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.
Evotec presents practical and methodological approaches to preclinical drug abuse liability assessment of CNS-active candidates in light of International Regulatory Agencies’ recommendations. Two webcasts cover critical parameters that should be considered when designing animal behavioural studies. Watch the webcast.
Tech transfer is a multifaceted endeavor with multiple variables that must be carefully considered. Get insights on key considerations for a successful process transfer for manufacturing a drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Download now.
This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Download now.
Worldwide there are over 300 million people living with one or more identified rare diseases. The development of new treatments to address these unmet clinical needs clearly represents an important global health priority. Despite improvements, difficulties remain for drug developers in bringing these medicines to market. Download now >>
Extended care programs are available to help people in need. However, as the law rolls out, there are some clear communication disconnections that may make the process cumbersome. Download the eBook to read about a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all.
Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more.
Optum brings together cross-industry experts to share a case study detailing how an employer, provider, payer and pharmaceutical company worked together to address a hard-to-diagnose condition: migraine. Register now.
Hybrid, Virtual, and Synthetic trials are becoming part of a growing number of drug and biologics development programs. Join us as Rho experts discuss how to maximize the benefits of decentralized trials. Register now!
Before businesses can recover, they will need to reboot, which will involve developing a holistic approach to managing new health risks, rethinking workforce safety, maximizing productivity, and furthering sales –while protecting and maintaining compliance with privacy and cybersecurity rights. Register now.
Join us to discuss strategy, timing, process, practical and execution aspects to be considered in order to achieve a target outcome. Case studies will be presented that demonstrate each of these challenges and the considerations necessary to meet fast-track timing requirements of clinical trials and registration applications. Register now.
Repurposing approved compounds carries both opportunities and risks. Download the article to learn how including ototoxic assessment in a preclinical safety package for COVID-19 therapies can de-risk regulatory review, preserve patient hearing, and improve market positioning.
In this webinar you will hear from technology company uMotif on how they collaborate with pharma companies undertaking virtual and decentralized trials. Hear how new patient populations can be reached using cloud-based technology and learn what types of research data can be collected from different devices and wearables. Register now.
Join us to gain an understanding of how to combine two different polymers, one “inside” and one “outside” the ASD to maximize performance, physical stability, and drug loading of ASD drug products. Register now.
Continuous manufacturing brings uncertainties with regulatory and adoption rates. Industry expert, Ajaz S. Hussain, PhD, will discuss these uncertainties and provide more insight into this innovation. Register now!
To better understand the landscape today, Catalent and FiercePharma asked 200+ people involved in the oral dose market from April to May 2020 for their views on barriers to the development of oral formulations and technological responses to them. Download the infographic now.
How can you make the process of bringing your product to market less complex while also reducing costs? This eBook identifies opportunities to simplify channel strategies for biopharma companies, their customers and patients. Discover how you can deliver savings and innovation to your business. Download now.
Pharmaceutical and biotech companies are spending years and millions of dollars developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Download now.
Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Download the Fact Sheet here.
Spray-dried dispersions (SDDs) are utilized to increase the bioavailability of poorly soluble molecules, however excipient requirements can limit their dose range. A novel platform has been developed to enable SDD dosage forms with high drug loadings, decreasing the size or number of tablets required. Download the whitepaper.
Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Click here to download the eBook.
Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Click here to download the Case Study.
The complexity of clinical trials is increasing, and patient recruitment and retention continue to pose challenges. New platforms are providing the life sciences industry with an opportunity to improve the efficiency of clinical trials and reduce costs while remaining compliant and reducing risk. Download the whitepaper to learn more.
In a BioPharma Dive industry survey of 150+ individuals with responsibility for clinical supplies, planning and forecasting were identified as top concerns for trial sponsors and were seen as activities that can yield significant benefits. In response to this need, the Clinical Supply Management (CSM) team at Catalent has developed a factbased methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Download now.
Regulatory agencies have provided recommendations on when and how to identify and characterize drug metabolites to ensure their non-clinical toxicity has been adequately evaluated. The studies conducted to comply with these recommendations are often referred to as metabolites in safety testing or MIST.
This presentation will review the origins of these recommendations and the specific requirements that need to be considered in designing studies to address the regulatory expectations. Register now.
This virtual roundtable will explore the challenges and opportunities facing companies developing oncology and rare disease products during the COVID-19 pandemic. Parexel will be joined by Sara’s Cure, a Clear Cell Sarcoma patient advocacy group and charitable foundation. Register now to learn more.
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.
It’s not uncommon for companies who launch commercial drug products in the pre-filled syringe format to do so after initially using other product formats such as vials for the development and clinical trial phases. Switch-overs need careful and strategic consideration because doing so requires investment in the new format but also offers critical patient benefits and improved stakeholder outcomes. During this webinar, you will learn more about benefits and risks of changing primary components during product development and how a design of experiments approach can be used to address issues and risks. Register now.
Cell & gene therapy supply chains are inherently complex, requiring the utmost attention to quality, cold chain logistics, and chain of custody requirements. Join Thermo Fisher Scientific and Pluristem Therapeutics as we discuss lessons learned in developing the just-in-time supply chain for their phase III hip fracture study, and how these lessons are being used in their current efforts to treat severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS) in the United States. Register Now.
The world as we knew it prior to COVID-19 no longer exists. Since late 2019, the novel coronavirus has rapidly changed the way people work, play, socialize, relax — essentially, the way they live their lives. In this whitepaper, Health Union summarizes key findings from a series of online surveys among people with chronic health conditions to illustrate how those at higher risk of COVID-19 are reacting and responding to this global health crisis. Download the whitepaper.
This presentation will benefit scientists wanting to learn more about DILI and/or those needing guidance on crucial transporter studies for better assessment of DDI potentials that is aligned with regulatory guidance. Register for our Webinar, featuring Kan He, on BSEPcyte® and MDR3cyte®: Innovative Solutions for Investigating Drug-Induced Liver Injury.
RxMx’s Chameleon -- built on InterSystems IRIS for Health® -- features a configurable platform and a suite of apps to support the unique needs and challenges facing specialty medicines. Join this webinar to learn how the team has developed a variety of products to support solutions ranging from managing COVID-19 test data to keeping MS patients on track for scheduled infusions.
Join this webinar to hear Joel VanderMeulen, Senior Director, N&I Commercial Strategy and Operations at EMD Serono, and Derek Choy, Co-founder and President at Aktana, discuss:
- Emerging market trends in the post-COVID world
- How commercial teams can adapt to the “next normal”
- The three key components for successful omnichannel engagement
There is a high attrition rate during the development of biotherapeutics impacting the high cost of development. Early identification of the preferred expression host for manufacturing, along with lead candidate screening and material supply can help to reduce both attrition rates and cost. Register for the webinar to learn more.
University of Florida precision medicine leaders highlight current knowledge and trends to advance the future of health care in this quarterly webinar series. Register today.
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.
In this webinar, Optum will bring together their life sciences consultants, a large payer and pharmaceutical industry experts to share understanding about how patients are managing their medications — and how payers are managing patients — in the ever-changing COVID-19 world. Register now.
Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Click here to download the presentation.
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!
We are in unprecedented times causing change and disruption like deferral of elective procedures and restricted access to HCPs. In this webinar, you will learn how MedTech companies are planning to rebound from COVID-19 by digitally re-engaging with physicians, HCPs, and health systems as elective procedure volume rebounds. Register now.
This webinar will present the results from BHE's industry survey with FiercePharma on how 100 of your peers are leveraging data analytics to respond to today’s challenges and generate timely, high value insights. The webinar will discuss how data analytics are being conducted across functional areas, how analytics approaches vary according to company size and type, which real-world data sources are most commonly leveraged, and more. Register now!
In this webinar we will examine a number of the benefits of Lonza’s , XS® Pichia 2.0 including : speed, simple fermentation regimes, robust and scalable processes that can be tuned according to the specific objectives of a program, helping to advance new drug candidates through the development pipeline. We will examine the benefits of XS® Pichia 2.0 by referencing a number of case studies with different molecule formats. Register now.
A handful of cannabinoid-based pharmaceutical products are on the market today, and an ever-growing number are in the global development pipeline. Cannabinoids are being explored as a treatment for several indications. However, formulating effective pharmaceutical products with CBD and other cannabinoids introduces scientific, regulatory, and even legal challenges. This webinar will explore key considerations in developing cannabinoid-based pharmaceutical products, including an overview of global pharmaceutical cannabinoid usage today, common challenges formulating with CBD and other cannabinoids, and more. Register now!
FierceBiotech’s upcoming series will cover technology’s role in clinical trials. Panel discussions include: the use of sensors, wearables and other remote monitoring devices for tracking patient statistics, real-world data and patient-centric technology, and the role manufacturing plays in clinical trials. Register now.
This Fierce webinar will bring together executives with expertise in biopharma discovery, R&D and clinical trial design to discuss the benefits and challenges of the fail-fast strategy. It will include representatives of companies that have implemented such a strategy successfully and can provide advice on what did and did not work. Click here to register!
Register for our Webinar, featuring David Kwok, on Human Gut Microbiome-Based Contract Research Applications in Toxicology and Microbiome-Based Drug Discovery. Save your spot & register today!
Rapid and systematic column and mobile phase screening has become an essential component of method development workflows at Cambrex Durham for NCE APIs and drug products. Utilizing the latest technologies in UPLC, a systematic approach to screening in method development can quickly provide more robust methods earlier in the clinical development lifecycle. Register now.