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-- Data-driven Patient Recruitment: Tools for Early Planning and
Predictive Management: Approaches to Data-driven Site Selection and LPI
Planning -- Session Chair and Speaker: Joshua Schultz, MS, Vice
President, Clinical Research Services, PAREXEL (2:00 p.m. -- 3:30 p.m.)
-- Innovative Medicines and the EMEA: Strategizing for Success in the EU
-- Session Chair and Speaker: Cecil Nick, MS, Vice President,
Biotechnology, PAREXEL Consulting (2:00 p.m. -- 3:30 p.m.)
-- Evolving Natural Health Products Market Size and Its Development.
Cosmeceuticals: Marketing Topical Products without Making Licensable
Medicinal Claims in Europe -- Peter Lassoff, PharmD, Vice President,
PAREXEL Consulting (4:00 p.m. -- 5:30 p.m.)
Wednesday, June 25
-- Imaging Biomarker Data Management: Qualification and Validation of
Imaging Biomarkers -- George Q. Mills, MD, Vice President, Medical
Imaging Consulting, Perceptive Informatics (8:30 a.m. -- 10:00 a.m.)
-- Biosimilars/Follow-on Biologics: Unique Aspects of the Development of
Follow-On Biologics Products -- Session Chair and Speaker: Bruce
Babbitt, PhD, Principal Consultant, PAREXEL Consulting
(8:30 a.m. -- 10:00 a.m.)
-- The Expanding Use of Genomics Studies Methods, Regulatory
Considerations and the Impact on Evidence-Based Medicine -- Session
Chair: Nayan Nanavati, MS, MT, Vice President Peri Approval, Americas,
PAREXEL; Speaker: Ramita Tandon, Director, Project Management, Clinical
Research Services, PAREXEL (8:30 a.m. -- 10:00 a.m.)
-- Opportunities and Challenges of Globalizing Clinical Research: Adding
Value to Early-stage Biotechnology Product Development -- Matthias
Grossmann, MD, PhD, Vice President and Principal Consultant, Clinical
Pharmacology, PAREXEL (10:30 a.m.-- 12:00 p.m.)
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