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16 Dec 2011

Last year Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) launched a landmark joint project to develop a successful Alzheimer’s Disease (AD) data standard and research database. Data from eleven AD clinical trials from seven of C-Path’s Coalition Against Major Diseases (CAMD) member organizations (who are also CDISC members), was converted into the CDISC SDTM standard. During the process, new formats were added to SDTM to create a resulting new therapeutic area specific standards package, the CDISC AD standard. The data were then ready to be aggregated, and the result was a database incorporating detailed data from over 4,100 individuals afflicted with AD, a groundbreaking achievement that will assist researchers in developing safer and more effective treatments for those suffering with AD.

 

The collaboration between CDISC, C-Path, government agencies, academia, patient groups and the AD clinical community in developing the CDISC AD standard is a valuable model of how a successful consortium can support faster and safer drug development. In much the same way that CDISC has collaborated with C-Path to develop Alzheimer’s data standards, CDISC and the Innovative Medicines Initiative (IMI) have recently signed a Memorandum of Understanding (MOU), agreeing to collaborate for the shared purpose of accelerating the development of new therapies for patients worldwide.

 

IMI, the largest public-private partnership in Europe, supports further innovation in healthcare through the formulation of partnerships between industrial and academic experts to aid in the creation of a more cooperative environment for R&D, encouraging the development of safer and more effective drugs for patients. IMI seeks to address certain inadequacies in R&D causing delay in the drug development pipeline through four research priorities: 1) predicting safety, 2) predicting efficacy, 3) knowledge management and 4) education and training. With knowledge management in particular, IMI seeks to more effectively utilize data to determine safety and success.

 

15 Dec 2011

 

The Oncology Colloquia was one of six Colloquia sessions held during the CDISC International Interchange 2011 on 6 therapeutic areas: Oncology, Virology, Pain, Diabetes, TB and Imaging.  Bron Kisler, VP of Strategic Alliances at CDISC, initiated the session introducing himself, Bron’s background with CDISC is on Terminology.  He was one of the first people with CDISC to work on Therapeutic projects beginning with the TB and Acute Coronary Syndrome projects back in 2006.  “We have seen growing interest in disease specific standards from the CDISC community and FDA as well as communities new to CDISC including NIH institutes, foundations and professional societies”, Bron mentioned.  He also stated that one of the nice things about Oncology is that we don’t have to start from scratch due to the great work already done across the National Cancer Institute (NCI) community.  During the meeting, Dianne Reeves from NCI provided an in-depth orientation of this work, which was followed by a working session.

 

The attendees, who were also active CDISC team members, represented a good cross-section of organizations: Astrazeneca, Celgene Corporation, Critical Path Institute , eClinical Solutions, Eli Lilly, FDA, GlaxoSmithKline, Genentech, NCI, Otsuka Pharmaceutical and Pharmastat.  CDISC and C-Path are partnering on numerous disease projects with 9 therapeutic areas in the works and at various stages of development.  CDISC is so pleased to be partnering with the C-Path team out of Tucson, AZ on this new work as they bring incredible value including their project management expertise.  It was also exciting to hear that FDA was very pleased with the growing CDISC C-Path relationship.

6 Dec 2011

Grand Hyatt Hotel, New York City

7-8 November 2011

 

A fascinating panel at Partnering for Cures in New York City was that of the ending plenary session, where leaders from academia, non-profit and for-profit companies, and government came together to discuss best practices in successful collaborations. Those on the panel were:

 

  • Gordon R. Bernard, M.D., Professor of Medicine, Associate Vice Chancellor for Research, and Senior Associate Dean for Clinical Science, Vanderbilt University
  • Kathy Giusti, MBA, Founder and Chief Executive Officer, Multiple Myeloma Research Foundation
  • Brian Harvey, M.D., Ph.D., Vice President, U.S. Regulatory Policy, Sanofi
  • Thomas R. Insel, M.D., Director, National Institute of Mental Health (NIMH), National Institutes of Health
  • Jeffrey M. Trent, Ph.D., FACMG, President and Research Director, Van Andel Research Institute; President and Research Director, The Translational Genomics Research Institute (TGen)

 

The plenary began with each panelist introducing their background and key components of successful collaborations that each of their organizations had been able to forge. Highlights during this discussion were of successfully merging the business and science at the beginning of the process of collaborating, thereby gaining information from a wider-varied number of backgrounds, but at the same time making certain the partnerships that are being formed are strategically created for the work that needs to be done.

21 Nov 2011

Presentation by Dr. ShaAvhree Buckman, M.D., Ph.D., Director Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

 

If there is something that clearly caught my attention during Dr. Buckman’s keynote speech is that FDA needs to have a standards-based environment, from end-to-end, to support a fully electronic receipt, review, and dissemination environment.

 

Dr. Buckman started her presentation talking about the current challenges for the 21st Century Drug Development.

 

Patients want the most up to date information on products and quickly, and this is only one part of an extremely complicated healthcare system. “The amount of time spent in the preclinical and clinical trials as well as the amount of time it takes for one FDA drug approval, involves tremendous effort, time and money!” Dr. Buckman stated.

 

She portrayed the current situation by providing an example of having “one New Molecular Entity” and explained that it will entail having over 9 gb of data and over 8.8 gb of documentation. She went on to mentioned that if the FDA receives a copy of a submission, that will require ~1.7 million pages, while if they have five copies then printed at FDA, they will need 8.5 million pages! The FDA spends a lot of money on paper, and solving this issue requires having some sort of electronic submission interface which will also certainly allow for greater efficiencies. We will have efficiencies if we have new ways to get eSubmissions; we can then improve regulatory decision-making through advanced analytics.

 

 

14 Nov 2011

One of the most exciting components of the CDISC International Interchange is the session in which representatives from CDISC Coordinating Committees from around the world present on the progress that has been made throughout the past year.

 

Shannon Labout, Senior Director of Education for CDISC, opened the session and introduced the speakers:

 

• Rebecca Kush, CDISC President and CEO, speaking on behalf of Dr. Sukil Kim, Korea CDISC Coordinating Committee (K3C)

 

• Sheila Leaman, CDISC Manager of Global Relations, speaking on behalf of Simon Wang, China CDISC Coordinating Committee (C3C)

 

• Dr. Yoshio Tsukada and Hiroshi Azuma, Japan CDISC Coordinating Committee (J3C)

 

• Peter Van Reusel, speaking on behalf of Dr. Pierre-Yves Lastic, Europe CDISC Coordinating Committee (E3C)

7 Nov 2011

“I am going to talk about how CDISC and the work you are doing is already playing a role in the learning health system and may play an even greater role in the future,” said Dr. Charles Friedman in his opening keynote at the CDISC International Interchange.

 

Dr. Friedman cited the definition of a Learning Health System from the Institute of Medicine (IOM). A Learning Health System (LHS): …one in which progress in science, informatics, and care culture align to generate new knowledge as an ongoing, natural by-product of the care experience, and seamlessly refine and deliver best practices for continuous improvement in health and health care.

 

“In other words, it’s what your group does,” he stated. The vision would be nationwide safety surveillance with personalized medicine based upon research results upon which clinical decisions can be made--- not in the 17 years it currently takes, but in 17 months or 17 days(…or someday 17 seconds?)

 

3 Nov 2011

The CDISC International Interchange 2011 was held again in the heart of Baltimore, MD at the Renaissance Harborplace Hotel, what an amazing location! The Interchange this year was quite rich of knowledge and information that many of you have missed if you could not attend. But, we are happy to share some of this information to keep you informed of our progress and to maintain your participation in our global mission, with a vision towards “Informing patient care and safety through higher quality medical research”. We are in a technology developing era that is fast-paced. Each day is a treasure for us to make use of the time towards the continuous progress of our CDISC projects. We are committed to utilizing our data standards wisely and efficiently for the humanitarian purpose of streamlining the development of cure for patients. During this year’s International Interchange, CDISC had a set of Colloquia sessions where many FDA folks were happy to be involved, providing their input on the work they do for the sake of patients and public health and how adopting the CDISC Standards ensures global consistency by avoiding errors and loss of time. The Colloquia was made possible by C-Path, ACRP & APPI.

 

 

  

 

The first colloquia session that I attended was on Tuesday, 11 October. It focused on the Virology domains and datasets. There was an FDA presenter, Helena Sviglin, who had drafted the initial Virology domains for comment. There were also 3 FDA reviewers attending this session, along with CDISC team members and experts from other organizations. Ms. Sviglin was happy to share the updates with us and was asking for comments from the attendees. She started off the session by telling us that they work with Dr. Chuck Cooper on validating data efforts of any of the review divisions; Dr. Cooper is an FDA reviewer, MD, in the Office of Translational Sciences, CDER, FDA.

 

 

 

27 Oct 2011

I had the opportunity to attend Session 3 on the afternoon of 12 October at the CDISC International Interchange. This session included four presentations discussing Metadata and the CDISC Shared Health and Clinical Research Electronic Library (SHARE). The speakers and their specific topics were:

 

21 Oct 2011

One of the greatest opportunities for CDISC Platinum Members attending the CDISC International Interchange is that, through their ability to have a seat on the CDISC Advisory Board (CAB), their representatives are invited to special events, such as the US Food and Drug Administration's (FDA) Town Hall Meeting that was held on the evening of Tuesday, 11 October. There was a fantastic turnout, and the hall was literally packed all the way to the doors with CDISC CAB members who came to pose questions to the FDA representatives.

 

19 Oct 2011

I sensed an exciting buzz at the CDISC Interchange in Baltimore this past week. On Wednesday afternoon, I attended Session 5, which was entitled “Standards “Up Front””. As a long time BRIDG Semantic Coordination Committee (SCC) member and liaison to the BRIDG Board, I was quite interested in the presentations from this session, which included topics such as the Protocol Representation Model (PRM), BRIDG, and the Study Data Model in XML (SDM-XML). [SDM = Study Design Model]