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Big Pharma Facing Increasing Complexity, More Collaboration

By Cormac Sheridan
Staff Writer

BRUSSELS, Belgium – Continuing the habit of starting the day's proceedings with unexpected musical choices, the audio-visual technician in charge of the Silver Hall meeting room chose Louis Armstrong's and Ella Fitzgerald's inimitable rendition of "Let's call the whole thing off" to kick off Tuesday's sessions at the BioPartnering Future Europe meeting at the Square Brussels Meeting Centre Tuesday.

The song was hardly an appropriate scene-setter for a meeting focused on collaboration and partnering, but then again, that particular session was focused on drug regulation, a point in the development process at which some companies have no option but to throw in the towel. Finding alternatives to that grim scenario is, arguably, what the meeting was all about, but managing to do so is getting harder than ever, while the wider health care ecosystem is under greater budgetary pressure than ever.

Successive sessions on regulation, drug development and open innovation all pointed in the same direction – toward greater collaboration and greater complexity.

Right now, the drug development industry faces a paradox, Maya Said, head of strategy, external innovation and science policy at Paris-based Sanofi SA's global R&D organization, told delegates at a big pharma strategy session. The science has never been more exciting, but efforts to translate it into products that have real impact on patients' lives have not been very successful.

The pharmaceutical industry had its heyday about three decades ago, she said, in terms of achieving improvements in life expectancy and reductions in mortality. "The last decade has been, let's say, a little less glorious for the industry," she said.

And now, the growth of health care costs is outstripping economic growth. "No matter how you look at it, or which country you're looking at, the system is not sustainable," she added.

From a scientific perspective, all companies converge on the same limited set of targets and use the same tools to interrogate them. "We're all looking for the same thing, with the same way of looking," Said observed.

Asked to describe a future model for drug discovery, she replied that biology has yet to achieve the same shift that occurred when engineering and computer science emerged from physics. Those are now separate disciplines, which do not have to refer back to first principles in order to progress.

"We started as an industry in a fairly translational way," she said, referring to the physiological focus of the drug industry that preceded the current era of molecular medicine. A possible way forward, she suggested, may be to combine elements of both. New technology has enabled the industry to increase its search by a factor of 10, while assuming that the old assumptions about screening and modeling approaches remained valid. "It's not a surprise we're going to fail 10 times more than before."

Open innovation increasingly has been promoted as one way for companies to access innovation more efficiently or more effectively, although companies are still tinkering with various approaches rather than adopting it as a core competence.

"This is just part of the reality of dealing with an infinitely more complex environment with multiple stakeholders that we have to get used to," Francis Marsland, head of European corporate development at Biogen Idec Inc., of Weston, Mass., said during a roundtable discussion on the subject.

Biogen Idec adopted a controlled crowdsourcing approach to respond to a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on its dossier for the multiple sclerosis drug Ampyra (dalfampridine).

It involved selected internal employees outside the core drug development team as well as a network of external experts. Without undertaking any additional trials, the company was able to reverse the decision by presenting the data differently. "People should break out of the idea that the only people with creative ideas are in R&D," Marsland said.

Simon Schneider, head of Europe Middle East and Africa at Waltham, Mass.-based InnoCentive Inc., a crowdsourcing open innovation platform, said that real open innovation takes place outside a company's four walls.

"The idea is whatever room you're in, there are smarter people outside the room," he said. However, internal crowdsourcing, which involves a company's employees only, can be a useful stepping stone. "If you do it internally first, you don't have any IP question marks," he said.

However, the pharmaceutical industry remains reluctant to part with its intellectual property, said Jackie Hunter, a co-founder of Weston, UK-based consultancy OI Pharma Partners and a former senior executive at GlaxoSmithKline plc. "As an industry, we have a fear of failure until it comes to spinning something out, where we have a fear of success," she told delegates. "There's got to be better ways of reducing this bureaucracy of fear."

EMA Moving Toward Adaptive Licensing

Should a company – or group of companies – succeed in getting a product as far as a regulatory submission, they will find that environment is also undergoing change. European Medicines Agency (EMA) Executive Director Guido Rasi told delegates that the agency he leads is increasingly moving to a drug regulation model based on adaptive licensing, a term which, he said, describes "iterative phases of evidence gathering followed by regulatory evaluation and license adaptation."

Conditional approval represents an aspect of that approach – the EMA granted two in 2010 and another four in 2011 – and it will be further strengthened by the advent of new legislation on pharmacovigilance.

"I do not think at this stage there are real alternatives to adaptive licensing," said Rasi, noting the "disappointing experience" the FDA has had with companies not fulfilling their postmarketing commitments under the existing regime.

Cancer and advanced therapies represent two areas where the approach already is being practiced, he said. In cancer, approvals are granted on an indication-by-indication basis, usually at the level of specific organs. The eventual conditional approval of Amsterdam, the Netherlands-based UniQure BV's gene therapy for lipoprotein lipase deficiency, Glybera (alipogene tiparvovec), earlier this year, following a highly protracted process, also fits under this heading. (See BioWorld Today, July 23, 2012.)

The case wasn't referred to directly, but it was obliquely. "I have to admit there are cases which did not work, or [where] we made mistakes, but we are learning," said Paola Testori Coggi, director general of the European Commission's Directorate General for Health and Consumers, which now oversees the EMA. Testori Coggi, who was speaking at the same session, told delegates that innovation now accounts for around half of the cost increases in health care.

In Europe, national health care administrators are moving toward a common platform for conducting Health Technology Assessments, in order to manage costs using medical, economic and ethical perspectives. New legislation on cross-border health care is due to come into force at the end of next year. That, she said, will form the basis for the creation of common metrics and approaches that health authorities in different countries can use when entering reimbursement negotiations.

The 2012 meeting closed Tuesday. For those who refuse to call the whole thing off, the conversation will continue at BioPartnering Future Europe 2013, which will be held in Stockholm, Sweden, Oct. 13 to 15.