TL;DR: sitem-insel AG is a public-private partnership designed to accelerate translational medicine. It educates scientists in bio-entrepreneurship, establishes collaboration between stakeholders, and supports regulatory affairs. Scientists often struggle with the basics of getting started in business. Patents are necessary today but alternatives should be explored. Open Innovation and involving patients more could significantly improve outcomes.
About Dr. Nadine C. Martin
Dr. Nadine C. Martin is in charge of innovation management at sitem-insel AG. She is a physician with more than 20 years of pharmaceutical experience. She serves as vice-president of the Luxembourg Institute of Health (LIH) board and is an expert judge and mentor at MassChallenge.
What is sitem-insel AG?
The Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) was founded in 2014 as a public-private partnership. It focuses on three core areas:
- Education: Teaching the process of translating medicine from laboratories to patients, including bio-entrepreneurship training for scientists
- Collaboration: Bringing together clinicians, startups, associations, and industrial organizations to create productive partnerships
- Regulatory Affairs: Helping innovations navigate the complex regulatory landscape to reach the market
Main Challenges Preventing Medicines from Reaching Patients
The biggest barriers in translational medicine often are not scientific but practical:
- Missing knowhow and connections: Researchers and startups frequently lack the knowledge and networks needed to bring innovations to market. For example, a physician with a new medical device idea may have no idea who to talk to about manufacturing, regulation, or commercialization.
- Bridging the gap between researchers and clinicians: sitem-insel helps researchers connect with clinicians who can provide the proof of concept needed to move forward.
Many brilliant innovations die not because the science is wrong, but because the researchers behind them don't know the first steps of turning an idea into a product that reaches patients.
Bringing Innovation to Market: The Patent Question
In today's pharmaceutical landscape, patents are generally necessary for bringing new medicines to patients. The reasoning is straightforward:
- Clinical trials require enormous amounts of money
- Investors need a return on investment (ROI)
- ROI requires patents to protect the investment
However, alternatives exist and should be explored. Two notable examples:
- DNDi (Drugs for Neglected Diseases initiative) — develops treatments for neglected diseases using alternative funding models
- M4K Pharma (Medicines for Kids) — develops treatments for rare childhood cancers under an Open Science model with no patents
Fundraising as a Bottleneck
Fundraising remains one of the most significant bottlenecks in translational medicine. Traditional venture capital is not always the right fit, and alternative funding mechanisms like crowdfunding are beginning to emerge as viable options for early-stage biomedical innovations.
The Academic-Entrepreneur Dichotomy
Being a successful scientist and being a successful entrepreneur require fundamentally different skills and mindsets. The transition from one to the other is not natural for most researchers, and this gap represents a major challenge in translational medicine.
Scientists who want to translate their research need a mindset shift that includes:
Responsibility
Researchers must be aware that their work is largely funded by taxpayers. This creates a responsibility to maximize the return on that investment for society—not just in terms of publications, but in terms of real-world impact on patients' lives.
Knowhow
Researchers need to understand their options for translating discoveries, including:
- Creating a spinoff company
- Assembling a founding team with complementary business skills
- Licensing technology to existing companies
What Can We Do to Improve?
Patient-Centered Innovation
Involving patients more deeply in the innovation process can dramatically improve outcomes. This is especially important for chronic diseases, where patients live with their conditions daily and have invaluable insights into what treatments and devices would actually improve their quality of life.
Concrete steps include involving patients in clinical trial design, gathering patient input on device usability, and incorporating patient-reported outcomes into research endpoints.
Open Innovation
Open Innovation means involving more people in the innovation process. This can take several forms:
- Internal Open Innovation: Breaking down silos within organizations to enable cross-departmental collaboration
- External Open Innovation: Partnering with patient groups, academic institutions, startups, and other external organizations
- Public Open Innovation: Engaging the broader public in research and development through citizen science and crowdsourcing
The advantages of Open Innovation are clear: more horsepower, new viewpoints, and a broader base of ideas and expertise to draw upon. By opening up the innovation process, we can accelerate the translation of scientific discoveries into treatments that reach patients.
About Bio2040
There are so many challenges in drug discovery. We are a group of entrepreneurs and scientists who want to improve things.
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