Companies can encounter a number of pitfalls on the path to moving a drug from preclinical to clinical trials. Understanding these hurdles—and properly preparing for them—can prevent a drug development program from stalling or, worse, stopping altogether. During this webinar, biopharma R&D professionals will review strategies for moving successfully and efficiently from preclinical studies to first-in-human trials. They will call upon their own experiences to provide advice that will help others in the industry navigate this crucial transition. Register Now.
When your manufacturing process depends on healthcare professionals working with the patients to get the front-end and back-end of the processes exactly right, those professionals need to understand your process unequivocally. That may mean having a team of trainers to make that happen. We’ll discuss the challenges posed by this new wave of therapies and how the pioneers in the field are tackling them. Register Now.
In this webinar, attendees will learn about the CALIPER program and how it established a comprehensive database of pediatric RIs for over 180 clinical biomarkers, how the stratification of cytokine results based on age and/or sex specific RIs is expected to facilitate more accurate interpretation of cytokine expression patterns, and about Ella™, a multi-analyte immunoassay technology the CALIPER team is using to investigate pediatric cytokine profiles. Register Now.
In a recent survey, 89% of clinical adjudication users agreed clinical adjudication provides value to clinical trials. Why? Because using unbiased experts to evaluate a drug or device against predetermined criteria helps determine patient safety and clinical efficacy. Join two Bioclinica experts for a discussion of these and other survey results to understand how they could impact your studies. Register Now.
An efficient supply chain is critical to any first launch in Europe. This webinar will identify and address the critical aspects that companies must consider when creating a distribution and financial infrastructure in Europe. Our expert panel will share their experiences, as well as discuss the key benchmarks and pitfalls on the journey to building the optimal supply chain infrastructure. Register Now.
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.
Pierre-Simon LaPlace, a famed French scientist, stated “nature laughs at the difficulties of integration.” We have assembled a panel of integration experts to share their tips for overcoming those difficulties. Our experts discuss these challenges, and the solutions proven to resolve them. Register Now.
Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. Read our new whitepaper to learn more about how sponsors can gain a competitive edge in oncology trials. Download 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.
“GMP-Like” plasmid services are rapidly expanding in cell & gene therapy. Understanding what value this creates is important as suppliers innovate to support researchers through the stages of clinical development. Please take a short survey to provide clarity to the value proposition it may provide.
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.
Pharma brand managers have moved from traditional marketing models for many reasons. However, the now favored Omnichannel approach has been difficult to implement because it requires the discipline of a cross-channel strategy that seamlessly integrates content to provide consistency across multiple “buyer” physician touchpoints. This webinar covers how RWD can accelerate executing on a true omnichannel outreach. Register now.
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.
To produce a drug product with ideal biopharmaceutical properties, formulators must understand the molecule’s characteristics and create optimal formulations by utilizing technologies and processes that address the unique challenges presented by each API. But accelerating drug development timelines can force innovators to opt for quick-to-clinic dosage form approaches which may lead to suboptimal performance in patients. Download this Executive Summary to learn more.
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.
Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes. Download 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.
Engage with experts in gene therapy to learn about important considerations, the necessity of a strong plan for plasmid at the early stages of candidate development, and potential obstacles. Panel experts join Aldevron to discuss how continuity and consistency are crucial for commercialization. Learn about the original GMP-Source® service, developed in collaboration with leading gene therapy researchers, and how this continues to enable early phase clinical research. Register Now.
Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Download now.
Read about expansion and characterization of NK cells grown in a feeder-free culture system using Gibco™ CTS™ NK-Xpander™ Medium, which can support an average of 1,500-fold expansion of NK cells within two weeks. Download the white paper now.
Paper discusses how today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition, adapt to market demands and external forces out of their control; in order to deliver faster, cheaper, more successful launches rooted in integrated commercialization and operational agility. Download 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.
Realizing the full potential of viral vector-based therapies requires a successful manufacturing platform for AAV vectors. In this whitepaper, compare differences between AAV platforms and the pros and cons of each to help evaluate which option is best suited for your gene therapy. Download now.
Pharmaceutical companies driving an active ingredient to clinical trials need an API CDMO that overcomes challenges with creative problem-solving and a high level of flexibility. This white paper explores how to move from process R&D to clinical APIs quickly and effectively with the right CDMO. Read more 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.
The path to starting a prescription can be complicated. Patients need a guide that empowers them with information to understand the steps along the way. Leverage a patient's mobile device and, voila, there's a digital Sherpa in the palm of their hand. Register now.
How do today’s patients engage in social networks? Learn what’s working for innovative health marketers as consumers facing chronic health conditions re-think the relationships and resources that help them manage their disease. Register now.
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.
Secure regulated and non-regulated content, keep data GxP compliant, and simplify how teams work together. Download eBook 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!
This whitepaper explores how powerful, fast and modern, modular architecture, combined with interactive data management, visualization and analysis platform can accelerate the entire discovery and research process. This resource is helpful for companies that are looking to help scientists and research IT teams to reclaim months of their time usually spent on manual steps to bridge gaps in their current software or reinventing the wheel while trying to optimize their lab and IT processes. Learn More.
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.
COVID-19 showed us the potential and need for radical improvement in the life sciences industry. Pandemic programs reset expectations for how quickly drugs and vaccines can reach patients with unprecedented R&D timelines. Changing patient expectations and technology are catching up with industry needs, setting the stage for a period of transformation that will accelerate the development of life-changing medicines. Download now.
Biopharmaceutical drug pricing and market access contracting have become more complicated and interrelated than ever. Join us to discuss how a more integrated, intuitive approach to pricing and contracting can create organizational agility. Discover how this inter-connected approach can have a radical impact on the profitability of life sciences organizations as well as align incentives across the health care ecosystems. Register now.
HitGen has established an industry-leading drug discovery platform for small molecules and nucleic acid drugs centered on the design, synthesis and screening of DNA encoded chemical libraries (DELs), fragment-based drug discovery (FBDD) and structure-based drug design (SBDD) technologies. HitGen founder Dr. Jin Li and Vernalis chief scientist Professor Rod Hubbard will join hands to illustrate advancing innovative drug discovery by DNA Encoded Library and FBDD/SBDD methods. Register Now.