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.
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.
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.
Customers demand more from their marketing—and healthcare brands are no exception. Is your brand providing the customer experiences that patients, providers and hospital administrators expect? Find out in our new e-book.
The world of life sciences is evolving. The industry is poised to transition to modern, technology-driven methods that can produce faster results with higher quality. This whitepaper will explore the advantages and challenges of adopting these new approaches. Download now.
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!
This industry survey seeks to gain insight on the drug developer’s perspective on bioavailability enhancement technologies and the reasoning behind the use of certain technologies over others in preclinical and early-stage clinical development. Take the survey for a chance to win a $5 Amazon gift card.
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!
Patients are enjoying greater choice and simplicity in their daily lives. Whether it’s listening to curated playlists on Spotify or being recommended their new favorite movie on Netflix. Healthcare providers must keep pace with these changing consumer demands. Our latest whitepaper explores how new technologies and AI developments are allowing businesses in the healthcare sector to keep up with patients’ heightened expectations. Download your copy.
As the healthcare landscape is evolving to value-based care, payers are implementing new strategies to adapt to this environment. TKG met with payer advisors to learn more about what these stakeholders are doing to improve healthcare for patients, enhance efficiencies for providers, and reduce costs for themselves. Download the whitepaper.
This whitepaper discusses 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. Click here to download the executive summary!
Most research-driven organizations spend far too much money on scientific literature access. Read this brief guide to discover three common mistakes that result in wasteful spending—and learn simple tactics for big cost savings. Download now.
Download this white paper to learn:
- The top four indicators of low adoption
- How to design training that changes what people do, not just what they know
- The key to change management
- What brain science says about training that works
White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. Download the white paper.
The biggest challenge facing clinical research today is the need to gather, analyze, and report data. To collect patient data more efficiently, researchers are increasingly exploring BYOD strategies for their trials; that is, allowing patients to utilize their own devices to collect data within the context of a clinical trial.
Our white paper discusses BYOD advantages and misconceptions, regulatory, copyright, and equivalency considerations, and a Phase III case study. Read now and consider a BYOD ePRO approach for your next clinical trial.
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!
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.
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 white paper provides an overview of findings from the Medidata eConsent study, which includes the most recent feedback and guidance from relevant regulatory bodies. This paper seeks to share global regulatory positions, adoption, their concerns and variability regarding eConsent. Read now >>
Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%. Download the white paper.
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.
The Veeva 2020 Unified Clinical Operations Survey examines the life sciences industry’s progress in reducing system and process complexity to improve study execution and simplify how study partners work together throughout the trial lifecycle. The goal of this research is to understand the drivers, benefits, and barriers of a unified and connected clinical operating model.
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.
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.
Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Click here to download the Executive Summary.
Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Click here to download the presentation.
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.
Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more.
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.
This white paper highlights the challenges of implementing the right digital twin strategy while providing use cases in manufacturing with highest impact in terms of expected return, and a vision of technology trends shaping the future of digital twins. Click here to download the whitepaper.
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.
In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Click here to learn more!
It's clear that healthcare prices weigh heavily on the minds of Americans, and the time has come for the pharmaceutical industry to take the reins of the prescription drug pricing dialogue with consumers. Download this whitepaper now to learn more about prescription drug price transparency and its role in creating affordability, accessibility, and accountability.
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.
This whitepaper explores how a data lake, enabled by AI and ML, can be used to ingest, aggregate, standardize and provide secured data access and the value it can deliver in reducing risk and driving efficiency, speed and cost savings. Download now.
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.
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.
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.
Fully integrated CDMO for biologics bulk drug substance and sterile injectable drug products. Benefit from our turnkey upstream and downstream support for eukaryotic, microbial and viral expression as well as finished dose services.
- Cell, Viral, and Microbial
- Single-Use Platform (2L to 4000L Scale)
- Process & Analytical Development
- Parenteral Formulation Development
- Fill/Finish Capabilities
- Vials & Pre-Filled Syringes
- Liquid & Lyophilized products
To learn more, visit us at CPhI WW, Stand 120A50 or contact us at [email protected]
When consistent supply for your patients is critical, you can rely on an ANI Global Source collaboration. ANI Global Source is a specialty CDMO supporting late stage development and commercial pharmaceutical manufacture of:
- Oral dosage forms
- Creams & Gels
- Potent compounds
- Class II controlled substances
Manufacturing your product requires more than raw materials and established processes. At ANI Global Source, expertise, safety, reliability, and integrity are at the core of everything we produce. Visit us at booth 121H63 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.
We assists clients with small molecule cGMP projects from lab to multi-metric ton quantities. Our team provides phase appropriate route and process development solutions for short-term scale-up and long-term manufacturing challenges.
With vast experience in downstream purification techniques (chromatography, crystallization), we have completed 100+ chemical API projects (10 ongoing commercial products), including: complex multi-step synthesis, potent handling, and controlled substances. FDA & Health Canada inspected.
To meet our team at CPhI (booth 121H42), email [email protected]!
Formulation challenges. Clinical supply hurdles. Lifecycle management. Risk mitigation. Patent expiry concerns. At BioPharma Solutions, a business unit of Baxter, we know the high-stakes challenges you face in today’s complex parenteral marketplace — and how the work we do is vital to the patients you serve.
If you have an injectable molecule and are looking for sterile contract manufacturing services, we invite you to stop by our stand at CPhI Worldwide in Frankfurt (Hall 12.1, Space F81) to meet with a representative and discuss how we can help you achieve your molecule’s full potential. Learn more.
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 interview, Greg Fry, Patient and Consumer Analytics - ZS Associates, discusses consumer data and marketing trends and how to optimize digital campaigns. Watch the video.
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!