When to prepare for commercialization

Congratulations, your product has made it out of Phase 1 clinical trials! You and your team are probably excited, anxious to move forward and perhaps a little apprehensive about what comes next.

As you enter Phase 2, you’re likely still worried about patient recruitment and retention. In fact, you may be even more worried because now you’ve got more patients to recruit, manage and retain.

As your study size grows to include hundreds of patients, healthcare commercial intelligence and input from key opinion leaders (KOLs) will be critical to successfully handling issues of patient eligibility and engagement.

Over the two-plus years of Phase 2 trials, those KOLs, market data and analytics can also be invaluable resources for sales and marketing teams asking pre-launch questions such as:

• Where are our ideal patients and how are they navigating the healthcare system?
• How are our competitors operating in the market?
• Who are the key decision-makers and influencers within our target organizations and provider groups?
• Which KOLs are best suited to support our clinical trials and communicate the results?

There’s still a long road from Phase 2 to Food and Drug Administration (FDA) approval for your product. About 66 percent of new therapies fail to meet year-one expectations. Those that outperform the pack have the information and infrastructure in place to smoothly transition out of development and into the market.

Equipping your team early with the right market information and expert insights could help you get there with fewer delays.

Engage industry experts to solve problems before they start

In last week’s post, we noted the value of key opinion leaders—and the importance of quickly finding those with the unique experience and affiliations to keep your Phase 1 trials running smoothly.

During Phase 2, KOLs can continue to support your patient recruitment and retention efforts. Unlike in Phase 1, though, Phase 2 studies typically feature no healthy participants. Because all participants will have the disease or condition being studied, you may need help from KOLs to find both patients who meet complex eligibility requirements and the trial sites with a great performance record. 

It’s also a great time to identify and engage with industry experts who can help you generate pre-launch market demand and strengthen your messaging well ahead of commercialization.

As your clinical trials begin to generate early efficacy results, KOLs with the right expertise can communicate those results to providers and healthcare organizations. Experts can leverage their industry affiliations to tout your early successes and build interest among influential institutions and provider groups.

KOLs can also develop programs and materials to educate the scientific and clinical communities about your therapy or device, ensuring physicians and other healthcare professionals are familiar and comfortable enough with the product to prescribe it.

Identifying and engaging KOLs in Phase 2 ensures you have ample time to incorporate experts’ insights about patient and clinical needs, building your product profile and product labeling.

Of course, KOLs aren’t all created equal. The ideal KOL is likely a published expert in your targeted disease state or condition, with experience in clinical research or life sciences development. They should also have connections with providers or institutions who work closely with your target patient cohort.

To find these experts quickly, you’ll need healthcare commercial intelligence that tells you whose work is most relevant to your own.

Can claims data simplify clinical development decisions?

As Phase 2 clinical trials progress, your sales and marketing teams are tuning up their go-to-market strategy. FDA review and commercialization are still several years out, but your teams will need plenty of time to understand your patient base and the providers who treat them.

With some efficacy data in hand from your ongoing trials, you know a little more about who your ideal patients are and how to market your product to their providers. Medical and prescription claims data can provide even deeper insights into the most granular healthcare market segments.

Paired with expert analysis and reporting, claims data enable you to ground your market strategy in the clinical activity of relevant providers.

Your team can leverage these data to perform competitive analyses, map patient journeys and prioritize crucial decisions like territory assignments. Claims data can tell you which other drugs and devices your patients are using and help you to identify potential adverse interactions earlier in the development process.

Claims data become even more valuable when combined with provider reference and affiliation data. Together, this healthcare commercial intelligence could even serve as a unifying source of truth for your entire organization.  

Why Phase 2 is the right time to start preparing for commercialization

Only about one-third of therapies move on from Phase 2, according to the FDA. So why start considering commercialization if there’s a significant chance development could be delayed or discontinued?

In Phase 2, your studies will begin generating data about the safety and efficacy of your drug or device. These data could be a goldmine of market excitement—if you have access to the KOLs who know how to parse it and communicate the most meaningful data points throughout the scientific and clinical communities.

Supported by input from industry experts, early efficacy data can also help to shape the messaging and positioning of your product. The earlier your drug or device is known within its relevant community, the faster it can get into the hands of patients after launch.

Get the healthcare intelligence that your product deserves

Next week, we’ll look at Phase 3 clinical trials and discuss how life sciences companies can approach commercialization with confidence.

Last week, we looked at the barriers that life sciences companies encounter during the first phase of clinical trials in the product development process.

Looking for data solutions to help you discover pre-commercialization opportunities?

Explore the benefits of healthcare commercial intelligence that pairs expert profiles with medical and prescription claims data. Sign up for a free trial today.