In June, Lundbeck participated in the Pharmaceutical Research and Manufacturers of America (PhRMA) annual Researcher Fly-In event. The goal is to educate federal policymakers on the scientific innovation happening in the U.S. while illuminating the many risks and challenges, particularly in neuroscience, pharmaceutical companies face throughout the various research and development phases.
As one of the only biopharmaceutical companies solely focused on brain health, Lundbeck’s point-of-view is unique and essential to policymaking conversations regarding life sciences innovation considering the significant unmet needs that exist in brain health research. Jackie Blankman, senior director of biology, at Lundbeck’s La Jolla Research Center represented Lundbeck’s U.S. R&D footprint.
Always an avid science aficionado, Jackie Blankman majored in Chemistry at Northwestern University before obtaining her PhD in Chemical Biology at Scripps Research, where she focused on revealing the molecular mechanisms of the endocannabinoid system. Jackie then joined the biopharmaceutical industry and was part of the team that first brought monoacylglycerol lipase (MAGL) inhibitors into the clinic, where Lundbeck continues to evaluate them for the potential to improve brain health by amplifying endocannabinoid signaling. She credits this as one of her most rewarding moments in her career however, the lengthy development process is typical but an unknown reality to many.
Jackie now leads a 15-person team of biologists and pharmacologists that work closely with their Research colleagues in other scientific departments to bring new candidate medicines into the clinic. Jackie represents the knowledge gained by her and her team as a co-chair of Lundbeck’s global council that helps identify what new projects should advance into the Lundbeck pipeline.
The innovation happening at Lundbeck’s La Jolla Research Center site is focused on finding new ways to treat brain diseases and their most burdensome symptoms by developing small molecule medicines using state-of-the-art capabilities in proteomics and metabolomics. And after a drug candidate is developed by the Research team in La Jolla, it is transferred to the Lundbeck Development organization for progression towards clinical testing in humans – an example of the global impact of innovation in the U.S.
It takes approximately 10-15 years, or more, for a new drug to move through the pharmaceutical value chain from when an idea is conceived until approved treatment is available to patients, and brain research is 3 times more likely to fail compared to other disease areas. This is due to many factors including the challenges of delivering medicines into the brain (i.e. the blood-brain-barrier) and the inability to monitor brain disease pathology in biopsies and blood samples. But that doesn’t stop Jackie, “We all know someone who lives with a brain disease. I am proud of Lundbeck’s dedication to this critically important, but especially challenging, disease space.”
Innovation is a vital part to increasing patient’s options because finding pharmacological treatment therapies are not a one-size-fits-all situation. Jackie notes “New neuroscience medicines are desperately needed. There are many rare brain diseases with no approved medicines as well as patient populations that are underserved by the currently approved therapies.”
Finding biological targets and new drug classes with innovative approaches will help enable meeting unmet needs in patient communities.
Congress is uniquely positioned to solidify America’s leading role in the global quest to find new medicines for unmet needs by advancing a policy environment that fosters innovation throughout the ecosystem. Therefore, our policy recommendations that could have the greatest near-term impact include:
1) Fix the pill penalty in the Inflation Reduction Act
2) Restore the ability to immediately deduct R&D expenses
3) Increase funding for the Neurology Drug Program at the FDA
The Inflation Reduction Act is likely to have a disproportionate impact on small molecule research, and particularly neuroscience research, given the potential for selection of government price setting after only 7 years after the first indication approval, while allowing for 11 years for large molecules or biologics. Small molecules, typically in the form of tablets or capsules, are the molecule of choice for researchers seeking to penetrate the blood brain barrier due to their simpler chemical structure. Congress should fix the pill penalty by ensuring small molecule medicines should not be eligible to be selected for price setting before they have been on the market for at least 11 years.
As of 2022, research-based companies, like Lundbeck, could no longer immediately deduct their R&D expenses but instead spread them out over 5-15 years. This limits our access to capital to reinvest. Congress should restore the immediate R&D expense deducting.
In the 2023 financial year Omnibus Appropriations Act, Congress provided $2 million (USD) for the Neurology Drug Program at the FDA which will fund 6 full-time employees at the Food and Drug Administration (FDA) focused on advancing policy and guidance documents that will accelerate neuroscience treatments. Lundbeck joined the neuroscience community of patient groups, providers, think tank and other neuroscience innovators in advocating for this Neurology Drug Program. Congress should continue to support this Program and provide a modest increase to allow for additional focus on the over 100 million Americans living with a psychiatric or neurologic condition.
Our focus on research remains the most important pillar in Lundbeck’s ambition to improve brain health, by making innovative treatments available. In 2022, Lundbeck invested over $500 million USD back in our research and development programs, this corresponds to approximately 20% of our global revenue. With this level of investment, and passionate colleagues like Jackie, we know we can continue to improve the lives of those living with complex brain diseases – but we need Congress as a supportive partner.
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