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:
- increasingly complex supply chains and outsourcing models
- patent erosion
- a continued focus on cost management
- the rising importance of emerging biopharmaceutical markets.
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