Welcome!

News Feed Item

Dr. Jeanne M. Novak, President & CEO Of CBR International Corp.®, To Attend World Health Organization (WHO) Meeting To Address Leading Experimental Treatments And Vaccines For The Ebola Virus, September 4 - 5, 2014, Geneva, Switzerland

CBR International's Scientific Experts Supporting Mapp Biopharmaceutical Pertaining to ZMAPP™

BOULDER, Colo., Sept. 2, 2014 /PRNewswire/ -- Dr. Jeanne M. Novak, President and CEO of Boulder, Colorado-based CBR International Corp.®, a full-service biopharmaceutical product, clinical, medical device and regulatory development and compliance group, has been invited by Dr. Larry Zeitlin, President of Mapp Biopharmaceutical to attend the World Health Organization's Investigational Treatment for Ebola conference in Geneva, Switzerland, September 4 – 5. Over the last several months, CBR International's expert team of clinical, regulatory and scientific consultants has been supporting and collaborating with Mapp Biopharmaceutical, Inc., the San Diego-based biotech company responsible for developing ZMappTM, the monoclonal antibody cocktail that has been employed for compassionate use in the current Ebola outbreak.

Working side-by-side with Mapp Biopharmaceutical, Inc.,  Kentucky Bioprocessing (KBP), Emory University Hospital (Atlanta), ELWA Hospital (Paynesville City/Monrovia, Liberia), London's Royal Free Hospital (UK) and the U.S. Food and Drug Administration (FDA), CBR International has helped to ensure that the proper dosing, safety monitoring and all regulatory procedures were followed for the administration of ZMapp.

"CBR International Corp. has been committed to supporting Mapp Biopharmaceutical during the emergency use of the investigational product," said Dr. Jeanne M. Novak, President and CEO of CBR International Corp. "We will continue to support Mapp throughout its ongoing clinical development while also lending our expertise to the myriad of other affiliated health and regulatory organizations during this crisis."

Dr. Kevin Whaley, CEO of Mapp Biopharmaceutical noted that, "Without the collaboration and support of CBR International associates, especially Dr. Jeanne M. Novak, Dr. Miles Brennan, Mr. Kevin Hennegan, Dr. Tara Nyhuis, Dr. James Merritt, and Dr. Dana Weinberger, patients may not have had the opportunity to volunteer to receive ZMapp."

The WHO meeting in Geneva will address leading experimental treatments and vaccines for Ebola, including potential risks and benefits, short- and long-term availability, potential use and key considerations for deployment in West Africa, as well as clinical testing and ethics. Its goal is to help develop strategies to pave the road for future Ebola preparedness.

About Dr. Jeanne M. Novak
Dr. Jeanne M. Novak founded CBR International Corp. in 1999 (originally Colorado BioReg). She is an internationally-recognized authority in the biotechnology and pharmaceutical industries and is currently consulting in numerous product development areas including recombinant biotechnology, naturally-derived products, cell and gene therapy, devices and vaccines. She is an author, lecturer and strategic development advisor to industry executives worldwide.

Additionally, Dr. Novak has almost 20 years of experience in product and assay development and validation, clinical trial design and oversight, quality assurance systems development, cGMP manufacturing and compliance and global regulatory development to advise cost and time-optimized development for new and established biotech and pharma companies.

Prior to founding CBR International, Dr. Novak served as Senior Scientist in the Center for Biologics Evaluation and Research (CBER) responsible for several programs and policy development.  Before joining the FDA, Dr. Novak conducted scientific research in the area of recombinant vaccine development at United States Army Medical Research Institute of Infectious Diseases.

Dr. Novak received a Ph.D. in Experimental Pathology (Cell Biology) and Immunology and a B.S. in Biology from the University of Utah.

About CBR International Corp.
CBR International Corp. is a full-service product, clinical, and strategic regulatory group dedicated to providing comprehensive product development services to the biotechnology, pharmaceutical, and device industries worldwide. The Company's expert staff of scientists is experienced in an all-encompassing range of indications for drugs, novel antibodies, recombinant protein therapeutics, small molecules, vaccines, cell therapy, devices and combination products throughout all phases of program development and commercialization. For more information, please visit www.cbrintl.com.

SOURCE CBR International Corp.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes how...
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Phil Hombledal, Solution Architect at CollabNet, discussed how customers are able to achieve a level of transparency that e...
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, discussed how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved efficienc...
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...
"We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Between 2005 and 2020, data volumes will grow by a factor of 300 – enough data to stack CDs from the earth to the moon 162 times. This has come to be known as the ‘big data’ phenomenon. Unfortunately, traditional approaches to handling, storing and analyzing data aren’t adequate at this scale: they’re too costly, slow and physically cumbersome to keep up. Fortunately, in response a new breed of technology has emerged that is cheaper, faster and more scalable. Yet, in meeting these new needs they...
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, provided an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data professionals...
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...