Medicon Valley Alliance and Quotient Science would like to welcome you to a Good Morning Meeting 24th of October 2024. Drug product optimization is a critical development step that is common for most drugs that are progressing through today’s development pipelines to respond to suboptimal exposure profiles, to transition from an early development formulation to […]

Medicon Valley Alliance and Fortrea would like to welcome you to a Good Morning Meeting 6th of November 2024. Join us for an insightful exploration of the evolving clinical research landscape as our expert speakers delve into how digital health, technology, and AI are enhancing clinical development productivity. Gain a deeper understanding of the positive […]

Medicon Valley Alliance and Kvantify would like to welcome you to a Good Morning Meeting 26th of September 2024. Our upcoming presentation will explore the transformative role of computational methods in drug discovery, which save time, conserve resources, and enhance efficiency in drug discovery pipelines. We’ll demonstrate how novel physics-based methods, rooted in physical principles, […]

Medicon Valley Alliance and Menarini Biotech would like to welcome you to a Good Morning Meeting 25 th of September 2024. Menarini Biotech brings over 20 years of expertise in antibody and bioconjugation drug substance development, formulation, and drug product manufacturing to biotech companies everywhere. If you’re working with antibodies and looking to accelerate your […]

Medicon Valley Alliance and GemPharmatech would like to welcome you to a Good Morning Meeting 24th of September 2024. In the fast-paced world of drug development, timing is everything, and the expertise of your research partner can make or break your project. Join us for an exclusive event designed to help you master the art […]

Medicon Valley Alliance and IQVIA would like to welcome you to a Good Morning Meeting 5th of September 2024. Real world evidence (RWE) is becoming increasingly important throughout the product lifecycle. Once considered optional, it is now a necessity. With increasing focus from both regulatory and market access stakeholders, RWE requirements need to be planned […]

Medicon Valley Alliance and Quotient Sciences would like to welcome you to a Good Morning Meeting. In this presentation, Dr. Andrew Parker will discuss transitioning from pre-clinical to clinical stages, covering regulatory expectations and enabling technologies for poorly soluble molecules. He will also showcase solutions developed by our team using the Quotient Sciences Translational Pharmaceutics® […]

Medicon Valley Alliance and PharmaLex are pleased to invite you to a Good Morning Meeting on the 11th of June in Copenhagen focusing on How to help being compliant with EU GMP Annex 1 – A practical perspective. The EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” came into effect as of August 2023, […]

Medicon Valley Alliance and PharmaLex are pleased to invite you to a Good Morning Meeting on the 7th of June in Copenhagen. Clinically developing targeted therapies is considered a complex and time-consuming process, requiring a deep understanding of disease biology and the molecular mechanisms driving disease. But the complexities go far beyond the science. Targeted […]

Medicon Valley Alliance and BioAgilytix would like to welcome you to a Good Morning Meeting. In the realm of biotherapeutics, which include a diverse array of antibodies, proteins, hormones, enzymes and peptides, understanding and managing immunogenicity is of paramount importance. As biotherapeutic modalities increase in complexity, so too does the immunogenicity assessment strategy and the […]

Medicon Valley Alliance and Celerion would like to welcome you to a Good Morning Meeting. Abstract: Transitioning an experimental drug from preclinical animal models to the clinic is a critical milestone in bringing new medications to the market. First-in-Human (FiH) clinical studies have undergone a significant evolution, from a basic “feed-and-bleed” model in the 1970s, […]

Medicon Valley Alliance and Syneos are pleased to invite you to a Good Morning Meeting on the 13th of March in Copenhagen focusing on: Navigating the current funding environment and other key challenges in drug development for 2024 and beyond. An overview of the recent dynamic environmental, economic, regulatory and payer developments which are creating […]

Medicon Valley Alliance and PharmaLex are pleased to invite you to a Good Morning Meeting on the 23rd of January in Copenhagen focusing on: How to successfully address non-conformances raised by your Notified Body? Key learnings for the medical device manufacturers and to the Notified Body Opinion (NBOp) applicants   Topics will include: Typical Notified […]

All projects are different, but a number of parameters are consistent in addition to the guidelines/requirements from ICH, FDA, EMA. Selected characteristics of Small Molecule development projects will be discussed. Highlighting topics concerning: Management of risk and investment Optimization and adaptation of MedChem procedures towards manufacturing Sustainability Introduction of green(-er) chemistry Cost of waste management […]

Join us to gain a greater understanding of the cancer patient journey as our speakers discuss early phase trial design along with optimal data collection and endpoint analysis. You’ll also hear about applying the right digital solutions to balance the needs of the patient, optimizing recruitment and retention and expediting key decision-making. This symposium unites […]

We invite you to join us for a breakfast meeting centered around the crucial topic of Sponsor oversight for clinical trials, that are partly or fully outsourced to a Contract Research Organizations (CROs). This meeting aims to explore and elucidate the best practices and strategies for ensuring effective oversight in such Sponsor-CRO collaborations. As the […]

Medicon Valley Alliance and Genscript ProBio are pleased to invite you to a Good Morning Meeting on the 5th of October in Copenhagen focusing on accelerated ADC development via integrated antibody discovery platform. Key learning objectives: Brief overview of history and current trending of antibody-drug conjugates Tools and strategies for ADC naked antibody discovery & […]

Medicon Valley Alliance and IQVIA are pleased to invite you to a Good Morning Meeting on the 4th of October in Copenhagen focusing on how to create value for biotech companies through reducing risk, time to market and optimizing peak sales. Early stage biotech companies need to fill the evidence gaps at their stage of […]

The transition from early (phase 1, expansion cohorts and single-arm phase 2) trials to later phases of clinical development poses several challenges. While many of these challenges are of strategic and financial natures, some usual methodological pitfalls can be addressed in a somewhat systematic fashion. In this presentation, we will explore these pitfalls and attempt […]

Recent years have seen a resurgence and rapid growth in the field of cell and gene therapies as therapeutic options to treat diverse clinical indications including neuromuscular diseases, ophthalmic disorders, haemophilia, cancers and much more. Designing and executing a complete bioanalytical strategy to support the preclinical and clinical development of cell and gene therapies can […]

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 […]