Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

According to the UK’s Economic and Social Research Council (ESRC), the 

 of Pfizer’s UK R&D facility, announced last week, is part of a long-term decline in drug development that is affecting all major UK pharmaceutical multinationals. The ESRC blames the decline on “failure of innovative drive in the industry, failure of the UK to support basic research, failure of venture capital to invest in early stage research, or failure of the Health Service to provide smart procurement”.

In particular, the stunted innovation has been attributed to the “lengthy and expensive regulatory system”, according to an 

. Although regulation impacts all products developed by any industry sector, it is significantly felt in the pharma industry where it affects overall company strategies, which companies succeed and fail, and, ultimately, the entire structure and dynamism of the sector as a whole.

According to research by the ESRC’s Innogen centre, the pharma industry is approaching a “tipping point” in the not-too-distant future in which innovation will no longer be sustainable.  However, “radical reform” of regulatory systems could help to better ensure a productive and profitable pharma sector — both globally and in the UK.

“We do not need less regulation, but smarter regulation that can deliver expected standards of safety and efficacy, and that is flexible enough to respond to new scientific discoveries and do so more efficiently than our current systems within a shorter timeframe,” Professor Joyce Tait, Director of the ESRC's Innogen Centre, said in the statement.

ESRC believes that radical regulatory reform for the life sciences industries should be a priority in discussions regarding the industry’s future. “Reform could provide the lever to profitably unleash the creativity that has been so effectively generated from public funding of basic science, leading to something closer to the innovative performance that we have seen in information and communication technologies over the past twenty years,” said the ESRC.

A related PharmTech blog about the effect of the Pfizer plant closure on the UK can be read 

Articles

According to the UK's Economic and Social Research Council (ESRC), the closure of Pfizer's UK R&D facility, announced last week, is part of a long-term decline in drug development that is affecting all major UK pharmaceutical multinationals.

Regulations Causing Innovation Failure

India is set to become a “biosimilar powerhouse”, with manufacturers in this country well placed to capitalize on the growing biosimilars market, according to market analysts at Datamonitor.

“The domestic market for biosimilars in India is limited by low levels of health insurance and therefore poor access to biologic drugs; however given the high level of branded-generic loyalty of the emerging middle class, this could act as a driver of biosimilar uptake,” Alistair Sinclair, Healthcare Analyst at Datamonitor, said in a press statement.

Many copycat biologics are already available in India, but they are often approved as new drugs, which makes it difficult to quantify biosimilars sales. Despite this, Datamonitor estimates that biosimilars sales in India are between $20 million and $200 million, but will grow to approximately $580 million by 2012.

Many Indian biosimilar manufacturers are also looking to expand globally, but they could face difficulties in these areas. Although biosimilars are prevalent in India, their emergence in Europe and the US has been much slower. The EU began approving biosimilars in 2006 and a handful of products are now available, but the US only approved its first biosimilar in 2010. In both regions there are still a number of regulatory hurdles and concerns. 

 “The developed pharma markets may be difficult to access alone due to the complex and expensive clinical trials and registration process,” said Sinclair. “However, licensing agreements with multinational companies, such as the recent deal between Biocon and Pfizer, can facilitate access to these markets.”

India is set to become a "biosimilar powerhouse", with manufacturers in this country well placed to capitalize on the growing biosimilars market, according to market analysts at Datamonitor.

India To Become A Biosimilar Powerhouse

 of Pfizer’s UK research and development (R&D) facility, announced last week, is part of a long-term decline in drug development that is affecting all major UK pharmaceutical multinationals. The ESRC blames the decline on “failure of innovative drive in the industry, failure of the UK to support basic research, failure of venture capital to invest in early-stage research, or failure of the Health Service to provide smart procurement.”

In particular, the stunted innovation has been attributed to the “lengthy and expensive regulatory system,” according to an 

. Although regulation impacts all products developed by any industry sector, it is significantly felt in the pharma industry, where it affects overall company strategies, which companies succeed and fail, and, ultimately, the entire structure and dynamism of the sector as a whole.

According to research by the ESRC’s Innogen Center, the pharmaceutical industry is approaching a “tipping point” in the not-too-distant future in which innovation will no longer be sustainable.  However, “radical reform” of regulatory systems could help to better ensure a productive and profitable pharma sector—both globally and in the UK.

“We do not need less regulation, but smarter regulation that can deliver expected standards of safety and efficacy, and that is flexible enough to respond to new scientific discoveries and do so more efficiently than our current systems within a shorter timeframe,” Professor Joyce Tait, director of the ESRC's Innogen Center, said in the statement.

ESRC believes that radical regulatory reform for the life-sciences industries should be a priority in discussions regarding the industry’s future. “Reform could provide the lever to profitably unleash the creativity that has been so effectively generated from public funding of basic science, leading to something closer to the innovative performance that we have seen in information and communication technologies over the past 20 years,” said the ESRC in the press statement.

See a  related blog post on PharmTech Talk, titled, 

Pfizer Site Closure “Shocking Wake-Up Call” for UK

Regulations Causing Innovation Failure, Impact Pfizer

Pfizer is to close a UK R&D facility in Sandwich (Kent), affecting more than 2000 positions, as it seeks to reduce expenditure by realigning its R&D division. The Sandwich facility conducts research in the therapeutic areas of allergy and respiratory disease.

A number of other facilities will also be affected by the realignment, with the company planning to shift selected resources from its Groton (CT, USA) plant to Cambridge (MA, USA) and outsource certain functions. According to a 

, Pfizer will also enhance its presence in Cambridge, San Francisco, New York, La Jolla in the US and Cambridge (UK). 

“We continue to closely evaluate our global research and development function and will accelerate our current strategies to improve innovation and overall productivity. Key steps in this process include greater focus in disease areas of greatest scientific, medical and commercial opportunity, a realigned global R&D footprint to increase our presence in key biomedical innovation hubs, and an increased level of outsourcing for services that do not drive competitive advantage for Pfizer,” Ian Read, President and CEO, said in a statement.

"Today's news is a real shame for all those involved in the UK pharmaceutical industry, but sadly reflects the fact that all businesses, including those in the pharmaceutical sector, are continuing to face tough decisions if they are to remain lean and healthy in the current economic climate,” Esther Smith, Pharmaceuticals employment law Partner for Thomas Eggar LLP, commented in a statement. 

The closure is a major blow for the UK. In a 

 issued in response to the closure, Richard Pike, Chief Executive of the Royal Society of Chemistry (RSC), said: “What we are witnessing is the hemorrhaging of the lifeblood of the British pharmaceuticals industry.” 

According to the RSC, the UK has seen almost 6000 job losses in the last 12 months from a number of pharma players including AstraZeneca, GlaxoSmithKline, Vectura, MSD, Aptuit and Qinetiq.

, the Sandwich facility employs approximately 2400 people and is Pfizer’s largest R&D centre in Europe. The staff will be made redundant over the next 18 months to 2 years, although the company did add that it hopes to transfer several hundred positions to other Pfizer sites or to external partners.

 As well as announcing the closure, Pfizer also revealed its Q4 and full year 2010 financial results. Revenues were $17.6 billion for Q4 and $67.8 billion for the full year. The full year results represent an increase of 36% compared with 2009 when revenues were $50 billion. The results were favorably impacted by $18.1 billion (37%) from Wyeth legacy products.

The company also announced that it has authorized a share repurchase program for up to $5 billion, which will increase its current authorization to $9 billion. 

“We believe that the planned increase in share repurchases and the decrease in research and development spending will serve to provide a greater degree of certainty and a more clearly defined path for us to achieve our 2012 adjusted diluted EPS target of between $2.25 and $2.35,” said Read.

Pfizer is to close a UK R&D facility in Sandwich (Kent), affecting more than 2000 positions, as it seeks to reduce expenditure by realigning its R&D division.

Pfizer To Cut Over 2000 UK Jobs

The European Medicines Agency (EMA) has published its final 

, a document that sets out the agency’s key drivers for progress and strategic vision of operation for the next 5 years. The agency plans to prioritize public health needs, improving access to medicines, and optimizing the safe and rational use of medicines.

The road map builds on previous initiatives between 2005 and 2010 and proposes the following three priority areas:

Addressing public-health needs: stimulating medicines development in areas of unmet medical needs, neglected diseases and rare diseases, and for all types of medicines for veterinary use; facilitating new approaches to medicines development; applying a more proactive approach to public-health threats where medicines are implicated.

Facilitating access to medicines: addressing the high attrition rate during the medicines-development process; reinforcing the benefit/risk-balance assessment model; continuing to improve the quality and the regulatory and scientific consistency of the outcome of the scientific review. 

Optimizing the safe and rational use of medicines: strengthening the evidence base in the post-authorization phase; enhancing patient safety by avoiding unnecessary risks to patients as a result of the use of medicines; becoming a reference point for information on medicines evaluated by the agency; improving the decision-making process by taking due account of patient experience.

The road map is a response to some of the key drivers for progress and change that are affecting the EMA. Since the road map to 2010, the EMA explained that its roles and responsibilities have expanded to cover more activities. For instance, new legislative provisions from the European Commission concerning falsified medicines and pharmacovigilance will have important consequences for the EU regulatory network and the EMA in particular given its coordinating role. 

The EMA is also concerned by emerging public health challenges, such as demographic changes, antimicrobial resistance, climate change (particularly in view of the emergence of new diseases) and the rapid development of new technologies, including e-health). Additionally, there is a need to further develop the regulatory framework for new and emerging science, such as personalized medicine, nanotechnologies, regenerative medicines and synthetic biology, with respect to benefit/risk evaluation, potential safety issues, and ethical and environmental considerations. 

The EMA has also noted the growing public demand for greater transparency, particularly with regards to the availability of up-to-date information on medicinal products, adverse drug reactions and clinical trials. However, the EMA also added that this will be a challenge. “Providing greater transparency will entail specific challenges, such as finding the right balance between making more information and documents available more quickly and protecting commercially confidential information, while also complying with personal-data legislation,” said the road map.

Detailed information about the implementation of the road map will be published in a separate document entitled 

. This document will provide information on the required prerequisites and the enablers (including operational and organisational aspects). 

To optimize the implementation of the road map, the EMA will also complement its planning process by applying a multi-annual programming approach that will address aspects such as workload and resources forecasts and budget planning.

The European Medicines Agency (EMA) has published its final 'Road map to 2015', a document that sets out the agency's key drivers for progress and strategic vision of operation for the next 5 years.

EMA Outlines Priorities To 2015

Taking inspiration from nature, researchers have devised a way of giving drug-bearing polymer vesicles ‘armored protection’ that could enhance drug delivery.

The researchers, based at the UK’s University of Warwick, experimented with covering polymer vesicles with a variety of nanoparticle layers that offer different benefits. For instance, a layer of gelatin-like polymer can help the vesicles to avoid the body’s defenses during drug release. Another layer or ‘armor’ type comprised highly regular, packed microscopic polystyrene balls, which enable the researchers to design a vesicle with a permeable reinforced barrier for drug release, as a result of the crystalline-like ordered structure of the polystyrene balls.

Advances in polymerization have led to a surge in vesicles made from polymer molecules, which have interesting chemical and physical properties that make them good candidates for drug delivery vehicles.

, Stefan Bon, Associate Professor and Lead researcher on the University of Warwick team, said: “We took our inspiration from nature, in how it adds protection and mechanical strength in certain classes of cells and organisms”. He added, “In addition to the mechanical strength provided by the cytoskeleton of the cell, plants, fungi, and certain bacteria have an additional cell wall as outermost boundary.”

 Journal of the American Chemical Society

Taking inspiration from nature, researchers have devised a way of giving drug-bearing polymer vesicles armored protection that could enhance drug delivery.