Adding Value To The Development Process

By William Crown, Ph.D.

One of the greatest challenges facing life sciences companies today is the growing move to evidence-based medicine with a need to generate health outcomes data throughout the full drug or device development process. The so-called “value proposition” is increasingly important in guiding everything from the creation of protocols for registration for clinical trials to providing a clear indication of the value and benefit of medicines, vaccines, and devices, which affects pricing and uptake. This is a fundamental change from the way drugs historically have been developed. The change is being influenced by external and internal factors. The drive to limit ever-escalating healthcare costs is leading to a growing move to value-based pricing. Meanwhile, life sciences companies are struggling to cut the high costs of successfully developing and delivering new medicines and devices.

The current environment places a new, compelling need for life sciences companies to obtain, analyze, and demonstrate real-world evidence of the value of their products from discovery through clinical development and then on throughout commercialization. If done properly, starting early, this evolution in product development and commercialization can help ensure that life sciences companies realize the full value of their products throughout the full life cycle.

Missing The Big Picture
Unfortunately, many life sciences companies of all sizes are missing the big picture by not taking a broad, comprehensive, global view of their regulatory and development (R&D) strategies, to focus on the needs of multiple stakeholders — regulators, practitioners, consumers, and payers. Too many companies continue to look at the R&D process in segments and not as a unified path to success. Many companies continue to engage CROs to help them execute the strategy, however fail to take advantage of the broader perspective that they might gain from working with an external partner that is able to bridge the strategic divide between drug development and commercialization/market access. A true strategic partner can bring more to the table, and can act as an advisor in both the design and execution of research that meets the needs of multiple stakeholders. There is a growing need for companies to have a comprehensive strategy in place that bridges the regulatory, development, and commercial marketing functions, to serve as a key driver for product development and decision support in all stages.

For companies looking for outside support from CROs, there is a danger in focusing on clinical trial design, and in the process, overlooking the market access objectives that they ultimately need to achieve. A true partner needs to be able to provide both input into the strategy and the ability to execute upon the strategy. Today, as life sciences companies are under mounting pressure to deliver and succeed in an ever-changing and increasingly competitive global economic and regulatory landscape, many, if not most, are likely to benefit from a more comprehensive approach to engaging and gaining from expertise that spans the full product development and commercialization time line.

It is important that companies start early on gathering the evidence to address the tough questions, including:

• How will a potential new entry differentiate itself from currently available therapies?
• What will drive its adoption by most patients, providers, and payers?
• What value does a drug bring to marketplaces?
• Will the development package be sufficient in and of itself to demonstrate value, or will there be a need for additional data and trials?
• What are the benefits related to current health policy, and what are the implications economically, as well as therapeutically?

Preapproval stage research is vital and sets the stage for late-phase, patient-focused outcome studies to further reinforce the values and benefits of treatment in evidence-based settings. Today, more than ever before, the life sciences development process does not end with regulatory approval and a marketing plan. While the three traditional hurdles to new product approval — safety, efficacy, and quality — remain in place, companies now face increased pressure to deliver post-marketing surveillance, earlier recognition of safety signals, and a rapid response to potential problems.

William Crown, Ph.D.
Dr. Crown is group president of health economics and outcomes research and late phase research for OptumInsight’s life sciences group.