THE TRANSCELERATE MONTHLY

Save the Date:

TransCelerate Global Town Hall

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 TransCelerate initiatives for the

remainder of 2016 and beyond.

Given the global reach of our organization,

we have scheduled two calls for this event,

with identical content, although panelists

may change.

Additional information, including links to

register, will be emailed to all active

members. Please note that the call is for

active Member Company colleagues, only.

1

Leadership Lens This month, the Leadership Lens features Workstream Lead Hilde

Vanaken (Janssen) discussing the eConsent initiative and its

potential benefits to both patients and the industry.

Click the image below to play the video.

Volume 3 Edition 4 April 2016

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

In This Issue

Announcements

Open Resource Needs

Inside the Portfolio

Member Spotlight

Inside TransCelerate

Subcommittee &

Enabling Function

Highlights

Internal Events

... 3 - 4

..... 6 - 7

..…. 5

.......5

April 2016

..... 8 - 9

...... 2

...... 3

2 April 2016

Announcements

Thanks to Jonathan Zung

Congratulations to Jonathan Zung former Chair of the TransCelerate Oversight Committee

as he leaves his position at UCB and his role at TransCelerate. Jonathan’s leadership and

commitment have been instrumental to TransCelerate and will be missed.

We wish Jonathan the very best in his future endeavors.

Congratulations to Andy Lawton Congratulations to Andy Lawton (BI) who retired at the end of

March. Andy had been a major participant in the Risk Based

Monitoring team since inception and has brought a lot of

innovative ideas to the team. Per Andy’s team, he was always

ready to truly get the work done.

Andy was very visible and active on behalf of TransCelerate,

presenting at several conferences around the world, organizing

events for his team’s face-to-face meetings and in particular, co-authoring the article Defining a Central Monitoring

Capacity: Sharing the Experience of TransCelerate BioPharma’s Approach, Part I which won the DIA Global Inspire

Award in 2015.

We thank Andy and wish him the best on his retirement.

View the Roche TransCelerate Video Recently, Roche released a video for internal use, about TransCelerate, its initiatives, and the reasons why Roche is a

member of TransCelerate. Click the image to the right to view the video, featuring Board Member Corsee Sanders,

Oversight Committee Member Virginia Nido, Kimberley Barnholt from Roche, and TransCelerate CEO Dalvir Gill.

Andy Lawton (BI) (left) and Brett Wilson (BMS) (right)

accepting the award from DIA representative.

Jonathan Zung

3 April 2016

Inside the Portfolio

Catching up with Clinical Data Standards and Introducing Initial CDISC Fellows

When TransCelerate was founded in 2012, one of the first five initiatives was Clinical Data Standards. In a

collaboration with the Clinical Data Interchange Standards Consortium (CDISC), the Critical Path Institute (C-

Path), the National Cancer Institute—Enterprise Vocabulary Service (NCI-EVS), and the FDA as part of the

Coalition for Accelerating Standards and Therapies (CFAST), the team develops industry-wide Data Standards

in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research data and

metadata, to aid in improving patient safety and outcomes. Recently, the Clinical Data Standards team

published its 20th TA User Guide (TAUG), all of which are available online.

The TAUGs represent collaborative

efforts between stakeholders to

accelerate clinical research and

medical product development. By

establishing (and maintaining)

these TAUGs, the industry benefits

include ease and speed of

regulatory reviews, consistent and

accurate data collection, and

operational efficiencies. During

2016, the team is publishing 10

TAUGs, launching a SHARE API pilot, and working with the Common Protocol Template (CPT) team to develop

additional TA libraries.

As part of the collaboration between TransCelerate and CDISC, some members of the Data Standards team

joined the inaugural class in the CDISC Fellows program. CDISC Fellows have the unique opportunity to learn,

and contribute to, innovative approaches to developing concept-based standards. The goal is to increase

knowledge and expertise of CDISC standards throughout their own organizations and the global research

community while contributing to the efficient development and enhancements of CDISC data standards. On

the next page, we’ll introduce you to three members of the Data Standards team who completed the CDISC

Fellows program.

TransCelerate Open Resource Needs

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

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

3. QMS Assessing the CQMS Team Member (Sponsors Subcommittee): One individual at 15-20% with an

immediate start.

4

Inside the Portfolio

April 2016

Ina Assfalg (Boehringer-Ingelheim)

Over the last year I had the opportunity

to work with CDISC and TransCelerate

by participating in the CDISC Fellowship

program. As a fellow, I learned best

practices on how to develop standards

such as CDASH, SDTM, or TAUGs by

working closely with the various

experts; and additionally by attending

CDISC meetings and educational

webinars. I learned a lot about the

technology CDISC uses to accommodate global collaboration

between CDISC staff and the large number of volunteers world-

wide, for example the CDISC WIKI or SHARE tools. I also

participated in several group interactions and forums, like the

Concept Modeler Forum, or assisted in multiple project

management tasks. In particular I worked on the

Cardiovascular (CV) Imaging and Major Depressive Disease

(MDD) TAUGs as a metadata developer and contributed to

various other TAUGs (through review, comment resolution/

triaging, etc.). In addition, I worked on CDISC protocol

concepts, a project with the goal to create a formal vocabulary

for common protocol concepts. For each protocol concept a

preferred label and concept definition will be created. In a first

step, common protocol concepts from multiple sources such as

CT.gov, EudraCT, or WHO were mapped; existing protocol

related work (e.g. list of protocol concepts, CDISC CTR-XML

Specification) was taken into account. Learning CDISC through

the hands of experts will also help to promote and cultivate

internal experience at my company. Throughout my fellowship,

I was impressed with the transparent and open communication

within the community during the standards development

processes, and I would like to summarize this experience with a

quote by Henry Ford, “Coming together is a beginning, staying

together is progress, and working together is success.”

Christine Fleeman (UCB)

In 2015, I had the great pleasure of working on

several different CFAST TAUG teams as a CDISC

Fellow including: Traumatic Brain Injury (TBI),

Diabetic Kidney Disease (DKD), Cardiovascular

Imaging, Rheumatoid Arthritis (RA), and Chronic

Obstructive Pulmonary Disease (COPD). In addition,

I participated in various forums and working groups

that address commonly seen issues across all

TAs. Any remaining spare time was dedicated to

collaborations on a few foundational standards that

provide support into all CFAST TAs. My fellowship

ended in December 2015 and I remain active on

several CDISC teams.

My participation in the CDISC Fellows program has

enriched my CDISC knowledge and provided me

with opportunities I might not have been offered

otherwise. I am immensely grateful for the kindness

and patience shown to me by my CDISC

colleagues and would recommend this experience

to those who are willing to learn and enjoy the spirit

of collaboration. Join in the fun!

Gloria Jones (Johnson & Johnson)

I have been honored and very blessed to have had the opportunity to work with CDISC and

TransCelerate over the past several years developing TA submission standards for clinical

data. This past year in particular as a CDISC Fellow, I worked on the Hepatitis-C, COPD, and

Rheumatoid Arthritis TAUGs as a concept modeler and metadata developer. In addition, I was part

of the Biomedical Concept Pilots designing processes for this new way of modeling research

concepts which uses a semantic layer for the operational standards. This semantic layer improves

traceability to clinical information and provides a way to communicate and document the

meaning of information in ways that are accessible to clinical researchers as well as standards

developers. This new Biomedical Concept model allows for the re-use of research assessment

models in the development of new CDISC TA standards. This year I am continuing my work with

Biomedical Concepts in the development of the Prostate Cancer TAUG.

The CDISC Fellowship allowed me to work with a group of individuals dedicated to the advancement of clinical

research and the quality of clinical information. The TransCelerate and CDISC initiatives are bringing medicines to

improve and save the lives of many people. It doesn’t get any better than that.

Introducing CDISC Fellows On this page, Ina, Christine and Gloria share

their stories and experience in the CDISC

Fellows program. Congratulations to all for their

hard work and completion of the program.

5 April 2016

Member

Spotlight

Name: David Wilson

Home Location: Cary, North

Carolina

Member Company: UCB

TransCelerate Role:

Technology Council, Patients

Subcommittee Technology Advisor

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

visibility to the team member’s roles and responsibilities.

What are your responsibilities at TransCelerate?

I work with our Finance Lead, Tony Garges, and I am responsible for financial activities such

as monthly and yearly reporting, forecasting, budgeting, and FTE reporting. On a monthly

basis, I conduct financial closing activities and on a yearly basis, I conduct audit

preparation. I also assist with value assessment—capturing the quantitative and qualitative

value of our workstreams to show the value to our Member Companies. A portion of my time

is dedicated on leading financials for BioCelerate, TransCelerate’s preclinical subsidiary.

How do you spend your free time?

In my spare time, I enjoy playing basketball with my friends, dining out at new restaurants in and around Philadelphia, and

attending sports events. I’m an avid fan of the Lakers, Rams and Phillies. I also spend my time looking at properties as I’m

seeking to move into a new home this summer.

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

I would love to travel to Bora Bora and stay in one of the huts that sticks out into the ocean with the glass floor so I can

watch the sea life swim underneath.

Lysien Lakuriqi Finance Analyst

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

I am the Director, Global IT Clinical Development & Partnership, with the privilege of leading a talented team responsible

for technology solutions used in data acquisition, trial management, data transparency and streamlined connectivity with

external partners. One area of focus that I’m extremely passionate about is “Bringing the Trial to the Patient” where we are

looking to challenge the classic ways of acquiring data in clinical trials by introducing digital/mobile solutions that bring real

value to patients and other stakeholders in the value chain. Both UCB and I are “Inspired by patients. Driven by science.”

What are your responsibilities on your workstream?

I’m a member of the TransCelerate Technology Council and the Technology Advisor for the Patients subcommittee along

with Mahruq Siddiqui (Allergan). The Patients subcommittee currently includes the eConsent, eLabels and Clinical

Research Awareness & Access workstreams. In my role, I’m engaged directly with leadership of the subcommittee and my

accountabilities are to:

Assist workstreams with identification of technology needs.

Ensure connectivity amongst workstreams as it pertains to technology.

Serve as a technical expert to ensure fit against reference architecture.

Identify technical resource gaps and raise to the Technology Council.

The embedding of Technology Council members as Technology Advisors in subcommittees is new starting in 2016 where

Advisors are in not only Patients but Ideation, Sites, Sponsors and Information Sharing & Harmonization.

What are some of your interests outside of work?

I’m very focused on fitness and health and try to work out most days of the week before work or after work. A few years

ago, when my wife and I became “empty nesters” we took up cycling and enjoy finding trails or “less traveled” roads

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.

6

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.

April 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.

The Patient Awareness & Access workstream has been renamed to Clinical Research Awareness &

Access to better reflect their intent to raise awareness with patients as well as other stakeholders

involved in clinical trials such as caregivers, family members, and the general public.

The eConsent team developed their external engagement plan and has a full slate of external

engagement activities planned with patients, sites, IRBs and Health Authorities.

The Shared Investigator Platform went through a series of purposeful re-planning sessions in the past

months. Release 1.1 is on target for 30-Jun with Release 2.0 (Introduction of new capabilities, one of which

includes the introduction of a Document Management and Safety letter functionality) on target for

30-Nov.

On 11-April, the Investigator Registry (IR) turned on Data Sharing for Member Companies. Now, Member

Companies using the IR can access site investigator data from other participating Member Companies

and truly realize the value and function of the IR.

The Quality Management System submitted their Concept Paper to DIA’s journal, TIRS and recently

submitted the Issue Management manuscript which is currently in peer review. The team continues to

raise awareness of its Clinical QMS Conceptual Framework through these publications in peer-reviewed

journals. Stay tuned to External Engagement Highlights for more information on these publications.

The Risk Based Monitoring team continues to move forward with their next Open House, occurring in June.

Details on the event will be in next month’s The TransCelerate Monthly. The team is also moving forward

with external engagement and plan their next events to the Society for Clinical Trials (Emmes) and Clinical

Trial Innovations Summit.

7 April 2016

Enabling Functions Highlights

Digital Collaboration Update: Latest TransCelerate SharePoint Features Last month, we announced we had migrated our SharePoint to better align with our new governance model and its in-

creased collaboration across workstreams. This month, we’re excited to announce additional SharePoint improvements,

designed to provide you with a better SharePoint experience, including:

1. A new Master Contact List: Looking to find out who from

your company is involved with TransCelerate, or are you

looking for teammates and colleagues across projects?

The Master Contact List includes easy-to-search records

for all Member Company talent engaged with

TransCelerate efforts.

2. An Events Calendar: Are you curious about when

TransCelerate may next be meeting with an industry

stakeholder or Health Authority or at a conference? The

Events Calendar provides insight into the frequently held

meetings by TransCelerate leadership, workstreams and Councils.

The calendar replaces previous Excel trackers and has custom

views for easy navigation based on event type.

3. Simpler User IDs: Now, you can use your Member Company email

address as your Microsoft ID and replace your old account that

ended with “@transceleratebiopharma.onmicrosoft.com” We

understand how difficult it can be to remember so many user

names and passwords. Plus, you’ll no longer have to wait for a

SharePoint admin to reset your lost or forgotten password. Click

here for the instructions for Part 1 of this two-part process.

We appreciate your feedback on our SharePoint and we look

forward to providing you with a better SharePoint experience. We

thank you for your patience as we work to improve our important collaboration tool. If you have any questions regarding

SharePoint, please contact Brian Egan.

Active Subcommittee Highlights (Cont.)

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 order to meet the objective of 100 converted studies into the data sharing solution, the Placebo/SoC

team is actively organizing brainstorming sessions at participating Member Companies in order to

generate excitement about the data and identify real-life situations based on the Use Cases.

After releasing the Common Protocol Template to the public in December, the team is working towards

Release 3 of the template in mid-May, which will be the first technology-enabled version of the Common

Protocol Template.

8 April 2016

Internal Events

Technology Council held a Face-to-Face 31 March in Indianapolis, IN

Members from the Technology Council met face-to-face to review further plan and

deliver to the new charter for the Council, along with a review of the Technology

Council Advisor role and overall collaboration within TransCelerate.

The group was very engaged and the Council will continue to refine the role of the Tech

Advisor across the different workstreams and subcommittees in order to ensure delivery of

maximum value to TransCelerate.

The eSource Team held a Face-to-Face 5-6 April in Collegeville, PA

The eSource workstream held their second face-to-face

workshop on April 5-6 at the GSK Navy Yard facility in

Philadelphia with an in-person attendance of 28 representatives.

During this meeting, the team made significant progress on

finalizing the upcoming sponsor survey of eSource

practices in TransCelerate Member Companies. The team also

discussed other upcoming stakeholder engagements, upcoming

landscape and point of view manuscripts, and

started planning change management activities.

The team is looking forward to the next workshop in June at

Allergan in Jersey City, NJ. During this upcoming meeting, the

team plans to complete the draft of their first landscape

manuscript and to begin the process of vendor

engagement.

Common Protocol Team Members met Face-to-Face 6-7 April, King of Prussia

GSK hosted the CPT Core Team F2F in King of Prussia, PA April

6th and 7th. Accomplishments included finalizing content

and adding an approach for amendments for the May

template release and drafting an RFI to progress towards a

digital protocol model.

From left to right: Pete Milligan (GSK), Charlie Haddad (Lilly), Dave Wilson (UCB), Tom Kelly (Accenture),

Nils Schlote (Roche)

Left to right: Seated: Diane Klatzman (J&J), Tina Fahmy (KPT)

Middle: Anne Cropp (Pfizer), Rob DiCicco (GSK), Cathy Stein-Izsak,

(Allergan) Mitzi Allred (Sanofi), Susan Colby (BMS), Julia Billiard (GSK),

Vivian Combs (Lilly), Virginia Nido (Roche), Stacy Tegan (Accenture),

Andrea Rose-Legatt (J&J), Rob Ferendo (Lilly) Back Row: Bill Lander

(GSK), Nils Schlote (Roche), Frederik Malfait, Mark Makurath (Merck),

Nareen Katta (AbbVie)

Front to rear: Julian Jenkins (Sponsor - GSK); Second row: Susan Bornstein (Pfizer), Brett Wilson (WSL - BMS); Third row: Jaclyn Patterson

(Merck), Abhijit Parab (Allergan), Andy Ware (UCB); Fourth row: Prasann Mehta (Merck), Kristin Baird (Merck), Chrissy Johnson (Pfizer), Bill

Kesil (Roche); Fifth row:Chris Bowen (Pfizer), Michelle Crouthamel (GSK), Wendy Snyder (Amgen), Patty Mcintire (Pfizer), Mark Fry (GSK);

Sixth row: Brian Poirier (Pfizer), Ken Milstead (PM - Kinapse), Aleny Caban (Astellas), Ed Kellar (Astellas), David Schwab (Kinapse)

9

Internal Events

April 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:

Romania, Germany, and Australia

Upcoming workstream and council meetings:

Oversight Committee Face-to-Face, 18-19 May, Philadelphia, PA

Clinical Data Standards Face-to-Face, 24 May, Raleigh, NC

CPT Open Call Session 26 May, 11 a.m. - noon EST

The Common Protocol Template (CPT) team will be introducing Open Calls as a service to Member

Companies to share best practices and respond to Member Company questions. CPT Subject Matter Experts will

be available to answer both content and technology questions. Stay connected—reach out to your CPT

representative for more information about these calls and other CPT resources.

Join the Webex (Meeting Number: 312 797 959; Password: CPT 123) or call in toll-free (US/Canada) 1-855-244-8681

Team Members in Belgium met 26-April

Member Company representatives in Belgium met virtually on Tuesday, April 26. for the first time. 11 Member Companies

were represented by 13 representatives. Country Lead Marah Wajskop (UCB) hosted the meeting. TransCelerate Director

of Operations Sarah Plush provided an overview of TransCelerate, the Realization Subcommittee, and a review of recent

accomplishments. TransCelerate Communications and Operations Analyst Brian Egan reviewed in more detail the Site

Qualification workstream, with a focus on the recently released Informational Programs for Site Staff Less Experienced in

Conducting Clinical Research.

Marah led the audience in an engaging conversation to determine the needs for the audience in future meetings and

identify engagement opportunities in 2016 and beyond.