In this webinar, we discuss the latest in library synthesis technology, and its use to build innovative libraries that harness structural and developability features to cover a wide range of antibody drug targets. We show how these libraries enable the discovery of high-affinity drug-like antibodies, often without the need for affinity maturation. Register Now.
Learn about the latest advances in leveraging bespoke ctDNA testing in clinical trials. Find out how Signatera has been applied in early stage and late stage disease. Dive into New published and presented data across multiple tumor types. Discover improvements to clinical trial design with Signatera including: identifying early relapsers, enriching for patients potentially most likely to respond to therapy, accelerating time to trial readout, predicting clinical outcomes as early as 6 weeks into treatment. Register Now.
AWS and Accenture share how they help transform pharma manufacturing, supply chain and quality control processes to deliver more personalized products faster and improve the patient experience. Register Now.
Development of HPAPIs presents unique challenges for product containment and requires special consideration in equipment selection, operating procedures, and safety processes. This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization. The speakers will also share the key advantages of using micronization technology for the development and manufacturing of HPAPIs. Register Now.
Join us to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan: progressively developing knowledge of the molecule’s critical quality attributes to justify the manufacturing and control strategy, planning for continuing development, and identifying opportunities to enhance with scientific advice. Register Now.
Join this webinar to explore how running a customer-centric organization leads to organisational agility, process efficiency, and ultimately faster speed of innovation. Register now.
In this webinar, you will learn physician’s current and expected futures use of genomic sequencing, the impact of genome sequencing on individual healthcare, views on how genome sequencing will change the practice of medicine, perspectives on physicians’ concerns about genome sequencing for their patients, and how genome sequencing is changing cancer treatment plans. Register Now.
Favorable regulatory outcomes and a high demand for novel and on-demand cell and gene therapies has poised viral vector manufacturing for a significant jump. With new efficiencies on the horizon, what does this mean for the future of these therapies and their potential to treat a wider patient population? Register now.
We’ll explore the landscape of technologies and services that match patients to clinical trials, providing feedback from CRO executives who have experience with them. Topics include how innovative technology is being harnessed to extract information from electronic medical records in order to identify the most appropriate patients for clinical trials, best practices for using social media to match patients to clinical trials, and more. Register Now.
In this paper, readers will learn what hybrid virtual engagement looks like, how to match virtual engagement tactics with different meeting and audience types, how to incorporate virtual elements into face-to-face interaction, beyond table stakes like cost reduction and increased participation, the meaningful benefits of engaging virtually, and the foundational elements of a virtual-first strategy for medical device organizations. Download Now.
Explore stories from diverse, Cerner Learning Health Networkᵀᴹ health system members about how they’re fueling real-world data, launching or furthering their research efforts and making research and clinical trials a reality. Discover how you can unlock the power of your health system’s data and bring research to all. Download Now.
Are you implementing an eTMF for the first time and don’t know where to start? Check out Trial Interactive’s eTMF Implementation Quick Guide to see the primary considerations you should focus on to reduce risks, maintain compliance, and establish effective eTMF processes. Download now.
Advanced analytics is the key to extracting enormous value from an existing asset: your LIMS data. Discover the difference between a lab that uses digital tools and a digital lab. Integrate analytics into your lab informatics with LabVantage. Download whitepaper now.
This white paper will explore areas for pharma marketers to consider as they adapt to a privacy-first environment, including alternative one-to-one patient engagement approaches, first-party data strategies, implementation of contextual targeting, and opportunities to shift marketing spend to reach high-quality patient audiences. Register Now.
Navigating each phase of your small molecule’s journey with the right CMC strategy is a critical component to enable success. Register Now.
Join this interactive panel to explore the depths of radiomic data in clinical trials. Learn real world applications and practical strategies for radiomic use in clinical trials, personalized drug development and therapy response. Register Now.
This talk will discuss processes for the metabolism of a drug, referred to as ADME, and the safety testing to provide requisite information to move a drug through IND and into clinical trials. Prior to marketing a new drug and actually prior to administering a candidate drug to humans in clinical trials, it is important to ensure that drug will not only be effective in the therapeutic manner prescribed, but also be safe and not bring any undo harm to patients. If you are involved in the development of potential new therapeutics, this discussion will help you gain necessary knowledge to inform your drug development decisions. Register Now.
To learn how you can chart an optimal path from gene to the clinic by tailoring your cell line development program to match your molecule type, timelines, yield requirements and risk priorities, register for our webinar now.
This webinar will bring together experts in preclinical trial design, R&D efficiency and regulatory affairs to offer advice on how companies can best engage the FDA early in the research process. Topics include strategies for determining the best timeline for approaching the FDA with a new drug candidate, a review of new technologies designed to speed up preclinical testing, and ensuring the proper balance between streamlining preclinical research and gathering enough data to satisfy regulators. Register Now.
A data lake is a great first step to transforming real world data into real world evidence that can be trusted to make critical decisions that drive forward the life changing therapies that you bring to patients today and tomorrow. During this webinar, hear from ex-CTO of Kaiser Permanente, ex- Data strategy leader of Merck, AWS Cloud Life Science leader and the LS product leader from Innovaccer on why we all need to think ‘beyond the data lake’. Save Your Spot.
Many drug developers naturally turn to contract manufacturers, but even with the best, they need to stay deeply involved, and aware of what is happening with their CDMO. A manufacturing plant that runs into FDA concerns, even for something unrelated to your efforts, can still delay years of work and the rewards of a drug approval. We’ll look at the diverse set of tactics companies can use to forestall manufacturing disappointments, from recruitment to partnerships to regulatory communication and more. Register Now.
Cell therapies represent a burgeoning area of clinical research and given the current number of new INDs the FDA expects 10-20 cell and gene therapies approved annually by 2025¹. This white paper explores common pitfalls in the clinical development of these complex therapies, lessons learned and best practices supporting accelerated approvals and reduced costs. Download Now.
Is it time to rethink your approach to commercialization? Learn how the right partner and mix of solutions can put you on the path to delivering disruption innovation. Register Now.
COVID-19 has changed the way healthcare is delivered and taught consumers the benefits of technology-enabled continuous connectivity with their physicians, care teams and pharmacies. This enhanced connectivity creates opportunities to make progress on some of the health system’s most difficult problems, such as the issue of medication nonadherence, which compromises health outcomes for patients across a wide range of conditions. Download now.
Bringing Cell, gene-modified cell and gene therapies successfully through the clinical trial process introduces a level of supply chain risk, complexity and specialized requirements which are not yet fully understood. This infographic focuses on taking a closer look at unique clinical supply challenges and unique needs associated with cell and gene therapies. Download to Learn More.
This White Paper provides an introduction to real-time qPCR and discusses the different approaches to real-time qPCR, outlines considerations to help you quickly compare previously optimized qPCR assays with a new qPCR Master Mix, offers guidance for optimizing your real-time qPCR assay, and provides a tool for comparing qPCR reagent formulations. Download Now.
G protein-coupled receptors (GPCRs) are one of the most promising drug targets due to their pathophysiological role in the human body. However, at the same time, GPCRs have proven to be one of the most challenging targets for antibody drug development. This webinar will describe the use of next-generation DNA synthesis tools to overcome the DNA bottleneck in antibody-based GPCR drug discovery, the discovery and creation of both antagonistic and agonistic GLP-1R antibodies by panning this GPCR-focused phage display library on a GLP-1R overexpressing Chinese hamster ovary cell line, and more. Register Now.
For decades, scientists have used sandwich ELISA assays as a reliable tool for understanding disease mechanism, progression, and prognosis. Download this paper now to learn which ELISA features are most important to scientific researchers in 2021, the impact of in-house validation studies to research workflows, and specifications to consider when purchasing ELISA assays for your research. Download Now.
While the rapid development of COVID-19 vaccines helped to wind down the pandemic, it also brought to light the many challenges involved in ramping up the production of injectables that must be made in sterile, aseptic environments. Several companies struggled to compress what’s normally a year-long process of getting up to speed into a matter of months. Such pitfalls can be avoided, however, by improving planning processes and adopting new technologies to streamline manufacturing. Register Now.
This webinar features a Catalent expert presenting a roadmap for formulation and process development that can aid in seamless scale-up. Another expert from EuroAPI will provide an overview of typical tech transfer and scale-up processes, highlighting how thermodynamic modelling, engineering modifications, API conservation and cleaning techniques in large scale settings can help optimize overall processes in terms of yield and run times. Register now.
This white paper provides a concise overview of the trends currently shaping the market access environment in Europe, as well as the implications for biopharma companies. Download now.
The Webinar will cover challenges of MDR for sterile medical device manufacturing companies, phases of Design Control for the development process of sterile disposable medical devices, advantages of a one-stop-shop during development and production in MDR environment, and contract Manufacturing partnership. By attending the webinar, you will get insight on MDR requirements and their impact on the development of medical devices, relevance of adequate documentation during MDR conform development of sterile medical devices, and advantages of Contract Manufacturing as strategic partnership to fulfill MDR requirements--especially for pharmaceuticals companies. Register Now.
Secure regulated and non-regulated content, keep data GxP compliant, and simplify how teams work together. Download eBook now.
Monica Commerford, Ph.D., Head of Regulatory Affairs at Thermo Fisher Scientific, discusses the strategies available to meet critical regulatory requirements to accelerate early to late state CMC product development. Register Now.
This survey examines the life science industry’s progress in reducing system and process complexity to improve data transparency, study execution, and simplify how partners work together throughout the trial lifecycle. The goal of this research is to understand the drives, benefits, and barriers of a unified and connected clinical operating model. Take the survey.
During the COVID-19 pandemic, several pharma companies moved so fast to develop vaccines that the amount of time between the sequencing of the virus to the introduction of the first three vaccines was less than a year. This Fierce webinar will include input from vaccine R&D professionals, including experts in clinical trial design, regulatory affairs and manufacturing. They will draw upon their own experiences in vaccine development to offer tips for incorporating elements of the successful COVID-19 vaccine rollout into future vaccine programs. Register Now.
Risk-based, Remote, Centralized Monitoring – all can play a critical role in clinical trials, but which is right for your study? If you are responsible for a clinical trial, leading clinical operations, project management, outsourcing, or clinical monitoring, learn about the breadth of technology choices and what you should consider to determine the ideal solution for your unique study needs. Register now.
In this webinar, we will establish the medical backdrop for COVID-19 virus sequencing in drug development, connect insights from population surveillance to potential solutions for drug developers, describe the biological relevance of sequencing in drug development, and outline approaches to COVID-19 virus sequencing, including the application of both targeted and whole genome sequencing to drug development. Register now!
In November, clinical trial platform developer Medable raised $91 million in private funding, amid the COVID-19 pandemic that touched off huge demand among pharmaceutical companies looking to initiate “siteless” or virtual clinical trials. This webinar will explore the role of CROs in siteless trials and the opportunities and challenges for CROs to expand their capabilities in this burgeoning area. Register now.
In today’s complex market, emerging and mid-size pharmaceutical manufacturers require the expertise and supporting technologies, across multiple disciplines, to effectively maximize product revenue and optimize market access functions. Join us on July 22, as industry expert, Tracy Mumpower, shares strategies for integrating a Business Service operations model with your Commercial and Market Access teams, to continue to drive operational excellence and insights through the power of People, Process, and Technology. Register Now.
Pharmaceutical companies are continuing to rethink how they develop, make and distribute medicines to position themselves for success in the post-pandemic environment. The pandemic showed they need more nimble technology stacks that enable them to pivot at scale and continue to adapt their operations to challenges and opportunities. Learn how low-code enterprise systems give pharma companies more capability AND more flexibility when combined with modern Development Operations suites and tools. Download now.
Real-world data are currently supporting decision making across the spectrum of oncology care. Join us as we discuss the current paradigm of oncology product development life cycle and the use of real-world oncology data to drive innovation, efficiencies, and improvements in patient outcomes. Register now.
In this webinar hear from “both sides of the house” – first from an innovative information technology leader and then a senior scientist who uses the solutions provided by IT. Learn how MOMA Therapeutics’ innovative lead discovery solution can be applied to the needs of your biotechnology discovery workflows. Save Your Spot.
Wearable biosensors are transforming clinical research to the benefit of patients, sites and sponsors alike. This whitepaper discusses the challenges and considerations Sponsors need to consider before they can realize the promise of wearable biosensors. Download Now.