9:00 - 11:30 Workshops A: Optimization of Capacity Planning, Resource Allocation and Scheduling for Portfolio of Clinical Trials

Efficient capacity planning and resource allocation is becoming a hot topic for biopharmaceutical companies and Clinical Research Organizations (CRO) due to increasing pressure to reduce cost of drug development. It is critical for many clinical organizations to find a better approach to increase effectiveness in resource capacity planning in clinical process, especially for multiple clinical trials. Developing and using powerful tools which allows to optimize resource capacity planning, allocate resources (both manpower and budget) optimally between planned and ongoing clinical trials. This technique can save up to 30% by uncovering better resource allocation solutions.

What you will learn:

• How to apply optimization technology to capacity planning in biopharma
• How to derive workload demand and supply (overview) on a role level
• How to optimize capacity planning and resource allocation across portfolio of clinical trials for both biopharma companies and CROs
• How to identify resource bottleneck
• How to reallocate resources due to prioritization or cancellation of clinical trials
• How to calculate understaffing risk

How you will benefit:

• How to schedule new clinical trials to maximize manpower and budget capacity in biopharmaceutical company?
• How to “pack” maximum number of clinical trials in different therapeutic areas to maximize capacity utilization (for CROs) across employee roles
• How to optimize capacity planning across portfolio of clinical trials using ORBee proprietary tool

Your Workshop Leader:

Vladimir Shnaydman, PhD
President
ORBee Consulting

12:00 - 2:30 Workshops B: Quality and Efficiency for Cost & Temperature Controlled Transportation

The workshop will facilitate a discussion of considerations for choosing a transportation method, including international regulations, shipping environments, and the strengths and weaknesses of available temperature control options for air and ground transport. The group will discuss solution options and criteria for designing best practice transportation systems and procedures that appropriately blend the needs of your product, your business, and available services. We will also explore the effectiveness of various choices by considering case studies for both ground and air transport.

What you will learn:

Gain insight into carrier quality systems for both standard transportation and temperature control including:

• Strategies for implementing best practices for achieving high quality and safety in both air and ground transport
• Effective procedures to address transport risk issues
• Decision making factors for evaluating cost-effective transportation strategies for cold chain

How you will benefit:

Through case studies of real-life examples and interactive exercises, you will understand how transport systems can be designed to significantly reduce or eliminate common problems in domestic US and international air transport. You will gain an appreciation for the relative costs and benefits of achieving your transportation objectives within the framework of your GDP requirements and discuss how to minimize those costs while maintaining safe transport requirements.

• Improve your ability to implement high quality, secure, and costeffective transportation
• Enhance your ability to apply industry and governmental guidance on Good Distribution Practices in your transportation plans
• Increase your understanding of how to effectively work with your carrier to maximize the quality, consistency, and economy of your shipping lane

Your Workshop Leader:

Karl Kussow
Manager Quality & Validation
FedEx Custom Critical

3:00 - 5:30 Workshops C: Successful Regulatory Filing and Approval Based on "Well-Understood" Clinical Supplies/Trials

Clinical Trials represent a significant milestone for the regulatory approval process of any NCE. In fact, many “not-Approvable” outcomes of NCE’s are attributed to the lack of proper scientific understanding involved in the design/execution of clinical supplies and clinical trials. Furthermore, many cases of market-share and revenue-loss are often caused by poor clinical trial design/planning. This workshop will discuss the value of using “scientific-based” planning of clinical trials and clinical supplies with an eye on approval and post approval marketing.

What you will learn:

You will learn the value of using “scientific-based approach to plan clinical supplies/trials to achieve timely regulatory approval and successful post-approval marketing including:

• The effect of the biopharmaceutical/physicochemical properties the API on the formulation and delivery system design of the final product
• Importance of timely & appropriate process development/scale up in achieving the desired clinical trials objectives.
• Packaging/labeling of the clinical supplies as well as the logistics of shipping and receiving (with stability in mind)
• Planning clinical trial phases based on phase-objective approach.
• Interactive relationship between clinical trial design/objective and clinical supply needs.
• Regulatory approval of product label as final goal when planning/designing clinical trials.
• Planning clinical trials with achieving maximum market potential post marketing approval.

How you will benefit:

• Critical Regulatory requirements and meetings, including the end-of-phase2 meeting
• The value of applying delivery system-relevant GMPs during the various phases of development
• Real-life case studies will be thoroughly discussed to cover the critical scientific knowledge that will be needed in the design/planning of clinical supplies and clinical trials to achieve Regulatory approval
• The participants will learn effective management of expectations of company’s leadership and market opinion through the use of scientific-based approach and planning

Your Workshop Leaders: