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THE TRANSCELERATE MONTHLY
Please take t ime to
complete the TransCelerate
P o l i c y T r a i n i n g :
Confidentiality, Information
Exchange & Antitrust Course.
The course is hosted on the
TransCelerate SharePoint.
If you are having SharePoint
issues, please send an email.
Save the Date! TransCelerate
Town Hall 9-Dec!
Hear from TransCelerate
leaders on a review of 2015
accomplishments and a look
ahead to 2016. Plus, submit
your questions for our live
Q&A. For more information
email Internal News
1
Leadership Lens This month, the Leadership Lens features Operations Committee member and
Clinical Data Transparency Sponsor Peter Ronco (BMS). Peter discusses how
the work done by the Clinical Data Transparency team will affect not only the
industry, but also patients. In addition, Peter sheds light on the alignment
between TransCelerate and the overall R&D strategy at BMS.
Click the image below to play the video.
Edition 17 October 2015
For all TransCelerate Member Company Colleagues. You may forward within TransCelerate Member Companies
In This Issue
Workstream and
Council Highlights
Announcements
Inside TransCelerate
Inside the Portfolio
Member Spotlight
Internal Events
...... 2 - 5
...... 6 - 8
...... 8
..…. 9
.......10
October 2015
....11 - 15
Workstream and Council Highlights
Clinical Data Standards – Efficacy (as a collaborator in CFAST) Workstream Lead: Dave Jordan (AbbVie)
The CDISC International Interchange meeting will
be held in Chicago during the week of 9-Nov.
Presentations will be conducted by Trisha
Simpson (UCB), Christine Fleeman (UCB), Rachael
Zirkle (Lilly), Gloria Jones (J&J), and Mike Ward
(Lilly). The meeting includes a keynote by Rob
Califf, Deputy Commissioner of the FDA. Stay
tuned to External Engagement Highlights for
more information about this meeting.
Click here to view an expanded scope of the
Data Standards Program Overview of upcoming
Therapeutic Area Data Standards.
2
Clinical Data Transparency
Workstream Leads: Andrew Freeman (GSK) and Ben Rotz (Lilly)
The Returning Summary Results team engaged in a recent HRA task force meeting to provide feedback on the
Guidelines on Summaries of Clinical Trial Results for Laypersons. This team is also finalizing the Recommendations for
Drafting Non-Promotional Lay Summaries and sent a draft version to the HRA on 28-Oct for potential consideration as
recommendations into the EU guidance. The team is also working with the MRCT to provide comments on their
updated guidance document.
The EMA recently released a draft Submission Guidance Implementation of the EMA Policy on the Publication of
Clinical Data which provides further details on the procedural aspects related to the submission of clinical reports,
including how the documents should be sent to the EMA and the process leading to publications of these files. The
team is preparing feedback on the technical guidance and will submit to the EMA on 30-Oct.
October 2015
Therapeutic Area Project
Charter Approval
Concepts Completed
Internal Review
Public Review
Projected Publication
TBI v1 Oct 13 Sep 14 Mar Jul Q415
Breast Cancer v1 Oct 14 Oct 14 Mar Oct Q116
COPD v1 Sep 14 Dec 14 Jul Oct Q415
ADaM Supp to Diabetes v1 NA NA Mar Jul Q415
Diabetic Kidney Disease v1 May Aug Oct Dec Q116
Tuberculosis v2 Apr Apr Sep Nov Q116
RA v1 Jun Oct Dec Q216
CV Imaging v1 May Jul Oct Dec Q216
Prostate Cancer v1 Oct Q316
MDD v1 Oct Q316
GAD v1 Triple-Scope Q316
Bi-polar Disease v1 Triple-Scope Q316
Common Protocol Template
Workstream Lead: Rob DiCicco (GSK)
Feedback from Member Companies evaluating and using Release 1 of the Common Protocol Template is being used
to shape future releases—including the upcoming public release. The team continues to respond to requests for
facilitated installations at Member Companies and questions submitted to [email protected].
The schedule for creation of additional Therapeutic Area (TA) libraries will be developed based on an upcoming
Member Company survey on TA prioritization.
Work has begun, in conjunction with CDISC, to map terminology required for clinical trial registries. This will be used as
an input to enable automated disclosure via the Common Protocol Template.
Comparator Network
Workstream Lead: Jason LaRoche
(TransCelerate)
The team has ramped up their Change
Management efforts and is focused on creating
materials to help Member Companies with
voluntary adoption.
The team is working on the requirements and design
of the next release of the Comparator Network
Exchange, the system which supports all the Member
Company transactions in the network. The next
release is expected in 2016.
3
e-Labels
Interim Workstream Lead: Jodi Smith-Gick (Lilly)
The team is preparing for a face-to-face meeting on 3-5 Nov in Biberach, Germany, hosted by BI. During the meeting,
the team plans to prioritize ideas for potential labeling productivity tools, work on their Health Authority engagement
strategy and progress their efforts on the implementation toolkit.
eConsent
Workstream Lead: Hilde Vanaken (Janssen)
The team has refined their scope to focus on an eConsent Framework, an associated Implementation Toolkit for
Sponsors and supporting External Engagement activity.
In conjunction with CTTI, the team submitted an abstract for the 2016 DIA Annual Meeting in the US to present 1) CTTI’s
informed consent project and 2) TransCelerate’s efforts with eConsent.
Investigator Registry
Workstream Lead: Bill Jordan (Sanofi)
Release 1.0 of the Supplemental Investigator Registry (IR) went live on 15-Oct and the team is finalizing Phase 2 scope
and related next steps.
The team continues to progress integrations with the Shared Investigator Platform (SIP) Release 1.0. The team has
aggregated, merged, and matched records.
October 2015
Right: Growth of the Network (Year over Year Transactions )
Placebo / Standard of Care (PSoC)
Workstream Lead: Ed Bowen (Pfizer)
The team finalized the Member Company Data Sharing Agreement in September and is obtaining signatures from
participating companies. Upon execution and subsequent submission of clinical trial data, the team will begin to load
clinical trial data from the first 50 identified trials into the data sharing solution for eventual conversion and pooling
activities.
4
Risk Based Monitoring (RBM)
Workstream Lead: Brett Wilson (BMS)
The Data Integrity and GCP Misconduct (DIGM) Framework and the Central Monitoring II papers have been
accepted by DIA’s Therapeutic Innovation & Regulatory Science (TIRS). Both will appear online in December and in
print in January. The team is working on a follow-up paper to the DIGM Framework that focuses on statistical
monitoring.
The RBM Technology white paper is nearing completion and is on target to be published on the TransCelerate website
in December.
October 2015
Shared Investigator Platform (SIP)
Workstream Leads: Jackie Kent (Lilly), Dan Seretti (Merck) Krupa Patel (Merck) and Munther
Baara (Pfizer)
Release 1.0 testing and Early Adopter Integration activities continue in preparation for launch next month.
In parallel, the SIP functionality-based Module teams continue to formalize Release 1.1 requirements. Leadership
oversight has been expanded with the appointment of Munther Baara as SIP Workstream Lead for R 1.1.
SIP Release 2.0 development is also progressing; the release will expand existing functionality and deliver new SIP
capabilities.
Team members continue to hold discussions with Member Companies exploring SIP adoption.
Members of the SIP and Investigator Registry teams participated in the recent SCRS Global Site Summit 9-10 Oct in
Amelia Island, FL. The team members staffed the TransCelerate Learning Lounge and briefed attendees on key SIP
and IR features. SCRS attendees provided some great feedback from sites about the SIP. Read more about the
summit in the October External Engagement Highlights.
Quality Management System (QMS)
Workstream Lead: Deb Driscoll (Merck)
The team completed the draft of the full Clinical QMS Conceptual Framework Concept Paper and met with the CRO
Forum to discuss their comments in the socialization phase.
The team is in its second phase of engagement with Health Authorities, gaining feedback on the full Clinical QMS
Conceptual framework from FDA, EMA and PMDA. Additionally, they have plans to speak with ANVISA (Brazil), Health
Canada, CFDA (China) SWISS MEDIC, MHRA (UK), and BfArM (Germany). Socialization and input will also be obtained
from other key industry stakeholders.
Site Qualification and Training (SQT)
Workstream Lead: Katarina Hugeneck (Lilly)
The team launched a new process for trainers to self-attest their GCP meetings minimum criteria on the TransCelerate
website. This process will greatly reduce the burden on sites and improve existing processes within the team.
The Mutual Recognition of eDC (Electronic Data Capture) training subteam continues to progress drafting the mutual
recognition process on how to make it easy for members to accept vendors and other Member Companies’ non
protocol specific eDC training.
5
Regulatory Council
Council Lead: Sanjay Jalota (Janssen) The team is preparing for upcoming meetings with CFDA (3-Nov), PMDA (20-Nov) and the FDA and EMA along with
scheduling meetings with Regulatory Authorities in other countries.
The team held a face-to-face in Bridgewater, NJ 29-Oct. Read more about this meeting in next month’s The
TransCelerate Monthly.
October 2015
Technology Council
Council Lead: Pete Milligan (GSK) For the Shared Investigator Platform (SIP) and Investigator Registry (IR), the Council is continuing to work with
TransCelerate Director of Quality to provide Member Company security experts to be part of the SIP Security Advisors
which is part of the vision for long-term security governance.
Council Highlights
Change Management Council
Council Leads: Michaela Herdick (EMD Serono) and Nazma Rosado (Astellas)
Change Management Council leadership continues to work on analyzing the findings from the TransCelerate
Implementation Survey that was completed earlier this fall. The Council is working with the Finance team to develop a
customized summary report for each workstream as a supplement to the blinded data that was shared at the
Operations Committee Face to Face in London. In addition to providing increased transparency across
TransCelerate, the summary findings will inform TransCelerate on current levels of participation in, and implementation
of, TransCelerate initiatives.
6 October 2015
Announcements
TransCelerate Colleague Announcements This past month, TransCelerate has refreshed some key leadership positions across the Board of Directors, Operations
Committee, Workstreams, Councils, and Country Network. Please join us in welcoming new
members and thanking members who have transitioned to new roles.
Board of Directors
Dr. Roy Barnes, SVP of Global Clinical Development for Merck, and Dr. Bernie Zeiher,
President of Global Development for Astellas were appointed to the TransCelerate
Executive Committee on October 20. Congratulations to Roy and Bernie and we look
forward to their continued support and leadership.
Operations Committee
Julian Jenkins (GSK), Vice President of Innovation Performance and Technology at GSK, tran-
sitioned into the Operations Committee role previously held by Pete Milligan (GSK).
Common Protocol Template
Dave Jordan (AbbVie) has taken on the Sponsor role of the workstream.
Shared Investigator Platform
Jackie Kent (Lilly) has taken on the Sponsor role of the Shared Investigator Platform (SIP)
workstream, previously held by Dave Jordan (AbbVie). Jackie will remain the SIP Workstream
Lead for SIP Release 1.0. Munther Baara (Pfizer) will assume the SIP Workstream Lead role for
Release 1.1.
Dan Seretti (Merck) and Krupa Patel (Merck) will remain SIP Release 2.0 Workstream Leads.
Investigator Registry
With the transition of Munther Baara (Pfizer) to the SIP workstream, Bill Jordan (Sanofi) will re-
main as the sole Workstream Lead.
Technology Council
Pete Milligan (GSK) assumes the role of Council Lead, a role previously held by Dave
Jordan (AbbVie).
China Country Lead
QingAn Jiao (J&J) is the new China Country Lead and is replacing Jie Zhao (GSK). Based in
Beijing, QingAn will work to organize future China Country meetings.
Dr. Bernie Zeiher
Dr. Roy Barnes
Julian Jenkins
Placebo Team Milestones in October
White Paper Published on TransCelerate Website
On 28-Oct, the Placebo team’s White Paper: Development and Implementation of a Pharma-Collaborative Large
Historical Control Database was published on the TransCelerate website. The paper provides guidance on the potential
applications of our large historical Placebo/Standard of Care PSoC database, as well as examples for the possible
implementation of historic data in seven specific applications (use cases).
Received First Dataset for Sharing
On 29-Oct, the PSoC team received their first dataset for sharing via the TransCelerate PSoC Data Sharing initiative. The
study contains 372 patients who received placebo. The delivery of the first study is a significant milestone on the journey to
drive secondary value from clinical trial datasets. The team is targeting 50-75 studies in their first year.
7 October 2015
Announcements
Available Now:
Adverse Events and Safety
Clinical Research Overview
Clinical Practice vs. Clinical Research
Arriving by Q1 2016:
Conducting a Study
IRB/IEC Responsibilities and
Informed Consent
Delegation and Training
Investigational Product
Essential Documents
Source Documentation
Facilities and Equipment
Monitoring and Auditing
Themes from the 2015 TransCelerate Engagement Survey
On 30-Aug, a survey was sent to all active workstream and council members to provide your opinions and insights about
your experience working within TransCelerate. It’s incredibly important for us to understand your experiences so we can
ensure best practices for structure, communications, and engagement.
We would like to thank you for your feedback and
share some overall results from the survey results.
Five main themes emerged from our analysis.
Overall, across all participating Member Companies,
the results were very positive. Nearly everyone
(98.6%) who works with TransCelerate finds their work
interesting and would like to continue to be
involved. However, there are some areas for
improvement around role clarity, communications,
and recognition, as indicated in the chart.
TransCelerate is actively working to prepare results
for each Member Company basis and identifying
ways to improve your experience both within
TransCelerate and within your Member Company.
SQT Releases First Three Topics in the Informational Program for Site Staff Less Ex-perienced in Conducting Clinical Research
This month, the Site Qualification and Training (SQT) team released the first three topics of 11 total topics in the new
program to describe the basic concepts of Clinical Research in accordance with the ICH Guideline for Good Clinical
Practice: Consolidated Guidance (E6). Addressing 11 major areas, all topics will all be available on the SQT page of the
TransCelerate website by Q1 2016.
The program may be used in its entirety or in part by site personnel: to supplement existing information, used as onboarding
information, used as a remediation tool, or to create awareness when considered for a study by a Member Company.
Inside TransCelerate
Each month, we’ll profile a TransCelerate core team member in order to bring more
visibility to the team member’s roles and responsibilities.
8 October 2015
Sarah Plush Director of Operations
What are your responsibilities at TransCelerate?
I am responsible for a wide range of activities that span several areas of the business.
As a primary point of contact for membership inquiries, I engage the necessary
people and materials to help companies explore the value of TransCelerate
Membership. It’s important that our membership application process remains
consistent with our governing bylaws. As new companies join TransCelerate, I help
deliver onboarding for new leaders and the Member Company Colleagues who will
work on TransCelerate initiatives. Recently, we introduced a refreshed onboarding
process to ensure new people joining workstreams/councils were also provided an
opportunity to have a consistent and valuable onboarding experience.
As TransCelerate , and excitement around it grows, I work with teams to drive
agenda planning, content creation, meeting documentation, tracking of actions and more for the governance support
needed for the Operations Committee and the Board. Also, I help to lead regional activities in partnership with a local
country lead to enhance our global network. Back at our office , I have responsibility for information technology,
confidentiality agreements, and internal operations.
How do you spend your free time?
When it’s warm out, you can find me by the pool or tending to my garden. In the fall, my family loves having backyard
bond fires. I also volunteer on my step son’s Cub Scout Leadership Committee to help plan and support all their activities.
If you could visit anywhere in the world, where would it be? And why?
I would travel to Italy. I’ve heard so many great stories from others who have traveled there and cannot wait to go myself.
Announcements
Phase I of the Supplemental Investigator Registry is Live
This month, the Investigator Registry team reached an important milestone: Phase 1 of the
Supplemental Investigator Registry (IR) live. Effective now, Member Companies can join the IR
platform. This is a wonderful achievement and we look forward to much more from this team. A
sincere thank you to all team members for their hard work and dedication.
Read more about the IR and the team’s work on Phase 1 in the Inside the Portfolio section.
The Risk Indicator Library is Live
This week, the Risk Based Monitoring team released the Risk Indicator Library on the TransCelerate website. The library is the
result of a survey distributed to TransCelerate Member Companies in Q4 2014 in which Member Companies were asked
about risk indicators, either in use or proposed. A library was compiled, which currently comprises over 100 risk indicators.
From this library, clinical trial sponsors can pick, choose, and adjust risk indicators and apply them to their clinical studies.
With more experience gained, the library will be further refined and may reduced, changed, or be structured differently.
9
Inside the Portfolio
October 2015
Where does the data come from? Data comes from user and facility profiles, existing Member Company information, the
DrugDev (technology vendor providing the platform and whose solutions are featured in the IR) network, and other third
party data sources.
How is this different from Investigator Databank? The IR builds on a pre-TransCelerate collaboration, the Investigator
Databank. Both the IR and the Investigator Databank use DrugDev core capabilities
such as the Golden Number and the Data Query System (DQS) search tools. Both
platforms allow each company to store their data in their own locked private
database, and all private databases are hosted on the same cloud technology.
Where the two platforms differ is that IR members are only able to share with IR
TransCelerate members and the platforms have different data sharing rules. The
biggest differentiator is that the IR integrates with the Shared Investigator Platform.
Data that comes in through the Shared Investigator Platform is only shared with
participating TransCelerate members.
What’s next for the team? In addition to supporting SIP future releases, Phase II of the IR
will focus on four areas: Investigator engagement, expanded data elements, data
visualization, and network affiliations.
Benefits of the IR can be realized by various functional groups within your Member Company. To learn more, contact your
internal IR team representative.
Congratulations again to the IR workstream on the wonderful achievement of Phase I go live!
What is the IR and how is it used?
The IR is a platform solution that
integrates Person, Facility, and
Protocol Data from various
sources. With the IR, there is now
one record for a training provider.
So, there may be data for a “Dr.
Michael Smith”, a “Dr. M Smith”,
and a “Dr. Michael W. Smith” that
are all entered into the Shared
Investigator Platform (SIP) by
t h r e e d i f f e r e n t M e m b e r
Companies. The IR works
independently and in support of
the SIP. The IR is the “engine” that
matches all user and facility
data to a unique identifier (the
Golden Number) then masters
and stores this profile data in a
secure location.
That single record can be used by participating Member Companies for: accessing data at the study, country and thera-
py area level, supporting study planning, feasibility, site identification, site qualification activities, and CTMS data cleaning
activities. Data from the IR can also be used internally and shared with business partners.
“The Investigator
Registry is the ‘engine’
that matches all user
and facility data to a
unique identifier, then
masters and stores this
profile data in a secure
location.”
The Investigator Registry Goes Live
We sat down with Investigator Registry (IR) Workstream Lead Munther Baara (Pfizer) , to better understand the impact of
Phase I of the Supplemental IR—an important milestone—that went live this month and Member Companies can now join
the platform. This is a wonderful achievement and a great first step toward improving the site investigator experience.
10
Name: Nishchal Chudasama
Home Location: New Brunswick, NJ
Member Company: BMS
TransCelerate Role: Primary Liaison for BMS sales on the Comparator Network
What is your “Day Job” at your Member Company?
I am Group Leader Integrated Supply Chain Operations within Research & Development at Bristol-Myers Squibb (BMS). In
this role, I lead a team of supply chain professionals who support end-to-end manufacturing from Drug Substance
Manufacturing (both large and small molecule) to Packaging & Labelling for Clinical Supplies, including Purchasing,
Warehousing, Dispensary Operations and Global Logistics.
What are your responsibilities on your workstream/council?
I am the primary liaison for the sale of BMS drug product to other Member Companies in the Comparator Network. In this
role, it is my responsibility to ensure that BMS personnel are well informed about the upcoming demand for our products
and also deliver consistently strong customer service to Member Companies both in terms of supplying product and the
related documentation/guidance.
Within most Member Companies, R&D personnel interface minimally with Commercial personnel, developing robust SELL
workflows therefore presents them with a unique challenge. My prior role with the BMS Commercial Supply Chain and cross
-functional network within BMS enabled me to collaborate and develop effective process flows that were responsive to
the needs of Member Companies. Based on our success, we were able to share the BMS SELL Model with other Member
Companies and influence the evolution of SELL processes within the TransCelerate Comparator Network.
What are some of your interests outside of work?
I love the outdoors: hiking and traveling. In the past year, though, my boy-girl twins have kept my hands full.
October 2015
Member
Spotlight
11
Internal Events
October 2015
The Operations Committee had a Face to Face in London, 30-Sep—1-Oct
The Operations Committee held its second face-to-face of the year in London at the Marriott Kensington. Over the two
days, the Operations Committee, Workstream and Council Leaders, Project Managers, and the TransCelerate core team
reflected on our collective impact to the industry and celebrated accomplished milestones to date, reviewed workstream
value metrics to understand key insights from the Value Assessment and Implementation Survey to encourage voluntary
Member Company adoption, along with the taking the opportunity to connect/reconnect with colleagues.
There were separate breakout sessions for the Operations Committee Members and Workstream and Council Members
along with Interactive sessions in which workstream leaders received interactive, real-time feedback with each Operations
Committee member about their particular workstream.
Operations Committee Members held a working session on Day 1 to align on solutions to re-energize leadership
engagement, drive future success of TransCelerate’s portfolio and enable effective governance. Day 2 involved a review
of, and decisions around, the next steps for ideation (potential new TransCelerate workstreams) scoping efforts.
After a presentation on the results of the 2015 Engagement Survey, Workstream and Council Members spent Day 1
evaluating engagement, and brainstormed solutions to address opportunity areas in order to maintain success across
TransCelerate Workstreams and Councils. Also, the teams identified ways to work effectively to mitigate risk, increase
global focus, evolve regulatory engagement, and facilitate Member Company adoption. Day 2 had a focus on business
continuity and brainstorming sessions around knowledge transfer, deliverable ownership, communication, and value and
metric reporting.
The Operations Committee and Workstream Leaders came back together for a presentation on workstream value metrics
before the meeting closed.
Overall, the meeting was a great success and representation and engagement from all Member Companies and
workstreams was very high. The two days provided valuable feedback to the way TransCelerate will operate in the future
and the teams are currently assessing the meeting outcomes and developing solutions that will be shared in the coming
months.
Quality Management System met 28-29 Sep in London The team held a face-to-face workshop 28-29 in London with 33 team members present to progress deliverables from the
3 main focus areas of the workstream: Clinical QMS Conceptual Framework, Knowledge Management, and Issue
Management. The team spent part of the agenda discussing Change Management strategies to support the success and
flexible adoption of workstream deliverables. Finally, the team reviewed and endorsed a proposal for new scope:
Assessing the CQMS.
Highlights included:
Welcoming several new members including members of the new QMS AsiaPac team;
A review and update to the External Engagement plan;
Advanced work on the Clinical QMS Concept Paper
A review of the survey results on Clinical Knowledge Management current state and an outline for a Clinical
Knowledge Management framework; and
A review of 2016 objectives and timelines including target timelines.
The team also enjoyed an evening dinner at Babylon, hosted by Roche.
Feedback from the workshop indicated it was the best meeting to date. The team is actively planning their next full team
workshop in Raleigh Durham, NC 19-21 Jan, hosted by GSK.
12
Internal Events
October 2015
Seated from left to right: Mireille Zerola (BI), Kate Owen (Novo Nordisk), Gloria McHugh (Accenture), Stuart Shaw (BI),
Kate Marshall (Astellas), Mary Cusack (BMS), Susanne Norskov (Novo Nordisk).
Standing from left to right: Marcin Makowski (AZ), Yakov Datsenko (BI) Andy Ware (UCB), Francisca Samson-Graveland
(Astellas), Satoshi Saeki (Astellas), Peter Thomasma (Astellas), Jennie Moseley (Astellas), Stacy Foley (Merck), Brett Wilson
(BMS, Team lead), Takuya Kita (Shionogi), Kees van der Ploeg (Astellas), Mitsutaka Shinoda (Shionogi), Ed Kellar (Astellas),
Sarah Plush (TransCelerate), Andy Lawton (BI) Joanne Benedict (Roche), Gosia Orywals-Sykes (Amgen), Heather
Achenbach (Novo Nordisk).
The Risk Based Monitoring Team met 5-6 Oct in Frankfurt, Germany
The RBM team held a face-to-face workshop 5-6 Oct in conjunction with the RBM Open House in Frankfurt, Germany. The
focus of the meeting was to align the team and advance current thinking and planning for the RBM
Community of Practice which will be proposed and developed for 2016. Since the concept is still being developed within
TransCelerate and across workstreams, much of
the time was spent developing various scenarios
for how the operating model will work and what
mitigations the team might want to think about.
There were also several breakout sessions to
develop specific content for upcoming
deliverables as well as to plan for some upcoming
Health Authority meetings.
The team also had a chance to spend time
together and enjoy some sightseeing in the Rhine
River Val ley, the towns of Mainz,
Weisbaden, and of course Frankfurt, which was
celebrating the 25th anniversary of the German
Reunification.
RBM Held Second Open House 2-Oct in Frankfurt, Germany
The RBM team and Boehringer Ingelheim hosted their 2nd RBM Open House in Frankfurt Germany, which included a Meet
& Greet the evening prior. Close to 60 people attended the RBM Meet & Greet at the Paulaner Restaurant in The Squaire
on Thursday evening, which was conveniently located attached to the Frankfurt Airport. The Meet & Greet proved a
popular way to network with colleagues that had flown in for the open house the next day, and everyone enjoyed the
collegiality and Oktoberfest food and beer.
The Open House was attended by 77 people, mostly from various European countries. The day opened with Brett Wilson
(BMS & RBM Team Lead) and Andy Lawton (BI host and
team member) welcoming the crowd. The Plenary session
on the topic of Quality Management System (QMS) was
headed by Christa Maurer, (BMS) QMS team member. The
attendees were enlightened about the relationship
between QMS and RBM and many commented that it
gave them a much better understanding of the larger
picture of quality and risk. Additional topic-specific sessions
were held in the morning in three different tracks, then a
networking lunch was held which also proved to be a very
popular crowd pleaser. A poster session followed the
lunch, then additional sessions in the afternoon. The
Closing session included highlights of each facilitated
session held during the day, and feedback indicated it was
quite interesting. An interactive Q&A with the SMEs and
facilitators also enhanced the closing of the day.
Survey feedback continues to provide the planning team with
good insight into what the attendees enjoyed. 70% of
attendees felt the Open House was high value, and find that
the networking and the opportunity to hear directly from
colleagues who are working on implementations in their
companies are the most beneficial aspects of the open
houses. The Open House Concept will continue to evolve as
the RBM team shifts to a community of practice.
13
Internal Events
October 2015
Placebo/Standard of Care met in London 5-6 Oct
The team held a face-to-face workshop 5-6 Oct in London, hosted by GSK. During the workshop, the team reviewed the
go-live process once the Data Sharing Agreement execution is completed by Member Companies.
In addition, key FDA feedback from the August meeting was considered as the team discussed whether and/or how to
incorporate it into the team’s remit and vision. Also in regard to the team’s vision, the 2016 objectives and milestones were
reviewed and slightly updated based on team discussion. Updates included external engagement initiatives for which the
team sketched out high level targets for next year.
A substantial amount of time was spent discussing how to craft the workstream’s value story including performance
measurement; the larger goal being the attraction of new TransCelerate Member Companies to participate in the
workstream and to objectively be enabled to depict the workstream’s impact. As such, the team agreed to proposed
value metrics and templates to best capture value data.
On the second day, there was a candid yet fruitful discussion about existing challenges and barriers within the Member
Companies for successful launch and execution of the workstream. Borne out of that discussion, the team agreed to
create job aides (work instructions) for application of the solution to each use case. In this way, core team members can
better articulate how one may go about executing a use case from a detailed perspective.
Site Qualification and Training met 6-7 Oct in High Wycombe, UK
On 6-7 Oct, the SQT team met for a face-to-face meeting—the first time this meeting took place outside of the US. The
meeting was hosted by Janssen in High Wycombe, UK. Updates from ongoing subteams were made and feedback was
discussed in relation to finalized initiatives and adoption. The main focus during the meeting was business continuity, and
in particular, how to accomplish effective business continuity and still ensure each of the SQT initiatives continues to be
easily available for sites and for TransCelerate Member Companies. Handover criteria was established as well as potential
deliverable owners for the various SQT initiatives. The need for oversight was highlighted and suggestions were shared
about how this could be achieved. Part of the agenda was also spent on how to manage knowledge transfer and
communication.
From left to right (Back row): Martina Schlickenrieder
(Allergan), Katarina Hugeneck (Lilly), Dawn Furey (Merck),
Sheri Jacobsen (AbbVie), Adam Colley (Merck), Denise
Gaul (Roche), Cheryl Lichtenthal (Sanofi). Front row: Lorri
Erhardt (Astellas), Theresa Stewart (Allergan), Lucy Kiessig
(J&J), Paulo Moreira (EMD Serono)
14
Internal Events
October 2015
TransCelerate Day at Roche 23-Sep in San Francisco, CA
In September, Roche held a TransCelerate Community Event with more than 200 people in attendance from the Roche
South San Francisco Clinical Operations team. Excitement was buzzing as individuals spent more than two hours learning
about TransCelerate and interacting with the TransCelerate Roche workstream leads and members.
TransCelerate Vice Chair of the Board Corsee Sanders,
(Roche) gave an overview of why Roche and TransCelerate
collaborate and shared a few of the great success stories that
have come out of Roche’s involvement with Transcelerate.
TransCelerate Operations Committee Member Virginia Nido
(Roche) provided an overview of TransCelerate and Kim
Barnholt (Roche) introduced Roche team members involved
with TransCelerate.
The main focus of the event was the “mix
and mingle” where attendees had an
opportunity to visit workstream booths to
chat, ask questions and more. Overall,
attendees were highly engaged and it was
a great opportunity to spread the word
about TransCelerate and get people
excited about the impact on the industry.
15
Internal Events
October 2015
Upcoming workstream and council meetings:
Regulatory Council, Bridgewater, NJ 29-Oct
Contact Us:
Stay Connected:
Website
Twitter: Follow @TransCelerate
Key SharePoint
Resources:
Overview deck
Operations Committee Highlights
Member Contact List
TransCelerate Country Network Activity
TransCelerate Team Members in Germany met 7-Oct
The first ever TransCelerate Country Meeting was held in Germany on 7-Oct. The meeting was well attended and
generated a lot of excitement. During the meeting, John Bots (AbbVie) provided an overview of the Shared Investigator
Platform (SIP) including functionality and benefits and Andy Lee (Pfizer) and Brett Wilson (BMS) provided an overview on
Risk Based Monitoring. Sarah Plush (TransCelerate) gave an overview on TransCelerate and provided an overview on the
Site Qualification and Training and Comparator Network workstreams.
The first ever Germany Country Meeting.
Upcoming Country Meetings:
The following countries have upcoming
meetings:
Spain, 5-Nov
Japan, 12-Nov
In addition, the following countries are plan-
ning meetings:
Turkey
S. Korea, 10-Nov
e-Labels, Biberach, Germany 5-6 Nov
TransCelerate Team Members in Austria met 23-Oct
Member Company representatives in Austria met in Vienna
on 23-Oct, hosted by Pfizer. This is Austria’s second Country
meeting. During the meeting, Alexander Celedin (Pfizer)
gave introductions and showed the new
About TransCelerate video.
John Bots (AbbVie) presented on the Shared Investigator
Platform (SIP) including an overview, the value proposition,
stakeholder impact and benefits, and functionality
highlights, along with objectives and timing.