Seminar 6: CRO-Sponsor Relationships
CRO-Sponsor Relationships: Best Practices to Improve Efficiency and Regulatory Process Outcomes
Seminar Overview
Offered March 5, 2019
Strong sponsors partnerships with contract research organizations (CROs) can deliver substantial benefits for animal health product development both in efficiency and deliverable quality resulting in faster product approvals. However, strategic partnerships require significant investment of effort to develop and maintain. By jointly confronting the barriers to success, and coming to agreement on the needed changes and time commitment required, sponsors and CROs can increase their probability of success.
This seminar will explore the benefits, barriers and best practices for success for truly productive partnerships.
Seminar Documents
Academic Perspectives on Sponsor/CRO Partnerships
Hans Coetzee, BVSc, Cert CHP, PhD, DACVCP, DACAW, DECAWSEL, department head and professor, anatomy and physiology, College of Veterinary Medicine, Kansas State University
CROs' Perspectives on Effective Relationships with Sponsors
Chris Chase, Ph.D., D.V.M., president, Research Technology Innovation (RTI), South Dakota State University
Observations from the Receiving End: What Data Package Quality Reveals about Partnerships
Donna Gatewood, president, EDGE Veterinary Vaccines Consulting Group
CRO-Sponsor Relationships
Kelly Lechtenberg, MVS, CSRC, VRC, president/owner of Midwest Veterinary Services, Central States Research Center, Veterinary and Biomedical Research Center and Timber Creek Vet Hospital
Sponsor Perspectives on Effective Relationships with CROs
Doug Shane, assistant researcher for clinical efficacy, Food Animal, Bayer LLC
Michele Nichols, senior clinical trials manager, Dechra Development LLC
Melissa Andrasik, non-clinical studies manager, Product Development, Dechra LLC
Agenda
| 1 p.m. | Welcome |
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Paul Casady, executive in residence, professor of practice, K-State Olathe |
| 1:05 p.m. | Laying the Foundation for Effective Sponsor/CRO Relationships |
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Kelly Lechtenberg, president, MVS, CSRC, VRC Session will discuss the history of relationship development, current market conditions and trends for the future.
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| 1:30 p.m. | Sponsor Perspectives on Effective Relationships with CROs |
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Doug Shane, assistant researcher for clinical efficacy, Food Animal, Bayer LLC Speakers will discuss the benefits of partnerships, the dangers of accepting unrealistic expectations, and key factors for success in establishing partnerships.
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| 2:15 p.m. | Break |
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| 2:30 p .m. | CROs Perspectives on Effective Relationship with Sponsors |
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Chris Chase, Ph.D., D.V.M., president, Research Technology Innovation (RTI), South Dakota State University Speaker will discuss the benefits CROs can provide, ways to set achievable expectations, and key factors for success in establishing partnerships.
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| 3:15 p .m. | Academic Perspectives on Sponsor/CRO Partnerships |
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Hans Coetzee, BVSc, Cert CHP, PhD, DACVCP, DACAW, DECAWSEL, department head and professor, anatomy and physiology, College of Veterinary Medicine, Kansas State University Speaker will discuss opportunities and challenges related to academic-industry partnerships. Specifically, the discussion will focus on issues related to the creation of intellectual property, conflict of interest management, confidentiality and quality assurance and approaches to managing these considerations to create mutually beneficial relationships.
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| 3:45 p.m. | Observations from the Receiving End: What Data Package Quality Reveals About Partnerships |
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Donna Gatewood, president, EDGE Veterinary Vaccines Consulting Group Speakers will share their perspectives on what aspects of a partnership work well from the perspective of data package review and product approvals. |
| 4 :30 p.m. | Panel Discussion |
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Moderated panel discussion with all speakers.
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| 4 :55 p.m. | Closing Remarks |
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Paul Casady, executive in residence, professor of practice, K-State Olathe |
Speakers
Melissa Andrasik , R.V.T., B.S.
Non-clinical Studies Manager
Dechra Development LLC
Karen Bond
Senior Clinical Trials Manager
Product Development
Dechra Development LLC
Christopher Chase, D.V.M., Ph.D.
Chief Scientific Officer / President
RTI LLC
Hans Coetzee, BVSc, Cert CHP, PhD, DACVCP, DACAW, DECAWSEL
Professor and Department Head
Department of Anatomy and Physiology
Kansas State University
Donna Gatewood , D.V.M., M.S.
President
EDGE Veterinary Vaccines Consulting Group
Kelly Lechtenberg , D.V.M., Ph.D.
President/Owner
Midwest Veterinary Services, Central States Research Center, Veterinary and Biomedical Research Center and Timber Creek Vet Hospital
Douglas Shane, D.V.M., Ph.D.
Assistant Research Clinical Efficacy
Bayer Animal Health