Tablets Capsules

TC0317

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W Tablets & Capsules March 2017 11 outsourcing Good advice: The value of outside expertise Matthew Knopp Editor Outside expertise is critical to the success of virtual companies and small startups. It's also important to large manufacturers. In this article, experts from different areas of the industry discuss their work and how it contributes to their clients' success. hile high-profile CROs, CMOs, and CDMOs consoli- date and grow, a cadre of individual consultants soldier on. Tablets & Capsules spoke with several of them about their work. They are Anthony Grenier, Ben Locwin, John McCarty, Chris Moreton, and Michael Tousey. Q Many pharma companies have a good amount of in-house expertise, as do many CROs/CMOs/CDMOs. Where does your work fit in? A Grenier: My clients are experts in developing new molecules and making some promising early-stage clinical trials. But when it comes to scaling up and working in a full cGMP environment, they need strong guidance and to be put in the right hands. They need additional expertise to move to the next clinical stage, which is always crucial, but especially for one-product companies. In other cases, a virtual pharma company acquires late- stage or legacy products from Big Pharma and are man- aged by executives in business development or finance. Even if they negotiated a great deal to acquire the assets, when it comes to finding the right partner to transfer their product they often end up dealing with a partner that is not a good fit for their market size or they're not flexible enough to address their needs. Because I own my own business, I can respond quickly to clients and it's eas- ier to get on the same page so I can help with their pro- ject. Locwin: It helps to shake up the status quo, and we're always prepared to confront the "sacred cows" of an orga- nization. There are a great number of misconceptions about how business processes should look during research and development of candidate drug molecules, and about how development and trials must be per- formed. You don't want to do things just because "We've always done it that way." McCarty: IntraTAB is not a CRO/CMO. We're a spe- cialty pharma company with a drug delivery technology. I still do some consulting, but only on projects that will develop drug products for truly unmet clinical needs and that involve products that are a challenge to formulate. For example, currently I am consulting for a company in Israel that has a drug to treat mild cognitive impairment, for which there is currently no approved product. Moreton: My experience is as a formulation scientist. I've worked on projects at every stage from preclinical formulation, to transfer, to commercial manufacture, and not just with tablets and capsules. The ultimate objective is to launch a successful product, and I can see the bigger picture. I then translate that understanding into how I advise my clients. For example, there may be several ways of resolving an issue, and you have to know the best way forward to achieve an efficient development pathway. I work directly for my clients, and they can share information with me that they would not think to share with a CDMO. I also know what questions to ask. I've worked with CDMOs for a number of years, and their motivations don't always align with the customer's. I can act as a bridge between my client and the CDMO and

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