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PharmaQbD.com Mission
PharmaQbD advances a smarter approach to drug development—a more scientific, efficient and less "hit-and-miss" approach. It does this via peer-to-peer exchange of best practices, as well as solutions-oriented, actionable information and ideas to improve the drug development process. There is an urgent need for "best practices" for implementing Quality by Design (QbD) programs and thinking within the drug industry. Currently, as the pace of new drug introductions slows and some established "blockbusters" are found to have serious safety issues, it can take 10-12 years and $1 billion to develop a new drug. Drug makers need to optimize quality and safety, as well as "manufacturability" from the earliest stages of any drug's development and to improve speed to market. This critical industry movement is being advanced by FDA, EMEA and other global regulatory agencies, and is a key part of the ICH's (International Council for Harmonization) Q8, 9 and 10.
Led by Experts—PharmaQbD Editorial Advisory Board
PharmaQbD is honored to have the expertise and experience of numerous industry experts serving on the PharmaQbD Editorial Advisory Board:
- Michael Kowolenko, Senior VP, Wyeth Biotech
- John Avellanet, CEO, Cerulean Associates
- Moheb Nasr, Director, Office of New Drug Quality Assessment, FDA
- Ranjit Barshikar, GMP/Quality Consultant
- Prabir Basu, Executive Director, National Institute for Pharmaceutical Technology and Education
- Bihash Chatterjee, President, Pharmatech Associates
- Joseph De Feo, CEO, Juran Institute
- Alistair Gillanders, CTO and VP North America, DynoChem
- Steve Jolley, Vice President of Pharmacovigilance, Patni Life Sciences
- Jason Kamm, Principal, Tunnell Consulting
- Michael Meagher, Professor, University of Nebraska-Lincoln
- Justin Neway, CSO, Aegis Analytical
- Rakesh Patel, Assistant Professor, Ganpat University, India
- Russ Somma, President, SommaTech, Inc.
PharmaQbD.com Audience by Title
- Scientists
- Chief Scientist
- Members of the Technical Staff
- Director, Manager, VP, SVP of:
- Process development
- Product development
- Technology transfer
- Research and Development
- Business development
- Clinical R&D
- Clinical safety and pharmacovigilance
- Clinical manufacturing
- Clinical supply operations
- Clinical trial and project management
- Chemical Manufacturing Control (CMC)
- Compliance
- Quality Assurance and Control
- Outsourcing
- Regulatory affairs
- Risk management
- Strategic planning and alliance development
- Manufacturing and Operations
- Engineers
- "C" Level Executives
- CEO
- President
- CFO
- COO