TIPPA 2016

CMPP CREDITS AVAILABLE!

Healthcare Education Associates presents

THE 15TH ANNUAL

INTERNATIONAL PUBLICATION PLANNING MEETING Innovative and Collaborative Approaches to Increase the Reach and Readership of Global Scientific Communications February 29 - March 1, 2016

Loews Coronado Bay Resort

San Diego, CA

Join fellow publication professionals to share

Highlights Include:

best practices, challenge

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conventional and emerging methods, and reveal lessons learned at this one-of-a-kind, interactive event!

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A comprehensive discussion on the new GPP3 Guidelines and how to implement them into your current workstream Up-to-the-minute analysis of emerging technologies that can increase the readership and comprehension of your publications

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A candid discussion on the increased use of patient-centered approaches to scientific communications

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A behind-the-scenes look at publication management from a small, medium, and large company perspective

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Decoding the secret to maintaining consistency in messaging on a global scale

•

And more!

SPONSORS

GOLD

S I LV E R

BRONZE

To Register: Call 866-676-7689 or visit us at w w w.healthcare - conferences.com

Get ready to dig into the challenges and changes facing publication planning teams today!

We’ll explore ideas like: • • •

Publication planning has gone though some dramatic changes

•

over the past few years – with even more changes on the horizon.

The fate of your pub planning department hinges on its ability to

• •

adapt and innovate. TIPPA’s 15th Annual Meeting brings together a variety of players involved in the publication planning process

How to implement the new GPP3 Guidelines into your current work-stream How emerging technologies can increase the readership and comprehension of your publications How the pharmaceutical industry is increasing its use of patient-centered approaches to scientific communications How publication management looks from a small, medium, and large company perspective How to maintain consistency in messaging on a global scale And more!

Join us to share experiences, communicate ideas, and network with peers at this outstanding industry event!

to discuss current trends and issues facing scientific and medical communications professionals. Our renowned meetings provide a venue that promotes lively and constructive discourse on a

Register today! Call 866-676-7689 or online at www.healthcare-conferences.com.

wide range of topics across the lifecycle of a publication -- from

Sincerely,

the protocol to post-publication. This celebrated industry event

Christine Marez

tackles all of the trouble spots and problem areas you face on a daily basis including new regulations, evolving ethical standards, technological advances, and globalization. Roll up your sleeves, ask

Christine Marez, Conference Director HEALTHCARE EDUCATION ASSOCIATES

daring questions, hear innovative solutions, and walk away with

P.S. Register before December 17th, 2015 to save $200!

tangible tools that you can apply right away in your publication planning department.

Our Renowned Speaking Faculty Donna Simcoe, SIMCOE CONSULTANTS, INC. Monica Ramchandani, AMGEN, INC Dikran Toroser, AMGEN, INC Surendra Sharma, ALCON LABORATORIES INC. Renu Juneja, MEDIMMUNE Carolyn McAuliffe, MASIMO CORPORATION

Debra Mayo, TEVA PHARMACEUTICALS Richard White, OXFORD PHARMAGENESIS LTD Jack Yeager, SYLOGENT Dheepa Chari, NOVARTIS PHARMACEUTICALS CORPORATION Robin LeWinter, AEGERION PHARMACEUTICALS

Leslie Citrome, INTERNATIONAL JOURNAL OF CLINICAL PRACTICE Lisa DeTora, HOFSTRA UNIVERSITY Susan Ryan, INSCIENCE COMMUNICATION George Samman, PFIZER INC. Mary Beth DeYoung, ASTRAZENECA

Who Should Attend?

Top Reasons to Attend

This conference is designed for senior-level publication professionals in the medical technology industries, with responsibilities in the following areas:

•

• • • •

•

Medical or clinical publications Medical or scientific communications Medical writing Medical or clinical affairs

The event will also be of interest to members of the academic community engaging in collaborative projects with the medical technology industry

•

• • • •

Sponsorship and Exhibit Opportunities We can design custom sponsorship packages tailored to your marketing needs, such as a cocktail reception or a custom-designed networking event.

To learn more about sponsorship opportunities, please contact Jennifer Clemence at 704-341-2438 or jclemence@healthcareconferences.com

• • •

Chandra C. Abbott, SIRTEX Carolyn Hustad, MERCK & CO. Tim Collinson, FISHAWACK COMMUNICATIONS Neil Matheson, HUNTSWORTH HEALTH Stephen Douthwaite, ALPHABIOCOM Welyn Bui, MERIDIUS HEALTH COMMUNICATIONS

Find out how to incorporate the new GPP3 guidelines into your processes Learn best practices for managing author expenses and other payments Get tips for achieving buy-in and support from the top down and across teams Data-sharing – what are the guidelines and best practices?

Learn how to integrate patient-level data, input and perspectives into clinical development and data dissemination plans Get tips for maintaining consistency in messaging on a global scale Identify strategies for targeting and reaching the optimal audience for your specialty drug publications Hear current trends in article acceptance – what kinds of articles are journals looking for right now?

Find out about tech solutions that can broaden readership and comprehension Learn how to handle requests to publish the protocol and statistical analysis plan

DAY ONE: Monday, February 29, 2016

8:00 - 8:45 8:00 - 8:45 8:45 – 9:00

Registration Breakfast sponsored by Chairs’ Opening Remarks

9:00 – 10:00

Implementing the New GPP3 Guidelines

• • • •

• Topline changes from GPP-2 to GPP-3 ◦◦ Best practices for following the new GPP3 guidelines • How does the new version compare to the previous version? ◦◦ How does GPP-3 complement ICMJE? How are companies addressing the grey areas in GPP3?

What to do when a journal has stricter guidelines than GPP3?

How are the new guidelines being applied?

How are the translations being handled?

Donna Simcoe, MS, MS, MBA, CMPP, Medical Publication Consultant SIMCOE CONSULTANTS, INC. Monica Ramchandani, PhD, Global Biosimilars Development AMGEN, INC Dikran Toroser, Medical Writing Senior Manager AMGEN, INC

10:00 – 11:00

• • • • • • •

Evolving Best Practices for Working with Authors – Authorship and Beyond

• Authors writing their own manuscripts from sponsored trials • What to do when an internal investigator/author has left the company What constitutes an author?

What kind of credit does each author get?

What is the criteria used to determine this?

Limiting the number of authors listed on a publication – how will this work in real life?

Best practices for managing author expenses and other payments Travel and hotel reimbursements When, if ever, is it appropriate to pay an author? ◦◦ Reimbursements ◦◦ Specialty doctors ◦◦ Doctors acting as consultants

Surendra Sharma, MD, Global Medical Publications-Head ALCON LABORATORIES INC. Chandra C. Abbott, Ph.D., Senior Manager, Scientific Communications- Americas SIRTEX Stephen Douthwaite, CMPP, President ALPHABIOCOM 11:00 – 11:15 Morning Break sponsored by

11:15 – 12:15

•

Publication Planning Department Management in 2016 and Beyond – One Size Does Not Fit All

What do pub planning best practices look like for small, medium, and large companies?

• Questions to consider: ◦◦ When to start a publication plan? Who should be involved?

Publication Steering Committees and External Stakeholders ◦◦ Who is in charge of the budget? ◦◦ Freelance vs. in-house writers – what is best for your company? ◦◦ How can you achieve buy-in and support from the top down across teams? ▫▫ Cultivating communication with other departments for integrated and consistent messaging ▫▫ Maintaining compliance and ethical standards • Innovative ways smaller companies can function with smaller teams and budgets • Adopting best practice strategies as companies grow • Regulatory implications of using the same team for commercial and publication writing functions • Keeping scientific and commercial strategies in line • Relationship engagement for optimal response from authors, investigators and collaborators • What metrics do you look at?

• Impact factor – how important is it and how should it drive strategy?

• Similarities and differences for medical device firms • How are things changing – what will the pub planning department look like in 3 years?

Moderator: Welyn Bui, EVP, Scientific Communications MERIDIUS HEALTH COMMUNICATIONS

Panelists: Renu Juneja, Head of Medical Communications MEDIMMUNE Carolyn Hustad, Executive Director, Publication Management MERCK & CO. Carolyn McAuliffe, CMPP, Senior Manager, Clinical Advocacy MASIMO CORPORATION 12:15 – 1:15 Networking Luncheon sponsored by

1:15 – 2:00

Clinical Trial Data Transparency – Data Sharing and Third Party Data Inquiries

•

To what extent are companies sharing their data with authors and journals?

• How is patient-level data sharing being handled?

• Informed consent for data sharing • How is patient privacy being maintained?

• Guidelines and best practices for sharing data • Access and utilization of clinical research data ◦◦ Company portals for submission of requests and scientific review boards • EudraCT – what you need to submit Debra Mayo, Vice President, Global Scientific Communications TEVA PHARMACEUTICALS

2:00 – 3:00

• • • • • • •

Adapting to a More Patient-Centered Approach to the Scientific Exchange

Recognizing the benefit of patients taking a more active role FDA and other agency initiatives Integration of patient-level data, input and perspectives into clinical development and data dissemination plans The use of social media initiatives to share medical information with the public How to prevent inaccurate information being disseminated Planning and coordinating patient lay summaries Working with patient advocacy groups to share clinical trial results with patients and the general public

Richard White, MA, PhD, Commercial Director OXFORD PHARMAGENESIS LTD Mary Beth DeYoung, Global Publications Lead ASTRAZENECA

3:00 – 3:15

Afternoon Break sponsored by

3:15 – 4:00

Operating on a Global Scale – Streamlining Global Publication Strategies

• •

Maintaining consistency in messaging across countries Developing partnerships and collaboration between global clinical operation and global publications to maintain the integrity of scientific flow of data dissemination • Establishing a global policy group to evaluate the various scientific platforms and define a standardized platform for all global affiliates to work off Jack Yeager, Chief Executive Officer SYLOGENT

4:00 – 5:15

Publication Strategies for Personalized Medicine, Specialty Drugs and Biosimilars

• The rise of specialized disease teams and their effect on pub planning • Considerations when building a publication strategy for rare diseases • Opportunities for collaboration to expand outreach in rare diseases • How do we educate on the rare disease -- background, real world applications – with a limited data set?

• Targeting and reaching the optimal audience for your publication • How oncology and other disease specialties can learn from rare disease strategies Dheepa Chari, MS, CMPP, Director, US Scientific Communications NOVARTIS PHARMACEUTICALS CORPORATION Robin LeWinter, Senior Director, Global Publications AEGERION PHARMACEUTICALS Monica Ramchandani, PhD, Global Biosimilars Development AMGEN, INC.

5:15 – 6:15 Cocktail Reception Immediately Following Contact Jennifer Clemence for more information on our sponsorship opportunities at jclemence@healthcare-conferences.com or 704-341-2438

DAY TWO: Tuesday, March 1, 2016 8:15 - 8:45 8:45 – 9:00

Continental Breakfast Co-Chair’s Recap of Day One

9:00 – 9:45

Journal Editor Perspective – Trends in Publishing for 2016 and Beyond

•

• What cutting edge technology and materials are they using?

• Current trends in article acceptance – what kinds of articles are journals looking for right now?

Publishing without peer review – who’s doing it and what is the fallout?

12:15 – 1:15

Networking Luncheon

1:15 – 2:00

Publication Contracting Made Simple

• • •

Assess current contracting practices and define process inefficiencies Understand and measure overall business impact Identify, develop and implement novel ways for managing contractual transactions

George Samman, Director of Operations/Team Leader PFIZER INC.

Leslie Citrome, MD, MPH, Editor-in-Chief INTERNATIONAL JOURNAL OF CLINICAL PRACTICE Clinical Professor of Psychiatry & Behavioral Sciences NEW YORK MEDICAL COLLEGE

2:00 – 2:15

9:45 – 10:30

• •

• • • • •

2:15 – 3:00 Extending the Reach of Your Publication through Advanced Technology

The Benefits and Challenges of Integrating HEOR Data into Your Publication Process

• Integration of pre-clinical, clinical, and HEOR data • What’s driving HEOR manuscripts?

Staying compliant with global HEOR data The requirement vs. the reality – is all HEOR data being published or just positive results?

How to maintain scientific rigor and critically evaluate the outcomes of other companies’ HEOR patient outcomes and cost effectiveness reports – especially when reports conflict with other companies’ findings?

How are these models controlled for accuracy?

Considerations for writing for health outcomes

Susan Ryan, Medical Communications Strategic Director INSCIENCE COMMUNICATION

10:30 – 10:45

Morning Break sponsored by

10:45 – 11:30

Case Study: Authorship Selection Issues

• • •

Tim Collinson, CMPP, Business Unit Head, West Coast FISHAWACK COMMUNICATIONS

• • •

HUNTSWORTH HEALTH • • • •

• • •

Working with collaborative platforms to increase efficiency The increasing role of social media and other apps to share medical information Developing a social media policy – best practice guidelines Utilizing technology for a more streamlined research process Technology that can broaden readership comprehension ◦◦ Supplemental video imbedding in posters and articles ◦◦ Utilizing augmented reality and alt-metrics ◦◦ Uploading posters to conference websites

3:00 – 4:00

Neil Matheson, Global CEO

11:30 – 12:15

Afternoon Break sponsored by

Two Years of Sunshine – How Are We Doing?

Lessons learned from the first reporting year What did companies actually report?

Rethinking reporting strategies What is CMS doing with the reported data? ◦◦ Will there be audits?

How are companies measuring transfer of value?

Revising your transfer of value calculations and reports How has Sunshine effected the publication planning business process?

• • • • •

Transparency in the Clinical Trial Design – Spotlight on the Protocol

How is the protocol developed? ◦◦ From concept to approved protocol What goes into the front end of the clinical process?

What steps must be taken to ensure compliance with regulatory and other guidelines?

Registration and post-approval trials Novel trials Determining the correct sample size Dealing with requests to publish the protocol and statistical analysis plan How and when to engage investigators/authors

Lisa DeTora, Assistant Professor of Writing Studies HOFSTRA UNIVERSITY

4:00

End of Conference

Carolyn McAuliffe, CMPP, Senior Manager, Clinical Advocacy MASIMO CORPORATION

Media Partners

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Get Answers To These Important Questions • • • • • • • • • •

How do the new GPP3 Guidelines compare to previous versions?

When, if ever, is it appropriate to pay an author?

How do you ensure alignment of your scientific and commercial strategies?

To what extent are companies sharing their data with authors and journals?

Should patient reviews be a consideration when planning your publication process?

What is the best approach for building a publication strategy for rare diseases?

Current trends in article acceptance – what kinds of articles are journals looking for right now?

Is all HEOR data being published or just positive results?

How are companies measuring transfer-of-value for Sunshine?

How are companies dealing with requests to publish the protocol and statistical analysis plan?

The Conference Organizer Healthcare Education Associates is a division of Financial Research Associates, LLC. HEA is a resource for the healthcare and pharmaceutical communities to improve their businesses by providing access to timely and focused business information and networking opportunities in topical areas. Offering highly targeted conferences, Healthcare Education Associates positions itself as a preferred resource for executives and managers seeking cutting-edge information on the next wave of business opportunities. Backed with over 26 years of combined conference industry experience, the producers of HEA conferences assist healthcare professionals, actuaries, attorneys, consultants, researchers and government representatives in their professional endeavors. For more information on upcoming events, visit us online: www.healthcare-conferences.com

Loews Coronado Bay Resort 4000 Coronado Bay Road San Diego, CA, 92118 (619) 424-4000

Venue Details

We have a limited number of hotel rooms reserved for the conference.

The negotiated room rate of $229 per night will expire on February 4, 2016. Rooms block may sell out before the expiration date - book early to ensure you receive a room at the negotiated rate. Upon sell out of the block, room rate and availability will be at the hotel’s discretion.

Refunds and Cancellations For information regarding refund, complaint and/or program cancellation policies, please visit our website: https://www.health care-conferences.com/thefineprint.aspx

CMPP Credits

Check our website for more CMPP Credit information– www. frallc.com/conference. aspx?ccode=P714

Perched on its own 15-acre peninsula, Loews Coronado Bay is a private oasis of tranquility with views of the shimmering bay waters and the San Diego skyline.

Hotel Highlights Include: • • • • • •

439 luxury guestrooms, including 37 plush suites 65,000 square feet of flexible function space Three heated pools, hot tub spa and dry sauna Mistral restaurant serves a global-fusion menu that showcases Mediterranean flavors and seafood Sea Spa offers signature treatments, therapies, and products Complimentary Wi-Fi in every guest room—and in public spaces

Team Discounts

• • •

Three people will receive 10% off Four people will receive 15% off Five people or more will receive 20% off

In order to secure a group discount, all delegates must place their registrations at the same time. Group discounts cannot be issued retroactively. For more information, please contact Rhonda West at 704-341-2647 or rwest@healthcare-conferences.com

CPE Credits Financial Research Associates is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors.

State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.learningmarket.org.

The recommended CPE credit for this course is up to 14 credits in the following field(s) of study: • •

Communications Specialized Knowledge & Applications

For more information, visit our website: https://www.healthcareconferences.com/thefineprint.aspx

Gold Sponsor Sylogent develops internet-based software solutions that streamline core business processes and regulatory disclosure, thereby saving our clients millions of dollars through improved compliance, reduced employee workload and lower operating costs. Our validated applications are easy to deploy, can be configured specifically for your business needs and require minimal user training. Study Investigator & Participant Screeners Protocol Registration Clinical Trial Results & Documents Disclosure Publication Planning Journals, Conferences and Authors Profiles Transparency Websites Document Approvals & Clearance Dynamic Structured Publishing

Meridius Health Communications, Inc. specializes in high-quality medical and scientific communications. We are an all-encompassing professional services firm with capabilities that range from inception and strategizing of medical education programs to execution of scientific writing and meeting logistics.

Compliance-minded and forward-focused, integrity is at the cornerstone of our business.

In all of our activities, Meridius Health Communications recognizes the need to convey timely, clear, consistent, and evidence-based communications, while ensuring accuracy and strategic alignment.

Silver Sponsor PubsHub™ is a leading-edge organization with an uncomplicated approach to designing and delivering technology solutions for pharmaceutical, biotechnology, medical device and researched-based organizations. PubsHub is looking for a dynamic, energetic and focused Implementation Specialist team member to support our clients. PubsHub, a subsidiary of the CHC Group, a company which, for nearly 20 years, has served the needs of more than 270 global pharmaceutical clients with medical communication products that exceed their expectations in quality and service. inScience Communications is a global medical communications agency built on professional integrity, scientific intelligence, and strategic insight. Our dedicated team is driven to deliver the highest quality scientific programs through innovative channels that meet the communication needs of our clients. inScience Communications is committed to our core vision of communicating the science and value of medicines to the highest standards of accuracy, clarity and ethical practice on a global and regional level.

Oxford PharmaGenesis™ are the HealthScience Communicators. Founded in 1998 and now with more than 100 employees across offices in Oxford, London, Basel and Philadelphia, Oxford PharmaGenesis™ specialize in creating compelling communications and publications in HealthScience – the new discipline of clinical, economic, social, behavioral and political understanding that is essential to demonstrating value in the healthcare systems of today and tomorrow.

Bronze Sponsors

Envision Pharma Group offers a unique blend of scientific and technology solutions providing comprehensive and compliant strategic global publication planning and related scientifically-focused communication and consultancy services. These are complemented by industry-leading technology solutions, including Datavision™ for strategic publication management, Visiontracker™ for activity management and Clear™ for compliant release. Our newest product is Medinfo™ a next-generation global medical information solution. Envision Pharma introduces the iEnvision platform to connect all our technology products, starting with Medinfo, on a shared architecture bringing new levels of synergy, flexibility and quality across our family of scientific communication solutions.

The Fishawack Group of Companies is one of the largest independent medical communications specialists, with offices near Philadelphia, in San Francisco, and in the UK and Switzerland, as well as a partner agency in Singapore.

For over 15 years, we have partnered with US- and Europe-based pharmaceutical, biotechnology, and medical device clients. We have comprehensive experience of ethical publication development, compliance regulations, implementing auditable processes, and working under corporate integrity agreements and the Sunshine Act. In addition, we have 23 Certified Medical Publication Professionals across the Group.

15th Annual International Publication Planning Meeting Four Ways to Register

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CMPP CREDITS AVAILABLE!

Healthcare Education Associates presents

THE 15TH ANNUAL

INTERNATIONAL PUBLICATION PLANNING MEETING Innovative and Collaborative Approaches to Increase the Reach and Readership of Global Scientific Communications February 29 - March 1, 2016

Loews Coronado Bay Resort

San Diego, CA

To Register: Call 866-676-7689 or visit us at w w w.healthcare - conferences.com