SoCalBio Conference: Finding the Best Clinical Research Organizations

Now, there are many companies that outsource all or part of their pre-clinical and clinical research to Contract Research Organizations CROs.  As a result, CROs are becoming an integral part of pharma and device product development value creation. Given the complex regulatory landscape of the bioscience industry, the selection of a CRO should be made carefully as it impacts the prospects of getting favorable FDA outcomes. Identifying the best-fit CRO involves a variety of processes and people. This event will help small and mid-size biotech and MedTech companies tackle the following issues:

• Determining internal champions/selection committees
• Strategic Sourcing
• Procurement workflow/checklist
• Documentation and Regulations
• Collaborating with your Clinical Partner to meet FDA monitoring standards
• Challenges of CRO Outsourcing
• The role of genomics, technology, and big data in the future of CROs
•  Changing CRO business models
• Best Practices to get the best value
• Involving patients in drug/device development

This meeting will feature the following speakers:

• Avid Bioservices, Inc.
• Charles River Laboratories
• CROMSOURCE
• GenScripts
• Parexel International
• Science 37
• Scientist.com
• WCCT Global Inc.

Agenda

10:00 am

Welcoming Remarks and Introduction by Ahmed Enany, President & CEO, SoCalBio

10:10 am

“Harnessing Today’s Innovations: Introducing Scientists.com, A Marketplace for
Outsourced Scientific Services”
Presentation by Arne Brandon, Chief Commercial Office, Scientist.com

10:40 am

“Keep Your Eye on the Price: Using a commercial lens to optimize clinical development”
Presentation by Michael Davitian, Director, Market Access Group, Parexel International:

11:10 am

“Making Research Easy”
Presentation by Michael Lau, Ph.D. Regional Sales Manager, GenScripts

11:40 am

“Achieving Success in Developing Clinical Candidates”
Presentation by Marcus Wagstaff, BSc, Associate Business Development Director – Discovery Services, Kristin Power, MSc, Business Development Director – Safety Assessment & Srna Vlaho, BSc, Business Innovation Manager – Research Models and Services, Charles River Laboratories

12:10 pm

Break and Luncheon

1:00 pm

“Phase 1 CROs: Guiding You Through Partnering in Early Clinical Development”
Presentation by Robina M. Smith, MD, Medical Director, WCCT

1:30 pm

“Navigate the Medical Device Development Process with a Proven Regulatory and Clinical Strategy that Works”
Presentation by “David R. Dills, Director, and Head of Regulatory Affairs, CROMSOURCE

2:00 pm

“Digital Solutions to Facilitate Clinical Research”
Presentation by Science 37

2:30 pm

“The Difficult Decision – Identifying What’s Important for CDMO Selection”
Presentation by Mike Faughnan, Director, Business Development,

Avid Bioservices, Inc.

3:00 pm

“Concluding Remarks,” by Ahmed Enany, President & CEO, SoCalBio

3:15 pm

Meeting Adjourns

Have questions about SoCalBio Mini Conference: Working with the Best Clinical Research Organizations (CROs)? Contact Southern California Biomedical Council