volume 3 edition 4 april 2016files.ctctcdn.com/ae373ce0501/e79e7cf3-ad37-4712-9e23-dab7b794… ·...
TRANSCRIPT
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:
Stay Connected:
Website
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.