Life Science Leader Magazine Supplements

CMO 2016

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

Issue link:

Contents of this Issue


Page 21 of 63

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 22 TECH TRANSFER Outsourcing additional layer of complexity. However, according to Ulrich, what nobody wants is to "have to do it twice, because of some failure the first time." Despite the pressures, he says, there's usu- ally more time that first time, and it gets more expensive with any failures. "Smaller sponsors also understand well the financial pressures and the cost rationalization that's going on in the industry today. The expectation is, if you don't know something, you should know somebody who does, and you should bring them on board to help sooner rather than later." What sponsors may find after confer- ring with consultants is that a solid dose of introspection is in order and, perhaps, so is a renewed commitment to the same partner. Stern suggests if you're a small company contracting a CMO, and it's not quite working out, perhaps from a new technology-transfer perspective, you probably do want to see if you can work through it. He puts it this way: "Finally, understand the structures that need to be in place around the project, including starting with doing a business development plan. You need agreements that ensure alignment from business, legal, technical, and quality standpoints. Ensure you understand the obligations of both partners. The best tech transfer strategy is the one where both sides are completely on the same page." THIRD-PARTY CRASHING Getting on that same page may require another pair of hands. Assisting with tech transfer is one of the most impor- tant roles consultants and other trusted partners play in the client-provider relationship. For example, there are times when sponsors have been working with a CRO or CMO because of recognized expertise or relationships earlier in the life of the project. The sponsor, though, may become less certain of the CMO's prow- ess for the next phase. Both Stern and Ulrich agree if you don't feel comfortable — or have the sense that either you or your partner does not have the capa- bility — you should consider finding a third-party source to help you, whether that's a consultant or another partner company. Of course bringing in a third party to help you understand or execute on a critical tech transfer can also add an selected the CMO with the right experi- ence for their projects. Ulrich Ernst, SVP Manufacturing & Quality Operations, Amunix Operating, Inc., agrees the methodology and best practices selected for a tech transfer depend on the partners involved. He's arrived at his views from the perspec- tives of someone who has worked at large and small pharma, and as a con- tract manufacturer. Here are his three "points of attention" for both partnering organizations: "First is the overall scope of the project the client is bringing in. By that I mean it's important for both sides to ensure there's proper communication on the intent, scale, specific needs, timing, and quantities to be delivered, and all the expectations around those parameters. Scale is important both on an operat- ing level and in terms of the technical requirements at that level. You're build- ing a lot of detail into a mutual plan for success. "Next, you need to explore and understand strengths and weaknesses on both sides. A large partner on either side may bring a lot to the table, but a smaller one can bring certain pieces as well. If any of the pieces, such as process development, project and facilities management, or quality requirements, differ from the partner's expectations, you'll run into problems at some point. By L. Garguilo WHO'S GOT THE BEST TECH TRANSFER PROTOCOLS? I've learned it's not a matter of who has the best tech transfer strategies but, more importantly, who has the most experience. S I D D H A R T H J . A D V A N T President of Biologics, Kemwell Biopharma It's important for both sides to ensure there's proper communication on the intent, scale, specific needs, timing, and quantities to be delivered, and all the expectations around those parameters. U L R I C H E R N S T SVP Manufacturing & Quality Operations, Amunix Operating, Inc.

Articles in this issue

Links on this page

Archives of this issue

view archives of Life Science Leader Magazine Supplements - CMO 2016