#LIGHTFORUM2018 Q&A: Susan Schaeffer

Susan Schaeffer is Editor Emeritus at BioCentury. She was previously Senior Editor in charge of Product Discovery & Development coverage from 2010 through 2012. She was Managing Editor of BioCentury and BioCentury Extra from 2004 through 2010. She joined BioCentury in 2003 after 10 years as an editor in the consumer packaged goods sector, including work with international strategy consultants Kurt Salmon Associates. At LIGHT 2018, Susan will be moderating the panel, “Patient Pathways in Cardiology: An Example of the Future” (May 9, 3:35 pm).

 


Which trends in biotech and Pharma are you closely following?

BioCentury covers the biopharma landscape from the idea in the lab all the way to drugs getting to patients, so we focus on trends that will further or hinder new treatments to patients. That includes everything from cutting-edge technologies like CRISPR and CAR Ts, to new biology. And it’s not just about new therapeutic targets, it is new ways of thinking about pathways and networks and nodes that can lead to new ways to intervene in disease. We also closely follow trends related to regulation, politics and policy, such as the drug pricing discussion that has been heating up over the past year.

Increasingly, we are focusing on trends that are helping generate better quality data more efficiently and faster to improve decision-making by stakeholders throughout the ecosystem, including regulators, companies, patients and physicians. These include novel clinical and statistical designs that are yielding higher quality data, model-informed drug development, and the use of AI to extract information from biology and patient populations quicker to get treatments to patients.

In your time reporting, have you observed a changing narrative when discussing the roles and relationships between different healthcare players—payers, providers, patients, biotechnology, and others?

I’ve covered biopharma for fifteen years, and even 10 years ago the landscape was incredibly different—stakeholders didn’t collaborate and were not integrated into an ecosystem. Biotechs were the innovators discovering new drugs. Pharmas served as acquirers or licensers of biotechnology, but they were totally opaque. They didn’t engage with trade media, and deals between biotech and pharma were very much arms-length affairs—the assets went into pharma and in some cases were never heard from again.

Regulators were the gatekeeper to the marketplace, and were seen as being rigid and not being approachable or innovative. People in R&D thought very little about payers, and even less about patients, except in the abstract—I mean, everyone was working toward treating and curing disease, but drug developers were not delving into or prioritizing what patients really wanted.

Now the ecosystem functions much more like an ecosystem. Pharmas are a lot more open and outward-facing. They collaborate with academics and biotechs in true partnership. Regulators have become more open, creative and innovative. While they still hold drug developers to a rigorous standard, they have been more creative in in accelerating the development of promising new treatments. And now payers are the gatekeepers to the market. Just because a regulator approves drug, doesn’t mean the payers will pay for it. Payers are saying no more than ever.

Finally, patients are beginning to take the reins, driving research and inserting their voices into regulation.

What do you believe is driving all of these changes?

Payers are driven by increasing healthcare costs. They are in fear for their budgets, and drugs are an easy cost item to pinpoint.

Pharmas are driven to be more collaborative by the need to fill pipelines with innovative products. And the increasing openness and innovativeness of regulators has been helped by improved relationships with industry. Several years ago in PDUFA negotiations, the focus changed from rigid adherence to deadlines, to much more outcomes-based goals. It’s now about “what are ways that we can improve the development process to accelerate to patients?”

Patients are becoming more healthcare literate as they are asked to shoulder a larger cost of their own care.

In September of last year you discussed the role of pharmaceutical companies in keeping a social contract. As technology merges in the healthcare world and novel therapies in precision medicine advance, what considerations should the industry make to ensure they do not breach their social contract?

Our point of view, as discussed in September, is that for biopharmas, the social contract means the sole purpose cannot be to sell pills and vials to increase shareholder value— its purpose has to be to help people live better and longer. This social contract—which we didn’t invent, Brent Saunders from Allergen famously invoked the social contract when he pledged to cap drug price increases for his company—is two-sided. Society, usually through government or philanthropy, must fund basic research that industry can translate into medicines. Society also agrees to pay enough for those medicines to justify industry’s huge and risky investment in the R&D process. Governments need to provide science-based regulation and IP protections for an agreed-upon and limited time.

When society does those things, it creates obligations for drug companies to make the investment necessary to develop new drugs and, while doing so, pave the way for public health and prosperity. They are obligated to abide by science-based regulation and IP laws that stipulate when and how monopolies will end. Above all, for the contract to work, patients have to have access to medicine at prices they can afford. Industry has to continue to operate with the patient in mind and to invest in long-term gains that will sometimes come at the cost of shorter term rewards.

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