May 2009

BIO 2009 - Gene Bridges

We spoke with Tim Zeppenfeld, a molecular biologist at Gene Bridges, about the latest advances in cloning technologies.

Posted by Kristina Ebenius on May 21, 2009 at 5:39 PM
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BIO 2009 - Robert Caughlin, Mass Biotech Council

I caught up with Robert Caughlin, president and CEO of the Massachusetts Biotechnology Council, who discussed the benefits for biotech companies doing business in the Bay State.

Posted by Lauren Arnold on at 4:07 PM
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The Big Bang

BIO started off with a bang on Wednesday with a Town Hall Forum featuring Massachusetts Governor Deval Patrick, Massachusetts Life Sciences Center President & CEO Dr. Susan Windham-Bannister and other state leaders who discussed how the Massachusetts Life Sciences Supercluster is growing as a result of the state’s $1 billion investment. They discussed how state, federal and private funding is being integrated to push forward new and established companies and researchers in today’s economy.
 

Posted by Lauren Arnold on at 6:55 AM
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BIO 2009 - Bjarte Reve

We spoke with Bjarte Reve, CEO of Oslo Cancer Cluster. The Norwegian cluster is a collaboration between pharma, biotech, research institutions and hospitals, patient groups and other organizations committed to making a difference for cancer patients.

Check out what Bjarte had to say about their initiative.

Posted by Kristina Ebenius on May 20, 2009 at 12:33 PM
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Schwartz Team at BIO 2009

Lauren Arnold, Joe Pacheco, Jim Weinrebe, Jayme Maniatis and Kristina Ebenius at the Biotechnology Industry Association (BIO) annual conference in Atlanta. Welcome to booth 4715!

Posted by Jim Weinrebe on May 19, 2009 at 11:55 PM
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BIO 2009: Despite Bleak Economy, Optimism Still Flows

Attendance is down at this year’s international BIO conference and many of the clinical stage attendees are in a frantic race against their respective burn rates, but this event once again distinguishes itself as a forum where many of the industry’s best and brightest convene to be passionate about their science and its life changing potential, despite the formidable odds faced by so many. And while Big Pharma stalks the aisles and presentations looking for the next hidden gem that will restore luster to their aging portfolios, it is, once again, the little guys who really shine as the sources of innovation.

What has changed are the business models and pipeline strategies. They are far more practical in outlook and expectations than ever before. Projects of real scientific merit but commercially less within reach are being shelved in favor of more focused business strategies. With sharper focus on fewer projects, but ones with nearer term potential, these companies are operating with far more operating savvy that will help them weather the storm.

Big Pharma would be wise not to approach this as a buyer’s market. Even a biotech on the brink of running out of cash may have the cure that ails their portfolio. This is a more sober, more realistic partner match making environment where it is advisable to tread carefully.

Posted by Jim Weinrebe on at 11:30 PM
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Stuffy nose, be gone! New pharmacy market in Sweden

Suffering from a cold, with a severely stuffed nose and light fever, I stumbled into a grocery store in my native country, Sweden. I was baffled to find that nose sprays and pain/fever relievers were not sold in the store. I actually had to go to a government owned pharmacy to purchase my remedy even though these were clearly OTC products.

This was in the early 2000s, and I had been living in the U.S. since 1995 and, apparently, forgotten about the Swedish pharmacy system faster than I could say “gesundheit”.

Sweden is according to a United Nations ranking of 154 nations, the most advanced nation in Information and Communication Technology (ICT). We pride ourselves for being extremely savvy on the tech side. Even though we’re known as a nation of early adaptors, we have clearly fallen behind in other areas.

But this is all in the past, today we’re facing a whole new reality. From July 1, 2009, there will be both government and private pharmacies in Sweden. They expect the deregulation of the Swedish pharmacy system to lead to more pharmacies, better opening hours as well as lower prices on pharmaceuticals due to price pressure. Go figure what some healthy competition can do!

However, many of us Swedes like our pharmacy system – at least the part of it with really competent staff. We feel safe in our pharmacy and feel comforted by the familiar look and feel. On the other hand, we do look forward to go to the corner store when the cold hits a late evening to pick up some OTC products (imagine the thrill of not having to wait for office hours). From November 1 this year, OTC products like allergy/cold medicine and pain relievers will be available for sale outside of pharmacies for the first time.

We will be following the developments on the Swedish pharmacy market with great interest. To be continued!

Posted by Kristina Ebenius on May 14, 2009 at 3:19 PM
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Biotech Entrepreneurs Must Be Heard in Biosimilars/FDA Regulatory Pathway Debate

Have we at last reached the point where U.S. lawmakers finally establish an FDA regulatory pathway for follow-on biologics?  The Zeitgeist says it is so.  You can feel it, see it, hear it and know it. There is just way too much hurting in this economy and far too much of a mandate for healthcare reform for political gridlock or inertia to win out.

And now, as they say, the Devil is in the Details, because we have a plethora of competing bills to debate. If the stars are aligned, H.R. 1548, the Pathway for Biosimilars Act and a forward-thinking piece of bipartisan legislation co-authored by Representatives Anna G. Eshoo (D-CA),  Jay Inslee (D-WA) and Joe Barton (R-TX) will be the result. H.R. 1548 is a win-win-win for patients and families who desperately need more affordable access to safe and properly-manufactured life-saving biologics, for payers and employers seeking to cut costs, and for an industry whose innovation and high-wire risk-taking can’t even exist if investor incentive is squelched.

With some kind of regulatory pathway seemingly inevitable for follow-on biologics, the stakes are higher than ever to make sure that H.R. 1548 or some reasonable facsimile emerges. Industry would be wise to more prominently feature the voice of clinical stage biotechnology companies and entrepreneurs in this debate. Early evidence suggests this may not be happening enough. Too many of the press releases and op/ed’s on this issue are being churned out by the global giants, cultivating an impression that the biotechnology industry and Big Pharma are one and the same. While consolidation, M&A and licensing agreements have brought about de facto convergence, we should know by now that Big Pharma’s voice doesn’t  evoke much sympathy in the Court of Public Opinion.
 
But winning this battle isn’t just a matter of clever scripting and casting for a lobbying campaign. Entrepreneurial biotechnology companies will always be the most bountiful source of innovation in this industry. The potential for significant therapeutic advances depend on them. Big Pharma needs them for aging pipelines. It’s a daunting landscape right now for these companies. About one-third of them only have six months of operating cash left. Seed and venture capital are drying up. Investors and partners are increasingly opting out of deals and walking away from projects both early and late.  The Public Markets are a non-starter. The wrong kind of FDA regulatory pathway could make this group even more of an endangered species by discouraging early stage investment in these most highly speculative ventures. The regulatory pathway debate must be as much about preserving innovation as it is making biologics more affordable, and industry is certainly “on message” in this regard but Big Pharma just isn’t the best messenger.

If industry doesn’t want the regulatory pathway debate to succumb to the political grandstanding tactics that are always aimed at the drug industry, then it must galvanize the voices of innovators, not just big marketers. Biotech entrepreneurs have the most authentic and sympathetic voices to define what separates biotechnology from pharmaceuticals in terms of innovation, the complexities of safely replicating therapies, the cost of discovery, R&D and materials, the uncertainty of survival and why there’s a need for a Pathway that provides longer-term protection of IP for biologics in the first place. 

For their sake – for everybody’s sake – it’s time for industry to help these voices be more forcefully heard.

Schwartz will be at the International BIO Conference in Atlanta so please stop by our booth #4715 to chat if you'd like to.

Posted by Jim Weinrebe on May 5, 2009 at 4:15 PM
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Some Simple yet Sage Advice on Communicating

Yesterday’s Xconomy Forum “Tomorrow’s Biotech: Innovators and Innovations” featured a first-rate slate of speakers and case studies. If you didn’t attend, Luke Timmerman’s Xconomy post provides a nice recap.

The afternoon concluded with an engaging “fireside chat” keynote between biotech founding fathers Walter Gilbert and George Church moderated by Boston University Biomedical Engineering Professor Jim Collins. One of many issues discussed during the conversation was the pressure on early stage biotechs to quickly demonstrate proof of concept—particularly given the challenges of securing funding in today’s market.

Church made two points I thought particularly instructive to anyone managing a communications program for a biotech company.

The first is simple yet incredibly prudent advice: build and communicate value. Sounds obvious, but in today’s environment cash-strapped startups can fall into the trap of setting their sights on a short term milestone to demonstrate proof of concept for a technology that will not provide real value in the long run.

This is often where business and development strategy and intersects with communications strategy. Are you communicating something of value to your key constituents or are you generating hype merely to get the attention of potential and existing investors?

The second point that resonated with me: biotech businesses have a tremendous opportunity to educate. Whether it is clinicians or consumers, the biotech industry has a responsibility to inform people who use their products about how they work and about the diseases they treat. This will be increasingly important in the realm of personalized medicine when a growing number of diagnostics will be targeted directly to the consumer. (Church practices what he preaches--check out the Personal Genome Project he's leading to help make personal genome sequencing more affordable, accessible and useful).

Often an effective communications program has nothing to do with promoting a product, a company or a technology and everything to do with conditioning or educating the market.

Posted by Chris Stamm on May 1, 2009 at 4:56 PM
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