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Q&A with Timothy Moore and Jack Mycka, Indegene

Pharmaceutical Executive chatted with Timothy Moore, Senior Vice President, Emerging Biotech Development & Commercialization for Indigene and Jack Mycka, Vice President, Pricing, Reimbursement & Market Access for MME, an Indegene PRMA Business to discuss the current state of financing deals and go-to-market strategies coming out of a brutal bear market as well as the evolution of the biotech commercialization model, and more.

Pharm Exec: The future of biotech funding has remained a hot topic in the last quarter of this year. What are your views on the dry powder available with investors for small and emerging biotech as the dust settles down on valuations and necessity for clinical evidence?

Timothy Moore: Over the last two years, the biotech industry has experienced the worst bear market in history; for both equity prices and fundraising. Over this same time, the number of new biotech assets and companies has risen significantly. Fortunately, we are seeing signs that the market is improving, but the rise in the number of new biotech products means that there will be more competition for investment than ever before.

In this crowded market, it’s difficult for biotech companies to differentiate themselves. Historically, the asset was the differentiator. Now, demonstrating that you can successfully commercialize in a difficult and price sensitive market is becoming another important differentiator. In response to this shift, biotech companies have begun looking for ways to set themselves apart.

With many new companies coming to market, investors are increasingly nervous about the ability of biotech’s management teams to be successful. These investors have begun to encourage biotech companies to find a strategic partner with significant commercialization experience, thus increasing their likelihood of a successful launch and their chances of securing funding.

Pharm Exec: Will this scuttle innovation?

Timothy Moore: I don’t think so, not in a meaningful way. Biotech is resilient, and the need for new innovations to fill disease gaps that are largely untreated, undertreated or too small for large pharma still exists. There are so many categories where much progress is still needed, such as NASH, pancreatic and other cancers, Alzheimer’s and so much more.We are just starting to see the potential for gene therapies as well. Despite the last two years, the potential for innovation in the biotech space is still almost infinite.

Pharm Exec: There appears to be a shift in the commercialization approach for small/medium (SME) biotech companies — pivoting to a digital-first approach. Do you have any indicators of how companies have performed on this digital index in the past year, and do you believe this will also have a bearing on investor sentiments for subsequent funding rounds?

Timothy Moore: We have data that underscores the shift to digital, and we are beginning to see that digital has the potential to be more effective than the traditional field model. We have experimented with the impact of digital versus in-person reps, and we have continually found that our digital approach matches or outperforms in-person interactions and does so at a fraction of the cost. Most importantly, HCPs prefer it.

It is increasingly difficult to stand out in the digital space. It’s never been more important to get the content right and to send the right message at the right time with the right mix of channels.

We are already seeing savvy investors asking whether they really need to spend millions on a sales force when digital has the potential to maximize ROI.

Pharm Exec: Several biotech companies went prematurely public. Some were lucky, some IPOs bombed. What’s the secret formula given the change in scenario in public markets? What kind of companies will be most sought after in the next five years?

Timothy Moore: There is a formula for success, which is an open secret now. Despite the challenging market, most CEOs are doing their best to get their products to the market. Having a unique asset in a unique space will always improve the chance of success. There are a few things that can drive success: Partnering with world class pricing and market access support and getting them involved much earlier is key. It’s also important to leverage your medical affairs and medical communications teams earlier and more frequently. Understanding your marketing mix and creating strategies that optimize the ideal mix of digital and in-person interactions is essential. And finding a partner that can do all the above improves the chance of launch success.

Let’s direct the next couple of questions to Jack Mycka. How would pricing strategies alter for SME biotech for new launches in the coming quarters and what bearing will the Inflation Reduction Act have on this segment?

Jack Mycka: Pricing your product correctly is critical when it comes to valuation, especially given the Inflation Reduction Act (IRA). And not just as you get close to launch. Pricing strategies should be considered throughout the development of the product regarding endpoints and clinical data. The preapproval information exchange (PIE) provides an opportunity to do things in a different way and communicate to US payers sooner. This shifts the timeline for planning and action back before New Drug Application (NDA) or a Biologics License Application (BLA) filing. Major price adjustments post-launch will no longer be an option.

Anything else you want to add for biotech CEOs’ playbook for the coming year? 

Jack Mycka: The playbook should incorporate global pricing strategies, implications of the Inflation Reduction Act and PIE, and an effective way to communicate value to all stakeholders. Investors should focus more on how clinical endpoints affect market access, funding, order of approvals, price points, and reimbursement. Investors are asking those questions earlier on and are looking for management to look beyond traditional approaches. To succeed, communications need to be packaged in better ways. That is where you address how digital can support your launch in a whole different way and how you can be innovative in an optimized way.

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