Welcome!

Apache Authors: Pat Romanski, Liz McMillan, Elizabeth White, Christopher Harrold, Janakiram MSV

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]


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
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Major trends and emerging technologies – from virtual reality and IoT, to Big Data and algorithms – are helping organizations innovate in the digital era. However, to create real business value, IT must think beyond the ‘what’ of digital transformation to the ‘how’ to harness emerging trends, innovation and disruption. Architecture is the key that underpins and ties all these efforts together. In the digital age, it’s important to invest in architecture, extend the enterprise footprint to the cl...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessio...
IoT is rapidly becoming mainstream as more and more investments are made into the platforms and technology. As this movement continues to expand and gain momentum it creates a massive wall of noise that can be difficult to sift through. Unfortunately, this inevitably makes IoT less approachable for people to get started with and can hamper efforts to integrate this key technology into your own portfolio. There are so many connected products already in place today with many hundreds more on the h...
No hype cycles or predictions of zillions of things here. IoT is big. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, Associate Partner at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He discussed the evaluation of communication standards and IoT messaging protocols, data analytics considerations, edge-to-cloud tec...
Announcing Poland #DigitalTransformation Pavilion
Digital Transformation is much more than a buzzword. The radical shift to digital mechanisms for almost every process is evident across all industries and verticals. This is often especially true in financial services, where the legacy environment is many times unable to keep up with the rapidly shifting demands of the consumer. The constant pressure to provide complete, omnichannel delivery of customer-facing solutions to meet both regulatory and customer demands is putting enormous pressure on...
CloudEXPO | DXWorldEXPO are the world's most influential, independent events where Cloud Computing was coined and where technology buyers and vendors meet to experience and discuss the big picture of Digital Transformation and all of the strategies, tactics, and tools they need to realize their goals. Sponsors of DXWorldEXPO | CloudEXPO benefit from unmatched branding, profile building and lead generation opportunities.
DXWorldEXPO LLC announced today that All in Mobile, a mobile app development company from Poland, will exhibit at the 22nd International CloudEXPO | DXWorldEXPO. All In Mobile is a mobile app development company from Poland. Since 2014, they maintain passion for developing mobile applications for enterprises and startups worldwide.
The best way to leverage your CloudEXPO | DXWorldEXPO presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering CloudEXPO | DXWorldEXPO will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at CloudEXPO. Product announcements during our show provide your company with the most reach through our targeted audienc...
@DevOpsSummit at Cloud Expo, taking place November 12-13 in New York City, NY, is co-located with 22nd international CloudEXPO | first international DXWorldEXPO and will feature technical sessions from a rock star conference faculty and the leading industry players in the world.
Everything run by electricity will eventually be connected to the Internet. Get ahead of the Internet of Things revolution. In his session at @ThingsExpo, Akvelon expert and IoT industry leader Sergey Grebnov provided an educational dive into the world of managing your home, workplace and all the devices they contain with the power of machine-based AI and intelligent Bot services for a completely streamlined experience.
DXWorldEXPO | CloudEXPO are the world's most influential, independent events where Cloud Computing was coined and where technology buyers and vendors meet to experience and discuss the big picture of Digital Transformation and all of the strategies, tactics, and tools they need to realize their goals. Sponsors of DXWorldEXPO | CloudEXPO benefit from unmatched branding, profile building and lead generation opportunities.
22nd International Cloud Expo, taking place June 5-7, 2018, at the Javits Center in New York City, NY, and co-located with the 1st DXWorld Expo will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud ...
In his keynote at 19th Cloud Expo, Sheng Liang, co-founder and CEO of Rancher Labs, discussed the technological advances and new business opportunities created by the rapid adoption of containers. With the success of Amazon Web Services (AWS) and various open source technologies used to build private clouds, cloud computing has become an essential component of IT strategy. However, users continue to face challenges in implementing clouds, as older technologies evolve and newer ones like Docker c...
JETRO showcased Japan Digital Transformation Pavilion at SYS-CON's 21st International Cloud Expo® at the Santa Clara Convention Center in Santa Clara, CA. The Japan External Trade Organization (JETRO) is a non-profit organization that provides business support services to companies expanding to Japan. With the support of JETRO's dedicated staff, clients can incorporate their business; receive visa, immigration, and HR support; find dedicated office space; identify local government subsidies; get...
Dion Hinchcliffe is an internationally recognized digital expert, bestselling book author, frequent keynote speaker, analyst, futurist, and transformation expert based in Washington, DC. He is currently Chief Strategy Officer at the industry-leading digital strategy and online community solutions firm, 7Summits.
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science," is responsible for setting the strategy and defining the Big Data service offerings and capabilities for EMC Global Services Big Data Practice. As the CTO for the Big Data Practice, he is responsible for working with organizations to help them identify where and how to start their big data journeys. He's written several white papers, is an avid blogge...
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, added the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor analytic...