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TransCelerate Collaboration Highlighted in International Clinical Trials

Operations Committee Member Jackie Kent (Lilly) was interviewed for the November issue of International

Clinical Trials, in which she explained the collaborative efforts that

are helping to streamline processes for sites and investigators—and

ultimately get innovative medicines to patients faster.

In her interview, Jackie describes the Shared Investigator Platform, its

benefits and capabilities, and future outlook

for both SIP and the industry.

Click here for the full article (see pages 44-45).

Edition 20 13 November 2015

EXTERNAL ENGAGEMENT HIGHLIGHTS

TRANSCELERATE IN THE NEWS & ENGAGEMENT WITH INDUSTRY GROUPS, HEALTH REGULATORY AGENCIES, AND CONFERENCES

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

In This Issue

November 2015

TransCelerate In

the News

Regulatory Review

Conference Corner

Industry

Engagement

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November issue, International Clinical Trials

TransCelerate In the News

TransCelerate BioPharma Now on Faster-

Cures Consortiapedia

We’re pleased to share that TransCelerate now has a listing on

the FasterCures Consortiapedia.

The site lists more than 400 organizations all focused on Re-

search & Development.

Be ing l i s t ed on t he s i t e w i l l i nc rease

TransCelerate visibility and help drive collaboration between

consortia throughout the industry.

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CFDA (China) met with Quality Management System (QMS) and Risk Based Monitor-

ing (RBM) 3-Nov

QMS and RBM Workstream leaders met with CFDA leaders to provide an update on current activities for RBM

and consult on the QMS Concept Paper to inform and gain feedback.

PMDA (Japan) met with TransCelerate Leadership on 11-Nov

TransCelerate and PMDA leaders recently met face-to-face. Shigeki

Tanaka (Astellas—Japan Country Lead) opened the meeting with a

few comments about local Japan TransCelerate activities; Dalvir Gill

(TransCelerate, CEO) provided an update on progress since last No-

vember. PMDA was very interested to understand how new projects

are started at TransCelerate and understanding the growth of the

portfolio; Satoshi Saeki (Astellas—RBM) presented an update on Risk

Based Monitoring. Virginia Nido (Roche—Operations Committee Mem-

ber) introduced PMDA to the CPT workstream. To close the meeting

Takuko Yamada-Sawada (Shionogi- TransCelerate Board of Directors

member) provided closing thoughts on TransCelerate and the impact

to the industry.

Regulatory Review

November 2015

PMDA to meet with QMS on 20-Nov

Next week, members from the QMS workstream will meet with PMDA to discuss the Clinical QMS Concept

Paper. The QMS team will reconfirm alignment on the conceptual framework proposed in the paper and

communicate how feedback to the framework was incorporated.

RBM to meet with FDA 19-Nov

The RBM team will provide the FDA with a follow-up summary of quantitative and qualitative

measures and engage in a discussion with the FDA. This meeting is a

continuation of a series of engagements dating back to the draft stage of the RBM concept paper.

Additional Meetings

The Regulatory Council is working together with Regulatory Authorities around the globe, along with

TransCelerate Country Leads and Workstream Leads to schedule activities in the upcoming months. Planned

engagements include:

Mexico—COFEPRIS

Brazil—Anvisa

Europe—EMA

TransCelerate and PMDA Meeting Participants

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2015 RAPS Annual Meeting 24-28, Oct 2015 – Baltimore, MD

TransCelerate CEO Dalvir Gill participated in a panel along with the CEO of the Center for Policy Analysis on Trade and

Health (CPATH) and the CEO of Medical Device Innovation Consortium (MDIC) titled, New Regulatory Business Models:

Consortiums and Public-Private Partnerships.

SCRS European Site Summit 2-3, Nov 2015 – Nice, France

Operations Committee Member Jackie Kent (Lilly) presented to more than 100 sites at the SCRS EU

Summit in Nice. Jackie provided an overview on TransCelerate along with a brief update on Trans-

Celerate accomplishments and a glimpse into the future. Jackie was joined by Marion Wolfs

(Janssen), to provide insights from Risk Based Monitoring, Site Qualification & Training, the Shared

Investigator Platform (SIP), and Investigator Registry (IR) initiatives.

Jackie Kent also held a breakout session that focused on the site benefits of the SIP and IR

initiatives, and a deeper review of the SIP.

Conference Corner

DIA Japan 15-17, Nov 2015 – Tokyo,

Japan

This year, the theme of “Medicine Development” is

selected to discuss how to achieve actual results,

building on discussions from previous years.

Ann Meeker O’Connell (Janssen) will present the

Quality Management System (QMS) initiative on

behalf of TransCelerate.

Stay tuned to External Engagement Highlights for

additional details on DIA Japan.

Upcoming Conferences:

November 2015

Pharma Integrates 17-18, Nov 2015 –

London, UK

TransCelerate will be represented by Alex Robertson

(AZ) and Pete Milligan (GSK – Technology Council

Lead). During the panel titled: The Myths, Successes

and Challenges of Collaboration, Panellists will discuss

the drivers of pharmaceutical collaboration and any

ongoing initiatives, what successes they’ve

experienced and the key parameters that led to

achieving those goals. Also to be discussed: the main

challenges. What are the hurdles, both real and

imagined, how can we address them and what areas

should we be working on? TransCelerate experience

on driving industry collaboration and change will be

examined.

Society for Clinical Data Management

Annual Conference 20-23, Sep 2015—

Washington, DC

Rachael Zirkle (Lilly) chaired a session titled, CFAST

Therapeutic Area Standards Development—Goals, Process,

and Impact to Clinical Trials and Regulatory Submissions.

Other presentations included a CFAST program overview,

case studies from cardiovascular and tuberculosis teams, a

preview of the upcoming CDASH model, and applications of

CDASH in therapeutic area data standards development.

Mark Travers (Merck) participated as a panelist for a session

about Risk Based Monitoring and TransCelerate Treasurer &

Operations Committee Member Andy Lee (Merck) was the

Keynote Speaker for the conference.

2016 Conference Planning

In 2016, conferences will

continue to be an important

p a r t o f T r an s Ce le ra t e

e n g a g e m e n t w i t h

industry leaders. We’re

currently mapping out our

2016 conference calendar. If

you have suggestions for future conferences at which

TransCelerate should participate, or are interested in getting

involved, contact Internal News.

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Contact Us:

Email

Stay Connected:

Website

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Twitter: Follow

@TransCelerate

Key SharePoint

Resources:

Overview deck

Operations Committee

Highlights

What’s Tweeting?

Each month, we’ll take a look at our top Tweets that are

generating buzz throughout the industry.

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577 views!

Don’t miss out — follow us @TransCelerate

Industry Engagement

In addition to the external engagement efforts

highlighted in this newsletter, each initiative continues

to conduct engagement efforts, specific to their

initiative, with various industry groups.

November 2015

TransCelerate Collaborates with EFPIA On 6-Nov, TransCelerate leaders met with members of the European Federation of Pharmaceutical Industries and

Associations (EFPIA) as part of the two organization’s commitment to stay connected and ensure collaboration

opportunities and any potential overlaps / duplication of efforts are identified. During this meeting, TransCelerate

provided an update on the QMS initiative, as well as high-level Information about potential future opportunities around

Patient Engagement.

Conference Corner

Upcoming Conferences continued:

Partnerships EU 18-19, Nov 2015 – Hamburg, Germany

TransCelerate will have a lively dialogue during a plenary session Leadership Panel. Panelists include TransCelerate

Chair of the Board of Directors Iris Loew-Friedrich (UCB), TransCelerate Senior Vice President of Global Operations,

Janice Chang, Common Protocol Template Workstream Lead Rob DiCicco (GSK) and Matt Cooper from the UK’s

National Institute for Health Research—Clinical Research Network (NIHR-CRN). There will also be a Risk Based Monitor-

ing panel and a featured presentation on the Shared Investigator Platform. Plan to read more about this event in the

December edition of External Engagement Highlights.