01.09.2024
The Europe Issue: Challenges and Opportunities for Bio-startups
Welcome to the second issue of our online magazine, where we explore the dynamic and diverse landscape of European biotech and healthcare innovation. Our goal in this edition is to equip you with a foundational understanding of the European biosciences ecosystem, while also offering a wide range of perspectives and strategic insights that can help […]
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13.10.2024
Navigating Regulatory Differences: The Role of Qualified Persons in Israel and the EU
In the global landscape of clinical trials, regulatory frameworks vary significantly from one region to another. One of the most critical aspects of these frameworks is the role of the Qualified Person (QP), a function that is mandatory in the European Union but differs considerably in other regions, such as Israel. Understanding these differences is […]
Read more
13.10.2024
Portugal is more than sun, good beach, food, and vacations.
Portugal is mostly seen abroad as a country of good food, beautiful beaches and wonderful to spend some sunny days, but for Biotech and pharmaceutical companies, especially those that are dedicate to rare diseases, there are good opportunities. Why must Biotech invest in Portugal? The rare disease market in Portugal is quite “young,” starting almost […]
Read more
13.10.2024
5 Unique Attributes Powering Europe’s Bio-Startup Revolution: Unlocking Opportunities for Growth and Innovation
Unlock Europe’s biotech revolution! In this exclusive piece, David Brühlmann, Managing Director of Brühlmann Consulting and Host of the Smart Biotech Scientist Podcast, reveals five key drivers transforming the European bio-startup landscape. From ancient academic powerhouses to cutting-edge funding models, discover how Europe’s unique ecosystem is reshaping biotech’s future. Whether you’re a scientist, startup entrepreneur, […]
Read more
13.10.2024
Harmonizing Regulatory and Reimbursement Strategies: Navigating EU and US Market Access for Medical Devices and Pharmaceuticals
Navigating the regulatory landscape for medical devices and pharmaceuticals is a complex endeavor for startups aiming to enter both the EU and US markets. While securing approval from the European Medicines Agency (EMA) or, for medical devices, compliance with the Medical Device Regulation (MDR), is often seen as an initial step, it is crucial to […]
Read more
13.10.2024
To CDISC or not to CDISC? or: a time and place for everything.
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organisation devoted to the development data standards for use in broader medical and especially in clinical research. Both the US FDA and the Japanese PMDA require the use of specific CDISC standards in submissions, but notably the EMA in Europe does not have equivalent requirements. […]
Read more
01.09.2024
Reflections on Working with the EMA: A Personal Journey Through the European Regulatory Affairs Landscape
In 1995, I attended a conference in Paris where a significant announcement was made—the establishment of the European Medicines Agency (EMA). At the time, the vision was ambitious: within three years, all medicinal products would be approved through a centralized procedure, streamlining the process across Europe. Nearly three decades later, while this vision remains only […]
Read more
01.09.2024
Orphan Designation
An “orphan designation” is granted by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a drug/biologic to create financial incentives for developing therapies for rare diseases. This article focuses on incentives offered, the prevalence that defines an orphan disease, as well as the procedural process of obtaining the designations. Introduction A […]
Read more
01.09.2024
Navigating the Clinical Supply Chain for Clinical Trials in the EU
At IMP Clinical Supply Services Ltd., we are privileged to oversee a crucial aspect of the clinical trial process: the clinical supply chain. The European market presents a unique set of challenges and opportunities for bio-startups, particularly in the realm of clinical trials. Understanding and navigating these complexities is essential for any company looking to […]
Read more
01.09.2024
Leveraging EU Funding: A Bio-Startup’s Gateway to the European Market
In the competitive and innovation-driven pharmaceutical industry, accessing the European market can be both a challenge and an opportunity for bio-startups. European Union (EU) non-dilutive funding offers vital support to startups aiming to navigate this complex environment, providing the financial and strategic resources needed to bring innovative solutions tothe market. The Power of EU Funding […]
Read more
01.09.2024
Why Biopharma Companies Must Prioritize GDPR Compliance for EEA and UK Clinical Trials
In the dynamic and highly regulated landscape of biopharmaceuticals, compliance with international regulations is crucial for maintaining operational integrity and securing future business opportunities. One critical regulation that biopharma companies worldwide must prioritize is the General Data Protection Regulation (GDPR) when conducting clinical trials in the European Economic Area (EEA) or the United Kingdom (UK). […]
Read more
01.09.2024
Differences in Investigational Product Labeling for Clinical Trials Requirements Between the US and the EU
Investigational product (IP) labeling for clinical trials is a critical aspect of regulatory compliance and patient safety in both the United States (US) and the European Union (EU). While there are similarities in their respective requirements, several key differences exist that sponsors and clinical trial managers must understand and navigate effectively. Regulatory Framework In the […]
Read more
01.09.2024
Navigating Quality Guidelines for Biological Investigational Medicinal Products: A Comparative Analysis of EMA and ICH Q7 Standards
Good Manufacturing Practices (GMP) are outlined in several guidelines. For commercial Active Pharmaceutical Ingredients (APIs), the primary reference is ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients). However, when manufacturing biological products during clinical studies in the EU, the quality requirements detailed in ICH Q7 may be overly stringent. It is advisable to […]
Read more
01.09.2024
Reimbursement for Digital Devices: The GermanDigital Health Applications (DiGA)–A Short Overview
Uniquely in Europe, Germany offers a pathway for certified digital health applications of risk class I or IIa according to MDR to be prescribed by medical doctors and the manufacturers are reimbursed by the statutory health insurance companies. Only digital health applications that are listed in the so called DiGA directory of the BfArM (Federal […]
Read more
01.09.2024
Navigating Second Medical Uses: Chemical Solutions with a Mechanical Cause
The European Patent Office issued a decision which could allow a broader range of claimed innovations to benefit from the so-called “second medical use” exception of Article 54(5) of the European Patent Convention (EPC). Such an exception is limited to a “substance or composition” only and is thus not available for medical devices. Historically, compounds […]
Read more
01.09.2024
Cracking the Swiss Market: Essential HR and Legal Strategies for Long-Term Success
In 2023, loads of new companies popped up worldwide, for instance, around 600k in Germany and 52k in Switzerland alone. But here’s the kicker: about 75% of these won’t be around in five years. Why? It’s a mix of many reasons, such as cultural issues, employment challenges, lack of ambition, and inflexibility in changing their […]
Read more
01.09.2024
Navigating the EMA’s SME Initiative: A Strategic Advantage for Biopharma and MedTech Startups
The European Medicines Agency (EMA) is a cornerstone in the regulation of medicines across the European Union (EU). Recognizing the unique challenges faced by small and medium-sized enterprises (SMEs) in the biopharma and MedTech sectors, the EMA has established a dedicated SME initiative. This program is designed to support innovation by simplifying regulatory processes and […]
Read more
01.09.2024
Clinical adoption of AI-based products in lung cancer screening: barriers to market entry, and a comparative, multi-center, cross-European study.
Lung Cancer is the second most common type of cancer and the number one cause of cancer death. The majority of patients diagnosed with lung cancer are already in the late stages and, therefore, have a poor prognosis with a five-year survival rate of only 10–20%. Diagnosing lung cancer at an early stage, before the […]
Read more
01.09.2024
Navigating the European Bio-Startup Ecosystem: A Founder’sGuide
The European bio-startup scene is a mosaic of invention, challenge, and opportunity where entrepreneurial spirit meets modern science in settings buzzing with activity. Over $54 billion financed over 1,936 deals in just the first half of 2024 indicates a startling 102% year-over-year rise.1 At the core of this ecosystem are energetic innovation hubs, notably in the […]
Read more
28.05.2024
The Bio-Startup Standard Crosswords
Read more
28.05.2024
The Tech Transfer Issue: Bridging Innovation and Industry
In the pharmaceutical world, Technology transfer (TT) is part of the product’s lifecycle. TT refers to the process of transferring knowledge, technologies, and methodologies from one institute or facility to another. This broad definition encompasses various activities, from moving academic discoveries to the commercial sector to sharing innovations between different companies or research facilities. In […]
Read more
28.05.2024
The Founder’s Perspective: Building Trust and Identifying Gaps for Successful Technology Transfer
From my experience as a biotech startup founder, the technology transfer (TT) process involves due diligence and relationship building with the principal investigator (PI) and lab members, the Tech Transfer Office (TTO), Or an incubator’s management team. Most times, things don’t go as smoothly as expected, and this article will focus on what can be […]
Read more
28.05.2024
Technology Transfer Companies: Turning Academic Research into Tangible Solutions and Startup Companies
Technology transfer companies play a crucial role in translating groundbreaking research into practical solutions that benefit society. They serve as bridges between academia and industry, facilitating the transformation of theoretical discoveries into marketable products and services. Ramot, established in 1973a subsidiary of Tel Aviv University Ltd. is the Tech-Transfer company of Tel Aviv University, responsible […]
Read more
28.05.2024
Assessing the Market Need for a New Idea in Healthcare
In the ever-evolving field of healthcare, bringing a new idea to fruition involves a meticulous understanding of the market need. Whether it’s a new drug, a revolutionary medical device, a healthcare app, or a unique service model, the success of such innovation hinges on its relevance and demand within the healthcare market. Here’s a structured […]
Read more
28.05.2024
Early Market Access Planning for Successful Commercialization of Healthcare Innovations in the USA
There are many considerations to account for, both prior to and during the development of any new healthcare solution or innovation. Proactive steps such as performing market research, assessing competitors, and developing a strategy to comply with country-specific regulatory requirements are very important and well-established. If the strategic plans for your offering include making your […]
Read more
28.05.2024
Unlocking EU Funding for Pharma Startups and Tech Transfer
The pharmaceutical industry is at the forefront of the European Union’s efforts to drive innovation and technological leadership. A staggering 25% of pharmaceutical startups emerge from technological transfer, the process of transforming cutting-edge research into commercially viable products and services. By bridging academia and industry, tech transfer catalyzes economic growth, job creation, and groundbreaking deep-tech […]
Read more
28.05.2024
Technology Transfer Regulatory Requirements
The WHO guidelines define technology transfer as a logical procedure that controls the transfer of products, processes, and knowledge, together with their documentation and professional expertise, within a facility or between facilities. It may involve development, manufacturing, and testing sites. The transfer may occur during a product’s development phases or after obtaining marketing authorization. The […]
Read more
28.05.2024
Streamlining Pharmaceutical Technology Transfer for Enhanced Drug Production
In the pharmaceutical industry, technology transfer is critical to ensuring that knowledge about product development and manufacturing processes is shared effectively across different phases and sites. Technology transfer aims to facilitate product realization by transferring essential process knowledge and control strategies between development and manufacturing teams and across manufacturing sites. Collaborative Foundations for Success The […]
Read more
28.05.2024
Analytical Technology Transfer in the Pharma Industry
In the pharmaceutical industry, analytical technology transfer (ATT) is a crucial process that involves moving validated analytical methods from one laboratory to another. This is typically done between different locations within the same company or between different companies. The transfer ensures that the recipient laboratory can perform the analytical method reliably and consistently, producing results […]
Read more
28.05.2024
Drug Licensing Vs. Apartment Rental
The Virtual-Tangible Fine Line Drafting a technology license agreement is a complex professional matter, typically handled by lawyers specializing exclusively in the field. Surprisingly, the principles and rules of an apartment rental agreement, a topic familiar to many, can assist in navigating and understanding the concepts of IP licensing. Below, we will review the overlapping […]
Read more
13.10.2024
Navigating Regulatory Differences: The Role of Qualified Persons in Israel and the EU
In the global landscape of clinical trials, regulatory frameworks vary significantly from one region to another. One of the most critical aspects of these frameworks is the role of the Qualified Person (QP), a function that is mandatory in the European Union but differs considerably in other regions, such as Israel. Understanding these differences is […]
Read more
13.10.2024
Portugal is more than sun, good beach, food, and vacations.
Portugal is mostly seen abroad as a country of good food, beautiful beaches and wonderful to spend some sunny days, but for Biotech and pharmaceutical companies, especially those that are dedicate to rare diseases, there are good opportunities. Why must Biotech invest in Portugal? The rare disease market in Portugal is quite “young,” starting almost […]
Read more
13.10.2024
5 Unique Attributes Powering Europe’s Bio-Startup Revolution: Unlocking Opportunities for Growth and Innovation
Unlock Europe’s biotech revolution! In this exclusive piece, David Brühlmann, Managing Director of Brühlmann Consulting and Host of the Smart Biotech Scientist Podcast, reveals five key drivers transforming the European bio-startup landscape. From ancient academic powerhouses to cutting-edge funding models, discover how Europe’s unique ecosystem is reshaping biotech’s future. Whether you’re a scientist, startup entrepreneur, […]
Read more
13.10.2024
Harmonizing Regulatory and Reimbursement Strategies: Navigating EU and US Market Access for Medical Devices and Pharmaceuticals
Navigating the regulatory landscape for medical devices and pharmaceuticals is a complex endeavor for startups aiming to enter both the EU and US markets. While securing approval from the European Medicines Agency (EMA) or, for medical devices, compliance with the Medical Device Regulation (MDR), is often seen as an initial step, it is crucial to […]
Read more
13.10.2024
To CDISC or not to CDISC? or: a time and place for everything.
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organisation devoted to the development data standards for use in broader medical and especially in clinical research. Both the US FDA and the Japanese PMDA require the use of specific CDISC standards in submissions, but notably the EMA in Europe does not have equivalent requirements. […]
Read more
01.09.2024
Reflections on Working with the EMA: A Personal Journey Through the European Regulatory Affairs Landscape
In 1995, I attended a conference in Paris where a significant announcement was made—the establishment of the European Medicines Agency (EMA). At the time, the vision was ambitious: within three years, all medicinal products would be approved through a centralized procedure, streamlining the process across Europe. Nearly three decades later, while this vision remains only […]
Read more
01.09.2024
Orphan Designation
An “orphan designation” is granted by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a drug/biologic to create financial incentives for developing therapies for rare diseases. This article focuses on incentives offered, the prevalence that defines an orphan disease, as well as the procedural process of obtaining the designations. Introduction A […]
Read more
01.09.2024
Navigating the Clinical Supply Chain for Clinical Trials in the EU
At IMP Clinical Supply Services Ltd., we are privileged to oversee a crucial aspect of the clinical trial process: the clinical supply chain. The European market presents a unique set of challenges and opportunities for bio-startups, particularly in the realm of clinical trials. Understanding and navigating these complexities is essential for any company looking to […]
Read more
01.09.2024
Leveraging EU Funding: A Bio-Startup’s Gateway to the European Market
In the competitive and innovation-driven pharmaceutical industry, accessing the European market can be both a challenge and an opportunity for bio-startups. European Union (EU) non-dilutive funding offers vital support to startups aiming to navigate this complex environment, providing the financial and strategic resources needed to bring innovative solutions tothe market. The Power of EU Funding […]
Read more
01.09.2024
Why Biopharma Companies Must Prioritize GDPR Compliance for EEA and UK Clinical Trials
In the dynamic and highly regulated landscape of biopharmaceuticals, compliance with international regulations is crucial for maintaining operational integrity and securing future business opportunities. One critical regulation that biopharma companies worldwide must prioritize is the General Data Protection Regulation (GDPR) when conducting clinical trials in the European Economic Area (EEA) or the United Kingdom (UK). […]
Read more
01.09.2024
Differences in Investigational Product Labeling for Clinical Trials Requirements Between the US and the EU
Investigational product (IP) labeling for clinical trials is a critical aspect of regulatory compliance and patient safety in both the United States (US) and the European Union (EU). While there are similarities in their respective requirements, several key differences exist that sponsors and clinical trial managers must understand and navigate effectively. Regulatory Framework In the […]
Read more
01.09.2024
Navigating Quality Guidelines for Biological Investigational Medicinal Products: A Comparative Analysis of EMA and ICH Q7 Standards
Good Manufacturing Practices (GMP) are outlined in several guidelines. For commercial Active Pharmaceutical Ingredients (APIs), the primary reference is ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients). However, when manufacturing biological products during clinical studies in the EU, the quality requirements detailed in ICH Q7 may be overly stringent. It is advisable to […]
Read more
01.09.2024
Reimbursement for Digital Devices: The GermanDigital Health Applications (DiGA)–A Short Overview
Uniquely in Europe, Germany offers a pathway for certified digital health applications of risk class I or IIa according to MDR to be prescribed by medical doctors and the manufacturers are reimbursed by the statutory health insurance companies. Only digital health applications that are listed in the so called DiGA directory of the BfArM (Federal […]
Read more
01.09.2024
Navigating Second Medical Uses: Chemical Solutions with a Mechanical Cause
The European Patent Office issued a decision which could allow a broader range of claimed innovations to benefit from the so-called “second medical use” exception of Article 54(5) of the European Patent Convention (EPC). Such an exception is limited to a “substance or composition” only and is thus not available for medical devices. Historically, compounds […]
Read more
01.09.2024
Cracking the Swiss Market: Essential HR and Legal Strategies for Long-Term Success
In 2023, loads of new companies popped up worldwide, for instance, around 600k in Germany and 52k in Switzerland alone. But here’s the kicker: about 75% of these won’t be around in five years. Why? It’s a mix of many reasons, such as cultural issues, employment challenges, lack of ambition, and inflexibility in changing their […]
Read more
01.09.2024
Navigating the EMA’s SME Initiative: A Strategic Advantage for Biopharma and MedTech Startups
The European Medicines Agency (EMA) is a cornerstone in the regulation of medicines across the European Union (EU). Recognizing the unique challenges faced by small and medium-sized enterprises (SMEs) in the biopharma and MedTech sectors, the EMA has established a dedicated SME initiative. This program is designed to support innovation by simplifying regulatory processes and […]
Read more
01.09.2024
Clinical adoption of AI-based products in lung cancer screening: barriers to market entry, and a comparative, multi-center, cross-European study.
Lung Cancer is the second most common type of cancer and the number one cause of cancer death. The majority of patients diagnosed with lung cancer are already in the late stages and, therefore, have a poor prognosis with a five-year survival rate of only 10–20%. Diagnosing lung cancer at an early stage, before the […]
Read more
01.09.2024
Navigating the European Bio-Startup Ecosystem: A Founder’sGuide
The European bio-startup scene is a mosaic of invention, challenge, and opportunity where entrepreneurial spirit meets modern science in settings buzzing with activity. Over $54 billion financed over 1,936 deals in just the first half of 2024 indicates a startling 102% year-over-year rise.1 At the core of this ecosystem are energetic innovation hubs, notably in the […]
Read more
28.05.2024
The Bio-Startup Standard Crosswords
Read more
28.05.2024
The Tech Transfer Issue: Bridging Innovation and Industry
In the pharmaceutical world, Technology transfer (TT) is part of the product’s lifecycle. TT refers to the process of transferring knowledge, technologies, and methodologies from one institute or facility to another. This broad definition encompasses various activities, from moving academic discoveries to the commercial sector to sharing innovations between different companies or research facilities. In […]
Read more
28.05.2024
The Founder’s Perspective: Building Trust and Identifying Gaps for Successful Technology Transfer
From my experience as a biotech startup founder, the technology transfer (TT) process involves due diligence and relationship building with the principal investigator (PI) and lab members, the Tech Transfer Office (TTO), Or an incubator’s management team. Most times, things don’t go as smoothly as expected, and this article will focus on what can be […]
Read more
28.05.2024
Technology Transfer Companies: Turning Academic Research into Tangible Solutions and Startup Companies
Technology transfer companies play a crucial role in translating groundbreaking research into practical solutions that benefit society. They serve as bridges between academia and industry, facilitating the transformation of theoretical discoveries into marketable products and services. Ramot, established in 1973a subsidiary of Tel Aviv University Ltd. is the Tech-Transfer company of Tel Aviv University, responsible […]
Read more
28.05.2024
Assessing the Market Need for a New Idea in Healthcare
In the ever-evolving field of healthcare, bringing a new idea to fruition involves a meticulous understanding of the market need. Whether it’s a new drug, a revolutionary medical device, a healthcare app, or a unique service model, the success of such innovation hinges on its relevance and demand within the healthcare market. Here’s a structured […]
Read more
28.05.2024
Early Market Access Planning for Successful Commercialization of Healthcare Innovations in the USA
There are many considerations to account for, both prior to and during the development of any new healthcare solution or innovation. Proactive steps such as performing market research, assessing competitors, and developing a strategy to comply with country-specific regulatory requirements are very important and well-established. If the strategic plans for your offering include making your […]
Read more
28.05.2024
Unlocking EU Funding for Pharma Startups and Tech Transfer
The pharmaceutical industry is at the forefront of the European Union’s efforts to drive innovation and technological leadership. A staggering 25% of pharmaceutical startups emerge from technological transfer, the process of transforming cutting-edge research into commercially viable products and services. By bridging academia and industry, tech transfer catalyzes economic growth, job creation, and groundbreaking deep-tech […]
Read more
28.05.2024
Technology Transfer Regulatory Requirements
The WHO guidelines define technology transfer as a logical procedure that controls the transfer of products, processes, and knowledge, together with their documentation and professional expertise, within a facility or between facilities. It may involve development, manufacturing, and testing sites. The transfer may occur during a product’s development phases or after obtaining marketing authorization. The […]
Read more
28.05.2024
Streamlining Pharmaceutical Technology Transfer for Enhanced Drug Production
In the pharmaceutical industry, technology transfer is critical to ensuring that knowledge about product development and manufacturing processes is shared effectively across different phases and sites. Technology transfer aims to facilitate product realization by transferring essential process knowledge and control strategies between development and manufacturing teams and across manufacturing sites. Collaborative Foundations for Success The […]
Read more
28.05.2024
Analytical Technology Transfer in the Pharma Industry
In the pharmaceutical industry, analytical technology transfer (ATT) is a crucial process that involves moving validated analytical methods from one laboratory to another. This is typically done between different locations within the same company or between different companies. The transfer ensures that the recipient laboratory can perform the analytical method reliably and consistently, producing results […]
Read more
28.05.2024
Drug Licensing Vs. Apartment Rental
The Virtual-Tangible Fine Line Drafting a technology license agreement is a complex professional matter, typically handled by lawyers specializing exclusively in the field. Surprisingly, the principles and rules of an apartment rental agreement, a topic familiar to many, can assist in navigating and understanding the concepts of IP licensing. Below, we will review the overlapping […]
Read more
