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Entrepreneurship is the act of creating and managing a new business to meet a market need. Key elements include innovation, risk-taking, and effective resource management. It requires resilience, adaptability, and strategic planning, playing a crucial role in economic development and societal progress. 

The fusion of transfer and entrepreneurship in life sciences research is crucial for translating laboratory discoveries into real-world applications. Researchers and academic staff in research centers play a key role in this process, converting scientific insights into commercial products that benefit society and health. This journey from research to market requires a combination of scientific expertise and business acumen, fostering innovation and contributing to both economic growth and societal well-being.

Entrepreneurship in the life sciences sector encompasses unique challenges and special aspects distinct from other industries. Here's a brief summary:

• Complex regulatory environment: navigating stringent and evolving regulations
• High R&D costs: significant investment with long development timelines
• Intellectual property challenges: Essential role of patents and risk of infringement
• Specialized knowledge needed: Dependence on scientific expertise and skilled personnel
• Funding issues: high initial capital requirement and challenges in attracting investment
• Market dynamics: navigating niche markets and understanding healthcare trends
• Ethical considerations: balancing profit with social responsibility and ethical concerns
• Collaborations essential: partnerships crucial for research, development, and distribution

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Summary: The Field Study Fellowship program, aimed at identifying customer needs through interviews and fostering a customer-focused mindset among scientists, offers up to €23,000 for personnel and material costs, and an additional €5,500 for field study experts. This program supports one or two individuals working part-time to full-time for three months, providing resources and expert guidance for conducting effective customer research. 

More information and application on the Helmholtz transfer website

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Summary: The Spin-off Program provides up to €230,000 in funding for personnel and material costs, with a 25% co-financing requirement from the research center, and offers advice from an external panel of spin-off experts. The program includes a two-phase process with initial kick-off, 1:1 expert support, participation in external programs like accelerators, and an expert review at the eighth month for further funding decisions, targeting individuals or teams with at least 100% personnel capacity and requiring direct supervisor and technology transfer center support

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The "GO-Bio initial" program, run by the German Ministry of Education and Research, supports early-stage life sciences research with innovation potential. It aims to advance research outcomes to make them eligible for more established programs like “VIP+”, “EXIST-Forschungstransfer”, and “KMU-innovativ”.

Pre-proposals can be submitted annually by February 15. The program includes two funding stages: an initial conceptual period (up to 12 months and up to 100.000€) and a feasibility stage (up to 24 months and up to 1 Million €). It also offers an add-on module for experimental projects at technology transfer institutions, lasting up to four years with a possible three-year extension.

More information and application here.

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In the first funding phase, GO-Bio next is aimed at research teams from German universities and research institutions who are willing to set up a company.

In the second funding phase, GO-Bio next supports small technology-oriented corporations. As a rule, these should have been founded as a result of the first funding phase, with the main know-how carriers of the underlying technology contributing their knowledge and manpower to the new company. An important prerequisite for the second funding phase is counter-financing from investors. Cross-entry into the second funding phase is possible. T

The requirements for this and information regarding registration can be found here.

The "Validierungsförderung - VIP+" is a German government funding program managed by the Federal Ministry of Education and Research (BMBF). It targets researchers from universities and non-university research institutions, supporting them in validating the technological and societal innovation potential of their scientific research.

The program funds projects for up to three years with a maximum of 1.5 million euros.

It's designed to bridge the gap between basic research and practical application, helping to turn research findings into innovative products, processes, or services. Applications for the program can be submitted continuously, and the evaluation is done regularly by a panel of experts.

For more information, please visit their website 

EXIST Transfer of Research has two phases of funding:
In the first phase, results of research that have the potential of becoming the basis of a start-up business are developed further. The objective is to carry out further resource development to clarify fundamental problems involved in converting academic findings into technical products and processes. The business concept based on these findings should be made into a business plan and the planned business start-up should be prepared systematically. In the second phase of funding further resource development, measures to start business operations and meeting the prerequisites for external business financing are at the centre of interest.

Find more information and application here.

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The EXIST Business Start-up Grant (Gründerstipendium) is a German government-funded program designed to support aspiring entrepreneurs and scientists from universities and research institutes in developing their technology-based startup ideas. The program provides financial assistance, including a living allowance for the founding team, material expenses, and coaching, typically for a period of one year. This grant aims to enable recipients to focus on developing their business plan and prototype without financial stress. The program also offers access to university resources and mentorship from experts, facilitating a smooth transition from academic research to a market-ready product or service. Additionally, EXIST fosters networking opportunities, helping grantees connect with potential investors and industry partners.

More information on the official site

• Program: EXIST-Women, supported by the German Federal Ministry for Economic Affairs and Climate Action, assists women at universities and research institutions in entrepreneurial development.
• Target Audience: Female graduates, scientists, students, and women with vocational training linked to a university. Excludes those who have received previous startup funding from federal or state governments.
• Offerings: A 12-month qualification program, individual coaching, mentor support, access to a national network, a one-time allowance of 2,000 Euros, and an optional 3-month scholarship (1,000 – 3,000 Euros/month).
• Commitments: Attend a founders seminar, participate in network events, and present a business idea in a one-pager at the end.
• Outcome: Development or refinement of a business idea, networking, and potential co-founder or financing connections.
• Location and Selection: Program conducted online or on-site, with participants selected by the universities.

For more details, visit the EXIST-Women websit

For detailed information about important dates, specific funding amounts, and application procedures, please visit the EXIST Women program page.

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European Innovation Council programs

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ELSA is short for Entrepreneurial Life Science Accelerator. The ELSA program kicks off with the Bootcamp in September. The other check-ins will take place in Göttingen in the period from October to December.

Find more information here.

More information and application here
 

The German Accelerator Life Sciences program is designed to assist life sciences startups from Germany in achieving global market success. It offers tailored support such as personalized mentoring, access to a global network of partners and investors, and individualized guidance on strategy, market entry, and operations.

The program is open to startups in diagnostics, digital health, medical devices, and therapeutics, providing resources and workshops for international expansion.

Participation is free, with no equity taken. For more information, visit their website.

The Science4Life Venture Cup is a prestigious German business plan competition focused on life sciences and chemistry. Established in 1998, it aims to support startup founders in these fields.

The competition is organized into three phases: idea, concept, and business plan, providing opportunities for participants to receive feedback and attend workshops.

Winners can attend Academy-Days for further development and have the chance to win significant prize money. The main sponsors are the Government of the State of Hesse and Sanofi.

For more detailed information about the Science4Life Venture Cup, you can visit their website.

The Creative Destruction Lab (CDL) offers a non-profit, objectives-based program designed for massively scalable, seed-stage, science- and technology-based companies, including a specific stream for health startups.

This program is well-suited for early-stage ventures or even pre-incorporation projects that have a prototype or key early validation data on their technology. The focus is on translational science and technology innovations that improve human health and wellness. CDL Health helps startups in areas like diagnostics, digital health, medical devices, and therapeutics to bring their innovations to market, offering advice and guidance from experienced entrepreneurs, operators, doctors, scientists, and investors.

The program involves mentorship, opportunities to raise capital, advice on technology roadmaps, and business development support from top students.

There are no fees for participation, and CDL does not take any equity. The program operates out of various locations globally, including Berlin, Oxford, Seattle, Toronto, Vancouver, and Wisconsin, and runs from October to June.

For more information, you can visit their website

The Life Science Accelerator Baden-Württemberg is a 12-month program aimed at fast-tracking life science startups. It offers two semester seminar cycles, individualized training, and a strong focus on life sciences.

The program includes tailored mentorship, expert sessions, and a robust network of mentors, corporates, and investors.

Startups can participate in pitch events and benefit from a program free of equity and fees. It's designed for BioTech, MedTech, and digital health startups, particularly those preparing for investment-readiness. The program provides comprehensive support from the idea stage to the final investor pitch. 

For more information, you can visit their website.

The 4C Accelerator, offered by the Medical Innovations Incubator, is a specialized program focused on MedTech startups. It provides comprehensive training and coaching in four critical areas: Commercialization, Certification, Clinical Studies, and Copyright, known as the 4Cs. The program includes interactive workshops, individual coaching, and practical training in Regulatory Thinking®. This approach helps startups integrate regulatory requirements into their business models from an early stage.

The program, which is free of charge, aims to prepare participants for investor readiness and consists of two parts: 15-day workshops followed by a year of individual coaching. It's designed to help startups navigate the complex healthcare industry, emphasizing the development of regulatory-compliant and entrepreneurially successful business models.

For more information, you can visit this website.

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Before being placed on the market, medicinal products and medical devices usually undergo an extensive authorization process.

• Quality, safety and efficacy of new medicinal products must be proven with the aid of data from extensive studies prior to market authorization.
• There are various authorization procedures in the European Union. A medicinal product can be authorized for individual countries, a group of countries or the entire European Economic Area.
• Even after being authorized, medicinal products still continue to be monitored. In the event of safety concerns, authorization can be permanently revoked or temporarily withdrawn.

Federal Institute for Drugs and Medical Devices

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health (BMG). The BfArM's core tasks include the licensing and registration of medicinal products, recording and assessment of risks related to medical devices, monitoring of the legal traffic in narcotics and precursors, as well as the publication of medical coding systems for healthcare sectors.

Paul Ehrlich Institute

The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, is responsible for the research, assessment, and marketing authorisation of biomedicines for human use (e.g. sera, vaccines, blood and tissues, allergens, advanced therapy medicinal products (gene therapeutics, somatic cell therapeutics, and biotechnogically manipulated tissue products)), genetically engineered blood components) and immunological veterinary medicinal products.

Authorization of medical devices in Germany

In order for medical devices to be placed on the European market or put into operation, they must be marked with a CE mark. The CE marking may only be affixed if the product meets the essential safety and performance requirements. Manufacturers must establish a special quality management system that, among other things, ensures that a risk management procedure (minimization of risks) and a clinical evaluation are carried out for each product. TÜV SÜD  e.g. has extensive know-how and in-depth experience with the global sales markets for medical devices. This means they can provide manufacturers with advice and support and provide them with effective support in the approval of their products in key markets worldwide.

 

When applying for authorization, pharmaceutical companies submit detailed documentation on quality, efficacy, and safety, which is reviewed by the relevant authority within a maximum of 210 days. The European Union offers various application procedures for medicinal product authorization:

National Procedure:

• Used for medicinal products intended solely for the German market.
• The Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) manages this process.

Decentralized Procedure (DCP):

• Facilitates simultaneous authorization in several EU countries.
• Often used for generic products.
• One country leads the review process.

Mutual Recognition Procedure (MRP):

• Expands national authorization from one country to others within the EU.
• Based on mutual recognition of an existing authorization.

Centralized Procedure:

• Applies for authorization across the entire European Economic Area.
• Coordinated by the European Medicines Agency (EMA) and involves experts from national authorities and the EMA’s Committee for Medicinal Products for Human Use (CHMP).
• The European Commission issues the authorization.
• Mandatory for new active substances for certain diseases like cancer, diabetes, autoimmune diseases, or rare diseases.

These procedures ensure a streamlined process for the authorization of medicinal products across different regions of the EU while maintaining rigorous standards of review.

The extent of documentation required for the authorization of a medicinal product depends on its novelty. Special authorization procedures may be applied in urgent situations or when the efficacy and safety of an active substance are well-known, allowing for authorization with less extensive documentation.

Accelerated Procedure at the EMA:

• The European Medicines Agency (EMA) offers accelerated authorization procedures for urgently needed medicinal products, such as those addressing severe illnesses or pandemics.
• Despite the expedited process, the EMA ensures rigorous review of data, maintaining high standards for quality, safety, and efficacy.

Orphan Drugs for Rare Conditions:

• Orphan drugs are developed for rare conditions that affect fewer than 5 in every 10,000 people in the EU.
• The EMA offers a free authorization procedure for these drugs, providing exclusive marketing rights for ten years upon authorization to offset research and development costs.

Medicinal Products for Children:

• New medicinal products must prove their suitability for children and adolescents through appropriate studies, as per Regulation (EC) No 1901/2006.

Authorization for Generics and Biosimilars:

• Generics, essentially identical to an authorized original (reference) medicinal product, do not require separate clinical trials for efficacy and safety, but must demonstrate comparable effects on the body.
• Biosimilars, typically complex biological products differing from the reference product, require separate laboratory studies and clinical trials to prove comparable effects.

This framework ensures the availability of necessary medicinal products while maintaining safety and efficacy standards.

Almost all new medicinal products require authorization, but there are exceptions where a simplified registration procedure is applicable, or standard authorization exempts certain products from the need for full authorization.

Registration Procedure:

• Used for homeopathic medicinal products without a specific therapeutic indication and traditional herbal medicinal products.
• For these products, pharmaceutical quality and safety must be demonstrated.
• In the case of traditional herbal medicinal products, efficacy and safety are shown through evidence of traditional use, requiring at least 30 years of medicinal use, including 15 years within the European Union.
• Unlike standard authorization, clinical trials are not necessary to prove efficacy in the registration process.

Standard Authorizations:

• Certain medicinal products are exempt from mandatory authorization if they meet established quality, efficacy, and safety standards and pose no potential risk to people.
• Examples include many herbal medicinal teas or medicinal products individually prepared in pharmacies.

This system allows for certain less complex medicinal products to enter the market through less rigorous processes while ensuring their safety and qualit

Clinical trials are essential for evaluating the quality, efficacy, and safety of new medicinal products and are necessary for the authorization of new active substances. These trials follow preclinical studies conducted on cells and animals to ensure the product's non-toxicity.

Clinical trials are divided into four phases, which sometimes overlap:

Phase 0: assessment of pharmacokinetics, particularly oral bioavailability and half-life of the drug in small, subtherapeutic doses in a very small number of patients. Often skipped for Phase I.

Phase I: involves a small group of healthy volunteers (less than 100), mainly to assess safety and optimal dosing, except in certain cases like cancer where affected patients are involved from the start.

Phase II: testing of drug on participants (100–300 participants with a specific disease) to assess efficacy (therapeutic effect is not assumed before) and side effects.  

Phase III: testing of drug on participants (300–3,000 people with a specific disease) to assess efficacy, effectiveness and safety (therapeutic effect is assumed).

Phase IV: post marketing surveillance in public to monitor long-term effects and detect rare side-effects.

Quality criteria for clinical trials include having both a treatment group and a control group, where the latter receives a placebo or an established product without participants' knowledge. This process, known as "blinding," and random assignment to groups are crucial for unbiased results. Voluntary participation and the option to withdraw at any time are also fundamental principles of clinical trials.

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A new drug approval typically lasts for five years, or one year in the case of a conditional approval. After this period, experts review the product to ensure that its medical benefits still outweigh its risks. If there are no safety concerns after the first five years, the approval can be renewed indefinitely.

Monitoring of approved drugs
The Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (PEI), in cooperation with the European Medicines Agency (EMA) or other EU regulatory authorities, monitor the side effects of approved drugs.
Very rare side effects that occur after marketing authorization, especially serious ones, may lead to the withdrawal or temporary suspension of marketing authorization.
Post-approval changes:

If a pharmaceutical company needs to make changes to a drug after it has been approved, it must notify the regulatory agency. Significant changes require approval from the agency.

Black triangle symbol:
Products with new active ingredients, biological products, and those with conditional approval are marked with a black triangle to indicate careful monitoring due to potentially limited data, especially on long-term use.
More information about the black triangle can be found on the BfArM website.

Coverage by health insurance companies:
In Germany, health insurance companies cover the costs of approved drugs.
In the first year after approval, the manufacturer determines the price of the product. Thereafter, the Federal Joint Committee (G-BA) determines the appropriate price based on an early benefit assessment.