Drug development in China is progressing quickly, due in part to shifting regulations, increased innovation and growing opportunities for global partnerships. However, making the most of market opportunities requires not only a focus on the intended end results but also careful, early phase planning. At a recent clinical seminar in China, a panel of Covance market access experts shared their thoughts on how to increase a product’s commercial potential.
Incorporating a business case
“In China, we discussed the theme of ‘beginning with the end in mind,’” said Eric Lang, MD, Vice President and Global Head of Clinical Development Leaders, Early Phase Development Solutions. “We find that a lot of biopharmaceuticals are focused more on the science of their treatment and don’t realize that they also need a strong business case to develop a product,” he said.
Moving a product forward also requires a view that looks beyond passing the next regulatory milestone. “Meeting regulatory requirements only determines whether or not to sell the product, but doesn’t mean that anyone wants to buy the product,” Lang explained.
“Beginning with the end in mind is really about driving value in early development,” added Heather McElroy, Director, Health Economics and Outcomes Research. “If you can present differentiation early on in development, you can show that you have a unique product and will be able to sell it at a higher price to a partner or articulate its full potential before market launch.”
Looking at a stakeholders’ needs
To gain success within China and the complex global market, companies need to show they have a unique product and understand the needs of the market’s key stakeholders from multiple perspectives. Stakeholder research evaluates needs at global, national, regional and local levels to represent a complete outlook on the landscape ahead.
“While some large biopharmaceuticals may already incorporate this practice, this was a new idea to many of the emerging companies at our clinical seminar in China,” said McElroy. “Many had not considered these steps and were excited by the concept.”
“When you can differentiate a product to payers, patients and providers with robust and credible data, you’ll enhance your potential for higher valuations and accelerate the coverage process in the market,” said Bill Hanlon, PhD, Vice President, Head of Global Regulatory Affairs.
“We can help biopharmaceutical companies in China differentiate their product so that people are willing to buy it. Otherwise, you may get approval and run global trials on a product that no one wants to use.”
Payers are most receptive to products that can offer at least one or more of the following attributes:
- Effective against high-visibility unmet needs
- Lower short-term treatment costs
- Safe and effective in difficult-to-treat populations
- Demonstrated clinical superiority on key attributes, preferably through head-to-head studies
If a drug developer can display these differentiation points, then they can expect to accelerate the coverage of the product and expand the market potential.
A multidisciplinary approach
Throughout the drug development continuum, creating a successful therapy requires a multidisciplinary approach that unites scientific, regulatory and clinical strategies. From informing early decision making to outlining the route to commercialization, market access complements development by defining early phase strategies, gathering and analyzing market evidence and communicating product value to key stakeholders.
While a market access strategy can include a number of services across several stages of development, each product has unique attributes and needs that require an equally unique set of solutions, supported by extensive policy knowledge and experience.
“In China, we’re often recognized for running global clinical trials, but we offer so much more as part of our integrated solutions within ‘One Covance.’ Our team supports companies—both small and large—to validate their market opportunity and help bring their product to market,” said Lang. “Whether the goal is to sell or license, biopharmaceutical companies need to develop a market access strategy that accelerates their coverage process and enhances their product valuation.”
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