My Presentation at the Advancing Drug Development Forum San Francisco, CAThursday, June 14, 2018

1. The Human Side of Drug
Development - Building
Relations
Advancing Drug Development Forum
San Francisco, CA
Thursday, June 14, 2018
Eyal S. Ron, Ph.D.
Eyal@MADASH.com
MADASH, LLC.
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2. Outline
 How to form a perfect partnerships
 Model relationships in clinical trial supply outsourcing
 Identifying methods to find your ideal vendor to improve results
 It’s a team effort
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3. The Challenge
 Creating a team that will work together interdependently and
cooperatively to meet the needs by accomplishing their
purpose and goals
 Internal and external team
 Finding a high quality collaborators that is suited to the needs of your
organization (technically, culturally, size, etc.)
 Soliciting the a proposal (external)
 Managing the relationship & oversight (internal / external)
 Opportunity to interview key stakeholders and bridge the gap between the
vague aspirations that launch a project and the concrete, measurable
requirements that guide it to successful conclusion
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4. Internal Relationship
 Team building – “the process of turning
a group of individual contributing
employees into a cohesive team”
▪ A “forced” process (such as using
external facilitation)
▪ An organic “creation” (such as
setting a budget, goals, timeline,
positive employee recognition, etc.)
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5. External Relationship: Through a
Request for Proposal (RfP)
A request for proposal (RfP) is a solicitation, often made through a
bidding process, by an agency or company interested in procurement
of a commodity, service or valuable asset, to potential suppliers to
submit business proposals. It is submitted early in the procurement
cycle, either at the preliminary study, or procurement stage
https://en.wikipedia.org/wiki/Request_for_proposal
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6. Steps - the Request for Proposal Process
 Internally:
▪ Establish the project's boundaries
▪ Identify key stakeholders and advisors
▪ Define your project needs
▪ Draft the RFP
o Create a draft of the scoring criteria
o Review with the team (stakeholders and advisors)
 Externally:
▪ Select 3 – 5 vendors
▪ Circulate the RfP
▪ Review proposals
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7. What Information Should be Included
in the RfP?
 Organizational background
 Project Description / objectives
 Timeline (create a reasonable timeline)
 Milestones
 Deadlines
 Questions and required information
 A “Killer” criteria
 Questions based on past experiences
 Technical items: QC methods, synthesis pathways, etc.
 Payments’ structure
 Contact information and deadline for submission
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8. RfP Specifications
 The RFP Should Make Introductions. The RFP should provide basic introductions to
the company (who is requesting the proposal)
 The RFP Should Present the Need. The RFP should provide a brief project overview,
stating the business case for the project and the need to be filled.
 The RFP Should State Requirements. The RFP should state the service and
technical requirements and specifications upon which the proposed solution
must be based. Every requirements statement should include a "definitions"
section to ensure that all parties share a common understanding of all business
and technical needs.
 The RFP Should Set Terms and Conditions. The RFP should state the expected
terms and conditions for solutions acceptance, including delivery requirements,
payment terms, and regulatory requirements.
 The RFP Should Set Expectations. The RFP should describe the overall RFP bidding
process, including response submission requirements, "winning" evaluation and
selection criteria, process deadlines, and related technical procedures (response
format, submission mechanisms and how to submit questions and feedback).
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9. What Information Should NOT be
Included in the RfP Process?
 Misleading information
 Different verbal and written communication
 Request for “Freebies”
 Champion receiving lowest prices
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10. Evaluate RfP - Do not Judge a Vendor
Solely by the Cover of the Proposal
 Meet the vendor
▪ Management
▪ Team
▪ Project leader
▪ Communication style
 Optionally, audit the vendor
 Ask for references
 Does the vendor really wants
to win the proposal
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 Quality
 Timeline
 Cost
▪ Quality of communication
▪ Project leader
▪ Do they “get us”?
Cost True Cost
Quality Due Diligence / References
Delivery Lead time
Innovati
on
Number of ideas / improvements by the
vendor

11. Evaluate Proposals
by Alex Lichtenberger • Allgemein, IT Governance
MADASH, LLC.
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12. The Proposal’s Challenges
 Not all vendors with the appropriate capabilities will be interested in the
amount of business that are offered
 Forecasts of future needs are uncertain, but they set the foundation for
credibility with the vendor
 Rushing through the outsourcing process can lead to costs inaccuracies
and mistakes (→ amendments are costly)
 Product’s quality must be of the highest possible level
 Changes will require a single point of communication
 Managing the end of a relationship is often viewed as adversarial and
therefore not addressed until a crisis occurs
 The vendor’s team that wins often isn’t the team that services the business
relationships
 Ensuring compliance with regulatory directives
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13. Establishing Assessment Strategies
 Conduct negotiations
 Consider subjective criteria (other than price)
 Award contract
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14. The Agreement
 Responsibilities
 Term and Termination
 Payment / Reimbursement of
costs
 Intellectual Property
 Confidentiality
 Publications
 Indemnification
 Insurance
 Governing Laws
 Arbitration
 Notices
 Assignments
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15. Quality Agreement and CRO Oversight
& Collaboration Plans
 Draft a Quality Agreement that prescribed standards, expectations, and
responsibilities
 Do not forget to include:
▪ Transfer of Responsibilities (TOR)
▪ Scope of Work (SOW)
▪ Audits

16. Oversight Metrics / Benchmarks
 Is the vendor doing what we hired it to do?
 Is the vendor adhering to the plan?
 Is vendor performance meeting or exceeding expectations?
 What issues should be escalated?
 Why are we behind schedule?
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17. Define Quality Agreement and Vendor
Oversight & Collaboration Plans
 Draft a Quality Agreement that prescribed standards, expectations,
and responsibilities
 Do not forget to include:
▪ Transfer of Responsibilities (TOR)
▪ Scope of Work (SOW)
▪ Audits
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18. Risk Management Beneficial Vendor
Relationships
Risk assessment consists of the identification of hazards and the analysis and
evaluation of risks associated with exposure to those hazards. Quality risk
assessments begin with a well-defined problem description or risk question.
When the risk in question is well defined, an appropriate risk management tool
and the types of information needed to address the risk question will be more
readily identifiable. As an aid to clearly defining the risk(s) for risk assessment
purposes, three fundamental questions are often helpful:
 What might go wrong?
 What is the likelihood (probability) it will go wrong?
 What are the consequences (severity)?
• Regulatory
• Processes
• Culture
• Communication
September 2015 EMA/CHMP/ICH/24235/2006 Committee for Human Medicinal Products
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19. Risk Management & Oversight
 Risk assessment
 Risk identification
 Risk analysis
 Risk control that includes decision making to reduce
and/or accept risks
“Not everything that can be counted counts, and not
everything that counts can be counted.”
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20. It’s a Team Effort
 Empower teams through collaboration and workflow
 Avoid micromanagement but perform the oversight
 Measure the process not the people
 If the vendor has weakness or lacking, how are these issues
impacting the program execution?
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21. Key Factors in Sponsor – Vendor Relationship
 Trust
 Respect
 Rapport
 Diversity
 Communication
• Method (Telecon / meetings)
• Format (styles)
• Frequency
• Outcomes
 Information sharing
 Single point of Contact
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22. Motivation
 Bonuses for achieving milestones / targets
 Agreement for a continued work / revenue stream in exchange for
commitments
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23. Beneficial Vendor Relationships
 Establish a written Quality Agreement to record the respective
responsibilities:
▪ Purpose/Scope
▪ Terms (including effective date and termination clause)
▪ Dispute Resolution
▪ Responsibilities, including communication mechanisms & contacts
▪ Change control and revision
▪ Formal agreement that delineates cGMP responsibilities (including
quality measures)
 Evaluate contractors for quality and if needed for their cGMP compliance
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The Ultimately the Responsibility is on the Sponsor!
FDA Guidance for Industry Contract Manufacturing
Arrangements for Drugs: Quality Agreements

24. MADASH, LLC.
THANK YOU
Eyal S. Ron, Ph.D.
eyal@madash.com
https://www.linkedin.com/in/madash
@EyalSRon
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