As more clinical trial activities are outsourced to contract research organizations (CROs) and other third party vendors, successful clinical trial execution increasingly depends heavily upon building quality partnerships. Establishing and maintaining realistic and explicit expectations from each partner in the outsourcing relationship is crucial to running efficient clinical trials. Cambridge Healthtech Institute’s “Outsourcing for Clinical Trials” conference features case studies and lessons learned from sponsors and other third party vendors on how to optimize the outsourcing partnership.
TUESDAY, MAY 10
10:00 am Conference Registration
10:40 Chairperson’s Remarks
Lee Yuan, Conference Director, Cambridge Healthtech Institute
10:45 Considerations for Third Party Vendor Management in a Risk-Focused Environment
Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University
One major reason for unsuccessful partnerships is disconnect between study protocol development at the sponsor level and outsourcing start up and execution of the study to a CRO and/or third party vendors. Risk-based quality management needs to be developed jointly with all parties involved, that will have a major impact on strategic partnerships and allow to meet stringent regulatory expectations in risk-focused environment. Successful vendor relationship have many components, but a key factor is a well-defined communication plan. Transparency, upfront goals, cross check for key milestones and adoption of common quality and risk management strategies are vital in establishing and maintaining strong partnership throughout life cycle of the project.
11:30 Crafting Effective RFPs for Novel Therapy Studies
Kate Nabewaniec, Director, Clinical Outsourcing, Bluebird Bio
When launching a study investigating unusual or novel therapies, it can be difficult to define the critical success factors of the sponsor/CRO relationship in an RFP, which may result in responses that are too differentiated to evaluate on a common scale. In this presentation we will explore how to tailor the RFI/RFP process to highlight the fit of the CRO’s proposed team and tools, and to avoid boilerplate responses and inconsistent pricing (without a bid grid!). Targeted towards smaller biotechs, rare disease, and single study/single product RFPs.
12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:00 Dessert Break in the Exhibit Hall
1:30 Session Break
1:55 Chairperson’s Remarks
Lee Yuan, Conference Director, Cambridge Healthtech Institute
2:00 Small Fish in a Big Pond: Strategies for Small and Mid-Size Pharma to Successfully Partner with CROs
Marie Rosenfeld, Director, Development Operations, Contracts & Outsourcing Vendor Management Lead, Astellas Pharma Global Development, Inc.
The pharmaceutical industry is increasingly evolving towards a model that is built on mutually beneficial partnerships between pharma and the external vendors they work with. In this era of risk sharing, it is increasingly important for pharma and their CROs to have effective strategies for leveraging performance and value. For smaller and mid-size pharma, with limited R&D resources, it is especially important to work in the right partnership model to be able to affect and influence quality and performance within their relationships. This talk will cover different methods to maximize influence and quality performance within these partnerships.
2:30 Outsourcing at Small Biotech Companies: How Could CROs Align Themselves Better with the Needs of Their Clients from the Very First Interactions and Project Planning Discussions
Sophie Egholm Chapelle, COO, Senior Management, Cerespir
Small biotech companies have few resources, and rely on CROs to provide the relevant and expert resources needed for execution of clinical trials. In a recent major and comprehensive bid process for a large and complex, pivotal, adaptive design trial in early Alzheimer’s, we found most proposals and project plans to be generic and not sufficiently tailored to the client needs. We suggest very specific areas of improvement in the client/CRO engagement process.
3:00 Managing the Site Payment Process in an Outsourced, Global Environment
Jessica Dolfi, Manager, Solution Consulting, Medidata Solutions
Sponsors commonly outsource the site payment process to a CRO partner—in fact site payments are managed by CROs on 80 percent of all studies globally. Outsourcing is here to stay. How can sponsors do it better? Answers include: defining KPIs to improve oversight of the payment process, implementing a financial reporting process, and considering site payment technology requirements. This presentation will compare different models for outsourcing site payments, highlighting considerations for choosing the right one.
3:30 Refreshment Break in the Exhibit Hall
4:00 PANEL DISCUSSION: CRO & Sponsor Perspective on Meeting Outsourcing Needs and Challenges of Small and Mid-Sized Biotech and Pharma
Sophie Egholm Chapelle, COO, Senior Management, Cerespir
Marie Rosenfeld, Director, Development Operations, Contracts & Outsourcing Vendor Management Lead, Astellas Pharma Global Development, Inc.
Sponsors and CROs discuss their perspectives and approaches on how to better meet the outsourcing needs of small and mid-sized biotech and pharma.
5:00 Close of Day
WEDNESDAY, MAY 11
8:30 am Interactive Breakout Discussion Groups with Continental Breakfast
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
9:25 Chairperson’s Remarks
Jessica Dolfi, Manager, Solution Consulting, Medidata Solutions
9:30 Speed Networking
10:00 Partnering Quality with Our Quality Partners: Managing Clinical Trial Quality through Oversight and Collaboration with Our CRO Partners
Derek Hall, Associate Director, Quality Assurance GCP, Incyte
This presentation will cover: 1. Managing audits of vendors in a large global market, 2. Establishing quality contacts and regular communication, and 3. Writing and establishing a quality agreement.
10:30 Resource Planning, Real-Time Project Reporting and Dashboards
Donna Gandt, Area Vice President, Unanet
The presenter will demonstrate how customers utilize Unanet to facilitate Resource Scheduling & Skills Management; Time Tracking; Real-Time Reporting on Project Status, Margin, Utilization, etc.; Billing & Revenue Recognition; Integrated Financials.
10:45 Coffee Break in the Exhibit Hall
11:30 Issue Escalation for Fully Outsourced Studies
Rosemary Dillon, Associate Director, Clinical Outsourcing & Operations, Bristol-Myers Squibb
12:00 pm Vendor/Sponsor Performance Metrics: How Are We Doing?
Randy Krauss, Director, Clinical Process Optimization, Shire
Completing clinical trials in a timely, cost-effective, and safe manner is key to the success of both the vendor and sponsor. The number and types of metrics to be implemented can be dizzying. Understanding what is important to the sponsor will help determine what metrics are best to be implemented. Further, not all metrics are created equal. This talk will focus on developing a metrics hierarchy and how to use them to improve performance.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:15 Session Break
1:55 Chairperson’s Remarks
Jessica Dolfi, Manager, Solution Consulting, Medidata Solutions
2:00 PANEL DISCUSSION: Project Tracking and Establishing Appropriate Metrics from Both the Sponsor & CRO Perspective
Randy Krauss, Director, Clinical Process Optimization, Shire
Timothy S. LaCroix, MBA, Head, Business Development, PharPoint Research, Inc.
Marie Rosenfeld, Director, Development Operations, Contracts & Outsourcing Vendor Management Lead, Astellas Pharma Global Development, Inc.
From both the sponsor and CRO perspective, we will discuss what are considered the “right” metrics to collect on vendor performance and how well projects are being completed. Are there appropriate “hard” and “soft” metrics that should be considered when working with sponsors, CROs and other clinical vendors (labs, imaging centers, reading centers, etc.)?
3:30 Close of Conference