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The patient is the point: The changing landscape innovation in drug development – MedCity News

The complex, dynamic, and highly rewarding world of biopharma is constantly evolving. Despite this, the goal remains the same: helping patients live longer and healthier lives, and in some cases, even saving lives. We are in a time of exciting healthcare innovation, from promising new gene therapies for rare diseases to mRNA technology that allowed the development of the Covid-19 vaccine in record time. But with these gains come challenges, from the pitfalls of legacy thinking to outmoded pricing paradigms.

As a biopharma executive, I’ve spent most of my career as a commercial leader—weaving in and out of sales, marketing, and market access functions for the last few decades. Just prior to my current role, I was the Head of Global Market Access and Pricing. In this position, I focused on a holistic approach to the way we commercialize drugs while keeping the patient—our most important stakeholder—at the center of our efforts from start to finish. Too often, health authority approval is considered the finish line of drug development when it is a critical milestone along the path. Getting reimbursed medication to patients who need it—that’s the finish line. To do this, we need to break down silos and replace them with bridges that connect R&D, market access, and the greater commercial organization so they can work hand in hand to ensure that new drugs can help as many patients as possible. That’s the ultimate goal. So, where do we begin?

Early Collaboration Is Key—with an Eye on Market Access

In practical terms, prioritizing the patient from the start can involve many factors, one of which is making sure that clinical trial design considers what is required for access stakeholders, including payers and Health Technology Assessments bodies. For this, you need quality market access insights given at the right time during clinical development. What does that mean? If you ask an R&D person, they’ll tell you one thing; if you ask commercial, they’ll tell you another. Market access will tell you that you should involve them prior to proof-of-concept, or just before the start of phase II. Too often, market access is left out of the development process until the team needs to refine pricing and reimbursement assumptions closer to launch. At this point, it’s too late for access insights to help optimize the development and increase the likelihood that the innovation finds its way to patients who will benefit most. The good news is that this is beginning to change—with market access being acknowledged as critically important earlier on in the process. Increasingly, market access is being recognized for the value it brings beyond just pricing and reimbursement. When optimally deployed, market access maximizes company assets—identifying differentiating endpoints, defining patient segments with high unmet need, setting the country and indication launch sequence, and thereby, informing trial recruitment strategy to maximize access and value across markets. This impact is not limited to the asset level. With a broad perspective that considers patient and societal benefit, relative health system value, cross-country consideration, and health policy implications alongside potential costs and value to the company, market access supports the decision-making process across the whole portfolio.

Long View: Integrated Approach to Drug Development

Necessarily, market access is evolving away from what was once a sort of niche expert function into a broader commercial strategic pillar—the three pillars being medical, marketing, and market access with each having equal input into programs and commercialization. Having a commercialization background in traditional sales and marketing coupled with an understanding of the market access viewpoint is becoming invaluable across the industry.

This is a promising and rewarding time if we are willing to evolve as rapidly as innovation is. Bringing in market access and collaboration earlier in the process, viewing reimbursement as the last leg of the developmental journey, and collaborating across key functions are practices we can evolve so that as many patients as possible can reap the rewards that are waiting for them.

Photo: z_wei, Getty Images

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