The New ICH M10 Guidelines A critical component of the regulatory decision regarding the efficacy and safety of therapeutic products is the bioanalytical concentration of therapeutic products in biological matrices. Therefore, it is imperative that the bioanalytical methods used are well characterized, validated, and documented to best support regulatory decisions. Explore the new ICH M10 […]

More so than any other core function of the biopharma industry, clinical trials have been buffeted by the prevailing winds of the pandemic. From the turbulent waves of infection causing overstretched healthcare facilities, inaccessible sites and patient availability through to the relative plain sailing of mammoth Phase III vaccine trials, COVID-19 has permanently changed the […]

– Overcoming challenges when moving from non-clinical to clinical Going from non-clinical to clinical is no easy step. That’s why we’ve gathered a few of our key experts from essential product development areas to talk about how to survive and minimize the early risks biotech companies face during the life cycle of product development. Join […]

– Breaking through the current limitations Recombinant antibodies are highly specific detection probes in research, diagnostics, and have emerged over the last two decades as the fastest growing class of therapeutic proteins. Mammalian cell lines, especially the Chinese Hamster ovary (CHO) cell line, represent the most widely used expression systems for the production of these […]

Connecting with and managing relationships with key opinion leaders (KOLs) is a crucial part of any research-based organization, as well as the surrounding ecosystem. Speaking with the right expert at the right time is invaluable. Breaking through the knowledge silos that exist within the life science industry is critical for any organization. However – finding, […]

Generalized Pairwise Comparison (GPC) is an innovative statistical method used to design and analyze clinical trials to make the best possible use of the data collected. This allows the analysis to take into account several endpoints, providing deeper insights into the net treatment benefits. Specifically, the GPC method enables you to: Assess clinical trials based […]

The pharmaceutical pipeline is gaining momentum, led by many first-time launchers. But the reality is companies spend >$200MM over three years leading up to launch, and 66% of drugs still don’t meet launch expectations. This looming risk, echoed by general industry pressures, leaves developers and investors alike looking for more advanced commercialisation options that effectively […]

One of the major recent trends in drug development in oncology, particularly with highly targeted therapy and immunotherapy, is a great concern with efficacy assessment in early phases of development. This was not frequent before the era of precision medicine. As a result, phase 1 trials now routinely have efficacy endpoints and even sample-size justification […]

– an international outlook and regional challenges  Hologic Global Women’s Health Index is a unique survey based on 120 000+ interviews representing 2.5 billion women and girls. Using the index as a starting point, we discuss possible ways forward for Swedish and Danish women’s health – with a focus on cancer prevention. How can we mitigate the impact […]

Join us for this live webinar to learn about Molecular Classification-based identification of diagnostic and treatment targets in glioma. Dr. Xiaolong Fan, professor at Beijing Normal University in China will provide a high-level overview of his experience in dealing with the challenges of this project. His team has been pursuing this project for about 15 […]

The ISO 13485 sets out the requirements for a quality management system specific to the medical devices industry. Why should you have a QMS in the first place, and why use the ISO 13485 standard? We’ll share hands-on experience on what the standard means in practice, as well as ideas on how you can ensure […]

Sino Biological presents: A Comprehensive Overview of the CRO Service Platform Sino Biological is dedicated in providing the scientific community with high-quality recombinant protein and antibody reagents to promote life science research and drug discovery. Several robust recombinant protein expression platforms and antibody discovery methods have been established and are available for customized contracted research […]

– tackling two of the most intensely regulated pathways in one go   Combination products are a fast developing market but a tricky one. Yet this market is really picking up speed. New technologies enable patient care in ever improving levels. But how do you tackle two of the most intensely regulated pathways in one […]

Starting with an overview of beyond rule of five (bRo5) drugs and the key challenges behind these drugs, in this webinar, experts will discuss how intracellular concentrations of drugs is influenced by drug-transporting proteins and metabolizing enzymes and how they are involved in delivering effective drug as well as determining toxicity and drug interactions. The […]

Drug development in oncology is undergoing several changes brought about by precision medicine, which makes it appealing to move efficacy assessment to earlier-phase trials and questions the need for randomized trials. Indeed, some remarkably efficacious drugs have even been approved based on uncontrolled phase I or II trials. With very few exceptions, we challenge the […]

Introducing the new single-use separator, Alfa Laval CultureOne™ From greater flexibility to shorten the time to market, to increased assurance of patient safety, several factors have driven the growing transition to single-use processing in the biopharma industry. More manufacturers are seeking solutions that enable smaller batches and predictable, scalable production. Of course, this requires compact […]

Implementing and Validating Meso Scale Discovery – ECL Detection for Clinical Trials When implementing biomarker strategies for clinical trials, it is not only important to choose the right analysis platform but also have the assays validated and performed to meet regulatory submission requirements. Unilabs Serving Pharma group, in collaboration with Meso-Scale Discovery (MSD) will present […]

The success of several drugs in amorphous systems in the commercial market confirm that amorphous drug delivery system is one the efficient ways of enhancing solubility and optimizing bioavailability of poorly soluble drugs. Spray drying and hot melt extrusion are the two technologies most widely used for the preparation of amorphous solid dispersion. In addition, […]

Keep up with transparency trends and leverage disclosure data for patient engagement and recruitment While the complexity and costs of clinical trial transparency regulations continue to increase, there are growing opportunities to leverage investments in disclosure compliance. Understanding the requirements and trends helps identify opportunities to reuse the disclosure data beyond submissions to regulatory authorities […]

The 7 most important things to update in your technical documentation and your QMS, and how they interact Do you want to understand which parts of the MDR that you as medical device manufacturer must have in place on May 26th and what you need to adjust in your technical documentation, when CE-marking a device […]

Biopharmaceutical products in development continue to increase in complexity, which effects how companies choose to express proteins and eventually, manufacture at clinical and commercial scale. In this webinar, co-organized by Medicon Valley Alliance and Catalent, experts from Catalent Biologics and Sartorius will discuss new cell line development methodologies, including new instrumentation, which are enabling complex […]

Welcome to Medicon Valley Alliance Good Morning Meeting with IQVIA on: Value creation in a changing world: Optimising clinical trial success through a purposeful use of data and technology With over 4,000 assets in clinical development, developing medical innovation that can truly stand out has become increasingly more challenging for biotech players. Designing a compelling […]

Welcome to Medicon Valley Alliance Good Morning Meeting with Syneos Health on: Using a ‘virtual pharma model’ to attract targeted investors for biotech innovators De-risk investment, de-risk operational delivery and maximize the return on investment (ROI) for all parties How to position your organization for fundraising using a virtual pharma partner model – Using the […]

Welcome to Medicon Valley Alliance Good Morning Meeting on “Cancer immunotherapies – Preparing for a successful clinical program” with KLIFO. Recent advances in immuno-oncology have shown great promise for effective and safer treatments. Best examples are the check point inhibitors which are moving towards first line treatment in various cancer types. Currently, numerous drug modalities […]

Welcome to MVA’s Good Morning Meeting on “Biomarkers analysis challenges in Clinical Trials” with HalioDx. One of the biggest challenges in immunotherapy area is to find accurately which patients will benefit from a therapy or a combination of therapies. To help drug developers getting this information, the assessment of biomarkers through clinical research studies represent […]

Ökad samverkan över sundet, Köpenhamn & Malmö Medeon Science Park & MVA Medicon Valley Alliance bjuder in till frukostmöte. Varmt välkomna till ett frukostmöte där ni möter Medeons CEO Ulf Andersson som kommer att berätta om Medeons strategi 2016 och tankar på närmare samverkan över sundet och nya former för samarbeten med akademin. Ni får […]