Aside from the keynote speakers, there was also a poster session bringing together some 30 sets of research from British universities. Topics ran from small-scale chromatography resin development for the purification of Japanese encephalitis virus to a biotechnology-based platform to optimise the expression of monoclonal antibody (MAb) sequence variants in CHO cells. University College London was extremely well represented, contributing almost a third of all posters. There was a competition for best poster and the winner was Rhian Grainger from the University of Sheffield with the title “Cell line specific control of recombinant antibody N-glycosylation.”

Howard Levine, president of BioProcess Technology Consultants, discussed the changing landscape of mammalian cell culture manufacturing capability and presented some very interesting data. He noted that MAbs are driving biopharmaceutical revenue and predicted that commercial antibody demand could double by 2016. But what about manufacturing capacity to cope with increasing biopharm demand? The main take away point was that while utilisation currently stands at 43%, this figure is expected to increase to 64% in five years and because much of the capacity (around 75%) is controlled by only 10 companies, access to manufacturing could become difficult. Are CMOs readying themselves?

Research Centre Jülich’s Peter Rohe stepped up the technical detail with his research into boosting bioprocess optimisation through the use of an automated micro-titer plate cultivation system. The system aims to hit the middle ground between controlled conditions and high throughput.

Aidan Courtney from Roslin Cells gave a thought provoking talk on scaling up cell manufacture from the point of view of translating research protocols into GMP processes. He noted that “the destination defines the journey” meaning that, depending on the application of a particular cell therapy, the quantity of cells required for treatment becomes a crucial parameter. Courtney went on to provide numbers for a couple of example scale-up scenarios; ischemia therapy would probably require 100000000 cells per treatment, so estimating perhaps 10,000 treatments per year, the numbers start multiplying faster than the cells… He concluded that GMP translation and scale-up are challenges best addressed in tandem.
There were several more presentations during the first day including an introduction to the “Kymouse” from Kymab’s Tom Shepherd. Watch this space. The final lecture was given by this year’s recipient of the Peter Dunnill Award, Professor Mike Hoare from University College London. It was an inspiring presentation and almost a supplication for companies, funding organisations and academic institutions to continue working together to facilitate breakthroughs in bioprocessing. Focusing on ultra scale-down for enhanced bioprocess discovery, Hoare concluded “Design for manufacture; design for lower cost.”

Regrettably, I couldn’t make the second day of the conference, but I hope that PharmTech will be able to deliver some of that content through contributions from some of the speakers in 2012. You can find more information about BioProcess UK conference here.

Those following us on Twitter (PharmTech.com/twitter) will already know the winner of the Innovation Awards, but for those who do not, I will enlighten you, though you will have to provide your own virtual drum roll…

The bronze prize went to Johnson Matthey for its colour-tag protein (CTP) technology, which was developed to provide an efficient way of measuring protein expression. CTP technology, as its name suggests, uses a protein tag that exhibits an intense yellow colour and allows even small amounts of protein to be quantified in a crude extract of cells, significantly speeding up the screening process.

The silver award went to Acuros for a novel device designed for the continuous delivery of small volume parenterals. Using standard primary packaging components, the device is fully disposable and requires no power supply—instead, osmotic actuation drives the device and provides a precise and stable flow rate.

And finally, the gold award was given to Glycotope for its GlycoExpress platform technology, designed to optimise glycosylation in antibodies and other biotherapeutics. The technology is based on an entire set of human glycoengineered cell lines that express proteins exhibiting different glycosylation patterns; bioassays then identify the pattern that provides the optimal product characteristics.

The six finalists for the Innovation Awards were judged not only on the level of innovation but also, crucially, on the commercial potential of the technology by a distinguished panel chaired by Hendrik Baumann of CU Chemie Uetikon.

Before the main awards, a Sustainability Award was presented to Solvias, a privately held company based in Basel, Switzerland that delivers customised solutions for drug development.

Congratulations to all winners!

In tomorrow’s blog, I will share news from the press room, including developments from the RX-360 consortium, an update from EXCiPACT, and the European Fine Chemical Group’s stance on the proposed Generic Drug User Fee Act (GDUFA), as well as other news from the show floor.

How has the show been for you? Let us know in our quick survey. We’ll be publishing some of the responses anonymously in our next newsletter.

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research.

When he signed the America Invents Act in September, President Obama committed to developing a National Bioeconomy Blueprint by January 2012. The blueprint will describe ways to manage investment in biological research to improve the nation’s health and create the “jobs of the future.” Aside from identifying potentially productive investments in R&D, the blueprint will also describe regulatory reforms to reduce burdens on biopharmaceutical manufacturers.

Illustrating the maxim that great minds think alike, FDA is already seeking to identify and reform burdensome and inefficient regulations as part of its own initiative to stimulate biomedical innovation. At the same time, the agency plans to establish a common understanding among stakeholders to clear the approval pathway for exceptionally promising therapies. These goals are included in the agency’s recent report titled Driving Biomedical Innovation: Initiatives to Improve Products for Patients.

Biological research is the foundation of a significant portion of the American economy, as the White House website notes. The combined efforts of the president and FDA could help discover and develop new therapies. If they also encourage biopharmaceutical companies to hire new employees, they will help mitigate an urgent problem that has not yet been addressed sufficiently.

Some drugmakers have blamed what they see as a slow and overly cautious FDA for the industry’s weak pipelines. Last week, I cited drug-approval figures to show that the agency was not standing in the way of innovation. A closer look at the figures contradicts another part of the critics’ argument—the industry’s pipelines may not be so weak after all.

So far this year, FDA has approved 20 new molecular entities (NMEs), according to The Wall Street Journal. That’s nearly the same number of NMEs that the agency approved throughout all of 2010. “We’re seeing a lot of innovation, much more than in recent memory,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told The Wall Street Journal. She went as far as to say that the industry had reached a “turning point” in drug development.

The change in the industry’s approach to research seems to be helping to enhance its development productivity. Many companies have shifted from an expensive, and potentially wasteful, “mass production” approach to one that relies on collaboration. Bristol-Myers Squibb’s (BMS) recently approved melanoma drug was originally discovered by a scientist at the University of California, Berkeley. The scientist worked with small biotech company Medarex to develop the drug, which eventually appeared on BMS’s radar. After BMS and Medarex formed a partnership, the rest was history. Shire also has used this collaborative strategy successfully.

Woodcock’s comments reaffirm my belief in the industry’s ability to market innovative drugs that improve patients’ lives. If the pace of NME approvals continues at its current level, it will soften the blow of the patent cliff for many companies. Maybe reports of Big Pharma’s impending death are greatly exaggerated.

Several developments in 2004, particularly concerns about Merck’s arthritis treatment Vioxx, led patients and lawmakers to question the safety of marketed drugs. FDA received a lot of public criticism for not being vigilant enough, and the agency responded by re-evaluating its practices.

“The FDA’s shift in recent years to an increasingly cautious, risk-averse posture toward new drug approvals has had the unintended consequence of reducing investment in life-sciences innovation due to the significant additional time, cost, and uncertainty it has added to the drug-development process,” said Leff in written testimony to the US House of Representatives’s Energy and Commerce Committee. Medical research “is exploding with potential,” he added, but FDA’s new caution makes it hard for investors to earn returns.

But drug-approval figures seem to undercut Leff’s argument. In testimony before the same House committee, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, cited a trend toward greater first-cycle approvals for priority new molecular entities (NMEs). The average first-cycle approval rate for priority NMEs has increased from 46% in 1992 to 68% to date, she said. First-cycle approval rates for standard NMEs have also increased from an average of 30% to 38%, according to Woodcock.

Woodcock also countered claims that FDA approves drugs more slowly than EMA. “Of the 35 cancer drugs approved by FDA or the EMA from October 2003 to December 2010, FDA approved 32—in an average time of 261 days,” she said, citing an article in Health Affairs. In contrast, “EMA approved only 26 of these products, and its average time was 373 days.”

Drugmakers’ lack of approved new drugs might have many causes. Now that the low-hanging fruit has been picked, drug discovery itself has become harder. Although FDA is a fair target for criticism, I don’t think the agency can be blamed for quashing innovation. With appropriate funding, scientific expertise, and federal help, drugmakers should be able to develop the new products that keep them and their patients healthy.

Only 40 of the more than 270 publicly traded large-molecule companies are profitable, and the rest must rely on venture capital. Companies without products on the market are having a tougher time attracting funding these days. Up-front payments have decreased about 55% in the past five years, according to Ernst & Young. Money is increasingly contingent on achieving drug-development goals. This strategy might help investors get returns more easily, but it could discourage the kind of risk-taking research that produces real innovation. Indeed, it’s becoming less important for companies to have scientific expertise and more important for them to have “market awareness,” Glen Giovannetti of Ernst & Young’s global biotech unit told Bloomberg.

Investors’ reluctance to fund early-stage biologics firms has hurt the latter’s research and development (R&D) budgets. Companies without products on the market had to decrease research spending by 1% in 2010, according to Ernst & Young. Small biopharmaceutical companies are thus cutting their research budgets just as many traditional pharmaceutical firms are doing. It seems to me that this continuing trend could become a vicious cycle in which small biologics companies keep spending less on research, which in turn prevents them from discovering potentially marketable products that could keep them afloat.

Biopharmaceutical companies do seem to be more innovative than traditional pharmaceutical companies. But it looks like the large-molecule playing field could shrink over time as big companies get bigger and small companies fail. This shift would mirror the evolution of the small-molecule industry. Likewise, market pressures are already making it harder for early-stage large-molecule firms to get R&D funding—and encouraging a conservative approach to research. If the biopharmaceutical innovation engine eventually runs out of gas, what will the drug industry do?

They’re likely to pursue acquisitions, thus continuing the trend of the past few years. The burgeoning biopharmaceutical industry shows potential for yet more growth, making those companies tempting targets for small-molecule manufacturers. In public, pharmaceutical executives describe modest acquisition goals, sometimes mentioning price tags of $5 billion or less.

But David Snow, chief executive of Medco Health Solutions, doesn’t take these statements at face value. Any biotechnology manufacturer—even heavyweights like Biogen Idec and Amgen—could be a takeover target, he told the Reuters Health Summit. “You have to become awfully large to be unaffordable—there’s lots of cash, lots of capital out there for acquisitions,” he said, according to Reuters. Drugmakers who are still flush might see biopharmaceutical acquisitions as a safe path through rough seas.

Not so fast. Regulatory approval for these mergers might soon become tougher to obtain. Late last week, Senator Herb Kohl (D-WI) asked the Federal Trade Commission to examine pharmaceutical-industry mergers with care, lest they exacerbate the problem of drug shortages. “[F]ewer drug companies competing in a therapeutic class may lead to fewer prescription drugs being developed and sold within that class,” said Kohl, citing a study by the Government Accountability Office.

He also quoted a Washington Post article on the same topic. A smaller pool of drugmakers means “that when raw material runs short, equipment breaks down, or government regulators crack down, the snags can quickly spiral into shortages,” said the article. Patients would certainly be in trouble if mergers slowed innovation and made drugs harder to get.

So how will drugmakers stay afloat during these turbulent times? They might well need the cunning of Odysseus.

Many drugmakers have taken their investors’ advice to heart. One salient example is Pfizer, whose CEO Ian Read plans to slash R&D budgets by about 25% over the next two years. Chris Viehbacher, CEO of Sanofi, told Reuters that R&D cost cutting would increase throughout the industry this year and next. Companies are likely to focus their discovery efforts on the most lucrative areas in an attempt to get more bang for their R&D buck.

But, profitable or not, don’t patients need new and better drugs? Where will they come from? Drugmakers may well outsource innovation by partnering with entities such as universities and contract research organizations, Tim van Biesen, head of Bain and Company’s healthcare practice, told Reuters. They’d be following Hollywood’s strategy of sourcing “movies and scripts from all over the place,” he said. Shire already seems to have started along this path.

Big Pharma also might take advantage of its scientific expertise and marketing muscle by creating follow-on biologics. Cheaper versions of biopharmaceutical treatments for rheumatoid arthritis and cancer are in big demand, said David Snow, CEO of Medco Health Solutions, to Reuters. Making follow-on biologics could be a way for Big Pharma to boost sales. In addition, the discount for these medicines likely will be less than that for small-molecule drugs because they’re tougher to copy—and fewer competitors will manufacture them.

While these strategies might eventually improve Big Pharma’s bottom line, they also represent a shift away from the traditional model of what a drug company is. And even if it helps the drug industry, will the emerging model serve patients’ interests?

But there are still hurdles that the industry must overcome. At its international symposium on biosimilar medicines held earlier this week in London (UK), the EGA issued a call for an EU industrial policy that will enhance the competitiveness of the region’s biosimilar medicines industry.

In a press statement about the symposium, Greg Perry, EGA Director General, explained that new, smart approaches are required to further develop and sustain the EU’s biosimilars industry. “The regulatory framework should be adapted to allow and accept global development programmes for biosimilars in order to ensure the availability and affordability of this important category of medicines”.

According to the EGA, it is also important to promote the EU’s high standards for biosimilars across the rest of the world and to boost uptake. Perry emphasised: “We need incentives for the demand-side, a consistent rational approach towards interchangeability, acceptance of different cost-price structures than for generic medicines, and an increase of awareness and information aimed at reinforcing the confidence of patients and healthcare professionals in these high quality biopharmaceuticals.”

Definitely, says the Hay Group, a management-consulting firm. Big Pharma’s executive-compensation plans reward compliance and short-term financial gains when they should be encouraging risk-taking, according to the firm’s research. About 80% of criteria that determine incentives are financial, and only 12% relate to drug development and commercialization. Although short-term incentives are common, they’re inappropriate for the pharmaceutical industry because of its long product-development processes, according to Hay Group.

In light of Hay Group’s research, the compensation package for former Pfizer CEO Jeffrey Kindler makes no sense at all. The company was facing distinct problems when its board gave Kindler the boot in December 2010. Not only had Pfizer’s share prices languished for four years, several promising drugs had failed in late testing, including a potential replacement for Lipitor. Despite these problems, Kindler got a 60% raise over his 2009 compensation. A performance-related bonus brought his compensation to $4.9 million. Kindler seems to have been rewarded for failure, which, to my mind, is even worse than being rewarded for short-term gains.

To overcome its current challenges, Big Pharma will have to change how it defines, measures, and rewards performance, according to Hay Group’s research. Fortunately, Big Pharma can use mid-sized drugmakers and biopharmaceutical firms as models. These companies “have been much more creative in weaving pipeline and R&D measurements into their incentive strategies,” said Hay Group in a press release. By learning from these firms’ compensation strategies, Big Pharma might match their level of innovation.

It’s easy to blame circumstances for our failings, and harder to admit our own missteps. If it took Hay Group’s recommendations seriously, Big Pharma might reclaim its reputation for innovation. And achieving this goal naturally would be good for the world’s patients as well as for industry.