Bracket Visits The City of Slot Machines and CNS

By Gary Sachs, MD

Bracket attended the International Society for CNS Drug Development (ISCDD)’s annual meeting in Las Vegas, Nevada – March 20 -22, 2013.

With highly engaging speakers, sessions were highly informative, interactive and produced fruitful discussion of topics such as “Developing Tools to Enable Earlier Termination of Futile Clinical Programs”, “Data Mining by the FDA: What Should Be Prioritized?,” and ”A Proposal to Develop Fit-For-Purpose Outcome Measures”. We all learned valuable lessons from first in public presentations on recent clinical development efforts.

My own personal take away from the presentations at this conference was a sense of optimism that such sharing and consensus building are key parts of a precompetitive process that can move the field forward.

Our field is beginning to see data validating some innovative approaches and learning how not to repeat errors. ISCDD will be establishing working groups with our colleagues, sponsors, regulators and other vendors to build on the momentum from this meeting.

The International Society for CNS Drug Development (ISCDD) was formed in 2002 with the goal of establishing a forum for improvement of methodology in CNS research. To find out more about the organization, you can visit their website here.

Dr. Sachs is a Therapeutic Area Leader at Bracket.

4th Annual Outsourcing in Clinical Trials East Coast

By Cheryl Selleny, Marketing & Communications

Arena International’s 4th Annual Outsourcing in Clinical Trials East Coast conference was held last week in the City of Brotherly Love, Philadelphia. Although an unexpected snow storm arrived in PA and the surrounding states the night before opening day, professionals from pharma/biotech companies and clinical trial supply services made the trek for the conference, which proved to be a worthwhile event. Bracket had the opportunity to exhibit at the conference, enabling us to share our offerings with attendees.

The program for the conference highlighted how to make a business case for outsourcing in clinical trials by refreshing one’s strategy for outsourcing. Key topics included: overcoming economic challenges in the industry; forming and maintaining a successful working relationship with your partners in order to achieve optimal efficiency; and working to find solutions for site management difficulties.

The agenda included informative sessions covering such topics as Maximizing Data Accuracy to Ensure Patient Safety and Satisfy Regulatory Scrutiny presented by Jesse Kooker, Global Head of Data Management, Galderma; and Conducting Effective Vendor Qualifications to Mitigate the Rick of a Failed Partnership presented by Tarra Shingler, Associate Director, Outsourcing, Endo Pharmaceuticals. Interactive roundtable sessions took place on Day 2, offering an opportunity for attendees to network and learn from their peers.

Learn more about Outsourcing in Clinical Trials Southeast, the next upcoming conference at which Bracket will be exhibiting, May 7 – 8th in Cary, NC.

Summary of the Clinical Trial Supply New England Conference

By Jen Burstedt, Marketing & Communications

Last week’s Clinical Trial Supply New England conference at the Revere Hotel in Boston, MA, drew professionals from across clinical trials and commercial supply services, allowing for satisfying exchange between pharmaceutical and biotech sponsors with the partners providing service for them. In addition to exhibiting at the event, two members of Bracket’s Client Services team – Nicole Graves and Sofia Lalani – were in attendance, learning from their clients firsthand how vendor client service was perceived.

Nicole Graves, who is Director of Client Services within Bracket’s eClinical division, works closely with Bracket’s Interactive Response Technology (IRT, also known as IVR/IWR or IXRS technology). She has been working within the IRT service for seven years and gained insights as a provider of services for pharma sponsors.

Nicole reflected, “where Clinical Supplies are concerned, the challenges we see from an IRT perspective typically don’t change from sponsor to sponsor. Hearing the roadblocks that the Clinical Supplies and Clinical CRO/Sponsor teams endure was insightful. It helped to put our own challenges in perspective, and even gave me a few ideas of where we can implement solutions so that as a vendor, we can continue to offer solutions to, rather than contribute to, any challenges!”

Presentations included David Sherris, CEO and President of Paloma Pharmaceuticals, who spoke on the topic of “Detailing Traits That Determine A Good Service Provider And The Right Management System To See A Trial Through To Completion On Budget And On Time” to a case study by Carla Oliva, Manager of Clinical Supply Operations and IVRS at Millennium Pharmaceuticals, entitled “Optimizing Efficient Trial Forecasting So As To Effectively Plan The Needs Of Your Clinical Supply Chain.”

Learn more about the Arena International’s Clinical Trial Supply New England conference.

Learn more about Bracket’s IRT solution, known as RTSM.

Findings at the 11th International Conference on Alzheimer’s and Parkinson’s Disease

By Keith A. Wesnes, BSc, PhD, FSS, Cpsychol, FBPsS

On Day 1 of the 11th International Conference on Alzheimer’s and Parkinson’s Disease (AD/PD), I delivered an oral presentation in a Symposium on Cognitive Deficits in Parkinson’s Disease. My paper, entitled The Prevalence of Mild Cognitive Impairment in Parkinson’s Disease Appears Greater with Automated Cognitive Testing, was based on an analysis of research conducted with my co-author, David Burn MD, Newcastle University, UK. We found that in 380 PD patients, speeded cognitive test scores were more sensitive than accuracy scores in identifying MCI in PD; and that using the latest MDS criteria, up to 82% of PD patients could be identified as PD-MCI with the CDR System. This contrasts to detection rates of PD-MCI of around 25% in previous large surveys, which had largely relied on traditional pencil and paper scales. This incidence is more realistic considering the rapid conversion to dementia in PD, compared to the much slower conversion of MCI to Alzheimer’s disease (AD). The take home message was that one of the major cognitive deficits in PD is to attention and information processing capability; deficits are not well detected by non-automated tasks, which though able to measure response accuracy cannot properly assess the speed of the various cognitive processes involved in task performance. The clear recommendation of the Symposium was to include more sophisticated cognitive test procedures in therapeutic trials in PD and related areas.

I also had the opportunity to present two posters revealing the first human evidence of impaired neurogenesis in both PD and AD patients using a CDR System object pattern separation task. Both posters confirmed preclinical data (much of which was presented at the conference) showing compromised dentate gyrus hippocampal neurogenesis in animal models of PD and AD. The poster in PD, co-authored by David Burn and David Miller of Bracket, showed that a task measure shown previously in man to be sensitive to dentate gyrus (DG) activity was selectively impaired in 348 PD patients, and that the impairments could not be accounted for by either disrupted attention/information processing nor impulsivity. To view the poster, click here .

The other poster in a well characterised AD sample confirmed preclinical data by demonstrating that this DG sensitive measure correlated selectively with the CSF levels of Aß42, as well as being selectively impaired in AD patients with double APOE ϵ4 alleles. To view the poster, click here .

Both posters have important implications for new therapies in PD and AD – as many target neurogenesis, and this 4 minute task will not only provide a non-invasive human proof of concept of this mechanism of action, but will also serve as a treatment outcome for such therapies.

11th International Conference on Alzheimer’s and Parkinson’s Disease

By Cheryl Selleny, Marketing & Communications

The 11th International Conference on Alzheimer’s & Parkinson’s Disease (AD/PD) is taking place in Florence, Italy. Medical professionals from around the world are gathering to discuss cutting-edge research and new discoveries in neurodegenerative diseases. Review the full scientific program.

Bracket subject matter experts presented a total of three scientific posters at the Conference on Thursday, March 7. Click on the links below to review the posters.

Laterality Index – A means Of Identifying Sites Of Concern In Parkinson’s Disease Clinical Trials 
Presented by Alan Kott, MD, Bracket and Jina Swartz, MD, PhD, Bracket

Evidence That Compromised Neurogenesis In Alzheimer’s Disease Is Linked To APOE4 Status And CSF Aß4 
Presented by Keith A. Wesnes, BSc, PhD, FSS, Cpsychol, FBPsS, Bracket

First Human Behavioural Evidence Of Compromised Dentate Gyrus Neurogenesis In PD is Unrelated To Poor Attention And Impulsivity 
Presented by Keith A. Wesnes, BSc, PhD, FSS, Cpsychol, FBPsS, Bracket; David S. Daniel, MD, Bracket; and David J. Burn, MD, Institute for Ageing and Health

Clinical Trial Supply Europe Takes Place in the German Capital

By Jen Burstedt, Marketing & Communications

Within the Hotel Palace Berlin, outside of the cold German winter, clinical supplies professionals and their partners came together to attend the 14th Annual Clinical Trial Supply Europe conference, held in Berlin, Germany, February 26 – 27th, 2013. Attendees included professionals from Europe, the United States, Japan as well as other parts of the globe.

Hiroki “Rocky” Mitsuhashi, Bracket’s Japan Regional Manager, was given the opportunity to speak at the conference. On Wednesday, February 27th, Rocky presented on the topic of Working Between Europe & Japan: Clinical Supplies from the IVRS Perspective, giving an overview of the current market situation in Japan, adding a novel perspective on some of the challenges in working between Europe and Asia and outlining several potential solutions.

View Rocky’s presentation [PDF].

Conference website: http://www.arena-international.com/ctseurope.