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Flexible Manufacturing Strategies

By Kristin Brooks, Contract Pharma | April 4, 2016

Michael Lehmann of Patheon discusses solutions for pharmaceutical forecasting errors

While at DCAT Week ’16, Contract Pharma spoke with Michael Lehmann, executive vice president sales and marketing for Patheon about the timely topic of flexible manufacturing and the strategies and potential solutions for pharmaceutical forecasting errors. Also discussed, were the company’s recent partnerships with Amgen and Grünenthal.
Patheon recently sponsored a survey, “Pharmaceutical Product Forecasting and Its Impact on Manufacturing,” conducted by ORC International, which found a majority of companies had either overestimated or underestimated demand for new drugs by as much as 25%, with some reporting instances off by more than 50%. The white paper includes insights from 50 pharma industry senior managers. Whether failing to meet forecast demand or overestimating demand, the impact can be detrimental to both sponsor and supplier.
“Making accurate demand forecasts is extremely challenging for pharmaceutical companies, particularly forecasts for new product launches,” said Mr. Lehmann of Patheon. “As a driver of innovation and a transformative force in the industry, Patheon is focused on helping clients find innovative solutions to their challenges.”
He added that the challenges around forecasting present an opportunity to evolve CDMO and sponsor relationships for capacity planning. As an example, allocating space for sponsors (i.e. the “condo” model), in which a sponsor provides the equipment and the CDMO provides dedicated space. Larger service providers will likely better handle this sort of arrangement as they can be more flexible leveraging their larger footprint to fulfill various needs.
Notably, Patheon recently signed a manufacturing agreement with Amgen to provide flexible manufacturing services for their therapeutics. “We believe the departure from the “build or buy” paradigm represents a superior value for our clients,” said Mr. Lehmann. “These flexible capacity solutions require a strategic and collaborative approach – different from the traditional “price per batch” concept.  This agreement with Amgen is representative of the changing dialogue in the pharmaceutical services industry.”
Additionally, Patheon has signed a strategic agreement with Grünenthal, a research-based pharmaceutical group based in Germany, to serve as its preferred development partner forits products using Grünenthal’s abuse deterrent formulation technology INTAC.

Patheon will assist with the development of advanced INTAC-based products including single-entity and fixed-dose combination solid oral dosage forms with immediate and modified release properties. Grünenthal will install specialized equipment at Patheon’s Cincinnati manufacturing site, allowing clients to benefit from Patheon’s process, staff and infrastructure designed to simplify manufacturing.
We also discussed growth drivers for the industry and how Patheon has positioned itself in these areas. In particular, small-scale capabilities are increasingly important as the growing personalized medicine market requires smaller units. Additionally, as products are more complex in nature, specific capabilities such as spray drying and solubility challenges are of interest to Patheon.
What’s driving outsourcing in today’s market is complexity, consolidation on the part of sponsor and service providers, cost pressures, and the need for efficiency. As a result, the industry needs to do things faster and better.