Within Germany, Baden-Württemberg's healthcare industry is at the top of the league. Yet, changes, such as digitalization and new licensing regulations are presenting the front runners with certain challenges. In his guest article, the Managing Director of the state-affiliated BIOPRO organization, Professor Ralf Kindervater, sets outs four propositions to explain what health researchers should do to ensure that Baden-Württemberg stays ahead.
“Bless you” That's something we hear more and more often these days: after all, the seasons in which people most often catch cold are upon us.
Today, we're in the fortunate position to be able to do a great deal for our health and to treat illnesses. The part of the economic sector that deals with health issues is known as the health economy. The part of the health economy concerned with production is the healthcare industry, which encompasses the biotechnology, pharmaceutical and medical engineering sectors. There are over 1000 companies active in Baden-Württemberg's healthcare industry, which are involved in production, development and research. Speaking of research – research is the foundation for all progress, including within the healthcare industry. This is evident in new treatment methods, diagnostic processes and technical devices. Everything we know today about the functional connections within the body, disease patterns and their causes, medicines, germs, genes, treatments, diagnostic processes, environmental factors, such as stress and nutrition as well as the promotion of good health, is thanks to research. The spectrum of research disciplines relating health is broad: biology, biotechnology, pharmaceuticals, medical engineering, information technology, physics but also the sports and nutritional sciences to name just a few examples.
Professors ought to be keeping an eye out for start-up potential and be sensitizing and their students to chances and opportunities and motivating them.
Managing Director of the state-affiliated BIOPRO organization, Prof. Ralf Kindervater
Proposition 1: Data is the new capital
This proposition is not new. Google, Facebook, Apple, Amazon, IBM are just a handful of examples for the economic importance of data. There are IT companies that use code, content and CPUS to analyze, processes and apply data. All sectors work with data in one way or another, and the healthcare industry is no exception to this. What is changing, however, is the importance of data in medical research. Until now, doctors have been able to treat illnesses using a plethora of diagnostic processes, medical devices and pharmaceutical agents or drugs, in other words, the three Ds.
There is now a fourth D – data. This means a fundamental change for medical research. So far, researchers have been concentrating on processes, devices and drugs.There were few connections between these different areas, because doctors tended to apply the respective resources successively as part of a graduated process: First, a blood test (diagnostic device), then ultrasound (medical device) to complete the diagnosis after which some type of medication (drug) was used to treat the complaint. At an event hosted by BIOPRO Baden-Württemberg, Professor Jochen Maas from Sanofi, a pharmaceutical company, recently provided some examples of the links between diagnosis, devices and drugs. Insulin pumps, which automatically dispense the correct amount of insulin within the patient's body, are a case in point.
The patient's blood sugar level is measured by a sensor within the body and the insulin pump is activated as required. Diagnostics, Only those who help to shape the future will stay on top The healthcare industry is facing a transformation, which will require a rethink in science and research. a medical device and a drug all act in harmony. However, there are very few companies within the pharmaceutical sector that have mastered this triad. So, when the medical research sector is inundated by huge data volumes, it will not exactly be easier for established companies to expand their own portfolios. Data-savvy companies, such as Google and Apple are working on driverless cars, which can be seen as evidence for the fact that these companies have no reservations about working with other sectors. They work at a high level of abstraction, identifying data pools, thinking about how they could be exploited and then developing new applications. So the medical research sector needs to look beyond existing analytic and diagnostic parameters. IT-related topics, such as artificial intelligence, the Internet of Things, virtual and augmented reality must also be considered in relation to applications in the healthcare economy. And, additional data needs to be taken into account and processed for health profiles. Which data and precisely how it can be used and protected is a challenge for the research community.
The university-based research community will need to deploy campus resources in new ways. Until now, high-performance computers have primarily been used by the engineering sciences. However, the desire for computing performance is now increasing in the life and medical sciences, as the synthesis between the biosciences, computer sciences and mathematics is already in full swing under the heading “system biology”, the objective of which is to map complex cellular processes with the aid of mathematical models and simulations. The data volumes generated during the simulation of metabolic cascades and intracellular signaling paths are enormous, but they deliver results that can be used in practice. Such data-based procedures are already established in the field of biotechnology. We should not fail to utilize these new methods in healthcare research.
For scientists active in medical research, the main question then changes from „can it be done?” to „how can we get this through the approvals process?”
Managing Director of the state-affiliated BIOPRO organization, Prof. Ralf Kindervater
Proposition 2: Medical research must take account of research right from the start.
The regulatory standards applicable to the medical engineering and pharmaceutical industries are very demanding. Progress has even created situations in which both sectors, i.e., the pharmaceutical and medical engineering sectors mesh. In such cases, it needs to be decided whether a given products is more characteristic of a medicament or a medical engineering application. In addition, the authorization modalities pertaining to the production of medicines, in particular, are currently undergoing a radical upheaval.
So, it can happen that a given product suddenly lands in a high risk medical technology class, although this was not intended at the start of the development process. It then needs to comply with much more stringent requirements, the costs increase and its profitability is called into question. Researchers need to be up-to-date on the subtle distinctions between the respective regulations as well as their ramifications. Contact centers should, therefore, be created where questions about licensing and approvals could be clarified in the early stages of research. For scientists active in medical research, the main question then changes from “can it be done?” to “how can we get this through the approvals process?” Ultimately then, it is the approval criteria that set the boundaries of feasibility, not technical sophistication. Greater support with regulatory issues right from the start would make research, particularly in the medical engineering field, more efficient and faster.
Proposition 3: The basics of starting a business should be taught as a standard part of the university curriculum
In every academic year, there an immense number of potential entrepreneurs, whose ideas and technologies could transform the relevant markets. Some of them will capitalize on their capacities, but most will abandon their ideas and seek careers outside of the business incubators and innovation highways. This is a significant loss both for the healthcare economy and patients, which could result in certain diagnostic processes or treatments only emerging at a later time or being developed elsewhere. 50 companies were launched in Baden-Württemberg's healthcare sector between January 2015 and June 2018, about half of which are biotechnology companies specializing in the development of novel therapeutic agents. That's extremely encouraging, both in terms of future therapeutic achievements and for the region. But, in my view, a few more would be very welcome.
We already have structures and programs in place to support new ventures. Nevertheless, in my opinion, the start-up culture still has too few supporters at the institutional level. We need to generate some enthusiasm for start-ups, precisely because the healthcare sector is so strictly regulated and can appear rather daunting to young entrepreneurs. Professors ought to be keeping an eye out for start-up potential and be sensitizing and their students to chances and opportunities and motivating them. It would be better still if the subject of entrepreneurship were a standard part of the academic curriculum. Then it would finally become what it should be – a strategic instrument for business development in Germany as a high-tech region, embedded within our universities.
If healthcare research is to have an impact where it is urgently required, namely on people, then networking is more important than the prestige of any journal.
Prof. Ralf Kindervater, Managing Director of BIOPRO Baden-Württemberg GmbH
Proposition 4: Reward collaboration and networks with an impact factor
If one considers the questions with which the healthcare industry is concerned, one has to conclude that the solutions can no longer be developed at the level of individual institutes or professorial chairs. For diseases such as cancer, we can hardly talk in terms of a clinical picture. The cellular and molecular-biological entanglements and the many consequences for the organism are more reminiscent of a collage made up of hundreds of images, so complex are the influencing factors involved. Thanks for technological developments and our high level of knowledge, we can now look at things from multiple perspectives. And yet, we still often get the impression that we can only recognize a small excerpt from the overall picture. To be able to advance medical research going forward, we will be more reliant than ever on establishing, exploiting and continuously pushing longterm collaborative arrangements. We need many collaborators to enable us to take in all the various perspectives on a given disease incidence. We need more consortia and more collaboration beyond the consortia, because more specialist disciplines need to be involved.
In our capacity as an innovation agency, we at BIOPRO Baden-Württemberg repeatedly find that many stakeholders know nothing about each other, but would be a good fit in terms of content. In the health economy, that applies particularly to the connections between academia and the business sector. Clearly, the old adage of the need to network is still as applicable as ever, but what we often forget when it comes to networking is that rapid successes are rare. The commitment to a given network requires two things: a lot of reciprocal visits and a preparedness to get involved.
The science community likes to cite the journal impact factor, in other words, the relative ranking of the journal in which one publishes one's findings, as a mark of quality. Regardless of how one feels about this practice , the fact remains that, if healthcare research is to have an impact where it is urgently required, namely on people, then networking is more important than the prestige of any journal. We should first increase our network impact factor and only then worry about journal ranking lists. The healthcare industry in Baden-Württemberg is at the top position within Germany in terms of employment, gross value added and export volume. In 2017 alone, some 88026 employees generated 16.5 billion euro gross value added. So, there's not much to complain about. But, enough of the self-congratulations! As everyone knows, it doesn't do to rest on one's laurels.
Prof. Dr. Ralf Kindervater
As a Graduate Chemist specializing in biochemistry and biotechnology, Professor Dr. Ralf Kindervater earned his doctorate at the Technical University of Braunschweig for his work in enzyme technology with the Gesellschaft für Biotechnologische Forschung mbH (Research Center for Biotechnology) in Braunschweig. Following stints at the Eberhard Karls University of Tübingen and the Fraunhofer Institute of Interfacial Engineering and Biotechnology IGB in Stuttgart, Kindervater held interim board memberships and managing directorships in several biotech companies. He has been the Managing Director of BIOPRO Baden-Württemberg GmbH in Stuttgart since 2003 with responsibility for the healthcare industry and bio-economy. Dr. Kindervater has held an honorary professorship at the Karlsruhe Institute of Technology since 2014, where he is active in the Faculty of Chemical and Process Engineering.