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Posts Tagged ‘drug development’

Isn’t it time we flipped around the old ‘divide and impera’ (‘divide and conquer’) strategy attributed to the Romans and used for centuries to assert dominance? (The correct Latin term for “unite” might be “iungo”, but you get my gist). While the strategy has pretty effectively helped many generals and emperors take over large pieces of our world’s map, I am proposing that it is also the single most important reason for which most major empires have ultimately failed, being reduced to history book chapters or precious relics needing the controlled environment of museums to survive… This should not remain a history book story, but a living lesson for today’s world.

Now, fast forward to what is happening in the pharmaceutical industry today, where several companies that have dominated the world of pharmaceuticals, not unlike the great empires with their own achievements, territorial claims and peculiar corporate cultures are marching toward the “patent cliff”. The causes for what I believe is essentially a pharma innovation problem could fill in many posts. The current pharma model is increasingly more analyzed and scrutinized and thought to be unsustainable. Every day brings new stories that have created for me the vision of  a pharma’s “python phase”. To feed their draining pipelines, many companies ingest and digest consecutive boluses, M&A, expansions and cuts, which constantly inflate and deflate their bodies. What I decided to do here is to simply summarize how observations I made from a completely different situation – to me, a great way to learn! – may hold clues about other powerful strategies to survive life-or-death challenges.

I have recently learned about the practical and harmonious solution to survive the extreme challenge of the frigid waters in the Bay area during my recent visit at the Dolphin Club, a swimming and boating club in San Francisco. I have already raved elsewhere (Sports-inspired life and business lessons) about my admiration for its members who challenge the frigid open waters of the bay. If I had to summarize in only two points what was needed to survive those waters from an individual perspective, it would have to be: 1) cross-training and 2)… being “Zen”! But I also learned fascinating things about the strategy that constitutes the basis of the club and about its inner functioning from Reuben Hechanova, the current boat captain and upcoming 2011 president of the club. Everybody has to share learnings such as hypothermia classes and to regularly work together to maintain the wooden boats, even if they are not rowing them, as one day they may save their life. While touring the club one of the returning rowers reported to Reuben having had a “fantastic” row! “I had the opportunity to save a swimmer who was beginning to experience hypothermia”. These people not only share the waters (politely giving way), but they closely collaborate to successfully conquer them. For instance, I learned that for long swims, the club members move in a well-orchestrated formation, again reminiscent of the Roman’s tactics, with the swimmers in the middle surrounded by small boats, while all being flaked by the bigger wooden boats protecting from them from the potential impact of passing tankers and being ready to take back to safety anyone succumbing to hypothermia. In my many years as a rower, I had never come across such tight symbiotic collaboration between swimmers and boaters. I believe the reason is that I do not know of any other place that chose to deal with such an extreme challenge: normally rowing clubs have rules that require members to stop operating when the water temperature gets too low to be comfortable for swimming (to prevent hypothermia in case the rower accidentally falls into the water). Most outdoor swimming facilities close even earlier in the year! But, what is one to do in San Francisco, where the temperature of the Bay waters is never warm enough for most people to comfortably swim in it? Here, some people choose to jump into frigid waters and seem to love it, but not before having a survival strategy in place that capitalizes on the close, symbiotic, collaboration between rowers and swimmers. Rowers need to be able to withstand swimming if needed, swimmers need to be able to rely on or become rowers should one need to be saved from hypothermia.

Just had a great row... saving a swimmer!

So here are the three main points I derived from my recent visit about how collaborations may work for survival:

1. Goal/Need to conquer the same domain/major challenge, e.g., the frigid open waters.

2. Have complementary strengths: some are experts at moving inside the water, some over it.

3. Should share enough trust, knowledge, and capabilities to be able (and willing) to jump to the rescue or even into the other’s shoes, in this case, at the drop of an oar!

Also based in San Francisco is the UCSF. Last week, a press release announced a major common effort with Pfizer, which is expected to lose exclusivity for world’s largest ever earning drug, Lipitor, in exactly one year from now . The waters below that patent cliff might be very frigid indeed! We applaud this trend, it may produce some of the greatest example of ‘unite and impera’ our common global challenge: developing new therapeutics to address the unmet medical need. Let’s see, do the other, sports-inspired lessons apply? Do the two partners have different strengths? Check: academia excels at the “fuzzy” innovative front end of life science discoveries, while pharma’s strength is the late stage development and commercialization of therapies.

And, how about the third lesson: How much do pharma and academia share in terms of trust, knowledge, and capabilities? More and more facilities that are appropriate for drug development are becoming available, either “for hire”, being used by or built for academia’s and other self starters’ use. Mind you, several have been deserted specifically due to pharma’s budget cuts, including Pfizer’s own site demise in Ann Arbor, Michigan, and many are operated via new government programs. Do I dare say the major lasting dividing problem remains the lack of trust and knowledge sharing, not only of intellectual property (IP) per-se, but even that of common “know how” of drug development. A better shared understanding of “what” and “how” to develop a new medicine will only increase our common ability to conquer diseases. This knowledge, “as good as gold”, could be as enabling as the precious coins made of it, or, if not shared, will remain as elusive as the buried treasures of a lost pharma empire.

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You guessed it! Location, location, location

A new research study from my Alma Mater, McGill University in Montreal, demonstrates major DNA differences between genes in blood cells and tissue cells of the same individual. Specifically, the researchers found a DNA mutation (of the BAK gene involved in cell death) in the tissue cells harvested from patients, but not in their blood cells. This study and other recent ones challenge the major current assumption under which we have operated for years, i.e. that our DNA is the same in all the cells throughout the body, a specific master template faithfully reproduced in each of us. We are not talking cancer where local mutations are known to occur in tumors. What does this mean for you?

–       As a researcher, therapy and/or diagnostic developer, etc., it means that you will likely have to look in the right place in the body, analyzing “the right” (relevant) cells. This is exciting, as it opens up a lot of potential great discoveries, cures and diagnostics. It is also good news for those who had set up or already work with tissue banks (is anybody reading: much more work needed? are we going to run into the needle in the haystack issue?)

–       As a regulator, decision maker, media, etc. you will have to realize that there is much more to come, so you might want to give it a chance… Many have begun not only to openy question the wisdom of genetic testing to derive disease associations, but to actively block any initiative along these lines.

–        As a patient and consumer of health innovation, you might have to be willing to allow removal of tissues (other than blood) from your body for accurate genetic testing. Only you can decide if that is good for you…

Yet another dimension is being added to “personalized medicine”. The biology of our bodies includes features that are manifested and influence locally and systemically (globally). The genetic information is less global than previously thought. Thus the testing, treatment and care will need to be not only tailored to the individual, but also to the specific tissue/body component affected and targeted for prevention or cure of the disease.

So, coming back to the old tried and true wisdom, when it comes to our most precious piece of real estate, our own body, we will need to chose wisely the location (of genetic testing, treatment, etc.)…

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Life sciences and medical practice have made tremendous advances, creating the opportunity for great medical innovations that will allow us to cure most major diseases, and live healthier, longer lives. Yet, what is known as the “unmet medical need” continues to outweigh our capacity to find viable solutions.

What are the major, maybe specific, challenges that confront this type of innovation? My take is that the best chance to come up with solutions will come from genuinely seeking to understand all points of view and by working together to overcome barriers amongst the major stakeholders in the process, a fine example of “constructive interference”.  Reportedly a similar view was recently publicly expressed by Andrew von Eschenbach, the outgoing head of the U.S. Food and Drug Administration. Miriam Hill cited him on philly.com saying: “the drug industry will have to break down the walls not only between competitors but between big drug companies, smaller biotechnology firms and medical-device makers. The era of personalized medicine will require diverse types of companies to cooperate to generate solutions for patients, acting more like a team than individuals focusing on their own products. ‘They’re all playing golf,’ he said. ‘They need to play basketball.'”

At the upcoming Biotechnology International Conference, BIO2009 I had proposed and will be facilitating an interactive discussion between representatives of major stakeholders on the topic of: Fast forwarding life science innovation: what works, what doesn’t, where do we go from here. Meanwhile I am seeking to gain a better understanding of different points of view through this blog.

To get started, I will offer several perspectives on the current challenges I have gained from the different standpoints I came across during my work in the area of life science innovation, and as a user/consumer of medical products. Check the accompanying postings following this one. Hopefully they will be stirring enough, please do interfere!

The other posts regarding various perspectives: consumer, scientist, developer, investor, can be found by clicking on the BIO2009 category/tag under this post or in the tag “cloud” on the right hand side menu.

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The short answer I gained from working in discovery/early development in the pharmaceutical industry when it comes to implementing medical innovation is: it takes too long and it is too expensive.

True, except for some very specific conditions that had been clearly connected to genetic modifications, personalized medicine is still in its infancy. The great majority of diseases have been or could be connected with a myriad of risk factors, some of them possibly related to individual genetic make-up. Efforts in preventive medicine are not compensated.

A great amount of thought and work goes into identifying risk associations, integrate all the pieces of information, and then confirming these findings, hence a lot of support is required (money + time). Public corporations need to create value for their investors, and so are known to spend a great deal of effort to prove (positive) financial achievements each quarter. Innovation, which to me means not only discovering, but also creating and implementing something new, takes much longer than that and can cost a lot. As often said, “you get what you measure“. Fittingly, in response to my request to define innovation, Ondrej Zaoral offered (on LinkedIn) his favorite definition: “Research and development turns money into knowledge. Innovation turns knowledge into money.”

Furthermore, due to very good reasons, new products designed for human health have to pass through additional rigorous hoops. Consider the time it currently takes from the discovery to the launching of a pharmaceutical product, which was widely reported to be in average 10 years and was calculated to cost in the realm of a billion dollars. Consider also that most of these products are not revolutionary, many represent improvements of previous versions. The pharmaceutical companies were the most likely to survive such a formidable journey, but their money is drying up as most are losing patent protection for their big selling drugs and fewer new products are approved. New business models are clearly needed. A major question is: who is willing and able to pay (and wait) for real medical innovation? Maybe the investors? The government? Anyone out there?!?

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