API Development Solution from Patheon

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API Development Solution from Patheon

750x195 interviewWith an overarching theme of strategically transforming pharmaceutical relationships, a key topic at this year’s Pharma Integrates event, organised by Life Sciences Index (LSI), is outsourcing. Offering a new development service for biologics and small molecule APIs, LSI caught up with Mike Mencer, Senior Director, Pharmaceutical Development Services, from headline sponsor Patheon to discuss how this innovative solution will benefit the pharmaceutical industry.

Mike described Patheon OneSource as a new, end-to-end service offering that provides a vertically integrated outsourcing solution for Phase I and Phase II projects that covers both drug substance and drug product development from API to the delivery of packaged products. The offering, he explained, was a key component of the strategic merger between Patheon and DSM Pharmaceutical Products, which closed in March 2014 and created DPx Holdings BV, and now operates under the brand name of Patheon. The merger was particularly attractive because the end-result allows Patheon to develop and focus on a truly integrated offering.

But, he emphasized, it’s a service that the industry has been enquiring about and requesting for some time: a way to simplify the supply chain, improve time-to-market and do it all under the premise of not missing a beat regarding on-time delivery, right first time production and scientific expertise. What OneSource™ does, said Mike, is combine the capabilities and services from across the Patheon business portfolio and support pharmaceutical companies with fully integrated services based on simplicity, speed and quality founded on industry leading expertise.

Customer Benefits

“Small and/or emerging companies may not have a fully developed supply chain management infrastructure, which is something that they’re looking for and, where the benefits of Patheon OneSource can meet an industry need,” noted Mike. Often, companies are looking to outsource the complexity surrounding these issues and OneSource is custom tailored to support organizations that may not have the bandwidth or expertise to undergo full product development and provide a simplified solution that adds customer value. “Our expertise in development and large-scale production, of both drug substance and drug product has been seamlessly integrated into one, lean, and complete drug development process,” added Mike.

Looking beyond individual companies, Patheon OneSource could offer benefits for the wider healthcare/pharmaceutical community — including patients. “If you’re in the development phase of a pharmaceutical project, the main benefit is going to be speed to clinic; the faster that we can get a new molecule to clinical investigation, the faster we can get results and progress the development cycle and, ultimately, we can get a product to market quicker,” said Mike.

“If you’re in the commercial space right now, a simplified supply chain means less complexity, which eventually translates into a greater assurance of market supply. We’re looking at launching this offering in two ways; first, we’re focusing on development and the pre-registration phase for both drug substance and drug product from OneSource™; also, we’re in the process of preparing the second wave, which will address commercial supply needs. There’s a tremendous number of benefits to be derived from both before and after commercialization using this integrated approach,” he added.

When asked about activity in the antiviral market, in response to the Ebola outbreak, Mike commented: “There’s certainly a buzz in that area at the moment, with companies coming forward and talking about their development needs, which probably represents a significant disclosure about where they are — and where the industry is — regarding their pipelines and the likelihood of finding an effective treatment in the short-term. It’s not so much an impetus to develop new molecules as opposed to applying pressure on companies to expedite drug candidates that are already in the development pipeline.”