No matter the brilliance of the research, or researcher, life science innovation relies on a rigorous regulatory and commercialization pathway before its potential to improve lives can enter patient care, at almost any scale.
Universities rely on their technology transfer offices and commercial entities like Bayer to pull high potential research and technologies out of the academic or research environment into clinical utility.
Dr. Hanna Eilken, strategic alliance manager with Bayer, provides insights into her organization’s red flags, processes, requirements and what she wishes more researchers knew about Bayer’s methodology for pulling research out of a university setting and into your commercialization pathway in the following Q&A.
- What attracts you to research coming out of a higher education setting?
Drug discovery and development becomes increasingly challenging with long development times, increasing costs, growing competition, and insufficient predictability of translation of preclinical data. Thus, engaging with universities and associated research institutions, to join forces and complement competencies is an important pillar to drive innovation in pharmaceutical companies. Academic research provides access to scientific excellence, disruptive technologies and cutting-edge approaches that are a source of creative solutions which are required to successfully develop effective treatment options, and to bring innovation to patients.
Bayer has recognized that complementing its in-house expertise with the know-how of academic scientists is mutually beneficial for both partners. We set up and execute co-operations in a collaborative fashion with shared risks and rewards. For example, Bayer has established the Joint Precision Cardiology Lab with the Broad Institute of MIT and Harvard which aims to combine Broad’s innovative methods for basic science discovery such as single cell sequencing and clinical expertise, with Bayer’s long experience in drug development to discover new potential therapeutics in cardiovascular diseases. Thus, we combine our expertise to jointly enable the development of new therapies for patients with cardiovascular diseases such as heart failure.
- What are the top red flags when engaging with academic institutions?
Usually, scientists in a university setting have the same motivation as pharmaceutical companies: bringing innovative therapeutics to patients. However, bringing together academia and industry also means – for both parties – accepting different cultures, mindsets and approaches. Often, both partners have the same goals but different ways of achieving them. A red flag would be to not: be open for new ideas, willingness to adapt, constant alignment, collaboration and personal interaction on the scientist and leadership level. From my perspective, it is very important to invest time to understand each other and build a healthy relationship.
- Where do your interactions begin and how do they progress especially regarding the people and what you need from them?
Interactions begin through various channels, e.g. through Bayer scientists, BD&L, Open Innovation and Leaps teams who are pro-actively scouting for technologies, assets and expertise that synergize with our in-house activities. In addition, we are often approached by academic researchers who wish to discuss their innovation with Bayer. We ask them to present their data and invite them to jointly discuss opportunities and potential challenges of the technology in non-confidential conversations. In the event there is mutual interest, we align on details of how a collaboration should look like and what partnership model we would pursue.
- At what point do you closely examine IP and what do you require to proceed?
Patent protection is a prerequisite for drug development in a company like Bayer, and it is essential that the patent term is sufficiently long after commercialization. We review the prospective patent portfolio early in the due diligence process.
- What do you wish more tech transfer officers knew about your methodology for pulling research out of a university setting and into your commercialization pathway? What do you wish more researchers in higher education knew about what’s needed to successfully transfer their work into a commercialization pipeline?
While many scientists do have a basic understanding of the drug development process, it is important to understand how they need to tailor their program towards commercialization. Talking to investors, big pharma or other potential partners can help to resolve some of the open questions and better understand how these potential partners are thinking. Many Tech Transfer Offices possess a solid understanding of what big pharma is looking for and they work with their investigators to identify gaps and shape a program towards commercialization.
Bayer has recently launched a few programs which are tailored to bring innovators from academia and young start-ups closer to big pharma, for example mentoring programs, Bayer-Access and the Center for Regulatory Excellence. In the Bayer Access program, Bayer offers expert guidance from multiple business and scientific perspectives, e.g. preclinical pharmacology, data science, drug discovery sciences, formulation and BD&L, and we jointly mentor the scientists, providing expertise and recommendations in a 1:1 session.
The Center for Regulatory Excellence is a novel initiative by Bayer and MassBio enabling academic scientists and young start-ups to learn from regulatory experts. We offer Think-Tank, educational sessions where we share our knowledge, expertise and experience when working with the FDA and other regulatory authorities. In addition, innovators can also apply for a selective 1:1 mentoring session with Bayer regulatory experts to discuss their project-specific questions.
In depth conversations as described above are extremely valuable for scientists and help to understand the complexity of the drug development process.
AdvanSE 2021 is fast approaching! Will you join us?
Southeast Life Sciences thanks Hanna for sharing her insights with us. Come see the best of what the southeastern U.S. life science ecosystem has to offer at the 2021 edition of our flagship event, AdvanSE, October 27 – 29 in Charleston, SC.