Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology & Hematology

Posts tagged ‘Biotechnology Innovation’

Today is the first “Innovation Day” at Children’s Hospital Boston. For those, like me, who can’t be in Boston for it, you can follow on Twitter using the hashtag #iday or watch online via live streaming.

Children's Hospital Boston Innovation Acceleration ProgramI’m impressed that the hospital has an Innovation Acceleration Program focused on supporting “clinical care that impacts patients around the world.

I think this event is a really great way to showcase some of the interesting research and collaboration that is taking place in the hospital in the field of device development, healthcare IT and process innovation.

The program starts at 1.00pm EST. On the Agenda are a few talks that caught my imagination:

Does my baby have a “flat head”? Using the web and digital photos to triage visits to the doctor’s office,  Joseph R. Madsen, MD

Pediatric Vision Scanner: A handheld device that diagnoses vision problems in preschoolers,  David Hunter, MD, PhD

New directions in drug delivery: A contact lens that dispenses medication, Dan Kohane, MD, PhD

The Children’s Hospital Boston science and innovation blog (Vector), which is well worth reading, also has a preview of their Innovation Day.

Given the ease and low cost with which events can be webcast or live streamed, and the potential to reach a global audience, I hope that other institutions will follow Children’s Hospital Boston and showcase their innovation in this way.

Good luck to all at Children’s with your first Innovation Day!

According to a forthcoming article published in Forbes, excerpts of which appear on Matthew Herper’s blog “The Medicine Show,” big pharma should take bigger risks and outsource R&D to smaller, innovative companies.

At least that’s the philosophy of Bernard Munos, the former Lilly sales executive who has focused on the innovation problems faced by the pharmaceutical industry. According to Forbes, he believes that big pharma should “cut research and development” and “rather than do research in house, companies should close their labs and outsource the work to tiny, nimble startups that can explore bigger, crazier ideas.”

However, as Munos goes on to say in an excerpt published by Matthew Herper:

“You cannot script innovation,” Munos says. “You cannot boil it down to a code of best practices. Because it is unpredictable and the opportunities in science do not match the opportunities in markets.”

That is why Munos’ strategy of outsourcing drug discovery may not be the right one – there is no formula that you can give a vendor on how to be innovative.  Indeed, leveraging the innovation of small biotechnology companies is nothing new – isn’t that what big pharma already does with its licensing deals and alliances?

The question that comes to mind from the provocative Forbes article is whether innovation of drug development is a service like clinical trials that can be outsourced? Contract Research Organizations (CRO) are now the route by which the majority of companies conduct clinical research. They possess the efficiency and economies of scale to do what is a mundane, process driven task of setting-up, monitoring and processing data associated with a clinical trial on a global basis.  Those models works reasonably well and are now the norm.  Standard Operating Procedures (SOPs) exist for everything a CRO does in what is a heavily regulated process of gathering data for regulatory submissions.

Is this the same for drug discovery? I am not so sure.  Firstly, if you outsource you have to give direction. You have to have a commercial or scientific target, and resources have to be allocated accordingly. Who decides where R&D investment should be spent? Ultimately in any outsourced venture, the company spending the money makes that decision.  So all you are doing is shifting the execution of the task, not the development of the strategy, which is where the innovation needs to take place.

Indeed, if one looks at the clinical trial service model, what has happened is that consolidation of small and medium size CRO’s continues to take place.  Small companies simply lack the resources to get the job done. I am not convinced that small is necessarily best when it comes to drug discovery.

What’s more, Munos, in the recent Science Translational Medicine (STM) commentary on innovation that he wrote with William Chin, appears to argue for a different model than the one he proposes in Forbes.  He states that:

“pharmaceutical companies cannot mitigate risk adequately by pursuing “safe” incremental innovation, instead the industry should reengage in high risk discovery research on a broad scale and only take genuine breakthroughs to the clinic.”

This is easy to say in practice, and may not be a realistic strategy when there is money and sales to be made from me-too and follow-on compounds. How many companies are going to say we are not going to continue with this business model?

According to Munos in Science Translational Medicine (STM) the options open to big pharma are to:

  • Participate more decisively in collaborative networks
  • Form precompetitive consortia and other partnerships to share costs
  • Adopt new research models such as public-private partnerships

To me, there seems to be a disconnect between what Munos says in the Forbes article and what he says in his STM commentary.  If he has a clear vision for the future of pharma innovation, he should at least be consistent.

Where I do agree with Munos is the conclusion of his STM commentary that success starts with breakthrough science. This message was also clearly stated at BIO 2011 by the panel on innovation that included GSK’s Moncef Slaoui.

Pharma R&D $ needs to be spent more wisely. In my opinion there is a role for incremental, as well as breakthrough, innovation. The two are not mutually exclusive.

Is cutting R&D and outsourcing discovery the route to success as Munos suggests in Forbes?  Only time will tell as pharma R&D retools and refocuses for the future.

ResearchBlogging.orgMunos, B., & Chin, W. (2011). How to Revive Breakthrough Innovation in the Pharmaceutical Industry Science Translational Medicine, 3 (89), 89-89 DOI: 10.1126/scitranslmed.3002273

I recently returned from a few days in Boston & Cambridge, so today, in memory of the late Alastair Cooke and his Letter from America, broadcast for 58 years from 1946 to 2004, I wanted to share with you my “Letter from Boston”.

New England is the No 1 biotechnology region on the East Coast of the United States and the Boston/Cambridge area of Massachusetts is the hub.

What makes Boston/Cambridge so attractive as a biotech region?  Amongst many, I’d suggest 3 factors stand out to me:

  1. Access to World-Class Science with an Entrepreneurial Focus.  With over 50,000 students in the Boston/Cambridge area it is a city with a focus on higher education.  Harvard, MIT, Boston University, Northeastern, Tufts, Massachusetts General Hospital are but a few of the many research institutions.  However, what strikes me about the researchers in Boston/Cambridge area is the entrepreneurial focus they have.  The idea of starting up a company, commercializing an innovation or finding the application of science is something a lot of people want to do.  This entrepreneurial focus is key to the success of industry/academic colloboration in the area.
  2. Critical Mass of Industry infrastructure. There’s a range of companies in the Boston/Cambridge area. From start-ups such as Blueprint Medicines to more established companies such as Ariad, Vertex and Millennium-Takeda, what Boston/Cambridge offers is a critical mass of talent and people. Those working in the area have sufficient opportunities to move to new companies and positions, that it’s not a major career risk to move to the area.  There’s also a lot of early stage infrastructure such as the Novartis Institute of Biomedical Research that bridges the gap between basic research and early stage commercial development.
  3. Geographic Location. Finally, what stands out for me is the excellent location that Boston has. You can easily reach New York’s investors and analysts, Washington Policy Makers or New Jersey big pharma without too much difficulty. At the same time, Boston is easily accessible for European companies, and the travel time to London can be less than going to the West Coast.

Pfizer recently announced further R&D investment in the Longwood Medical area, Harvard are building a new science campus in Allston and Vertex recently broke ground on a new headquarters in the South Boston innovation district.

For biotechnology companies at all stages of development there are a lot of opportunities in the Boston/Cambridge area.

Innovation involves insight that allows you to see around the corners. That’s the perspective according to Andrew Marks, Professor of Physiology & Cellular Biophysics at Columbia University Medical Center, who recently wrote a Commentary on Innovation in Science Translational Medicine.

Entitled “Repaving the Road to Biomedical Innovation Through Academia”, Professor Marks’ commentary captures the reader’s attention in the first sentence:

“The path to biomedical innovation requires a synthesis of seemingly unrelated observations.”

He goes on to say, “innovation requires joining the pieces to solve the puzzle.”

Innovation according to Marks is difficult to define, something I also noticed at BIO 2011 in the industry panel that I attended.

However, like pornography, “we know it when we see it” to paraphrase Justice Potter. Mark gives examples of innovation in the biological sciences: germ theory of disease by Lister, discovery of antibiotics exemplified by Fleming, Watson & Crick’s work on the structure of DNA.

I don’t disagree that these are examples of paradigm shifting scientific discovery fueled in some cases by serendipity. But are they the best examples of innovation in the biological sciences? Has nothing innovative happened in the past 50 years that is worth mentioning?

In his commentary, Marks goes on to outline the reasons he thinks biomedical research is threatened in the current environment. This includes the standard litany of woes expressed by many academics today:

  • increased costs
  • insufficient support
  • limited industry support
  • prolonged postdoctoral training
  • limited opportunities for research careers in academic medicine

Interestingly, however, he suggests that part of the fault for this lies with academia.

Academia and the National Institutes of Health (NIH) have failed to evolve with the times, he writes. They “have been guilty of a lack of innovation” in how they support science.

Today’s challenge according to Marks is the need to balance revolutionary research that is innovative with incremental research necessary to further knowledge.

Marks goes on to say that the NIH is not well equipped to judge innovative groundbreaking research.  Moreover, “the unwritten rule, often said tongue in cheek, is that when applying for NIH funding one should only propose experiments that one has already done and for which one can show convincing preliminary data.”

The solution he proposes is to change the way federal funding of biomedical research takes place. The NIH should divert to industry the costs of clinical trials and establish distinct funding mechanisms for high-risk research. I am not sure I agree with this, as many clinical trials would not be funded by industry and translational research is not just about basic science, but is from bench to bedside.

The solution proposed by Marks also predisposes that you can properly assess and judge innovative research when you see it.  This is not as easy as it seems. As Marks points out:

“NIH likely would not have funded proposals to test the germ-theory, antibiotic-action, or DNA double–helix hypotheses because these projects either would have been deemed too risky (that is, they have a low likelihood of success) or too speculative (lacking in sufficient “preliminary data”) or because the approach would have been criticized as being misguided.”

Instead of looking for new ways to fund basic science, Marks proposes a rework of the way NIH funds research.  Cutting the same cake in a different way is unlikely to solve the fundamental problem: there is simply not enough government funding to go around. In the face of the US budget deficit, it is hard to imagine a significant increase in NIH funding to create new funding opportunities.

Would a more innovative approach be to ask academics to rethink how research is funded in their institutions?  Focusing on the NIH and Federal Government funding is not the optimal solution in my opinion.

Marks is right in that Academia needs to innovate how science is supported. Incremental change of the way NIH funding takes place may fill in some potholes, but will not repave the road to biomedical innovation.

ResearchBlogging.orgMarks, A. (2011). Repaving the Road to Biomedical Innovation Through Academia Science Translational Medicine, 3 (89), 89-89 DOI: 10.1126/scitranslmed.3002223

Today and tomorrow, Northern California’s Life Science organization BayBio has their annual meeting.  Entitled ‘Powering Global Innovation” it’s a meeting that covers a lot of ground from deal making to partnering, emerging markets and company presentations.

According to their website, they plan to be live streaming to their website.  However, if you are interested in following the Twitter discussion (hashtag #baybio2011), you can do so using the aggregator below – just click on the play button to see the tweets:

Nanotechnology is leading to innovation in drug delivery, and new ways to treat diseases.

In an April 3, 2011 online article in Nature Chemistry, researchers from the IBM Almaden Research Center, Institute of Bioengineering and Nanotechnology in Singapore and Zhejiang University in China publish groundbreaking data on how biodegradable nanoparticles could be used to treat infectious diseases such as methillicin-resistant Staphylococcus aureus (MRSA).

The research shows how nanoparticles can selectively disrupt microbial cell membranes, walls and inhibit the growth of gram-positive bacteria, MRSA and fungi.

What makes this research exciting, is that the nanoparticles did not cause haemolysis or break-up of red blood cells.  The authors note that nanoparticles for the treatment of infectious diseases could be “synthesized in large quantities and at low cost” and are therefore “promising as anti-microbial drugs.”

The global market for infectious diseases was $90.4 billion in 2009 and is projected to reach $138 billion in 2014.  In the United States there are now more deaths from MRSA than there are from AIDS (18,650 MRSA deaths in 2005 compared to 16,000 for AIDS according to a paper in JAMA).

With more than 94,000 MRSA infections a year in the United States, and the increasing resistance of MRSA to existing anti-microbial therapies, treatment of infectious diseases is a major public health concern. Hospital acquired MRSA infections particularly target the elderly and those vulnerable through weakened immune systems.

Innovations in nanotechnology and drug delivery, such as the one published by Nederberg, Zhang, Tan & Xu in Nature Chemistry, open the door to potential new anti-microbial therapies.  It will be interesting to see how this research is commercialized and translated into new products and treatments.

ResearchBlogging.orgNederberg, F., Zhang, Y., Tan, J., Xu, K., Wang, H., Yang, C., Gao, S., Guo, X., Fukushima, K., Li, L., Hedrick, J., & Yang, Y. (2011). Biodegradable nanostructures with selective lysis of microbial membranes Nature Chemistry DOI: 10.1038/nchem.1012

Thanks to Justin Chakma, a student at the University of Toronto, who brought to my attention an interesting article on innovation that he published on Vijay Govindarajan’s Harvard Business Review Blog.

Justin discusses how in emerging markets, venture capitalists (VC) create intentional links between the companies they invest in, compared to the more typical stand-alone investment model we see in Western countries.

By creating an innovation ecosystem, VC’s in emerging markets are able to leverage their investment in multiple companies.  I encourage you to read Justin Chakma’s article, in which he discusses the advantages of this approach in emerging markets.

However, he takes the analysis further and argues that a systems based approach to innovation also has relevance in developed markets.  As an example he states:

“It’s possible for a drug discovery start-up to identify the most relevant patients, and improve clinical trial success and reimbursement rates, if the VC invests in diagnostics or biomarkers at the same time.”

I certainly think that in emerging markets, where there may be a lack of infrastructure and service providers, taking a portfolio or systems based approach can help bring products to market, and capture value for the VC.

However, are venture capitalists in developed countries really interested in creating an ecosystem around their investments?  A VC investing in a biotechnology company has no need to buy a contract research organization for clinical trials, plenty exist nor is there a need to develop the whole system of outsourced service providers necessary to bring a drug to market. I am also not sure that VCs in America are interested in the huge cost of biomarker and diagnostics development for start-ups.

Many VC’s already diversify by investing in a range of companies within a sector.  Is there additional value to them in creating formal links and synergies within this portfolio, turning VC’s into mini-conglomerates?  I think we need to see more data in support of the idea that a systems based approach does in fact speed-up innovation and time to market.

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