Tragara Pharmaceuticals, Inc.Building a “Valuable” Relationship Between Sponsor and Vendor

Mary SytoDirector, Clinical Operations

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Outsourcing is Big BusinessGlobal Contract R&D Marketplace

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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.

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The Traditional Sponsor-Vendor Relationship

Getz-Zuckerman “Sourcing 2015: Sponsor-CRO Relationships of the Future”

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How do you “Value” the Softer Side of the Relationship?

PriceQualityTimelinesDeliverablesStaff Turnover Site/Investigator Satisfaction

Team Building

TransparencyCommunication Tools

Quality Meetings

Collaborative mindset

Effective Meeting MinutesQuality Process™

Open Communication

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Approaching Relationship Buildingwith 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”

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How the Relationship Starts

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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.

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Knowledge is POWER!

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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

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The Value of “Full Disclosure”

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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.

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The Contract

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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.

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Communication

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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.

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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

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Questions?