Team:LMU-Munich/Application/Expertise

From 2014.igem.org

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(Dr. Andreas Koch & Dr. Gerhard Weinzierl)
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Our Motivation
Our Motivation
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* Informations on the Research and Development process of new medicinal products
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* Informations on the Research and Development process of new medical products
* Principles of patents and their role for funding
* Principles of patents and their role for funding

Revision as of 15:10, 12 October 2014

Experts

Medizin Innovativ - MedTech Pharma 2014

"Funktion": Congress and Exhibition

"Anliegen": Learn about new developments of the health sector and network with its experts

"What we learned": We gained an in depth-look into innovations of the broad medical field and their corresponding affairs and had a great opportunity to connect with participants and exhibitors from various disciplines.


To learn about recent developments in the healthcare sector and network with experts, we participated at the two-day congress Medizin Innovativ taking place at the Nuremberg Convention Center in July. This congress with nearly 1000 participants has become one of the most important meeting points for the medical sector in Germany in recent years. Combining a series of lectures on scientific, technical and operational market-related topics with a large exhibition comprising 120 exhibitors, the congress provides ideal conditions to connect participants from various disciplines. The variety of participants from company representatives to scientists and clinical users has always been a unique feature of this event. On the first day, we attended the lecture session about Regulatory Affairs: Pharma&Diagnostics which informed us about the new European regulations on clinical trails. In this session, we also learned about risk management of medical products. Later on, we heard about innovative Smart Medical Systems. During the breaks, we introduced our project idea to several exhibitors, such as representatives of pharmaceutical companies or patent lawyers, in order to receive feedback, first estimations about its feasibility and problems we might face. The next day, we continued our tour through the exhibition and talked to regulatory authorities and companies focusing on the design and accomplishment of clinical trails. Moreover, we had a look at the poster session, where scientists from universities and research institutions presented their latest results. In the afternoon, we participated in the lecture session about Market Access Strategies, where we heard about different financing strategies and about price regulations on the European market. All in all, the congress was a great opportunity to get introduced into all facets of the healthcare sector. We had an awesome chance to network with experts and are very thankful for their kind cooperation and their feedback, which gave us a lot input for our further considerations on our project’s potential and its implementation strategy.

Find more impressions and information:

http://www.medtech-pharma.de/english/congress/congress.aspx

Prof. Dr. Jörg Hasford

"Funktion":

  • University Professor for Medical Information Processing, Biometry and Epidemiology at the Ludwig Maximilian University of Munich
  • Co-chairman of the „Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V.“


"Unser Anliegen":

  • How does the admission procedure of drugs work? What are the relevant authorities?
  • Which ethical aspects have to be considered?


"What we learned":

  • Overview about admission procedure primarily at national level and current legal requirements
  • Personal contacts to several authorities
  • Detailed information about the work and responsibility of ethics commissions in the design and implementation of clinical trials


In the end of July 2014 a delegation of our team had the great pleasure to meet Prof. Dr. Jörg Hasford at the University Clinic Großhadern after we listened to his very interesting and for our project highly useful talk at the „Medizin Innovativ – MedTech Pharma 2014“ Congress in Nuremberg. After a short overview about the iGEM competition and all its facets, we introduced our BaKillus project and our idea of using BaKillus as a nasal spray. We were really excited of getting feedback from an expert with medical background and were delighted to hear that also in his opinion there is an absolute need of new and innovative therapies against multi-resistant bacteria. He explained that our BaKillus spray would be defined as a drug and not as medical device since BaKillus interacts with the environment on chemical levels. Therefore our nasal spray has to adhere to the drug law of the particular country or community of states. He further showed us the milestones every new drug has to overcome – starting from preclinical evaluation to different clinical phases to application for marketing authorisation – only possible with close collaborations with the responsible authorities. Fortunately Prof. Hasford could name us several authorities we could address, sometimes even with personal contact information. Not only synthetic biology but of course also the admission procedure of new drugs has to face ethical concerns. Since Prof. Hasford has been a member of several ethics commissions we had the privilege to get a in-depth look in the work of an ethics commission, which is always looking for the right balance between the risks and the benefits for the patient and the general public.

Dr. Andreas Koch & Dr. Gerhard Weinzierl

Function

  • European Patent attorneys and Co-Founders of “Schiweck, Weinzierl, Koch - European Patent Attorneys”
  • Assistant lecturers in the area of “IP and patent laws” for the Department of Genetics, Faculty of Biology, LMU


Our Motivation

  • Informations on the Research and Development process of new medical products
  • Principles of patents and their role for funding


Take-Home Message

  • Patents protect your innovation
  • Patents are indispensable for the funding of R&D process of medical products


To get an insight into the principles of marketing a new medical product we met with Dr. Andreas Koch and Dr. Gerhard Weinzierl, two european patent attorneys. It is standard practice that the R&D process of a new promising product or compound always starts with a patent application. However, our intention for BaKilllus was to create a cheap medication available to everyone. In the discussion Dr. Andreas Koch and Dr. Gerhard Weinzierl pointed out that patents should not only be regarded as a tool favouring big companies and hindering progress by prohibiting the use by other researchers, but also as a mechanism to protect your innovation. This is specifically important for BaKillus as a medical product: the patent serves as a guarantee for potential investors and ensures the funding of the high costs associated with the approval of a new medical product. Due to their experience we were provided insights into the biomedical industry and had the chance to discuss the emergence of new uprising companies, e.g. [http://www.glycotope.com/ Glycotope]. The discussion helped us shed light into the marketing process and showed us that patents are not bad per se, but are a useful tool depending on the intended use of the owner. Moreover, tools like the BioBrick™ Public Agreement (BPA) show that patents and open source are not a contradiction.


Hi there!

Welcome to our Wiki! I'm BaKillus, the pathogen-hunting microbe, and I'll guide you on this tour through our project. If you want to learn more about a specific step, you can simply close the tour and come back to it anytime you like. So let's start!

What's the problem?

First of all, what am I doing here? The problem is, pathogenic bacteria all around the world are becoming more and more resistant against antimicrobial drugs. One major reason for the trend is the inappropriate use of drugs. With my BaKillus super powers, I want to reduce this misuse and thus do my part to save global health.

Sensing of pathogens

To combat the pathogenic bacteria, I simply eavesdrop on their communication. Bacteria talk with each other via quorum sensing systems, which I use to detect them and trigger my responses.

Adhesion

The more specific and effective I can use my powers, the lower the danger is of provoking new resistance development. So I catch pathogens whenever I get hold of them and stick to them until my work is done.

Killing

Talking about my work - killing pathogens is finally what I am made for. In response to quorum sensing molecules of the pathogens, I export a range of antimicrobial substances leading to dissipation of biofilms and the killing of the targeted bacteria.

Suicide switch

When the job is done and all the bad guys are finished, you don't need a super hero anymore. So after fulfilling my work I say goodbye to the world by activating my suicide switch.

Application

Of course I'm not only a fictional hero, but a very real one. In two different prototypes, I could be used for diagnosis or treatment of pathogen-caused diseases. However, there is still a whole lot of regulational and economical questions that have to be answered before.

See you!

So now you know my short story - and it is time for me to return to my fight for a safer world. Feel free to take a closer look on my super powers, the process of my development or the plans for a medical application.