Posts tagged ‘Biotech Consulting’
August 5th, 2011
Innovation is key to the success of any business. Whether it is coming up with the idea of new products or services to offer customers, or better or more efficient ways to do something, innovation is something that all businesses do.
Innovation can be breakthrough, think of Pfizer’s crizotinib for the treatment of ALK-positive advanced non-small cell lung cancer. It can also be incremental e.g. improvements in formulation and drug delivery that may mean fewer doctor visits and better patient adherence.
It is undisputed that the pharmaceutical industry has not received a good return on investment (ROI) from it’s R&D spending over the past ten years. One only has to look at the number of new products that have come to market during this period.
Several commentators believe the problem has been the strategy for innovation within the industry. Pieter Droppert on Biotech Strategy Blog has recently written a series about different views on how innovation in drug discovery could be improved:
- BIO 2011 panel on future for innovative medicines
- Science Translational Medicine Commentary by Elazer Edelman & Martin Leon
- Science Translational Medicine Commentary by Andrew Marks
- Science Translational Medicine Commentary by Bernard Munos & William Chin
There is an active debate around innovation and drug development strategy. Whether the paradigm will shift to a new model remains to be seen.
In the meantime, we at Icarus Consultants are constantly thinking about new ways to offer more value to our clients. That’s something we should all strive to do, whatever business we are in.
August 2nd, 2011
It takes desire, discipline and determination to blog regularly, and as a result many blogs fall by the wayside over time. However, Sally Church has been writing a blog on oncology, hematology, cancer science & biology, clinical trials and new product development for the past five years. It continues to go from strength to strength thanks to Sally’s passion for the area.
Sally recently announced on Pharma Strategy Blog that she had reached the 900 blog post milestone. In recognition of this, Sally took the time to answer the follow questions:
- Why do you blog?
- How do you decide what to write about?
- What makes a good blog post?
- Looking back on 900 posts – which posts are most memorable?
- What are your future goals for Pharma Strategy Blog?
You can find out Sally’s answers in the following video:
June 23rd, 2011
In the run up to the 2011 BIO international convention next week in Washington DC, Pieter Droppert on Biotech Strategy Blog discusses a recent Nature Reviews Drug Discovery paper on Pharma R&D productivity.
One of the take homes from the analysis of 28,000 pharma R&D compounds investigated since 1990 is that “therapeutic innovation has become more challenging and complex.” At Icarus Consultants we agree with that conclusion.
One only has to look at the increasing complexity surrounding oncology pathways as an example. Choosing the right molecular target and one where there is a market opportunity is key to success. Increasingly, patient selection is also becoming a key part of the paradigm.
New Product professionals need to do a comprehensive landscape analysis around potential target indications. Some of the questions to ask:
- Who are your competitors?
- What stage of development are they in?
- Which sub segment are you competing in?
- What does the clinical science show regarding molecular targets?
- Which patients should be included/excluded from the trials?
- What combinations might be relevant – chemotherapy or targeted therapies?
- Which line of therapy are you going for?
- What is the market opportunity for your new product?
These are things we often help our clients with at Icarus – as we learn more about the increasingly complexity of the underlying biology of disease, so the challenge with clinical trials in terms of tumour types and patient selection increases.
Choosing the right target is key to Pharma & Biotech drug development success.
April 21st, 2011
The ability to sequence and screen the entire genetic information of an individual is now within reach. DNA sequencing costs have decreased over a 100-fold over the past 3 years, a rate faster than Moore’s law on computer power increases with time would predict.
Sally in her post on Pharma Strategy Blog discusses the two JAMA papers that look at whole genome sequencing in cancer patients. The first paper by Link and colleagues from Washington University, St Jude Children’s Research Hospital and University of Chicago is a sad case of a woman diagnosed with breast cancer at 37, ovarian cancer at 39 who died of treatment related AML (tAML) aged 42. Whole genome sequencing showed that she had a novel deletion of 3 exons of the TP53 gene. Screening her children for this deletion will help identify potential future risk.
In the second paper, Welch and colleagues at Washington University report on the whole genome sequencing of a 39 year old woman initially diagnosed with AML, and how this led to discovery of a novel insertional translocation on chromosome 17 that produced a pathogenic PML-RARA gene fusion. Once this was discovered after sequencing, the patient’s diagnosis and treatment was changed to incorporate this knowledge, with an improved prognosis; she remains in remission according to the paper.
The cost of whole genome sequencing is still too high for it to be part of routine screening for everyone, but the time will come in the not too distant future when this is cost effective, opening up a new era of personalized medicine.
Sally Church has published an in-depth analysis of whole genome sequencing and a review of the JAMA papers on Pharma Strategy Blog that is well worth reading.
April 20th, 2011
Pieter Droppert in a previous position worked as a Global Project Director for a phase II Alzheimer’s clinical trial program in emerging markets. He maintains an interest in this area and the new products in drug development.
In a new post on Biotech Strategy Blog, Pieter writes about research published in the journal Neurology that showed magnetic resonance imaging (MRI) could detect pre-symptomatic Alzheimer’s disease (AD).
Brad Dickerson and colleagues from Mass General and Rush University in Chicago looked at two groups of subjects who were cognitively normal, and then over time investigated the brain differences seen in those patients who developed AD.
Their conclusion is that changes in cortical thickness are a biomarker for AD, in other words structural brain changes can be seen before they develop clinical symptoms.
This research is still very early and has a number of limitations, including the low sample size and the need for computer power to do the analysis.
That said, the promise of all the biomarkers under development to diagnose early stage AD, whether they be amyloid imaging of plaque through PET scans or via MRI, is they offer the hope of being able to detect those patients at risk before the brain becomes irreparable.
By the time clinical symptoms of dementia or mild cognitive impairment manifests itself, then it’s likely the damage has already been done, and the brain has been snagged or disrupted by the disease in a way that is hard to reverse.
Early detection of those individuals at risk allows the prospect of using neuroprotective drugs to delay the onset of clinical symptoms.
Recognition of the importance of preclinical diagnosis i.e. before symptoms develop was also shown by the announcement yesterday by the National Institute on Aging, a branch of the NIH – National Institutes on Health of new diagnostic guidelines for Alzheimer’s patients.
These guidelines divide patients into three diagnostic groups: preclinical, mild cognitive impairment (MCI) and dementia. The preclinical group is completely new and a recognition that structural and molecular changes occur in the brain before clinical symptoms manifest themselves.
There is considerable research into AD biomarkers to suggest that in the next 5 years we will be able to detect those people at risk, but the challenge remains in developing new drugs that slow down or reverse the onset of the neuronal tangling that occurs.
AD is a disease that will touch many families as the population in many countries becomes older. If you are interested in this area, you can read more on Biotech Strategy Blog.
April 12th, 2011
A venture capital firm in Boston yesterday bet $40M in first round financing that Dr Druker and his partners can repeat the success of Gleevec/Glivec with a new Boston/Cambridge life sciences start-up company, Blueprint Medicines.
If Daedalus had money to invest, a wager on Dr Druker would be as good as any in the biotechnology industry. After the successful development of Gleevec/Glivec, a tyrosine kinase inhibitor that Drs Druker & Lydon were instrumental in developing with Novartis for the treatment of chronic myeloid leukemia (CML), it’s hard not to believe that they cannot do it again.
Icarus Consultants’ Sally Church worked closely with Dr Druker while at Novartis Oncology. Starting in oncology new products she saw the potential of STI-571, and subsequently took the product to market in the U.S. market as Gleevec. We wish him well, and should Blueprint Medicines need any commercial, marketing strategy consulting services, we hope he’ll call us .
You can read more on Biotech Strategy Blog.