PharmTech:  Looking ahead to 2012, what factors, conditions, or other developments do you think will play an important role in determining the performance and direction of the pharmaceutical industry overall and manufacturing specifically?

John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply: Pharmaceutical manufacturers will need to ensure that their internal and external manufacturing capabilities are aligned for the expected needs of the emerging new-product pipeline.  They must have the strategic flexibility and agility to respond to a more dynamic market environment and increasingly volatile product demand.  In the emerging markets, manufacturers will need to look to partnership relations as opportunities for capturing competitive advantage.

Guy Villax, CEO of the CMO Hovione: Looking ahead to 2012 and onward, I see regulators adding new legislative powers to enable them to effectively control the new global industry landscape and establish effective oversight process. As the Generic Drug User Fee Act (GDUFA) passes into law in the US, and the Falsified Medicines Directive into national laws in 27 EU member states, we should expect shock waves to the supply chains of APIs in the generic-drug industry. We will witness a push toward higher standards and increased compliance. If there is increased demand from the few reliably compliant sources, this may trigger shortages, which may lead to API price increases although this is unlikely to translate into pharmacy-level price increases. The key dates are July 2013 for Europe and 2017 in the US, by which time, we shall have parity between foreign and domestic inspections in two of the major global regions. Japan may be less in the news, but Japan's Pharmaceuticals and Medical Devices Agency (PDMA) does expect the Japanese Drug Master File (J-DMF ) to mirror in detail the reality of what goes on in the plant and for the inspectors to verify compliance in the field against the Japanese version of the document; in fact, this is the only document they consider valid. Expect surprises.

Karen Zak, vice-president of marketing, pharmaceuticals, at the excipient and performance materials company Avantor Performance Materials: The following challenges faced in 2011 within the pharmaceutical industry will continue as we move into 2012:

• The need for flexibility and adaptability within the manufacturing environment will continue, driven by the emphasis on cost containment and efficiencies.
• The use of external resources and locally situated partnerships will grow as a means to enhance presence in global/emerging markets.
• The ability to participate in these emerging markets will depend on the capability to have small, batch operations that can cost-effectively produce finished products locally.
• There is a growing need for an ongoing comprehensive approach to resolving supply-chain security issues as they evolve around the globe.
• Uncertainty surrounding the sub-optimal performance of the global economy will continue to influence business decisions.
• Manufacturers will continue to contend with an environment of intense regulatory scrutiny, which will tighten on all aspects of the very complex supply chain.

Refer to: www.pharmtech.com