Join us for this event to explore the advantages and challenges of subgroup analysis in early drug development. Defining patient subgroups more likely to benefit from novel treatments is an increasing imperative in this era of precision medicine. Moreover, an increasingly competitive market space provides further incentive for defining such patient subgroups. Predictive biomarkers play […]

In recent years, pharmaceutical outsourcing of bioanalysis has grown tremendously. Simultaneously, bioanalytical programs have become more complex due to increasing regulatory demands. While a comprehensive understanding of the regulatory guidelines is required to develop a winning bioanalytical strategy, several other challenges, such as strategic timing, are common with outsourcing. Additionally, the regulatory environment of bioanalysis […]

Medicon Valley Alliance and Worldwide Clinical Trials are pleased to invite you to a Good Morning Meeting on the 24th of May in Copenhagen focusing on Rare but achievable – factors for successfully navigating rare oncology trials. Conducting clinical trials in rare oncology populations can have its challenges. This event – designed for C-level Executives, […]

Continued Process Verification (CPV) is replacing the traditional three PQ batch approach in the pharmaceutical industry. The FDA issued Warning Letters to seven companies in fiscal year 2021 for process validation issues, citing 21 CFR 211.100 (Subpart F- Production and Process Controls, written procedures; deviations). If you are currently in stage 3 and have not […]

Medicon Valley Alliance and pci Pharma Services are pleased to invite you to this Good Morning Meeting on the 11th of May in Copenhagen focusing on Preparing to Outsource – Selecting the Right Vendor. In today’s digital-first economy, globalization is the new norm, major organizations worldwide are now outsourcing and augmenting their staff more rapidly […]

To succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow need to be considered. As the inventor or manufacturer of a medical device, a key success factor is to choose the right partners, that have the capacity to meet your […]

Medicon Valley Alliance and Metabolon are pleased to invite you to a Good Morning Meeting on the 20th of April in Copenhagen, focusing on advancing basic, clinical and applied research using state-of-the-art metabolomics data. Global biochemical profiling provides an informative assessment of the metabolome, which is reflective of a system’s active biology. Through metabolomics, opportunities […]

Biopharma companies are constantly looking for ways to accelerate time-to-market with minimal operational impact. Yet, when it comes to development, manufacturing and clinical supply of a biologic drug, they face challenges to increase productivity, reduce cost, mitigate risk, and optimize timelines to bring products to market faster. However, having the support of an integrated approach […]

Advancing your drug or vaccine candidate from late-stage discovery into the clinic is one of the most critical steps in development. To maximize your chances of success, it is essential to de-risk your drug candidates as early as possible. This meeting will provide insights and solutions on how to de-risk your development and how to […]

Medicon Valley Alliance and Iqvia are pleased to invite you to a Good morning meeting on the 28th of November in Copenhagen focusing on maximizing your asset’s value using Real World Evidence. Regulators and payers are increasingly using real-world evidence (RWE) to support their decision-making. What does this mean for biotech companies and how can […]

In this Good Morning Meeting, you will learn about successful strategies for recycling and future-proofing the valuable data assets generated in clinical studies. The most common destiny of the data from clinical studies is to be condensed into a one-off report and then archived. Meanwhile, lots of everyday activities throughout the organization can be accelerated […]

Strategies & Approaches to Optimize Your Clinical Immuno-Oncology Development Precision and Immuno-Oncology drug development is being optimized through well-defined preclinical and clinical strategies focused on safety, endpoints and biomarker targets. Evolutions in the regulatory framework, a deeper understanding of cancer and re-defining key endpoints for success in Immuno-Oncology and Precision Medicine are combining to de-risk […]

Learn about the benefits of phospholipids in pharmaceutical dosage forms and innovative drug delivery systems. Natural and synthetic phospholipids are ideal multi-purpose excipients with an unrivalled safety profile in state-of-the-art pharmaceutical dosage forms. In innovative drug delivery systems phospholipids – as enabling excipients – are crucial for ensuring the efficacy of therapeutics and vaccines. Within […]

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 […]

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 […]

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 […]

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, […]

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 […]