Supporting product development

What motivated and led you to accept the position of Head of the Translational Project Management Office (TPMO) at the DZIF?

There are several aspects to this. One is that my interests are deeply rooted in the field of infection research. My first professional employment was in the field of antibiotic agent research, which I thoroughly enjoyed at the time.

In my next position at Evotec, I also worked on projects investigating anti-infective agents and immunology. Another aspect is that direct interaction with academic research drives me: I believe that academic research plays a very important role in the progress of biomedical research, both in general terms and for the DZIF in particular, because companies have withdrawn from the field anti-infective drug development. And finally, what inspires me is that we use the DZIF’s impressive potential to really try and develop products; novel products, improved and additional products with which we can meet the medical need for anti-infective agents.

What are your responsibilities in this position?

I am not one hundred percent sure that I can already answer this question fully from where we stand today. In a way, I see the TPMO as a service provider: as a bridge between the research provided from within the DZIF and the need to also translate this research into product candidates. In more concrete terms, I often interact with regulatory institutions, currently the Paul-Ehrlich-Institut (PEI) and there in particular with Dr Christoph Conrad, who runs PEI’s Office for Scientific and Regulatory Advice. Regulatory supervision of the DZIF’s projects by the PEI calls for a TPMO that can process regulatory issues and maintain the PEI’s independent status as a higher federal authority at the same time. My further tasks include consulting ongoing projects from a product standpoint and also evaluating project proposals. I interact with researchers who conduct projects here and have applied for funding. The main responsibilities for me here are to analyse feasibilities, examine patent situations, understand the market or to simply offer advice. Of course, my role in this is pro-active, i.e. I am expected to identify technologies of interest to the DZIF, and to ensure that the legal grounds for implementing them are given through appropriate licence agreements and contracts. I am also currently setting up a DZIF Technology Transfer Consortium together with the regional patent exploitation agencies.

To what extent is the implementation and/or translation of projects in your hands?

Overall, the TMPO has a more coordinating and advisory role. Of course, I hope that I will soon be able to also specifically manage selected projects. If we are to do translational work in the sense of product orientation, a particular challenge will be accomplishing the regulatory pathways. This would mean that preclinical development must be conducted to regulatory standards, i.e. according to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Clinical trial application submissions and other procedures all the way up to starting patient recruitment would also be affected.  I would like to develop and offer services for infection researchers working in this country. This would include describing the required regulatory and organisational pathways as well as executing them from this office. So somebody would come to us and say: “DZIF, I would like to do a project with you. I have great technology and a project with enormous potential and I would like to work with you. Not only because you have funding, but also because you have the experience and the processes with which I can realise this project.” It would be important for me to not only be perceived as part of the DZIF infrastructure, but as someone who can help to advance projects quickly, concretely and visibly. This is what drives me.

In your position you surely need to be good at identifying promising and translatable active agent candidates – how did you develop this skill?

I have been doing similar things to what I currently do for over 15 years. I have identified active and diagnostic agent candidates in dozens of projects, developed them into pre-clinical development stages and followed them through to their clinical development stages. And yes, over time, you do develop a skill for this. But I also have to add that this intuitive skill is actually relatively secondary to the simple fact that you have to read and discuss, and you must be familiar with the state of the art technology. You have to know who works in the field and understand to what extent developments have advanced. Other factors that play a role are project leader and sponsor motivation for the project and the intensity of their interactions. Many things have to come together to finally achieve success. At the same time, you need an open and inviting approach to people to prepare the ground for open and honest discussions about a project’s progress.

Do you already have starting points for some early stage products? Could you give us one or two examples?

I think we have the great privilege of having researchers at the DZIF who contribute to product development very creatively and innovatively. In December, we had several meetings at the PEI with partners receiving DZIF funding, to obtain scientific advice on requirements for structuring a phase-I-study. In this case, we were looking at a project for boosting immune defence in patients with blood cancer by administering specially prepared white blood cells. There is a second project which has now received funding for a phase-I-study to investigate a Helicobacter pylori vaccine. Additionally this week, I have talks with a research group in Bonn that pursues a natural product candidate for a tropical disease indication in preclinical development. Clinical studies are also on the way for the indications malaria and hepatitis B. Yes, I see these projects ready to go into hospitals, and I also see other projects reaching this stage of maturity further down the line, in the next one, two or three years.

What do researchers have to do to develop plans together with you?

I think the easiest thing would be to tell me what you need. I imagine that it may frequently not be clear as to what can be expected from the TPMO. I, on the other hand, do not know what I can expect from the researcher. Hence, the easiest way of getting started would be to say “This is where I am at and I need this and this. Can you help me with it?” I will always try to find a joint way forward. I think what may be difficult for me and the TPMO’s role is if projects are predominantly run regionally without interacting with this central structure. In such cases our ability to coordinate would be reduced and, because our function establishes part of the DZIF identity, it could also weaken DZIF recognition. At the end of the day, one performance measure for all of us are the products going into the hospitals as well as those that are at some point launched onto the market.

Thomas Hesterkamp

After graduating in Human Biology in Marburg, Thomas Hesterkamp’s path led towards scientific applications relatively quickly. His PhD thesis “Stress response and protein folding in bacteria” was followed by research activities at the German Cancer Research Center in Heidelberg, and a post-doctoral position in Freiburg im Breisgrau. From there, Hesterkamp moved to Switzerland where he was involved with the development of Iclaprim and the search for new antibiotic agents at the pharmaceutical company Arpida. In 2000, Hesterkamp joined Evotec, one of the leading European biotechnology companies for drug research. Evotec collaborates with universities on the one hand and pharmaceutical companies on the other to create alliances for developing new products. He worked in senior management positions at Evotec where he was active at the interface between research and the pharmaceutical industry until he changed to his current position.