Workshops - Tuesday 23 September 2008
Pre conference workshop 1: successful outsourcing strategies for pharma and biotech companies
Outsourcing strategies for phase I early development trials have challenges which are unique to these first-in-human studies. What are theses challenges and how can a sponsor effectively partner with those phase I units, functional service providers and CROs to meet those challenges or opportunities? This workshop will allow delegates to acquire practical skills and tools to develop their own outsourcing strategy for early clinical development.
Agenda:
- Phase 1 outsourcing challenges
- Site selection – priorities and practicalities
- Budgets- units vs. milestones
- Clinical operations
- Contracts
- Partnerships for successful phase I
- CRO and academic site challenges
- Vendors
- Strategic and operational Issues
- Site selection
- RFPs and Bid Grids
- project management plan for outsourcing
Workshop leaders:
Lynn Newbould, Senior Associate , RH Bouchard & Associates BioPharma/Clinical Research Consulting
R.H. Bouchard & Associates, Inc. is a consulting firm dedicated to working with pharmaceutical, biotechnology and contract research organizations; designing and implementing best practice across
all drug development partners.
Since joining the consulting firm in 2005, Ms. Newbould has provided outsourcing and contract/budget negotiations for major pharmaceutical and biotech companies as well as CROs. Prior to joining the firm, Ms Newbould was the Director of R&D Global Contracting at Centocor, Inc., a subsidiary of Johnson & Johnson. She has 11 years of experience with contracts and outsourcing for the pharmaceutical and biotech industry.
Beatrice Perotti, President & Principle Consultant, Beatrice Perotti Pharmaceutical Consulting
Dr. Perotti has 14 years of pharmaceutical and biotech product development experience. Her expertise includes pharmacokinetics, drug metabolism, preclinical development, IND program management, preclinical & clinical outsourcing, high value contract negotiation, vendor management, Six Sigma process improvement and meeting facilitation.
Dr. Perotti trained with Dr. Les Benet and graduated with PhD in Pharmaceutical Chemistry – Pharmacokinetics & Drug Metabolism from the University of California, San Francisco, and with MBA from the University of California, Los Angeles.
Dr. Perotti held leadership positions in Pharmacokinetics, Product Strategy/ Early Development, Strategic Business Operations and Outsourcing & Contracts at Pfizer and Amgen. Beatrice is a Certified Meeting Facilitator and a Six Sigma Black Belt.
Dr. Perotti started Beatrice Perotti Pharmaceutical Consulting since 2006 and consults for biopharma and biotech companies worldwide. Dr. Perotti personally provides expert consultation for departments such as PKDM, Clinical Operations, Program Management and Business Operations, while other consultants also service scientific departments in preclinical and clinical development, including Pharmacokinetics, Toxicology, Pathology, Pharmaceutics and Molecular Biology.
The workshop will begin at 09:00 and will end at 16:45. Lunch and refreshments will be provided.
Pre conference workshop 2: processes behind model-based early drug development
This practical and interactive session will look at the key elements in PK/PD clinical studies in phase I trials. It will address the challenges and techniques implemented for the safe transition from animal data to first-in-man and proof-of-concept studies.
Agenda
- Getting to know your data – building datasets efficiently
- Tips for checking the validity, accuracy, consistency and formatting
- Modeling building and evaluation
- Common methodologies
- Available tools and their use
- Application of modeling and simulation in decision-making
- Case Studies
Workshop leaders:
Dr Seth Berry, Associate Director, Modeling and Simulation, Global phase I, Clinical Pharmacology, Quintiles, Inc.
Dr Berry is primarily involved as an associate research pharmacokineticist writing and conducting population pharmacokinetic / pharmacodynamic data analyses, developing D-optimal designed sampling plans, and performing clinical trial simulations for phase I, II and III studies.
Dr Todd Dumas, Manager, Modeling and Simulation, Global Phase I, Clinical Pharmacology, Quintiles, Inc.
Dr Dumas is responsible for design, implementation and data analysis of clinical pharmacokinetic and pharmacodynamic studies for new drug entities in early clinical development. He is involved in all aspects of Phase I development.
Dr Konstantine Manouilov, Director, Modeling and Simulation, Global Phase 1, Clinical Pharmacology, Quintiles, Inc.
Dr Manouilov is involved in the development of data analysis plans and pharmacokinetic evaluation of PK/PD data from Phase I-II studies, and population PK, PK/PD analysis of Phase I-III data.
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