|By PR Newswire||
|October 22, 2013 04:01 AM EDT||
FRANKFURT, Germany, October 22, 2013 /PRNewswire/ --
CPhI Expert Industry Panel Members Comment on Future Contingencies for Pharma in Part II of CPhI Industry Report
Pharma to change business model to include increased academic partnerships, CMO development work, more niched products, industry-wide QbD and regulation of suppliers
Report's expert highlights
Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers:
- Big pharma to develop niche medicines and associated companion diagnostics
- Technical advances in design and development to reduce costs- with a more collaborative model between partners and increased outsourcing in development processes
- Academic partnerships with pharma and CMOs to increase innovation
William Botha, Sensei, Interlean:
- Increased outsourcing to lower risk processes such as packaging and logistics
- Increased vertical integration when risks are higher (e.g. APIs)
- Changing pharma business model towards niche products or commodity-based low margin products
- Regulators to pay increased attention to human factors and staff turnover
Bikash Chatterjee, President and CTO, Pharmatech Associates:
- Pharma to focus on improving drug discovery and development effectiveness
- CMOs need to develop larger service development offerings
- Understanding of foreign regulatory requirements, beyond FDA, to become increasingly common
- FDAs enforcement of QbR in generics to reduce GMP transgressions
Ajaz Hussain, Independent Consultant:
- Continuous manufacturing processes to continue to grow, encouraged by the FDA
- CDER manufacturing metrics to help regulators identify data that is too good to be true and potential compliance issues
- Industry to witness more frequent inspections of foreign facilities
CPhI Worldwide and CPhI Pharma Evolution, part of UBM Live's Pharmaceutical Portfolio, announce the release of the second edition of its annual report - with its expert industry panel identifying the market trends set to affect growth and innovation across the industry.
Part i of the report was launched prior to CPhI Worldwide, with a further eight industry expert panel submissions being released in part ii of the report, over two days at the show (Tuesday 22nd and Wednesday 23rd October).
The first four articles for part ii of the report indicate that over the next few years, big pharma's business model is shifting from its traditional markets and moving towards the development of niche medicines, companion diagnostics, and perhaps most significantly, towards increased partnerships, both with CMOs and academia. The implication of this is that innovations and IP processes will be coming from outsourced partners, big pharma and academia. QbD is seen as being essential to the process of harmonizing product and process development, which will accelerate standards, enabling more developed partnerships and strategic uses of outsourcing.
Sam Venugopal, Director, Healthcare at PricewaterhouseCoopers forecasts in his submission that big pharma will move towards the development of niche medicines, alongside companion diagnostics for patients with specific genotypes.
Echoing these sentiments, William Botha, Sensei at Interlean, says that as well as a move towards niche medicines, pharma will increasingly diversify towards commodity-based, low margin products- meaning we will see an increased specialisation, particularly amongst small and medium pharma. To achieve this goal, he argues that there will need to be increased connection between product development and manufacturing so that products can move more seamlessly through the development process.
Bikash Chattejee, President and CTO at Pharmatech Associates, argues that two essential developments that will be universally adopted over the next five years are the concepts of Quality by Design (QbD) and Quality by Review (QbR). If we are to move towards the harmonization of product and process development cycles, QbD will be essential not only in safeguarding quality but also in reducing the cost of development. However, one area that is forecast for particular change is the application of QbR within the generics drugs industry. For instance, FDA enforcement approaches, it is forecast, will start to look more at baseline characterisation activity, which will reduce the number of GMP transgressions in the medium-term future.
One longer-term change that all experts across the industry panel agree on is the increased collaboration with strategic outsourcing partners and particularly the commercial development of innovations coming out of academia.
Ajaz Hussain, an independent consultant and formerly of the FDAs PAT team, continued: "Academic partnerships such as that between Novartis and MIT will also be increasingly important over the coming years and academia will play significant roles in both technology and policy. This partnership concept will also expand to relationships with suppliers and manufacturers where there is a need for knowledge-based relationships, particularly in the areas of QbD and FDASIA."
Hussain also believes that manufacturing metrics from CDER will allow regulators to identify data 'too good to be true' and decrease non-compliance over the coming years.
Another growing trend is the increased outsourcing across the supply chain and development cycle with industry building symbiotic relationships, commented Bikash Chatterjee. He highlighted that a CMOs ability to provide product development services will be essential to companies moving into emerging markets and smaller start-ups looking to tap into the global marketplace.
Botha however, sees significant risks in too much outsourcing and predicts that lower risk downstream processes such as packaging and logistics will grow, alongside upstream vertical integration of high-risk areas such as APIs: "Outsourcing isn't always the answer. In some cases it is just abdicating or abrogating responsibility."
Venugopal expands on these ideas in his contribution, and believes that the ability to handle increasing volumes of data will facilitate partnerships with reduced risks and enable the global implementation of QbD: "Our ability to increase collaboration and knowledge has increased with our ability to manage data. We can now gather and analyse knowledge to an unprecedented degree." His view is that whilst contracting will increase, this will be more strategic in nature across the global supply chain.
Chris Kilbee - Group Director, Pharma, commented: "The CPhI Pharma Evolution annual report highlights the main industry trends over the next five years, with tighter regulatory controls and processes (e.g. QbD) and diversification of ingredient suppliers featuring prominently in all submissions. Harmonising product and development process partnerships are going to be critical to the success or failure of this- which proves the importance of making strategic partnerships at events such as CPhI."
For full copies of the submission and overall reports please visit: http://www.cphi.com
Notes to editors
About CPhI Pharma Evolution annual report and expert industry panel
Earlier this year, CPhI launched a major new initiative with the introduction of its annual report published in cooperation with Pharma Evolution- written by a panel of world-leading experts across the pharmaceutical supply chain.
The vision was to harness the power of CPhI's independent position within the industry so that it could produce unbiased analysis of the global pharmaceutical industry and help bring different perspectives together.
The annual report utilises expert in-depth essays, looking at future contingencies. Experts were given carte blanche to evaluate current industry practices and examine the future implications for the industry.
CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, China, India, Japan, Southeast Asia, Russia and South America co-located with ICSE for contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical packaging and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-Online.com and hosts a global community with news and analysis at PharmaEvolution.com.
For more information visit: http://www.cphi.com
The UBM Live annual schedule of Pharmaceutical events also includes CPhI Worldwide, ICSE, P-MEC Europe and InnoPack (22-24 October, 2013 at Messe Frankfurt, Germany); CPhI and P-MEC India (3-5 December, 2013 at the Bombay Exhibition Centre in Mumbai); CPhI, ICSE, P-MEC, BioPh and Pharmatec Japan (9-11 April, 2014 in Tokyo); CPhI Russia and IPhEB (16-17 April, 2014 in St Petersburg, Russia); CPhI, P-MEC and Innopack South East Asia (20-22 May, 2014 in Jakarta, Indonesia); CPhI Istanbul (4-6 June, 2014, Turkey) and CPhI, Hi and Fi, ICSE, P-MEC, BioPh and LabWorld China (26-28 June, 2014 at SNIEC, Shanghai, China). CPhI South America (5-7 August 2014 at Expo Centre Norte, Sao Paulo- Brazil)
About CPhI Pharma Evolution
CPhI Pharma Evolution (http://www.pharmaevolution.com) launched in February 2013 as a global online community where professionals from across the pharmaceutical manufacturing sector can talk with their peers and share best-practices and regulatory updates across the pharmaceutical ingredient and contract manufacturing space. Pharma Evolution is the new go-to community for industry professionals to exchange thoughts and network on key areas including: formulation, APIs, excipients, drug delivery, R&D, manufacturing and quality, packaging and anti-counterfeiting, regulatory compliance, and outsourcing and supply chain management. Pharma Evolution was created as an extension of CPhI's global events business as a forum and resource for pharmaceutical executives to employ 365 days a year. Pharma Evolution is published by CPhI and UBM DeusM (http://www.deusm.com), the marketing services division of UBM specializing in building and operating highly engaged communities of qualified users within specialist B2B markets, using a strategy of best-practices focused on content and technology.
About UBM Live
UBM Live connects people and creates opportunities for companies across five continents to develop new business, meet customers, launch new products, promote their brands, and expand their market. Through premier brands such as TFM&A, Internet World, IFSEC, MD&M, CPhI, Cruise Shipping Miami, the Concrete Show, and many others, UBM Live exhibitions, conferences, awards programs, publications, Websites, and training and certification programs are an integral part of the marketing plans of companies across more than 20 industry sectors.
SOURCE UBM Live
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Architect for the Internet of Things and Intelligent Systems at Red Hat, described how to revolutioniz...
Nov. 21, 2014 09:15 PM EST Reads: 1,023
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com), moderated by Ashar Baig, Research Director, Cloud, at Gigaom Research, Nate Gordon, Director of T...
Nov. 21, 2014 08:00 PM EST Reads: 1,139
Technology is enabling a new approach to collecting and using data. This approach, commonly referred to as the "Internet of Things" (IoT), enables businesses to use real-time data from all sorts of things including machines, devices and sensors to make better decisions, improve customer service, and lower the risk in the creation of new revenue opportunities. In his General Session at Internet of @ThingsExpo, Dave Wagstaff, Vice President and Chief Architect at BSQUARE Corporation, discuss the real benefits to focus on, how to understand the requirements of a successful solution, the flow of ...
Nov. 21, 2014 08:00 PM EST Reads: 1,180
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, and physical persons. In the IoT vision, every new "thing" - sensor, actuator, data source, data con...
Nov. 21, 2014 08:00 PM EST Reads: 1,065
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 21, 2014 07:00 PM EST Reads: 1,057
ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ -- IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's platform-as-a-service. The new platform enables developers to build ap...
Nov. 20, 2014 11:00 PM EST Reads: 1,232
Focused on this fast-growing market’s needs, Vitesse Semiconductor Corporation (Nasdaq: VTSS), a leading provider of IC solutions to advance "Ethernet Everywhere" in Carrier, Enterprise and Internet of Things (IoT) networks, introduced its IStaX™ software (VSC6815SDK), a robust protocol stack to simplify deployment and management of Industrial-IoT network applications such as Industrial Ethernet switching, surveillance, video distribution, LCD signage, intelligent sensors, and metering equipment. Leveraging technologies proven in the Carrier and Enterprise markets, IStaX is designed to work ac...
Nov. 20, 2014 09:15 PM EST Reads: 1,260
"There is a natural synchronization between the business models, the IoT is there to support ,” explained Brendan O'Brien, Co-founder and Chief Architect of Aria Systems, in this SYS-CON.tv interview at the 15th International Cloud Expo®, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 20, 2014 07:30 PM EST Reads: 1,430
C-Labs LLC, a leading provider of remote and mobile access for the Internet of Things (IoT), announced the appointment of John Traynor to the position of chief operating officer. Previously a strategic advisor to the firm, Mr. Traynor will now oversee sales, marketing, finance, and operations. Mr. Traynor is based out of the C-Labs office in Redmond, Washington. He reports to Chris Muench, Chief Executive Officer. Mr. Traynor brings valuable business leadership and technology industry expertise to C-Labs. With over 30 years' experience in the high-tech sector, John Traynor has held numerous...
Nov. 20, 2014 06:00 PM EST Reads: 1,217
Bit6 today issued a challenge to the technology community implementing Web Real Time Communication (WebRTC). To leap beyond WebRTC’s significant limitations and fully leverage its underlying value to accelerate innovation, application developers need to consider the entire communications ecosystem.
Nov. 20, 2014 04:45 PM EST Reads: 969
The 3rd International @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades.
Nov. 20, 2014 01:00 PM EST Reads: 1,462
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover how hardware commoditization, the ubiquitous nature of connectivity, and the emergence of Big Data a...
Nov. 20, 2014 12:30 PM EST Reads: 1,695
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
Nov. 18, 2014 09:00 PM EST Reads: 1,956
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, phone and digital TV services to consumers primarily in rural areas.
Nov. 18, 2014 08:15 PM EST Reads: 1,503
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada. Our partner network encompasses some 300 of the world's leading systems integrators and security s...
Nov. 18, 2014 08:15 PM EST Reads: 1,432
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what the future may hold. Mike Kavis is Vice President & Principal Cloud Architect at Cloud Technology Pa...
Nov. 18, 2014 01:30 PM EST Reads: 1,965
Cloud Expo 2014 TV commercials will feature @ThingsExpo, which was launched in June, 2014 at New York City's Javits Center as the largest 'Internet of Things' event in the world. The next @ThingsExpo will take place November 4-6, 2014, at the Santa Clara Convention Center, in Santa Clara, California. Since its launch in 2008, Cloud Expo TV commercials have been aired and CNBC, Fox News Network, and Bloomberg TV. Please enjoy our 2014 commercial.
Nov. 13, 2014 05:00 AM EST Reads: 3,510
From a software development perspective IoT is about programming "things," about connecting them with each other or integrating them with existing applications. In his session at @ThingsExpo, Yakov Fain, co-founder of Farata Systems and SuranceBay, will show you how small IoT-enabled devices from multiple manufacturers can be integrated into the workflow of an enterprise application. This is a practical demo of building a framework and components in HTML/Java/Mobile technologies to serve as a platform that can integrate new devices as they become available on the market.
Nov. 10, 2014 12:30 PM EST Reads: 2,619
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Nov. 10, 2014 12:00 PM EST Reads: 5,917
Located in booth #314, the Bsquare team will present DataV demos and discuss how DataV will help customers put their data to work to improve business outcomes. DataV is unlocking new initiatives across a wide landscape of customers in industries such as industrial manufacturing, transportation, retail and mobile. The solution is designed to complement a new project start or help to enrich an existing machine investment.
Nov. 6, 2014 03:15 PM EST Reads: 2,344