CPhIWorldwideexpertsmake pharma predictions for 2015:

The good, the bad and the ugly

Continuous Manufacturing and QbD expanding,with FDA becoming ‘industry tutor’, but pharma concerns about supply chain persist

2015’s PharmaTrends Highlights:

  • The Good:Big growth in use ofQbD,continuous manufacturing and Quality Metricswith contract manufacturers and generic companies also starting to implement
  • Shift in USFDA’s role from just being an “investigator” of products to an “enabler” of better quality processes and cultures within pharma manufacturing
  • Breakthrough treatments for infectious diseases and growth across NCEs and biopharmaceuticals
  • The Bad:Shortages of popular drugs in Western markets due to marginal pressures and reducedstockpiling
  • Fears for pharma not‘walking the talk’- QbD and continuous manufacturing and other quality changes are being implemented in finished dosage, but in API, not enough necessary manufacturing changes have occurred
  • Challenging year for virtual drug developers as pharma exercises closer inspection of the robustness of CMC regulatory packages
  • The Ugly truth:It’s crucial for pharma to take greater control over ingredients
  • Outsourcing and related quality issues are unlikely to be reduced in the near future. Big Pharma may even, in some cases, repatriate key elements of the drug development chain
  • Battle between IP protection and patient access set to hot up in 2015

30January 2015:CPhI Worldwide, organised by UBM EMEA, has delivered its expert panelforecast for the pharmaceutical industry in 2015.

Panel members PrabirBasu, Consultant at Pharma Manufacturing;Hendrik Baumann, CEO of Arevipharma GmbH;Brian Carlin, Director, Open Innovation, FMC;EmilW Ciurczak, President Doramaxx Consulting;Girish Malhotra, President EPCOT International;Hedley Rees, Managing Consultant at PharmaFlow;and Dilip Shah, CEO, Vision Consulting Group, have all predicted trends for the year ahead.

The biggest talking point amongst the industry experts, and members of the panel, was how the consistent growth in big pharma’s implementation of continuous manufacturing and QbD over the next 12 months will unfold. For example, IFPAC (International Forum on Process Analytical Chemistry)are holding several sessions this yearto encourage an increased use of generic PAT/QbD and a new Office of Pharmaceutical Quality, as launched by the FDA, will also encourage an increased QbDadoption throughout the industry.Beyond this, industry and the FDA will continue to emphasize Quality Metrics but nothing substantial is expected. Interestingly, Indian pharmaceutical companies are,according to PrabirBasu, also showing significant interest in implementing OPEX-which could be asignificant cultural shift.

Dilip Shah predicts an evolution inthe FDA’s role to become more of an“enabler” of better quality processes– rather than just an ‘investigator’ – helping the industry to adapt and implement new approaches. Emil W Ciurczak goes further and believes that in 2015we will also see the CDMO market actively implementing QbD and PAT as a source of competitive edge.Vertex hasalready paved the way for future industry uptakeby proving continuous manufacturing’s capability and incorporating itwithin the process part of their ANDA(abbreviated new drug application).

Another positive advancement is anticipated acrossinfectious disease treatments. Hendrik Baumann forecasts a major breakthrough for HIV, Hepatitis C or Malaria, and he also predicts solid growth for NCE’s (new chemical entities) and within the biopharmaceuticals market.

Not all aspects of pharma supply are facing a positive outlook in 2015. Marginal pressures caused by a greater profit driven approach to sourcing and consequential reduced stockpiling by pharmaceutical producers and wholesalers will have a major effect on Western drug markets- with popular drugs in danger offalling short of demand warns Baumann. The production of popular medicines will be less appealing to companies who will decrease warehouse capacities and stockpiling to cope withincreasing marginal pressures.

Moreover, Girish Malhotra has called for action on QbD, continuous manufacturing and PAT to finally take holdacross the pharmaceutical industry. One thing he did stress however is that whilst continuous processing is ideal for finished formulations, in API we need whole new solutions. This is where his concerns are greatest and despite a lot of talk about positive change, not enough progress will be implemented in 2015. Both Girish and PrabirBasu warn that outsourcing and quality related issues are not likely to reduce in the near future.

Declared as ‘the ugly truth’, it is now crucial for pharma to take greater control over ingredients and consistency of products should be ensured. Brian Carlin calls onthe pharma industry to push for tighter controls. Pfizer, for example, hasrecently announced a “movable” process line to ensure product consistency, ensuring no variability of quality across products from different global locations.

Due to well-documented supply chain issues, Hedley Rees claims Big Pharma may repatriate some of the drug development chainin the coming months. Similarly, there is also the potential for a Big Pharma acquisition of a CDMO, which would give full control over the supply chainand reverse the huge outsourcing trend of recent years. Despite these concerns, Prabir is predicting that the progressive trend of outsourcing towards India and China will continueapace.

This year is set to be a challenging one for virtual drug developers, as pharma increases scrutiny of the robustness of CMC packages that are part of in-licensing agreements.Hedley Rees predicts a strain on the industry as developersare forced to meet their ever-increasing commitments to GMP/GDP. This will also lead to increased pressure to exceed expectations of potential pharma partners as they look to see a tighter grip on the supply chain.

According to Dilip Shah, another huge industry changewillsoon be unfolded by developed economies as we see an increasing battle between IP protection and patient access. Developed economies are looking to balance the interests between innovators and patients in the pharma industry, which would put increased pressure on patented products to become cheaper and more accessible.

Other significant trends forecast by the panel include“an increased Government influence over healthcare systems” and “a rise in generic API’s sold through ‘tender businesses’which will reduce marginsand may lead to a reduction in quality”.Hendrik also argues that continuous improvement of current processes combined with permanent technology investments and cGMP compliance will guarantee the existence of European API producers and hold key to their success.Finally, Dilip believes drug regulators will face societal pressures to facilitate entry of follow-on innovative drugs to promote competition in the patented segment.

Full predictions from the expert panel can be found in the appendix below.

“New technologies like continuous manufacturing, QbD and PAT continue to expand in importance within the pharma industry, yet age-old issues regarding the supply chain andworking with the right partners are also seen as essential in 2015- demonstrating the integral role CPhI will continue to play. Strategic partnering has been a theme for some time in the industry and CPhI provides the necessary tools to establish more pharma contacts and makeimproved business decisions.”Chris Kilbee, Group Director Pharma at UBM.

-ENDS-

Notes to editors

Full expert panel predictions:

PrabirBasu, Consultant at Pharma Manufacturing

  • Outsourcing will continue to increase, especially to India and China. Outsourcing and related quality issues are not likely to be reduced in the near future.
  • There will be continued interest in Continuous Manufacturing. There will be a push for regulatory agencies to start developing some guidelines for regulating this type of manufacturing.
  • Industry and FDA will continue to emphasize Quality Metrics though nothing substantial is expected.
  • Pharmaceutical companies in India will show interest in implementing OPEX programs though progress is expected to be slow.

Hendrik Baumann, CEO of Arevipharma GmbH

  • Smart operation of multipurpose plants, continuous improvement of the current processes, permanent investments in technology and people and cGMP compliance without compromise will guarantee the existence of the European API producers and key for their success.
  • Biopharmaceuticals will grow continuously and NCE’s (new chemical entities) will develop moderately. We might see a breakthrough in HIV treatment, Malaria treatment, and therapy of Hepatitis C or similar viral infections.
  • Individualized medicine will become more and more popular. Either via individual dosages, mixtures of different API’s or new biopharmaceutical treatments. The pharmacist will lose influence; compounding pharmacies will become more important.
  • Government influence over health systems will increase. More and more generic API’s will be sold through so called “tender businesses”. Margins will continuously decrease and popular medicines will be less attractive to produce. Pharmaceutical producers and wholesalers will decrease warehouse capacities and stockpiling. Consequently, there will be shortages of popular drugs.

Brian Carlin, Director, Open Innovation, FMC

  • Greater focus on impact of raw material variability on the quality of finished pharmaceutical products.
  • Increasing adoption of continuous manufacturing of pharmaceuticals.
  • Multivariate continuous monitoring through product lifecycle.
  • Increasing regulatory focus on quality of applicants manufacturing history.

Emil W Ciurczak, President Doramaxx Consulting

  • QbD will be extended to contract manufacturers and generic companies (IFPAC 2015 has several sessions about generic PAT/QbD this year).
  • Continuous manufacturing is the wave of the future. Vertex submitted their first ANDA with CM as the process part of the application. The CM equipment is excellent for doing DoE's: the amounts of RM and API are minimized (thus, the cost is minimized), the time required to run a proper DoE falls from weeks to days, and, in my opinion, the best thing is that the design stage is the production level. That is, there is no scale-up time. That saves a minimum of 12-18 months before introduction of a product (essentially extending the patent live over a year).
  • The "movable" process line (Pfizer announced it was doing this) may be brought to a remote site to ensure consistency of products, no matter where produced. This is possible by performing a mini-DoE, using locally available raw materials (we all know excipients vary from country to country). This allows a proprietary company to produce "home-style" products at any contract site.

Girish Malhotra, President EPCOT International

  • The industry will continue with a “regulation-centric” approachdespite the benefits of the“process-centric” methodology.
  • QbD, continuous manufacturing and PAT are needed across the industry, particularly in finished formulation. However, in API manufacturing the industry needs to review its current model and practices and at present the industry seems unlikely to consider and implement.

Hedley Rees, Managing Consultant at PharmaFlow

  • Big Pharma will begin to repatriate certain drug development value chain activities to regain control over quality, lead times and cost. Could a big Pharma buy a CDMO?
  • FDA’s launch of the new Office of Pharmaceutical Quality will provide much needed focus and integration in the US regulatory process, which will drive drug developers and manufacturers to design quality into their products at a much earlier stage– congratulations, Dr. Woodcock!
  • Recent progress in precision medicine and advanced therapies will begin to seriously challenge the prevailing wholesaler/Pharmacy distribution networks, as diagnosis and treatment become every more closely linked.
  • Virtual drug developers will be challenged to meet their ever-increasing commitments to GMP/GDP and also to meet expectations of prospective big Pharma partners with respect to the robustness of their CMC packages.

Dilip Shah, CEO, Vision Consulting Group

  • The role of the USFDA may change from that of mere an "investigator" to that of an "enabler" bringing in attitudinal and culture changeand transform product quality oversight from a qualitative (subjective) to a quantitative (objective) and expertise-based process toensure adequate supply of safe, effective and quality medicines to the U.S. citizens.
  • The drug regulators will face societal pressures to facilitate entry of follow-on innovative drugs to promote competition in the patented segment.
  • The USTR, confronted with conflicting commercial interests, may not allow itself to be driven by the Big Pharma as more pharmaceutical companies adopt win-win business models which ensure that IP and Access can co-exist.
  • The developed economies may move towards balancing the interests of the innovators and the patients in the field of pharmaceuticals.

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, Korea, China, India, Japan, Southeast Asia, Istanbul, Russia and South America and co-locates 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.

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The UBM EMEA annual schedule of Pharmaceutical events includes; CPhI, P-MEC and Innopack South East Asia (08-10 April, 2015 at the Jakarta International Expo- Jakarta, Indonesia); CPhI, ICSE, P-MEC, BioPh and Pharmatec Japan (22-24 April, 2015 at the Big Sight Exhibition Centre- Tokyo). CPhI Russia and IPhEB(27-29 April, 2015 at the VVC, Pavilion Nr 75, Moscow Russia); CPhI Istanbul (3-5 June, 2015, at the LutfiKirdar Convention and Exhibition Centre- Turkey); CPhI, Hi and Fi, ICSE, P-MEC, BioPh and LabWorld China (24-26 June, 2015 at SNIEC- Shanghai, China); CPhI, ICSE Korea (7-9 September, 2015 at the COEX- Seoul, South Korea); CPhI, ICSE, P-MEC and InnoPack Worldwide (13-15 October 2015, IFEMA- Feria de Madrid, Spain)

About UBM EMEA

UBM |EMEA 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.

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