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The confluence of science, technology, and regulation will provide our industry with the guidance to move forward.
The year 2012 will be challenging for the biopharmaceutical industry. The marketplace is shifting, bringing unique challenges to manage and explore. Exciting advancements like new drug discoveries and therapies, the increasing importance of biotechnology, growing global demands for better healthcare, and the changing demographics of our societies are taking their place at the global table. At the same time, there is a confluence of economic, political, and regulatory changes influencing business models and mandating new and innovative practices. Some key drivers that our industry is facing include:
As a leading nonprofit association, the Parenteral Drug Association (PDA) and its Board of Directors have been hard at work implementing a strategic plan that will guide the association forward. PDA will continue to focus on "Connecting People, Science, and Regulation" in an industry where "change" is the hallmark of our future. Specifically, the association plans to: focus resources to deliver more PDA technical reports, technical surveys, and guidance; continue signature meetings such as our annual PDA/FDA Joint Regulatory Conference (September 2012); introduce new "hot topic" conferences and workshops on subjects such as glass quality; expand global training activities (60 are currently offered worldwide); and expand synergy to work with global regulatory agencies to enhance pharmaceutical science and advance patient healthcare.
The 66th PDA Annual Meeting, Apr. 16–18, 2012, in Phoenix, AZ, will focus on many of these themes. Industry and regulatory speakers will present on "Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology." Major educational tracks include: Innovation and Productivity in Large Scale Manufacturing; Personalized Medicine/Cellular Therapeutics; and Control Strategies for Biopharmaceuticals.
The conference will also offer training courses on Reprocessing of Biopharmaceuticals; Recommended Practices for Manual Aseptic Processes; Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations; Process Simulation Testing for Aseptically Filled Products; and several others.
The industry business drivers noted above will impact how we work and interact. The confluence of science, technology, and regulation will provide our industry with the guidance to move forward, improve patient healthcare, and create future business models needed to survive.
I look forward to your feedback, and would like the opportunity to welcome you to our community.
Richard Johnson is president of the Parenteral Drug Association (PDA), Johnson@pda.org.