While the concept of artificial intelligence (AI) began gelling more than 50 years ago, its use in the pharmaceutical industry is just starting to gain significant traction. In January, the first drug designed entirely using AI entered the human clinical trials phase—five times faster than it usually takes to get a drug to this stage. But is the rest of the industry ready to deploy AI technologies? Download the whitepaper.
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.
Vaccine trials against COVID-19 are leading the effort before studies begin in children. This white paper describes the challenges facing COVID-19 pediatric clinical trials from protocol to planning of pediatric sites. Download the whitepaper.
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.
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.
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!
Looking for ways to engage with HCPs more effectively in your virtual events? Join this 45-minute webinar including a live Q&A, on Tuesday, November 10, and learn how to optimize customer engagement across channels. Register Now.
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.
Lonza has decades of experience in the development of liquid-filled hard capsule formulations, especially in the handling and manufacture of highly potent active ingredient formulations. We also provide integrated product development, analytical method development and manufacturing services. Download Now.
Changes in the Drug Substance (DS) process as it scales up can affect the Drug Product (DP). As processes change, many properties of the DS can also change. Therefore, as DS manufacturers evaluate and optimize the synthetic route, process conditions, crystallization solvents, etc., they must understand and track these changes, and discuss them with DP formulators to anticipate challenges in formulation. Download now.
In the wake of COVID-19, clinical research sites are in dire need of extra resources to help run their clinical trials. By utilizing qualified, experienced WCG Clinical Research Coordinators (CRCs), these professionals can help overburdened study teams get tasks done, and get them done with efficiency and precision. Download Now.
With COVID-19, the value of virtual trials with direct data capture (DDC) is obvious. Bring-your-own-device (BYOD) electronic patient-reported outcome (ePRO) solutions increase adherence while precluding the transfer of devices among patients. Download Now.
One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. Download the whitepaper.
Viral vectors have the potential to address unmet vaccines and there is currently a shortage in manufacturing capacity. Companies pursuing vaccine manufacturing as well as gene therapies must figure out a way to close the gap.
For many, this means facing a build versus buy capacity decision. Read the article to see why accelerating the production of viral-vector based therapy requires you to understand:
• The strategies available to address the viral vector manufacturing shortage
• How to select the most cost-effective solution for your next-generation therapeutic
Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now.
LabVantage Pharma, the first pre-configured, pre-validated laboratory information management solution dedicated to pharmaceuticals, reduces cost and risk by deploying needed functionality without custom code. Serving regulated industries, the LIMS helps ensure regulatory and data integrity compliance. Download the whitepaper.
This paper demonstrates how an integrated compliance model leads to increases in safety, efficiencies and it can move the needle from cost center to value; by demonstrating the value of increasing data-driven and technology-infused competitiveness in the successful commercialization of a new-age biopharma product. Download 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.
What will it take to bring a COVID-19 treatment to market? What have we learned from efforts to ensure supply chain stability at the height of the pandemic? Leaders from AmerisourceBergen's Strategic Global Sourcing team share their perspective on how we'll make sure the right pieces are in place. Download Now.
Discover the latest advantages of using a personalized, tumor-informed circulating tumor DNA (ctDNA) test to design oncology clinical trials in solid tumors, and Breast Cancer in particular. Learn how Signatera, a breakthrough technology, can be applied in early stage and late stage cancer trials, potentially enriching for patients most likely to respond to therapy, accelerating time to trial readout, or identifying early relapsers. Register Now.
Key findings reveal the solutions that matter most to patients when deciding on clinical trial participation. Download volume 1 findings now and see where they rank the importance of medication delivery, reimbursement, travel assistance, study apps, and much more! Get exclusive data that reveals a growing demand for telehealth and innovative technologies. Also see the impact of COVID-19 on clinical trial interest.
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.
At least 12 U.S. states have now passed laws that cap the insulin costs for diabetic patients. More than 30 are currently considering such legislation. What challenges will such legislation pose for pharmaceutical manufacturers seeking operational solutions for reimbursement, compliance, and data handling? Download the white paper on the Alec Smith Insulin Affordability Act to learn not just about the law but about the portal platform designed to change the entire process for manufacturers, pharmacists, and patients. Download 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.
A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Download Now.
Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Download 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.
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.
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.
Speed, Collaboration, and Expertise. That’s what Cascade Chemistry brings to API process R&D and clinical manufacturing for Phase 1&2 trials. Growing over 40 years into an API CDMO, we’ve mastered the art of strategic partnership and deliver innovative solutions to clients’ complex chemistry. Download now.
Researchers from Novo Nordisk, Medical College of Wisconsin and Veradigm have published a new study in the journal Diabetes Therapy, employing de-identified patient data sourced from a nationwide, electronic health record platform. Download this article now at no charge.
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.
Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and expectations for a development and manufacturing partner during the drug product process development phase. Download 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. Register Now.
Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. Find out more about the various automated processes that can help to achieve these efficiencies, and reduce manual work. See how to improve the quality of metadata and increase consistency across studies. Download now.
A provider offering a robust set of capabilities — such as video recording for central-rater review — is more likely to be able to accommodate the needs of your trial, providing you with the necessary tools to simplify monitoring and oversight. Learn more about Clinical Ink’s CNS solution. Download now.
A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success. Lack of preparation for scale-up activities needed for eventual commercialization can often cause major time delays, increased costs, and a significant amount of rework. This eBook provides insights on key approaches and considerations for preparing your program for long-term success. Download now.
There are a number of strategic advantages companies can achieve in pharmaceutical production by transferring production between sites. They can safeguard supply by producing at more than one site, and improve distribution by moving production closer to critical markets. Download now.
Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow. Download Now.
Developing and bringing a new drug to market is a long, expensive and uncertain process. Read this article to learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Download now.
Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. Download the whitepaper.
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.
The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them. While it seems fairly obvious that drug development is centered on the patient, the truth is that patients were not always an integral part of the process. Perhaps more importantly, patients were not involved in the conversation as to whether the drugs being developed would actually be beneficial and improve the patient’s quality of life. Download Now.
Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development.
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 white paper discusses how pre-commercial pharma companies that commercialize products independently can see an average market capitalization six times greater than companies who consistently license. Learn more how these decisions impact the current and future market valuation. Download 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.
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, 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.
This survey will determine different companies' use of Plasmid DNA, if they outsource its manufacture, and how often they use it in their labs. The first 50 qualified respondents will receive a $5 Amazon gift card. Take Survey.
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.
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.
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.
Becoming patient-centric begins with real-world evidence: Technology drives innovation, but research and trials must be accessible, privacy-safe and return value to participants. Learn how real-world evidence generation is evolving to meet patient needs. Download now.
Master protocol studies are meant to increase efficiency and expedite drug development. The challenge is the protocol is amended to follow positive signals, which can be both a costly and slow process. Modern technology is needed to support these complex trial designs to enable flexibility, speed and quality trials. Download 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!
Acorn AI is a Medidata company that represents the next horizon of the industry leader’s 20-year mission of powering smarter treatments and healthier people. Acorn AI is designed to make data liquid across the entire lifecycle and to answer the most important questions in R&D and commercialization for customers. Download the case study.