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. Register today!
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!
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.
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.
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.
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!
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!
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.
How will 2020 change US healthcare? InCrowd’s physicians weigh in on what the new year will bring. Join Diane Hayes, PhD, InCrowd Co-Founder and Board Member and Daniel S. Fitzgerald, InCrowd CEO and President, for InCrowd’s 2020 Healthcare Predictions Webinar. Register Now!
Learn how we used a tiered model-based approach of a bi-specific antibody to appropriately cover multiple antigen pairs to help teams with informed antibody design, prioritization of experiments, and triaging of challenging antigen pairs. Register today.
This new year, take a fresh look at your monitoring processes and learn how to improve efficiency across the entire monitoring lifecycle. Register for the webinar here.
The focus of this webinar will be on the design and process approach for next generation large volume delivery systems for prefilled cartridge delivery, as well as on providing an overview of key critical product requirements, such as compatibility with sensitive drug products, system functionality, and fill-finish implementation. Register now.
This webinar reveals results from a recent industry survey that sought to gain insight on trial sponsors’ perspective on offering a DTP option and their current level of awareness and understanding of any factors that may influence their ability to do so. Register now to learn more.
Are there certain types of clinical sponsors and studies that are at greater risk of experiencing supply challenges? This webinar will explore aspects of the study protocol that can directly influence clinical supply strategy and how sponsors can proactively understand and address clinical supply-related risks. Register now.
From the basics such as service level expectations for couriers versus integrators, to how to evaluate domestic and international lanes, and finally – how to balance risk and cost, this webinar will help you understand how to start tackling your clinical supply chain. Register now.
Join us as an interdisciplinary group of experts from the Digital Medicine Society (DiMe) provide a brief introduction to core concepts and terms that define digital medicine, along with practical tips for implementation and case examples.
Today, the rise of a new generation of robotic, precision, and surgical devices has created vast stores of video, imaging, and electronic surgical notes, prompting the question: How do you leverage these datasets and improve patient treatments and outcomes? Register now to learn how a connected data platform offers a definitive answer.
Why should the primary container system be considered an excipient? Register for West’s webinar on December 5, to gain insight on considerations that should be made to mitigate packaging risks early in the drug development process!
In this webinar, AstraZeneca and Catalent Biologics experts will share a case study on a 30-day commercial launch plan for a product into new markets and why this approach was important for patients. Register now.
Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management. Learn how to reap the rewards of a straightforward build and a modern EDC during this webinar. Register now.
Accenture experts will explore the emergence of SaMD as a new class of medical device and discuss the potential challenges that biopharma companies face in the development of these solutions. Register for this webinar now.
Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. At the same time, they must meet GxP requirements, update antiquated systems and processes, and address the demands of an increasingly tech savvy workforce. Register now to learn more about the role that content management plays in pharmaceutical manufacturing.
Liquid-filled capsule technology has a proven record for addressing complex API formulation challenges, but also offers a simple and effective pathway to the clinic. Register now to learn more about lipid-based formulations.
Join industry experts as they analyze the critical role of innovation in OTC products, and strategies for achieving it. Register now to learn more about survey insights, market trends, and latest technologies.
The transformations now taking place in the emerging field of connected packaging have the potential to address all these product challenges—protection, engagement, traceability—while delivering powerful supply chain insight. Register now to learn more.
Why is diversity in clinical trials important? Minority populations are more likely to be diagnosed with certain cancers, stroke, diabetes, and are more likely to die prematurely than White Americans. Health disparities by race and ethnicity could increase if minority populations are not included in clinical trials.
Register now to learn who is participating in clinical trials and why.
Integrated Imaging and EDC ensures the right data is presented to the right users at the right time, free from manual intervention. Taking data reconciliation to a whole new level means your trial not only saves time, resources and cost, but also drastically reduces your clinical trial risk. Register now to learn more.
In this webinar, we'll highlight some of these approaches and demonstrate how data and analytics can be used to gain a competitive advantage and create differentiation. Register now.
Discover an approach to solubility and bioavailability enhancement of poorly water soluble drug molecules, approaches to aqueous-based spray drying of bio-pharmaceuticals as well as small molecules intended for inhalation delivery. Join us for this webinar to learn more.
Register for this webinar to learn about the tools and technologies for creating dosage forms such as orally disintegrating tablets (ODTs), multi-particulates, and modified release formulations.
In this webinar, you will hear from Alan Louie, Ph.D, Research Director at IDC, Bill Swavely, CIO at Pharm-Olam, and Rama Kondru, Ph.D, CIO at Medidata about the need for a platform approach in clinical research, the rationale for switching from disparate systems to a unified platform, and the benefits that could be realized. Register now.
This webinar will address how the use of technology for deploying data and analytic standards can be utilized to meet the challenge of understanding and comparing findings between studies conducted by different researchers, by facilitating the standardization, transparency, reproducibility, and replicability of RWD research. Register now.
In this webinar, we'll share insights to harness the strategic value of real world data to build optimized drug development programs that minimize the time and cost of sponsor-driven studies. Register now!
Join us for this webinar as we bring together a panel of industry experts to discuss the changing landscape of biosimilar development and how it will affect pricing in the future.
With increasing competition for patients, the ability to effectively and efficiently execute on clinical development plans has increased focus on alternative data sources. In this one-hour session attendees will hear from former FDA leaders and industry experts who will address what Synthetic Control is and how it can be leveraged in clinical development.
Eight years after the FDA issued its guidance of process validation, some still ask the question “Is process characterization optional anymore?” This webinar will cover the basics of process characterization, whether it is optional or not, and what “good” process characterization really looks like. Register now!
Developing a combination product? Join experts Susan Neadle, Sr. Director, Global Value Chain Quality Design, Johnson & Johnson and Jennifer Riter, Sr. Director, Lab Services, West to learn how you can create an effective risk management program. Register Now!
Hear from Moderna’s Chief Digital and Operational Excellence Officer how they have eliminated data siloes to accelerate data-driven decisions at an enterprise level, and established a production environment capable of consistent delivery of complex drug products including a “batch of one”. Register Now!
This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. Attend to hear about two case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.
Please join the experts from CMIC Group, Japan’s largest CRO with over 30 years of analytical service experiences in US and Japan, to learn the insights and tips on developing an immunogenicity assay in a regulated laboratory, selecting a format for the neutralization assay for immunogenicity assessments, and quantitative Bioanalysis of Oligonucleotides by LC-MS. Register Now!
In this webinar, manufacturing experts will discuss the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Register now!
Enrollment can be very fast for post-operative acute pain studies which brings with it unique challenges in study execution. This webinar will address the differences between bunionectomy and abdominoplasty models, the importance of rater and site training, and considerations for data collection and analysis.
Join Lash Group’s Vice President of Market Development and Strategy, Michael Craig, and Product Director of Adherence Services, Dale Hanna, as they discuss the critical nature of clinical expertise in tech-enabled patient support solutions and the importance of training teams in empathy. Register now.
Nick Dyer ( CEO, Catalyst Clinical Research ) and Stacey Yount ( VP of Product, Trial Management Solutions, Medidata ) will discuss the industry challenges and share how Medidata’s Rave CTMS breaks down operational silos by providing a centralised solution to manage issues, deviations and associated actions. Register now.
Join this webinar to hear from two of Veeva’s subject matter experts, Lalana Dararutana and Serena Peirson, on ways to achieve a successful RIM implementation. Register Now!
Join this webinar to learn how Raman, NIR, and mass spectrometry provide raw material ID and bioprocess monitoring for:
- cell culture and fermentation monitoring
- moisture analysis of lyophilized materials
- near real-time discrimination of bulk protein product
Join this webinar to learn how industry leaders are using DocuSign to modernize their systems of agreement while implementing GxP validation processes. Hear best practices about how to simplify and scale your business processes while also reducing your regulatory risk.
This Fierce webinar will feature clinical trial site leaders and R&D executives, who will pass along the latest strategies for boosting site and patient enrollment in phase 1 trials. They will discuss best practices for communicating with both investigators and patients. Register now to learn more.
You’ve identified your product as a candidate for approval via the 505(b)(2) pathway and completed a successful pre-IND meeting. What comes next? Register now to find out!
Understanding the existing relationships among health care professionals not only optimizes your ability to connect with them, but it also maximizes the impact of marketing communications in achieving the desired clinical behavior change that will improve patient care.
Join our webinar to learn more about how you can do more with less through “HCP Impact” strategies.
Register for this webinar to get insights from industry experts on:
- Demand led manufacturing and supply
- Forecasting and inventory management
- Innovations and considerations in labeling
- Direct-to-patient distribution
Join us to learn how recent enhancements to protein expression platforms can significantly increase expression levels for complex proteins. New technologies for simplifying and increasing expression levels of multi-chain and complex proteins will be presented. Register Now!
Join this webinar to learn the five characteristics of a unified platform and how each benefits clinical research both for a single trial and across your suite of research efforts. Register Now!
Patient-centricity gets a lot of buzz, but what are the benefits of involving patients in the planning of a clinical trial? This webinar looks at where in the process to get patient input, the benefits, and what tactics to use to get input. Register now.
A new, promising data source that could help explore and unlock new discoveries lies in the use of simulated data that can be used in place of real patient information. Join our experts as they provide insight on this newly emerging data source. Register Now!
Join senior leaders from Accenture and Salesforce to find out how future-focused Biopharma companies are delivering growth amid compressive disruption and leveraging that investment in digital technologies by embracing New Science to drive value for the healthcare ecosystem, including, and most importantly, to raise the standard of care for their patients. Register Now!