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
This presentation will discuss NIHR Clinical Research Network support for Biosimilar clinical trials. It begins with a background to biosimilars and the changing landscape in their drug development and regulatory pathways. It then focuses on the opportunities that the NHS via the NIHR CRNs can engage in biosimilar clinical trials across therapeutic indications.Read more >
Growing patient influence combined with new technologies and the requirements of new reimbursement models means clinical research is undergoing rapid transformation. Industry is being compelled to move towards more patient centric solutions to keep up with these changes. With healthcare stakeholders in agreement that patient engagement is key to realising the value of clinical trials, regulators, sponsors, CROs, research funders and publishers are all moving towards more patient-focused models.
With the advent of new methodologies, such as electronic data sources and medical records, recruiting patients for trials now demands extensive collaboration between patients and trial centers to effectively and efficiently run trials. The patient has never been more important.
To mark Clinical Trials Awareness Week, pharmaphorum, in partnership with INC, will present a live webinar exploring the challenges and solutions of the current environment and how collaboration can benefit research participation, as well as the vital role the patient advocate plays in these matters.
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
Challenging patents involving unpredictable technologies for obviousness is particularly difficult due to the well-established factor of “reasonable expectation of success” and the related KSR factor of “limited number of predictable solutions”. This webinar, presented by attorneys that have successfully argued on both sides of this issue for chem/pharma/bio patents, will discuss two to three leading PTAB decisions, including related appeals, that illustrate when obviousness challenges have and have not been successful. The case discussions will provide (1) a summary of the documentary evidence relied on, including critical excerpts from that evidence, (2) a summary of the “story” that was being told by each party and (3) the role that expert testimony appeared to play in the PTAB decisions. This one-hour seminar will also briefly explore what types of cases are better challenged in court and what types of cases are better challenged at the PTAB. The goals of the seminar are to allow parties to evaluate the chances of success for a contemplated or recently filed PTAB challenge and to help parties to a PTAB proceeding develop a record to support their respective positions. CLE available.Read more >
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 >
A biosimilar medicine is a biological medicine which is highly similar to another biological medicine already licensed for use. It is a biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy.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)
New vaccine process designs – and all the kinks that go with them – are typically hammered out in a small scale capacity, for example, prior to manufacturing for early phase human clinical trials. They are then upsized and further defined for industrial scale to supply the vast market. Single-use technologies (SUTs) have been a hot topic for several years now and their advantages well-known: easy product changeover, processing in lower classification areas, reduced CAPEX, elimination of glass, sterility assurance, to name a few. In vaccine manufacturing, SUTs are used throughout the processing stages, from cell culture all the way to filling. SUTs are quickly and conveniently designed, purchased and implemented for short-term manufacturing of clinical trial phase materials. Here a large percentage of new vaccines in Research and Development do not even make it to market.
As the final production stages are critical as they are the last stages before patient injection, the scope of thisarticle covers SU applications involving drug substance formulations, adjuvant processing, final bulk formulation and filling. The actual process itself may include some or all of the following: filtration, pumping, ingredient addition, mixing, adsorption, filling, labelling, sampling and and storage.
In this presentation only liquid formulations (“presentations”) will be discussed.
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 >
According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2), both men and women of child bearing potential (WoCBP) can be included in Phase I and II trials before the conduct of the male and female nonclinical fertility studies, since an evaluation of the male and female reproductive organs is performed in the repeat-dose toxicity studies. As such, much of the early assessment of potential test article-related effects on the reproductive system falls on the nonclinical toxicologic pathologist. This requires the pathologist to have a have a sound understanding of spermatogenesis, stage-aware evaluation of the testis, estrous and menstrual cyclicity, and normal physiology and endocrinology in order to carefully and thoroughly evaluate potential xenobiotic-related effects on the reproductive system. However, even with the most thorough pathology assessment, the design and conduct of nonclinical general toxicity studies can greatly impact the pathologist’s evaluation of the reproductive system. Commonly encountered challenges include age (onset of puberty and reproductive senescence), body weight changes and systemic toxicity, husbandry practices, strain differences, small sample size (non-rodents), and even histologic sectioning patterns.Read more >
How do you gather intelligence about a judge, to pitch a new client or inform case strategy? A blast email to colleagues just won't suffice anymore. Join this 30 minute webcast, where our speakers will discuss how Legal Analytics helps you predict your judge's behavior, based on data from all dockets from prior cases: Time to termination/trial/other case milestones, transfer rates, case resolutions, damages, remedies, findings, and more. Your competition uses Legal Analytics to win the client and the case; can you afford NOT to?Read more >
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.