|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 @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
Jul. 1, 2015 02:21 PM EDT Reads: 213
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
Jul. 1, 2015 11:30 AM EDT Reads: 2,222
To many people, IoT is a buzzword whose value is not understood. Many people think IoT is all about wearables and home automation. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed some incredible game-changing use cases and how they are transforming industries like agriculture, manufacturing, health care, and smart cities. He will discuss cool technologies like smart dust, robotics, smart labels, and much more. Prepare to be blown away with a glimpse of the future.
Jul. 1, 2015 11:30 AM EDT Reads: 732
"We have a tagline - "Power in the API Economy." What that means is everything that is built in applications and connected applications is done through APIs," explained Roberto Medrano, Executive Vice President at Akana, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 1, 2015 11:00 AM EDT Reads: 526
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.
Jul. 1, 2015 10:30 AM EDT Reads: 2,109
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, discussed how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at the same time reduce Time to Market (TTM) by using plug and play capabilities offered by a robust IoT ...
Jul. 1, 2015 09:45 AM EDT Reads: 1,917
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driving this change including privacy controls, data transparency and integration of real time context wi...
Jul. 1, 2015 08:00 AM EDT Reads: 855
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.
Jun. 30, 2015 09:45 AM EDT Reads: 952
SYS-CON Events announced today that BMC 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. BMC delivers software solutions that help IT transform digital enterprises for the ultimate competitive business advantage. BMC has worked with thousands of leading companies to create and deliver powerful IT management services. From mainframe to cloud to mobile, BMC pairs high-speed digital innovation with robust IT industrialization – allowing customers to provide amazing user experiences with optimized IT per...
Jun. 29, 2015 12:15 PM EDT Reads: 2,682
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not the disruptee.
Jun. 29, 2015 11:00 AM EDT Reads: 2,184
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will addresses this very serious issue of profound change in the industry.
Jun. 29, 2015 09:45 AM EDT Reads: 2,530
Business as usual for IT is evolving into a "Make or Buy" decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud business applications and services across multiple cloud delivery models.
Jun. 28, 2015 11:00 AM EDT Reads: 2,230
In his General Session at 16th Cloud Expo, David Shacochis, host of The Hybrid IT Files podcast and Vice President at CenturyLink, investigated three key trends of the “gigabit economy" though the story of a Fortune 500 communications company in transformation. Narrating how multi-modal hybrid IT, service automation, and agile delivery all intersect, he will cover the role of storytelling and empathy in achieving strategic alignment between the enterprise and its information technology.
Jun. 27, 2015 10:00 AM EDT Reads: 2,254
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists peeled away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud environment, and we must architect and code accordingly. At the very least, you'll have no problem fillin...
Jun. 26, 2015 12:00 PM EDT Reads: 2,239
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
Jun. 26, 2015 10:00 AM EDT Reads: 2,118
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, discussed IoE and the enormous opportunities it provides to public and private firms alike. She will share what businesses must do to thrive in the IoE economy, citing examples from several industry sectors.
Jun. 25, 2015 02:00 PM EDT Reads: 2,033
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
Jun. 25, 2015 01:30 PM EDT Reads: 2,190
SYS-CON Events announced today that the "Second Containers & Microservices Conference" will take place November 3-5, 2015, at the Santa Clara Convention Center, Santa Clara, CA, and the “Third Containers & Microservices Conference” will take place June 7-9, 2016, at Javits Center in New York City. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Jun. 22, 2015 02:15 PM EDT Reads: 2,820
SYS-CON Events announced today that the "First Containers & Microservices Conference" will take place June 9-11, 2015, at the Javits Center in New York City. The “Second Containers & Microservices Conference” will take place November 3-5, 2015, at Santa Clara Convention Center, Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Jun. 20, 2015 12:00 PM EDT Reads: 3,895
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal an...
Jun. 15, 2015 08:45 PM EDT Reads: 4,141