Karen King, President of DSM Biologics, discussed the implications of the company's recent joint venture with Crucell, which has increased upstream productivity. The technology, PER.C, has reportedly boosted fermentation yields in human cells to over 27 grams/L compared with 15 g/L a few months ago. Higher yields will enable smaller, more flexible and less expensive production.(For more on this collaboration, click here). For a brief audio clip of the interview click here. A native of Illinois, Ms. King seemed a bit wistful about leaving Evanston, but says she is getting used to and enjoying life in New Jersey.

DSM Biologics' next focus, she says, will be on bioseparations, which, within the industry, has not always kept pace with upstream.

Green chemistry and PAT remain cornerstones of the company's culture, she and colleagues noted. Meanwhile, news of the winner of DSM's 2008 innovation award came yesterday: Andreas Walther, at the University of Bayreuth, who has developed new polymer materials based on "Janus" particles, whose two surfaces can interact differently, and specifically with diverse materials. The materials show promise for sensor development and new drug delivery systems.

For more, read on.

AMS

One session on Wednesday morning addressed the use of molecular modeling in drug development. Ian Wilson, Portfolio and Strategy Manager, GE Healthcare discussed the development of PET clinical biomarkers. He mentioned the need to collaborate early, and the fact that academic partners can be great partners.  One important question to ask, he notes, is whether or not you need preclinical capabilities.

He then went on to  discuss GE Global’s clinical imaging network, an expertise hub for image acquisition and analysis designed to help speed drug development.  Merck, University of Manchester’s Wolfson Molecular Imaging Center and University of Texas MD Anderson’s Cancer Center are all actively involved in imaging research. (For some clinical case studies, click here).

Anderson and GE are developing the center with the goal of being able to take compound development, perform pathology, tissue and biomarker analysis, so that sites can be identified that have high or low levels of expression of a given target that is linked to progression of specific cancer…

Also important were: Imaging platform development, operational rigor, and manufacturing platforms such as PET and SPECT.

A major dilemma for industry right now is lack of resources, Wilson said.  Companies are focusing so heavily on drug development that many ask, should these efforts be diluted by dedicating resources to imaging?

AMS

Spoke briefly with one, Michael Kowolenko, SVP of biopharmaceutical manufacturing at Wyeth, who talked about the industry’s fear of change, why it exists and offered some suggestions on what to do about it. Below are some (raw) audio snippets of the interview.

An Interview with Michael Kowolenko of Wyeth Biopharma, Part One

An Interview with Michael Kowolenko of Wyeth Biopharma, Part Two

AMS

Missed Madame Piramal’s presentation, unfortunately, while running back and forth between segments of the building and the show floor. The message behind speakers at the session on Indian Biotech was clear: don’t think “low cost,” think innovation.

BMS alumnus Rashmi Barbhaiya used the Nano, India’s new model car, as a metaphor. He and Ramesh Adige, director of communications at Ranbaxy, offered a glimpse of the Indian biotech landscape. For YouTube-quality video, taken by yours truly:

Rashmi Barbhaiya, CEO, Advinus Therapeutics on Biotech in India

Ramesh Adige, Ranbaxy Labs, on India's Biotech Efforts

AMS

Caution. People Crossing.. (San Diego’s only about 40 miles away from the Mexican border. BTW, these are highways that nobody should ever attempt crossing)

Best radio station  by far– Channel 28 from Baja California, Mexico.

AMS

At a session on Wednesday afternoon, Richard Friedman of CDER discussed FDA and foreign inspections of manufacturing sites, and mentioned proposed solutions that would harmonize requirements and lighten the load, while maintaining standards.  They include a global system of surveillance and mutual inspectorate acceptance.  In this plan, FDA and EU inspectors who had inspected certain facilities would share reports with inspectors from nations in the rest of the world, in lieu of onsite inspections.  It would involve expanded use of certificates of pharma products and use of risk-based models outlined in ICH Q9.  Triggers would include facility size, recent history…outdated information, time since last inspection, product risk (e.g. sterile products would require more requent inspections) and process risk (i.e. contamination).

The EU and FDA have launched a pilot program for joint inspection of plants, to start by the end of this year, early next year.

We’ve been following FDA’s Pharmaceutical Inspectorate for some time…was surprised to see that the Agency still hasn’t been formally accepted into PIC/S.  Come on, now!  It has been under discussion for two years now.   Wonder what this means? 

AMS

Unfortunately, missed meatier case studies, only to hear motherhood and apple pie presentations about what contract manufacturers need to offer their customers, although Dr. Wiltrud Treffenfeldt, Director of Bioprocess Development, Dow AgroSciences LLC mentioned some innovative German CMOs, including Greenovation and Rentschler as well as Richter-Helen Biologics. Dr. Uwe Marx of ProBioGen AG discussed the fact that the quality of German clinical contract manufacturing more than made up for the higher costs of doing business with a Europen partner. Our esteemed competitor, PharmaOnline ran the following article.

AMS

On Tuesday afternoon, a panel discussed ways in which corporations might be able to stimulate the development of more therapies for serious diseases----the world’s top killers such as malaria. The topic is one that I’m very interested, but, unfortunately, I arrived late and missed much of the discussion.

Genzyme has been doing some pioneering work with orphan drugs and its Gaucher’s disease treatment, Cerezyme, has been profitable.

James Geraghty, SVP of International Development with Genzyme presumably discussed the company’s Humanitarian Assistance for Neglected Diseases Initiative, and efforts such as the one underway with the Oswaldo Cruz Foundation in Brazil.

Una Ryan, President and CEO of Avant Immunotherapeutics, Ltd., also participated in the discussion. Her company has been developing drugs for neglected diseases, including cholera and typhoid, as well as an HIV vaccine, in efforts funded by the Gates Foundation.

Elizabeth Bailey of Commons Capital works with venture capitalists to obtain funding for early stage drug development.  Currently, Commons is working with Gates, Rockefeller and  Lloyd's Foundations.to fund research into therapies for neglected diseases.  At the conference she discussed financing models(some of which were touched on in a 2005 paper, which came out of a workshop on this subject). Financing is most feasible in early stages, she said.

Dr. Ryan  agreed, and emphasized the importance of venture capital in funding these efforts. Big pharma or Big Bio is too locked into production schedules and unlikely to recoup investments, so, despite its worthiness, it’s a hard sell to management. Profitability is critical.

Vaccines are excellent candidates for attracting venture capital for global development, Dr. Ryan said. During the Q&A, someone in the audience spoke of the need to develop an infrastructure that would permit scientists in developing nations to develop innovator products, rather than “copy cat” products. Presumably, they won’t face the 10-year, billion-dollar hurdle that innovators face here.

AMS

Scheduled meetings kept me from the events I’d most wanted to attend:

• the live versions of Schwarzenegger’s and Craig Venter’s keynotes (I made it to the tail end of the “overflow” line, where we were treated to lunch and the keynotes on video)

• a meeting of former FDA commissioners, “A Blueprint for FDA” in which Dr’s Kessler, McClelland and others discussed the Agency’s challenges and the issues it faces.

Dr. Venter has always fascinated me, since he was apparently a “late bloomer” in science and, some report, almost dropped out of high school (joining another mover and shaker of the biopharm world, Bill Gates, whose foundation is bringing cures within the reach of more people throughout the world).

There are precious few late bloomers to be found among today’s scientific elite, as evidenced by the winner of the BioGENEius high school science competition.

And no traces of the surfer dude could be detected in Dr. Venter’s serious and low key presentation (at one point, he had to point out a joke that the audience had missed). Among the highlights was a discussion, toward the end, on why biotech research is so essential (growing population, pollution) as well as an overview the Venter Institute’s recent pioneering work in synthetic genomics.

Dr. Venter’s presentation was presumably the piece de resistance, but the Governor was late, so he “opened” the session.

Whether or not you agree with his politics, Governor Schwarzenegger has become a consummate public speaker. Although his public approval rating in the state has, by some accounts, slipped to around 20%, he was a natural leader at the podium.

He opened the speech with a gentle joke about political differences between himself and his wife, flattered the scientists in the audience, and also spoke compassionately about the importance of biotech research to developing cures for Alzheimer’s disease, referring touchingly to his father-in-law’s condition, something that many families can relate to.

He also highlighted the fact that his administration has done more to advace cutting-edge medical research than some nations. With Proposition 71 four years ago, California devoted $3 billion to fund stem cell research taking on a controversial cause that Washington has preferred not to deal with.

….When Arnold later moved to the California booth on the show floor, a mob scene ensued.

AMS

OK, this is not coming at the speed of the Internet. Not even close, as BIO 2008 winds down today. But blame an interesting program spread out on a grand scale. Roller skates or a Segway were a must for anyone attempting to navigate BIO 2008 at the San Diego Convention Center this week.

This was my second BIO show (my first was in Chicago two years ago). While some may criticize the lavishness and spectacle of the conference, there are few events where one can interact so directly with top scientists, officials and professionals within the industry. All you have to do is to ask a question, during Q&As or after their presentations. I saw young professionals ask experts for advice on specific problems they were facing. And they weren’t rebuffed, either.

San Diego is a beautiful town, in that part of California where “beach” means warmth, sand and sun, not rocks, goose bumps and a wet suit. It is also quite cosmopolitan, with a single short stretch of 4th Avenue, in the city’s historic gaslamp quarter, offering Indian, Chinese, Persian, Japanese, French, Italian, Spanish and Arab cuisine.

It may be in an `80’s time warp, with notices of concerts by Billy Idol and others of that era----and a hit musical review, “Boomers.” (It might even have been a bit worse in L.A., where posters of a well-preserved Engelbert Humperdinck were in evidence along the freeway) Coincidentally, Artefill was among the products exhibited at BIO this year. Designed as a companion to Botox, to fill in laugh lines around the cheek, it’s made of polymethylmethacrylate, so the connection to the biotech world seemed somewhat tenuous---alas, no samples

The impact of an aging U.S. population was on the short list of leading topics this year, and the program emphasized the usual subject areas, including intellectual property protection, translational medicine but also some important accents: funding universal access to life-saving medicines and the ascendancy of new drug development powerhouses in Asia, particularly in India.

Thailand: Don’t Patronize Us, Please
On Tuesday morning, one discussion on how corporate biopharma might improve global access to biotech products reportedly brought an angry reaction from a representative of Thailand in the audience, who bristled at any suggestion, however, subtle, that future breakthroughs would necessarily come from the West.

The show dailies and even brochures were more snappily written this year (perhaps reflecting the influence of The Scientist, which wrote the show daily?), although there were a few cliches (shareholder salsa and Indian spice) and curve balls in conference titles “It’s life but not not as we know it, Jim” (on chimeric embryos), for instance, or “what the vector is happening here”…(gene therapy) or my favorite, .the enigmatic “evolving attitudes to obviousness” (about IP). Hmmm. Always easier to edit other people’s work, isn’t it?

The show floor brought the usual lavish booths, competing regional governors (“anything they can do we can do better”), the dueling music from different regional development authorities, there were the usual tschotchkes, freebies (basketballs, for example, from Kansas, whose team won the NCAA championships) and bizarre booth shows, like the puppeteer with the ostrich.

Winning the prize for practicality this year was the foot massage. There were also the spectacular cruises, receptions and parties, including one on the U.S.S. Midway. Oh, yes, and the celebrities, among them Harrison Ford, who, along with E.O. Wilson, took part in an event on Wednesday night publicizing the Invitrogen Foundation’s first grants.

But undoubtedly the main attractions this year (even trumping Colin Powell) were keynote speakers California governor Arnold Schwarzenegger and Craig Venter, whose work has made modern biotech possible.

People began lining up two hours before the luncheon keynote (no preferential treatment for the press this year)

AMS