This webinar will explain the baseline requirements for elastomeric physicochemical and functional properties. Examples to illustrate qualification of components for intended applications will be included. 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.
We are seeking talented pharmaceutical executives to join our mission to reliably supply affordable, high-quality, essential medicines through U.S. based advanced manufacturing processes. If you are a driven team player who wants to do something significant and serve patients, we invite you to apply.
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.
Brigham Hyde, Ph.D., discusses in his white paper how predictive analytics and machine learning have the potential to transform healthcare by helping us identify diseases faster, decrease costs through precision therapies, improve clinical trial enrollment, and increase operational effectiveness. Download the white paper.
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.
Cambrex can now offer the capabilities and services as a true end-to-end CDMO across the whole product lifecycle. This extensive broadening of our toolkit is part of our ongoing mission to become the world’s leading small molecule CDMO. Download the eBook.
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.
The FDA announced a new Coronavirus Treatment Acceleration Program (CTAP), a special emergency program designed to expedite the availability of treatments to COVID-19 patients. Learn more about CTAP as well as a recommended strategy for biopharma companies with COVID-19 programs in this white paper.
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
Remotely connecting to your study site Electronic Investigator Site Files (eISF) is now a requirement for operating clinical trials. In this whitepaper learn how sponsors and CROs are streamlining clin ops by connecting directly to the study sites on the largest eISF platform in the world. Download now.
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.
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.
With pharma sales reps sidelined by COVID, communication with professionals is more important now than ever before. TI Health is responding to weekly EMR and Telehealth fueled data feeds, to engage and target 600,000+ professionals who are newly diagnosing and treating patients in your disease states. Download the case study now.
The Research to Accelerate Cures & Equity (RACE) for Children Act requires all new drugs intended for adult cancer treatment to be studied in pediatric cancers. This white paper discusses how to navigate the unique challenges that accompany pediatric clinical trials under RACE. Download now.
“How to Select the Right Data Provider” is a comprehensive guide for life science organizations in need of a robust & tangible methodology to evaluate data partners and find the RIGHT fit. To make evaluation easy & presentation-ready, we offer a scorecard matrix for calculating the fit score. Download this Buyer's Guide to learn more.
Based on workshops led by instructor and author James Vesper, this book provides practical tools for both a thorough understanding of risk-based CAPA investigations and regulatory acceptable applications. It is the perfect companion for your library shelf or computer or, perhaps, both. Buy yours.
Get an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain. Watch the webinar.
Over the next five years, healthcare data is projected to grow at a rate of 36%. Innovations in drug therapy and technology have opened up new ways of capturing and analyzing information related to patient goals, priorities. Download the infographic 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.
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 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.
Accurate, timely insights are everything. Whatever the question, the answers demand real world data you can trust. Healthy data advances reliable insights, and takes the error out of AI. Healthy data is not just useable, but invaluable. Healthy data starts with InterSystems. Watch now!
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.
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!
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!
Built on advances in Artificial Intelligence (AI), data mining, and information integration into various systems at 100% accuracy, the new era of intelligent automation is integral to life sciences for devising new treatments faster and at a lower expense. Download the eBook.
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.
Join this webcast as experts present the exclusive survey findings and introduce innovative scalable drug delivery technologies proven to address the industry’s growing need for improving solubility and enhancing bioavailability. Register now.
Biotech companies are under pressure to develop drugs faster and faster. But to compete with big pharma, smaller firms must be able to do more with less. This white paper shares four smart strategies for optimizing R&D efficiency and overcoming barriers to success. Download now.
Cell and gene therapies have the potential to provide long-term therapeutic efficacy, but their development is both risky and cost-intensive. Obtaining a better understanding of the specific structural attributes of vector proteins that influence clinical delivery and outcomes is essential for advancing both individual candidates and the platforms on which they are based. Download this eBook and learn how the application of advanced analytical techniques can help improve selection of candidates and guide development decisions, leading to a greater number of safer, more efficacious cell and gene therapies successfully completing development and entering the market.
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.
In a series of innovation sessions, Catalent RP Scherer softgel capsules were quickly identified as the ideal solution to drive incremental growth. With a highly-successful launch and halo growth for the entire brand, the new line extension increased the brand’s overall market share. Learn more in this whitepaper.
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!
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.
Download The Adherence Marketing Manifesto to find out how to harness consumer marketing and behavior change tactics to help patients start and stay on their medications.
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!
Our white paper describes the complexity of GI trials and shows how a therapeutic specific data capture solution overcomes their significant, but typical, challenges. Clinical Ink’s intimate knowledge of and experience with GI trials enables a better deployment experience and improved trial conduct. Download now!
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.
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.
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.
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.
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!
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.
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.
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!
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.
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.