By establishing an early dialogue with the FDA—when potential products are still in preclinical testing—companies can gain valuable insights that could boost their chances of success. This webinar will bring together experts in preclinical trial design, R&D efficiency and regulatory affairs to offer advice on how companies can best engage the FDA early in the research process. Register now.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain. Watch the webinar.
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.
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.
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.
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.
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.
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!
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.
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.
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!
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!
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.
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.
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!
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.
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!
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.
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!
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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!
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.