THE TRANSCELERATE MONTHLY

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1

Leadership Lens This month, the Leadership Lens features TransCelerate Treasurer and Quality

Management System Sponsor Andy Lee (Merck). Andy discusses being a

founding member of TransCelerate and the benefits of Quality Management

System and other TransCelerate initiatives both to Merck and to the industry.

Click the image below to play the video.

Edition 18 November 2015

For all TransCelerate Member Company Colleagues. You may forward within TransCelerate Member Companies

In This Issue

Workstream and

Council Highlights

Inside TransCelerate

Member Spotlight

Internal Events

...... 2 - 5

...... 6

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...... 7 - 8 November 2015

Workstream and Council Highlights

Clinical Data Standards – Efficacy (as a collaborator in CFAST) Workstream Lead: Dave Jordan (AbbVie)

Team members attended the CDISC

International Interchange meeting in Chica-

go during the week of 9-Nov. Presentations

were conducted by Trisha Simpson (UCB),

Christine Fleeman (UCB), Rachael Zirkle

(Lilly), Gloria Jones (J&J), and Mike Ward

( L i l l y ) . S t a y t u n e d t o

External Engagement Highlights for more in-

formation about this meeting.

Three draft TA data standards user guides

are in Public Comment period at this

time: Tuberculosis [comment period closes

Nov 30th], COPD [comment period closes

Dec 7th] and Breast Cancer [comment peri-

od closes Dec 9th].

2

Clinical Data Transparency

Workstream Leads: Andrew Freeman (GSK) and Ben Rotz (Lilly)

Non-promotional recommendations for lay summaries are on target and will soon be published to the

TransCelerate website.

The returning summary results group is going to be initiating a new deliverable: Implementation Guidelines.

The team received OC endorsement to extend the 2016 timeline through the end of Q4, to assess the im-

pact of EMA Policy 070 and update deliverables accordingly.

November 2015

Common Protocol Template

Workstream Lead: Rob DiCicco (GSK)

The team is finalizing plans and preparations in anticipation of launching the Common Protocol Template

for public release, via the TransCelerate Website early next month. Read more about this significant mile-

stone next month!

Instructions on using the CDISC Portal Public

Comment Tracker for Public Review can be

found using this link: http://portal.cdisc.org/

CT/Pages/CCTT-Help.aspx

Comparator Network

Workstream Lead: Jason LaRoche

(TransCelerate)

The team has ramped up their Change

Management efforts and is focused on creating

materials to help Member Companies with

voluntary adoption.

The team is working on the requirements and

design of the next release of the Comparator

Network Exchange, the system which supports

all the Member Company transactions in the

network. The next release is expected in 2016.

3

e-Labels

Interim Workstream Lead: Jodi Smith-Gick (Lilly)

The e-Labels Workstream held a successful face-to-face meeting in Biberach, Germany on 3-5 November

(see internal events in this newsletter for an overview). The Core Team recently completed a health check

survey, which indicated strong team alignment with project scope and effective Core Team operations.

eConsent

Workstream Lead: Hilde Vanaken (Janssen)

The team is detailing an external engagement strategy for working with Patient Advocacy Groups and

IRBs. This includes a preliminary draft list of PAGs & IRBs and key stakeholder questions.

The wave 1 draft eConsent Framework and wave 1 draft Toolkit are planned for February / March

completion.

Investigator Registry

Workstream Lead: Bill Jordan (Sanofi)

Congratulations to the IR Team for Release of Phase 1.1 of the Investigator Registry. TransCelerate

Supplemental IR participants now have access to information from the FDA on debarred/disqualified

investigators. By making this information available to TransCelerate IR users, members can create more

tailored investigator lists without the need for accessing additional data sources outside of the Investigator

Registry tool.

November 2015

Transaction Value (Year over Year Growth)

Placebo / Standard of Care (PSoC)

Workstream Lead: Ed Bowen (Pfizer)

The team has loaded data from the first 4 trials into the data sharing technology solution for eventual

conversion and pooling activities. Work continues to identify trials from the member companies for future

conversion to bolster the value that can be achieved.

4

Risk Based Monitoring (RBM)

Workstream Lead: Brett Wilson (BMS)

The Data Integrity and GCP Misconduct (DIGM) Framework and the Central Monitoring II papers will ap-

pear in DIA Therapeutic Innovation & Regulatory Sciences online in December and in print in January. The

DIGM Statistical Monitoring Manuscript was submitted to DIA TIRS at the end of November and

awaiting confirmation on a publishing date.

The RBM Technology white paper is nearing completion and is on target to be published on the TransCel-

erate website in December.

The team is actively engaging with global Health Authorities in November including: CFDA (China), MFDS

(S. Korea), FDA, PMDA (Japan), and EMA (EU).

November 2015

Shared Investigator Platform (SIP)

Workstream Leads: Jackie Kent (Lilly), Dan Seretti (Merck) Krupa Patel (Merck) and Munther

Baara (Pfizer)

The team is in the final stages of testing and Early Adopter Integration in preparation for launch.

Requirements for SIP Release 1.1 are being finalized, and development activities for Release 2.0 continue.

Team members continue to hold discussions with member Companies exploring SIP adoption.

Quality Management System (QMS)

Workstream Lead: Deb Driscoll (Merck)

The team continues its second phase of engagement with Health Authorities, recently meeting and

gaining feedback on the full Clinical QMS Conceptual framework from CFDA (China), MFDS (S. Korea)

and PMDA. Additionally, they have working on plans to speak with FDA, BfArM (Germany), COFEPRIS

(Mexico), ANVISA (Brazil), Health Canada, and MHRA (UK). Socialization and input from other key industry

stakeholders is also underway.

The Issue Management sub-team has completed their draft of a conceptual Issue Management

framework. To gain Member Company feedback on the framework, the team will be conducting a series

of feedback session webinars in November and December.

Site Qualification and Training (SQT)

Workstream Lead: Katarina Hugeneck (Lilly)

The team continues to work on a new informational program which will describe the basic concepts of

Clinical Research in accordance with the ICH Guideline for Good Clinical Practice: Consolidated Guid-

ance (E6). In December, an additional four topics will be all be available on the SQT page of the Trans-

Celerate website. These include: Conducting a Study; IRB/IEC Responsibilities and Informed Consent;

Delegation and Training; and Source Documentation.

5

Regulatory Council

Council Lead: Sanjay Jalota (Janssen) The Reg Council held a F2F meeting on Oct 29th at Sanofi in Bridgewater, NJ. The primary objective of the

meeting was to consider feedback on how the Reg Council model has been working and develop a

refreshed model which considered that feedback.

The team recently prepared meetings with the CFDA (China), MFDS (S. Korea) and PMDA (Japan). Read

more about the meetings in the November External Engagement Highlights.

The team is continues to support workstream and local member company Health Authority engagement

plans by planning meetings with FDA and EMA (EU) along with scheduling meetings with Regulatory

Authorities in other countries.

November 2015

Technology Council

Council Lead: Pete Milligan (GSK) For the Shared Investigator Platform (SIP) and Investigator Registry (IR), the Council is continuing to work

with TransCelerate Director of Quality to provide Member Company security experts to be part of the SIP

Security Advisors which is part of the vision for long-term security governance.

The Technology Council is holding its first face-to-face workshop in early December, with the intention of

developing its objectives for 2016.

Council Highlights

Change Management Council

Council Leads: Michaela Herdick (EMD Serono) and Nazma Rosado (Astellas)

A combined report out of the Value Assessment and Implementation Survey efforts are complete, and

each Workstream and Member Company has received their individual reports. In addition, each Mem-

ber Company has received a customized report outlining their specific results from the 2015 Engagement

Survey.

The Council is preparing for 2016 and how best to support the revised TransCelerate Operating Model.

6

What is your “Day Job” at your Member Company?

At Lilly, I am a Data Scientist and I help plan and execute the data strategy for Lilly’s non-insulin diabetes compounds in

Phase II-IV development. I enjoy working on teams and committees—my favorite of which is our Diabetes Therapeutic

Area Standards Team (TAST).

What are your responsibilities on your Workstream?

I love the work I do with TransCelerate and CFAST (Coalition for Accelerating Standards for Therapies). For the most part I

have held various project management roles, where I get to work with a team of talented physicians, statisticians,

standards developers, and writers. Our team members come from industry, academia, non-profit, and regulatory, with the

goal of publishing a CDISC (Clinical Data Interchange Standards Consortium) therapeutic area data standard for use in

clinical trials. I led the team that published the therapeutic area user guide for Diabetes in 2014. Currently, I am leading

the Diabetic Kidney Disease (DKD) team and the Diabetes ADaM team. I co-lead the CDASH

2.0 team and the TransCelerate Data Standards Implementation subteam. Earlier this year, I

joined the CFAST TAPSC (Therapeutic Area Program Steering Committee) and over the summer

I had the opportunity to fill in as the Data Standards Workstream project manager. Fun fact:

Also over the summer, I organized a flash mob (with some TransCelerate member participation)

in honor of Wayne Kubick’s retirement from CDISC.

What are some of your interests outside of work?

I live just outside Seattle with my husband and two young daughters. We live on a lake next to

the mountains, which we really enjoy. When it isn’t raining, we venture outside for fishing,

kayaking and swimming on the lake, and hiking and biking in the mountains.

November 2015

Inside TransCelerate

Each month, we’ll profile a TransCelerate core team member in order to bring more

visibility to the team member’s roles and responsibilities.

What are your responsibilities at TransCelerate?

For the communications portion of my role, I work on internal TransCelerate

communications including newsletters, announcements, and Workstream overview materials.

Additionally, I work on recognition efforts for Member Companies and help to plan & organize

TransCelerate events such as TransCelerate Days and most recently, the Learning Lounge at the

SCRS Global Site Summit.

On the operations side, I manage SharePoint accounts and access, and assist with onboarding new members through the

TransCelerate 101 and Policy Training.

How do you spend your free time?

When not at work, I spend a lot of my free time exploring different activities and restaurants in and around Philadelph-

ia. I also take part in small runs and bike rides around the city. When unable to be outdoors, I enjoy going to see shows

and movies, or stay inside with a good book.

If you could visit anywhere in the world, where would it be? And why?

I would love to travel around all of Scotland on a motorcycle. There’s something about the scenery that draws me and

I figure there’s no better way to take it all in than on two wheels.

Name: Rachael Zirkle

Home Location: Seattle, WA

Member Company: Eli Lilly

TransCelerate Workstream: Clinical Data Standards

The Regulatory Council Met 29-Oct in Bridge-water, NJ The Regulatory Council met face to face October 29th at Sanofi in

Bridgewater NJ. The objective of the meeting was to review and

refresh the Regulatory Council model to ensure it continues to

adequately support TransCelerate’s Health Authority (HA)

engagement needs. An additional objective was to begin to put

together an overall view of planned 2016 HA engagements.

Highlights of the face to face included:

A renewed and intentional focus on strategy through focused

planning discussions and workstream support

Agreement on the need for a series of templates and workflows

that will ensure a consistent TransCelerate look and will simplify

workstream, Reg Council and local country meeting planning and

coordination

Development of a dashboard overview of all planned and

completed HA engagements

Expansion of the HA liaison role into local countries where there is

a need for connection with the HA and trade associations

A refreshed model of the Reg Council which includes a tighter

connection with the Country Network

The Regulatory Council is planning their next Face to face in April 2016.

7

Internal Events

November 2015

Pictured: Back-row: Zulfo Husovic (AZ), Nicola Barnes (Pfizer), Erik Schrage (Amgen), Michael Moorman (Pfizer), Kristen

May (Amgen), Bernd Steffens (BI), Jeff Bedford (GSK) Middle-row: Matthew Meador (Accenture), Anna-Karin Felix (AZ),

Natalia Grygaroicz (AZ), Jodi Smith-Gick (Lilly), Jason Drukenmiller (Actavis), Jennie Deem (Lilly), Scott Bailey (Roche/

Genentech), Nirav Shah (Accenture),Rhonda Koehl (Lilly), Jason James (BMS) Front-row: Saburo Murata (Astellas), Stacy

Reisner (Roche/Genentech), Keris Huang (Merck), Gyuri Bae (Merck), Stella Ha (Roche), Alex Roberson (AZ), Susanne

Gomm (BI)

Not Pictured: Lynn Ridella (AbbVie), Jan Pieter Kappelle (UCB), Todd Smith (Pfizer), Mike Arnold (Pfizer), Laurnt Dhervilly

(Pfizer), Rocco Barone (Merck), Paul Skerker (Merck), Michael Stephenson (Merck), Meinrad Kopp (Merck), Roger

Lauwers (Janssen), Kati Mortier (Janssen), Bianka Kadner (Roche), Imran Shakur (Boehringer-Ingelheim).

The e-Labels team met 5-6 Nov in Biberach, Germany

The e-Labels initiative held a face-to-face meeting on 3-5

November in Biberach, Germany. Feedback from in-person

attendees indicates that great progress has been made by

each of the initiative’s Subteams.

During the meeting, the Core Team aligned on the 2016 vision

and timeline for the initiative, provided detailed feedback to

each Subteam, facilitated a breakout session to help prepare

for voluntary implementation of e-Labels, and finalized

prioritization of potential labeling productivity tools. One

labeling productivity tool option was selected by the team for

development in a technology assessment, “Labels that can

be read electronically.” The Health Authority Engagement sub

team presented key results from regulatory landscape analy-

sis, and received initial Core Team input on draft health au-

thority engagement strategy.

The Design and Delivery Subteam continued to make progress

on several sections of their implementation toolkit.

Pictured: (Left to right): Sarah Plush

(TransCelerate); Sanjay Jalota (JNJ); Debi Tran

(Pfizer); Linda Bowen (Sanofi); Andrew Womack

(Roche); Cindy Lancaster (AstraZeneca); Leslie

Wehr (Accenture); Jennie Deem (Lilly); Lori

Birkenberger (JNJ)

Not Pictured: Carlos Garner (Lilly); Rhian Thomas

(Amgen); Sandra Usik (Lilly)

8

Internal Events

November 2015

Upcoming Workstream and Council meetings:

Technology Council, Gaithersburg, MD (hosted by AZ), 02-03 December

CPT Core Team, South San Francisco, CA (hosted by Roche), 02-03 December

Contact Us:

Email

Stay Connected:

Website

LinkedIn

Twitter: Follow @TransCelerate

Key SharePoint

Resources:

Overview deck

Operations Committee Highlights

Member Contact List

TransCelerate Country Network Activity

TransCelerate Team Members in South Korea, 10-November

Upcoming Country Meetings:

Country meetings are currently being

planned in:

Australia, Brazil, Canada, France, Ireland & UK.

Andy Lee (Merck— Operations Committee) met with TransCelerate

colleagues from AbbVie, AstraZeneca, BMS, Lilly, Merck, Pfizer and

Roche in Seoul, South Korea. They discussed the vision of TransCel-

erate, and updates on the harmonization efforts to find solutions to

some of the most critical industry issues.

Andy Lee, and members from South Korea

TransCelerate Member Companies.

TransCelerate Team Members in Japan, 12-November

Dalvir Gill (TransCelerate—CEO); Sarah Plush (TransCelerate—Director of Operations); Andy Lee (Merck—Operations Com-

mittee); and Virginia Nido (Roche—Operations Committee) met with an enthusiastic group of colleagues from

TransCelerate Member Companies while in Japan earlier this

month.

Colleagues from the TransCelerate Japan Country Meeting