Longevity biotech investing in a healthier future, Regulation in the biotech industry: key issues for investors and innovators in Poland and globally

Publication date: April 04, 2023

On 5 April 2023 KIEŁTYKA GŁADKOWSKI KG LEGAL will participate in the conference “Longevity Biotech: Investing in a healthier future”. As part of its life science specialisation, our biotech and pharma lawyers offer comprehensive legal services to its clients in many areas of law, including extensive legal services to companies operating in the longevity biotech sector and biotech companies engaged in life extension and human health. Within this specialism our law firm offers assistance in respect of trademark protection and patent issues, regulatory law, certification, contractual, and litigation and arbitration issues. At KG Legal, we know that a key role in the biotechnology sector is innovation and responsiveness to changing market needs. Therefore, we offer our clients a proactive approach, flexibility and efficiency in action. All these qualities of our firm make us recognized as one of the leading law firms in Poland and the world, especially in the field of cross-border specialization and knowledge. As a result, our firm is regularly recommended by international rankings such as the Legal 500.

Longevity biotech investing in a healthier future

KG LEGAL Law Firm is pleased to announce that it will participate in a conference on longevity biotech investment. The theme of the conference is “Longevity biotech investing in a healthier future”. The conference is designed to introduce investors to the longevity biotech industry – Focused on delivering clinically transformative products that solve the most challenging aspects of today’s medicine, and to help navigate the rapidly changing investment landscape in this field. The conference will discuss defining longevity biotech, the opportunities, risks and business models associated with investing in companies in this industry. Speakers at the conference will include Robin Lauber, CEO of single family office Infinitas Capital, Davide Ottolini, Founding Partner at Korify Capital, and James Peyer, PhD, CEO and co-founder of Cambrian Bio.

Robin Lauber is an experienced angel investor and entrepreneur. He has co-founded a number of ventures, including his family offices Infinitas Capital, Korify Capital and real estate company GreySky Properties Holding AG. He is a graduate of the University of Basel and Cass Business School in London.

Davide Ottolini – Co- Founder and Managing Partner at Korify Capital. Koeify Capital is an investment firm that is focused on the biotechnology sector in the United States, Europe and Israel. Their goal is to invest in companies that help people live longer, healthier and happier lives, both by preventing age-related diseases and treating mental illness. Davide Ottolini is also a General Partner at Infinitas Capital. 

James Peyer, CEO and co-founder of Cambrian Bio, has dedicated his life to the mission of preventing diseases such as cancer and Alzheimer’s. He was a founder and managing director at Apollo Ventures, the world’s first international venture capital firm focused on the longevity industry. He also worked as a biotechnology research and development specialist in McKinsey & Company’s New York office, serving important pharmaceutical clients. He earned a PhD in stem cell biology from the University of Texas Southwestern Medical Center as a National Science Foundation Fellow and received his bachelor’s degree with honors from the University of Chicago.

Biotech Start-ups: Innovative Solutions for Medicine, Agriculture and Industry.

Biotechnology companies, also known as biotech start-ups, are companies that are engaged in scientific research, the manufacture and distribution of biological products and the application of biological technologies, molecular biology in various fields such as medicine, agriculture, industry and environmental protection. These companies apply the latest advances in science and technology to develop innovative solutions that have a positive impact on the quality of human and animal life. The focus of biotechnology companies is primarily the study and use of biomolecules, such as proteins, enzymes, nucleic acids or polysaccharides. Their goal is to develop new methods of diagnosing diseases and therapies based on biomolecules, as well as to provide solutions for the growing healthcare market.

It is important to mention that biotech companies play a key role in today’s world, as their innovative approaches to medicine can revolutionize the way diseases are treated. Through molecular research and the development of new drugs, these companies are striving to find solutions to diseases that were previously incurable or required lengthy and expensive treatment. The biotechnology sector is one of the fastest-growing sectors of the economy, with an estimated market value of hundreds of billions of dollars. Such companies focus on researching and developing innovative solutions for the elderly and finding ways to improve the quality of life for seniors. Examples include anti-cancer, anti-viral, anti-inflammatory drugs, as well as research into neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease. Using the latest biotechnology methods, these companies are researching medications, dietary supplements, functional foods, cosmetics, biodegradable materials, biofuels, as well as laboratory research and consulting services.

Biotechnology companies are popular with investors because of their huge growth opportunities and prospects for high profits. As of 2021, the global biotechnology market was worth $714.5 billion, up 7.4% from the previous year. It is expected that in the next few years the value of the biotech market will continue to grow, and with it the number of biotech companies and investors. First, many of these companies have strong growth potential, which means that an investment in them can yield high returns. Second, many are engaged in innovative projects that can have a positive impact on human health and the environment, which attracts investors with social interests. Third, biotech companies are often backed by governments and nonprofit organizations that invest in scientific research and technological innovation, which contributes to the value of these companies. 

Examples of innovative biotech companies include Moderna, BioNTech and Novavax, which have developed effective vaccines against COVID-19. Other examples include Genentech, Biogen, Vertex Pharmaceuticals and Amgen, which have already developed effective medications.

Longevity biotech companies in Poland and around the world

Longevity biotech is biotechnology sector that focuses on developing therapies, medications and medical products that aim to extend the length and quality of human life. Longevity biotech companies are engaged in molecular, genetic and pharmaceutical research to develop new drugs and therapies that can help treat diseases associated with the aging process. Examples of longevity biotech companies include: 

Unity Biotechnology, which is developing therapies for age-related diseases such as arthrosis and Alzheimer’s disease; this company is located in San Francisco and is researching medications to delay the aging process. In 2018, the company conducted an IPO on NASDAQ, raising more than $200 million.

BioAge Labs, which uses artificial intelligence technology to study the aging process and develop new medications, In 2020 the company raised more than $90 million in a Series C funding round. 

Juvenescence, which focuses on research into age-related diseases such as Alzheimer’s, heart disease and cancer, In 2018, the company raised more than $100 million from investors including Amazon and GlaxoSmithKline.

Insilico Medicine, which uses artificial intelligence to design new medications and therapies.     

There are also longevity biotech companies in Poland, although the sector is still relatively undeveloped. One example is Bio-Tech Consulting, a company that, among other things, researches new drugs and therapies related to age-related diseases, and Selvita, which focuses on researching new anti-cancer therapies and developing new drugs and therapies for patients with metabolic and autoimmune diseases.

What legal issues do longevity biotech companies face?

Longevity biotech companies engaged in research and development of therapies and drugs face a number of legal issues, both in Poland and internationally. Here are some of those issues:

Intellectual property protection – Longevity biotech companies typically invest heavily in research and development of new drugs and therapies. To protect their investments, they must pay attention to protecting their intellectual property rights, such as patents, trademarks and industrial secrets. 

Regulatory compliance – Research and development of new drugs and therapies usually requires clinical trials and regulatory approvals.

Ethical requirements – In developing new drugs and therapies, longevity biotech companies must comply with ethical and moral requirements. In some cases, this may mean that certain studies or tests are not allowed or must be carried out with great care.

Product liability – The longevity biotech companies are responsible for the safety of their products and therapies. In the event of any illegal or ethical activities, these companies can be charged with product liability violations. 

Funding – Longevity biotech companies often need large amounts of funding for research and development. As a result, they need to seek investors and pay attention to various financing issues, such as restrictive loan terms or stock issues.

Patent law: Biotechnology companies, including longevity biotechs, can apply for patents on their discoveries and inventions. Many of these patents relate to discoveries in genetics, gene therapy and other scientific fields, which can lead to litigation and legal challenges. 

Copyright: Biotechnology companies often work with software and other information technologies that may be protected by copyright. If these rights are violated, companies may have to pay damages or be subject to criminal prosecution.

Right to privacy: The operations of longevity biotech companies may require the use of patient data and other medical information. As such, the companies must comply with privacy laws, including data protection laws.  

Patient consents: Many biotechnology studies require the use of human samples and medical data. To do so, companies must obtain patients’ consents to use their data and samples. 

Market regulations: Biotechnology companies must comply with strict market regulations, such as product registration requirements, certification and approval procedures, as well as quality standards.

Legal regulations for biotech companies in Poland: What do you need to know before starting your own company?

In Poland, longevity biotech companies are regulated by a number of different laws that can affect their operations, such as the Pharmaceutical Law – the Pharmacy Act of September 6, 2001 and the Medical Devices Act of April, 7, 2022 regulate the pharmaceutical market in Poland and set requirements for clinical trials, registration and distribution of drugs and medical devices. Longevity biotech companies must comply with these regulations when developing new therapies and medications.

Additionally longevity biotech companies can be affected by the Regulation EU 2017/745 on medical devices.

Patent Law – The Industrial Property Law of June 30, 2000 and the Law on the Protection of Plant and Animal Varieties of July 24, 2015 regulate the protection of intellectual property in Poland, including patents for inventions and plant varieties. Longevity biotech companies must obtain relevant patents for their research, therapies and drugs.

Personal Data Protection Act – The Personal Data Protection Act of May 10, 2018 regulates the processing of personal data, including patient data, by longevity biotech companies. It requires companies to comply with relevant rules for processing and protecting personal data. These regulations introduce a number of obligations for the processing of personal data by companies, including biotech companies. For these companies, due to the nature of their business, the personal data processed is often particularly sensitive and legally protected. Biotech companies may process the personal data of their employees, contractors, as well as patients participating in clinical trials, for example, as part of the process of bringing new drugs to market. The processing of this data must be carried out in accordance with the provisions of GDPR, which means, among other things, that consent must be obtained to process the data, that it must be secured against unauthorized access, and that the rights of data subjects can be realized. In the event of a violation of GDPR, biotechnology companies may be liable for fines, as well as negative image and reputational consequences.