Magazine

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 […]

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 […]

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 […]

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 […]

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).   […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]