THE TRANSCELERATE MONTHLY

Join us on Thursday, June 16 for a call with

TransCelerate and Member Company

leaders when they recap recent significant

accomplishments and highlight the

progress of patient-centric initiatives.

We have scheduled two calls for this event,

with identical content, although panelists

may change. Click the link below to register

for the session that works best for you.

Session 1: 11 a.m.— noon EST

Session 2: 8—9 p.m. EST

1

Leadership Lens This month, the Leadership Lens features Oversight Committee

Member Diane Driver (UCB) who discusses the alignment of

priorities between UCB and TransCelerate and the focus on the

patient in clinical trials.

Click the image below to play the video.

Volume 3 Edition 5 May 2016

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

In This Issue

Announcements

TransCelerate Triumphs

Inside the Portfolio

Member Spotlight

Inside TransCelerate

Subcommittee

Highlights

Open Resource Needs

Internal Events

…...4

...... 8

..…. 5

.......6

May 2016

..... 8 - 11

.... 2 - 3

...... 3

.......7

2 May 2016

Announcements

Welcome new Oversight Committee Members

Please join us in welcoming Gill Hodkinson, Global VP Clinical Development Operations for

AbbVie to the Oversight Committee. Gill will replace Dave Jordan as the Oversight

Committee representative for AbbVie. A veteran of many different leadership roles over the

past decades, Gill has interfaced with TransCelerate initiatives since 2012.

Dave Jordan will continue to represent AbbVie as the Workstream Lead for Clinical Data

Standards. We would like to take this opportunity to thank Dave for

his leadership at TransCelerate.

Please also join us in welcoming Laura Galuchie, Director, Clinical

Performance, Analytics, and Innovation at Merck to the Oversight

Committee. Laura takes over from Andy Lee who remains as

Treasurer for TransCelerate.

Prior to joining the Oversight Committee, Laura was heavily involved with the Shared Investiga-

tor Platform and Investigator Registry workstreams along with acting as a liaison internally to

Merck for TransCelerate workstreams.

View the Placebo / Standard of Care Data Sharing Video We are proud to share a new video that provides

an overview of the Placebo/Standard of Care

Data Sharing solution which highlights the poten-

tial benefits of information sharing.

Click the image to the right to play the video.

You’ll need to enter the password: bliss

Laura Galuchie (Merck)

Gill Hodkinson (AbbVie)

Clinical Data Standards Releases Breast Cancer Therapeutic Area User Guide

In May, the Data Standards team released a new TA User Guide focused on Breast Cancer. The User

G u i d e w i l l s u pp or t c l i n i c a l re se a rc h a n d en a b le me d i c a l p ro d uc t

development through the establishment and maintenance of data standards, tools and methods for

conducting research in breast cancer. This project marks only the beginning for standards that will

improve cancer research. In addition to breast cancer, the Data Standards team is working with

CDISC on standards for prostate and colorectal cancer and will begin work on a standard for lung

cancer by the end of the year. Developing standards for oncology is a priority for the team.

3 May 2016

Announcements

TransCelerate Triumphs Each month, we’ll highlight the real-life value and impact of a TransCelerate developed solution. This

month, we take a look at the impact of the Placebo/SoC (PSoC) initiative.

The PSoC workstream was established to enable the sharing of data to maximize the value of clinical

trial data collected historically in the placebo and standard of care control arms of clinical trials. Earlier

this year, the collaboration between two Member Companies directly resulted in a realization of the

value of the initiative.

In the spirit of collaboration, Member Company A provided the TransCelerate PSoC database with

placebo data from stroke studies. Member Company B is planning to run hemorrhagic stroke studies later in 2016 and

has downloaded the data from the TransCelerate PSoC solution and will be able to use the data to reduce the

number of subjects in the control arm. The value from sharing this data includes:

Cost savings of $8M and the study time is reduced by 30% (11 months instead of 16)

20 patients now avoid taking placebo and an observational trials are now avoided,

The transaction of placebo data between these two companies perfectly exemplifies the TransCelerate goal to

improve the health of people around the world by simplifying and accelerating the research and development of

innovative new therapies. As the PSoC solution continues to grow, and more studies are added, we are very much

looking forward to the impact that the data can have across the industry as more studies and Member Companies

share and utilize the data.

Want to learn more about PSoC? View the video on the previous page, and visit the PSoC initiative page on the

TransCelerate website.

Congratulations to the Comparator Network on First Official Placebo Exchange

In May, the first official exchange of matching active and placebo drug product was executed

through the Comparator Network. Member Companies developed and signed agreements to allow

this type of exchange through the network. Although there have been previous exchanges of active

and placebo executed through the Network in the past, they were considered unofficial. Due to the

clinical study timelines of participating members, previous exchanges of active and placebo were

executed, leveraging the framework established by the Network and have delivered a reported

savings of $4.5 MM USD to date. Exchanges of matching active and placebo drug have exceeded the

expectations of our members, with one selling company not only providing the drug, but also opening

up their regulatory filings for cross-reference by the buying Member Company.

Patients have benefited from the increased safety as the need to manipulate comparator drugs to achieve blinding has

been eliminated and Member Companies have benefited by avoiding the cost and delay of developing blinding

solutions in-house, as well as the assurance that the drugs will perform as intended during clinical trials.

4

Inside the Portfolio

May 2016

Site Qualification & Training’s Impact on the Investigator Experience As part of TransCelerate’s mission to improve the health of people around the world by simplifying and accelerating the

research and development of innovative new therapies, the founding members placed a focus on improving the site

investigator experience. One of the first five TransCelerate initiatives was the Site Qualification and Training (SQT) initiative,

which has maintained its focus and reached its target outcomes by addressing pain points voiced by investigators and

sites across the industry.

One of the first industry inefficiencies addressed was the process that requires investigators and sites to complete GCP

Training separately for each participating sponsor company. To reduce the amount of duplicative training that sites and

investigators were being asked to complete, the SQT team developed a set of minimum criteria to enable a voluntary

Mutual Recognition process of GCP Training across TransCelerate Member Companies. Through the creation of the

minimum criteria and its mutual recognition, more than 115,000 certificates have been issued. Once training is

completed, the investigator site can show that certificate to any participating TransCelerate Member Company and the

training is valid for 3 years. The Mutual Recognition of GCP Training is not just for sponsor-provided training; more than 150

industry training providers have self-attested their training also meets the criteria.

Another focus of the SQT initiative was to streamline processes and reduce inefficiencies by creating model forms for

investigator sites. Using the model version of the forms should reduce confusion and administrative burden while also

providing consistent definitions and improving quality through consistency. Forms include: Financial Disclosure, Site Profile,

Site Signature and Delegation of Responsibilities, and others that collect site information.

In March, the SQT initiative released the remaining Informational Programs for Site Staff Less Experienced in Conducting

Clinical Research. These topics address a need by sites within the industry who have the desire to provide educational

content to less experienced investigators, and site staff. The 11 topics may be used in their entirety or in part to

supplement the information provided to less experienced Investigators.

The Informational Programs aim to reduce study start-up times and the number and severity of protocol deviations. The

programs are the result of collaboration between TransCelerate’s SQT initiative, and representatives from the Society for

Clinical Research Site (SCRS) Site Advocacy Group, among others.

Most recently, the SQT initiative created an online framework to allow voluntary mutual recognition of completed, non-

protocol specific EDC system training by multiple sponsors, reducing the burden on investigator site staff. This functionality

will be enabled on the TransCelerate website soon. Historically, the process was repetitive and time consuming for

investigative site staff, and similar to the mutual recognition of GCP training, the process will be enhanced and simplified.

With the framework, sponsors and vendors that provide EDC system training can visit the TransCelerate website, update a

confirmation, along with a sample of their training certificate, creating a one-stop shop for sites to complete EDC training.

TransCelerate, and the SQT initiative remain

focused on improving the site investigator

experience. In order to maximize the value of the

contributions to investigator sites as SQT enters

Realization, and maintain high quality and

integrity of the solutions that addressed the

aforementioned industry pain points,

TransCelerate will maintain some deliverables on

its website and others will be assumed by outside

organizations, including SCRS. TransCelerate has

selected SCRS to maintain the Informational

Programs and several forms, which will be

available on the SCRS website soon.

5 May 2016

Member

Spotlight

Name: Edel Hendrickx

Home Location: Brussels, Belgium

Member Company: Sanofi

TransCelerate Role:

eConsent, Toolkit eConsent subteam

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

As Head of the Clinical Study Unit for Belgium and Luxembourg, I have the pleasure and privilege of leading a team of 40

talented clinical research specialists (Medical Advisors, Team Managers, Project Leaders, CRA’s and assistants) who are

ensuring that all the different clinical trial activities in Belgium and Luxembourg for Sanofi (both global and local) are done

to the best standards with the best possible quality. The “patient at the heart of a clinical trial” is not am empty phrase to

me and my team. We are always looking for the best solutions for the patients within, or outside, a trial.

What are your responsibilities on your workstream?

I’m a member of the TransCelerate eConsent workstream and part of the Toolkit subteam. The eConsent workstream has

three focus areas (framework, toolkit, and external engagement). The Toolkit subteam is focusing on writing guidance for

sponsors when using eConsent. We have just achieved our Wave 1 objective of writing the Introduction to eConsent Toolkit,

the Implementation Overview, and the eConsent external processes such as site, Health Authority, and IEC (International

Ethics Committee) and IRB (International Review Board) considerations. We are currently working on our Wave 2 objec-

tives:

Capabilities and organizational change management

Sponsor processes, such as vendor selection, eConsent components and process development

eConsent issues/concerns and associated guidance

eConsent Vision and Final Remarks

It is a great pleasure to work on this topic with so many motivated, talented, complementary, creative and knowledgeable

people. My catchphrase is “a day I learn something is a good day,” and being given the possibility to work with this team

gives me plenty of opportunities to learn.

What are some of your interests outside of work?

Being involved in different work groups does not leave me with much free time, but I do enjoy a good book and skiing

down the mountains in winter time. Every weekend, I’m the biggest fan of my children when they are out on the sport fields.

But my most favorite thing is travelling and visiting new countries and sharing the experience with my family. I just love

getting acquainted with new cultures and people, being impressed with the beautiful nature that surrounds us, and being

amazed by what man has built in the past and the present.

6 May 2016

Inside TransCelerate This month, we take a different approach to the Inside TransCelerate, and focus on our brand new facility.

In May, the TransCelerate team moved into its new headquarters, located in Conshohocken, Pennsylvania, approximately

12 miles northeast of the city of Philadelphia. Since its founding in 2012, TransCelerate has maintained office space inside

the GSK facility of Upper Merion, Pennsylvania. As the organization has continued to grow, the need for office space

dedicated wholly to TransCelerate activity also grew and the team began looking at facilities in the spring of 2015. Plans

were soon put in place to have the facility become the state-of-the-art headquarters of TransCelerate.

TransCelerate Director of Operations Sarah Plush took on the responsibility of ensuring the new space met all of the needs

of the team and, working together with Finance Analyst Lysien Lakuriqi, making sure the appropriate vendors and features

were in place for the team to make a seamless transition to the new space.

The new facility features a bright design that matches the TransCelerate branded color palate and versatile workstations

for the TransCelerate team. For visitors to the office, the options include workstations and hotel offices. For large meetings

and events, the team can take advantage of one of two conference rooms, or the conference center space located

within the same building, on the first floor. Knowing the importance of video conference in our virtual environment, each of

the conference rooms is equipped with a high-definition monitor and webcam.

On May 11, the TransCelerate team held a grand opening ceremony to mark the official opening of the new facility.

TransCelerate facility under construction March 2016 Executive Board Room

Entry and Reception

Active Subcommittee Highlights

Patients Subcommittee Objective: Improve the patient experience by enabling a better informed patient and improving

study participation.

Click here to view the 2016 Major Objectives for the Patients Subcommittee.

7

Sites Subcommittee Objective: Reduce the administrative burden placed on investigator sites by improving how sites

and Sponsors work together when executing Clinical Trials.

Click here to view the 2016 Major Objectives for the Sites Subcommittee.

May 2016

Sponsors Subcommittee Objective: Streamline redundant sponsor activities to reduce investigator and patient burden,

while refocusing resources to drive and deliver innovative drugs to patients faster and safely.

Click here to view the 2016 Major Objectives for the Sponsors Subcommittee.

Following Subcommittee Leadership endorsement, the eLabels workstream is moving forward with

execution of its delivery plan of Proof of Concepts (PoCs). The PoCs will support discussion with Health

Authorities, patients, sites and industry to demonstrate that eLabels are viable and efficient to use in

clinical trials and will lead to a more informed patient. The team plans to utilize select pieces of existing

Member Company PoCs as well as design interactive wireframes that will show a detailed end-to-end

view that can be adjusted based on stakeholder feedback.

The Investigator Registry (IR) has made some enormous strides and has been keeping busy in 2016, in

addition to the activation of data sharing and ongoing integration activities with the SIP, the IR has

onboarded 8 Member Companies to their platform and has kicked off Phase 2, the scope of which

includes growing the IR capability and data sets to benefit Member Companies.

The Shared Investigator Platform (SIP) has two releases planned for 2016 with a focus on enhancing the

existing SIP capabilities; Release 1.1 targeted for Q3 2016 and Release 2.0 has a target of Q4 2016 and

intends to deliver new capabilities to users while continuing to enhance the user experience.

The RBM team is preparing for the upcoming RBM Open House on 24-June in the Philadelphia area. The

event is being hosted by Merck. Space is still available. Please reach out to your Member Company RBM

team member if you’d like to attend.

Information Sharing and Harmonization Subcommittee Objective: Facilitate the sharing of clinical trial related information as appropriate amongst

industry stakeholders, and enable the industry to capture efficiencies and move toward greater

harmonization of clinical trial processes to advance technologies and processes.

Click here to view the 2016 Major Objectives for the Info Sharing and Harmonization Subcommittee.

In May, the Comparator Network added its 10th member, Merck. The addition of Merck exemplifies the

continued growth of the network and the team is looking forward to the increased product portfolio within

the network.

8 May 2016

TransCelerate Open Resource Needs

TransCelerate Day at BMS 12-May

On May 12, TransCelerate CEO Dalvir Gill joined leaders from BMS in Princeton, NJ for a

TransCelerate Day. In the morning State of the Science presentation, Dalvir Gill presented

an overview of TransCelerate and its initiatives’ success, before Francis Cuss (BMS) provided

an overview on BioCelerate.

Then, Dalvir joined Board Member

Peter Ronco (BMS), and Michael

Graziano (BMS) in a panel

discussion that was facilitated by

Oversight Committee member

Reb Tayyabkhan (BMS). The

event was well attended with

nearly 100 people in the room and more than 500 watching via

webcast.

Later that afternoon, BMS held a poster session that included

recognition of BMS team members working on TransCelerate,

and high-level overviews of the Common Protocol Template

presented by Susan Colby (BMS) and Clinical Research

Awareness & Access presented by Liz Beatty (BMS).

Internal Events

Francis Cuss (BMS)

Left to right: Mike Graziano (BMS), Peter Ronco (BMS), Dalvir

Gill (TransCelerate), and Reb Tayyabkhan (BMS)

Each month, we’ll feature a list of current resource needs for TransCelerate workstreams. If

you, or someone you know, are interested in fulfilling a need, click the Open Resource

Tracker to find out more about the role, its time commitment and who to contact. All

resource needs below are urgent critical needs.

1. Clinical Research Awareness & Access Market Research SME (Patients Subcommittee): One individual at

5% with an immediate start

2. Data Transparency Editor/Writer (Sponsors Subcommittee): One individual at 25% with a 15-June start.

3. eConsent External Engagement (Patients Subcommittee): Two individuals at 15% with an immediate start.

4. Comparator Network Process Technology Sub-team Lead (Info Subcommittee): One individual at 15%

with an immediate start.

5. Common Protocol Template Physician/Clinical Scientist (Info Sharing Subcommittee): One individual at

5% with a 1-June start.

6. Common Protocol Template Statistician (Info Sharing Subcommittee): One individual at 5% with a 1-June

start.

7. Comparator Network Training Developer/Technical Writer (Info Sharing Subcommittee): One individual at

15% with a 1-Aug start.

8. Clinical Research Awareness & Access Clinical Trial Registry SME (Patients Subcommittee): One

individual at 15% with a 1-Aug start.

9. eSource Technical Writer (Sponsors Subcommittee): One individual at 25% with an immediate start.

9 May 2016

Internal Events

Oversight Committee held a Face-to-Face in Conshohocken, PA 18-19 May

The Oversight Committee held its first face-to-face of the year in Conshohocken, PA,

On Day 1, Oversight Committee Members enjoyed breakfast in the new TransCelerate office prior to heading downstairs

for the day’s activities. Oversight Committee Chair Lynn Marks (GSK) facilitated the meeting and during his morning

remarks, Dave Jordan (AbbVie) was recognized for his leadership on the Oversight Committee. The morning session

included an organizational update from TransCelerate CEO Dalvir Gill

and an overview of current ideation efforts by Craig Lipset (Pfizer). In

the afternoon, the Oversight Committee Members had two strategic

roadmap planning sessions and a session dedicated to the Shared

Investigator Platform.

On Day 2, the Oversight Committee Members were joined by

Workstream Leads for breakout sessions in which the different

subcommittees could interact in order to gain feedback and

understanding on scope and solutions of a particular workstream or

project. Also, teams could highlight a specific request or need from

another team. The meeting also included an overview of the Clinical

Research Awareness & Access workstream by Oversight Committee

Member Paulo Moreira (EMD Serono) and a focus on Val-

ue Real i zat i on by Over s i gh t Commi ttee

Member Virginia Nido (Roche) and Jennifer Burgess

(TransCelerate).

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 how the teams can further work

together to enhance their solutions.

Top photo:

Oversight

Committee

Chair Lynn

Marks (GSK)

left, and TransCelerate Director of

Communications and

Engagement Jennifer Burgess,

right, present Dave Jordan

(AbbVie) with an award to

recognize his leadership.

Middle: TransCelerate SVP of

Global Operations Janice Chang

cuts the celebratory cakes on Day

2.

Left: Oversight Committee Face-to

-Face meeting attendees

Clinical Research Awareness & Access met Face-to-Face 13-14 April in Wilmington, DE

The Clinical Research Awareness & Access (CRA&A) team met for its second face-to-face meeting at the AstraZeneca

facility in Wilmington, DE. The team hosted Ken Getz from CISCRP on Day 1, when they discussed current research insights

and best fit scope and approach for meeting gaps in patient awareness and access to clinical research. On Day 2, each

of the three subteams (Awareness, Access, and Information Sharing) presented updated deliverable proposals and held a

series of breakout sessions to further refine their proposed contributions and approach to CRA&A workstream objectives.

Data Standards Team Members met Face-to-Face 24 May, in Raleigh, NC

Members of the Clinical Data Standards team met 24-May at the UCB offices in Raleigh, NC. 18 representatives from 12

Member Companies and CDISC were in attendance. The meeting focused on strategic planning and expanded collab-

oration across the Info Sharing subcommittee as well as the overall TransCelerate portfolio. Overall, the workshop was a

great success. The team left the session feeling very positive and motivated to continue to support the strategic value,

objectives, and direction of the workstream. As the team continues to progress on implementation deliverables and col-

laboration with the Common Protocol Template

(CPT) team to create additional CPT TA libraries

this year, the team is planning additional face-to-

face sessions.

Meeting attendees included: Adam Howard

(AbbVie) Brooke Hinkson (Merck), Claire Donovan

(Sanofi), Dave Jordan (AbbVie), Elizabeth Nicol

(Roche), Emily Pirc (BI), Frederik Malfait (d-Wise),

Lindsey Koleszar (BMS), Manuel Anido (Allergan),

Maria Perkinson (Kinapse), Melanie Paules (GSK),

Mikenlette Avent (UCB), Noelia Pacheco

(Accenture), Rachael Zirkle (Lilly), Sara Pauwels

(J&J), Shannen McGinnis (Amgen), Sofie Castella

(Novo Nordisk), and Trisiha Simpson (UCB)

10 May 2016

Internal Events

TransCelerate Day at Amgen 26-May

On May 26, TransCelerate CEO Dalvir Gill joined leaders from Amgen for a

TransCelerate Day in Thousand Oaks, CA. Board Member Elliott Levy and

Oversight Committee Member Sarah Carter kicked off the morning with a

Welcome Ceremony and Dalvir Gill presented an overview of TransCelerate

and its recent accomplishments. Then, Amgen TransCelerate team members

Kaari Bowen, David Wright, Jules Desmond and Kristen May each presented

on Shared Investigator Platform, Clinical Research Awareness & Access,

Placebo/SoC, and eLabels, respectively. The presenters were joined by Dalvir

and Sarah for a Q&A panel before heading outside for a poster

session. With nearly 200 in attendance both online and in person, the

engagement across the teams was very high.

Upcoming workstream and council meetings:

eSource Face-to-Face, 7-8 June, Jersey City, NJ

Placebo/SoC Face-to-Face, 7-8 June, New Providence, NJ

CRA&A Face-to-Face, 16-18 June, Rockland, MA

RBM Face-to-Face, 22-23 June, Philadelphia, PA

Left: TransCelerate

Board of Directors

Member Elliott Levy

(Amgen)

Below from left to

right: Oversight

Committee Member

Sarah Carter

(Amgen), Dalvir Gill

(TransCelerate), and

Amgen members

Kaari Bowen, Kristen

May, David Wright,

and Jules Desmond.

11

Internal Events

May 2016

Contact Us:

Email

Stay Connected:

Website

LinkedIn

Twitter: Follow @TransCelerate

Key SharePoint

Resources:

Overview deck

Member Contact List

Onboarding

Upcoming Country Meetings:

The following countries have upcoming

meetings:

South Korea 10-June

Belgium 16-June

Australia 12-July

Team Members in Peru met 12-May

Member Company representatives in Peru met on 12-May

to focus on highlighting another country that has worked

well together across membership to engage a Health

Authority through TransCelerate. Max Elizari (Roche) joined

the call to share his experience working as part of

TransCelerate with other members in order to plan the

Mexico MoH meeting. Peru is a newer country group and

was looking to gain an understanding of potential future

actions they may take. The meeting was a great learning

experience and the group appreciated Max sharing his

experience working with the TransCelerate Regulatory

Council.

Team Members in Germany met 3-May

On 3-May, team members in Germany met at the Frankfurt Conference Center in Germany to hold their second

Germany Country Meeting. The meeting began with Oversight Committee Member Axel Riedel (BI) and TransCelerate

Director of Operations Sarah Plush providing an overview of TransCelerate Q1 highlights before moving into workstream-

specific presentations. Elizabeth Bygate (GSK) presented on

the Common Protocol Template, Christopher Hart (AZ)

presented on Placebo/SoC, and Clinical Data Transparency

was presented by Robert Janiak (Merck) and Helle

Gawrylewski (J&J).

The attendees were very engaged in the material and

appreciated the opportunity to understand the projects on a

deeper level.

Thank You to Hyongyong Ji

TransCelerate would like to thank Hyongyong Ji (Lilly)

for her leadership as Country Lead for South Korea.

Over the past two years, she has done a wonderful job

to help spread the value and mission of TransCelerate

along with providing local knowledge and

connections.

Sarah Plush is working with Hyongyong and the

Oversight Committee to fill the open position, with a

new Country Lead named before the 16-June meeting.

Join us at DIA 2016 in Philadelphia, PA

This year, TransCelerate is proud to be part of 10 sessions at DIA over the course of five days. This is a wonderful

opportunity for TransCelerate to engage with the industry and for you to network with

colleagues who are also part of TransCelerate. For a full list of TransCelerate presentations, check out the

Events Calendar on SharePoint. Email us at InternalNews@TransCelerateBiopharmaInc.com if you’re able to

join us Tuesday, June 28 for a special networking evening reception.