Through this whitepaper, Samsung Biologics outlines the areas that were critical in adapting best practices for business management in dealing with the pandemic including employee safety, GMP compliance, supply chain management, and digital adaptation. Download now.
Digital Therapeutics are becoming increasingly important tools to drive meaningful improvements in patient outcomes and support the overall patient journey. Learn how life science organizations are leveraging cloud technology in the development and deployment of secure, low-latency digital therapeutic programs. Download the whitepaper.
One of the most critical elements in the quality control of pharmaceutical manufacturing is the use of lab balances and weighing equipment. When it comes to sample preparation and management, there is always the risk of error during measuring and weighing. Download the whitepaper to learn more.
AbSci’s Protein PrintingTM technology enables rapid E. coli SoluPro® cell line development for complex therapeutic proteins. We will detail our ability to go from gene to purified antibody in 10 days, including cell line construction, fermentation, purification, and protein characterization. Register Today!
During this webinar, attendees will learn about Thermo Fisher Scientific’s new 5KL bioreactor and how it benefits clients who outsource late-phase biologics drug substance manufacturing. An introduction of the 5KL bioreactor will be provided, as well as application data around performance and scalability, process economy comparison with traditional stainless steel bioreactors, and decision criteria that could be helpful in choosing between different cell culture strategies. Register Today.
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.
Accurate HCP data is more important than ever as pharma shifts to digital engagement. New research from Veeva reveals that 88% of reps are using digital channels to connect with customers. Read the report to understand the state of customer reference data and benchmark your organization’s progress.
Interested in complete supply chain real-time data visibility? Unlock productivity with digital workflows, manage plants inventory with real-time supply chain information and enable faster decision-making with data visualization with pci | bridge. Save your spot.
During this webinar, hear from Kalderos to learn:
- An overview of compliance and operational challenges facing the 340B program
- Why 340B rebates can eliminate duplicate discounts
- How covered entities, manufacturers, state Medicaid programs and other stakeholders will benefit from 340B rebates
To succeed in today’s environment, biopharmaceutical companies must leverage analytics and adopt innovative approaches to engage HCPs and improve outcomes for their customers and communities. Join us for a roundtable discussion with leading industry innovators to discuss how biopharma manufacturers can successfully increase and improve HCP engagement. Register now.
This webinar will provide an overview of the guideline and will explain the Established Conditions (EC) discussed therein, as well as the applicable regulatory requirements. A deep dive into Post Approval Change Management Protocols (PACMP) and Product Lifecycle Management (PLCM) as tools to manage change will also be discussed. Register Now.
In this webinar hear how Sanofi has demonstrated success with case processing automation via natural language processing, machine learning and artificial intelligence with Deloitte’s ConvergeHEALTH Safety Cognitive Platform on AWS Cloud. Register Now!
At Takeda, Linguamatics’ Natural Language Processing (NLP) software is used for systematic examination of gene-disease associations. Join us to discuss the value of text analytics for the identification of genetic mutations, genotype-phenotype association and disease severity, in order to develop a better understanding around the biology of rare diseases. Register now.
COVID-19 has posed major challenges to healthcare on a global scale. The Wave Assessment of coVid Epidemiology (WAVE) was developed to help inform site selection by considering the expected trajectory of the COVID-19 pandemic. In this whitepaper, we detail some of the use cases for the WAVE model. Read now.
Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Download now.
The only constant during a drug launch is change. Despite careful planning, commercial organizations must be ready to pivot in response to rapidly changing markets and regulatory conditions. This webinar will address key considerations and benefits of working with a cutting-edge data management and insights technology. Register now.
New research explores the impact of the COVID-19 pandemic on clinical trial management, including the acceleration of decentralized clinical trials. This report provides invaluable insight into the key challenges and opportunities surrounding these changes in this new environment. Download the report.
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.
COVID-19 has had a significant impact on clinical care and real-world research, one such being a shift from traditional clinical studies to virtual, or decentralized, studies. Gain insight into what factors determine whether a study is a good fit for a virtual model in this white paper. Read 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.
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.
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.
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!
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.
Early process development is critical to generating a high producing cell line. That is why Polpharma Biologics have developed Specific Productivity Optimization Technology (SPOT™) to increase cell line specific productivity and achieve titers up to 9 g/L that can be rapidly scaled up for pre-clinical, clinical and commercial supply. Watch On Demand.
While ELISA methods have historically been the main approach to detecting total HCP content, LC-MS based HCP detection methods have increasingly become an expected orthogonal standard in successful biologic development. Download this eBook and learn the advantages of LC-MS based HCP profiling for development of complex biologics.
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.
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.
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.
With more than 1000 Integrated Delivery Networks (IDNs) operating in the US today, a single IDN could encompass thousands of facilities and tens of thousands of physicians within a single coordinated network. How do you know its value? How do you access a complex web of individuals responsible for purchasing and formulary decision-making? Download this whitepaper to learn more.
45% of clinical sites transitioned patients to remote visits during the pandemic. Virtual trial solutions drive rapid response to disruptions affecting patients, monitors and CRAs. Assess your virtualization tech strategy against 8 parameters to implement for success. 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.
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.
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
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.
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.
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.
New survey findings identify the tools and technologies that can help patients more easily integrate clinical trial participation into their lives during COVID-19 and beyond – including solutions that address travel, reimbursement, medication delivery, remote visits, and virtual engagement. Download Now.
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.
This white paper outlines how one such law, Minnesota’s Alec Smith Insulin Affordability Act, has impacted the pharmaceutical industry and provides guidance about strategies businesses can employ to rapidly add support. 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.
Attend our partner presentations and learn data driven strategies to accelerate your molecule development. Discover Catalent’s OptiDose™ Design Solution, a structured approach to dose form design. Don’t miss our scientific research poster on Lipid-based Formulation that will be presented virtually. Register now.
This webinar explores the latest regulatory requirements in the post-marketing setting. It provides details about some of the most recent developments in this area, including a move by the FDA in 2018 to require that companies marketing drug-device combination products report all complaints about safety to the agency. Register 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.
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.
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 connect with us at CPhI Festival of Pharma virtual event October 5-19, 2020 using this link.
As a continuous manufacturing process, extrusion was cemented in pharmaceutical manufacturing in 1980s with market launch of sustained-release Verapamil, which contains embedded crystalline active pharmaceutical ingredient (API) in polymers. Following the Verapamil launch, researchers have turned to hot melt extrusion (HME) as an effective enabling technology to manufacture amorphous solid dispersions (ASDs) for poorly soluble compounds.
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.
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. What will you learn: Study planning, including quantity calculation, and how to minimize deviations, safely and successfully working with Schedule I products, packaging and labeling requirements for different countries and jurisdictions, and shipping and importation logistics during the COVID-19 era. 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.
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 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.
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.