|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
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 7, 2016 03:30 PM EST Reads: 370
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, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
Feb. 7, 2016 02:45 PM EST Reads: 138
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 7, 2016 02:00 PM EST Reads: 555
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 7, 2016 01:45 PM EST Reads: 360
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 7, 2016 01:30 PM EST
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
Feb. 7, 2016 12:00 PM EST Reads: 343
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 7, 2016 11:30 AM EST Reads: 344
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 7, 2016 10:15 AM EST Reads: 107
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
Feb. 7, 2016 07:00 AM EST Reads: 119
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry's single source for the cloud. Fusion's advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including clou...
Feb. 6, 2016 03:30 PM EST Reads: 719
Most people haven’t heard the word, “gamification,” even though they probably, and perhaps unwittingly, participate in it every day. Gamification is “the process of adding games or game-like elements to something (as a task) so as to encourage participation.” Further, gamification is about bringing game mechanics – rules, constructs, processes, and methods – into the real world in an effort to engage people. In his session at @ThingsExpo, Robert Endo, owner and engagement manager of Intrepid D...
Feb. 5, 2016 09:00 PM EST Reads: 785
Eighty percent of a data scientist’s time is spent gathering and cleaning up data, and 80% of all data is unstructured and almost never analyzed. Cognitive computing, in combination with Big Data, is changing the equation by creating data reservoirs and using natural language processing to enable analysis of unstructured data sources. This is impacting every aspect of the analytics profession from how data is mined (and by whom) to how it is delivered. This is not some futuristic vision: it's ha...
Feb. 2, 2016 02:00 PM EST Reads: 410
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Feb. 2, 2016 04:30 AM EST Reads: 851
Learn how IoT, cloud, social networks and last but not least, humans, can be integrated into a seamless integration of cooperative organisms both cybernetic and biological. This has been enabled by recent advances in IoT device capabilities, messaging frameworks, presence and collaboration services, where devices can share information and make independent and human assisted decisions based upon social status from other entities. In his session at @ThingsExpo, Michael Heydt, founder of Seamless...
Feb. 1, 2016 05:00 AM EST Reads: 940
The IoT's basic concept of collecting data from as many sources possible to drive better decision making, create process innovation and realize additional revenue has been in use at large enterprises with deep pockets for decades. So what has changed? In his session at @ThingsExpo, Prasanna Sivaramakrishnan, Solutions Architect at Red Hat, discussed the impact commodity hardware, ubiquitous connectivity, and innovations in open source software are having on the connected universe of people, thi...
Jan. 31, 2016 09:00 PM EST Reads: 726
WebRTC: together these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at WebRTC Summit, Cary Bran, VP of Innovation and New Ventures at Plantronics and PLT Labs, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it may enable, complement or entirely transform.
Jan. 31, 2016 07:15 PM EST Reads: 1,146
There are so many tools and techniques for data analytics that even for a data scientist the choices, possible systems, and even the types of data can be daunting. In his session at @ThingsExpo, Chris Harrold, Global CTO for Big Data Solutions for EMC Corporation, showed how to perform a simple, but meaningful analysis of social sentiment data using freely available tools that take only minutes to download and install. Participants received the download information, scripts, and complete end-t...
Jan. 31, 2016 10:00 AM EST Reads: 1,216
For manufacturers, the Internet of Things (IoT) represents a jumping-off point for innovation, jobs, and revenue creation. But to adequately seize the opportunity, manufacturers must design devices that are interconnected, can continually sense their environment and process huge amounts of data. As a first step, manufacturers must embrace a new product development ecosystem in order to support these products.
Jan. 31, 2016 10:00 AM EST Reads: 812
Manufacturing connected IoT versions of traditional products requires more than multiple deep technology skills. It also requires a shift in mindset, to realize that connected, sensor-enabled “things” act more like services than what we usually think of as products. In his session at @ThingsExpo, David Friedman, CEO and co-founder of Ayla Networks, discussed how when sensors start generating detailed real-world data about products and how they’re being used, smart manufacturers can use the dat...
Jan. 30, 2016 07:45 PM EST Reads: 790
When it comes to IoT in the enterprise, namely the commercial building and hospitality markets, a benefit not getting the attention it deserves is energy efficiency, and IoT’s direct impact on a cleaner, greener environment when installed in smart buildings. Until now clean technology was offered piecemeal and led with point solutions that require significant systems integration to orchestrate and deploy. There didn't exist a 'top down' approach that can manage and monitor the way a Smart Buildi...
Jan. 30, 2016 03:45 PM EST Reads: 1,268