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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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Michael J. Hennessy: MM&M 40 Under 40 AwardMichael J. Hennessy Jr., president and CEO of MJH Life Sciences™, parent company to BioPharm International, named to MM&M’s second annual 40 Under 40 list.
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Solving for Speed in Translational CMCWebinar Dates/Times: May 23rd 2023 8am PST | 11am EST | 5pm CET
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Phase-appropriate Compliance for Cell and Gene TherapiesUnderstanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
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CPHI Annual Survey Finds Global Pharma Resilient with India the Chief Beneficiary of Macro ChangesThese results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.
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Cryogenic Cold Solutions are Enhancing Vaccine Efficacy & YieldsPaper examines how cryogenic cold-temperature solutions are gaining favor versus traditional mechanical refrigeration methods in the manufacturing, storage, and distribution of vaccines due to their enhanced efficacy, stability and yield.
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Selecting an Off-Site cGMP Storage ProviderThis whitepaper explores the importance of safe cGMP pharma product storage, highlighting challenges CDMOs face with inventory bottlenecks and delays. It examines off-site cGMP storage benefits, including cost savings, flexibility, and compliance, while addressing key factors for maintaining product safety and accessibility.
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Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging ParvovirusesA series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
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Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
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The Importance of Process Intensification and PAT for Achieving Real-Time ReleaseCreativity and collaboration are required to overcome complex method development challenges.
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A Systematic Evaluation of Risks and Mitigation Strategies for Convalescent Plasma Therapy for COVID-19A task force details its findings of the risks associated with using convalescent plasma using failure mode and effects analysis
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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Assessing Data Integrity Risks in an R&D EnvironmentA data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.
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Efficient Method Development of OligonucleotidesThis article describes how to achieve optimal separation of oligonucleotides and related impurities by utilizing a dedicated method development software package based on AQbD.
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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
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Ensuring Cell Line Stability for Protein TherapeuticsStable cell line development can benefit from applying integrated analytical technologies.
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High Resolution Methods for Clinical Biomarker ValidationDiscover how high-resolution biomarker assays such as Meso Scale Discovery (MSD) and advanced Mass Spectrometry (MS) go beyond the limitations of traditional ELISA assays, and how they overcome central challenges in biomarker assessment and ligand binding assays (LBAs).
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Tactics and Strategies for Designing an Ideal Lentiviral Vector PlatformThere is growing pressure for robust and economically scalable viral-vector manufacturing technologies.
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Addressing Regulatory Requirements for CRISPR sgRNA Purity with Orthogonal ChromatographyWebinar Date/Time: Session 1: Tue, Oct 22, 2024 11:00 AM EDT Session 2: Tue, Oct 22, 2024 2:00 PM EDT Session 3: Wed, Oct 23, 2024 2:00 PM JST
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Connected Software Solutions Streamline Biopharma MS WorkflowsThe integration of modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant.
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The Evolution of Cellular Therapies in a New Clinical Research EnvironmentThe clinical trial research environment has evolved because of specific solutions designed to overcome uncertainty.
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Leveraging Blow-Fill-Seal Technology for Biologic DeliveryThe rising demand for biologics and technological innovations are driving blow-fill-seal capacity, harnessing manufacturing efficiency, and benefitting patients.
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Virus-like Particles as Therapeutic Moieties of the FutureAnalytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
