Lay Summaries Summit (CBI) by medical writing

2nd Annual

Lay Summaries Summit Improving Plain Language Processes, Writing and Distribution Methods September 26-27, 2017 • Wyndham Philadelphia Historic District • Philadelphia, PA

Dynamic Discussions Led by Leaders in Lay Summary Process Development CO-CHAIR

CO-CHAIR Jill McNair, MBA

Senior Director, Patient Engagement, Center for Information & Study on Clinical Research Participation (CISCRP)

Translational Medicine, Clinical Science and Innovation Novartis

Jessica Valencia, Ph.D.

Operational Excellence Expert, Novartis Institutes for BioMedical Research

Head, Regional Medical Support and Medical Information & Grants and Director, Global Medical and Clinical Affairs, Bayer Healthcare

Deborah Collyar

Barbara Bierer

Founder and President, Patient Advocates in Research

Professor of Medicine, Harvard Medical School; Faculty Co-Director & Co-Chair, MRCT Center of Brigham and Women’s Hospital and Harvard

Anna Marie Lane

Senior Medical Writing Specialist, Pfizer Inc

Jacob Agris, M.D., Ph.D.

David Parrish, Ph.D.

Jennifer Miller, Ph.D.

Jaime Houde

Manager, Clinical Trial Transparency, EMD Serono

Assistant Professor, NYU Langone Medical Center; President, Bioethics International

Keep Pace with Regulatory Requirements and Best Practices for Lay Summary Processes • Ensure patient needs are being addressed when writing summaries • Gain in-depth and practical strategies for lay summary writing from a two hour workshop • Evaluate the effectiveness of various distribution methods • Identify ways to maintain clinical trial content while translating lay summaries into different languages • Understand how to effectively communicate the outcome of clinical trials • Learn how new technology is changing the way clinical trial results are distributed to patients

PREMIER MEDIA PARTNERS:

SUPPORTING MEDIA PARTNERS:

A division of UBM Americas

With impending EU regulations for lay summary requirements expected for 2019, there is no better time to join your colleagues from across the bio/pharma industry than at CBIâ&#x20AC;&#x2122;s 2nd Annual Lay Summaries Summit! Explore innovative ways to implement plain language processes into your organization, new distribution techniques and how others are effectively communicating the outcomes of clinical trials. Benefit from hearing case studies to understand the best practices for writing non-promotional, accurate summaries.

WHO SHOULD AT TEND : You will benefit from this event if you are a vice president or director/manager at a pharmaceutical, biotech or medical device company with responsibilities in:

Clinical Operations

Trial Disclosure CRS

Clinical Transparency

Regulatory Disclosure Publications

Medical Writing

Clinical Trial Registration

Biometrics & Reporting

This conference will also benefit consultants, technology vendors and companies providing services.

CONFERENCE SPONSORS:

A GREAT PLACE TO MEET YOUR MARKET! Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought leadership and sharing expertise.For more information on how to position your company as a sponsor or exhibitor, contact Karen Hanover at 339-298-2184 or email karen.hanover@cbinet.com.

DAY ONE

• Describe the difference between a “patient summary” and a “lay summary” as defined by EMEA Jessica Valencia, Ph.D., Operational Excellence Expert,

Tuesday, September 26, 2017 7:30

Conference Registration and Breakfast

8:30

Chairman’s Welcome & Opening Remarks

Novartis Institutes for BioMedical Research

11:30

David Parrish, Ph.D., Translational Medicine, Clinical Science and Innovation, Novartis

Examine the Next Steps for Clinical Trial Disclosure Regulation 8:45

In light of the EU Clinical Trials Regulation 536/2014 (Article 37) going into effect in 2019, it is essential that sponsors begin planning their programs to develop lay language trial results summaries. This session discusses practical considerations, best practices and pitfalls to consider when establishing your organization’s lay language summary program.

Keep Pace with Regulatory Requirements for Lay Summaries Gain an evaluation of lay summary regulations. • Review progress on the EU disclosures and portal • Identify expectations for the EMA regulations • Address the final provisions of transparency regulations and implementation challenges Barbara Bierer, Professor of Medicine, Harvard Medical School; Faculty Co-Director & Co-Chair, MRCT Center of

• Utilize pilot projects to build a strong foundation and prepare for portfolio wide implementation • Leverage internal resources to set up your program MODERATOR:

Brigham and Women’s Hospital and Harvard

9:30

Patient Advocates in Research

10:15 Networking and Refreshment Break

Understand the Most Effective Techniques for Implementing Lay Summaries Summaries 10:45

Jill McNair, MBA, Senior Director,

Patient Engagement Center for Information & Study on Clinical Research Participation (CISCRP)

Let’s Make Summaries Useful for People How to address patient needs when creating study summaries. • Why are we writing public summaries? • What interests patients? • What can industry get out of study summaries? • How to overcome challenges you face in regard to summary processes Deborah Collyar, Founder and President,

Best Practices for Implementing Plain Language Summaries • Understand and address cultural challenges within your organization • Share lessons learned on implementing a new plain language summary initiative

FIRESIDE CHAT Establish a Standard Practice to Communicate Trial Results to Study Volunteers — Best Practices and Case Studies

PANELISTS:

Jaime Houde, Manager, Clinical Trial Transparency, EMD Serono Sarah Larson, Director, Clinical Global Operations, Biogen 12:30

Networking Luncheon

1:45

CO-PRESENTATION Evaluate Distribution Methods — Print vs. Electronics Discuss the pros and cons of various distribution methods. • Identify various methods of distribution • Evaluate the accessibility of each method • Discuss when this information should be distributed • Understand how to educate your patients about the results they receive • Review pitfalls in the communication process Thomas Wicks, Chief Strategy Officer, TrialScope Jacob Agris, M.D., Ph.D., Head, Regional Medical Support and Medical Information & Grants and Director, Global Medical and Clinical Affairs, Bayer Healthcare

CO-PRESENTATION Strategies for “Translating” Endpoints into Lay Summaries Effectively communicate the outcomes of clinical trials, by understanding current regulatory and industry guidelines on endpoint reporting. • Balance stakeholder interests and concerns to meet the needs of patients and participants • Overview of current sponsor practices in endpoint reporting • Strategies for selecting endpoints in an unbiased way • Keys to ensuring that communication of results is comprehendible and non-promotional Behtash Bahador, Senior Manager, Quality and Compliance, Communicating Trail Results, Center for Information &

Study on Clinical Research Participation (CISCRP)

DAY TWO

Wednesday, September 27, 2017 8:00

Continental Breakfast

8:30

Chairman’s Review of Day One Jill McNair, MBA, Senior Director,

Patient Engagement Center for Information & Study on Clinical Research Participation (CISCRP) IN-CONFERENCE WORKSHOP

Writing an Effective Lay Summary

Jessica Valencia, Ph.D., Operational Excellence Expert,

Novartis Institutes for BioMedical Research 3:30

Networking and Refreshment Break

4:00

DYNAMIC DIALOGUE Innovative Ideas for Lay Summary Implementation Hear from organizations that have been successful in incorporating lay summaries into their clinical trial processes. • Understand best practices for lay summary implementation • Discuss unique supplements that make it easier to understand clinical trial results • Overcome obstacles in development process • Evaluate lessons learned while implementing lay summaries • Gain insight into innovative ideas for obtaining patient insights • Develop key concepts when choosing your reviewers MODERATOR:

8:45

Workshop Objective: This workshop provides key methods, case studies and best practices for writing lay summaries.

Key Questions to Be Addressed: • Why is it important to write non-promotionally? • What are tips that have made writers successful? • Who should write lay summaries?

Workshop Outline: I.

• Who is qualified to write lay summaries? • Why is it important to write non-promotionally? II.

• Understand why certain approaches don’t work

PANELISTS:

III.

Pooja Phogat, Vice President and Global Head, Clinical Trial Disclosure, Kinapse, Inc.

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

Case Study • Hear what techniques worked

Patient Advocates in Research

5:00

Best Practices • Dissect successful templates

Deborah Collyar, Founder and President,

Anna Marie Lane, Senior Medical Writing Specialist, Pfizer Inc

Workshop Leader’s Welcome and Opening Remarks

Break Away Session • Utilize successful templates • Fill in the blank with the correct verbiage

Workshop Leader: Renee Entzminger, Ph.D., Principal, Clinical Alliance Partners 10:45

Networking and Refreshment Break

Emphasize the Importance of Being Patient-Centric 11:15

Create a Framework for the Translation Process Gain key takeaways on establishing translation processes.

Bridge the Gap between Patients and Industry

• Evaluate internal translation processes

Assess the best ways to connect with patients. • Understand the importance of patient centricity • Discovering the needs of the patient population • Utilize crowd-sourcing to ensure information is easy to understand Jennifer Miller, Ph.D., Assistant Professor, NYU Langone Medical Center; President, Bioethics International

• Combat different reading level expectations

• Establish expectations for translated material Jaime Houde, Manager Clinical Trial Transparency,

EMD Serono 12:45

Close of Conference

ACCLAIM FROM PREVIOUS ATTENDEES: “I enjoyed networking with new colleagues who are navigating the same processes.” “After attending this conference, I feel much better informed, I have knowledgeable contacts to consult, and I am much better prepared to tackle my next project.”

— Senior Medical Writer, Amgen

— R&D Senior Analyst, Process Lead – Lay Summaries, Sanofi US

“Some good points raised for me to use to follow up for some internal delivery improvement opportunities.” — Clinical Trial Transparency Operations Director, AstraZeneca

2nd Annual

Lay Summaries Summit

SCAN HERE

Improving Plain Language Processes, Writing and Distribution Methods September 26-27, 2017 • Wyndham Philadelphia Historic District • Philadelphia, PA

CBI 70 Blanchard Road Burlington, MA 01803

WAYS TO REGISTER NOW!

A division of UBM Americas

WEB

www.cbinet.com/ laysummaries

ANY QUESTIONS OR TO REGISTER CONTACT:

cbireg@cbinet.com

PHONE

800-817-8601 339-298-2100 outside the U.S.

Stuart Steller phone 339-298-2158 email stuart.steller@cbinet.com

LIVE CHAT

www.cbinet.com/ laysummaries

Lay Summaries Summit REGISTRATION FEE:

Conference

PC17030

VENUE: ADVANTAGE PRICING $1999

Standard $2299

Onsite $2399

cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.

GROUP RATE: Looking to bring your team? Contact Information Services to learn about potential group savings. Call 800-817-8601 or email cbireg@cbinet.com. * Advantage pricing rates do apply when applicable. Offer may not be combined with any other special pricing promotions. Offer may be used at CBI co-located events.

SATISFACTION GUARANTEED: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for CBI conferences is not required.

Wyndham Philadelphia Historic District 400 Arch Street Philadelphia, PA 19106 Phone Reservations: (877) 999-3223 Hotel Direct Line: (215) 923-8660

ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to: • Online: www.cbinet.com/laysummaries • Phone reservations: (877) 999-3223 and mention CBI’s Lay Summaries Book Now! The Wyndham Philadelphia Historic District is accepting reservations on a space and rate availability basis. Rooms are limited, so please book early. All travel arrangements subject to availability. PLEASE NOTE: All hotel reservations for this conference should be booked directly with the hotel. CBI does not use Housing Bureaus and none are authorized to call on our behalf.

SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. All cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. Cancellation of a conference due to events beyond our control* are subject to a $399 administrative charge should you or a colleague be unable to attend the rescheduled date. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI. *Events beyond our control include: severe weather conditions, natural and man-made disasters and any other similar events.