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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:
Stay Connected:
Website
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 [email protected] if you’re able to
join us Tuesday, June 28 for a special networking evening reception.