Pharmaceutical Webinars

Discover a groundbreaking webinar delving into antibody-drug conjugates (ADCs) manufacturing and the recommended strategies to overcome common challenges in potency testing and product purity. ADCs and cell/gene therapies are both advanced approaches in the field of biomedicine that aim to target and treat various diseases in innovative ways. Both rapidly evolving fields with complex landscapes, they each face significant challenges and require innovative solutions for development, scale-up and commercialization. Particularly, when it comes to ADC manufacturing, two key challenges lie in the realms of potency testing and product purity, posing obstacles to manufacturing ADCs at a larger scale and cost-effectively. Furthermore, more robust tools and streamlined processes are needed to ensure the timely production of ADCs for clinical trials and potential commercial launches. Additionally, meeting regulatory standards adds another layer of complexity to the manufacturing process. This webinar will delve into these challenges, exploring their impact and potential solutions for advancing ADC manufacturing.

Cambodia, Laos, and Myanmar are heavily reliant on imported pharmaceutical products. This webinar will provide an overview of the regulatory framework for the importation of pharmaceutical products in these three countries, including the requirements for obtaining marketing authorization. Speakers include Aye Thuzar Hlaing, David Mol, and Dino Santaniello from Tilleke & Gibbins.

In this stimulating webinar, gain insights into overcoming the challenges of biopharmaceutical process development, simplifying digital strategies for cell line development, upstream and downstream processing and analytical operations in modern drug modalities. Process development has evolved considerably to support the biopharma shift towards newer drug modalities and accelerated development pathways. However, the software applications available to process development teams remain a siloed array of rigid point solutions, legacy electronic lab notebook (ELN) and laboratory information management system (LIMS) applications, custom integrations and internally built systems. These software applications contribute to siloed data, poor user experience and high cost of ownership. A new digital approach is required for process teams to thrive in the modern era of biopharmaceutical development. In this session, the attendees will learn key digital strategies to improve process design for cutting-edge therapies, plan better experiments, unify process data and simplify technology transfer. The featured speakers will cover digital strategies for cell line development, upstream and downstream processing and analytical operations. Join this webinar to gain insights into implementing strategies in technology transfer and biopharmaceutical process development to drive innovation in modern drug modalities.

This live webinar will be a forum to discuss how we can move forward in ensuring pharmaceutical companies manufacture responsibly to limit the risk of AMR. The live webinar builds on examples from a new report published by the Access to Medicine Foundation in August 2023 that sets out the clear steps pharmaceutical companies can take to limit AMR risk by manufacturing responsibly. The webinar will touch upon the major changes needed to improve the landscape, as well as the roles that different stakeholders have to play, including companies, regulators, procurers and investors.

Today’s pharmaceutical industry is demanding more flexibility in manufacturing. Faced with rapidly evolving patient needs and relentless pressure to bring new drugs to market fast, companies must find ways to swiftly adapt, scale and optimize their production processes. But automation systems are traditionally rigid and expensive to change. To address this growing challenge, the manufacturing facility of the future is modular, using 'plug-and-play' technology to deliver greater versatility without increasing costs or compromising quality. In this webinar, you will find out how modular production based on this groundbreaking new standard is changing the industry for the better. You will also hear from Sebastian Härtner, Lead of Future Manufacturing for Life Science and Chemicals at EMD Electronics (a division of Merck KGaA, Darmstadt, Germany). Sebastian will introduce how these flexible manufacturing practices were implemented at one facility and what they have accomplished as a result. Key learning objectives: Why pharmaceutical companies need flexibility in manufacturing, How modularity is achieved using the Module Type Package (MTP) standard from NAMUR NE 148, How a flexible approach makes planning easier for everything from physical connections to IT/OT cybersecurity, Who is already leveraging modular production, and how it is transforming their business.

Discover a groundbreaking webinar delving into advancements in antibody-drug conjugates (ADCs) and related patent filings. Antibody-drug conjugates are among the most promising drug classes in oncology...

Circulating tumor DNA (ctDNA) profiling is increasingly used in solid tumor management to inform a variety of clinical research questions. ctDNA supports non-invasive testing for trial enrollment and longitudinal monitoring. It has potential applications in clinical study design, prognostication, and understanding when de-escalation may be possible.In this seminar, Valsamo Anagnostou of John Hopkins University will discuss implications in assessing ctDNA in advanced cancer given variable shed in patients, as well as considerations in selecting an approach. She will highlight data demonstrating the value of ctDNA dynamics and recently initiated clinical trials leveraging response-adaptive study designs and how this information can support clinical research to guide patient care.Mia Levy, chief medical officer at Foundation Medicine, will present clinical analysis for Foundation Medicine’s ctDNA tumor fraction method and how it can be leveraged for studies using only liquid biopsy to provide confidence in a negative result, support risk stratification, response-adaptive study designs, and dose selection. She will also highlight how the Foundation Medicine portfolio can support clinical studies leveraging ctDNA.The speakers will discuss:ctDNA-driven interventional clinical trials in immune-oncology based on molecular response.Response-adaptive study designs for targeted therapies.Early-phase clinical studies using ctDNA to support dose selection or early go/no go decisions.The clinical insights provided by Foundation Medicine’s ctDNA tumor fraction and portfolio of solutions for supporting clinical research and drug development.

Ever since regulatory agencies globally mandate pediatric clinical trials for drugs intended for pediatric use, there has been a significant increase in the number of industrially sponsored pediatric clinical trials in recent years. This webinar examines the world of pediatric dosage forms and how orally disintegrating tablets (ODTs) are emerging as a specialized drug delivery system for children.Featured speakers include: Prof. Afzal Mohammed from Aston University, and Leon Grother, Formulation Manager at Catalent.

Mushrooms have been used in medicinal and spiritual practices by Indigenous cultures around the world. This webinar will discuss the pharmacology and chemistry of psychedelic alkaloids found in the fungi kingdom and their use in psychedelic medicine.

From Lead Candidate to GMP Manufacture - Navigating the Drug Substance Development Journey is a webinar that will take place on 7 December at 3PM GMT / 10AM EST. Register now for free to learn more about the topic.