Mary Syto OCT SoCal 22Sep2014 FINAL
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The document discusses ways to build a valuable relationship between sponsors and vendors in clinical drug development. It suggests that traditionally these relationships have been transactional but are now evolving to emphasize partnership and trust. Specifically, it recommends that sponsors and vendors get to know each other better through multiple points of contact, share knowledge openly about expertise and limitations, disclose issues and information fully and timely to build trust, see contracts as starting conversations not dictating terms, and ensure communication tools provide relevant rather than excessive data. The overall goal is improving quality, efficiency and reducing costs and staff turnover through a collaborative rather than adversarial relationship.
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Mary Syto OCT SoCal 22Sep2014 FINAL
- 1. Tragara Pharmaceuticals, Inc.Building a “Valuable” Relationship Between Sponsor and Vendor Mary Syto Director, Clinical Operations
- 2. 2 Outsourcing is Big Business Global Contract R&D Marketplace
- 3. 3 Evolution of the Sponsor-Vendor Relationship • With the growth of CRO use, the Sponsor-Vendor relationship is evolving. • Sponsors want – Access to operational and therapeutic expertise – Quality data – Improved efficiency and productivity – Reduced costs – Speedy time to market • Vendors want – Client satisfaction – More business! • The Sponsor and the Vendor want to make this relationship work and create a shared vision of partnering and trust.
- 4. 4 The Traditional Sponsor-Vendor Relationship Getz-Zuckerman “Sourcing 2015: Sponsor-CRO Relationships of the Future”
- 5. 5 How do you “Value” the Softer Side of the Relationship? Price Quality Timelines Deliverables Staff Turnover Site/Investigator Satisfaction
- 6. 6 Approaching Relationship Building with Value in Mind • The Value of “Knowing Each Other” • The Value of “Sharing Knowledge” • The Value of “Full Disclosure” • The Value of “Contracting” the Relationship • The Value of “Communication Tools”
- 7. 7 How the Relationship Starts
- 8. 8 The Value of “Knowing Each Other” (or, how many points of contact should there be?) • CRO BD Rep – First contact • CMO and the CRO Executive Director • Sponsor Director/PMs with CRO counterparts • One point of contact for the Sponsor • Role of Sponsor and CRO Executive Management • Strategic and cultural fit • Closer relationships with operational team – In house ‘implants’ – Joint training: drug product and protocol – Remember most are not a 1.0 FTE – Can be motivating • Multiple pts of contact: – Less transactional – More commitment – Potential sounding boards? A Typical Approach… …With a Bit More Effort The Bottom Line: Potential for improved quality, possibility for reduced turnover, Strategic fit is important.
- 10. 10 The Value of “Sharing Knowledge” (or, are you willing to admit what you don’t know?) • PIE CHARTS! – We have the expertise in everything and anything you need! – And the people to do it! (At least after we hire them for your bid defense) • Sponsor says “Come to the table with your expertise” but I really want to do it my way • “Emperor’s New Clothes” or Vendor “Bobble-head” syndrome • Sponsor/CRO doesn’t know everything but doesn’t want to look dumb • Sponsors/CROs: Do your homework! – Good test: Feasibility of protocol • Operational and therapeutic expertise are rarely the same on both sides – Be clear about expertise gaps – “CRO should question a task if it may not make sense. • Staff turnover happens – Every new team member is a “reset” button. – Be proactive and ask new team member their expertise on current processes. A Typical Approach… …With a Bit More Effort The Bottom Line: “I not only use all the brains that I have, but all that I can borrow.” – Woodrow Wilson
- 11. 11 The Value of “Full Disclosure”
- 12. 12 The Value of “Full Disclosure” (or, how close to the vest do you play your cards?) • Sponsor: Limited info in RFP “Let’s see what they show us in the bid defense” • “The CRO is just a pair of hands.” – They don’t need to know the drug development plan. – The CRO should just focus on the task at hand. • CRO providing little info and no timely notification of problems • Sponsor and CRO may have plans for a Merger or Acquisition • Sponsor: Share info with CRO – Prior to the RFP – Press releases – Board/KOL feedback and involvement • CRO: Share info with Sponsor – Strive to be the ‘solution provider’ but don’t let that delay discussing issues – Inform Sponsor ASAP about any staff turnover – Press releases and development plans – Be proactive with ideas and other capabilities: adaptive trial design, RBM, new technology, etc. A Typical Approach… …With a Bit More Effort The Bottom Line: Timely updates of info and issues can build trust. Potential for more business – Current client is the easiest one to pitch to.
- 13. 13 The Contract
- 14. 14 The Value of “Contracting” the Relationship (or, should I make sure this is all in a pre-nup?) • Transactional contract – “Fee for Service” • Contract based on performance and outcomes – Milestone-based payments – Penalty clauses for poor performance – Bonuses for staff retention • When expectations aren’t being met, Sponsor whips out the contract • Vendor sends a change order for every small thing • Do homework before the big test! – Accurate forecasting of the timelines result in realistic plans. • Contract helps to start the conversation. It is not the glue that holds everyone and everything together. • F2F meetings with key players: – Kick-off – Kick-Start – Mid-study review – Governance committee – Lessons Learned meeting A Typical Approach… …With a Bit More Effort The Bottom Line: Potential for accurate timelines and realistic deliverables.
- 15. 15 Communication
- 16. 16 The Value of “Communication Tools” (or, how fancy should our meeting minutes be?) • “Check box” activities become the deliverable in the Vendor’s mind – Completion of project plans – Weekly trackers and status updates – Comprehensive meeting minutes • Vendor: Bury the sponsor in all the data they might ever ask for or want. • Sponsor: Ask for more data and assume that is enough for trial oversight. Issues will be easy to see. • “No news is good news!” • Utilize knowledge of best practices but remember that One Size Does Not Fit All. – Customize tools and plans – Watch out for too many plans! – Eliminate what is not useful – Set up the frequency and relevance of the info that the Sponsor wants/needs – Set a date mid-study to review relevance and utility of tools and plans • Tools are meant to inform. – Don’t rely on the tools and plans to take care of everything. – Tools are not a substitution for Sponsor oversight. A Typical Approach… …With a Bit More Effort The Bottom Line: Potential for better quality and more productivity. “Less may be more.” Real-time access to relevant data for the Sponsor.
- 17. 17 Key Takeaways • The Value of “Knowing Each Other” – Strategic and cultural fit can be critical. – Closer relationships are important. • The Value of” Sharing Knowledge” – Operational and therapeutic expertise are never the same on both sides. – There is always an opportunity to share knowledge. • The Value of “Full Disclosure” – Timely updates of info and issues can build trust. • The Value of “Contracting” the Relationship – Contract helps start the conversation. – It is not the glue that holds everything together. • The Value of “Communication Tools” – “One size does not fit all.” – Tools and data should be relevant
- 18. 18
- 19. 19 Questions?
Editor's Notes
- Sponsors are relying more and more on CROs. Increased efficiency and productivity, reduced costs, and faster path to market Vendor is being seen more as a partner rather than strictly your service provider. There are a lot of presentations and discussions about how to make this relationship the most effective and productive for both sides. Set-up Structure Process and strategies for oversight Metrics
- This is often how the relationship can feel like with the sponsor and CRO/vendor. Often, switching roles at various points of the trial.
- Left side – Buzz words Right side – Tangible things that the Sponsor focuses on. -Stay within budget -Quality data with the “right” patients -Meet agreed upon timelines What are the key relationship drivers to get all the value of the left side?
- One vendor point of contact – avoids miscommunication, misunderstood priorities, and delays associated with decision-making. There is NEVER one point of contact or if there is, there is something wrong. Strategic and cultural fit is often discussed but overlooked -Company culture -Development and funding stage -Board/KOL/Advisor involvement More effort: Joint training – helps to listen to feedback from individual team members apart from the usual meetings. Some team members are devoted to their work because of their relationship with the sponsor or the PM lead more than their own company. Several team members have been promoted but remain on my team in their previous roles. Team member has changed companies and bc of our good rapport are assigned to my study. Difficult to not be responsive to someone who you have a better connection with. Sponsors don’t always remember it but CROs do not usually put full time FTEs on your study so you may also be competing for another sponsor for time.
- DUE DILIGENCE It’s an interview! Some may promise more than they can deliver. Or present the “A” team at your bid defense who will not actually be on your team or have ever worked together or are new to the company. Do your homework. Homework – understand your provider’s operations, processes, personnel…which will help you find your match. Operational and therapeutic expertise are rarely the same on both sides Be honest from the start - be clear about expertise gaps within the sponsor organization; Discuss how to supplement the gaps. Continually do this. Do not assume that the Sponsor knows everything CRO should question a task if it may not make sense. Staff turnover Every new team member is a “reset” button. Examine the current processes in place and ask what they would change/improve. Smaller sponsors need to find CRO and vendor partners that understand, appreciate, and respect the needs, which often include: – Over communication (Even about what may seem like minute details) – “Teaching” as you go (Operational and technical expertise may be different) – FLEXIBILITY! (Decisions, decision makers, and funding may change throughout)
- Contract helps to start the conversation and set expectations but if you are pulling it out to manage the relationship, then something is already wrong. Contract helps to start the conversation and can serve as the basis for CRO oversight. It is a continuous process to ensure that the expectations are understood and managed so that timelines and deliverables are clear. Change order: Discuss changes before the $$$. Develop a process around change orders ahead of time so you are aware of your own flexibility and restraints. Changes may affect other areas of service that the sponsor is not aware of. Also, $$$ can take precedence over the needed changes. Accurate forecasting of timelines by sponsors and CROs result in realistic plans. Quality agreement should outline roles and responsibilities, expectations, timelines, deliverables, and quality standards and GCP requirements that apply, while a service agreement should spell out any transfer of responsibilities and delineate other business terms of the sponsor-CRO relationship. The contracts between a sponsor and a CRO can serve as the basis of a CRO oversight program. A good program should include a methodologyfor documenting issues or deviations during the trial and a corrective and preventative action (CAPA) plan which includes a process for escalation of issues that are deemed critical. Clinical trial staff turnover at the CRO and/or sponsor is inevitable and can lead to inefficiencies and bottlenecks. Therefore, an oversight program should also include a provision for delegation of responsibilities in case clinical trial staffers leave. Establish a Collaborative Environment Most problems related to poor communication (discussed above) can be avoided, or at least minimized, by establishing a collaborative environment from the onset of a sponsor-CRO relationship. Contracts (quality agreement, service contract) can help shape a collaborative environment by defining expectations, study requirements, corresponding deliverables, applicable GCP regulations, and audit requirements. A sponsor should also demand in the contract to be informed immediately if the CRO plans to use a subcontractor. The sponsor has to find the middle ground in managing the CRO by giving it ample “space” to execute the clinical trial and at the same time monitor the CRO’s activities closely. On the part of the CRO, it should maintain transparency and provide necessary information to the sponsor on a regular basis, prioritizing any issues that need input from the sponsor.
- Kick-off all relationships ensuring clear roles and responsibilities, communication plans, escalation plans, and other study framework – Watch out for too many plans!. What is the goal of the tool or the plan? Discuss its utility? Does it mask a bigger problem? Some CROs think that the tracker or plan is the deliverable but it is not. It is part of the process. Encourage CRO/vendors to provide accurate updates on challenges they are facing to ensure that changes to the contract do not need to be made mid-trial. Document decisions. Keep a change order list and history of the ups and downs of the trial. Clarifications made to what was assumed in the contract. Meetings – only involve pertinent players and decision makers. Establish a governance structure – clear escalation pathways
- Sponsor and Vendor worked hard to do all of this and completed a successful trial. Vendor was automatically awarded the next trial. Same companies, same team, same processes - > Trust built Differences for this next trial -compound -Phase of the trial -disease indication All these elements led to the breakdown in the relationship -Vendor was overwhelmed with different issues -Sponsor overly trusted the vendor and the company -Less checking and oversight by the sponsor -Vendor was overwhelmed with different issues and sponsor did not step in with support -Delayed timeline and missed deliverables -Eventually, there was a change in the middle of the trial. QUESTION: Does the vendor still offer skills, strengths, and styles that match your strategy, priorities, and development needs? Bottom Line: This is a continual process and there are new challenges with a new team, compound, company…don’t be complacent!