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.
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.
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.
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.
Navigating each phase of your small molecule’s journey with the right CMC strategy is a critical component to enable success. 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 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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Learn how a small, investigator-initiated project developed into a valuable COVID-19 chest CT dataset using Flywheel's research data management platform. You will also hear how Imbio is exploring the correlation between lung injury severity and patient prognosis, as well as developing AI to diagnose COVID-19. Digital transformation professionals, radiologists, data scientists, and clinical and translational imaging leads should attend to learn about integrating radiology research and AI solutions to enable collaboration and improve R&D efficiency. Register now.
The road to IND isn’t always easy. Balancing speed, risk, and future needs is a challenge. Join Paul Jorjorian, Vice President and General Manager, Thermo Fisher Scientific, and learn how you can take your molecule from discovery to FiH trials without undue risk or excessive timelines. Plus, find out how you can meet short-term goals while preparing for future commercialization success. Register Now.
This webinar focuses on manufacturing aspects that enable successful development and scale-up of the micronization process. Technical issues that must be investigated for successful development of effective API micronization will be explored. An overview of micronization and typical scale-up challenges will be presented along with a robust process development strategy to ensure critical-to-quality attributes are maintained. Register Now.
Life Sciences manufacturers that focus on streamlining the tendering and bidding process win more. Join our tender experts for a virtual session to learn strategies to optimize your bids, streamline processes, and improve collaboration and visibility across the tender lifecycle. You’ll also hear from Veronica Gil, Pricing & Tender Director, Baxter EMEA, on how her team leveraged technology to centralize processes and develop a winning tender strategy. Register Now.
Nearly a quarter of adults worldwide are thought to have non-alcoholic fatty liver disease; between 11% and 40% of them will progress to non-alcoholic steatohepatitis (NASH). Join industry leaders for a webinar dedicated to overcoming key challenges presented in NASH drug development. We’ll explore key considerations for liver biopsy collection and interpretation, emerging non-invasive biomarkers, and the connection between clinical practice and drug development. Register now.
Join this webinar to hear experts share how dissolution tools and PBPK modeling can help evaluate whether a molecule is suitable for controlled release applications and predict the effects of release rate on in vitro performance. In addition, the experts will cover all aspects of oral controlled release technologies and discuss current strategies to select the optimal technology to meet the intended release profile. Register Now.
Healthcare is becoming more virtual and digital healthcare tools more common, which presents new challenges and opportunities for pharma sales. In response, brands are turning to innovative digital solutions to enhance and augment sales, including intelligent bots powered by conversational AI that can automate and augment HCP education and support. In this session, you’ll hear from leading agency experts working to transform HCP experiences with conversational AI voice and chatbots. Register Now.
Optimizing the manufacture and delivery of significant amounts of therapeutically potent cells, extend today’s frontiers in the field of cell therapy and regenerative medicine. Leaders in the pharma and biotech industry, health care sector and life science researchers will get insights about the latest advances in regenerative medicine, gene editing platforms, tackling the critical limitations in developing CRISPR therapeutics and more. Register Today.
Before COVID-19, the typical vaccine took more than five years to develop. Biopharma companies raced from virus discovery to phase 3 testing of their COVID-19 vaccines in under a year. Now the industry is asking an important question: Can we take what we learned from COVID-19 vaccine successes and use it to speed up the development of other vaccines? Register now.
Large or small, cyberattacks are making headlines and elevating executive attention toward cyber resiliency. During this session, we will explore security considerations for developing cyber resilience covering security fundamentals and readiness planning to protect your IT and OT environments. Register now.
The recently heightened awareness of racial discrimination coupled with COVID-19’s disproportionate toll on disadvantaged communities has spurred the need for change. Yet the lack of equity and representation of minority groups in clinical research has been an open concern for decades. Attendees will learn how to optimize patient diversity and inclusivity of clinical trials. Register Now.
As we head into ASCO weekend, cancer experts will highlight closely watched data sets to be unveiled at the meeting. This discussion will take a close look at oncology's hottest fields, including CAR-T and precision medicine, as panelists zero in on the conference's most highly anticipated studies, 2021's biggest research trends, and the data they're most looking forward to seeing. Register now.
Learn how human pluripotent stem cells (hPSCs) are being manufactured at scale for clinical applications under current Good Manufacturing Practices (cGMPs) from Dr. Dhruv Sareen, the Executive Director of the Cedars-Sinai Biomanufacturing Center. Register Now.
When patients self-administer their medications, 60% do not take them as intended and over half of all patients are non-adherent. The resulting cost of non-adherence and non-optimized therapy is steep and everyone pays the price. The rules around healthcare engagement are now being rewritten, and technology has the potential to augment patient care, deliver value across the digital health ecosystem, and deliver better outcomes for all stakeholders in a more connected future. Register now.
Learn how Philips and QIAGEN are using mRNA technology in OncoSignal tests to quantify functional activity of disease-relevant signal transduction pathways in any cell and tissue type. This webinar will explore applications for both preclinical disease modeling and clinical measurement of response to targeted therapies and immunotherapies. Register now.
FDA is opening up to data gathered outside the hermetically sealed clinical trial setting as regulators recognize the need for a more flexible framework for evaluating treatments. As a new approach that requires significant investment, RWE use requires the right talent and technology. Where to find those resources and how to deploy them are some of the questions companies face. We’ll address these questions and more with the help of current practitioners in the field. Register now.
Interested in digitizing your R&D organization, but not sure where to start? Looking to move from a wealth of spreadsheets and outdated software systems into one centralized data repository? This webinar shows what a modern software system should look like for R&D and how that compares to how most companies operate today. Register Today!
UNITY Biotechnology partnered with Rho to execute a complex and fast-moving Osteoarthritis program with three concurrent clinical trials and database locks scheduled during the height of the COVID-19 pandemic. In this webinar, hear from both the Sponsor and CRO about the creative solutions they implemented and how they worked together to pivot quickly and meet critical study timelines in the midst of the pandemic. Register Now.
The field of oncology biomarker testing is growing rapidly. With so many new cancer treatments available requiring specific biomarkers for prescription, oncologists have plenty of new information to follow and many decisions to make when treating individual tumors. Register now.
Learn actionable and real-world recommendations from Honeywell’s experienced ICS/OT cybersecurity team, as they reveal how they’ve coached both sites and enterprises to establish a resilient ICS/OT cybersecurity program. Register Now!
Life science technology leaders will discuss how Apprentice.io’s pharma-compliant remote collaboration platform helped them steady supply chains, better manage operations, and increase speed to market during the pandemic. Hear about how the adoption of this platform helped their teams successfully navigate manufacturing challenges and ultimately deliver safer, more reliable drug products, treatments and therapies – from COVID to cancer. Register now.
Learn how Eli Lily put the power of text mining in the hands of primary (non-data-scientist) users through Linguamatics Web Portals. With the on-going information explosion, natural language processing (NLP)-based text mining has become important to gain meaning effectively from unstructured text. Register now.
Learn how Prognos Health and Datavant are transforming & improving the way life sciences can access an extensive network of integrated real world data sources to define an ideal patient cohort as well as key demographic, therapeutic & customer insights. Register now.
This Fierce webinar will feature executives from leading biopharma companies and technology-development firms, who will describe the latest tools and techniques for improving biomarker discovery. They will discuss how they chose and deployed these technologies, provide examples of how they led to the discovery of novel biomarkers, and offer tips for selecting tools to aid in biomarker discovery and incorporating them into established R&D processes. Register Today!
Biotechnology companies of all sizes face many challenges in the development of new cell and gene therapies. In this webinar, Mike O’Mara and Dr. Ian Gaudet will introduce the development and manufacturing approach used by Miltenyi Biotec and describe how a CDMO partner focused in process and analytical development can enable clinical readiness. Register Now.
In 2020, consumers purchased over-the-counter (OTC) medicine heavily in March, but then shifted their consumption to vitamins and dietary supplements (VMS) for the remainder of the year. In this webinar, Catalent partnered with NielsenIQ to bring forward new insights that provide starting points for re-establishing growth via innovation in the OTC market. Save Your Spot - Register Now.
Attend this webinar to learn about the role neutralising antibody testing plays in antibody detection, response to mass vaccination, longevity of immunity to SARS-CoV-2, and examine performance characteristics data. Register now.