Monday, April 22, 2013

#PCTUS Summit Day: The Power of Technology

Welcome to Summit Day at Partnerships in Clinical Trials 2013.  We began the morning with an exclusive looking to the Investigator Open House where Janssen, Merck and Eli Lilly shared how they're using technology to streamline an industry site database.  Throughout the day, we heard how technology can make the industry heather, grant access to patients and  make access to information - both for patients and companies easier.

The single most question of the day ways: Have you participated in a clinical trial?

Investigator Innovator Open House
Janssen, Merck and Eli Lilly decided to pool resources and develop a site databank in 2010. Instead of looking at each other as competitors, they've decided to join forces and share their knowledge about the sites they use and develop an extensive database detailing many of the critical aspects of sites. Pfizer has recently joined the initiative and the collaboration is leading to more innovative solutions for the industry.  This allows companies to share what sites have had training on procedures, protocols, clinical trial specialties.  Soon, the site investigators themselves will be able to comment and share their experience through their profiles.

We then transitioned into the Patient Centered Clinical Trials track where Komathi Stem of Genentech, Melanie Goodwin of Merck and Sean Aherns of shared their insights on the future of patient involvement in clinical trials.  Genentech always see patients as the center of their trial, however, when they’re designing protocols, they’re often left out. They’re striving to get patients to be partners when they design their clinical trials but it is a challenge due to perceived difficulties in the process. They’re trying to learn to do this by doing instead of overthinking and processing.

When we say “Patient Centric” is there a balance between what the patients want and how the industry is trying to create drugs to treat them? Technology is outpacing legislation. Regulators and the industry want to harness the power so more collaboration is needed as an industry.

Also mentioned in the track was the importance of personalized medicine.  By understanding the patient and how they're responding to medication,  Pharma will get better answers. It's important to look at what a company needs to complete a trial - not doing trials on a population bases and already looking at the drugs on the market based on genetic data. When listening to patients online, everything they talk about has been going on, most likely, for years. So Pharma needs to figure out how to integrate and treat this new data.

For the next portion of our morning, we moved into the Cost and Contract Management track and hear from Zaher El-Assi of Merge and Mark Milberg of Medtronic on Leveraging Technology to Create Efficiency When Contracting with Third Party Vendors.  They identified the usual methods companies use to contract with vendors: Hourly Rate Agreements, Flat Rate/ Fee for Service Agreements, Activity-Based Agreements, Milestone-Based Agreements and Hybrid Agreements.

Fee for Service can have many frequencies. Most commonly used. Pros: monthly costs are more even/predictable, ensures resources are allocated y CRO each month, Ideal for cost categories where work is less variable month over month.

Activity based contracting requires multiple cost categories. Drivers must identified. They have a strong correlation between work completed and work invoiced and there is much flexibility. On the downside, cost drivers need to be relevant and specific.

In terms of cost savings, efficiency is expected, project management waste should be eliminated, it is just as important not to have exorbitant costs.  In terms of the pay as you go model, there are no sunk costs, less upfront costs, more integrity in pricing assumptions, less needs for change orders.

Next, Matthew Eckman, Genentech presented An In-House Tool for Consistently Assessing Vendors’ Financial Health in the Cost and Contract Management track.   He started emphasizing that it’s important to analyze vendor health with the current trends in the global market including persistent economic troubles, drug development challenges, billions at stake outsourcing is on the increase, industry pain points and irrational competition.  Eckman believes that financial evaluation of vendors is better done in house.

What did he advice that a company would need to consider to make it work?  Multiple facets of financial performance, emphasis on  ratios and two-step tests, avoiding using too many market-based measures and to consider using multiple metrics in the same family

How can a company translate this data into action? The presentation should include the following measures.  The data and presentation should be simple to follow. Any tool will have text – give a description and teach others but don’t overload the financial analysis with text. The writer should also avoid financial jargon in the presentation. When developing numbers to present, a composite score to facilitate understanding. The composite scores give you a clear scale, have current, historical and average scores over time and can be tied to explicit risk levels.

Then this scale should be presented visually – in a graph, infographic, or another visual way to communicate the financial stability of the potential partners.

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