We started out the afternoon with the Avoca Update. This year's survey focused on risk sharing. One of the major findings to come out of the survey was that when providers are penalized, there is generally a more negative experience. Relationships between sponsors and providers require complete clarity. This changes the focus from high quality delivery to placing blame and takes away from the importance of the trials. About 50% of sponsors are using risk-related information to determine levels of over-site. Are risk-based approaches leading to better efficiency and higher quality? Not many are seeing more efficient use of resources but many are seeing increased quality. If you'd like to hear more about this year's Avoca Survey, listen to a Inside Outsourcing podcast we recorded with Partnerships Speaker Patty Leuchten.
At Millennium Pharmaceuticals, they do not do a lot of risk sharing and are working with three preferred providers. It has been discussed but the risk based approach model is something they've worked on since the risk based approach to build metrics for outsourcing because the ability to move forward is based on the risk sharing model. Coleen Glessner, Pfizer believes there are so many directions that risk management can take you. Pfizer has piloted the integrated quality management plan with the FDA. At the beginning of protocol development, they can identify where the largest risks in that trial and then they can put mitigation in place. What are you going to stop doing now that these are in place? Pfizer has shifted to quality – higher quality protocols are seen thanks to this new risk based approach. INC Research focuses on two types of risk: operational risk and clinical/scientific risk. Identify risks that you choose not to mitigate. You can’t de-risk protocols complete and you will have to accept some protocols immediately.
Next, David A. Kramer of Astellas Pharma Global Development and Nicholas Spittal of Chiltern discussed Implementing Mid-Size Tailored Functional Service Partnerships Through Strategic and Organic Means
There's been a move to functional relationships between Pharma and CROs. Ideal partnerships result in maximized efficiency with continuous improvement. The promise of the mega-FSP is reduced sponsor cost and guaranteed sponsor increase in revenues. Lilly and Covance have found their partnerships to be a win. Spittal believes that of this has not been cost savings but not cost shifting. How can small sponsors and CROs get the attention of a large counterpart? How can it be structured to benefit both organizations.
It is important start successfully from within the company, often meaning the sponsor should transfer management to the CRO and send back FSP team to the sponsor. This helps build relationships between teams. Any staff members who have had previous experience with the CRO staff should be on that team which leads to the implementation of best practices there. Upon this successful implementation the staff should be grown organically From there, the integrated staff can work on workshops, pipeline planning, policies and procedures and logistics.
With these staff members successfully in place, it's important to start pushing the team towards success. Deliverable teams meeting on a daily basis, ops meets weekly, management community and executive committee meet less frequently. A relationship manual is key because it defines: governance, ops plans and procedures, resource planning, contracts, etc. If the transfer of the clinical team moves to the CRO and stays, that shows a testament to how well the plan worked to move clinical operations. They had also opened their offices next to each other so that relocation wouldn’t be a factor.
What is needed to succeed in a successful mid-sized Pharma and CRO partnership? A cultural fit, a clear understanding of the goals, advanced planning, mutual trust and transparency, shared allocation of responsibilities, flexibility and governance and continuous communication.
For our last breakout session of the day, Christoper Erickson of Parexel and Daryl Najarian of Merck presented Adapting Strategic Partnership so the Needs of Emerging Markets
Erickson of Parexel started out identifying emerging markets as a significant place of growth and therefore a re-directed investment for the Pharma companies. Innovative products need an emerging market research component. It’s also about looking beyond the traditional products in major countries to see how it can be used in other companies. How do you ensure there’s high quality data with appropriate budgets? Scale the costs appropriately. The data from the emerging countries isn’t often as good of quality due to lack of experience. Decision makers in the partnerships space have seen that strategic partnerships have added value to their company.
Daryl Najarian of Merck identified knowing who owns the accountability as key to any strategic relationship. Regional governance should also be a clear cut. Also identifiable should be the project performance metrics and what the view of the relationship from both sides of the partnership. Feedback from stakeholders in the relationship and then share it appropriately. Other clear communication should include a sponsor is transparent about their trials in a region, then the CRO can be prepared and do a better job. Final protocol should be developed well in advanced and don’t be afraid to share the success of the trials with both parties. Detailed operational/contingency plans and share the plans of what’s driving those models.
In our last session of the day, Dierdre Bavard, Endo Pharmaceutical moderated the panel discussion among Kathleen Ford ofMerck Serono, Ed Pezalla of Aetna; Karen Kaucic of PPD, Kelley D. Davis of Express Scripts and Dalvir Gill, Transcelerate Biopharma. They looked at how innovation could spur more effective clinical trials.
Aetna uses their technology to examine claims data, diagnostic codes, laboratory values and increasingly values to identify potential patients who can participate in clinical trials. Karen Kaucic of PPD states that clinical trials are too long, too inefficient to develop molecules sustainability. They’ve approached the sponsors and stakeholders to advance the novel approach to clinical trials and are doing collaborative trials to become a driver for drug development over the next few years.
Aetna believes that they’re up to the task of dealing with tailored, personalized medicine. They can then prove the success of the medication based on the result of the medication. What does the insurance of the future look like with new personalized medicine. Coverage for entire systems of care is coming.
A frequent theme of this conference arose again - patients need to be involved earlier in design. Kathleen of Merck Serono believes that it’s difficult to go to a patient and ask what they should or shouldn't do because the procedure has to be balanced with what can be done. To test feasibility of running trials with patients in the room and having them weigh in on their willingness to participate with procedures is important. As they think about launching clinical trials, bringing patients in earlier to pressure test the operationalization of clinical trials to hear the voice of the patients would be preferred.
Rare diseases really need the insights of how patients feel about clinical trials because there are so few individuals who can actually weigh in on the procedure. Patient advocacy groups are a great way to identify this.
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