At Takeda, Linguamatics’ Natural Language Processing (NLP) software is used for systematic examination of gene-disease associations. Join us to discuss the value of text analytics for the identification of genetic mutations, genotype-phenotype association and disease severity, in order to develop a better understanding around the biology of rare diseases. Register now.
In this webinar hear how Sanofi has demonstrated success with case processing automation via natural language processing, machine learning and artificial intelligence with Deloitte’s ConvergeHEALTH Safety Cognitive Platform on AWS Cloud. Register Now!
This webinar will provide an overview of the guideline and will explain the Established Conditions (EC) discussed therein, as well as the applicable regulatory requirements. A deep dive into Post Approval Change Management Protocols (PACMP) and Product Lifecycle Management (PLCM) as tools to manage change will also be discussed. Register Now.
To succeed in today’s environment, biopharmaceutical companies must leverage analytics and adopt innovative approaches to engage HCPs and improve outcomes for their customers and communities. Join us for a roundtable discussion with leading industry innovators to discuss how biopharma manufacturers can successfully increase and improve HCP engagement. Register now.
During this webinar, hear from Kalderos to learn:
- An overview of compliance and operational challenges facing the 340B program
- Why 340B rebates can eliminate duplicate discounts
- How covered entities, manufacturers, state Medicaid programs and other stakeholders will benefit from 340B rebates
Interested in complete supply chain real-time data visibility? Unlock productivity with digital workflows, manage plants inventory with real-time supply chain information and enable faster decision-making with data visualization with pci | bridge. Save your spot.
AbSci’s Protein PrintingTM technology enables rapid E. coli SoluPro® cell line development for complex therapeutic proteins. We will detail our ability to go from gene to purified antibody in 10 days, including cell line construction, fermentation, purification, and protein characterization. Register Today!
During this webinar, attendees will learn about Thermo Fisher Scientific’s new 5KL bioreactor and how it benefits clients who outsource late-phase biologics drug substance manufacturing. An introduction of the 5KL bioreactor will be provided, as well as application data around performance and scalability, process economy comparison with traditional stainless steel bioreactors, and decision criteria that could be helpful in choosing between different cell culture strategies. Register Today.
The only constant during a drug launch is change. Despite careful planning, commercial organizations must be ready to pivot in response to rapidly changing markets and regulatory conditions. This webinar will address key considerations and benefits of working with a cutting-edge data management and insights technology. Register now.
Watch this webinar to learn how using a single vendor will save you time and money. The presentation will focus on the Integrated Offering and how it is defined for the client, with the focus on simplicity, time savings, reduced risk, and proven experience. Register now.
The past six months have highlighted both existing and unexpected enrollment challenges, as sponsors, CROs, and sites have been pressed to evolve their recruitment strategies. Join us as Rho experts discuss their approach to adapting CNS trial enrollment to a rapidly changing clinical landscape. Register now.
Few organizations maintain standards successfully over time. Join this webinar to develop best practices and checklists that can be applied across any size organization, regardless of standard type, to ensure efficient clinical trials. Register now.
During the session, you will learn how this enriched dataset can help you:
- Support regulatory initiatives
- Characterize and follow disease progression in hospitalized patients
- Identify previously unknown risk factors for contracting the virus
- Evaluate the effectiveness of inpatient treatments used in real-world clinical practice
- Set criteria for COVID-19 clinical trials
- Track changes in the course of patient care since early 2020
Sign up today to learn how you can leverage one of the only medical record reviews solely using real-world data from hospitalized COVID-19 patients.
Phase 1 clinical program planning is complicated these days with added pressure to get maximum study data and move quickly to Phase 2 or partner the clinical asset. During this webinar, presenters will review specific study components which can be highly beneficial in terms of time and cost savings when included in a Phase 1/ First-in-Man clinical studies. Register now for an insightful overview for anyone new to Phase 1 clinical study operations and useful information for those who have not run an early clinical program in some time.
In this webinar, experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies. Cell and gene therapy developers, research scientists, regulatory and legal professionals are all encouraged to attend. Register Now!
Join a panel of healthcare executives from Google Cloud, GSK, and Roche to discuss how life science organizations are transforming their supply chain efforts using data, analytics, and AI. Our panelists will discuss how leading life science organizations are using AI to enhance equipment availability, performance, and quality across the supply chain - helping to bring critical medications to patients more quickly and efficiently. Register Now.
This webinar will discuss life cycle management strategies for patients with swallowing disorders and the overall impact on patient perception. The webinar will include several panel speakers representing different perspectives and case study examples. Register now.
Early process development is critical to generating a high producing cell line. That is why Polpharma Biologics have developed Specific Productivity Optimization Technology (SPOT™) to increase cell line specific productivity and achieve titers up to 9 g/L that can be rapidly scaled up for pre-clinical, clinical and commercial supply. Watch On Demand.
This webinar will explore why adherence, safety and quality of life are important for patients, and how these key enablers contribute towards positive outcomes. We will also discuss existing challenges, such as drug development, regulatory, patient accessibility, and how device technologies can further improve patient outcomes. Register now.
Pharmaceutical R&D is focusing on developing ever more specialized drugs, resulting in increasingly more potent APIs. Therefore, the demand for highly potency drug product manufacturing has been steadily increasing over the years and this trend is expected to continue. Is your highly potent strategy efficient and optimal to scale-up? Register now.
In this webinar, learn the benefits of utilizing demand-led supply and direct-to-patient distribution models in the clinical supply chain, as well as how they can be used to both improve flexibility and better align with patient needs. Register now.
Gene therapy has become a one-time treatment method for a complete cure by fixing genomic errors which altered protein functions of normal cells. The high titer virus packaging and purity are essential for the success of clinical gene therapy. In this presentation, we report to establish a facility to manufacture GLP grade viruses and to develop the relevant QC assays at Frontage. Our efforts will facilitate the application of this modern cutting edge technology in clinical arena. Register Now.
Learn why consolidating Discovery, Pre-Clinical, Clinical, and Post Approval processes on a single platform drives efficiencies, margin improvement, and real time collaboration internally & externally. Register now!
Join us for a live webcast that will showcase valuable case studies and new methodologies that can help the wider CDMO industry in tackling delays in project deliveries. We will also cover our strategy to ensure the delivery of drugs to customers and patients in spite of the COVID-19 outbreak. Register now.
US biopharma companies have options for ex-US expansion. But how can a company decide on its best pathway to value? In this webinar, leaders who’ve done it outline how they weighed their options and made the right decisions.
This webinar explores the latest regulatory requirements in the post-marketing setting. It provides details about some of the most recent developments in this area, including a move by the FDA in 2018 to require that companies marketing drug-device combination products report all complaints about safety to the agency. Register now!
In this webinar, Catalent Biologics shares how to transition your product from pre-filled syringe to auto-injector more quickly with an experienced partner who can anticipate equipment and process needs. Register now.
Join this webinar to learn how to more efficiently engage with customers remotely using your digital footprint, how to maximize product launches virtually, and how to proactively identify customer support needs by leveraging analytics and insights. Register now!
Accelerate R&D processes across the value chain, maintain GxP compliance and reduce your overall IT footprint. Access, collaborate, and exchange non regulated and regulated content from one repository with Box. Register Now.
The testing landscape for companion diagnostics (CDx) in Europe will change. Register now and learn how to ensure patient access to IVDR-compliant CDx in Europe.
COVID-19 has presented the industry with many risks and challenges to the management of clinical trials. For many, the mitigation of these issues has accelerated the implementation of decentralized approaches to trials. Join us as we discuss these issues, ways they can be addressed, and Rho as a case study. Register now.
In this webinar, we will reveal the inner workings of the manufacturing and pharmacy department of a CRO/CDMO, so you understand the different regulatory and operational considerations faced by a clinical research pharmacy. You will learn about inherent challenges, and the appropriate mitigation measures and optimization solutions that deliver the most effective results and outcomes. What will you learn: Study planning, including quantity calculation, and how to minimize deviations, safely and successfully working with Schedule I products, packaging and labeling requirements for different countries and jurisdictions, and shipping and importation logistics during the COVID-19 era. Register Now.
In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. The experts share collaborative best practices and explain how features of Catalent’s OneXpress™ can reduce risks, accelerate timelines, and maximize utilization of resources across a global network to drive more successful outcomes. Watch now.
This webinar will place the oncology patient and the drug company at the heart of the conversation and will give situational awareness of the challenges both parties face, along with the proven solutions to help overcome these challenges. Register now.
Leverage spray drying to combat bioavailability and processing challenges. Learn more as global industry experts provide insight from early development to commercialization. Register now.
This webinar assembles experts with experience in biotech, pharma, and the FDA to discuss how to best identify the off-target liabilities of antibody and CAR-T therapies that are the primary cause of failure in preclinical and early clinical studies. Register Now.
In this webinar, pharma industry expert, Jesse Mendelsohn, VP of Model N, shares data-driven strategies to help you establish and negotiate commercial contracts with payers and providers, build and tune your European and overseas launch strategy, and make your product available to US government health insurance programs. Register today!
In this webinar, learn how an advanced quality management system (QMS) that connects data across the product life cycle can provide business intelligence insights and give management a better understanding of your processes and how to improve them. Register now.
Whether you’re developing a COVID-19 treatment or introducing a new drug to the market, serialization is a requirement. Learn why a configurable solution will get you to compliance faster, future-proof your deployments and reduce total cost of ownership. Register now.
Learn how technology transfers can optimize success and mitigate risk from product development to commercial launch. Register now!
Cancer experts and pharma execs will break down the headline-making data from ESMO, sharing their insights and analysis around the conference’s most closely watched studies. This discussion will examine how groundbreaking research unveiled over the weekend will change clinical practice and prime drugs for key new indications, and panelists will fill you in on the need-to-know takeaways from oncology’s hottest fields. Register now.
The widespread adoption of smartphones and wearables makes monitoring symptoms in real time a credible option using brief measures designed for these devices – but is this acceptable and feasible for patients? This webinar will delve into the research findings of Takeda Pharmaceuticals, Cambridge Cognition, and CTRL Group, and share lessons learned adopting new technologies in clinical trials. Register now.
This webinar will explain the baseline requirements for elastomeric physicochemical and functional properties. Examples to illustrate qualification of components for intended applications will be included. Register now.
This webinar will focus on the challenges isolated populations have faced during the global pandemic related to patient adherence, and the application of formulation strategies to create more patient centric solutions. Register now.
Do you want to better engage with your customers in the new normal? Do you want to know about the secret sauce to perfecting omni-channel marketing? Join the experts to review the current strategies and discuss the key enablers to driving a personalized customer experience. Register now.
Join this panel of industry experts as they discuss the results of a recent market survey on the challenges and benefits of adopting recent precision dosing guidelines for vancomycin. Register now.
Join experts Prof. Gerhard Bauer and Catalent’s Dr. James Crutchley as they discuss challenges and an innovative methodology to commercially scale autologous therapies. Register now.
Drug Development has always been about data. Research insight that comes from data often gets muddied by its vastness and inaccessibility. In this session we discuss Takeda Pharmaceutical’s Platypus, a comprehensive set of Tableau visualizations of clinical trial data. With the power of Tableau, Takeda is able to more effectively monitor patient safety through all clinical trial phases and help ensure data quality, leading to timely analysis and ultimately a faster path to life-changing medicines that patients need.This session will explore: how to increase quality and speed in data analysis to reduce time and achieve greater results, the impact of Takeda’s approach and user testimonials, and data visualizations, such as “COVID19 Patient Visit Dashboards,” show pandemic insights and enable study teams to view patient data, behavior patterns, and trial delivery milestones. Register now.
This webinar will detail practical implementation of innovative technologies and solutions such as multi-attribute method, modernized cell line development workflow using high-yield cell lines and automated systems, next generation purification resins. It will also showcase best practices and strategies such as phase appropriate quality systems, and integrated drug substance – drug product solutions that leverage standardized technology platforms. Register now!
Evotec presents practical and methodological approaches to preclinical drug abuse liability assessment of CNS-active candidates in light of International Regulatory Agencies’ recommendations. Two webcasts cover critical parameters that should be considered when designing animal behavioural studies. Watch the webcast.
Optum brings together cross-industry experts to share a case study detailing how an employer, provider, payer and pharmaceutical company worked together to address a hard-to-diagnose condition: migraine. Register now.
Hybrid, Virtual, and Synthetic trials are becoming part of a growing number of drug and biologics development programs. Join us as Rho experts discuss how to maximize the benefits of decentralized trials. Register now!
Before businesses can recover, they will need to reboot, which will involve developing a holistic approach to managing new health risks, rethinking workforce safety, maximizing productivity, and furthering sales –while protecting and maintaining compliance with privacy and cybersecurity rights. Register now.
Join us to discuss strategy, timing, process, practical and execution aspects to be considered in order to achieve a target outcome. Case studies will be presented that demonstrate each of these challenges and the considerations necessary to meet fast-track timing requirements of clinical trials and registration applications. Register now.
In this webinar you will hear from technology company uMotif on how they collaborate with pharma companies undertaking virtual and decentralized trials. Hear how new patient populations can be reached using cloud-based technology and learn what types of research data can be collected from different devices and wearables. Register now.
Join us to gain an understanding of how to combine two different polymers, one “inside” and one “outside” the ASD to maximize performance, physical stability, and drug loading of ASD drug products. Register now.
Continuous manufacturing brings uncertainties with regulatory and adoption rates. Industry expert, Ajaz S. Hussain, PhD, will discuss these uncertainties and provide more insight into this innovation. Register now!
Regulatory agencies have provided recommendations on when and how to identify and characterize drug metabolites to ensure their non-clinical toxicity has been adequately evaluated. The studies conducted to comply with these recommendations are often referred to as metabolites in safety testing or MIST.
This presentation will review the origins of these recommendations and the specific requirements that need to be considered in designing studies to address the regulatory expectations. Register now.