THE TRANSCELERATE MONTHLY

It is hard to believe August is

nearly at an end. As we look to

September, and the rest of 2015,

we wanted to remind you of two

items arriving soon to your Inbox:

2015 Engagement Survey: a

quick 10-minute survey to get

a pulse on what YOU think

about TransCelerate.

TransCelerate Policy Training:

Confidentiality, Information

Exchange & Antitrust Course:

an e-learning course for all

TransCelerate colleagues

d e s i g n e d t o e n s u r e

awareness of legal guidelines.

Stay tuned for more information.

As always, if you have

any questions, email us.

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Leadership Lens This month, the Leadership Lens features Rob DiCicco (GSK), the Workstream

Lead for the Common Protocol Template (CPT). At the beginning of August,

the Common Protocol Template was released to all Member Companies. In

this video, Rob provides a background on the team’s vision and the template’s

objectives. The team is hard at work to release the template to the public later

this year, via the TransCelerate website.

Click the image below to play the video. Click here to access the Common

Protocol Template. Also, let the CPT team know your thoughts about the

template. Send your feedback via email.

Edition 15 August 2015

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

In This Issue

Announcements

Workstream and

Council Highlights

Inside the Portfolio

Member Spotlight

Internal Events

Inside TransCelerate

...….... 2

...... 3 - 6

...….... 7

…...…. 8

..... 9 -10

August 2015

...…... 11

2

Announcements

August 2015

Quality Management System (QMS) Concept Paper Vision and Outline Published in DIA TIRS

On 30-July, the QMS team had their paper, Enhancing Quality and Efficiency in Clinical

Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision

and Outline published in DIA Therapeutic Innovation and Regulatory Science (TIRS).

In addition, Ann Meeker O’Connell (Janssen), one of the authors,

was featured on a DIA podcast.

Read more about the paper, the podcast and the workstream in

this month’s Inside the Portfolio.

TransCelerate Colleague Announcements

It’s been a busy month for TransCelerate Country Lead changes. Please join us in welcoming Valérie Bouchara (Merck) as

our France Country Lead and Paul Duffy (Merck) as our UK and Ireland Country Lead. We are excited to be joined by

Valerie and Paul and look forward to working with them as we host Country Meetings in their respective countries.

SIP Releases Fast Facts Video

This month, the Shared Investigator Platform (SIP) team released a SIP Fast

Facts video.

The video provides an overview of the current industry challenges,

workstream’s vision, and the platform along with the steps for using the

platform.

Congratulations to the team for putting out a great video that is not only

visually wonderful, but informative about the platform.

Valérie Bouchara Paul Duffy

Workstream

and Council

Highlights

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

The team has drafted a Chronic Obstructive Pulmonary Disease (COPD) User

Guide and a Traumatic Brain Injury (TBI) User Guide (currently in internal review)

both with a target publish date in Q4. In addition, the Diabetes ADaM

Supplement completed public review on 21-Aug. and Virology completed the

public review period 24-Aug. Both are on target to be published in September.

For future User Guides, the Rheumatoid Arthritis (RA) team is proceeding with

concept mapping and metadata development - on target for review in Q4. The

Prostate Cancer team continues to develop their draft charter. The Major

Depressive Disorder team is almost completely formed and is assessing potential

to develop Generalized Anxiety Disorder and Bipolar Disorder concurrently.

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Clinical Data Transparency

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

Reviewed the draft EFPIA reflection paper on Guiding Principles—CTR Content of Lay Summary and recommenda-

tions were sent to EFPIA representatives for consideration.

Participated in two media interviews about the Data Anonymization Paper with subsequent articles published in

Applied Clinical Trials and Health IT Security publications.

The team is preparing for upcoming EMA and HRA meetings in September.

Common Protocol Template

Workstream Lead: Rob DiCicco (GSK)

The team released version 1.0 of the template to Member Companies in August on the TransCelerate SharePoint. To

learn more about Release 1.0, see this month’s Leadership Lens, featuring Workstream Lead Rob DiCicco. The public

release of the template is on target for this fall.

The team is engaging with external groups such as CDISC, PhUSE, and the FDA to establish priority activities to progress

toward automated protocol processes and end-to-end use of data standards.

During the Core Team face-to-face 17-18 Sep in New York hosted by Pfizer, the team will prepare for next steps in

technology and implementation support.

August 2015

Comparator Network

Workstream Lead: Jason LaRoche (TransCelerate)

The number of transactions completed through the

Comparator Network continues to grow exponentially year-

over-year. Over the last 12 months (Aug 2014—Aug 2015), 56

transactions have been completed and spend through the

network had the approximate value of $29M. The graph to the

right charts the growth of the network.

The team is meeting at an upcoming face-to-face at EMD

Serono in Darmstardt, Germany 15-17 Sep. Among other

things, the team aims to address business process optimization

and enhancement to technologies for the network. Comparator Network Transactions (Year over Year)

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e-Labels

Interim Workstream Lead: Jodi Smith-Gick (Lilly)

The workstream recently launched two subteams: e-Labels Design and Delivery, which will focus on an

implementation toolkit for e-Labels, and Regulatory Engagement, which will focus on e-Labels regulatory analysis,

regulatory engagement strategy, planning and execution.

The Design and Delivery subteam met on 3-4 Aug in Florham Park, NJ for a face-to-face where they completed a

draft outline of the Implementation toolkit, and assigned section owners to draft the toolkit. The Regulatory

Engagement subteam held a kickoff face-to-face meeting virtually on 6-Aug and 11-Aug in which they conducted

preliminary analysis on global labelling regulations and began prioritizing Health Authorities for engagement in 2016.

The team identified a Lead for a third subteam focused on assessing opportunities for potential labeling productivity

tools. The Workstream Lead and Subteam Lead will be meeting in person to review the subteam’s approach prior to

launch.

The Core Team and subteams are targeting a face-to-face meeting in Biberach, Germany on 3-5 Nov, hosted by BI.

eConsent

Workstream Lead: Hilde Vanaken (Janssen)

The team held a face-to-face kickoff meeting and workshop in Brussels, Belgium 12-13 Aug. Read more about this

meeting in the Internal Events section.

Co-Leads have been identified for each subteam. Efforts are underway to create drafts of the Stakeholder

Engagement materials, the Framework and Guidance for common elements of eConsent, and the eConsent

Reference Toolkit. Drafts are on target to be completed later this year.

Investigator Registry

Workstream Leads: Bill Jordan (Sanofi) and Munther Baara (Pfizer)

The team continues to onboard Member Company data onto the IR platform and progress validation of the

Supplemental Investigator Registry as well as integrations with the Shared Investigator Platform (SIP) Release 1.0.

The team is finalizing Phase 2 scope and related next steps.

August 2015

Quality Management System (QMS)

Workstream Lead: Deb Driscoll (Merck)

The Clinical QMS Conceptual Framework Concept Paper Vision and Outline is available on DIA Therapeutic

Innovation & Regulatory Science (TIRS) website and is on schedule to publish in September. Read more about the

paper, and the workstream’s progress in this month’s Inside the Portfolio.

The full Clinical QMS Conceptual Framework Concept Paper has been drafted by the team and reviewed by

TransCelerate Member Companies.

The team is kicking off its second phase of engagement with Health Authorities, gaining feedback on the full Clinical

QMS Conceptual framework from FDA, EMA and PMDA. Additionally, they have plans to speak with ANVISA (Brazil),

Health Canada, CFDA (China) SWISS MEDIC, MHRA (UK), BfArM (Germany), and Korea. Socialization and input will

also be obtained from other key industry stakeholders.

The team kicked off a proposed scope expansion titled Measuring the Clinical Quality Management System. The

subteam is led by Janis Little (Allergan).

5

Placebo / Standard of Care (PSoC)

Workstream Lead: Ed Bowen (Pfizer)

The team is focused on finalizing the Member Company Data Sharing Agreement and obtaining signatures from

participating companies during the month of September. Once signed, the team will begin to load clinical trial data

into the solution.

The team met with the FDA on 27-Aug to present an overview of the workstream and receive feedback in relation to

identifying other potential applications for trial data. In particular, the team members seek to focus on the first two Use

Cases (Enhanced Safety Signal Interpretation and Reduced Size of the Control Arm). A recap of this meeting will be

included in the September External Engagement Highlights.

Risk Based Monitoring (RBM)

Workstream Lead: Brett Wilson (BMS)

The Data Integrity and GCP Misconduct (DIGM) framework and the Central Monitoring II papers are both going

through review and will be submitted to DIA’s Therapeutic Innovation & Regulatory Science (TIRS) later this year for

publication.

The team has finalized a date of Friday, 2-Oct for the second RBM Open House of 2015 and a workstream

face-to-face meeting the following week in Frankfurt, Germany. The Open House will be hosted by BI. During the

face-to-face, the team will discuss plans for business continuity in 2016. To register for the RBM Open House, please

contact your Member Company RBM representative.

The workstream closed the survey for IT vendors. The results of the survey will guide the creation of the Technology

paper. The paper is on target for posting to the TransCelerate website later in 2015.

August 2015

Site Qualification and Training (SQT)

Workstream Lead: Katarina Hugeneck (Lilly)

The CLEAR (Common Language Evaluation and Reconciliation) project led by SCRS (previously known as CLA or

Common Language Agreement) is moving forward with the development of common language for 5 identified

clauses and is planning for completion and acceptance of the language by year end 2016.

SQT recently received endorsement to continue the Mutual Recognition of eDC (Electronic Data Capture) training

process and is currently working on the development of a detailed project plan. Immediate next steps are the

collection of information from Member Companies and common eDC vendors needed to develop the mutual

recognition process.

The Informational Program for Site Staff Less Experienced in Clinical Research subteam continues to work on the

development of its 11 identified topics. The plan is to release the first three topics (“Adverse Events and Safety”,

“Clinical Research Overview”, and “Clinical Practice vs. Clinical Research”) on the SQT Initiative Assets page on the

TransCelerate website in October. The other topics will be included as part of two additional batches rolling out by the

end of 2015 and early 2016, respectively. Ultimately, all 11 topics will be released by the end of Q1 2016.

The SQT team is currently planning their next face-to-face 6-7 Oct in Marlow, UK, hosted by Janssen.

Shared Investigator Platform (SIP)

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

The team continues system testing for SIP Release 1, and early adopter integration activities.

There are discussions underway with several additional Member Companies exploring SIP adoption.

SIP Release 2 (R2) design activities are underway. R2 will deliver multiple enhancements and several new capabilities.

The SIP Organizational Change Management (OCM) team continues to finalize implementation of centralized Site

User communications for sites conducting the first SIP studies with early adopters.

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Change Management Council

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

The Council closed the second annual Implementation Survey. This cross-TransCelerate survey included questions for

all participated workstreams. The Council will be working with the Value Assessment team to combine the results into

a report for the Operations Committee (OC) face-to-face meeting. In advance of that report, each workstream will

have the opportunity to review their own blinded data. Finally, after briefings have taken place with each

workstream, a full set of blinded, compiled responses will be shared across TransCelerate for transparency. The

feedback from this survey will Inform TransCelerate on current levels of awareness, understanding, and interest in

TransCelerate initiatives.

Recently, Jim Byron (Pfizer) joined as a Member Company Change Lead, Manny Anido (Allergan) joined as a

Workstream Change Lead for Clinical Data Standards and Ram Narayanan (Amgen) joined as a Workstream

Change Lead for the Comparator Network.

Regulatory Council

Council Lead: Sanjay Jalota (Janssen) Provided guidance to the Placebo/SoC workstream for the 27-Aug meeting with the FDA. Read more about this

meeting in the September External Engagement Highlights.

Efforts continue on setting up meetings with ANVISA, the Brazil Health Authority, along with PMDA, CFDA, EMA and

other Regulatory Authorities.

August 2015

Technology Council

Council Lead: Dave Jordan (AbbVie) Continuing to work with TransCelerate Director of Quality to provide security planning and guidance for the Shared

Investigator Platform (SIP) R1 release.

Council Highlights

quality systems but what they describe as a system varies between Health Authorities. Each one has different ideas

related to how it should look and what exactly, should be included.

With so many inconsistent messages, how did the team narrow down its idea of how the guidance should work?

Health Authorities do agree that the FDA ICH Q10 is a good sample guidance to work towards. Although the guidance is

not for Clinical Research (its intended purpose is to guide manufacturing), the guidance is an example of international

harmonization designed to improve the pharmaceutical industry.

So, the team got started on creating a conceptual framework for Clinical QMS. The Concept Paper subteam began to

develop the paper in the early part of 2015. There were two core principles involved: The guidance must be flexible so

that other companies and organizations can use the guidance; and the

guidance must be proactive so that issues and risks can be identified before they

become true problems.

In order to meet both principles, the team met with many Health Authorities and

industry groups in order to engage broadly and get as much feedback as

possible. As part of efforts to meet with as many Health Authorities and industry

groups as possible, Ann and Workstream Lead Deb Driscoll (Merck) recently

completed a trip in May that included meetings with PMDA and PMA, and

presentations at DIA China and DIA US.

What’s next for the QMS team?

Now that the team has published the Concept Paper Vision and Outline in order

to reach those in the industry who couldn’t meet with the QMS team, the team

hopes to get additional feedback as they work to finalize the actual framework.

The Knowledge and Issue Management subteams continue to work on more tactical elements for implementing and

developing the framework and its ability to screen out issues that could impact data integrity, patient safety and

company trust.

Quality Management System: An Inside Look at the Concept Paper

To bring visibility to the vision and objectives of the Quality Management System (QMS) workstream, and in particular, the

Concept Paper, we held a Q&A session with Ann Meeker-O’Connell (Janssen), one of the paper’s authors and lead for the

Concept Paper subteam. This month, the QMS team’s Enhancing Quality and Efficiency in Clinical Development Through a

Clinical QMS Conceptual Framework: Concept Paper Vision and Outline was published in DIA’s Therapeutic Innovation &

Regulatory Sciences. Workstream Lead Deb Driscoll (Merck) and Ann are also featured on a podcast about the paper and

the team’s work, available in the September External Engagement Highlights.

Elements of a Clinical QMS Conceptual Framework

7

Inside the Portfolio

August 2015

QMS became a workstream in June 2014 and

one of the main reasons for the formation of

this initiative was due to the fact that poor

quality has broad impact for the industry,

stakeholders, and patients. The workstream

has three subteams: the Concept Paper

subteam, Knowledge Management and Issue

Management.

What was the main challenge faced by the

workstream?

One of the main challenges faced by the

w o r k s t r e a m i s t h a t R e g u l a t o r y

Authorities have been encouraging clinical

Ann Meeker-O’Connell (Janssen)

“People pay attention to

guidance that Health

Authorities provide. By

working with Health

Authorities to harmonize

guidance, our team can

greatly reduce rework and

streamline processes in order

to better the industry.”

8

Name: Frances Pu

Home Location: Iselin, NJ

Member Company: Merck

TransCelerate Role: Medical Writer on the Quality Management System and Risk Based Monitoring Workstreams

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

Actually, I do not have a “day job” at Merck. I was hired as an independent consultant medical writer at Cubist (now part

of Merck). When the opportunity arose for a medical writer to the TransCelerate QMS workstream, I was able to fill the role.

I am an independent consultant medical writer with my own company. My company mostly writes clinical development

and regulatory documents.

What are your responsibilities on your workstream/council?

I regularly attend meetings as needed to understand the pulse of the team so that I can edit and format manuscripts and

other papers for the team when requested. I participate in some live editing sessions during which I listen to the discussions

and put the thoughts into words real time. I hope that I make some contributions to content language by providing a non-

subject matter expert (although experienced pharmaceutical professional) perspective.

What are some of your interests outside of work?

I dabble in the entertainment world. I have performed in the local New Jersey Renaissance Faire for the last four years. I

have appeared in the crowd scenes for a few TV shows as a background actor (most notably Orange is the New Black

Season 2, Episode 10). This past January, I made my New York City stage debut playing an Asian tiger mom in OMG Chop-

sticks! (an off-off-Broadway show in a one-act play festival). I am a Society of American Fight Directors’ actor/combatant

proficient in theatrical (stage) combat without weapons and with sword, sword and shield, knife, quarterstaff, small sword,

single sword, and rapier/dagger.

I also like to kayak, stand-up paddle, and scuba dive. On occasion, I literally climb the curtains (aerial skills)! I love traveling

and my vacations are generally action-packed because I can lie around or sleep while at home.

August 2015

Member

Spotlight

The e-Labels Design and Delivery subteam met 3-4 Aug in Florham Park, NJ

During the session, they completed a draft review outline of the Implementation Toolkit, drafted expectations for a

content on each section of the toolkit, developed a research plan, and assigned section owners. The team also identified

work items and next steps through November, and coordinated meeting time going forward.

From left to right: Rhonda Koehl (Lilly), Michael

Stephenson (Merck), Rocco Barone (Merck),

Jason Druckenmiller (Allergan), Jodi Smith-Gick

(Lilly), Roger Lauwers (Janssen), Jeff Bedford

(GSK), Michael Moorman (Pfizer), Kati Moureau

(Janssen), Jason James (BMS), Jennie Deem (Lilly),

Laurent Dhervilly (Pfizer)

Not Pictured: Scott Bailey (Roche), Susanne

Gomm (BI), Matt Meador (Accenture),

Alex Robertson (AZ), Imran Shakur (BI)

9

Internal Events

August 2015

From left to right: Osie Gaines (Accenture),

David Hansen (Amgen), Kevin Hudziak (Lilly),

Sheila Young (GSK), Jennifer Lentz (Lilly),

Dawn Drake (Allergan), Norman Thompson

(Roche), Dawn Furey (Merck), Alexandra

Maier (UCB), Katrin Ong (BI), Sandy Vacha

(Janssen), Alison Bond (Janssen), Edel

Hendrickx (Sanofi), Hilde Vanaken (Janssen)

The eConsent team met 12-13 Aug in Beerse, Belgium

The newly approved workstream met to discuss the scope and approach of the three main focus areas, refine the project

plans for the workstream and network with their teammates. The team left with alignment on 2015-2016 objectives and

timelines.

The level of participation was high for the meeting and 15 team members from 11 Member Companies were in

attendance (2 virtually, 13 in person).

Italy TransCelerate Members met 6-July

Representatives from 10 Member Companies met at Roche Italy offices in Milan on 6-July. This was the seventh meeting

after the inception of the Italian TransCelerate country engagement in 2013 and attendance has been regular for all

meetings.

During the meeting, Sarah Plush (TransCelerate Director of Operations) participated in the meeting to provide key

updates about TransCelerate portfolio management, workstream status and an overall overview of country

engagements. Also, Enrica Andreoni (Roche) provided an update on the current and planned activities of the SQT

workstream. Brarbara Grassi (GSK), in her role of Country Lead, led a discussion on how to approach and educate the

Italian Regulatory Agency about TransCelerate. Barbara is working on the approach with the support of the Regulatory

Council.

Attendees included Barbara Grassi (GSK), Maria Primular Leone (GSK), Enrica Andreoni (Roche), Sergio Scaccabarozzi

(Roche), Alessandra Spirito (Pfizer), Cristina Lupini (BMS), Sergio Imbesi (BMS), Carmine D’Urzo (BI) Marinella Galbiati (BI),

Sefania Germani (Lilly), Francesca Zanoni (AZ), Francesca Vannini (Merck), Paola Fattore (Merck), Elena Pesenti (Sanofi).

10

Internal Events

August 2015

Upcoming meetings:

Operations Committee Face-to-Face, London, UK, 30-Sep — 1-Oct

RBM Open House, Ingelheim, Germany, 2-Oct

The following workstreams have upcoming face-to-face meetings:

Comparator Network, Darmstadt, Germany, 15-17 Sep

Common Protocol Template, New York, New York, 17-18 Sep

Quality Management System, London, UK, 28-29 Sep

RBM Face-to-Face, Frankfurt, Germany, 5-6, Oct

Placebo/Standard of Care (PSoC) London, UK, 5-6, Oct

Site Qualification and Training, London, UK, 6-7 Oct

Amgen Onboarding 4-5 Aug

TransCelerate team members traveled to Amgen on 4-5

Aug to complete onboarding sessions with Amgen leaders

and TransCelerate members. The 2-day session was a great

opportunity to network and discuss in person the

TransCelerate vision and portfolio. Board of Directors

member Elliott Levy and Operations Committee

representative Sarah Carter were both in attendance and

presented during the 2-day session.

Elliott Levy (left) and

Sarah Carter (right)

at Amgen

onboarding.

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.

11

Contact Us:

Email

Stay Connected:

Website

LinkedIn

Twitter: Follow @TransCelerate

Key SharePoint

Resources:

Overview deck

Operations Committee Highlights

Member Contact List

August 2015

Cara Rinaldi Director of Portfolio

Management

What are your responsibilities at TransCelerate?

At the highest level, I oversee the portfolio of TransCelerate projects and ensure a

balanced portfolio across the organization. A key responsibility of mine is to drive

delivery from a project management perspective, ensuring that we remain

delivery-focused across all initiatives and that we continue to deliver tangible

solutions into the industry. I also help to define and shape strategy across and within

initiatives. I spend a great deal of time on both internal and external engagements in

order to build partnerships across the industry.

What activities do you enjoy in your spare time?

Well, with three active boys, two dogs and a husband, I seem to run low on spare

time. Although I sometimes complain about it, I really do enjoy watching my three

Golf and gardening take up the majority of my summer spare time. When I find those rare quiet moments all to myself I

capitalize on them and will lose myself in a good book.

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

I would go back to my native Canada, and in particular, the Thousand Islands in Ontario. Not only is it a great opportunity

to see my family, I find it relaxing, peaceful and comforting. I love to share memories with my kids and every visit we create

new and fantastic memories as a family.

Upcoming SharePoint Changes

Member Resources

Beginning August 31, the Member Resources folder on

SharePoint will be re-organized in order to make it easier for

you to find the materials you need in a timely manner.

As a reminder, the Member Resources folder on SharePoint

is available to all TransCelerate members and contains

final, legal-approved materials and deliverables such as:

templates, communications, legal policies, and overview

decks.

Workstream Overview Decks

We are in the midst of updating the workstream overview

decks for all TransCelerate workstreams. In addition to

placing the decks in the new PowerPoint template, the

decks will have a uniform layout of content, so that each

deck contains the same categories of information.

Keep an eye out for the new decks as all will be updated

by September 4.