Posts tagged ‘Biotech Strategy’
At Icarus Consultants, we help pharmaceutical and biotechnology companies bring new products to market.
When we look at the market opportunity for a new product, it’s not enough to have a great product, key to success is getting paid for it. Pricing and reimbursement are important in the commercial strategy!
Is it better to obtain the highest price for a new targeted therapy or alternatively have a lower price and obtain more market share? From a marketing strategy perspective, there is sometimes a case to be made for a lower price, but it’s a hard sell to convince senior management they are not leaving money on the table.
As to cancer immunotherapy, Dendreon with sipuleucel-T have shown that it can offer a survival benefits to some cancer patients. Other vaccines and immunotherapies are in development.
However, as Pieter Droppert points out in an insightful post on Biotech Strategy blog about a pilot study for PANVAC (Bavarian Nordic, CV-301), there remain a number of challenges that still have to be overcome. These include:
- How do we identify upfront which patients will respond to the vaccine?
- How do we evaluate how well patients are doing without clinically validated surrogate markers to aid in assessment?
You can read more on Biotech Strategy Blog.
There is a plenary session on cancer immunotherapy at the AACR-NCI-EORTC Cancer Molecular Targets & Therapeutics conference that starts in San Francisco tomorrow.
We look forward to obtaining further insights on the opportunities and challenges with cancer immunotherapy at this meeting.
Sally Church, PhD on Pharma Strategy Blog has written about research on macrophage cell surface protein S100A10 and the role this plays in cancer metastasis and tumor growth.
As Sally notes, “macrophages are critical in driving tumour growth, invasion and metastasis. Macrophages are like the Pacmen of cells…” What a great visual metaphor!
Recently published research now shows that the macrophage cell surface protein, S100A10 plays an important role in how macrophages move to the site of tumor growth, a process that is key to tumor development and angiogenesis.
Is S100A10 a potential druggable target? You will have to read Sally’s insightful blog post to learn more.
Future advances in cancer drug development may come from targeting cancer metabolism and the pathways associated with this.
Image Source: Tak W Mak, Stockholm EMCC 2011
That was one of the key messages of Tak Wah Mak (Princess Margaret Hospital, Toronto) in his plenary presentation at the recent ESMO/ECCO multidisciplinary cancer congress in Stockholm.
An examples of this is the PI3-Kinase RAS axis that also inhibits glycolysis.
Sally Church in today’s post on Pharma Strategy Blog picks up on this, and how “understanding the process of tumorigenesis, ie tumour formation and growth, is critical to figuring out how to stop it.”
She discusses recent research from MD Anderson Cancer Center on Pyruvate Kinase M2 (PKM2) that is highly expressed in human cancer.
PKM2 plays an important role in glycolysis (Warburg effect) but also has a non-metabolic effect on tumor formation and growth.
The MD Anderson researchers showed how epidermal growth factor (EGFR) activation led to translocation of PKM2, but not PKM1.
You can read more on Pharma Strategy Blog about the significance of these findings and how this might lead to new biomarkers and treatment approaches.
Targeting Tumor Metabolism is one of the plenary sessions at the forthcoming AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Congress in San Francisco.
That sounds like a simple question, but can actually be difficult to answer.
As part of a market entry strategy or overview of the commercial landscape, we often have to look at the regulatory framework in a country.
For many products from pharma or biotech it’s obvious that something is a drug, medicinal product, biological product or device. However, for those involving nanotechnology, tissue engineering, biologics, or combinations of drugs/devices, it can be less clear.
Understanding how a product is classified from a regulatory perspective, something that may differ between countries, will impact a path to market strategy.
In the United States, under the Federal, Food Drug and Cosmetic Act (21 U.S.C. 321), the term “drug” includes:
“articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”
Dietary supplements such as vitamins are usually not considered to be drugs.
However, new research is coming out that shows vitamins may be more active than we may have previously thought.
Pieter Droppert on Biotech Strategy Blog has commented on research that showed giving vitamin E supplements to healthy men led to a 17% increased risk of prostate cancer.
In pancreatic cancer, researchers showed that Vitamin E may improve the effectiveness of gemcitabine.
In future it is possible that the regulatory classification for vitamins may change if they end up being given as active compounds for the treatment of a disease. What is a drug remains a simple question, but one that is not always easy to answer.
After all the “excitement” of hurricane Irene last week in the New Jersey/New York metro area, this weekend offers the Labor Day holiday. It is to many the last hurrah of summer.
According to the United States Department of Labor, the public holiday on the first Monday in September pays tribute to the American worker, “creator of so much of the nation’s strength, freedom, and leadership.”
Economic prosperity and access to healthcare are very much linked with employment in the United States, so it is sad to see the recent poor job creation results.
Icarus Consultants will be closed on Monday, September 5 and will reopen for business on Tuesday. We wish all our current and prospective pharma and biotech consulting clients an enjoyable weekend.
Pharma Drug Development – time for a new strategy and model of innovation?
August 5th, 2011
Daedalus
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.
Pieter Droppert has prepared a short (2 minute) video review of BIO 2011, in which he notes that one of the major themes of the meeting was facilitating partnering, licensing & business development discussions between pharmaceutical and biotechnology companies.
Astra Zeneca tweeted that they had 500 partnering discussions planned, a number that is perhaps not so surprising in light of their pipeline and patent cliff over the next few years.
Another major focus of BIO was the marketing of biotechnology regions that takes place in the exhibit hall and at satellite events. Pieter has written in more detail on Biotech Strategy Blog about the session on innovation he attended, networking opportunities and the face of biotech social media.
His not too serious BIO 2011 video, that you can watch below, captures what he thought of the meeting as a first-time attendee.
We wish our Canadian clients a Happy Canada Day today and our United States clients an enjoyable Independence Day weekend. Icarus Consultants will be open for business again on Tuesday, July 5th.
BIO 2011, the international convention of the Biotechnology Industry Organization (BIO) starts in Washington DC today and lasts until Thursday.
Pieter Droppert (@3NT) is attending and will be live tweeting from sessions. You can read more on Biotech Strategy Blog about Pieter’s top 10 sessions and some of the innovation challenges facing the biotech industry.
In case you are unable to be in DC for the meeting, you can follow the conference Twitter conversation (hashtag #BIO2011) using the aggregator below – just click on the play button to see the tweets:
Sally Church on Pharma Strategy Blog tackles the question of whether notch signaling is a target for Chronic Lymphocytic Leukemia (CLL)?
If you see a hematology theme, that’s probably because Sally attended the European Hematology Association (EHA) Congress in London last weekend.
Sally discusses recent research that shows “NOTCH1 activation at CLL diagnosis emerged as independent predictor of poor survival.”
Several companies have new products in development that are NOTCH inhibitors, including RO4929097, MK0752, BMS906024, PF03084014.
The NOTCH signaling pathway is disrupted by cancer and may be implicated in a number of disease areas.
Recent research from Duke using animal models has also shown that NOTCH signaling controls the differentiation of airway basal stem cells, potentially making it a therapeutic target for airway remodeling and lung disease.
Sally concludes on Pharma Strategy Blog that NOTCH signaling is “an interesting field to follow.” If you would like to know more about NOTCH signaling and the new product development opportunities associated with this pathway, please contact us.
Mice seem to get bad PR; there’s far more people that like cats……..So in the interests of fair balance, we’d like to draw attention to the increasing importance of preclinical mouse models in cancer drug development.
Pieter Droppert on Biotech Strategy Blog discusses how innovations in translational medicine, and improved mouse models of human cancer are having a major impact on bringing new cancer drugs to market.
So, time for some good thoughts about mice (with apologies to cat lovers out there).