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• Overview
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• Reimbursement & Market Access
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• Follow-on Biologics
• Medical Device Consulting
• Vaccines Consulting

Vaccines Golden Era
An industry leader has been quoted as saying that we are in a Golden Era for vaccines, and the stats back that up: While prescription drug sales are forecast to rise by a third in five years, vaccine sales should double, from $19 billion last year to $39 billion in 2013, according to market research firm Kalorama Information. That's five times the $8 billion in vaccine sales in 2004.*
*Source: Vaccines on horizon for AIDS, Alzheimer's, herpes by Linda Johnson A. Johnson (AP)

PAREXEL has been actively involved in more than 210 vaccine studies, involving more than 43,260 patients in projects ranging in size from 1 - 200 sites worldwide. These projects have ranged across the spectrum of clinical phases with experience in many indications. PAREXEL Consulting staff includes ex-regulators and ex-industry professionals that have worked directly iin vaccines prior to joining PAREXEL.

Key PAREXEL Consulting Offerings:

• Market Assessment
• Product Development Strategy including adjuvant considerations, manufacturing, non-clinical and clinical strategy development
• Regulatory (Meetings/Submissions)
• Clinical Trial Design (Phase I - IV)
• Pre-Clinical Study Design (GLP-Tox)
• Analytical Methods Development
• Manufacture and Scale-up of cGMP-Compliant Vaccine
• Compliance for cell substrates and novel designer cell substrates with respect to Pharm Eur, FDA, WHO and ICH
• Comprehensive Reimbursement and Market Access Services
• Comprehensive Medical Communications Services
• And, seamlessly take advantage of the fully integrated services of PAREXEL for your Vaccine development including: all phases of Clinical Research and enabling eClinical Technologies (IVRS/IWRS, CTMS, EDC, Imaging) to drive efficiency and informed decision-making throughout the vaccine product life cycle.
  

Value Proposition:
Vaccines development requires a highly specialized cross-disciplinary team effort. We apply our fusion of expertise to help ensure your product's success through:

• Selection of viable and vetted candidates for sound investment and development efforts
• Expert-guided development strategies with approval and access in mind that aim to minimize costs and delay and help ensure product life cycle quality and safety
• Development of your company's vaccine with approval and profitability in mind
• Effective program management that helps your company meet critical milestones and target approval dates
  

Please Contact Us for Further Information and to speak with one of our vaccines experts about your development / market access needs. Please indicate Vaccines Development in the comments field so we can serve you efficiently. Thank you!