As companies strive to get new treatments to patients, it is now suddenly vital to mitigate new unexpected risks to ongoing clinical trials. Join Parexel’s experts as they share tips and best practices for mitigating these risks. Register today!
Drug stored in glass primary containers risk losing efficacy and safety when not properly tested for corrosion or delamination. These phenomena occur when drug interacts with the inner glass surface over time causing glass matrix dissolution. In 2011, the FDA issued an industry warning leading to aggressive and extensive testing. Click here to register for this upcoming webinar.
A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays. Register now.
Join our experts as they share insights on:
- R&D Leadership During the Pandemic: John Chiminski, Chair & CEO
- Technology Integrators in Cell & Gene Therapy: Julien Meissonnier, VP & CSO
- A Novel Approach for High-Expressing CHO Cell Line Engineering: Greg Bleck, Ph.D., Global Head of R&D, Biologics
To better understand industry perspectives on the dosage forms, Catalent and FiercePharma surveyed 262 pharmaceutical leaders in 2019 to gather the views of individuals who have recently been involved in the development of oral dosage forms. Download this infographic to learn more about survey results and expert insight on trends uncovered by the survey.
The need for real-time data in a COVID-19 era. Join Parexel experts during this live webinar as they analyze the role of Real-World Evidence (RWE) and how it supports the urgent need in emerging therapies for COVID-19. Register Now!
Antibodies are the fastest growing group of biotherapeutics with over 100 antibody-based molecules (including biosimilars) approved in 2020. This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies. Download Lonza’s latest whitepaper.
Join Dr Sheng Guo to learn how to maximize your oncology in vitro datasets using in silico modeling. Find out how advanced data analysis is used to interrogate cell line and organoid genomics, novel combination regimens, and predictive biomarkers. Register here!
This guide provides clinical trial sponsors with strategies to help respond to patient and site engagement challenges from COVID-19. It includes solutions to minimize risks to enrollment timelines and help sponsors navigate FDA guidance on conducting clinical trials during a pandemic. Download the guide.
This webinar will address the impact of Covid 19 on clinical trials and highlight how industry-wide trial metrics and analytics can be used to support situation tracking, impact forecasting, and recovery planning. Register now.
To better understand why innovation is important to the OTC industry and how it is achieved, Catalent and FiercePharma conducted a survey which generated responses from 233 people from the OTC industry. Download this infographic to learn more about survey results and expert insight on trends uncovered by the survey.
Development programs in rare diseases are becoming a major focus for small biotech and pharmaceutical companies. A crucial consideration is the choice of control group used to assess efficacy. Through recent case studies, we will discuss factors to consider, appropriate analysis, and the critical role that externally controlled studies play in supporting marketing applications for orphan/rare disease products. Register now.
Continuous manufacturing represents a new paradigm in the development and manufacturing of oral solid dose products. In a continuous manufacturing process, products are produced via an integrated series of modular unit operations. The raw materials are fed into the process and converted into the oral solid dose product at a continuous rate without interruption. As a result, this process has greater control, no scale up and can provide multiple benefits in both development and commercial manufacturing. Register Today!
The editorial teams of FiercePharma and FierceHealthcare bring you another week of live virtual updates and expert panels discussing the coronavirus. We’ll do a status update about our progress so far and what challenges remain ahead. Watch the sessions on-demand.
To better understand sponsors’ perspectives on DTP and interest in using it in their studies, Catalent and FiercePharma surveyed 234 individuals involved in clinical supply and operations. Download this infographic to learn more about the survey results.
With the right data, analytic strategy, and program governance, forward-leaning companies can make an impact. Learn about Medtronic’s value-based healthcare strategy as a means to create benefits for providers, payers, and most importantly patients. Register now.
With the evolving situation of COVID-19 companies are rushing to get new vaccines to patients and bring this outbreak to a close. Join Parexel’s experts as they draw on vaccine experience and learnings to share tips and considerations for the fast start-up of vaccine trials. Save your spot today!
Discover the latest advantages of using a personalized, tumor-informed circulating tumor DNA (ctDNA) test to design oncology clinical trials in solid tumors. 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 to watch this recording!
As the pressure to prove the value of existing and new therapies increases, it’s critical to leverage more comprehensive data assets. This whitepaper addresses how the immediacy of EHR data availability can be significantly impactful, particularly as the health care system works to address COVID-19.
By modernizing agreement processes that are everywhere within life sciences companies, life-saving drugs and devices can get to market faster and business processes can be done smarter. Read the case study to learn more.
In this issue of ‘Patient Perspective’ we show you many ways the healthcare industry can place a greater emphasis on patient-centricity, and how pharmaceutical companies are developing products and services that better serve unmet patient needs. Download the magazine.
Learn how we used a tiered model-based approach of a bispecific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs. Watch the webinar on-demand.
A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months. Click here to register for this webinar.
FiercePharma and FierceHealthcare bring you a week of virtual updates and expert panels discussing the coronavirus. We're assembling a series of experts to discuss industry’s role in preparing for a pandemic and what steps can be taken to mitigate risk while dealing with the outbreak. Register for on-demand sessions now.
Today more than ever the ability to process real-time data from disparate sources is critical to patient safety and data quality. Join us for a discussion and Q&A on how to find errors, trends, and anomalies in data to mitigate risk effectively.
In this webinar, we'll explore how to address and overcome challenges in genetics-based clinical trials, using real-life case studies. InformedDNA is the authority on the appropriate use of genetic testing and the leading telemedicine provider of clinical genetics services.
Who should attend? Anyone involved in designing or operating clinical trials for rare disease therapies. Register now.
How is COVID-19 impacting HCPs and patients? Join Daniel S. Fitzgerald, InCrowd CEO & President and Philip Moyer, InCrowd VP of Crowd Operations, to review the key findings. Register now.
Join Parexel experts as they discuss lessons learned over the past three months in managing COVID-19’s impact on trials in China. Our panel will provide insights into what companies should be doing now to prepare for the upcoming ‘new normal’ and what longer-term changes are likely to occur because of the pandemic – and the opportunities and challenges these changes present. Register Now.
As Biologics and sequence-based therapeutics become more pervasive, a new set of Sequence-Activity-Relationship tools are gaining importance in drug discovery. This webcast will showcase how AbbVie has been working with PerkinElmer solutions that extend their SAR analysis capabilities to include both small molecules and biologics in a single extensible platform that promises to expedite the lead discovery process. Click here to register.
In this webinar you will hear about Sanofi’s journey and experience in building an industrialized big data & analytics platform in the cloud that handles billions of rows of RWD data with complete data traceability, security, and supports both traditional (e.g comparative effectiveness) and advanced analytics (e.g. machine learning , NLP) for day to day evidence generation (RWE). Register now.
To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help.
Using micro-dosing technology and powder-in-capsule (PIC) or bottle (PIB) approaches, biopharmaceutical companies have the ability to increase speed to clinic, quickly assess their candidate compounds, and remain cost-conscious in early stage development. Attendees working with an oral solid dosage development and manufacturing will benefit from this educational webinar. This webinar will also be informative to attendees with responsibilities for rapid first-in-human studies with oral solid drug product. Register now.
This webinar will address key considerations and best practices when combining clinical trial data with real world data to power big data analytics. Register now for the on-demand version.
Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights.
The life sciences industry has always relied upon empirical data and analytics to inform product development activities and commercial strategies. The goal of this research is understand the drivers, benefits and barriers to scaling analytics across all facets of a life sciences organization’s operations.
The webinar on March 26 is “Before GLP: The value of robust exploratory toxicology prior to pivotal GLP studies.” Mr. Ryan will share experiences and stories, as well as suggestions for how to set up a successful IND approach. We hope you will find our discussion insightful and help you avoid unexpected surprises in your IND-directed studies. Register to save your spot today!
Successful implementation of RBQM is a challenge many in our industry are facing. To understand what it is and how it impacts the management of your clinical trial, this webinar will address what exactly E6R2 is. We will use Rho as a case study for designing and implementing a strategy, discuss common misconceptions, and review lessons Rho has learned through implementation of RBQM. Click here to register for this webinar today!
Learn how Box is a critical force multiplier in the Best-of-Breed application stack with partners like Nintex, DocuSign and Slack in supporting clinical operations for both regulated and non-regulated content. Register now.
Join Thermo Fisher Scientific for a live webcast on its $800 million investments in its biologics, cell and gene therapy, and drug product capabilities to help biopharma and pharma companies of all sizes accelerate commercialization and bring medicines to patients faster.
Serialized products generate a wealth of data as they move through the supply chain. What if you could access and analyze this data to gain operational visibility and powerful business insight? It’s time to put your serialization investment to work for you. Learn how in this webinar.
Obtaining feedback from Life Sciences organizations are key in the delivery of actionable insights that our target customers come to expect. Our goal is to assess how far the adoption of AI technology has come in Life Sciences. Complete the survey for a chance to be one of 50 qualified respondents to receive a $5 Amazon gift card.
Learn how a Quantitative Systems Pharmacology (QSP) model and translational framework described for CD3 bi-specific molecules provides a holistic solution for quantitative decision making throughout the drug discovery and development process. Register now.
See why innovative BioPharma’s are partnering with Cloud Service Provider’s to design, manage and implement cloud strategies to smooth the path to FDA approval and enhance their competitive prowess. Download the whitepaper.
How does your organization measure clinical trial performance? Does it measure the right things? Does it measure them effectively? Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way. Download the whitepaper
When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed. Outsourcing to a CMO with experience in multiproduct facilities can be an option. Download the whitepaper.
Developers of cell and gene therapies can run into complex clinical and regulatory hurdles when bringing treatments to patients. Join experts from Cardinal Health Regulatory Sciences to explore critical factors that can help reduce the risk of failure and increase speed to market. Register for this webinar today!
Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor. Watch On Demand Now!
Current industry trends are creating a shift in how manufacturers are approaching their HUB programs. Download this whitepaper to explore a variety of factors to consider when choosing between insourced, outsourced, and hybrid HUB models.
Understanding the medical device design and how it forms integral and non-integral drug device combinations (DDC’s) is critical to navigate the new European regulatory landscape.Examples of these expectations will be presented to outline the overall impact of Article 117 and additional elements of the MDR 2017/745 pertaining to combination drug products as regulated within the European community. Register now.