Welcome!

Apache Authors: Trevor Parsons, Sematext Blog , Lori MacVittie, Sandi Mappic, Carmen Gonzalez

News Feed Item

CPhI Annual Expert Industry Report (Part II): Live from CPhI Worldwide

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.

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

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.

About CPhI

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.

For media enquiries, please contact:
Alex Heeley or Tristan Jervis    
De Facto Communications
T: +44-207-203-6745 / 6740
E: [email protected] / [email protected]


SOURCE UBM Live

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
The BPM world is going through some evolution or changes where traditional business process management solutions really have nowhere to go in terms of development of the road map. In this demo at 15th Cloud Expo, Kyle Hansen, Director of Professional Services at AgilePoint, shows AgilePoint’s unique approach to dealing with this market circumstance by developing a rapid application composition or development framework.

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...

"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.
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...
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...
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.
“In the past year we've seen a lot of stabilization of WebRTC. You can now use it in production with a far greater degree of certainty. A lot of the real developments in the past year have been in things like the data channel, which will enable a whole new type of application," explained Peter Dunkley, Technical Director at Acision, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
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...
DevOps Summit 2015 New York, 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 widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete at launch. DevOps may be disruptive, but it is essential.
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nigeria has the largest economy in Africa, at more than US$500 billion, and ranks 23rd in the world. A recent re-evaluation of Nigeria's true economic size doubled the previous estimate, and brought it well ahead of South Africa, which is a member (unlike Nigeria) of the G20 club for political as well as economic reasons. Nigeria's economy can be said to be quite diverse from one point of view, but heavily dependent on oil and gas at the same time. Oil and natural gas account for about 15% of Nigera's overall economy, but traditionally represent more than 90% of the country's exports and as...
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session at @ThingsExpo, Ryan Bagnulo, Solution Architect / Software Engineer at SOA Software, focused on desi...
"At our booth we are showing how to provide trust in the Internet of Things. Trust is where everything starts to become secure and trustworthy. Now with the scaling of the Internet of Things it becomes an interesting question – I've heard numbers from 200 billion devices next year up to a trillion in the next 10 to 15 years," explained Johannes Lintzen, Vice President of Sales at Utimaco, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"For over 25 years we have been working with a lot of enterprise customers and we have seen how companies create applications. And now that we have moved to cloud computing, mobile, social and the Internet of Things, we see that the market needs a new way of creating applications," stated Jesse Shiah, CEO, President and Co-Founder of AgilePoint Inc., in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, 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. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the industry’s first all flash version of HyperConverged Appliances that include both compute and storag...
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile devices as well as laptops and desktops using a visual drag-and-drop application – and eForms-buildi...
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
Code Halos - aka "digital fingerprints" - are the key organizing principle to understand a) how dumb things become smart and b) how to monetize this dynamic. In his session at @ThingsExpo, Robert Brown, AVP, Center for the Future of Work at Cognizant Technology Solutions, outlined research, analysis and recommendations from his recently published book on this phenomena on the way leading edge organizations like GE and Disney are unlocking the Internet of Things opportunity and what steps your organization should be taking to position itself for the next platform of digital competition.
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.
As the Internet of Things unfolds, mobile and wearable devices are blurring the line between physical and digital, integrating ever more closely with our interests, our routines, our daily lives. Contextual computing and smart, sensor-equipped spaces bring the potential to walk through a world that recognizes us and responds accordingly. We become continuous transmitters and receivers of data. In his session at @ThingsExpo, Andrew Bolwell, Director of Innovation for HP's Printing and Personal Systems Group, discussed how key attributes of mobile technology – touch input, sensors, social, and ...