The Idea Office – Turning Research into Product Ideas

An example of a successful transfer after consultation with the idea office is the project to produce a biodegradable drug-loaded surgical matrix for improved wound healing by Dr. Philippa Seika, Professor Dr. Christian Denecke, Lennard Kenneth Shopperly, M.Sc., and Jacob Spinnen, M.D., Ph.D.. To give future innovators a realistic insight into the project process as a participant in our funding programs, our start-up consultant, Dr. Bettina Otto, invited the four of them to talk to us about their experiences, goals and challenges. 

Thank you for taking the time to talk a bit about yourselves and your idea today. What exactly are you working on together?  

Philippa Seika: I am a surgical resident at the Department of Surgery at Charité. In visceral surgery, one of the major challenges we face is anastomotic leakage. After an operation on the gastrointestinal tract, the ends of the intestine need to be reconnected. If that connection does not heal properly, it can lead to serious complications like sepsis, organ failure, and extended stays in intensive care. We are working on a strategy to address this problem. 

I had just returned from a research stay in Boston, where part of my project was also working on tissue regeneration. Together, Christian, Jacob, Lenny, and I started thinking about how we could translate ideas from basic research into clinical application. That is what we presented at SPARK. Our project focuses on developing a biodegradable, 3D-printed product that delivers a specific therapeutic agent to support the wound healing process.  

How did the idea for your joint project come about?  

Philippa Seika: Christian and I have been working together for a while now, developing new ways to reduce surgical complications and support tissue regeneration. I had an idea for a potential therapeutic approach, but at first, I was not sure how far along it needed to be before I could talk to someone about it. I did know, though, that questions around patent strategy and intellectual property should not be addressed at the end of the research process, but right at the beginning. I started looking for support within Charité and that is how I came across your Idea Office. To move the idea forward, I also needed to collaborate with someone with a strong material science and drug delivery background who could help create the actual product. That is when you connected me with Tanja, the head of the SPARK-BIH team, who then introduced me to Jacob and Lennard.  

Lennard Kenneth Shopperly: Jacob is a resident in the Department of Trauma and Reconstructive Surgery and Junior Clinician Scientist at BIH, and I am a Research Associate in the Department of Trauma and Reconstructive Surgery. We both know a lot about 3D printing and materials science. Thanks to her surgical expertise and her experience with intestinal tissue, Philippa has skills that Jacob and I cannot cover ourselves, even though we are a kind of medical and scientific dual leadership in the lab. We immediately recognized that there was a good overlap between our projects and that we could come up with an interesting and promising use case as a team. We then submitted a joint application and were invited by the SPARK team for a pitch, for which Philippa came all the way from Boston to Germany for two days. 

Jacob Spinnen: We really appreciated that. At university, you often find that there is a desire and motivation and the theoretical competence to carry out projects. But then to put it into practice and to be prepared to take on all the organizational things is not a prerequisite. If someone flies across the equator for a day, that speaks volumes for their willingness to do research after clinical work. 

The SPARK-BIH program of Charité BIH Innovation supports innovative translational projects with milestone-based funding, mentorship and targeted training. You have been involved since the beginning of the year. What is your first impression? What do you hope to gain from the funding in addition to the financial support? 

Lennard Kenneth Shopperly: I have never submitted an application this quickly before. We have already submitted one or two applications. And here it was only about three months from the first meeting to the application to the approval.  

Jacob Spinnen: You usually only get the confirmation from the funding body that the papers have arrived within that period. 

Lennard Kenneth Shopperly: And only on request. [laughs] 

Philippa Seika: What I really appreciate about SPARK-BIH is how well it complements the theoretical knowledge and research experience with targeted training, continued education, and access to networks in industry and the patent landscape. As a clinician, you do not necessarily know all the steps involved in developing a product and that is exactly where SPARK-BIH steps in and guides you through the process. 

Lennard Kenneth Shopperly: SPARK-BIH is super strong when it comes to regulatory affairs. The regular meetings as well as the presentations where you present your project and where experts from the regulatory world and other scientists are present and ask critical questions are simply enormously important to further develop and finalize your own product idea at such an early stage. The milestones give you specific deadlines that you must meet every six months. However, this also keeps you focused on the ball and teaches you to set realistic goals. It even saves you work afterwards because you can use the plan that you have formulated beforehand as a guide. 

Since you just mentioned the milestones. What steps do you have ahead of you in the coming weeks and months?  

Lennard Kenneth Shopperly: The project is divided into three parts. First, the in vitro drug testing and then the in vitro release system. In the end, both are to be combined, so to speak in a first prototype, which should be available after a year. The third part concerns the regulatory process, the sharpening of the product idea and the design requirements: Whether you already have concrete indications for follow-up funding as to how things should proceed in regulatory terms and what the product should look like, particularly regarding the active ingredient.  

Jacob Spinnen: The IP is of course not an unimportant factor for what we are planning. It is very important to think about the project from the back and see how we can combine it with the IP that Lennard and I have already submitted for another project through Charité. At the end of the day, it will probably be a class 3 combination device, maybe even a drug, so a very complex product.  

We will have to assume an eight-figure sum in development costs. This means that we will certainly not be able to take over production and sales ourselves. So, an investor will have to take over at some point. An investor, in turn, is very interested in IP. But you only learn that when you have been in the SPARK-BIH program for a while, that you must think about these things from the back and that you are not done when the thing works, but only then do the big questions arise. Many products fail precisely because they are not thought through from the back. 

We have talked a lot about product development. Did you already think at the beginning of your studies that you would later found a start-up? What made you decide to go in the direction of product development? 

Jacob Spinnen: There are two reasons for this in my case. Firstly, after studying medicine, I decided that I wanted to become a surgeon. Solution-oriented research is more my thing alias there is a fracture and I need to fix it [laughs]. The second reason was my doctoral thesis with Dr. Sittinger, who is a translator himself and was researching autologous cartilage cell transplantation at the time. Whenever I asked him if I could do this or that, he said yes, but always with the thought behind it of what you could actually do with it. I received both a scientific education and a bit of predisposition. In my opinion, the translational bias in my doctoral thesis is the exception rather than the rule. I did not get to know science like that at the Charité. The general concept was not so much to think about how you could make it applicable, but rather to invent a cool concept and then withdraw. 

Lennard Kenneth Shopperly: I also got to know Professor Sittinger because I wrote my Bachelor thesis with him and Jacob wrote his PhD at the same time. That's when I also became aware of these aspects.  Of course, I was initially interested in science. It is fun to think about problems for longer and in greater depth.  But at some point, I asked myself what impact pure basic research has.  I then made a conscious decision that I wanted my work to have a concrete impact on patient well-being and therefore wanted to work translationally. And when you consciously decide to do this, your approach suddenly changes.  

Philippa Seika: In the clinic, and especially in surgery, we are often end users of a wide range of products and medications. In many ways, we are just like any other consumer. These products are often developed by industry or in basic science settings, with limited connection to day-to-day clinical reality. In academic medicine, we’re fortunate to have a bit more exposure through involvement in research and clinical trials. But ultimately, as the treating physician, I alone am responsible to my patients for the outcome of their surgery. My goal is always for my patients to be as well as possible after an operation, so I really see all of this as part of my area of responsibility. If I am the one held accountable in the end, then I want to know where the products come from, how they were developed, whether they truly are the best option or whether there is a way we could make them even better ourselves. When you’re that close to the patient, you also see firsthand the suffering that can result when complications occur. That sparked a personal drive in me: I want to have a say in every part of that chain. I want to contribute my own ideas and not just be a passive end user of a product that came from somewhere else. 

Christian Denecke: When an opportunity arises that allows you to make a real difference, one where you can achieve a lot in a short amount of time, that is incredibly exciting. I have also worked in basic research before, but I found it sometimes lacked direct clinical impact. Here, I can explore something that not only feels grounded in basic research but also has the potential for tangible, real-world applications. 

Who is behind the project? 

Dr. Philippa Seika is a resident in visceral surgery with a focus on upper gastrointestinal oncology and robotic surgery. She combines her clinical work with translational research on regenerative biomaterials and neuro-immunological therapeutic strategies for gastrointestinal tumors. As a postdoctoral fellow in the laboratory of Professor Subhash Kulkarni and Professor Leo Otterbein at Harvard Medical School, she conducted research on the role of the enteric nervous system and heme metabolites in tumor biology. Her current projects, including a SPARK-BIH-funded project, bridge the gap between basic research and clinical application.  

Professor Dr. Christian Denecke is Deputy Director of the Department of Surgery and Head of the Section for Upper Gastrointestinal Surgery at Charité - Universitätsmedizin Berlin. His clinical and scientific expertise lies in the surgery of esophageal and gastric carcinomas. In his translational research, he combines surgical innovations with molecular and systems medicine approaches to optimize perioperative outcomes. He has contributed significantly to the development and clinical implementation of robotically assisted procedures in esophageal and gastric resections and is committed to structured training concepts and the optimization of ERAS protocols in complex oncological procedures. 

Jacob Spinnen, M.D., Ph.D., is a resident in advanced training at the Department of Trauma and Reconstructive Surgery. He is the medical laboratory director in the BioReconstruction Lab at the Department of Trauma and Reconstructive Surgery at the Benjamin Franklin Campus of the Charité. He combines his work in the operating room with translational research to develop innovative medical implants for the treatment of segmental tissue defects. As a Charité Junior Clinician Scientist, he leads various transfer projects aimed at solving challenges in the surgical treatment of severely injured patients. 

Lennard Kenneth Shopperly, M.Sc., is currently completing his doctorate on the topic of controlled drug release from additively manufactured biomaterials. He is a scientific laboratory manager in the BioReconstruction Lab at the Department of Trauma and Reconstructive Surgery at Charité's Benjamin Franklin Campus. He contributes his extensive knowledge of the encapsulation and controlled release of active substances in biopolymers and his knowledge of 3D printing technologies for biomedical applications to various translational projects.