See Change

The 15,000-plus presenters, exhibitors, politicos, scientists, execs, salespeople, and hangers-on who attended last week’s Bio Industry Organization’s (BIO) 2012 International Convention here in Boston have all returned to their regular jobs and I am back to scribbling this week’s post at the last minute.  The BIO convention (as is the nature of conventions) is all about selling products, making the connections that will lead to sales, and learning where the next sales may be made, so most BIO 2012 attendees were focused on the serving the health needs of those with high incomes, but this year I noted some change in the sea of selling.  By my casual survey of session descriptions and attendance and conversations with attendees and exhibitors, more interest was shown in opportunities outside the major markets than in the half-dozen conventions I have attended before.  Moreover, I noted investment analysts, execs, venture capitalists, reporters, and scientists (who invent and make products), not only non-profit types, participating the out-of-the-main-channel sessions.

Here’s a recap of the sessions I noted, seven of which I was able to attend:

  • Driving Innovation in Global Health:  Why Biotechnology is Key-  I did not attend this press briefing by BIO Ventures for Global Health (BVGH), the advocacy organization partly backed by BIO itself, at which the group brought attention to its finding that 40% of small-medium biotech companies are conducting some type of global health product development (I reviewed this report in my post, “BD Needy”).  I hope they got good attendance.
  • A Practical Guide to Global Health:  Shared Experiences from Biotech Companies on Making Global Health Work for You-  I commented on this session, also organized by BVGH, in last week’s post and add that the “shared experiences” were fine but a “practical guide” it was not (but I hope one is in the works).
  • Global Biotechnology Forum:  The BRICS and Beyond-  another session I missed but its theme was how governments in emerging market countries are supporting biotech companies (including funding) to address pressing health needs, and attendance list was more than 50 persons.
  • Exploring Innovative Models for Investment in Global Health:  A Discussion about Unique Partnerships in Working Towards Solutions for Global Health-  I’m sorry I missed this session since it explored “the various models available for engagement with these funding groups [venture capitalists, governments, non-governmental organizations, and companies] in the development of vaccines, therapeutics, and diagnostics and how companies are working across these funders to develop new models for investment in global health.”  About 50 people had signaled an interest in attending.
  • Vaccines Beyond 2012:  Sustainable Business Solutions to Accelerate Global Access- as I noted in my comments in last week’s post (“BIO Bits”), Sanofi’s commitment to global health and pediatric vaccines was evident at this session which had about 40 attendees including those from major (e.g., Merck) and biotech companies (e.g., Novadigm).
  • Increasing Cancer Drug Availability in Resource-Limited Settings:  Models for the Future-   as I noted last week, the situation is dire and requires innovation in funding and distribution, not so much new drugs (which compose the major of drugs being developed by the US pharma/biotech industry).
  • Leveraging New Development Paradigms to Address Infectious Diseases in the 21st Century-  this session (another I missed) addressed the need for new vaccines that can be made quickly (and cheaply) against agents with multiple variants.
  • Traditional Manufacturers Beware: How Disposable Technology is Changing the Biomanufacturing World-  this session spoke to the shift of the biomanufacturing industry (makers of vaccines and biological drugs) away from large volume, high capital factories to small volume, regional, and flexible (able to make many products) plants.  As I have written in several earlier posts (e.g., “More Grease on the COGs”), this trend is important in lowering the cost of products as well as addressing the public health needs of developing countries.  In a side conversation with a rep from Xcellerex, a disposable technology company recently purchased by GE Health, I learned their sales team has made and is making sales calls all over the world.
  • Innovative Approaches to Financing R&D for Global Health-  as noted last week, I had hoped to learn more about the Gates Foundation’s program-related investment program, now funded to more than $1 billion (to used for all the Foundation’s interests including global health), but was disappointed.  The program could be structured like an investment firm, doing due diligence, making significant inputs, gaining board seats, and in general being more proactive in starting up global health companies.  Perhaps the other 30 or so attendees learned more than I.
  • Biologics and Biosimilars in Latin America:  Are New Regulations and Guidelines in Brazil, Mexico and Argentina a New Model for Drug Regulation?:  biosimilars is a hot button issue for the industry since the established players want to limit competition (e.g., Amgen has a Director of Brand Protection) and the emerging biotech industry wants a piece of the action (and governments want cheaper drugs).  I assume (wasn’t there) the new regulatory policies spell out what level of proof is needed for establishing “similarity,” likely including some number of trials and manufacturing process approval, but not as high a barrier as that recently set by the USFDA.
  • Emerging Markets Become Strategic Markets:  Biotechs Looking Internationally for R&D, Manufacturing, and Market Opportunities-  another session I missed and based on my review of the almost 100 prospective attendees, there was a lot of interest among reps from companies in the mid-income emerging market countries like Russia and Brazil as well as US and EU companies looking to sell into these markets.
  • Building the Global Pathway for Product Safety and Quality Manufacturing of Biologics and Drugs- I attended this session because of the importance to companies that want to sell products outside their home country.  The session turned out to be quite technical but I came away with an appreciation of the complexity of the global supply chain for drug manufacture (80% of the drug ingredients for US drugs come from outside the US) and the need for better and more universal standards and inspections.  FDA, multinational pharma companies, and a logistics trade group (Bio Supply Management Alliance) are working on this but have a long way to go.
  • Thinking Outside the Box:  A New IP-Sharing Model Brings Biopharma, Government Agencies, and Non-Profits Together to Accelerate R&D Collaborations for Neglected Tropical Diseases-   the new sharing model was the BVGH-managed Re:Search database and partnering “hub” on which I have written previously (“Window Dressing”).  I garnered some new information on Re:Search, e.g., no announced partnerships have yet resulted but 15 are in discussion.  I also learned that a relatively new product development program (PDP), the Center for World Health and Medicine at St. Louis University, was making progress in new therapies for neglected diseases (and rare diseases) but is approaching a funding crunch.

Do fourteen sessions (including mine) on neglected diseases, emerging and public markets, and low-margin products out of 125 offered at BIO 2012 and several hundred attendees out of 15,000 indicate a sea change in the biotech/pharma industry?  No.  But the trend is in the right direction.

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