Is big pharma killing innovation in drug formulation? - GSK defends the industry

In a packed audience hall in Vienna's Austria Centre, William Dawson, managing director of Bionet, argued the case for finding big pharma guilty of killing pharmaceutical innovation, while Patrick Crowley, GlaxoSmithKline's vice president of pharmaceutical development, defended the industry.

A passionate prosecutor, Dawson blasted the drug companies for the drop in new molecular entities (NMEs) despite a rise in global sales and R&D spending.

"Big pharma makes more money every year but this is not translating to more NMEs, last year there were only 28," Dawson said.

"This is also the case with formulations and delivery systems, so there is clearly something wrong in the way big pharma is now approaching drug development."

What is wrong, according to Dawson, is the industry's attitude to R&D big pharma has lost its discovery culture and it just works on more projects in the hope that more drugs will reach the market.

But this does not appear to be a winning strategy since out of 10,000 NMEs that are developed over a period of 10 to 15 years, only one makes it to commercialisation.

"In the last decade we have seen a decline in in-house discovery and an increase in partner discovery," Dawson noted.

"Now there are interesting molecules coming out of academia and biotech firms, I do not have a problem with the source, but clearly more partnerships are not yielding more drugs."

Dawson blamed the marginalisation of scientists by top management that makes decisions which are informed more by short-term economic considerations rather than good science.

In addition, the focus of innovation has shifted from individuals and small groups to big "tribes," which push medicines without understanding all the parameters that a drug's success is based on.

As a result there is too little work in areas such as toxicology, formulation and process development done at the early stages of the pipeline, leading to more failures later on.

"Teams are now getting too big, though as Patrick will point out, companies like Glaxo are now forming Centres of Excellence to improve communication," Dawson conceded.

"But what is important is not the background of the scientists, whether they are chemists, biologists or pharmacologists, neither the country they are working in, what matters is that every individual is able to think, and corporate culture at the moment discourages this."

Determined to clear big pharma of the charges, Crowley then took the floor in a confident and somewhat artistic mood.

He began by describing the early years of Joseph Haydn, the famous Austrian composer who knew hard times as a freelancer in Vienna before finding fame, even spending one night homeless on a park bench.

"Even during these arduous years of his life, Haydn found time to study music and write some of his early symphonies which would take him from rags to riches," Crowley said.

"Poverty is not a good thing but it does spring innovation."

Indeed many academics and small firms that are eager to raise funds are often those that come up with great ideas.

Big pharma on the other hand is far from limited in resources, so the only pressure to innovate comes from stakeholders who require return on their investment.

This pressure is not small, in fact it is so high that management is often forced into fast decisions and companies become less enterpreneurial.

"You get a call from someone asking if you have had time to look at their protein delivery system and you already have your hands full considering several others," Crowley said.

"So it is increasingly difficult to respond to fantastic ideas when they come up."

Making matters worse is the lack of transparency, with innovations in pharma companies kept under wraps and only shared when firms are willing to partner to mutual advantage.

Big drug firms are therefore not purveyors of novel technologies and may even be responsible for limiting innovation through patents that are not seen as profitable but still tie up products and technologies.

Yet in spite of these apparent flaws, according to Crowley big pharma remains the major avenue for delivering new formulations to patients.

"Though I walk through the valley of the shadow of death, I will fear no evil," exclaimed Crowley, not to show religious fervour but to sum up how many universities and small biotech firms feel when they struggle to make their innovations stand out from the crowd.

"It is not easy to sell your innovation to big pharma, but if you feel it is worth it

you have to keep the faith," he advised.

As an example of in-house innovation in drug delivery, Crowley cited GSK's blockbuster asthma drug Seretide, which formulates Serevent, a long-acting beta2 agonist, and Flutide, an inhaled corticosteroid, together in one dry-powder inhaler, allowing patients to receive two treatments simultaneously.

AstraZeneca has a similar product on the market while SkyePharma, Kos Pharmaceuticals, Schering-Plough and Novartis are also working on such co-formulated inhalers.

Furthermore, Crowley also suggested several examples in drug delivery where innovation has flourished through partnerships.

These include Nektar's and Pfizer's inhaled insulin device called Exubera, an advanced formulation system that improves the solubility of drug compounds called Captisol, licensed by Cydex to Pfizer, and several formulations of the hypertension drug verapamil developed by pharma companies in collaboration with clinical communities.

Crowley rested his case by acknowledging that many innovators often have to go through hard times like Haydn, but if their ideas add real therapeutic value, they can succeed.

The verdict: By a show of hands a large majority of the delegates found big pharma not guilty of the charge of killing innovation.