BIO Bits

I am abbreviating this week’s post since I’ve been busy attending BIO’s International Convention.  This annual confab is held in Boston every third year and last fall I was fortunate to have my proposal for a panel session on “Accelerating Access to Pubic Sector Markets” accepted by the program reviewers.  Also fortunately, I was able to garner the participation of a crackerjack panel (Una Ryan, CEO, Diagnostics for All; Inder Singh, former Executive Vice President, Clinton Health Access Initiative and now CEO Transform Health; Eric Olson, Cystic Fibrosis Franchise Lead, Vertex; Michael Watson, VP Vaccination Policy and Advocacy, Sanofi Pasteur; Ellen Strahlman, Senior VP and Global Head, Neglected Tropical Diseases, GlaxoSmithKline) that provided expert and useful insight to the Monday session attendees, who numbered about 15.  So as a substitute for my usual rambling, here is a selection of interesting bits I gleaned from the biofest, starting with my panel.

Accelerating Access:  during the Q and A, Don Joseph, CEO of BIO Ventures for Global Health, asked the panelists what is needed to get companies involved in global health product development, and the “wish list” was:

-more information on country-specific disease burdens to better gauge demand and reduce uncertainty;

-more information on disease pathologies, mechanisms, and targets;

-global harmonization of trade rules and regulation;

-government intervention to minimize middleman markups that make drugs expensive; and

-SBIR set asides for global health product companies.

A Practical Guide to Global Health:  while PDPs are doing a good job of getting product candidates into human testing, they expect a “hand off” to big pharma but are doing little if anything to make it happen, resulting in a “last mile” problem, that is, products may not reach patients.  My naïve idea is that they need to do more business development before and during trials to identify partners.

Palm PCR:  of course everyone knows that PCR (polymerase chain reaction) technology is used to increase the number of copies of a DNA molecule in the first step in reading its sequence of bases and therefore making it possible to tell if a DNA sample is from a pollywog or a psychotic killer.  I knew PCR machines were getting smaller but my jaw dropped when I saw the Palm PCR at the exhibit hall booth of Ahram Biosystems of Korea which, as names implies, is a hand-held DNA amplifier (Palm PCR).  It is fast (30 minutes for 1000 bases), reasonably priced at $3000 to $6000, and come in bright colors.  Now we need a palm sequencer so that scientists in the field like epidemiologists (and CSI) can tell really fast what animal, plant, or bug they’ve sampled.

Sustainable Vaccine Business Solutions:  Sanofi is serious about vaccines for global health.  In addition to a pipeline of about 16 vaccines, half of which intended to meet developing world needs (e.g., the soon-to-launch dengue vaccine and a TB vax in collaboration with the Statens Serum Institute), the company has some type of partnership with ten or so regional manufacturers and so will be in position to make and distribute vaccines at the lowest cost.

Cancer Drug Access:  I have written about the recent shortages of mainstay cancer drugs in the US (“Drug Bust”, 9/29/11) and learned at this session that the rest-of-world (ROW) situation is much worse- shortages, poor quality, and high prices.  The sad news is that the problem is complicated by weak health care systems and the lack of government support for cancer care (e.g., the most used ROW cancer drug is morphine for palliative care).  The less sad news is that, due to the low labor costs, some patients can be treated and cured at a fraction of the US cost (e.g., $100 to cure a case of cervical cancer).  Overall, a tough problem with few advocates.

Innovative Financing for Global Heath R and D (or PRIs Revealed):  as acknowledged by one panel member, David Farnum, the PRI (program-related investment) officer of the Bill and Melinda Gates Foundation (BMGF), the financing presented was not really innovative, just new to the BMGF.  I had hoped to learn more about the BMGF’s PRI program, specifically the rationale behind the investment of $10 million in Liquidia, a company with a “nanotechnology” platform and no global health focus.  Unfortunately the concerns I wrote about in a post last year (“BMGF Ventures LLP”, 4/14/11) were confirmed.  David described the three-year-old, $400 million PRI fund as “experimental,” and it looked like an uncontrolled experiment to me.  To date investments had been made almost randomly with unspecified amounts given to start-ups like Liquidia (others were not named but David said “a couple more are in the pipeline”) and into investment funds that somehow, somewhere seem to do something in global health (specifics were lacking).  The good news is that the experiment has been judged a success and the BMGF is assigning $1 billion to PRIs; the bad news is that there is no application or submission process so it looks like the PRI group will operate like the rest of BMGF- giving big chunks of money to insiders without established investment criteria or performance expectations.  Neal Fowler, Liquidia’s CEO, gave a few details of their deal:  it started by a chance meeting, BMGF got a board observer seat (not voting like the rest of the company’s investors), and the BMGF has been a great partner, which I took to mean undemanding of progress on global health products.  Neal mentioned the company is working on applying their technology to a pneumo vaccine, but did not give any details.  The company website refers to completion of a Phase 1/2a trial (Liquidia Vaccines) but not to published results.

Top O’ the Hub with Samsung Biologics:  the company held a nice reception at this landmark restaurant which, at 50 stories up in the Pru building, has great views of Boston and surrounds.  I enjoyed the food and drink and a conversation with one of their BD people who declined to confirm a plan I had suggested in a recent post, to sell very low cost biological drugs to the developing world (“Discount Drugs”, 5/24/12).  My suggestion to acquire new and possibly cost-saving technologies from academics was better accepted, and I wished them well in becoming the Wal-Mart of biosimilars.

Another half day at BIO today (Thursday) and if I hear any earth-shaking news, I’ll write about it.

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