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.
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.
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.
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.
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.
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!
In this paper we’re looking at the history of biomedical classification and how these systems have evolved to address new technology and use cases. We’ll explain the difference between taxonomies and ontologies, and discuss the challenges and successes that come with adopting and managing ontologies. Download the whitepaper.
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.
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!
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.
Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Download the report to gain clarity on key questions.
This webinar will explore real-world examples that will help you anticipate pitfalls, mitigate risk and accelerate development. Use the valuable insights we’ve gained from participation in multiple COVID-19 research studies to understand the contingencies for success and, just as critical, to anticipate pitfalls that can be avoided. Click here to save your spot!
During the current COVID-19 pandemic, regulatory and compliance risk is an acute concern by health authorities, pharmaceutical manufacturers, medical practitioners and patients. This webinar will discuss the challenges and potential mitigation strategies, in accordance with appropriate application of regulations and COVID-19 guidance documents, to ensure GCP compliance with respect to managing lost to follow-up and missing data. Register now.
Join industry experts as they propose best practices for incorporating translational omic data in clinical development in order to yield novel insights and improve patient / study outcomes. 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.
This Fierce webinar will bring together executives with expertise in R&D and technology implementation to explain the potential benefits of virtual clinical trials, as well as the ins and outs of designing and running them. It will include representatives from companies that have completed virtual clinical trials successfully and can provide advice on what did and did not work. Click here to save your spot today!
Register for the webinar to see how leveraging multiple solutions on a unified platform streamlines processes, drives operational efficiency, eliminates reconciliation, and provides faster data insights.
According to experts, quantitative image analysis can provide surrogate biomarkers in early phase clinical trials. In this webinar, experts discuss a seamless solution that facilitates data management and quantitative analysis of patient imaging data. Click here to register.
Major advances in our understanding of the causes of once-untreatable diseases have reshaped the global drug development pipeline over the past decade, paving the way for better health outcomes for many millions of people. To realize these emerging opportunities, drug developers need access to clinical trial capabilities tailored to the modalities and indications that now dominate their pipelines. To learn more, click here to download the whitepaper.
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.
Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug. Download the whitepaper.
In this webinar, the featured speaker will explore the key advances and critical hurdles for translating these emerging molecular biology technologies into real-world applications and commercial processes. Register for the on-demand webinar.
All parts of the product development cycle—clinical trial management, regulatory affairs, commercialization, and everywhere in between—have invested in technologies to support operational efficiencies and productivity gains. But there has always been a gap in these technologies: the inability to effectively manage transactions within an organization and to extend beyond its four walls. Download the whitepaper to see what DocuSign did to meed this need.
J. Jaime Caro, Chief Scientist, Evidera, provides a novel solution for clinical trials facing challenges in randomizing or enrolling patients due to the COVID-19 pandemic: using simulation to attempt to rescue these studies and make up for lost data. Read our white paper to learn more.
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.
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.
The combination of speed, accuracy and efficiency provided by the Microsart® ATMP Sterile Release kits means ATMP manufacturers can deliver QC results prior to treatment. In doing so, the industry stands to eliminate one of the outstanding risks to patients posed by ATMP, thereby setting the stage for the use of consistently safe lifesaving cell-based therapies. To learn more, download this infographic.
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.
You are invited to join Rousselot Biomedical for an insightful webinar on excipients for vaccine formulation. Highly purified gelatins can help accelerate vaccine development. Click here to know more and register now.
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!
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 FiercePharma for our ASCO pre- and post-show webinar series. We'll bring together a panel of experts to preview what to watch for at ASCO. Cancer experts will highlight closely watched data sets to be unveiled at the virtual meeting--and discuss how they could change prescribing patterns. Following the meeting, we’ll do a post-show wrap up to break down the biggest data that came out over the weekend, as well as the implications they could have for prescribers, patients and drugmakers.
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!
Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. However, sometimes, other strategies are better. Read this whitepaper by Recro Gainesville’s modified release experts to determine whether Wurster processing is the right option for your project. Download now.
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.
Unanchored ITCs of PFS are increasing for novel cancer studies approved using single arm trials. When two studies use different assessment schedules, there may be assessment-time bias (ATB) favoring later assessments. Learn how to use assessment schedule matching to adjust for ATB in our webinar. 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!
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.
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.
Continuous manufacturing enables the development of a more diverse pipeline of drug products by greater quality assurance, reduced API usage, and timeline efficiencies. It also reduces scaleup activities as a product increases in volume in the clinical phase through commercial. Click here to download the whitepaper.
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.
This trial uses a flexible trial design, known as an umbrella study, to allow for quick protocol amendments and variables on the investigational product. This provides a major advantage to the clinical operations and sponsor teams, but creates a number of challenges around randomization and trial supply management. Click here to download.
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!
Small molecule drug substance development is often completed without consideration for the final drug product formulation. However, both activities are intimately linked by the final purification and isolation step of the chemical synthesis and manufacturing process. Download this whitepaper 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.
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.
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.
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.
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.
Are rewards-based adherence programs appropriate for chronic oncology patients? HealthPrize & WEGO Health interviewed a panel of cancer patient influencers to find out. Get the special report.
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.
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.
A search for new manufacturing partners comes with an acute need to vet these new entities against multiple global watchlists to prevent fraud, money-laundering, or corruption risks. Download the 2020 State of Life Sciences infographic for the current industry snapshot. Find out where the main manufacturing hubs are and the level of corruption of the countries in which they are located.
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.
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.
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.
Not all capsules are created equal …
Capsugel® has a global network of manufacturing facilities, which are routinely inspected by regulatory authorities, customers and our own internal audit teams. We work diligently every day to ensure the strictest industry standards for our products. Learn more.
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.
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.
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!