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International Clinical Trials

Thinking Allowed

ICT: There has been a surge in demand for commercial drugs in trials – what are the key business implications for you?

Michael Cohen: That surge in demand has prompted a surge in scope and complexity. It is not enough to provide clients with a specific quote for a quantity of product. We need to give them a complete picture of a product’s availability in various markets, its shelf-life and any necessary documentation.

Companies today seem more sophisticated about sourcing comparator medications. What has driven this change?

When I joined Myoderm over 12 years ago, many prospective clients did not know there were companies that specialised in supplying comparators. Today, the rapid growth of internet marketing and online information, as well as an increase in industry conferences, has made it easier for sponsors to identify the ideal sourcing partner.

What are the main supply challenges when providing customised solutions to your clients?

Manufacturers have started to make it difficult, if not impossible, to acquire certain products. Providing trial information will sometimes help a sponsor gain access to supply, but in some cases the manufacturer outright refuses to supply.

Lead times can also be a problem, especially in the European Union (EU), where large quantities may take up to four months to receive. While this is not as big an issue in the US, there are unique challenges for US-sourced products. For example, documentation can be difficult to obtain, especially for branded products, which can prohibit the use of these comparators in trials in the EU and other countries.

To what extent is the industry using generics in trials, particularly as comparators?

Companies are using generics more often, but it has to be the right fit for the trial purpose. The reasons to choose a generic are not just about pricing, but also for provision of regulatory documentation and support, stability information and, at times, custom manufacturing of active and placebo.

Generic manufacturers are driven to sell, and they are more flexible than branded manufacturers in order to get the business, especially for larger and longer trials. There are also cases where a company will only source generics from certain manufacturers they perceive are ‘safe’, despite lacking evidence to back up that perception.

What do you predict will be the big sourcing and supply issues in the decade ahead?

The growth of biosimilar research and subsequent larger Phase 3 trials will impact the supply of products available for other clinical trials. Companies will need to make sure they have enough lead time to get supply, and may have to make choices about supplying trial information to innovator companies more often to ensure they receive that supply.

There will also be an increasing focus on the quality of comparator sourcing. It is not enough to have quality controls for product handling. Sourcing companies need to ensure that the supply of products is guaranteed authentic and handled with proper temperature controls. I believe the industry will start requiring temperature-controlled shipments not only for 2-8°C products, but also for those at room temperature. Canada has enacted this regulation and I expect the EU will soon follow.

What makes Myoderm stand out from its competitors?

I know it sounds like a cliché, but we have a unique passion to do whatever we can to serve our clients’ interests. I grew up running a retail pharmacy and medical supply business with my father and grandfather, so I have always understood what it is like to serve clients with commitment and high ethical standards.

Myoderm grew out of that business, and as we have grown, it has been paramount to me that we hire people who both know the industry and have a focus on serving our clients. This is not just about a commoditised transaction. Many lives are helped by the products we supply, either directly or by the new medications that are validated through the trials we support. We can never lose sight of that fact.

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Michael Cohen has been with Myoderm since 2001, enabling the company to grow into a global leader in comparator and commercial drug sourcing for clinical trials. He holds a BS in Statistics from the University of Pittsburgh, and an MBA from the University’s Katz Graduate School of Business.
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