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  

Leju Launches Mobile E-commerce Platform 2.0

BEIJING, July 16, 2014 /PRNewswire/ — Leju Holdings Limited (“Leju” or the “Company”) (NYSE: LEJU), a leading online-to-offline (“O2O”) real estate services provider in China, today announced the launch of Leju’s mobile e-commerce platform 2.0, which …

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.

21Vianet and GigaTrust Sign Exclusive Partnership Agreement for China

WASHINGTON, July 16, 2014 /PRNewswire/ — 21Vianet Group, Inc. (Nasdaq: VNET) (“21Vianet” or the “Company”), the largest carrier-neutral internet infrastructure services provider and the sole operator of Office 365 and Microsoft Azure in the Chinese Mainland market, and GigaTrust, the market leader for Microsoft-based email and document protection software solutions for mobile devices, announced today that they have signed an exclusive partnership agreement for the China market. Pursuant to the agreement, 21Vianet will market and sell the portfolio of GigaTrust security products to enterprises and Office 365 cloud subscribers in China. This partnership will provide Office 365 enterprise customers in China the ability to protect and render secure emails and documents from anywhere using Android and iPhone mobile devices.

GigaTrust Logo

Photo – http://photos.prnewswire.com/prnh/20140714/126761

21Vianet has more than 15 years’ experience in internet infrastructure services, with its core businesses covering data center management, managed network service, content distributed network service and cloud computing. The Company worked with Microsoft to successfully launch Office 365 services this April, delivering for the first time the familiar Office productivity suite, now equipped with more advanced communication and collaboration tools, as a local cloud service to business and government customers throughout China. The Company will leverage its cloud operation and service excellence to provide one-stop public cloud services to customers in China. According to Forrester Research, China is one of the fastest growing markets for public cloud services in the world and forecast to grow from $300M in 2011 to $3.8B by 2020. 

With the availability of GigaTrust’s secure mobility products, 21Vianet will provide Office 365 customers with a comprehensive security solution for both Android and iPhone devices, enabling highly adaptable cross-platforms and cross-devices experience.  Subscribers of Office 365 in China will be able to protect and consume protected emails and documents (Office docs and PDF formats) from anywhere securely to or from the mobile device.  In the past two years, smartphone sales in China have quadrupled, making China one of the world’s largest Smartphone markets in the world according to research firm IDC. Today, China has nearly 1 billion mobile phone users with roughly 40% or 400 million currently using smartphones, forecasted to reach 800 million by 2020.

Wing-Dar Ker, President of MS Cloud Business Unit at 21Vianet, stated, “Information security on mobile devices is a critical business requirement for Office 365 cloud customers. 21Vianet is pleased to deliver the industry’s leading mobility security solution from GigaTrust to Office 365 customers in China.”

“BYOD mobile environments are growing across all markets and GigaTrust is dedicated to providing secure email and document access to mobile devices anywhere. We are very excited to work with 21Vianet to provide GigaTrust’s mobile security products to Office 365 customers in China and to participate in the exponential growth of the China public cloud services market combined with the largest number of smartphone users worldwide,” said Bob Bernardi, Chairman and CEO of GigaTrust.

Frost & Sullivan Recognizes Dassault Systemes’ Apriso Mobility Solution for Discrete Industries

MOUNTAIN VIEW, Calif., July 16, 2014 /PRNewswire/ — Based on its recent analysis of industrial mobility applications in discrete industries, Frost & Sullivan recognizes Dassault Systemes with the 2014 Global Frost & Sullivan Award for New Product Innovation Leadership. Dassault Systemes’ unique manufacturing operations management solution, comprising the Apriso product portfolio, offers a unified framework and diverse set of applications to monitor and optimize operations across the production floor and extended supply chain.

Unlike most mobile solutions, which have been predominantly limited to field service, supply chain and warehouse management, the extended functionality of a DELMIA Apriso solution allows key enterprise personnel to view, control, and manage multiple production lines, facilities, business units, and plants across the globe.

The solution is finding increasing acceptance across discrete industries because of its seamless compatibility with multiple mobile platforms; cost-effective implementation using commercial, off-the-shelf devices; and user-friendly, role-based dashboards.

“As BYOD (bring your own device) takes precedence across discrete industries, the ability to use commercial mobile devices in complex industrial environments rather than expensive, industrial-grade tablets provides end users with a cost-effective approach to monitor their operational processes and equipment on the production floor,” said Frost & Sullivan Senior Research Analyst Rahul Vijayaraghavan. “Furthermore, the user-friendly interface of an Apriso solution allows diverse personnel across the facility to customize their dashboard to monitor and validate key performance indicators, such as line effectiveness, capacity requirements, utilization rates, and process efficiency.”

As manufacturing and production facilities continue to witness global expansions and new process additions, Dassault Systemes’ scalable framework to amass high volumes of data will foster greater market acceptance while providing a positive user experience.

“Using its manufacturing process intelligence (MPI) in conjunction with the online analytical processing (OLAP) database, Apriso solutions can streamline the collation of high-volume data from multiple plants and translate the data into profit insights — a key requirement in today’s competitive landscape,” said Frost & Sullivan Senior Research Analyst Srikanth MS. “Apriso’s manufacturing mobility solution has been successfully implemented in industries with intricate manufacturing processes, such as food and beverage (F&B) and aerospace and defense (A&D), which allows customers to manage shift changes appropriately, reduce downtime of operations, and facilitate end-to-end traceability.”

Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product. The award recognizes the value-added features of the product and the increased ROI, which, in turn, increases customer acquisition.

Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for outstanding achievement in areas such as leadership, technological innovation, customer service, and product development.

About Dassault Systemes & DELMIA

Dassault Systemes, the 3DEXPERIENCE Company, serves 190,000 customers across 140 countries, providing virtual universes for sustainable innovation. Dassault Systemes’ DELMIA brand offers products that connect the virtual and real worlds. As part of DELMIA, the Apriso product portfolio helps manufacturers transform their global operations to achieve and sustain operational excellence. Learn more at apriso.com, apriso.com/blog or follow us here: @Apriso.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies? Contact us: Start the discussion.

Contact:

Mireya Espinoza
P: 210.247.3870
F: 210.348.1003
E: mireya.espinoza@frost.com

Changyou to Invest in MoboTap

BEIJING, July 16, 2014 /PRNewswire/ — Changyou.com Limited (“Changyou” or the “Company”) (NASDAQ: CYOU), a leading online game developer and operator in China, and MoboTap Inc. (“MoboTap”), a Cayman Islands company that is the mobile technology develo…

First patient enrollment in MASCOT registry represents major milestone for COMBO™ Dual Therapy Stent and OrbusNeich’s clinical program

HONG KONG, July 16, 2014 /PRNewswire/ — OrbusNeich today announced that the first patient has been enrolled in the Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) post-marketing registry. The first COMBO™ Dual Therapy Stent implant was performed at the Amphia Hospital in Breda, The Netherlands.

Designed to assess the long-term safety and effectiveness of the COMBO Stent in routine clinical practice, the prospective, multicenter registry is the largest clinical study of the unique dual therapy stent to date, with a goal of 2,500 patients being followed for a year in up to 50 centers across Asia and Europe.

The study’s primary endpoint is device-oriented target lesion failure (TLF), defined as the composite of cardiac death, non-fatal heart attack (myocardial infarction or MI) not clearly attributable to a non-target vessel, or target lesion revascularization (TLR) from enrollment to 12 months.

The principal investigator is Prof. Antonio Colombo, M.D., San Raffaele Hospital, Milan, Italy; the director of the clinical coordinating center is Roxana Mehran, M.D., Mount Sinai Medical Center.

“Long-term safety remains an important area of clinical investigation with stents, particularly the avoidance of neoatherosclerosis and late stent thrombosis,” said Prof. Colombo. “The MASCOT registry will provide important information about the unique dual therapy approach of the COMBO Stent, which offers the possibility of functional arterial vessel healing, which we have not seen with any of the monotherapy drug eluting stents.”

“The clinical data gathered from COMBO stent trials to date show promise with respect to long-term safety and efficacy,” added Dr. Mehran. “For example, target lesion revascularization remained stable at 5.7 percent in both years two and three of the REMEDEE trial, with no thrombotic events over three years. If those results hold in the MASCOT registry, that will be good news for patients and cardiologists.”

OrbusNeich is supporting the COMBO Stent with one of the industry’s most robust clinical programs. In addition to the MASCOT registry, the REDUCE trial — which enrolled its first patient in June 2014 — aims to demonstrate the potential for a shorter period of dual antiplatelet therapy. Find more information on REDUCE here.

“The initiation of MASCOT, our largest registry trial to date, represents the commitment we have made to really understand the patient benefits of the COMBO Stent,” said B. Wayne Johnson, president and chief operating officer, OrbusNeich. “Only by delivering true vessel healing can patients feel safe for the long term. We expect the MASCOT trial to confirm what we have already seen with the COMBO Stent as it relates to vessel healing.”