sdbn.org

Biotechnology, Drug Discovery, Headline, SDBN Blog, SDBN Events »

September 28th Event Sponsored by Halozyme Therapeutics
Posted by Mary Canady September 6th, 2010 .
No Comments

We’re going to try something new for the San Diego Biotechnology Network in September. The folks at Halozyme have offered to start hosting events quarterly at their site in Sorrento Valley, and we’ll kick of the first event learning about their exciting science September 28th. They focus on therapeutics that work subcutaneously by targeting the extracellular matrix (the image is from a mural in their lobby) and have had lots of great news lately, so it will be nice to hear more. As always we’ll have plenty of time for networking in a casual atmosphere, and we’ll provide a light dinner. Hope to see you there!

Sponsored by:

Event Details

Who: Biotechnology professionals in the greater San Diego area
What: San Diego Biotechnology August Event Hosted by Halozyme
When: Tuesday, September 28th, 5:30-9:00 p.m.
Where: Halozyme Therapeutics, 11388 Sorrento Valley Road, San Diego, CA 92121 (Map)
Cost: $20/$15 Academic
Contact: http://sdbn.org/contact
For more information about the event: http://sdbn.org/september

Biotechnology, Conferences, Featured, SDBN Blog »

What’s BiotechCamp? A New Way to Share Ideas Is Coming!
Posted by Mary Canady July 11th, 2010 .
No Comments

Mary Canady BarcampSD 7 ‘Crowdsourcing Cat Herding’ from Mary Canady on Vimeo.

I presented at a local ‘unconference’ called Barcamp recently in San Diego. The event is great because it is unscripted and interdisciplinary, and we’d like to extend the model to biotech and life science, with the goal of having a ‘BiotechCamp’ in San Diego soon. Check out the presentation, and if you have any ideas, please feel free to add them to the wiki we’ve set up at http://biotechcamp.org. We have a team of about ten now who will be planning this event. As always, tell us what you think and stay tuned!

Biotechnology, Channels, Conferences, Drug Development, Featured, SDBN Blog »

Flip This Asset: San Diego’s Advanced BioHealing ‘Fixed Up’ Dermagraft for Profit and Growth #BIO2010
Posted by Mary Canady May 5th, 2010 .
No Comments

Wednesday I attended a regenerative medicine-focused breakfast at the BIO convention and learned about San Diego company Advanced BioHealing (ABH), who took a ‘fallen’ asset, Dermagraft, and not only turned it into an $85M/year product, but is also looking for new indications. Dermagraft was sold by Advanced Tissue Sciences, who had invested hundreds of millions into developing it, and even got FDA approval for the product to treat diabetic foot ulcers.
I spoke with Advanced BioHealing’s Senior VP Dean Tozer, and he describes their methodology as ‘reverse biotech,’ meaning that they first focused on commercializing products, and just recently hired their CSO Charles Hart. Hart will be spearheading the efforts to find soft tissue indications for Dermagraft. This is counter to how most biotechs in San Diego form, and it appears to be working for ABH as they are predicting 30-50% growth over the next few years.
This growth translates to jobs in San Diego, with 15 listed on the ABH careers page currently. ABH has locations in Westport, Connecticut and Nashville, Tennessee as well, and plans to continue manufacturing products in their 70,000 square foot La Jolla site near the Burnham Institute, and has recently acquired 20,000 square feet of office space nearby in an old Pfizer site. I asked Tozer whether the jobs will continue to be created in San Diego, and he said yes, because the talent pool here is so valuable to them.
What can other San Diego biotechs learn from this example? At BIO this year, I have seen successful repurposing of assets and information. It may simply be the product of a down economy, but I wonder what we can learn, and what could be gained by investigating failed assets that exist from local companies who have not survived? Tozer also believes strongly that the right people make the difference, and they were lucky to bring together a team which understands biotech commercialization. Surely, attracting or training more commercially focused professionals in the area would be a great start.

Biotechnology, Conferences, Drug Development, Featured, SDBN Blog »

How Does Biomarker Stratification Affect Drug Development Cost? It Depends. #BIO2010
Posted by Mary Canady May 5th, 2010 .
No Comments

On the San Diego Biotechnology Network LinkedIn group, we asked you what you wanted to hear about from the BIO Convention in Chicago, and you requested to hear about Biomarkers. Tuesday I attended a breakout session titled ‘Impact of Biomarkers on Drug Development Complexity and Cost,’ and it described a study done by panel members Federico Goodsaid of the FDA, Michael Palmer of Adaptive Pharmacogenomics, Mark Trusheim of MIT, Steven Averbuch of BMS, Theresa Long of the Van Andel Institute. The study modeled different scenarios utilizing biomarker information and the financial impact on estimated net present value (eNPV) of developed drugs. The group was truly interdisciplinary, and it was clear from the quality of the presentations that they likely worked well together due to their communication skills.
The session described a workshop held in October of 2009 in which case studies on oncology and alzheimers were discussed (featured in Nature Reviews Drug Discovery as well–requires login).
MIT economist Mark Trusheim began by describing the ‘pharmaeconomics’ of choosing patient populations for clinical trials. There are obvious benefits to using biomarkers to enrich populations, but there are many factors which need to be considered, and ultimately it depends on the science behind the drug and the market. The group determined three factors to be the most important: variability in the therapeutic effectiveness of the drug, prevalence of the biomarker, and the quality of companion diagnostics. Trusheim also described modeling different long term scenarios ranging from Phase II extending through to the end of market exclusivity, from the perfect ‘Nirvana’ situation, where everything goes perfectly, to ‘pharmageddon’ where it goes bad at every turn. Trusheim indicated that in both the oncology and Alzheimer’s study, a very significant increase in eNPV could be achieved by utilizing biomarker information.
Steven Averbuch, VP of Oncology at BMS, covered the study results for Herceptin and Vectibix for oncology indications. In the case of Herceptin, it had a large effect on a small population, saving money and adding to the eNPV by allowing a smaller clinical trial, but perhaps precluding the discovery of other biomarkers or indications for the drug, as was found to be important for drugs such as Gleevec. Vectibix had a large effect on a large population, obviating the need for biomarker stratification but giving the drug a higher eNPV because of a larger market size. Averbuch reiterated Trusheim’s three important factors, and the need for increased communication between all the stakeholders to utilize biomarker information to help move from the ‘pharmageddon’ to nirvana drug development situation.
Theresa Long, presented the study on the Alzheimer’s drug Bapineuzumab, and the effect of biomarker stratification on a chronic condition. They used the ApoE4 biomarker and started with data past Phase 2. Three different scenarios were modeled, from an all-inclusive to stratified, with an 80% increase in eNPV in the biomarker study. Long stressed the importance of knowing the prevalence of the biomarker in the population, even for chronic conditions such as Alzheimer’s which has blockbuster potential.
This session was inspiring as it showed how science can drive drug development and how biomarker stratification could lead pharma and healthcare towards a path of increased communication resulting in lower costs. The study has been submitted for publication and the modeling tools that were used will be available. Federico Goodsaid indicated that the tool could be made available to those who contact him.

Biotechnology, Channels, Conferences, Featured, SDBN Blog »

Translational Research Forum at #BIO2010: Learning From the Land of Lincoln
Posted by Mary Canady May 4th, 2010 .
No Comments

I attended the translational research forum Monday morning at the BIO 2010 convention in Chicago. The morning started with Congressman Dan Lipinski from Illinois, who was a great choice as he is a member of the House Committee for Science and Technology, as well as the House Committee on Small Business. He is sponsoring the NSF Reauthorization Bill, which will increase the NSF budget to $20B by 2015 and include funding for higher risk/reward projects. The bill will also have provisions for research infrastructure and education. This bill is slated to be brought to the House in the Memorial Day work period, and its passage will of course be beneficial to academic researchers, key to translational research efforts.
Congressman Lipinski also discussed the status of SBIR/STTR reauthorization, which is currently in limbo as there are House and Senate bills which must be reconciled. I did not realize that these programs are currently in a temporary extension and thus vulnerable to be no longer available for small businesses. One of the issues plaguing the reauthorization is the disagreement about whether venture capital (VC) funded companies should be eligible. Lipinski was vague as to the future of this bill, but assured us that these business grants are a high priority, especially since they will help to create jobs in this down economy.
The forum continued with a panel themed ‘From Science to Invention’ containing mostly academic panelists from Illinois, with a representative from Pfizer St. Louis (on the Missouri-Illinois border). Ted Mazzone of University of Illinois Chicago explained the organization of their CTSA (Clinical and Translational Science Awards) center, which has sophisticated infrastructure to support collaboration and commercialization across a ‘mini consortium’ that exists within the CTSAs in Illinois. Stephen Kent from the University of Chicago talked about his experience with translational research from early challenges in vaccine research to studies of the decreasing chiralty of drugs and its affects on NCE approvals. David McCormick from the IIT Research Institute talked about the importance of bioinformatics and stratification of patients.
Dean Welsch, Research Fellow at Pfizer, described his work in the Indications Discovery Unit, where drugs are being repurposed to treat new indications. Efforts to streamline internal information around compounds has been key to making these efforts successful. Pfizer is also looking externally, including a pharma portal within the CTSA to exchange materials or information. He also described how they find new partners and technologies, including utilization of resources such as this web-based network of research centers for Idiopathic Pulmonary Fibrosis. Pfizer also creating a model which they hope will also be adopted more universally called Foci of Expertise, in which CTSA experts can be found and connect. In Welsch’s three years using these methodologies, their modestly sized group has moved 5 compounds into the clinic, which is impressive. Welsch also hinted that a ‘creative’ collaboration between Pfizer and Washington University in St. Louis will be announced soon.
The panel discussed the future of translational research as well. Access to biobanking information, software and informatics challenges, and the traversing the ‘valley of death’ appeared to be the common thread among the discussions. The question that kept nagging me revolves around which entity is ultimately responsible for funding translational research, if any. Government initiatives such as CTSA and NIH Roadmap are certainly important, but are they enough to stimulate the level of collaboration needed? I was encouraged by the level of creativity demonstrated by Pfizer, and I’m guessing this has been driven by the need to economize. Hopefully, lessons that are learned will be applicable more generally. Interesting that I had never heard of a CTSA until today–they seem to be more prevalent in the midwest/east coast, but the Scripps Translational Science Institute is a CTSA. How could we apply these lessons in translational research collaboration in Illinois/Missouri to San Diego biotech?