Pharmaceutical Webinars

Get a comprehensive overview of the current AI landscape in the pharmaceutical industry with regulatory affairs leaders highlighting key trends, use cases, challenges, and opportunities.Experts in the field will share insights on how AI is changing the remit of regulatory affairs professionals and transforming regulatory processes.Attendees will gain a deeper understanding of AI applications in these areas and learn strategies to effectively adopt and leverage AI technologies for enhanced decision-making and efficiency in their roles.

The field of biosimilars, which seeks to offer cost-effective alternatives to biologic drugs, has garnered significant attention in recent years. This report aims to provide an in-depth analysis of the biosimilar industry, tracing its evolution, examining its current market status over the past three years, and exploring future opportunities. Omnitrope's launch in 2006 was a pivotal moment for biosimilars, introducing them as viable options in healthcare. Initial regulatory hurdles were substantial, as biosimilar guidelines were nascent. The industry saw a turning point with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) establishing a comprehensive approval pathway, which has since facilitated the entry of numerous biosimilars into the market. This report details the biosimilars approved up to the present, segmented by therapeutic application—such as treatments for growth hormone deficiency, anaemia, and autoimmune diseases. We highlight the first biosimilar moieties launched between 2021 and 2023, including their regulatory approvals and market impact on their reference drugs. The current regulatory environment and market dynamics for biosimilars are evaluated to understand their position in the healthcare landscape. We will analyze the upcoming biosimilars anticipated for launch in the upcoming years and their respective focused indications. The webinar offers a comprehensive analysis of the biosimilar landscape, from its inception to its future prospects. The increasing focus on research and development, combined with regulatory advancements, underscores the significant role biosimilars will play in enhancing patient access to affordable, effective treatments.

Oestrogen receptor 1 (ER/ESR1) mutations have arisen as crucial biomarkers for endocrine therapy resistance in ER positive metastatic breast cancer. Detecting these mutations is key for understanding acquired resistance during treatment.APIS will be joined by SensID GmbH to deliver this FREE educational webinar on ESR1 mutations and the importance of their accurate and sensitive detection.Gain insights into: - ESR1 mutations significance in breast cancer and their role in endocrine therapy resistance - APIS ESR1 Mutations Kit, an accessible method to detect ESR1 mutations - SensID ESR1 reference set to ensure accurate detection of mutations in cell-free DNA (cfDNA)Have your questions answered by experts in gene mutation assay development and validation!

Ensuring prescription drug affordability continues to be a top concern for consumers, caregivers, and policymakers. To address these concerns, state and federal legislators have taken action by enacting a variety of laws that would set limits on certain prescription drug costs. At the state level, this legislation frequently takes the form of Prescription Drug Affordability Boards, also known as PDABs. Currently, seven states have passed PDAB legislation, with several more states proposing PDAB legislation in 2023 and 2024. Unfortunately, for advocates, there is not one approach to PDABs. For example, some PDABs are only empowered to review drug prices, report on pricing trends, and offer policy recommendations to improve consumer affordability. Meanwhile, other PDABs have authority to implement price controls based on the Inflation Reduction Act (IRA) Medicare negotiations, international reference pricing, or upper payment limits. This diverse landscape of PDAB functions has created challenges for consumers to actively engage with these entities and ensure that the patient voice and lived experience are integral to these processes. To empower advocates in engaging with PDABs, Aimed Alliance is thrilled to host an upcoming webinar: Prescription Drug Affordability Boards 101: Everything You Need to Know. This webinar will provide a comprehensive overview of the diverse approaches employed by different state PDABs, shedding light on the mechanisms these boards utilize to tackle the challenge of rising drug costs. By incorporating insights from policy advocates and patient perspectives, attendees will gain valuable insights into the multifaceted strategies employed by PDABs. The discussion will delve into potential problems and uncertainties associated with PDAB implementation, addressing concerns such as the lack of patient representation, reduced innovation, and considerations about the data and methodologies used. With an interactive Q&A session, attendees will have the opportunity to explore the challenges and ambiguities inherent in the functionality of these boards. Attendees can expect to leave with an increased understanding of PDABs, their impact on drug affordability, how advocates can engage PDABs in 2024 and beyond; and key considerations for legislators proposing or considering to propose these bills. Ultimately, this free, one-hour webinar serves as a comprehensive guide to navigating the evolving landscape of prescription drug affordability, empowering advocacy organizations, patients, and providers to better engage these entities.

In general, large pharmaceutical companies favor adopting functional service provider (FSP) models over full-service outsourcing across their clinical and research and development (R&D) operations. FSPs allow for greater oversight and can offer better outcomes regarding accelerated delivery and higher quality data. Can smaller companies benefit from working with a contract research organization (CRO) through an FSP model? During this webinar, participants will delve into the explorative realm of FSP models, particularly how to curate them for mid-sized companies to elevate their clinical trial performance.

Cryopreservation, a cornerstone in the field of cell therapy, is the process of preserving biological source materials at ultra-low temperatures to maintain their viability and functionality for future therapeutic applications. In this webinar, industry experts will share their experience on the critical importance of cryopreservation, discussing considerations such as processing requirements, buffer composition, controlled rate freezing, and cold chain logistics. Join this webinar to learn about cryopreservation, a vital step in the manufacturing of today’s cell and gene therapies.

Discover an informative webinar focused on maintaining regulatory compliance with a high-quality reference standard program for pharmaceutical development. This webinar is designed for industry professionals looking to gain a practical understanding of reference standards, from their acquisition and qualification to their application in maintaining product quality and regulatory compliance.

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.