the importance of fair balance and documenting responses. Topics will also include important elements of writing a standard response letter (formulary dossier communications), promotional review committee best practices, and activities at scientific congresses. Role playing and mock examples will be used to re-enforce principles that emphasize the importance of our role to the industry and to the customers we serve.

Attendees will be presented with real-life scenarios that represent challenges that are common to our roles; groups will be asked to discuss and share their responses to the situations. Attendees will gain a better understanding of best practices within their job function and a broader awareness of the regulatory environment. Attendees will also learn how to work better as part of interdisciplinary teams, practice evidence-based medicine evaluation, and effectively use technology.

At the conclusion of the primer, 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 used 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 including understanding the background, content, and purpose of the AMCP Formulary Dossier

• Describe the distinct scientific value that medical communications provides on promotional review committees





DAY ONE | MONDAY, MARCH 18

8:00-8:30AM Short Course Registration and Breakfast *Short courses require an additional registration fee. Grand Caribbean Foyer

8:30AM-12:00PM Short Course 1: Medical Communications: Compliance in 2019 Grand Caribbean 1

InstructorsMonica Kwarcinski, PharmD, Executive Director, Medical Services, Purdue Pharma L.P.

Mark DeWyngaert, PhD, MBA, Managing Director, Life Sciences, Deloitte & Touche, LLP

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 short course 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 course with opportunity for discussion and questions.

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

• Discuss compliance hot topics in medical communications such as medical inquiry documentation; response development, review, and dissemination; Sunshine Act reprint reporting requirements: staff training; and sales force facilitated inquiries

• Discuss FDA guidances relevant to medical communications

• 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

Short Course 2: Pubs Planning Grand Caribbean 2

InstructorsMaryKate Lesnevich, MS, CMPP, Associate Director, Global Scientific Communications, I&I, Celgene Corporation

Bhakti Kshatriya, PharmD, Founder, Publication Practice Counsel

Publication of scientific and clinical research is fundamental in ensuring that findings are communicated to the scientific and medical community to ultimately help in improving patient’s lives. Scientific communications works to lead, organize, and develop the dissemination of quality and timely publications. The course will not only provide an overview of publication planning, but go into specific details on each element of the work process. Course participants should have a good understanding of the core elements of publication development and a desire to expand their skill set relevant to strategic publication planning. This will be a highly interactive course with ample time for discussion and questions.


• Discuss the role and responsibilities of scientific communications within the medical affairs organization • Describe the components of the publication planning process which include: gap analysis, needs

assessment, publication objectives, strategic publication plan, tactical publication plan, individual publication project planning, and development

• List the key activities, team members, and timing associated with the development of an individual publication project

• Identify the factors to consider when developing, implementing, and executing a publication plan • Discuss the need for capturing documentation of reviews and approvals associated with each individual

publication project• Explain the industry standards for publications, such the International Committee of Medical Journal

Editors (ICMJE) recommendations and Good Publication Practice (GPP3) guidelines as they relate to requirements for authorship, timeliness of publication, ensuring scientific rigor, and fair balance of content





Short Course 3: Effective Delivery of NDA and MAA Submission Packages Grand Caribbean 3

InstructorJonathan Edwards, MS, Medical Writer, Audubon PM Associates, Inc., United Kingdom

This short course will provide a practical overview of the key requirements and processes involved in delivering a regulatory submission package for a New Drug Application (NDA) and/or Marketing Authorization Application (MAA). In addition to presenting an overview of the fundamental regulatory document requirements (Clinical Summaries, Clinical Overview, etc.), the course will recommend ‘best practice’ processes and discuss the importance of agreeing a clear submission plan and scientific strategy. However, even when regulatory requirements are fully understood and ‘best practice’ approaches are followed, submissions may often deviate from the initial plan and strategy. Therefore, this course will also present a number of anonymized case studies to illustrate the challenges that may be faced and allow delegates to discuss approaches to avoid – or at least to mitigate and manage – such challenges. Although delivered from the perspective of a medical writer, this course will also be of relevance to regulatory professionals, clinical project managers, and other members of the clinical/regulatory team involved in submission delivery.


• Define the documents required to support an NDA/MAA submission and be able to describe the fundamental purpose of each of these documents and the key procedural steps required to prepare these documents

• Explain the importance of defining a clear and detailed scientific strategy for a submission and promote practical approaches to agree such strategy with the cross functional submission team

• Evaluate potential risks and pitfalls when planning for a submission, recognize when things are not going to plan during submission preparation, and have strategies in place to deal with deviations from the submission plan

Short Course 4: Advertising and Promotional Content Review: A Medical Information Perspective Grand Caribbean 4

InstructorsJanet Gottlieb, PhD, Executive Director, Medical Communications, Allergan, Inc.

Jimmie Overton, PharmD, Senior Director, Scientific Information, Allergan, Inc.

This short course will discuss the basics of promotional review, a critical component of product marketing. Promotional review is more than ensuring materials meet regulatory, legal, and scientific requirements: there is an art to the communication and relationship-building to foster a collaborative environment that will increase efficiencies. Medical information has the unique opportunity to interpret guidance as it applies to evidence that can be used to support a claim and work as a collaborative partner with commercial. Participants will learn principles and tenets of medical review of promotional materials and apply them in an interactive workshop. This course will benefit those new to promotional review as well as offer an update to the more experienced reviewer.


• Articulate the benefits and advantages of delegating medical information to promotional review

• Identify substantiation and expectations of data requirements for product claims

• Transition from reacting to content to a trusted collaborator

• Apply principles of promotional material review and learnings from FDA enforcement letters in an interactive pharmaceutical website review

10:00AM-12:00PM MSL Community Round Table Grand Caribbean 8&9

Are you seeking an opportunity to connect with Medical Science Liaisons (MSL) colleagues? This Community Round Table will provide you the opportunity to join your MSL colleagues from across industry for interactive round table discussions with the leaders in our MSL Community. Topics will include: MSL career paths, evaluating the value of the MSL team to the organization, capturing clinical/scientific insights, and considerations for MSL onboarding and training.





11:00AM-5:35PM Forum Registration Grand Caribbean Foyer

12:40-1:00PM DIA Mobile App Tutorial Grand Caribbean 6

The DIA Global App is designed to enhance your forum experience and provide valuable information in one place. Download today by searching “DIA Global” in your app store. Come and learn first-hand how to navigate and best use this tool while onsite at the forum.

1:00-1:30PM Welcoming Remarks Grand Caribbean 6

Sudip Parikh, PhD, Senior Vice President and Managing Director, DIA Americas

Track Co-ChairsPoonam Bordoloi, PharmD, Director, Medical Affairs Team Lead, Merck & Co.

Ed Cunningham, PharmD, Senior Director, Neurology Medical Science Liaison Lead, Sunovion

David Meats, Associate Director Midwest Operations, Medical Writing Manager, Trilogy Writing & Consulting

1:30-2:30PM Session 1: Keynote Address: Overcoming a Misunderstood Illness: A Story of Hope, Resilience, and Modern Medicine Grand Caribbean 6

Keynote SpeakerJennifer Brea, Independent Documentary Filmmaker, Canada

In this talk, Jennifer Brea offers poignant insight into the experience of living with a debilitating (and mostly misunderstood) illness—and spotlights the grit, resilience, and bravery exhibited by the patients fighting for better treatment and higher visibility. Brea inspires audiences to ask questions, find purpose, and, even in the darkest moments, believe in hope.


3:15-4:15PM Session 2: BREAKOUT SESSIONS

Track 1: All Aboard the Globalization Train Grand Caribbean 6

Session ChairTaleen Kalebjian, PharmD, Senior Manager, Medical Information, Gilead Sciences, Inc.

The trend towards medical information globalization is clear, but the path and final product can look different for each organization. The results from a survey of several biopharmaceutical companies show us why companies decide to globalize, how they approach this process, and key components to a successful shift towards a global medical information department. We will then see some of these key learnings in action as one company shares their globalization journey.

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

• Describe current trends in medical information globalization in areas including infrastructure, aspects of department globalization, and the use of technology

• Compare various models of globalization

• Discuss the value of globalization in regards to the company, the department, and the patient

• Recognize key challenges associated with globalization and best practices for overcoming them

PhactMI Benchmark Study ResultsSuzana Giffin, PharmD, Associate Vice President, Global Medical Affairs, Merck & Co.

MI Globalization – Partnering with Affiliates Ghiesla Nel, Head of Global Medical Information, Ipsen, United Kingdom

Track 2A: No Need to Fear the Journal Editor Grand Caribbean 1&2

Session ChairJennie Jacobson, PhD, Lead Medical Writer, Fishawack Communications

Journal editors are a writer’s first audience; if they don’t like our work, no other audience will see it. We know the basics – choose a journal with the appropriate scope for our subject and write a paper that is fair-balanced, compelling, and correctly formatted for the journal and submit it with a strong cover letter. But is there more we can do? Does reaching out to an editor hurt or help our chances? How can writers and editors engage to ensure that the best science is being published?





Leslie Citrome, MD, MPH, Editor in Chief, International Journal of Clinical Practice, Wiley

Darren Taichman, MD, PHD, Executive Deputy Editor, Annals of Internal Medicine

Track 2B: Health Canada – Regulatory Transparency and Openness Grand Caribbean 11&12

Session ChairStephanie Krupski, Consultant- Global Scientific Communications, Eli Lilly and Company

During this session, we will discuss the new Health Canada policy on public release of clinical information. We will also explore how the Health Canada policy compares and contrasts to the EMA Policy 70. Finally, we will go over how companies/medical writers can proactively plan for Health Canada transparency requests.


• Describe the goals/aims of the Health Canada policy on Public Release of Clinical Information

• Discuss the current state of the policy: How has the policy changed? What action groups are involved in defining the policy?

• Compare and contrast the Health Canada policy with/against the EMA Policy 70 on transparency

• Create action plan for medical writers to proactively prepare for the transparency requests

Teresa Armstrong, Advisor, Clinical Document Transparency, Eli Lilly and Company

Sandra Wainwright, Executive Director, Merck Canada, Inc., Canada

Track 3: Quadruple Aim Grand Caribbean 3-5

Session ChairKevin Appareti, MBA, Senior Director, Global Medical Science Liaison, Philips HealthTech

This session will cover a novel approach to addressing the many challenges facing healthcare. It is an interesting framework that describes an approach to optimizing health delivery performance. If one looks at designing new healthcare solutions while simultaneously considering 4 dimensions of care, you will see a marked increase in performance for all stakeholders. The four dimensions of care are: Quality and Experience of care the patient receives, Access to care and improved care of Populations, Access, Cost reductions per capita, and Experience and support of Care Providers.


• List the elements of the Quadruple Aim framework

• Describe the benefits of and the synergies of the Quadruple Aim framework

• Identify examples of the Quadruple Aim framework in action

Introduction of the Quadruple Aim FrameworkKevin Appareti, MBA, Senior Director, Global Medical Science Liaison, Philips HealthTech

The Positive Impact of the Quadruple Aim FrameworkIlya Gipp, MD, Oncology Solutions Executive, Philips HealthTech


Track 1: The Future of Medical Affairs: The Voice of the Visionary Grand Caribbean 6

Session Co-ChairsAnne Arvizu, PharmD, FASCP, PCC, CEO and Medical Affairs Advisor, RxER Communications

Isabelle Widmer, DrMed, Medical Affairs Consultant, elytra GmbH, Switzerland

This panel interview represents a new concept at MASC. Senior executive industry leaders, founders, and way-makers are being brought together to discuss their vision, why they founded their organizations, answer questions, and demonstrate how they continually move forward. We’ll focus our emphasis on niche markets, organizational design, and necessary business acumen in an ever-changing industry environment, to add as much value as possible. For the manager to director level MI observer, awareness of resources can be unclear. Participants will walk away with invaluable insight to think about what’s coming in the future of our industry, and to be able to apply takeaways for any sized company small, mid-sized, and large Pharma/Biotech.






• Identify the differences of major organizations and the value they provide and their niche

• Discuss the vision behind each and how to apply what is needed when they need it to small, mid-sized, and large Pharma/Biotech

Dominick Albano, PharmD, Vice President, Global Medical Information, Pfizer, Inc

Patrick Reilly, MSc, CEO, phactMI

William Soliman, PhD, President, ACMA

Track 2: Lay Language Process and Planning Grand Caribbean 1&2

Session ChairDan Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences

Lay language or plain language summaries and documents are increasingly required by regulatory agencies and are also part of good patient engagement practices. The problem is that writing related content for distinctly different audiences requires the writer to walk a line between documenting results in the detail required for regulatory review and also summarizing the same results for a non-technical audience without losing the key ideas in the simplification process. The speakers in this session will be detailing their knowledge and experience in accomplishing both goals through initial preparation and follow-through in the document process.

Plain Language Summaries – Simplification Without DumbificationDan Benau, PhD, Director, Biomedical Writing Programs, University of the Sciences

Plain Language Summaries: Stakeholder Perspectives and Best PracticesBehtash Bahador, Senior Manager, Quality and Compliance, Communicating Trial Results, Center for Information and Study on Clinical Research Participation (CISCRP)

A Survivor’s Guide to Lay SummariesLisa Chamberlain James, PhD, Senior Partner, Trilogy Writing and Consulting, United Kingdom

Track 3: MSL Field Insights: Executing Three Rights (Right Audience, Right Time, Right Information), Without Going in Circles Grand Caribbean 3-5

Session ChairEd Cunningham, PharmD, Senior Director, Neurology Medical Science Liaison Lead, Sunovion Pharmaceuticals, Inc.

Medical Science Liaisons (MSLs), with their advanced training, knowledge, and field focus, are uniquely positioned to help an organization understand the perspectives of its external stakeholders. The value of insights gathered and reported by the MSL team can span across a product lifecycle and involve a variety of customers that are ultimately impacted by the company’s decisions. This session will review approaches for optimizing the gathering and reporting of MSL field insights, while doing so in a timely, effective, and compliant manner.


• Discuss the role of MSLs and Field Medical teams in the gathering of scientific insights throughout each stage of the product lifecycle

• Describe best practices for identification of scientific insights which align with unique internal stakeholder needs

• Discuss tools and approaches for compliant documentation and reporting of insights

Ed Cunningham, PharmD, Senior Director, Neurology Medical Science Liaison Lead, Sunovion

Mike Abbadessa, PharmD, Founder and Chief Executive Officer, OpX Insights, Inc.

Avikk Ghose, Chief Executive Officer, kernel

5:35-6:45PM Networking Reception in the Exhibit Hall Outdoor Pavilion





DAY TWO | TUESDAY, MARCH 19

6:00-7:00AM DIA Fit - Zumba® Fitness Grand Caribbean 10

Take the “work” out of workout, by mixing low-intensity and high-intensity moves for an interval-style, calorie-burning dance fitness party! Once the Latin and World rhythms take over, you’ll see why Zumba® Fitness classes are often called “exercise in disguise.” Class focuses on all elements of fitness: cardiovascular, muscular conditioning, flexibility, and balance with easy-to-follow Zumba® choreography. Come ready to sweat and prepare to leave empowered and feeling strong!



8:00-8:15AM Remarks and Presentation of the Excellence in Service Award Grand Caribbean 6

Award Winners

David Bowers, PharmD, Director, Medical Communications, PPD

Darryl L’Heureux, PhD, MPharm, MSc, Global Strategic and Regulatory Documentation, Bristol-Myers Squibb

Lucy Rose, MBA, President, Lucy Rose and Associates, LLC

8:15-9:05AM Session 4: Keynote Address How to Communicate Information that Patients Need and Want Grand Caribbean 6

Keynote SpeakerDeborah Collyar, President, Patient Advocates in Research (PAIR)

Deborah Collyar knows patients after years of helping thousands, and she knows how to make patient engagement real while working in translational, clinical, and health delivery research. In this talk, Deborah will share how diagnoses impact patients, what kind of information patients look for (and why), and explain why health literacy (HL) matters, no matter who becomes the patient. She will also talk about how public trial summaries can help, and how to consider patient as KOLs.

At the conclusion of this session, participants should be able to:• Discuss the various medical conditions and illnesses faced by patients in today’s healthcare environment.

• Plan HL strategies that encompass regulatory affairs, usability/user testing, and patient engagement.

• Implement HL strategies to ensure that information in all forms, e.g. websites, social media, and print, is patient-centric

• Develop clear communication and information using appropriate context to break down barriers between patients and companies.

9:10-10:25AM Session 5: BREAKOUT SESSIONS

Track 1/3: What’s Your Favorite Channel? Dialing up Individualized Communication…An Advisory Board with Customers Grand Caribbean 6

Session Co-ChairsChristi Marsh, PharmD, Director, Medical Affairs, Medical information and Scientific Communication, HEMA Biologics, LLC

Sarika Sood, MD, Senior Director Global Medical Information, Abbvie, Inc.

Robin Winter-Sperry, MD, Head, Global Field Based Medical Excellence, Sanofi Genzyme

We invite all medical affairs personnel (MSL, Medical Communications, and Contact Centers) to attend our innovative session about dialing up the best communication channels tailored to enhance communication and transference of knowledge. Our session will be an advisory board-style panel. This panel will consist of three key customer types (MD, allied HCP, consumer, etc.) who will provide insights and feedback regarding how





medical affairs colleagues in the industry use different channels to present data. This session is intended to be interactive and engage the attendees to innovate based on the advisory panel feedback, adapting medical affairs and scientific communications’ practices, accordingly.


• Discuss preferred channels and trends for searching for information based on customer type

• Identify the preferences for receiving information by customer type

• Assess for focused areas of innovation for medical affairs and scientific communication channels (search and receipt) to help your teams tailor medical communication in a customer-centric manner

Evelyn Hermes-DeSantis, PharmD, BCPS, Clinical Professor, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey

Patricia Pagnotta, ARNP, Nurse Practitioner, Neurology Associates

Chris Maxwell, Patient Advocate

Track 2: EU GDPR and Medical Writing Grand Caribbean 1&2

Session ChairAndrea Meyers, Vice President, Medical Writing, Syneos Health

The General Data Protection Regulation (GDPR) became enforceable in the European Union in May 2018. A panel discussion will explore the impact of the EU GDPR as it relates to clinical trials, specifically with regard to the impact on the production of clinical trial documents prepared by medical writers. The session will explore the changes and the challenges of implementing the EU GDPR in clinical trial documents with input from clinical trial industry leaders. It will also look at how this has impacted the pharmacovigilance system in the UK and how the MHRA have adapted their data collection systems. MHRA will also provide an update on Brexit.


• Describe and discuss the EU GDPR changes that went into effect May 2018

• Apply the EU GDPR during the preparation of clinical trial documents, particularly the informed consent

• Disclose clinical trial data, using anonymization techniques compliant with the EU GDPR

Larry Singer, RPh, MBA, JD, Senior Corporate Counsel and Deputy Global Data Protection Officer, Syneos Health, Inc.

Lisa Zimmerman, MS, President, Axis Pharma

Mick Foy, Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group, Medicines and Healthcare products Regulatory Agency (MHRA), European Union, United Kingdom

10:25-11:10AM Refreshment, Networking, and Exhibits Break Grand Caribbean 7

11:10AM-12:25PM Session 6: BREAKOUT SESSIONS

Track 1: Sewing Together HCPs and Pharma’s Opinion on Medical Information Scientific Response Documents Grand Caribbean 6

Session Co-ChairsJacqueline Byun, PharmD, Manager, Medical Information, Sanofi

Sarika Sood, MD, Senior Director Global Medical Information, Abbvie, Inc.

Do we know if our current scientific response documents (SRDs) are of the highest quality for our customers? This session will present two different perspectives, from 400 healthcare providers and 27 Medical Information departments, on medical content in scientific response documents (SRDs). The phactMI benchmarking survey will describe the approaches of 27 member companies on medical information content while results from another phactMI survey of 400 healthcare providers will provide the opinions on the structure, content, layout, and delivery options of SRDs. In this session, we will provide strategies and roadmaps to enhance medical content based on customer preferences to deliver the highest quality responses utilized by HCPs in their clinical decision-making.






• Identify existing gaps to strategize the creation and maintenance of SRD to exceed customer expectations

• Evaluate the productivity of resources to deliver exceptional scientific content

• Develop transformational MI SRDs by integrating customer engagement through use of smart technology

HCPs’ Opinion on Medical Information Scientific Response DocumentsEvelyn Hermes-DeSantis, PharmD, BCPS, Clinical Professor, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey

PhactMI Benchmarking Survey: How Are Member Companies Managing Medical Content Through Response Documents?Ina Shah, PharmD, Director, Allergan, Inc.

Track 2: Techniques, Technology, and Templates: New Approaches to Writing Clinical Study Reports Grand Caribbean 1&2

Session ChairAnn Winter-Vann, PhD, Senior Medical Writer and Consultant, Whitsell Innovations, Inc.

A clinical study report (CSR) can be a confusing mass of data, or it can be a concise, effective presentation of study results. By introducing a strategy to develop consistent messaging across your document and teaching your team the benefits of a concise, streamlined document, you can produce clear, well-written CSRs in spite of your team’s preference to include the kitchen sink. In this session, you will also learn how – and why – to implement the new, thoughtfully designed, technology-enabled CSR template from TransCelerate.


• Employ new strategies to develop consistent messaging throughout a CSR

• Streamline the content of a CSR to decrease writing and review time

• Identify the advantages of the TransCelerate CSR template and structured authoring

Strategies to Maximize Efficiency in CSR WritingLisa Ambrosini Vadola, PhD, Medical Writer and Consultant, Whitsell Innovations, Inc.

TransCelerate’s Common CSR Template: A Consistent Approach to Writing Compliant CSRs with EaseElizabeth Brown, MS, PMP, Managing Medical Writer, Merck & Co, Inc.

Track 3: Balancing the Importance of Global Alignment and Local Execution for the MSL Role Grand Caribbean 3-5

Session ChairJim Wilkinson, PhD, Executive Director, Global Medical Affairs, Amgen, Inc.

In an increasingly interconnected world, medical affairs teams at the global, regional, and local level must effectively communicate and collaborate to share actionable insights, create medical strategies, and execute efficiently. This includes coordinated efforts within Field Medical (MSLs) to ensure opinion leaders around the world have valuable interactions with our Field Medical staff. This session will highlight the value that global collaboration can bring to provide one medical voice for the healthcare community. The importance of collaborations between internal stakeholders to align on external engagements and deliverables will be discussed. This will be an interactive session with discussion of best practices and case scenarios.


• Describe the importance of global alignment on MSL strategy and performance with local execution of the MSL activities

• Describe the value of a highly collaborative global team for the creation of MSL strategy, tactical plans, training plans, and medical resources

• Apply learnings from global best practices to inform and positively affect organizational goals of the MSL function





Jim Wilkinson, PhD, Executive Director, Global Medical Affairs, Amgen, Inc.

Lori Mouser, PharmD, Global Head, Medical Science Liaison, Roche, Switzerland

Jennifer Slade, PharmD, Senior Director, Global Lead MSLs, Novartis Pharmaceuticals

12:25-1:45PM Networking Luncheon in the Exhibit Hall Grand Caribbean 7

12:25-1:45PM Resident, Fellow, and Preceptor Luncheon and Professional Development Session: Difficult Conversations Grand Caribbean 10

Session ChairAlicia Cadogan, Director, Oncology Medical Information, Pfizer, Inc

After the Core Curriculum provides an introduction to the foundation of Medical Communications, the forum takes off at a rapid pace. The topics are intense, and the speed of the information can be a bit much for someone early in their career, such as the Residents and Fellows. This special development session has been designed to allow the trainees to reflect on the subject matter of the forum thus far, and to engage in discussion on what they have learned, what they did not follow, and what they would like to better understand. Experienced faculty will highlight key learning points that they may have missed from the previous sessions, and will provide tools that they can apply to the remaining sessions to ensure they are maximizing their learning opportunities, and can act upon what they have learned when they are back in the workplace.

Preceptors are encouraged to participate to better understand what challenges the trainees may have with the forum content, and to help them identify what actions they can take when back in the workplace.


Track 1A: The Three D’s of RWE Grand Caribbean 6

Session Co-ChairsDonna Booth, PharmD, Senior Director, US VEO Strategic Initiatives Lead, Customer Engagement, Value, Evidence, and Outcomes (CE-VEO), GlaxoSmithKline

Ellen Whipple, PharmD, Director of Medical Communications, Med Communications, Inc.

Real world data (RWD) and real world evidence (RWE) play an increasing role in healthcare decisions. RWD is derived from multiple sources outside typical clinical research settings, including electronic health records (EHRs), claims and billing data, product and disease registries, and data gathered through personal devices and health applications. RWE is the intersection between the structured rigor of a randomized control trial and the clinical exposure a treatment receives once it enters clinical practice as it is derived from analysis of RWD. Medical information departments vary in their understanding and approach to the 3 D’s (definition, decision makers, and dissemination) of RWE. As the US healthcare system continues to seek value for patients, it is increasingly important to have strategies for addressing RWE across the continuum of decision-makers (regulators, payers, HCPs and patients).


• Define RWE by discussing various types and differentiating from clinical trial data• Recognize decision makers receiving RWE and describe how RWE brings value based on their unique

perspectives• Propose strategies for dissemination of RWE by sharing examples utilized by various medical information

departments that demonstrated success as well as areas for improvement• Share strategies from audience members regarding dissemination of RWE

Real World Evidence: Therapeutic Effectiveness Beyond EfficacyFred Cox, PhD, President and Principal of CERES, Cox Econometric Research, LLC

Sharing the Value of RWEDawn Beach, PharmD, Medical Information Director, Respiratory US Medical Information, GlaxoSmithKline

Digital Dissemination of RWE: EvidenceFinderChirayu Parikh, PharmD, Medical Information Therapeutic Manager, Novo Nordisk





Track 1B: Is Your Contact Center Prepared for a Crisis? Grand Caribbean 11&12

Session ChairAmy Van Sant, PharmD, MBA, President and Senior Vice President, Medical Affairs, Ashfield Healthcare LLC

A crisis may be generally defined as an event or critical situation that has short-term or long-term impact. In the pharmaceutical industry, crisis situations may result from positive or negative news, and may be expected or unexpected. No matter the type of event, our contact centers are often impacted and need to be prepared as well as part of the solution in any effective crisis management plan.


• Describe the crisis management landscape and changing environment

• Identify examples of high-risk events or crisis scenarios in a call center

• Describe how a crisis can impact a pharmaceutical organization and its contact center

• Describe elements of a contact center crisis management plan

• Identify items to consider when preparing the contact center for a crisis

What is Crisis Management? An Overview of the Landscape and Changing EnvironmentAmy Van Sant, PharmD, MBA, President and Senior Vice President, Medical Affairs, Ashfield Healthcare, LLC

Are You Crisis-Ready? Planning for the Expected and UnexpectedMonica Kwarcinski, PharmD, Executive Director, Medical Services, Purdue Pharma L.P.

Crisis Management Case Studies - Operational Impact and Lessons LearnedFrank Lock, Director, Information Center, AstraZeneca Pharmaceuticals

Track 2: Medical Communication Data Visualization – New Ways of Presenting Clinical Data Grand Caribbean 1-2

Session ChairDave Meats, Associate Director Midwest Operations, Medical Writing Manager, Trilogy Writing & Consulting

This session will assess issues with current communication of clinical data, and suggest better presentation strategies to meet publication, regulatory, and medical affairs customer needs. The presenters will show different methods of data presentation from low to high complexity and discuss how different styles of data presentation can help with understanding complex medical information. In addition, the speakers will explore emerging digital presentation styles that can improve both internal and external audience engagement and understanding of a team’s drug development data. In conclusion, this session will explain how advanced data visualization is important to medical writing


• Recognize the reasoning for using different data visualization styles for presenting data and medical information for different audiences

• Evaluate how modifying data presentation style helps clinical stakeholders highlight important efficacy and safety information from complex datasets

• Apply new ways of presenting complex data to improve efficiencies and aid audiences’ understanding

David Clemow, PhD, Advisor, Scientific Communications Information Strategy, Eli Lilly and Company

Robin Whitsell, President, Whitsell Innovations, Inc.

Track 3: Thought Leader (TL) Identification and Tracking Best Practices Grand Caribbean 3-5

Session Co-ChairsKathy Bucci, PharmD, Senior Director, Medical Governance Lead, Pfizer, Inc

David Price, PhD, Advisor, US Field Medical, Lilly USA, LLC

The medical and clinical expertise offered by thought leaders (TLs) enables pharmaceutical and biotechnology companies to deliver on medical affairs strategy and objectives. It is also important for pharmaceutical and biotechnology companies to engage with TLs and others in the healthcare community to inform the safe and appropriate use of their products. Field Medical (e.g. Medical Science Liaisons – MSLs) have an essential role building and maintaining relationships with TLs. This session will provide an overview of MSL methods to identify and track TLs along with best practices for TL engagement.






• Describe criteria and approaches to identify MSL TLs to meet medical strategy and objectives

• Evaluate the various methods MSLs and MSL teams leverage to track the composition of their customer base using various platforms, processes, and capabilities

• Identify best practices to engage TLs to meet medical strategy and objectives

• Recognize the considerations for different size companies when choosing the appropriate method to track MSL TLs

Sarah Jarvis, MBA, Principal, ZS

Anthony Page, Co-Founder, Chief Executive Officer, Voxx Analytics



Track 1: Traversing Murky Waters Grand Caribbean 6

Session ChairMaureen Feeney, MBA, PharmD, RPh, Senior Director, Head Global Medical Information, Takeda

The environment medical information operates with in is constantly changing. Companies face increasing challenges to deliver high-quality and impactful materials. This session will discuss several areas that present challenges as we deliver for our customers, including delivering patient medical information, evolving privacy issues, and compendia interactions.


• Describe the complexities and successes delivering patient-centric information through traditional and non-traditional MI channels

• Explain the basics of GDPR and implications on current business practices

• Discuss the current challenges of compendia interactions

Medical Information: A Patient-Centric ApproachMichelle Quinlan, PharmD, Associate Director, Medical Information, Pfizer, Inc

Introducing GDPR – Background, Impact, and Implications for Medical Information TeamsIsabelle Widmer, DrMed, Medical Affairs Consultant, elytra GmbH, Switzerland

Compendia Engagements - How Do We Demonstrate Value?Jully Kim, PharmD, Director, Global Medical Information, Celgene Corporation

Track 2: ICMJE’s Data Sharing Requirements - Experience to Date Grand Caribbean 1&2

Session ChairRobert Paarlberg, MS, Principal, Paarlberg & Associates, LLC

The ICMJE’s new data sharing requirement requiring manuscripts contain a data sharing statement became effective July 1, 2018. The ICMJE also requires clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trial’s registration. This session will provide an update from an ICMJE journal editor regarding the journal’s experience with manuscripts they have received regarding the new data sharing requirement as well as collective experience from ICMJE member journals. The session will also provide a perspective on the interaction between publication planning and clinical trial disclosure groups.


• Discuss the ICMJE new data sharing requirements

• Understand how industry is implementing the new requirements

• Identify areas within their organization impacted by the new ICMJE requirements

Data Sharing StatementDarren Taichman, MD, PHD, Executive Deputy Editor, Annals of Internal Medicine





Promoting Data Transparency: ICMJE Data SharingCatherine Skobe, MPH, MT(ASCP), Senior Director, Publications Management Team Lead, Pfizer Inc

Data Sharing: The View from the TrenchesJennie Jacobson, PhD, Lead Medical Writer, Fishawack Communications

Track 3: Incorporating Proficiencies for Professional Development Grand Caribbean 3-5

Session ChairCraig Klinger, RPh, Global MSL Trainer, The Office of Medical Professional Development, Eli Lilly and Company

Proficiencies are important for MSLs to better comprehend their role and how to continue to develop. In this session, we will review the appropriate way to assess the MSLs needs and develop proficiencies. The session will include what proficiencies are important to the role (core job and interpersonal skills) and how to develop a curriculum to implement training to maximize results for success, which will align to medical affairs strategy. We will also address other areas individuals may gain and assess the skills for proficiency of the MSL.


• Identify how to assess a role and develop proficiencies to meet the needs for MSL development

• Implement proficiency-based training to ensure appropriate development and assessment of MSLs

• Recall skills that can be transferable to the MSL role to be successful

Michael Goles, MA, Director, Office of Medical Professional Development, Eli Lilly and Company

Hilary Mandler, PharmD, Director, Pharmaceutical Industry and Education Fellowship Program; Adjunct Associate Professor, Department of Pharmacy Practice, Philadelphia College of Pharmacy at University of the Sciences

4:30-6:00PM Resident and Fellow Poster Reception and Networking Grand Caribbean 7

6:30-9:00PM Dinner on the TownTraveling on your own or looking to connect with fellow attendees? Visit the DIA Registration Desk to link up for dinner! Sign-up sheets will be provided for various local restaurants. Cost of dinner is the responsibility of the individual attendee.

DAY THREE | WEDNESDAY, MARCH 20

6:00-7:00AM DIA Fit - Yoga Grand Caribbean 10

Start your day with a rejuvenating class to stretch the body and practice mindful breathing. Enjoy a class that will awaken your core muscles and elongate your posture. (Mats to be provided)



8:00-9:30AM Session 9: BREAKOUT SESSIONS

Track 1: Podium Pearls Grand Caribbean 6

Session ChairIvy Chang, PharmD, Principal Medical Science Director, Medical Affairs, Genentech, Inc., A Member of the Roche Group

Medical communications professionals will be presenting their successes, challenges, and “pearls of wisdom” on various topics through podium presentations.


• Discuss and share best practices, experiences, and innovative processes for medical communications topics related to social media, innovative delivery tools, infographic summaries, customer-centric communications, CRM implementation, and payer inquiries





Web-CRM Implementation Across Company Divisions and Contact Center Vendor During Product LaunchMallory Alonso, Manager, Medical Affairs, US Worldmeds

US Medical Information (MI) Social Media Activities: Where Are We Now Through Engagement Rate and Click-through RateMichelle Quinlan, PharmD, Associate Director, Medical Information, Pfizer, Inc.

A phactMI Benchmarking Survey: 27 Medical Information Departments on Healthcare Decision-Making Materials for Payer InquiriesAndrew Gazo, PharmD, MS, Director Internal Medicine and Biosurgery, Medical Information Services, Sanofi

Innovative Delivery of Medical Information Through an Interactive Web-Based Tool; A Use CaseAnnamaria Crisan, MSc, Pfizer, Canada

The Medical Information Journey to Clear, Customer-Centric, and More Visual CommunicationsDebra Bello, PhD, RN, Director, Specialty Therapies, Global Medical Information, AbbVie, Inc.

Satisfaction with Infographic Summaries as Part of Medical Information ResponsesHemali Patel, PharmD, RPh, Medical Information Therapeutic Manager, Novo Nordisk, Inc.

Track 2: Automation Technologies in Medical Writing Grand Caribbean 1&2

Session ChairRuggero Galici, PhD, Associate Director, Medical Writing, Pfizer, Inc

Automation technologies, especially when combined with artificial intelligence, are disrupting many sectors including the healthcare. This session will explore challenges and opportunities of automation technologies in medical writing. Few examples of how companies and the FDA are using or plan to use automation technologies to improve efficiencies will be discussed


• Identify potential automation technologies in medical writing

• Recognize challenges and opportunities when implementing automation technologies in medical writing

Automation and AI in Medical Writing: Pie in the Sky or a Paradigm Shift?Sian Ratcliffe, PhD, Vice President, Head of Medical Writing, Pfizer, Inc

AI in the Medical Writing Landscape – Tales from a Pilot ProjectJulia Forjanic Klapproth, PhD, President, Trilogy Writing and Consulting, Germany

Digitizing Decision Documentation at the FDA – Are We There Yet?Eileen Navarro Almario, MS, MD, FACP, Lead Medical Officer, OCS, Office of Translational Sciences, CDER, FDA

Track 3: The Emerging Role of Medical Science Liaisons in Clinical Research Grand Caribbean 3-5

Session ChairJ. Lynn Bass, PharmD, Senior Director, MSLs and Lead, Global Field Medical Affairs, Rakuten Aspyrian

In the recent past, the Medical Science Liaison (MSL) has been exposed to expanding and innovative opportunities within both medical and clinical affairs. Demonstrated success in clinical research is now a growing role for the MSL, as well as an interesting opportunity for the MSL to define their value proposition to a company. This is especially valuable if the MSL team of a given company can impact and shorten the development time for a given product. Through support of investigators from an educational perspective, the value of that effort by the MSL group can potentially translate into a value proposition for both the MSL team and medical affairs. This session will demonstrate best practices from across the industry on this growing opportunity for the MSL role in clinical development.

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

• Illustrate appropriate role of the MSL in clinical development/operations

• Discuss metrics for evaluating the MSL’s role in clinical studies

• Evaluate future opportunities for collaboration between MSL teams and clinical development/operations

Susan Shaffer, PharmD, MBA, Head of Global Medical Capabilities, Respiratory, AstraZeneca, United Kingdom

James Walter, PhD, National Team leader, Cardiometabolic RSDs, US Medical Affairs, Merck Research Labs





9:30-10:30AM Refreshment, Networking, and Exhibits Break - View Professional Posters Grand Caribbean 7

10:30-11:00AM Session 10: DIA Communities Update Grand Caribbean 6

Join us for an introduction to the Medical Communication, Medical Science Liaison, and Medical Writing DIA Communities. Hear updates about what their working groups have in store and learn about how you can get involved.

J. Lynn Bass, PharmD, Senior Director, MSLs and Lead, Global Field Medical Affairs, Rakuten Aspyrian

Frank Hubbard, PhD, President, Global Regulatory Writing Solutions, Inc.

Monica Kwarcinski, PharmD, Executive Director, Medical Services, Purdue Pharma L.P.

11:00AM-12:00PM Session 11: Patient Centricity: Is it Just Lip Service? How to Get Everyone Focused on the Common Goal Grand Caribbean 6

Session Co-Chairs Anne Arvizu, PharmD, FASCP, PCC, CEO, and Medical Affairs Advisor, RxER Communications


Fun fact: according to published work statistics, only about 30% of employees in any given company are ‘engaged’. Most are dis-engaged and feel disconnected for their common purpose. In our case in the Pharma/Biotech world, it’s patient centricity. Having the patient at the center of all we do is a common tagline, but how can we get the various functions to feel like active contributors to the mission? Leaders from across medical information/medical communications, medical writing, and field medical will show us how.


• Implement strategies in practice to become a vial force of patient centricity• Collaborate with other functions with a common goal• Compile resources to coach others and have critical value producing conversations

Anne Arvizu, PharmD, FASCP, PCC, CEO, and Medical Affairs Advisor, RxER Communications

Jamie Arvizu, MD, MPH, Head of Medical Affairs LATAM, Ultragenyx


Robin Winter-Sperry, MD, Head, Global Field Based Medical Excellence, Sanofi Genzyme

12:00-12:15PM Closing Remarks Grand Caribbean 6

Track Co-ChairsIvy Chang, PharmD, Principal Medical Science Director, Medical Affairs, Genentech, Inc., A Member of the Roche Group

David Price, PhD, Advisor, US Field Medical, Lilly USA, LLC

Ann Winter-Vann, PhD, Senior Medical Writer and Consultant, Whitsell Innovations, Inc.

12:15-1:30PM Networking, Luncheon, and Exhibits - View Professional Posters Grand Caribbean 7

1:30PM Forum Adjourns

DIAglobal.org/DIA2019




https://www.diaglobal.org/en/flagship/dia-2019