ProteinSimple Goes Big with the Simple Western

SANTA CLARA, Calif., July 21, 2014 /PRNewswire/ — ProteinSimple announced today that it has expanded the Simple Western product platform by launching a kit for the analysis of large proteins using Wes, Sally Sue and Peggy Sue. Now, Simple Western users can analyze proteins as large as 440 kDa while realizing all the benefits of the Simple Western — a fully automated, highly reproducible, truly quantitative assay.

The Simple Western eliminates a time-consuming bottleneck in protein research today — the Western blot. Traditional Westerns have real limitations. They require many manual steps, can take up to 24 hours to complete, and the results can be variable. The Simple Western eliminates the hassles of Western blot protocols – no messy gels, no transfer tanks, no blots, no imaging and no manual analysis. Simply load your samples, push a button, walk away and come back to fully analyzed, highly consistent data.

Until now, the Simple Western could analyze proteins up to 230 kDa in size. Now, with the introduction of the 66-440 kDa Master Kit, the Simple Western can quantify proteins as large as 440 kDa, giving researchers broader protein analysis capabilities with this platform.

“The Simple Western is rapidly becoming the technique of choice for users from a broad array of scientific disciplines and many have expressed the need for a broader size separation range,” commented John Proctor, Director of Marketing at ProteinSimple. “We are excited to deliver this kit to address their needs and expand the application of the Simple Western.”

Meet the entire Simple Western family at www.proteinsimple.com.

Simbionix’s Innovative Solution for Patient Specific Simulation Receives Further Global Recognition

CLEVELAND, July 17, 2014 /PRNewswire/ — Medical simulation technology provides an excellent approach to training physicians, nurses and allied health personnel. However, medical simulation development and utilization does not have to stop with training. Simbionix USA Corporation advances the concept of using its proprietary technologies and capabilities to turn the simulation experience into an essential part of pre-operative surgery planning.

(Logo: http://photos.prnewswire.com/prnh/20120502/529202-a)

The company’s revolutionary PROcedure Rehearsal Studio™ (PRS) steps up simulation by enabling physicians to rehearse a complete endovascular procedure on a virtual 3D anatomical model based on a specific patient’s CT data. The virtual model can be used for simulating, analyzing and evaluating pre-operative surgical treatment options prior to performing an actual case, which may increase a physician’s confidence in the upcoming procedure.

The advantages of patient specific planning have long been recognized in other fields within the healthcare industry, such as medical imaging. Simbionix is pleased to announce the signing of a collaboration agreement with the market leader in medical image analysis software, Pie Medical Imaging BV. The company manufactures and distributes the 3mensio software, a clinical application that enables the visualization and analysis of patient CT scans in both 2D and 3D modes.

The collaboration will enable exporting the 3mensio Vascular™ model into the Simbionix simulation environment to form a comprehensive planning solution that combines 3DR, data analysis and simulation on the same platform. The solution will allow physicians and clinical specialists to rehearse a procedure in a complete virtual environment without the need for physical tools. This will take users of the 3mensio software to the next level of preparedness for endovascular procedures, as it will allow added simulation insights. Cases created by the software may also be imported to the ANGIO Mentor simulator for full procedure practice using fluoroscopy, guidewires, catheters, and other equipment that is used in the cath lab.

Simbionix recently received the CE marking of conformity for its patient specific simulation, an important step towards launching this innovative technology and expansion of its use in the clinical practice. The PRS CE mark demonstrates the product’s compliance with stringent requirements related to the quality, safety, and performance of medical devices determined by the European Union legislation.

In addition, Simbionix PRS has recently been granted a patent in China. The company now has patents for this technology in three key countries: the USA, UK and China. These patents represent recognition for Simbionix’s comprehensive line of products, which provide innovative solutions to advance medical performance and ensure patient safety.

Gary Zamler, Simbionix CEO added that “Growing interest from the image analysis market, which 3mensio is part of, demonstrates the need for more comprehensive planning solutions. The ability to evaluate surgical treatment options using simulation anytime, anywhere, is a major factor in achieving the goal to increase patient safety and improve procedure outcomes. The collaboration agreement, CE mark and additional patent are all examples of the company’s key position as a market leader and innovator in the field of medical simulation.”

Visit: http://www.simbionix.com, FacebookTwitter and LinkedIn.

Contact: Rebecca Levy, Rebecca@simbionix.com, +1-216-2292040

MDiT Forum and Regulation Summit 2014: Gearing up MD Development by Regulation & Innovation

SHANGHAI, July 17, 2014 /PRNewswire/ — Following the huge success of MEDTEC China on-site conference 2012 & 2013, MDiT Forum and Regulation Summit 2014 will continue to focus on regulatory updates & market access, product design & manufacture and risk management & quality control of medical devices. The conference will be held on September 25th-26th at Shanghai World Expo Exhibition & Convention Center and will keep using the theme of “Gearing up MD Development by Regulations & Innovations” which was very well-received by attendees in 2013. The conference will aim to provide you with the latest regulatory updates and advanced technology sharing.

Conference Highlights

  • Covering hot topics of updates on Chinese/overseas regulation, new technology, new material application and quality control of medical device
  • Resource integration and sharing of MEDTEC Global, 23+ international high-quality speakers
  • Exploring advanced technique and market information and to acquire development opportunities
  • MEDTEC Investment Summit takes place during MEDTEC, looking for capital opportunity for product and in-depth business cooperation
  • 5 theme modules, MEDTEC exhibition and conference, showcase and presentation promoted simultaneously

Call for Speakers

UBM/MEDTEC is compiling a great roster of thought leaders and industry insiders for a program packed with timely insights, strategic views, and actionable items. If you would like to have the opportunity to speak at MEDTEC on-site conference 2014, please submit your proposed topic, biography and contact information to us.

Producer:
Ms. Jessie Jiang
jessie.jiang@ubm.com / +86 21 6157 3933

Sponsorship & Delegates:
Ms. Julia Zhu
Julia.zhu@ubm.com / +86 21 6157 3922

Ms. Heron Zhuang
Heron.zhuang@ubm.com / +86 21 6157 3928

Media & PR:
Ms. Alisha Zhou
Alisha.zhou@ubm.com /+86 21 6157 3930

Logo: http://photos.prnasia.com/prnh/20140612/0861404094-b

Logo: http://photos.prnasia.com/prnh/20140612/0861404094-a

 

CPhI Panel to Analyse New Industry Perspectives and Innovations Ahead of Predictive 2014 Annual Report

AMSTERDAM, July 16, 2014 /PRNewswire/ —

New panel additions Patheon, Almac and Arevepharma to provide global insights from the contract services sector 

CPhI expert panel members for 2014: 

  1. Prabir Basu, President at Pharma Manufacturing
  2. Girish Malhotra, President & Founder, Epcot International
  3. Hedley Rees, Managing Director at PharmaFlow Ltd
  4. Sam Venugopal, Director in the Healthcare Practice at PWC
  5. William Botha, Consultant and Founder Interlean
  6. Emil Ciurczak, President at Doramaxx Consulting
  7. Dilip G Shah, CEO of Vision Consulting Group and a regulatory expert
  8. Vijay Shah, COO at Piramal Enterprises and pharma business lead
  9. Hendrik Baumann, CEO of Arevipharma
  10. Lukas Utiger, President of Fine Chemicals and Integrated Offering at DSM
  11. Alan Armstrong  (CEO) and Douglas Cookson (VP corporate marketing), Almac
  12. Brian Carlin, Director Open Innovation at FMC
  13. Ali Afnan, President at Step Change Pharma

CPhI Worldwide, organised by UBM Live, has announced its full line up of confirmed expert industry panel members for 2014, building on the huge success of the CPhI annual report launched at CPhI Worldwide in October 2013.  

(Logo: http://photos.prnewswire.com/prnh/20130723/629764-a)

This year’s panel sees the return of ten thought leaders with the addition of three new members, covering the entire pharmaceutical supply chain from R&D through to finished products, regulatory requirements and economic implications. Additionally, this year panel members are utilising their market insights and analysis year round in the CPhI Pharma Insights series, which cover individual topics and developments across the industry – including the released R&D, manufacturing and Turkey reports, with a United States report due out imminently.

The new panel members are all from the contract manufacturing arena, with heavyweights Alan Armonstrong (CEO) and Douglas Cookson (VP corporate marketing) from Almac. Hendrik Baumann, the current CEO of Arevipharma, leverages his expertise within the German market and across API manufacturing. Lukas Utiger – president of Fine Chemicals and Integrated Offering at DSM – will lend his insights in the commercialization of pharmaceuticals. Collectively they provide a global overview of outsourcing with Almac and Arevipharma focusing on the international market from a European stance and DSM from a US perspective.

The returning members feature expertise across API and manufacturing efficiencies (Girish Malhotra) to quality systems and supply chain activities (Sam Venugopal), with insights also provided from some of the sectors biggest names and innovators, like Piramal’s Vijay Shah. Across supply chain issues, the panel will leverage the knowledge of Hedley Rees, whilst Prabir Basu, formerly of the National Institute for Pharmaceutical Technology and Education (NIPTE), will focus on the industry’s approach to innovation.

Regulatory expert, predominantly focussed on the Indian market, Dilip Shah also returns covering the intellectual property rules around innovation. Brian Carlin, who chairs IPEC Americas Excipient Qbd Committee, is also returning. He serves as the director of Open innovation at FMC and received the IPEC One World Regulatory Excellence Award in 2014. The winner of several FDA Commissioner Awards, Dr. Ali Afnan is another well-respected industry influencer and was a key contributor to the drafting and finalising of the current FDA Process Validation Guidance.

Emil Ciurczak, previously a member of the FDA’s PAT committee and president of Doramaxx Consulting draws upon his expertise across PAT, QbD and spectroscopy. Finally, William Botha, a respected trainer and mentor in manufacturing is also retuning to the panel; he is fluent in FDA regulations, including GDP and GMP.

Last year’s report examined major issues and developments across the industry including regulatory challenges from a globalised industry, cost savings through QbD and PAT, to the effect breakthrough drugs like ADCs will have on overcoming future disease pathologies.

The 2013 report was hugely successful with our experts providing insights into how the industry will adapt in the near future. This year we have been able to see the progress the industry has made along with the new challenges and threats ahead. Our experts will examine future potential breakthrough drugs, regulatory risks and supply chain issues. This year we also have representation from leading global CDMO players, Patheon, Almac and Arevipharma– adding a further depth of perspectives and providing a completely holistic picture of the global pharma landscape.” commented Chris Kilbee, Group Director Pharma at CPhI.

The 2014 annual report features a collection of in depth essays from each panel member – with experts again given carte blanche to prophesize how the industry will look and operate in the future from both an economic and practical perspective.

Kilbee added, “I am very pleased that we have been able to include in our panel many of the major figures in the industry, as they provide hundreds of years of experience both individually and collectively. The panels ability to provide a realistic approach to problem solving, coupled with an international outlook is essential in advancing market dynamics.”

For more information, please contact: cphi@ubm.com  

Coherus Announces Initiation Of Phase 3 Trial Of CHS-0214 (Investigational Etanercept Biosimilar) In Chronic Plaque Psoriasis (RaPsOdy)

REDWOOD CITY, Calif., July 16, 2014 /PRNewswire/ — Coherus BioSciences, Inc. announced the start of its Phase 3 trial of CHS-0214, a proposed biosimilar of etanercept (Enbrel®), in chronic plaque psoriasis (the RaPsOdy trial). This announcement follows the recent initiation of a Phase 3 trial of CHS-0214 in rheumatoid arthritis. The Phase 3 psoriasis trial is a 48-week, randomized, double-blind, active-control, parallel-group, multicenter, global study in subjects with active, chronic plaque psoriasis who are naïve to systemic biologic therapy. The study will seek to demonstrate biosimilarity between CHS-0214 and Enbrel® in terms of efficacy, safety and immunogenicity. The primary efficacy endpoint is based on percent improvement in the Psoriasis Area and Severity Index (PASI) at 12 weeks.

“The initiation of the Phase 3 RaPsOdy trial is an important step toward our goal of increasing access to biosimilar etanercept for patients worldwide,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “It represents a pivotal study in the global clinical development for CHS-0214 and, if positive, will provide support for our marketing applications in Europe, the United States, and a number of other countries.”

“Based on our evaluation of the analytical, nonclinical and clinical pharmacokinetic similarity of this molecule, we believe that this molecule has met our rigorous internal criteria for initiating our second Phase 3 trial in 2014,” said Denny Lanfear, Coherus Chief Executive Officer. “In concert with our partner Baxter, we are pleased to advance this product into late-stage development.”

“With two late-stage trials now underway in partnership with Coherus, we are advancing our collective goals to develop and deliver high quality biologic alternatives that address patient needs,” said Ludwig Hantson, Ph.D., president of Baxter BioScience.