There is no challenge more critical or costly in life sciences R&D than effectively managing the subject and operational data used in the development of new medical approaches. Poor data quality impacts the overall design, execution, quality, and management of clinical trials.
"The drug development process is predicated upon the availability of high quality data with which to collaborate and make informed decisions during the evolution of a product or treatment." - Informatica customer and CIO of leading Contract Research Organization.
Simplifying the complexity of clinical trials data management requires certain procedural steps that lead to reduced costs, shorter time to market, increased veracity of results, and improved compliance with industry standards and regulations.
Join John Jones, IT strategist focused on life sciences, and Informatica, the industry leader in all things data, for a webinar showcasing industry best practices that lower the direct cost of poor data management in clinical research studies.
You'll learn more about the strategic data management capabilities needed to positively affect clinical trial cost and duration.
View this on-demand recording now to learn how to:
• Automate the application of CDISC standards
• Obtain quality and timely data to support risk based monitoring (RBM)
• Prepare for the future of alternate data sources, for example from devices, wearable technology, and patient forums
Clinical Trial planning and resource management can be one of the most complex management challenges facing life sciences organizations and CROs. Often these organizations are managing hundreds of studies across thousands of sites and investigators making it extremely difficult to understand how and where to deploy costly clinical resources. With the variability of the studies and the massive competition in the industry, finding a solution to understand how and where all clinical resources are being utilized and a solution with the ability to perform predictive analysis on this information to improve site and investigator selection can give companies a competitive edge.
CA PPM for Clinical Research Planning from R2 Consulting gives you all of the tools needed to perform predictive analysis, plan and manage resource utilization, lower costs on expenses, and gather valuable information to assist in recruitment planning for sites and investigators.
Join us for a webinar on Tuesday, 11/11 to learn how several life sciences and Clinical Research Organizations (CROs) have been able to leverage CA PPM for Clinical Research Planning to lower the complexity associated with clinical trial design resulting in reduced costs and more effective clinical trial management.
There is growing momentum and recognition among researchers, regulatory agencies, policy makers and payers towards a more patient-centric approach to health outcomes research, including development and validation of Clinical Outcome Assessments, and participation of patients in clinical trials.
On 25th June 2015 at 3pm (GMT) PMGroup, in association with Adelphi Values, will host a free webinar that shows how a more patient-centered approach can be used to enhance outcomes research and conduct of clinical trials, providing examples from research in oncology and inflammatory disease.
The webinar will also demonstrate the importance of patient engagement at all stages of PRO development and will include direct feedback from a patient advisor, so you can learn about their experience as a partner in the research process.
Managing IP’s next webinar, run in cooperation with Birch Stewart Kolasch Birch LLP, will take place on May 12 at 4pm (eastern standard time); 1pm (pacific standard time) and will discuss ‘Pitfalls in Post-Grant Trials’.
The popularity of USPTO post-grant patent trials have only increased. Whether the PTAB institutes an inter partes review, a post-grant review, or a post-grant validity review of qualified business method patents, each trial has procedural pitfalls with considerable strategic considerations during the Second Phase of the trial (from the institution decision to the final written decision by the Board). This webinar will explore the most common mistakes the third party petitioner or patent owner during the 2nd Phase, with an explanation of key decisions by the PTAB (including those posted on the USPTO microsite) as well as the Federal Circuit. The focus will be on discovery, the patent owner motion to amend, oral hearing, and estoppel.
•Michael Loney, Americas editor, Managing IP (moderator)
•Eugene Perez, partner, Birch Stewart Kolasch Birch LLP
•Gerald Murphy, partner, Birch Stewart Kolasch Birch LLP
With post-grant trials becoming increasingly popular, having an in-depths understanding of the pitfalls and challenges is essential for sustaining a strong presence in the market place. The live audience will be able to ask questions of the speakers during the webinar, which will be in English and will last one hour.
This webinar relates to our April 16 discussion focusing on ‘Pitfalls in the first phase of Post Grant Proceedings’. You can listen to it here: https://www.brighttalk.com/webcast/327/149005
A discussion of an insightful statistical analysis of IPR and CBM trials at the PTAB. The analysis avoids pitfalls that obscure true picture of PTAB proceedings. More importantly, the discussion will address how the statistics should shape your PTAB trial strategies.
This webinar will cover topics including:
• A Dive Into Key PTAB statistics
• Overall success rates, on a claim by claim basis
• Comparisons of success rates for statutory grounds
• Trends in institution rates
• Comparisons to district court success rates
• Differences in technology areas
• The likely reasons behind the numbers
• A glimpse into the future
2016 will see SDN move from Proof of Concepts into the heart of the Service Provider to support the NFV transformation needed to prepare networks for 5G, Cloud and IoT. There are still challenges beyond the technology though and Service Providers must address these head on to the full capabilities of the technology: one is on interoperability and openness, the second is the operational aspects. In this seminar Elena Romero, Head of Ericsson Product Line SDN & Policy control will visualize the Ericsson SDN portfolio as well as address Ericsson’s approach to supporting our customers on this journey.Read more >
•Is your company seeking to enter the clinical trial process?
•Do you need expert advice on setting up a study?
•Would you like help developing your protocol for the NHS environment?
Supporting high-quality commercial contract clinical research across all therapeutic areas is a high priority for the National Institute for Health Research Clinical Research Network – the research delivery arm of the NHS.
We support the full spectrum of commercial clinical research including medical technology, device and diagnostic studies in addition to pharmaceutical products. We have dedicated research support staff and services to assist with study delivery at site level. This infrastructure provides you with unparalleled access to, and understanding of, the NHS research environment.
As well as helping you to navigate the NHS, we offer a range of practical services that can be tailored to your needs and are designed to help you set-up and deliver commercial research studies to time and target, whatever their size, design or therapeutic area. These include:
•Feasibility; early feedback during protocol development, site intelligence and site identification
•Commercial costing templates to expedite cost negotiations
•Streamlined processes for gaining NHS permissions
•Model agreements for faster contracting
•Study management and delivery by our dedicated GCP-trained research workforce
If you would you like to know more about our services you can join our live webinar hosted by Matt Cooper, Business Development and Marketing Director. This live online event will include a 30 minute presentation followed by an opportunity to ask questions.
On March 25, 2009, Cornerstone Research is sponsoring a webcast entitled "The JDSU Verdict One Year Later: Lessons from the Largest Securities Class Action Trial in History" that will feature two of the key players in that historic trial.
Jordan Eth, co-lead trial counsel for JDS Uniphase and several individual defendants, and Allan Kleidon, testifying expert for the defense on damages and causation issues, will lead a discussion of the extraordinary lessons learned from the rarest of events: a jury trial in a securities class action lawsuit. The panel will discuss their experience in defending this massive securities class action at trial, including the unique challenges, trial tactics and considerations posed by a trial in this type of case. In addition, the panel will discuss the effective use of expert witnesses in a securities class action trial.
Please join Jordan Eth, a partner at Morrison & Foerster LLP, and Allan Kleidon, Senior Vice President with Cornerstone Research, as they address these topics as well as your questions in a free, one-hour webcast. Moderated by Securities Docket's Bruce Carton.
Understanding the performance of virtualised network functions - the potential, boundaries and optimum configuration for real-world deployment - is of critical importance to all concerned in the emerging NFV ecosystem.
In this webinar, Francisco-Javier Ramón will present the current work of the PER Working Group, findings to date and development directions and focus for the coming year within the ETSI NFV ISG.
Then as Head of Network Virtualisation, GCTO Unit, he will highlight Telefónica's particular interest, introducing the two ISG Proof-of-Concepts which Telefónica is supporting, and further application of NFV in first use-cases such as vCPE.
This presentation will look at the state of the art in utilizing a free trial model in B2B marketing. Find out how to systematically increase revenues and lower customer acquisition costs using a self-service, free trial. The speaker will present findings from the analysis over over 1 million trial and paid customers. Learn how to find trial users most likely to buy, how to engage these prospects and turn them into paid customers.Read more >
"Pharma's Social Media Trials and Tribulations"
A Record of Social Media Events Impacting the Pharmaceutical Industry
The pharmaceutical industry is at a turning point in its adoption of new social media tools and applications for communication with healthcare professionals, consumers, patients, policymakers, and payers. Practically every pharmaceutical company has launched a social media project or application of one sort or another. To be sure, not all these efforts have been successful. This presentation will explore what worked and what didn't by highlighting the major trials and tribulations of pharma's social media "road trip"
Topics and discussion points include:
Is the Industry Ready for Social Media? Results of the Pharmaguy Social Media Readiness Self-Assessment Survey
History of FDA's Promise to Provide Social Media Guidelines. What's Gumming Up the Works?
The Major Milestones of Pharma Use of Social Media: The Good, the Bad, and the Ugly. All Offer Useful Lessons.
This webcast will highlight important recent developments in the government’s ongoing crackdown on insider trading, including lessons learned from recent high-profile criminal trials and debated legal issues. The panel will address:
• The recent separate trials of former SAC Capital portfolio managers Mathew Martoma and Michael Steinberg in the Southern District of New York.
• The effect prosecutions involving information from expert networks may have on the “mosaic theory.” Mosaic theory is the concept under which the SEC theoretically permits investors to piece together immaterial nonpublic information to form an investment thesis.
• The sentences—usually no jail time—handed down to defendants who plead guilty and cooperate with the government’s investigation, versus the relatively long sentences of defendants who are convicted at trial.
The speakers will include Lawrence Gerschwer, Partner, Morrison & Foerster LLP, and Allen D. Applbaum, Senior Managing Director and Global Leader of FTI Consulting’s Global Risk & Investigations Practice. Mssrs. Gerschwer and Applbaum are both former Assistant US Attorneys for the Southern District of New York.
Accelerating the Timeline to First-in-human Trials: NEW Case Studies on API in Capsule Technology
Accurately and precisely dispensing drug substances alone, in tiny amounts as low as 100 micrograms into capsules, excipients or bulking agents is changed the process of drug development.
Today, Pharma companies use micro-dosing technology to shorten drug development by reducing the need for costly time-consuming stability and pre-formulation studies. Reducing the time it takes to reach the critical "first in human" clinical decision point allows an increase in throughput of candidate compounds for development, thereby enabling pharma development departments to focus their resources on potential winners.
This webinar will feature NEW case studies on the Capsugel technology. Speakers include:
David Edwards, Director of Pharmaceutical Technology, Capsugel
Tim Scott, President, Pharmatek Laboratories
Joseph Forth, Manager, Pharmaceutical Development AMRI
Managing IP’s upcoming webinar ‘Effective obviousness arguments in district court and PTAB’, held in association with McAndrews, Held & Malloy, will take place on November 4 at 5:00pm London time (12pm Eastern/11am Central/9am Pacific).
In this webinar speakers will discuss:
•Obviousness: the evolving legal standard and its policy rationale
•What PTAB/district data tells us (does not tell us) about trends in obviousness holdings
•Patent holder tactics to combat obviousness during prosecution and after
•Strategies for challenging and defending a patent with no validity presumption and a broadest reasonable interpretation
•Best practices for petitioners at the PTAB and defendants in litigation
•Practical tips for deploying and combating the objective indicia of non-obviousness
•Robert A. Surrette, President, McAndrews, Held & Malloy
•Mary Elizabeth Mauro, Intellectual Property Counsel, Stryker Corporation
•Michael Loney, Americas editor, Managing IP (moderator)
Patent litigation and trials present unique challenges and opportunities for universities and other academic institutions. The panel will discuss these unique circumstances in depth, including national data on university patent litigation, effective university trial themes, PTAB validity challenges, university standing in patent infringement litigation, the assignment versus license of patent rights, and the enforcement of running royalty provisions. In addition, the panel will give an overview of successful enforcement actions brought by prominent academic institutions in federal court and the ITC, and provide the trial lawyer's perspective regarding what made these actions successful.Read more >
Remote site environments have specific IT challenges around footprint, on-site expertise and the cost of deployment and maintenance.
Join Mark Christie, Senior Systems Engineer at StorMagic for this webinar as he explains how SvSAN is ideal for these deployments.
Download your free trial of SvSAN today from the StorMagic website: http://stormagic.com/trial
Virtualizing your storage? Replacing your physical SAN with virtual SAN could save CAPEX and OPEX as well as cooling, power and maintenance costs.
Join Mark Christie, Senior Systems Engineer at StorMagic for this webinar as he runs you through why you should consider software-defined storage to replace your costly physical SANs.
Download your free trial of SvSAN today from the StorMagic website: http://stormagic.com/trial
As you clear the nonclinical hurdle in support of your IND submission, you are ready to embark on the exciting, yet demanding journey of clinical development. The journey begins with drafting your IND, followed by entering three, or more, phases of clinical trials with nonclinical support required at each step in the process. The goal is submitting your New Drug Application (NDA)/Biologics License Application (BLA) and regulatory approval to market your product. While many of the considerations from the previous topic “How Do I Get My Compound Into Phase I?” will be applicable when designing subsequent nonclinical support of Phase II, III, and registration, additional considerations will need to be taken into account for these post-IND activities.
During this webinar, our presenters will outline the early clinical trial design as well as the necessary nonclinical studies required to advance a therapeutic through post-IND drug development. We will cover general considerations in the design of the nonclinical studies, and variations of early clinical trials.
Careful assessment of the relationship between efficacy and toxicity is vital to drug developers as they seek advancement of their compounds. Nonclinical testing is required to establish a safe starting dose for the initial human clinical trials. In partnering with our pharmaceutical and biotechnology Sponsors, our goal is to improve the odds of selecting the right lead candidates, and to conduct the right studies in the right way, taking all factors into consideration to ensure a successful IND submission.
As part of this webinar we will outline the nonclinical studies needed to progress a therapeutic into a Phase I clinical trial. We will cover small molecules to vaccines to biopharmaceuticals as well as standard indications to life-threatening and rare/orphan indications.
Don't be a Dave! Be a Larry and choose StorMagic SvSAN, the most cost-effective, centrally managed virtual SAN for SME and distributed enterprise, and reduce your server and software spend by as much as 40%.
SvSAN makes the proven benefits of virtualization technology available to more cost sensitive SME and remote office locations. Although data stays local virtual environments can simply be managed from a central location, which removes the need for dedicated specialist IT staff at each site.
SvSAN delivers performance and reliability where it’s needed most; the remote and branch offices where customers connect with the brand.
SvSAN 6 is available to purchase now. Start being a Larry and get your free trial today by visiting: http://stormagic.com/trial/
StorMagic have announced a major new release of SvSAN bringing unprecedented flexbility, efficiency and performance to our customers and partners.
Join John Glendenning (SVP Sales and Marketing) and Luke Pruen (Technical Services Director) to learn more about how SvSAN 6 can modernize your IT infrastructure and take advantage of next generation software defined storage built on a proven platform.
StorMagic SvSAN 6 is available to purchase now and is available through StorMagic’s Preferred Partner Network and via the company’s global OEM agreement with Cisco. Order your free trial now by visiting http://stormagic.com/trial/
A primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity before entering into human clinical trials. Nonclinical testing is required to evaluate the potential efficacy of a new therapeutic and establish a safe starting dose for initial human clinical trials. Knowing when and where to invest your time and effort in preparing for these nonclinical studies is a critical component of a company’s drug development strategy. Many companies outsource their nonclinical testing to contract research organizations (CROs) and have little to no prior experience in working with a CRO. There are a number of technical challenges involved in the process of outsourcing, which if not taken under consideration, can cause delays and unexpected expenses in developing a compound. These challenges range from determining which species is appropriate for your project to basic formulation and dosing aspects. Being aware of and mitigating as many of these challenges early in the process as possible reduces the potential for delays and allows a company to proceed with increased confidence. This webinar will describe some common technical challenges that we have encountered while working with our Sponsors.Read more >