New, Industry-wide Focus on Translational Research May Speed Up the Drug Development Process

Innovation-Driven Necessity Brings Dynamic Change to Pharmaceutical Research & Development

COVID-19 has brought to the forefront the need to reduce the time it takes to bring drugs from the discovery phase to market for difficult conditions. COVID-19 presents a challenge to clinicians, patients and researchers that cannot wait for the traditional approaches that bring treatments to market at the speed of academia. Pressure to improve drug development is driving innovation to deliver better business and patient outcomes. 

For more than a decade, translational research has become a noteworthy topic of discussion within academic institutions, government research centers, and the biomedical products industry. The validation and promise that translational research offers has led many organizations to dedicate fully staffed departments to support and promote the objectives of translation research. The main driver of translational research is bringing pharmaceutical products to market faster without sacrificing safety and efficacy.

The current challenges within the research-based drug industry are plentiful and contain major concerns for every organization involved. These challenges place a unique focus on translational research, and many rely on the success of implementing new processes to bring product to market quickly, safely, and with confidence. Additionally, the pharmaceutical marketplace has become increasingly competitive. According to a recent study, competition is making it more difficult than ever to get the premium pricing and the kind of formulary coverage that most companies seek for their products. Many pharmaceutical companies cannot simply rely on safe and effective processes for new drug research and development. They must develop products more quickly and cost effectively. For this reason, translational research can no longer be a novel idea within the industry and companies must fully embrace this new research extension. Several areas that translational research will need to overcome, include safety assessments, risk management, and post-approval research requirements.

Lammasu Pharma was established in 2018 and was designed to capitalize on expertise in early translational research, eliminating the significant gap in the drug development process. With a strong focus on advancement past the preclinical stages, the company excels at pushing drug candidates toward phase I/II clinical trials. Severe acute pancreatitis, the initial target disease of the company, has no available treatment, resulting in the hospitalization of over 330,000 individuals annually in the U.S. alone. The severe, unmet medical need for an acute pancreatitis therapy creates a significant burden to the healthcare system and takes a toll on afflicted patients, who face hospitalizations and complications as a result. Lammasu Pharma’s first drug candidate is a small molecule, RABI767, developed by Mayo Clinic, which has been proven to possess a profound ability to mitigate mortality and morbidity associated with severe acute pancreatitis in animal models.  

Lammasu Pharma’s CEO and executive director of the Duke Preclinical Translational Research Unit, Dr. Gabi Hanna, has successfully merged the approaches of academia and industry laboratory research. His approach makes use of partnering in the preclinical phase, and strategic capital acquisition to ensure company growth. Lammasu Pharma’s unique business model works to secure strategic and non-dilutive capital as part of a business model. It successfully increases investor value early and establishes strong downstream relationships with partners, significantly improving capital efficiency and availability. The model reduces the time needed to secure capital, thus increasing the company’s value and maintaining stronger economic positions for early investors and partners. The objective of the company is to leverage one project into the next, rolling capital between drug candidates to create an asset factory. With this approach to business, investors obtain a smaller piece of follow-on assets, securing equity, exposure, and involvement in multiple products.  

Dr. Gabi Hanna’s innovative approach to collaboration between industry and academia brings to light a tremendous opportunity for streamlining the drug development process. Despite the difficulties associated with changing an already complex system, he has managed to utilize the unique capabilities of academia and industry. Lammasu Pharma is the culmination of Dr. Hanna’s diverse education and experiences. The approach he is taking to develop solutions through translation is not only innovative but adaptable. Dr. Hanna and his team will continue to refine the scientific process and the business model to create value for patients, clinicians, the healthcare environment, and the investment community. 

As a nation, we all face challenges due to this global pandemic. A major difference between COVID-19 and the Spanish Flu from 100 years ago is the acceleration and implementation of emerging technologies. For the pharmaceutical and biopharmaceutical companies, the challenges of yesterday are now accelerated to meet the demands of today. Thanks to COVID-19, the term translational research is making its way into mainstream conversations and is being discussed as a new pathway to not only address existing conditions, but to any future health concerns that may arise in the future. As we learn more, and as existing research modalities adopt translational research methods, the key to speeding up the movement of new medical therapies from ideation to mainstream treatment may be within reach. 

 

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