The wireless future of medicine February 27, 2010
Posted by senderovitz in Uncategorized.add a comment
On a talk from TEDMED, Eric Topol describes the newest possibilities in wireless medicine.
Greetings from TED February 11, 2010
Posted by senderovitz in Uncategorized.add a comment
At Long Beach at TED2010. As usual, a unique place to be!
Great discussions, fantastic presentations, tons of new ideas.
Clearly, Open Innovation and a change of the Healthcare agenda/R&D framework is now being discussed.
The Future of Medicine TEDU talk by Dan Kraft was spot on, and I hope this will reach ted.com.
Technology companies focusing on data collection and sharing, direct contact with patients etc. are now popping up all over, and Pharma R&D should pay attention to the opportunities here. I will write more, once back from TED.
2010 – the year for Open Innovation in Pharma? January 8, 2010
Posted by senderovitz in Uncategorized.1 comment so far
As 2010 is now on its way, it wil be very interesting to follow how the Pharmaceutical industry will transform itself. I think it is a given that it has to do so. More and more analyses reach the same conclsion – latest in Nature Reviews Drug Discovery in a very interesting article by Bernard Munos from Lilly, who has analysed the last 60 years of Pharma productivity. He concludes: ” The R&D model that has powered that success, however, is showing signs of fatigue: costs are skyrocketing, breakthrough innovation is ebbing, competition is intense and sales growth is flattening. “.
It is very clear that M&As have not improved innovation and NME outcome. It has to be the innovation process itself which is changed. The overall business model.
It is very tough change process which lies ahead of us. This is of course no excuse for not getting on with this change.
Happy holidays December 21, 2009
Posted by senderovitz in Uncategorized.add a comment
I have to apologize for my very infrequent blogging these last days. Well, the aren’t really any other excuses than I have been too busy. Now, when the holiday season is approaching rapidly, I will take this opportunity to wish you all a great holiday and all the best for 2010.
During tough times with financial constrains, innovation is even more important – building for the future and keeping the ability to adapt raopidly is key for continued success!
From February 1st, I will join my new company, privately held German Pharmaceuticals Group Grunenthal in Aachen, heading up the Global Development function. This is a challenge I am looking very much forward to, for sure!
I will be speaking at a couple of events during spring 2010:
- At the Partnerships in Clinical Trials US meeting in Orlando in April, where Iwill be giving a keynote lecture on: Thinking Small in Big Pharma: What Will Future Pharma R&D Look Like? just after Wired’s Chris Anderson.
- At The Drug Discovery Leaders Summit in Montreux, where I will chair an Open Innovation workshop.
New Editorial on Open Innovation available online now November 4, 2009
Posted by senderovitz in Uncategorized.add a comment
Expert Review of Clinical Pharmacology, November issue has an editorial by me about how Open Innovation could reinvigorate the pharmaceutical industry with fresh R&D opportunities. The paper is available online now.
Crossing the line – “sphere crossing” is an important word in the Open Innovation vocabulary October 29, 2009
Posted by senderovitz in Uncategorized.add a comment
Open Innovation is also about seeking opportunities outside your usual sphere. Actually, sphere-crossing is an important word in the OI vocabulary. The challenge is to allow for major change within the existing, large pharma organisaitons. Of course one can list all sort of reasons for not allowing such change to be properly supported – and re-defining your business is clearly not easy. In my view these opportunities are right there in front of us.
Real-time health surveillance (biomarker levels, remote sensoring/monitoring, compliance inmprovement etc.) is one such area of new business just waiting to be grabbed. Linking up the sensoring business(interesting issues of this journal on the horizon) , and integrating nanosensor technology with real-time biomarker analysis is an area I predict will grow tremendously. I already see small companies thinking about this business, or setting up their business in this area (e.g. Theranos). Here is a cool example of what we can expect much more of: health applications on our mobile devices.
Why should Pharma care about this? Well, for sure the Pharma return to shareholders isn’t exactly positive these days – probably rather zero or negative. The blockbuster business model is supposed to have died – yet I keep seeing more of the same: Linear discovery and development – same late stage designs – no real move towards Model Based Drug Development – little or no change in product focus (still focused on the drug rather than on the more holistic health care solution) – and most importantly: still focused on wanting to do everything ourselves.
Let me put a simple challenge forward: How many pharma companies have “High-Tech” scouting teams established? Teams, who constantly scout for new potential tech-areas relevant for the health care industry? Who constantly look for better, smarter solutions in IT, technology, computing, sensoring, nanotech etc?
Feedback is welcome….!
Changing the game – do we need more of the same drugs? October 20, 2009
Posted by senderovitz in Innovation.Tags: Discovery, Early Intervention, Networks, Open Innovation
add a comment
Each year, the Pharma industry is able to jointly send no more than approximately 25 so-called new drugs to the (US) market. In 2008, FDA approved 21 new molecular entities and 3 biologic licence applications (BLAs). In 1996 these numbers were 53 and 3. It is noteworthy that several of these new molecules were not first-in-class, but rather modifications on existing therapies. Maybe they are better, maybe not – but groundbreaking innovation? And it remains a fact that for about 40% of all patients taking medicines, the drugs do not work. The response rate in some cases is even significantly lower. The rerason is we apply drugs to popuations – not to individuals, and individuals response differently. For decades, population approaches have been applied and a mean value of the therapeutic effect has been the mantra, thus neglecting subpopulations who might respond substantially better, or supoplaitons at higher risk for certain adverse events.
The way the pharma industry handles drug discovery and development remains unchanged during the last decades. It is still a linear process – all the way from the discovery concept where a single cause is linked to the disease through a target: by hitting this (single) target (e.g. blocking an enzyme or a receptor) it is hypothezised that the drug will be an effective treatment for the disease. This may be true in a few, rare circumstances. Most diseases are however resulting from far more complex processes, and trying to treat them hitting single targets is really quite suboptimal. This linear process has several challenges: It requires a substantial initial input (thousands of molecules are screened to deliver one final candidate), and during the development [process, limited data (as compared to what could be captured) is captured and utilised to learn about the disease/drug.
Network Based Drug Discovery (NBDD) (see fx Scadt EE et al) is a new, intreaguing path forward allowing researchers and developers to fully explroe and understand the underlying physiological and pathological networks, and directing new treatments towards the restorage of these. The objective is not be to treat the disease, but to introduce early network normalisation before the disease progresses with organ damage. This is probably best achieved by looking at several targets in the imbalanced network, and opens up for a new paradigm: Chronic and severe iseases (such as diabetes, chronic inflammatory conditions, chronic cardiovascular diseases, cancer etc.) are really clusters of sub-conditions, all resulting from distruberd underlying networks. Mapping and understanding these abnormalities will help directing the discovery/development process. In fact, most of our traditional disease definitions as we know them today will become irrelevant, and connections actross diseases will emerge; single drug treatments will be seen as obsolete approaches, and combination therapies or multi-target approaches will become the main approach towards “network restorage” therapies.
Sciene fiction? Not really. The science and technology is here – or getting here – and this way of thinking, based on a fundamental insight into the underlying biological systems will lead to new discoveries of early interventions as well as biomarker “fingerprints”, which will help identify relevant sub-populations/sub patterns who thereby will be able to get individualised, optimised treatments.
The NBDD approach will clearly lead towards stratified, if not personalized medicine. The markets for such interventiosn have traditionally been challenged by the commercial organisaitons for being to small (and the dominating paraigm today is still: Go for the broadest indication!) . I disagree!
Here are some suggesitons on why the markets may in fact increase in size:
- Stratified medicine will lead to improved benefit/risk ratio for the patients
- Early intervention will lead to prolonged treatment per patient
- Higher efficacy and/or improved safet profile of the personalized medicine will increase compliance and drive sales up
- The improved risk/benefit ratio will enable premium pricing
- The imroved value proposition will make it much easier to pass HTA hurdles (NICE etc)
Thus, not only do we have a unique opportunity to redesign our discovery-development process by introducing NBDD, we also have the opportunity to move faster towards personalized medicine, and even do this in a way with true IP sharing and creation of new busienss opportunities.
Further on changing the Pharma Business Model October 19, 2009
Posted by senderovitz in Uncategorized.add a comment
Following on from my previous post, I am currently looking into different challenges/questions regarding Open Innovation in Pharma / Biopharma.
One of the key drivers for not changing the business model has been the extraordinary high return of investment seen years back (and now minimized, as mentioned above), partly driven by the intellectual property framework allowing companies many years of market exclusivity. This IP framework – now sometimes referred to as the “Old IP” has recently been criticized for being a key culprit in the decline of innovation. In a remarkable report from last year, The International Expert Group on Biotechnology, Innovation and Intellectual Property concluded that “a ‘New IP’ era that focuses on cooperation and collaboration is slowly emerging. Intellectual property is meant to assist in this process by encouraging cooperation among various brokers and stakeholders. The best innovative activity occurs when everyone – researchers, companies, government and NGOs – works together to ensure that new ideas reach the public, but are appropriately regulated and efficiently delivered to those who need them.”[i]
The key question regarding IP and Pharma is: Can we abandon the Old IP framework? And if the answer is YES: How.
It is still obvious that we struggle to get our hands around this. Real Open Innovation collaborations with access to new markets through clever collaboration is still a rare phenomenon. True: collaboration between academia and industry and industry/industry is increasing not least thanks to the Innovative Medcicines Initiative (IMI) , but the IP challenge remains in place in such mega consortium-type partnerships. Very often, I hear the phrase: “pre-competitive area”- but it seems to me that we are still caught in our “old IP” context.
One way of creating a better IP framework could be the creation of a new company with the newly generated IP shared amongst its partners – an independant organisaiton owing its own, new IP. For example, if a company wants to develoop a companion diagnsotic, why nto establish a new “theranostic” partnership between the pharma, the diagnsitic company and perhaps a third, biomarker company with a return of investment to each of the shareholders based on the investment made.
I would welcome a debate and ideas on how to further improve on this front, as it remains one of the key hurdles for introduction of OI in to our busienss.
[i] International Expert Group on Biotechnology, Innovation and Intellectual Property Montreal, Canada September 2008.
Open Innovation – why? August 26, 2009
Posted by senderovitz in Innovation.2 comments
It’s been a while since my last post – summertime in Italy without laptop. What a joy 
Since then, I am finalising an editorial in a scientific journal about Open Innovation, and several queations need to be discussed – I will elaborate more on these here – starting with the first question today.
Question 1:
Any recent examples on Pharma actually doing Open Innovation? Well, unfortunately not many, at least not available in the public domain – so much for openness. And furthermore, as these are quite early days, we probably have to wait soem years before we see the first financial analyses of the benefit of OI in Pharma.
However, some exampels seem relevant to follow.
Pfizer, for example, with their The Pfizer Incubator which “offers scientist-entrepreneurs an opportunity to bring their medical innovations to patients. In TPI, scientist-entrepreneurs contribute innovative ideas and the ability to solve complex scientific and technical challenges, while TPI provides all necessary resources to move ideas forward into practice. If the idea is proven and is ready to be commercialized, it can be incorporated into one of the most powerful life science research, development and marketing infrastructures in the world. “.
Eli Lilly & Co. have set up their Phenotypic Drug Discovery (PD2): ”Every year, investigators throughout the world are designing andsynthesizing compounds in university and biotechnology laboratories that are never fully evaluated as potential drug candidates. Among the challenges for academic investigators is ready access to assays reflective of disease biology and expertise in drug discovery and development. Finding a collaborator and investor is equally difficult. Pharmaceutical companies realize that the future of drug discovery relies on finding solutions for complex unmet medical needs. It is impossible for any single company to independently meet this challenge. Lilly recognizes that collaborative research is one part of the solution.”
A recent excellent initiative from Academia with founder Prof. Wim Vanhaverbeke from the Hasselt University in Belgium is the Exnovate forum, which “is a platform for companies and knowledge intensive organizations that are practicing open innovation or intend to do so in the nearby future. Particularly, Exnovate serves as a clearinghouse and network platform, linking together the international community of companies, academia and governments”.
Recently, Rosetta Inpharmatic’s founder Stephen Friend and scientific director Eric Schadt set up a new, not-for-profit medical research organization with the aim “to revolutionize how researchers approach the complexity of human biological information and the treatment of disease. “
According to the SAGE site, Sage’s objectives are:
- to build and support an open access platform and databases for building innovative new dynamic disease models
- to interconnect scientists as contributors to evolving, integrated networks of biological data
I would be very interested in additional examples.
Bottom line: Companies are beginning to try out various fora to open up – so far, it still seems they want external contributors to send their ideas to them, but it’s a start. Now, the next obvious question following this would be: Is there a risk of decreased competiveness between Pharma when opening up the IP? In fact, the entire IP field is highly important to discuss, as this seems to be one of the main reasons for NOT moving rapidly tropwards a more Open model. I will discuss this here in the nearest future. Contributions are welcome.
Steps towards the New Pharma R&D Model July 28, 2009
Posted by senderovitz in Innovation.add a comment
Now slowly recovering from last week in oxford, where open innovation and idea sharing was defintely in the minds and hearts of everyone, and where >50 speakers presented their thoughts on anything from supermassive black holes in the center of our galaxy to life saving water purification systems, wireless electricity (yes, that’s right: No more wires to get your laptop or TV fueld up), chartered cities and so much more.
I gave a talk at the TED University on the Future Pharma R&D Model, in which I briefly outlined why Pharma has to change, and what we need to do:
- Integrated Healthcare Solutions – rather than developing molecules only, look for opportunities in the full context: Drug, diagnostic, compliance systems, remote sensoring, real-time biomarker surveillance with reporting of health status to the patient’s PDA/cell phone (nano-sensors) and direct info to the health care team lookign after the patient. TYhis cannot be achieved by one company, but will need sharing of IP and collaboration actross industries – a bit like the construction of the iPOD.
- Work towards personalized medicine (nothing new there, except we just need to do it!), and increased investments in biomarker work for early decision making and patient stratification: This requires significant increased collaboration between companies and between companies and academia: We simply have to give up going for the broad applicaitons of our medicines, and rather focus on segments with significantly increased efficacy and minimized risk of adverse events. In other words: By targeting segments of the entire population, we will find increased efficacy of our medicines, leading to better risk/benefit ratios, smaller clinical programs needed (because the sample size of the clinical trials will be reduced due to the larger treatment effect), increased value added for the patients (because the % of responders will be closer to 100% on the market), increased compliance (and patient-loyalty), higher price etc. etc.
- Systems Biology approach: Clear understanding of the underlying biological systems – stop treating diseases (which almost by definition means organ damage and difficulties restoring normal function) , and start restoring distorted biological networks.
- Increased use of in silico development of new medicines. We should simply not accept exposing human beings to any of our medicines prior to significant simulations. It is already possible to run large-scale simulations of virtual patients, but this is far from utilised in all companies, and far from to the level, where we would start seing major decisions being made based on in silico work. Model Based Drug Development, which is a relatyive new discipline, is startiong to take off as a driving force in better decision making throughout the long, expensive and complex process of developing new drugs.
Significant hurdles are still blocking for the major change in the way we run R&D, not least because of a conservative attitude from regulatory agencies aroudn the world: Far too little cross-country/region collaboration, and in my view a lack of vision. While some groups within FDA, for example, are quite visionary, there is still a long way to go before the entire agency share this, and starts implementing the data-driven, model based approach.
Thus, it seems clear that we need an even more multi-disciplinary approach, in which we re-shape the way we develop new treatments – aiming at stratified/personalized early intervention, utilising neighboring disciplines as well as complete cross-industrial collaborations to generate fully integrated healthcare solutions.
