Executive perspectives: Briggs Morrison

Paul Tunnah interviews Briggs Morrison

AstraZeneca

Paul Tunnah speaks with the Executive Vice President, Global Medicines Development at AstraZeneca, Briggs Morrison on his views on emerging biological therapies, personalized medicine and clinical trial transparency.

Pharma R&amp,D is being shaped by many issues – biological therapies, personalized medicine and clinical trial transparency to name a few.

Briggs Morrison, Executive Vice President, Global Medicines Development at AstraZeneca shares his views on these issues and places them within the context of his organisation.

Interview summary

PT: During your career working within drug development, what are the biggest changes you have seen in the development process itself?

BM: Three things immediately come to mind. First, during my career, personalized healthcare has moved from a concept to a reality. AstraZeneca is using personalized healthcare in all disease areas and all phases of our pipeline. Through the effective identification and use of biomarkers we can potentially test whether drugs are likely to be effective much earlier in development and reduce late stage attrition. Because we can select patients for clinical trials who are more likely to respond, our drugs are more likely to succeed.

The second game-changing approach to drug development is the industry’s efforts to include payer feedback in our drug development programs. We are entering a world in which we are selling outcomes, not pills. My teams at AstraZeneca begin speaking with and listening to payers at the start of a medicine’s development. We discuss with them where the greatest clinical needs are and what type of data will be required to support access and reimbursement in their healthcare settings.

The third major change I’ve seen in drug development is the rise of what we call “predictive science”, which involves using computer modelling and simulation to provide drug project teams with important insights about disease targets, compounds and dose in advance of live laboratory or clinical testing. This can forecast safety risks before testing begins in people, it can cut time from our experiments, which in turn reduces cost, and it helps us identify promising programs early on so that we can invest in our development programs with greater confidence.

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“…personalized healthcare has moved from a concept to a reality.”

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PT: Playing that forwards, do you think we will still be following the same phase I, II, III trials program in 20 years’ time or will the process adapt (and if so, how)?

BM: The industry’s approach to clinical trials is adapting now and will absolutely continue to do so. Clinical trial costs are escalating while payers want to see clear evidence of each medicine’s value. AstraZeneca is part of cross-industry efforts to bring new medicines to patients faster while providing regulators and healthcare professionals with the confidence they need to make the right treatment decisions for patients. We are also engaging with regulators themselves to ensure the regulatory pathway can keep up with the changing medical and scientific landscape. For example, in oncology there is great promise in creating combination therapies to help patients whose cancer is resistant to existing therapies. But, the clinical trials required to test a combination of say a marketed product combined with an investigational product can be extremely protracted. Just as the industry tries to get smarter and faster in conducting appropriate clinical trials, we need clarity and dexterity from the regulators who decide whether or not our medicines will make it to market.

PT: How is cost containment impacting development decisions today?

BM: Today, delivering safe and effective medicines isn’t enough. The projects we invest in must also offer a clear, differentiating patient benefit and value to payers – the people or bodies who pay for healthcare. Payers either make or influence decisions about the reimbursement, listing and pricing of drugs. To make sure we meet the needs of these important customers, we continuously incorporate payer perspectives and real-world evidence of our medicines’ impact from early on and at every stage of the product lifecycle. We want to deliver the necessary data, analytics and regulatory packages that demonstrate the value of our products to governments and healthcare systems around the world.

I also want to acknowledge that as countries take steps to control public spending and restore fiscal credibility, healthcare budgets, and medicines budgets in particular, have been a visible target in driving down public costs. However, prescription medicines represent only about 10% of healthcare budgets. The real opportunity lies in collaborating across the public and private sectors to demonstrate where these medicines can have a positive impact on the other 90% of healthcare costs, and actually preventing even further burdens on our healthcare systems. Increasing – not decreasing – investments into innovative medicines can often be the most efficient way to spend healthcare dollars – even in times of austerity. Innovative medicines can create efficiencies and liberate resources and spend in healthcare systems by keeping patients well and helping them avoid expensive acute care settings.

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“We are entering a world in which we are selling outcomes, not pills.”

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PT: Can biological therapies live up to their promise in today’s price-constrained markets and, if so, how?

BM: The use of large molecules, or biologics, has become an important source of innovation, with biologics among the most commercially successful new products. Within our own pipeline at AstraZeneca, we have an integrated approach in our research, with a mix of small and large molecules across therapy areas. Forecasts for 2016 predict that of the world’s top 100 pharmaceutical products, 45% of sales will come from biologics. This compares with only 33% in 2010 and 15% in 2002. Most pharmaceutical companies now pursue both small molecules and biologics R&amp,D.

Since my medical training is in oncology, I am particularly excited by AstraZeneca’s commitment to developing potential new cancer drugs using a variety of biologics approaches via MedImmune, our global biologics arm. Our investigational biologics are directed towards molecular targets with a strong role in cancer progression and incorporate innovative technologies, providing the potential to eliminate cancer cells in more effective ways. Within biologics, we continue to progress a discovery and clinical pipeline that is balanced across different anti-tumor approaches, including impacting cancer cells directly (growth factor and survival signaling), modulating the blood supply that tumors need to grow (vascular modulation) and activating a patient’s own immune system to eliminate cancer cells (immune-mediated killing).

PT: How do you see the relationship between diagnostics and drugs developing as we seek more personalized approaches to treatment?

BM: Evidence suggests that drugs with a companion diagnostic approach are nearly twice as likely to succeed as those without a personalized healthcare approach. We are working in partnership with diagnostics companies to develop companion diagnostics for our medicines. We rely on these companies to take companion diagnostic tests linked to our products through regulatory submission and launch.

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“…we need clarity and dexterity from the regulators who decide whether or not our medicines will make it to market.”

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PT: What is your view on the whole debate about clinical trial transparency and making data more widely available?

BM: At its heart, this debate is about ensuring patient safety. As a patient myself, as a husband and father, and as a former practicing physician, I care deeply about the safety of the medicines we all rely on. It’s important to point out that clinical trial data is already presented to Regulatory Authorities in order to allow a rigorous assessment of the quality, safety and efficacy of all new medicines in development before they are made available to patients and their doctors. Regulatory oversight does not cease once a product is approved and data continues to be assessed. The benefit / risk ratio of a product is continuously monitored throughout the product lifecycle.

AstraZeneca has a long-standing commitment to making information about our clinical research publicly available to enhance the scientific understanding of how our medicines work and in the medical interest of patients. We are actively engaging with regulators, legislators, industry, medical and scientific bodies to discuss the complex issues raised by the proposals to routinely publish full clinical trial and patient data so we can collectively identify practicable solutions that deliver real benefits to medical science and to patients.

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About the interviewee:

Dr. Briggs Morrison leads our global late stage development organisation for both small molecules and biologics and is a member of the AstraZeneca Senior Executive Team. He joined AstraZeneca in 2012 from Pfizer, where he was Head, Medical Excellence, overseeing Development, Medical Affairs, Safety and Regulatory Affairs for Pfizer’s human health businesses.

Briggs has a track record of successfully developing novel medicines in roles at both Pfizer and Merck. He is the author of many original scientific publications in oncology, in other areas of medicine, and in the conduct of clinical trials.

Briggs received a B.S. (Biology) degree from Georgetown University and an M.D. degree from the University of Connecticut, followed by an internship and residency in Internal Medicine at the Massachusetts General Hospital, a fellowship in Medical Oncology at the Dana-Farber Cancer Institute and a post-doctoral research fellowship in Genetics at Harvard Medical School.

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