TTC is Sponsoring the 2nd Annual State of Clinical Development Cost Conference.

September 2011 - Philadelphia, PA

On January 10th and 11th 2012 the University of the Sciences will be hosting the 2nd Annual State of Clinical Development Cost Conference sponsored by TTC. This conference will discuss four major topics:

Current Industry practices - Key Note Speaker Dr. John Hubbard, Senior Vice President Worldwide Head Development Operations, Pfizer
What does Cost Data tell Us about the State of Drug Development - Dr. Harold Glass, PhD, Research Professor, Mayes College of Healthcare Business and Policy, USciences, and President, TTC, llc
Future Challenges for Big Pharma - Key Note Speaker Dr. Peter Aurup, Vice President Head Global Clinical Trial Operations, Merck
CROs in Today's Drug Development - Dr. Douglas Peddicord, Executive Director, Association of CROs

In addition, four different panel discussions were assembled on The Value of Cost Data to Upper Management, Working with Countries that are Difficult to Budget and Negotiate, Standard of Care - Trends and Case Studies, and Late Phase Study Planning and Budgeting.

Finally the 2nd Annual State of Clinical Development Cost Conference will have a special break-out round table discussion focused on your area of expertise:

Finance - Improved Long Range \Budgeting and Forecasting
Site Start-Up and Clinical Operations - Online Negotiations
Compliance - Assuring Fair Market Value

Panelist and Speaker Details:
There will be a variety of speakers from an array of different backgrounds.

Dr. John Hubbard, Ph.D., F.C.P., Senior Vice President Worldwide Head Development Operations, Pfizer
Dr. Peter Aurup, MD, Vice President Head Global Clinical Trial Operations, Merck
Ira Spector, Senior Vice President Global Development Operations, Allergan
Peter Carberry, Senior Vice President Global Development Operations, Astellas
Dr. Scott Treiber, Ph.D., Vice President Clinical Operations, Hospira
Jeff Trotter, Executive Vice President - Phase IV Development, PharmaNet
Dr. Alan Braverman, PharmD., Vice President North American Operations, PSI
Hani Zaki, MBA, PRA International
Michael Laurer, MD, FACC, FAHA Director, Division of Cardiovascular Sciences (DCVS) National Heart, Lung, and Blood Institute (NHLBI)
Anup Kharode, PricewaterhouseCoopers
Dr. Douglas Peddicord, Ph.D., Executive Director, Association of CROs

Who Should Attend?

This is an open conference to anyone interested in attending. Those who might find this conference most beneficial would be decision makers and specialists at Pharmaceutical, Biotechnology and Medical Device companies - sponsors, and CROs:

Clinical Budgeting and Finance	Clinical Strategic Sourcing
Clinical Grang Management	Lead Clinical Research Associates (CRAs)
Clinical Operations (Global & Country)	Purchasing and Procurement
CRO Business Development and Sales	R&D Compliance and Legal
Clinical Site Selection and Negotiation	Clinical Trial Project Management
Clinical Trial Performance & Operations	Clinical Trial Planners

For more information visit the conference website at http://stateofclindev.com/index.php. Or email moreinfo@stateofclindev.com.

State Laws on Standard of Care

More and more sponsors and CROs are identifying standard of care (SOC), routine care, or conventional care to their clinical trials for compliance and cost containment purposes. The frequently asked questions include; what state can SOC be applied? Who must pay? What services would be covered? Also, some would assume that SOC can only be applied to cancer trials. In summary, most states require all insurers within each state (Medicare, Medicaid, private insurers, individual and group health plans) to pay for the SOC procedures. Iowa, Indiana, North Carolina and many other states actually extended the SOC coverage to all trials, and this certainly seems to be a trend. Using Iowa as an example, the state law states that the following services/benefits should be covered by 3rd party insurers: "patient care costs of an approved clinical trial if the insurer would cover the same routine care costs if the patient was not in a clinical trial". - Clinical Trials: State Laws About Insurance Coverage

The clinical sites are all geared up for this trend in the industry. Most sites now have at least one designated personnel to conduct a coverage analysis for all trials that have a therapeutic intend. This includes phase I through IV, all therapeutic areas, vaccines and device studies.

From The Help Desk

Since many of our clients are now using the Standard of Care (SOC) tool in GrantPlan®, we would like to focus on some points that might be helpful to you. Our SOC tool is meticulously mapped to each indication and Current Procedural Terminology (CPT) code to generate the latest standard in payments for these codes. As a result, any TTC codes used in your budget will not be mapped to any routine care procedures since it is not a CPT code. In order to receive improved use of the SOC tool, it is possible to breakdown or change the code you are using to check if this procedure would be part of conventional care in a clinical setting. An example is indicated below:

74168: TTC Code: Computerized axial tomography, abdomen and thorax combined... would not be routine care. In this case, one could substitute codes : 71250 Computerized axial tomography, thorax, thoracic, chest...and/or code 74150 Computerized axial tomography abdomen, abdominal....

Please do email us while using the SOC tool (help@ttc-llc.com) and we can help you reap incremental benefits from the use of this tool.