THE TRANSCELERATE MONTHLY

Please take t ime to

complete the TransCelerate

P o l i c y T r a i n i n g :

Confidentiality, Information

Exchange & Antitrust Course.

The course is hosted on the

TransCelerate SharePoint.

If you are having SharePoint

issues, please send an email.

Save the Date! TransCelerate

Town Hall 9-Dec!

Hear from TransCelerate

leaders on a review of 2015

accomplishments and a look

ahead to 2016. Plus, submit

your questions for our live

Q&A. For more information

email Internal News

1

Leadership Lens This month, the Leadership Lens features Operations Committee member and

Clinical Data Transparency Sponsor Peter Ronco (BMS). Peter discusses how

the work done by the Clinical Data Transparency team will affect not only the

industry, but also patients. In addition, Peter sheds light on the alignment

between TransCelerate and the overall R&D strategy at BMS.

Click the image below to play the video.

Edition 17 October 2015

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

In This Issue

Workstream and

Council Highlights

Announcements

Inside TransCelerate

Inside the Portfolio

Member Spotlight

Internal Events

...... 2 - 5

...... 6 - 8

...... 8

..…. 9

.......10

October 2015

....11 - 15

Workstream and Council Highlights

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

The CDISC International Interchange meeting will

be held in Chicago during the week of 9-Nov.

Presentations will be conducted by Trisha

Simpson (UCB), Christine Fleeman (UCB), Rachael

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

(Lilly). The meeting includes a keynote by Rob

Califf, Deputy Commissioner of the FDA. Stay

tuned to External Engagement Highlights for

more information about this meeting.

Click here to view an expanded scope of the

Data Standards Program Overview of upcoming

Therapeutic Area Data Standards.

2

Clinical Data Transparency

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

The Returning Summary Results team engaged in a recent HRA task force meeting to provide feedback on the

Guidelines on Summaries of Clinical Trial Results for Laypersons. This team is also finalizing the Recommendations for

Drafting Non-Promotional Lay Summaries and sent a draft version to the HRA on 28-Oct for potential consideration as

recommendations into the EU guidance. The team is also working with the MRCT to provide comments on their

updated guidance document.

The EMA recently released a draft Submission Guidance Implementation of the EMA Policy on the Publication of

Clinical Data which provides further details on the procedural aspects related to the submission of clinical reports,

including how the documents should be sent to the EMA and the process leading to publications of these files. The

team is preparing feedback on the technical guidance and will submit to the EMA on 30-Oct.

October 2015

Therapeutic Area Project

Charter Approval

Concepts Completed

Internal Review

Public Review

Projected Publication

TBI v1 Oct 13 Sep 14 Mar Jul Q415

Breast Cancer v1 Oct 14 Oct 14 Mar Oct Q116

COPD v1 Sep 14 Dec 14 Jul Oct Q415

ADaM Supp to Diabetes v1 NA NA Mar Jul Q415

Diabetic Kidney Disease v1 May Aug Oct Dec Q116

Tuberculosis v2 Apr Apr Sep Nov Q116

RA v1 Jun Oct Dec Q216

CV Imaging v1 May Jul Oct Dec Q216

Prostate Cancer v1 Oct Q316

MDD v1 Oct Q316

GAD v1 Triple-Scope Q316

Bi-polar Disease v1 Triple-Scope Q316

Common Protocol Template

Workstream Lead: Rob DiCicco (GSK)

Feedback from Member Companies evaluating and using Release 1 of the Common Protocol Template is being used

to shape future releases—including the upcoming public release. The team continues to respond to requests for

facilitated installations at Member Companies and questions submitted to info@transceleratebiopharmainc.com.

The schedule for creation of additional Therapeutic Area (TA) libraries will be developed based on an upcoming

Member Company survey on TA prioritization.

Work has begun, in conjunction with CDISC, to map terminology required for clinical trial registries. This will be used as

an input to enable automated disclosure via the Common Protocol Template.

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 team is preparing for a face-to-face meeting on 3-5 Nov in Biberach, Germany, hosted by BI. During the meeting,

the team plans to prioritize ideas for potential labeling productivity tools, work on their Health Authority engagement

strategy and progress their efforts on the implementation toolkit.

eConsent

Workstream Lead: Hilde Vanaken (Janssen)

The team has refined their scope to focus on an eConsent Framework, an associated Implementation Toolkit for

Sponsors and supporting External Engagement activity.

In conjunction with CTTI, the team submitted an abstract for the 2016 DIA Annual Meeting in the US to present 1) CTTI’s

informed consent project and 2) TransCelerate’s efforts with eConsent.

Investigator Registry

Workstream Lead: Bill Jordan (Sanofi)

Release 1.0 of the Supplemental Investigator Registry (IR) went live on 15-Oct and the team is finalizing Phase 2 scope

and related next steps.

The team continues to progress integrations with the Shared Investigator Platform (SIP) Release 1.0. The team has

aggregated, merged, and matched records.

October 2015

Right: Growth of the Network (Year over Year Transactions )

Placebo / Standard of Care (PSoC)

Workstream Lead: Ed Bowen (Pfizer)

The team finalized the Member Company Data Sharing Agreement in September and is obtaining signatures from

participating companies. Upon execution and subsequent submission of clinical trial data, the team will begin to load

clinical trial data from the first 50 identified trials into the data sharing solution for eventual conversion and pooling

activities.

4

Risk Based Monitoring (RBM)

Workstream Lead: Brett Wilson (BMS)

The Data Integrity and GCP Misconduct (DIGM) Framework and the Central Monitoring II papers have been

accepted by DIA’s Therapeutic Innovation & Regulatory Science (TIRS). Both will appear online in December and in

print in January. The team is working on a follow-up paper to the DIGM Framework that focuses on statistical

monitoring.

The RBM Technology white paper is nearing completion and is on target to be published on the TransCelerate website

in December.

October 2015

Shared Investigator Platform (SIP)

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

Baara (Pfizer)

Release 1.0 testing and Early Adopter Integration activities continue in preparation for launch next month.

In parallel, the SIP functionality-based Module teams continue to formalize Release 1.1 requirements. Leadership

oversight has been expanded with the appointment of Munther Baara as SIP Workstream Lead for R 1.1.

SIP Release 2.0 development is also progressing; the release will expand existing functionality and deliver new SIP

capabilities.

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

Members of the SIP and Investigator Registry teams participated in the recent SCRS Global Site Summit 9-10 Oct in

Amelia Island, FL. The team members staffed the TransCelerate Learning Lounge and briefed attendees on key SIP

and IR features. SCRS attendees provided some great feedback from sites about the SIP. Read more about the

summit in the October External Engagement Highlights.

Quality Management System (QMS)

Workstream Lead: Deb Driscoll (Merck)

The team completed the draft of the full Clinical QMS Conceptual Framework Concept Paper and met with the CRO

Forum to discuss their comments in the socialization phase.

The team is in 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), and BfArM (Germany). Socialization and input will also be obtained

from other key industry stakeholders.

Site Qualification and Training (SQT)

Workstream Lead: Katarina Hugeneck (Lilly)

The team launched a new process for trainers to self-attest their GCP meetings minimum criteria on the TransCelerate

website. This process will greatly reduce the burden on sites and improve existing processes within the team.

The Mutual Recognition of eDC (Electronic Data Capture) training subteam continues to progress drafting the mutual

recognition process on how to make it easy for members to accept vendors and other Member Companies’ non

protocol specific eDC training.

5

Regulatory Council

Council Lead: Sanjay Jalota (Janssen) The team is preparing for upcoming meetings with CFDA (3-Nov), PMDA (20-Nov) and the FDA and EMA along with

scheduling meetings with Regulatory Authorities in other countries.

The team held a face-to-face in Bridgewater, NJ 29-Oct. Read more about this meeting in next month’s The

TransCelerate Monthly.

October 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.

Council Highlights

Change Management Council

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

Change Management Council leadership continues to work on analyzing the findings from the TransCelerate

Implementation Survey that was completed earlier this fall. The Council is working with the Finance team to develop a

customized summary report for each workstream as a supplement to the blinded data that was shared at the

Operations Committee Face to Face in London. In addition to providing increased transparency across

TransCelerate, the summary findings will inform TransCelerate on current levels of participation in, and implementation

of, TransCelerate initiatives.

6 October 2015

Announcements

TransCelerate Colleague Announcements This past month, TransCelerate has refreshed some key leadership positions across the Board of Directors, Operations

Committee, Workstreams, Councils, and Country Network. Please join us in welcoming new

members and thanking members who have transitioned to new roles.

Board of Directors

Dr. Roy Barnes, SVP of Global Clinical Development for Merck, and Dr. Bernie Zeiher,

President of Global Development for Astellas were appointed to the TransCelerate

Executive Committee on October 20. Congratulations to Roy and Bernie and we look

forward to their continued support and leadership.

Operations Committee

Julian Jenkins (GSK), Vice President of Innovation Performance and Technology at GSK, tran-

sitioned into the Operations Committee role previously held by Pete Milligan (GSK).

Common Protocol Template

Dave Jordan (AbbVie) has taken on the Sponsor role of the workstream.

Shared Investigator Platform

Jackie Kent (Lilly) has taken on the Sponsor role of the Shared Investigator Platform (SIP)

workstream, previously held by Dave Jordan (AbbVie). Jackie will remain the SIP Workstream

Lead for SIP Release 1.0. Munther Baara (Pfizer) will assume the SIP Workstream Lead role for

Release 1.1.

Dan Seretti (Merck) and Krupa Patel (Merck) will remain SIP Release 2.0 Workstream Leads.

Investigator Registry

With the transition of Munther Baara (Pfizer) to the SIP workstream, Bill Jordan (Sanofi) will re-

main as the sole Workstream Lead.

Technology Council

Pete Milligan (GSK) assumes the role of Council Lead, a role previously held by Dave

Jordan (AbbVie).

China Country Lead

QingAn Jiao (J&J) is the new China Country Lead and is replacing Jie Zhao (GSK). Based in

Beijing, QingAn will work to organize future China Country meetings.

Dr. Bernie Zeiher

Dr. Roy Barnes

Julian Jenkins

Placebo Team Milestones in October

White Paper Published on TransCelerate Website

On 28-Oct, the Placebo team’s White Paper: Development and Implementation of a Pharma-Collaborative Large

Historical Control Database was published on the TransCelerate website. The paper provides guidance on the potential

applications of our large historical Placebo/Standard of Care PSoC database, as well as examples for the possible

implementation of historic data in seven specific applications (use cases).

Received First Dataset for Sharing

On 29-Oct, the PSoC team received their first dataset for sharing via the TransCelerate PSoC Data Sharing initiative. The

study contains 372 patients who received placebo. The delivery of the first study is a significant milestone on the journey to

drive secondary value from clinical trial datasets. The team is targeting 50-75 studies in their first year.

7 October 2015

Announcements

Available Now:

Adverse Events and Safety

Clinical Research Overview

Clinical Practice vs. Clinical Research

Arriving by Q1 2016:

Conducting a Study

IRB/IEC Responsibilities and

Informed Consent

Delegation and Training

Investigational Product

Essential Documents

Source Documentation

Facilities and Equipment

Monitoring and Auditing

Themes from the 2015 TransCelerate Engagement Survey

On 30-Aug, a survey was sent to all active workstream and council members to provide your opinions and insights about

your experience working within TransCelerate. It’s incredibly important for us to understand your experiences so we can

ensure best practices for structure, communications, and engagement.

We would like to thank you for your feedback and

share some overall results from the survey results.

Five main themes emerged from our analysis.

Overall, across all participating Member Companies,

the results were very positive. Nearly everyone

(98.6%) who works with TransCelerate finds their work

interesting and would like to continue to be

involved. However, there are some areas for

improvement around role clarity, communications,

and recognition, as indicated in the chart.

TransCelerate is actively working to prepare results

for each Member Company basis and identifying

ways to improve your experience both within

TransCelerate and within your Member Company.

SQT Releases First Three Topics in the Informational Program for Site Staff Less Ex-perienced in Conducting Clinical Research

This month, the Site Qualification and Training (SQT) team released the first three topics of 11 total topics in the new

program to describe the basic concepts of Clinical Research in accordance with the ICH Guideline for Good Clinical

Practice: Consolidated Guidance (E6). Addressing 11 major areas, all topics will all be available on the SQT page of the

TransCelerate website by Q1 2016.

The program may be used in its entirety or in part by site personnel: to supplement existing information, used as onboarding

information, used as a remediation tool, or to create awareness when considered for a study by a Member Company.

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.

8 October 2015

Sarah Plush Director of Operations

What are your responsibilities at TransCelerate?

I am responsible for a wide range of activities that span several areas of the business.

As a primary point of contact for membership inquiries, I engage the necessary

people and materials to help companies explore the value of TransCelerate

Membership. It’s important that our membership application process remains

consistent with our governing bylaws. As new companies join TransCelerate, I help

deliver onboarding for new leaders and the Member Company Colleagues who will

work on TransCelerate initiatives. Recently, we introduced a refreshed onboarding

process to ensure new people joining workstreams/councils were also provided an

opportunity to have a consistent and valuable onboarding experience.

As TransCelerate , and excitement around it grows, I work with teams to drive

agenda planning, content creation, meeting documentation, tracking of actions and more for the governance support

needed for the Operations Committee and the Board. Also, I help to lead regional activities in partnership with a local

country lead to enhance our global network. Back at our office , I have responsibility for information technology,

confidentiality agreements, and internal operations.

How do you spend your free time?

When it’s warm out, you can find me by the pool or tending to my garden. In the fall, my family loves having backyard

bond fires. I also volunteer on my step son’s Cub Scout Leadership Committee to help plan and support all their activities.

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

I would travel to Italy. I’ve heard so many great stories from others who have traveled there and cannot wait to go myself.

Announcements

Phase I of the Supplemental Investigator Registry is Live

This month, the Investigator Registry team reached an important milestone: Phase 1 of the

Supplemental Investigator Registry (IR) live. Effective now, Member Companies can join the IR

platform. This is a wonderful achievement and we look forward to much more from this team. A

sincere thank you to all team members for their hard work and dedication.

Read more about the IR and the team’s work on Phase 1 in the Inside the Portfolio section.

The Risk Indicator Library is Live

This week, the Risk Based Monitoring team released the Risk Indicator Library on the TransCelerate website. The library is the

result of a survey distributed to TransCelerate Member Companies in Q4 2014 in which Member Companies were asked

about risk indicators, either in use or proposed. A library was compiled, which currently comprises over 100 risk indicators.

From this library, clinical trial sponsors can pick, choose, and adjust risk indicators and apply them to their clinical studies.

With more experience gained, the library will be further refined and may reduced, changed, or be structured differently.

9

Inside the Portfolio

October 2015

Where does the data come from? Data comes from user and facility profiles, existing Member Company information, the

DrugDev (technology vendor providing the platform and whose solutions are featured in the IR) network, and other third

party data sources.

How is this different from Investigator Databank? The IR builds on a pre-TransCelerate collaboration, the Investigator

Databank. Both the IR and the Investigator Databank use DrugDev core capabilities

such as the Golden Number and the Data Query System (DQS) search tools. Both

platforms allow each company to store their data in their own locked private

database, and all private databases are hosted on the same cloud technology.

Where the two platforms differ is that IR members are only able to share with IR

TransCelerate members and the platforms have different data sharing rules. The

biggest differentiator is that the IR integrates with the Shared Investigator Platform.

Data that comes in through the Shared Investigator Platform is only shared with

participating TransCelerate members.

What’s next for the team? In addition to supporting SIP future releases, Phase II of the IR

will focus on four areas: Investigator engagement, expanded data elements, data

visualization, and network affiliations.

Benefits of the IR can be realized by various functional groups within your Member Company. To learn more, contact your

internal IR team representative.

Congratulations again to the IR workstream on the wonderful achievement of Phase I go live!

What is the IR and how is it used?

The IR is a platform solution that

integrates Person, Facility, and

Protocol Data from various

sources. With the IR, there is now

one record for a training provider.

So, there may be data for a “Dr.

Michael Smith”, a “Dr. M Smith”,

and a “Dr. Michael W. Smith” that

are all entered into the Shared

Investigator Platform (SIP) by

t h r e e d i f f e r e n t M e m b e r

Companies. The IR works

independently and in support of

the SIP. The IR is the “engine” that

matches all user and facility

data to a unique identifier (the

Golden Number) then masters

and stores this profile data in a

secure location.

That single record can be used by participating Member Companies for: accessing data at the study, country and thera-

py area level, supporting study planning, feasibility, site identification, site qualification activities, and CTMS data cleaning

activities. Data from the IR can also be used internally and shared with business partners.

“The Investigator

Registry is the ‘engine’

that matches all user

and facility data to a

unique identifier, then

masters and stores this

profile data in a secure

location.”

The Investigator Registry Goes Live

We sat down with Investigator Registry (IR) Workstream Lead Munther Baara (Pfizer) , to better understand the impact of

Phase I of the Supplemental IR—an important milestone—that went live this month and Member Companies can now join

the platform. This is a wonderful achievement and a great first step toward improving the site investigator experience.

10

Name: Nishchal Chudasama

Home Location: New Brunswick, NJ

Member Company: BMS

TransCelerate Role: Primary Liaison for BMS sales on the Comparator Network

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

I am Group Leader Integrated Supply Chain Operations within Research & Development at Bristol-Myers Squibb (BMS). In

this role, I lead a team of supply chain professionals who support end-to-end manufacturing from Drug Substance

Manufacturing (both large and small molecule) to Packaging & Labelling for Clinical Supplies, including Purchasing,

Warehousing, Dispensary Operations and Global Logistics.

What are your responsibilities on your workstream/council?

I am the primary liaison for the sale of BMS drug product to other Member Companies in the Comparator Network. In this

role, it is my responsibility to ensure that BMS personnel are well informed about the upcoming demand for our products

and also deliver consistently strong customer service to Member Companies both in terms of supplying product and the

related documentation/guidance.

Within most Member Companies, R&D personnel interface minimally with Commercial personnel, developing robust SELL

workflows therefore presents them with a unique challenge. My prior role with the BMS Commercial Supply Chain and cross

-functional network within BMS enabled me to collaborate and develop effective process flows that were responsive to

the needs of Member Companies. Based on our success, we were able to share the BMS SELL Model with other Member

Companies and influence the evolution of SELL processes within the TransCelerate Comparator Network.

What are some of your interests outside of work?

I love the outdoors: hiking and traveling. In the past year, though, my boy-girl twins have kept my hands full.

October 2015

Member

Spotlight

11

Internal Events

October 2015

The Operations Committee had a Face to Face in London, 30-Sep—1-Oct

The Operations Committee held its second face-to-face of the year in London at the Marriott Kensington. Over the two

days, the Operations Committee, Workstream and Council Leaders, Project Managers, and the TransCelerate core team

reflected on our collective impact to the industry and celebrated accomplished milestones to date, reviewed workstream

value metrics to understand key insights from the Value Assessment and Implementation Survey to encourage voluntary

Member Company adoption, along with the taking the opportunity to connect/reconnect with colleagues.

There were separate breakout sessions for the Operations Committee Members and Workstream and Council Members

along with Interactive sessions in which workstream leaders received interactive, real-time feedback with each Operations

Committee member about their particular workstream.

Operations Committee Members held a working session on Day 1 to align on solutions to re-energize leadership

engagement, drive future success of TransCelerate’s portfolio and enable effective governance. Day 2 involved a review

of, and decisions around, the next steps for ideation (potential new TransCelerate workstreams) scoping efforts.

After a presentation on the results of the 2015 Engagement Survey, Workstream and Council Members spent Day 1

evaluating engagement, and brainstormed solutions to address opportunity areas in order to maintain success across

TransCelerate Workstreams and Councils. Also, the teams identified ways to work effectively to mitigate risk, increase

global focus, evolve regulatory engagement, and facilitate Member Company adoption. Day 2 had a focus on business

continuity and brainstorming sessions around knowledge transfer, deliverable ownership, communication, and value and

metric reporting.

The Operations Committee and Workstream Leaders came back together for a presentation on workstream value metrics

before the meeting closed.

Overall, the meeting was a great success and representation and engagement from all Member Companies and

workstreams was very high. The two days provided valuable feedback to the way TransCelerate will operate in the future

and the teams are currently assessing the meeting outcomes and developing solutions that will be shared in the coming

months.

Quality Management System met 28-29 Sep in London The team held a face-to-face workshop 28-29 in London with 33 team members present to progress deliverables from the

3 main focus areas of the workstream: Clinical QMS Conceptual Framework, Knowledge Management, and Issue

Management. The team spent part of the agenda discussing Change Management strategies to support the success and

flexible adoption of workstream deliverables. Finally, the team reviewed and endorsed a proposal for new scope:

Assessing the CQMS.

Highlights included:

Welcoming several new members including members of the new QMS AsiaPac team;

A review and update to the External Engagement plan;

Advanced work on the Clinical QMS Concept Paper

A review of the survey results on Clinical Knowledge Management current state and an outline for a Clinical

Knowledge Management framework; and

A review of 2016 objectives and timelines including target timelines.

The team also enjoyed an evening dinner at Babylon, hosted by Roche.

Feedback from the workshop indicated it was the best meeting to date. The team is actively planning their next full team

workshop in Raleigh Durham, NC 19-21 Jan, hosted by GSK.

12

Internal Events

October 2015

Seated from left to right: Mireille Zerola (BI), Kate Owen (Novo Nordisk), Gloria McHugh (Accenture), Stuart Shaw (BI),

Kate Marshall (Astellas), Mary Cusack (BMS), Susanne Norskov (Novo Nordisk).

Standing from left to right: Marcin Makowski (AZ), Yakov Datsenko (BI) Andy Ware (UCB), Francisca Samson-Graveland

(Astellas), Satoshi Saeki (Astellas), Peter Thomasma (Astellas), Jennie Moseley (Astellas), Stacy Foley (Merck), Brett Wilson

(BMS, Team lead), Takuya Kita (Shionogi), Kees van der Ploeg (Astellas), Mitsutaka Shinoda (Shionogi), Ed Kellar (Astellas),

Sarah Plush (TransCelerate), Andy Lawton (BI) Joanne Benedict (Roche), Gosia Orywals-Sykes (Amgen), Heather

Achenbach (Novo Nordisk).

The Risk Based Monitoring Team met 5-6 Oct in Frankfurt, Germany

The RBM team held a face-to-face workshop 5-6 Oct in conjunction with the RBM Open House in Frankfurt, Germany. The

focus of the meeting was to align the team and advance current thinking and planning for the RBM

Community of Practice which will be proposed and developed for 2016. Since the concept is still being developed within

TransCelerate and across workstreams, much of

the time was spent developing various scenarios

for how the operating model will work and what

mitigations the team might want to think about.

There were also several breakout sessions to

develop specific content for upcoming

deliverables as well as to plan for some upcoming

Health Authority meetings.

The team also had a chance to spend time

together and enjoy some sightseeing in the Rhine

River Val ley, the towns of Mainz,

Weisbaden, and of course Frankfurt, which was

celebrating the 25th anniversary of the German

Reunification.

RBM Held Second Open House 2-Oct in Frankfurt, Germany

The RBM team and Boehringer Ingelheim hosted their 2nd RBM Open House in Frankfurt Germany, which included a Meet

& Greet the evening prior. Close to 60 people attended the RBM Meet & Greet at the Paulaner Restaurant in The Squaire

on Thursday evening, which was conveniently located attached to the Frankfurt Airport. The Meet & Greet proved a

popular way to network with colleagues that had flown in for the open house the next day, and everyone enjoyed the

collegiality and Oktoberfest food and beer.

The Open House was attended by 77 people, mostly from various European countries. The day opened with Brett Wilson

(BMS & RBM Team Lead) and Andy Lawton (BI host and

team member) welcoming the crowd. The Plenary session

on the topic of Quality Management System (QMS) was

headed by Christa Maurer, (BMS) QMS team member. The

attendees were enlightened about the relationship

between QMS and RBM and many commented that it

gave them a much better understanding of the larger

picture of quality and risk. Additional topic-specific sessions

were held in the morning in three different tracks, then a

networking lunch was held which also proved to be a very

popular crowd pleaser. A poster session followed the

lunch, then additional sessions in the afternoon. The

Closing session included highlights of each facilitated

session held during the day, and feedback indicated it was

quite interesting. An interactive Q&A with the SMEs and

facilitators also enhanced the closing of the day.

Survey feedback continues to provide the planning team with

good insight into what the attendees enjoyed. 70% of

attendees felt the Open House was high value, and find that

the networking and the opportunity to hear directly from

colleagues who are working on implementations in their

companies are the most beneficial aspects of the open

houses. The Open House Concept will continue to evolve as

the RBM team shifts to a community of practice.

13

Internal Events

October 2015

Placebo/Standard of Care met in London 5-6 Oct

The team held a face-to-face workshop 5-6 Oct in London, hosted by GSK. During the workshop, the team reviewed the

go-live process once the Data Sharing Agreement execution is completed by Member Companies.

In addition, key FDA feedback from the August meeting was considered as the team discussed whether and/or how to

incorporate it into the team’s remit and vision. Also in regard to the team’s vision, the 2016 objectives and milestones were

reviewed and slightly updated based on team discussion. Updates included external engagement initiatives for which the

team sketched out high level targets for next year.

A substantial amount of time was spent discussing how to craft the workstream’s value story including performance

measurement; the larger goal being the attraction of new TransCelerate Member Companies to participate in the

workstream and to objectively be enabled to depict the workstream’s impact. As such, the team agreed to proposed

value metrics and templates to best capture value data.

On the second day, there was a candid yet fruitful discussion about existing challenges and barriers within the Member

Companies for successful launch and execution of the workstream. Borne out of that discussion, the team agreed to

create job aides (work instructions) for application of the solution to each use case. In this way, core team members can

better articulate how one may go about executing a use case from a detailed perspective.

Site Qualification and Training met 6-7 Oct in High Wycombe, UK

On 6-7 Oct, the SQT team met for a face-to-face meeting—the first time this meeting took place outside of the US. The

meeting was hosted by Janssen in High Wycombe, UK. Updates from ongoing subteams were made and feedback was

discussed in relation to finalized initiatives and adoption. The main focus during the meeting was business continuity, and

in particular, how to accomplish effective business continuity and still ensure each of the SQT initiatives continues to be

easily available for sites and for TransCelerate Member Companies. Handover criteria was established as well as potential

deliverable owners for the various SQT initiatives. The need for oversight was highlighted and suggestions were shared

about how this could be achieved. Part of the agenda was also spent on how to manage knowledge transfer and

communication.

From left to right (Back row): Martina Schlickenrieder

(Allergan), Katarina Hugeneck (Lilly), Dawn Furey (Merck),

Sheri Jacobsen (AbbVie), Adam Colley (Merck), Denise

Gaul (Roche), Cheryl Lichtenthal (Sanofi). Front row: Lorri

Erhardt (Astellas), Theresa Stewart (Allergan), Lucy Kiessig

(J&J), Paulo Moreira (EMD Serono)

14

Internal Events

October 2015

TransCelerate Day at Roche 23-Sep in San Francisco, CA

In September, Roche held a TransCelerate Community Event with more than 200 people in attendance from the Roche

South San Francisco Clinical Operations team. Excitement was buzzing as individuals spent more than two hours learning

about TransCelerate and interacting with the TransCelerate Roche workstream leads and members.

TransCelerate Vice Chair of the Board Corsee Sanders,

(Roche) gave an overview of why Roche and TransCelerate

collaborate and shared a few of the great success stories that

have come out of Roche’s involvement with Transcelerate.

TransCelerate Operations Committee Member Virginia Nido

(Roche) provided an overview of TransCelerate and Kim

Barnholt (Roche) introduced Roche team members involved

with TransCelerate.

The main focus of the event was the “mix

and mingle” where attendees had an

opportunity to visit workstream booths to

chat, ask questions and more. Overall,

attendees were highly engaged and it was

a great opportunity to spread the word

about TransCelerate and get people

excited about the impact on the industry.

15

Internal Events

October 2015

Upcoming workstream and council meetings:

Regulatory Council, Bridgewater, NJ 29-Oct

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 Germany met 7-Oct

The first ever TransCelerate Country Meeting was held in Germany on 7-Oct. The meeting was well attended and

generated a lot of excitement. During the meeting, John Bots (AbbVie) provided an overview of the Shared Investigator

Platform (SIP) including functionality and benefits and Andy Lee (Pfizer) and Brett Wilson (BMS) provided an overview on

Risk Based Monitoring. Sarah Plush (TransCelerate) gave an overview on TransCelerate and provided an overview on the

Site Qualification and Training and Comparator Network workstreams.

The first ever Germany Country Meeting.

Upcoming Country Meetings:

The following countries have upcoming

meetings:

Spain, 5-Nov

Japan, 12-Nov

In addition, the following countries are plan-

ning meetings:

Turkey

S. Korea, 10-Nov

e-Labels, Biberach, Germany 5-6 Nov

TransCelerate Team Members in Austria met 23-Oct

Member Company representatives in Austria met in Vienna

on 23-Oct, hosted by Pfizer. This is Austria’s second Country

meeting. During the meeting, Alexander Celedin (Pfizer)

gave introductions and showed the new

About TransCelerate video.

John Bots (AbbVie) presented on the Shared Investigator

Platform (SIP) including an overview, the value proposition,

stakeholder impact and benefits, and functionality

highlights, along with objectives and timing.