Ask The Board March 2011

By Life Science Leader magazine

Q: Regarding manufacturing efficiency, how can we learn from other powder processing industries?

Bulk powder processors, such as those producing more standardized products (e.g. cement), have faced relentless downward pressure on costs in terms of manpower requirements, energy consumption, and waste. Success stories from other sectors using bulk powder processing can provide a few pointers for the pharma industry. According to a cement producer I spoke with recently, anything less than 99.5% yield is uneconomic in their sector. And, they are not alone. For many bulk producers, efficiencies close to 100% are a daily necessity rather than a long-term aspiration.
While the pharma industry is still far away from this point (and there may remain sound chemical and physical reasons for this), steps toward continuous manufacture, automated control, and real-time release can be well-supported by exploring the lessons learned elsewhere. This is especially the case where unit operations are closely similar, such as size reduction or blending, for example. Building on the very best solutions for automated control already available will accelerate progress toward the more efficient manufacturing model envisaged by and for the industry.
Tim Freeman
Freeman is director of operations for powder characterization company Freeman Technology. He has 10 years’ experience understanding and characterizing powder behavior.

Q: What do you see as being the biggest issue for the life sciences industry in 2011?

I’ll be closely following the regulatory aspects of the biosimilars market. In March 2010, legislation was passed allowing biosimilars manufacturers to use an abbreviated path to file an NDA (new drug application) to gain regulatory approval. Unlike the generic versions of small molecule drugs, biosimilars are more complex to produce, and, in fact, small changes or variations in the manufacturing process may have big effects on the drug. The FDA is caught between improving access to lower cost (generic) drugs while still ensuring their safety and effectiveness. While an abbreviated approval process will lower development costs and allow less expensive equivalent drugs to come to market, with different manufacturers, processes, and even cell lines to produce the drugs, it looks to be a somewhat daunting task to define bioequivalency for biosimilars. Although no deadline has been set for defining a biosimilars approval process, the industry hopes for the issuance of guidance documents by the FDA in 2011.
Dr. Laura Hales
Dr. Hales has more than a decade of experience in biologics discovery research and is currently a founder of Extend Biosciences, Inc. and The Isis Group.

Q: What is the biggest issue regarding clinical development, and what’s the solution?

The most significant challenge may be the increasing difficulty in identifying clinical trial patients. While it varies widely by clinical indication, patient recruitment is a significant challenge to both sponsors and their partnering CROs. Investigators often exaggerate their enrollment capabilities to gain entry into the clinical trial and then struggle to meet their forecasts. Adding to the frustration of slow patient enrollment is the feeling of sponsors and CROs alike that the rate of enrollment is beyond their control.
The solution varies by therapeutic indication, but it begins with targeting the countries that will best complement the sponsor’s registration strategy while providing sufficient patients, and selecting not just the right investigators, but a surplus of them. Development of investigator-specific enrollment strategies at the trial’s outset and aggressive management by site managers is a key. Sponsors must assume enrollment will lag, and they must have risk mitigation strategies in place before the trial begins. Contingency plans and trigger points that are clearly identified and understood with designated responsibility and authorization are a must.
Tim Krupa
Krupa is president of TSK Clinical Development, a consulting firm providing leadership and solutions in clinical planning, project management, clinical operations, and outsourcing.

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