Posts tagged ‘Sally Church’
May 21st, 2013
To celebrate the launch of Pharma Strategy Reports, we are offering a complimentary executive summary on Chimeric Antigen Receptor Technology (CART), written by Sally Church, PhD.
You can obtain your complimentary copy of this report on the Pharma Strategy Reports website. You will gain insights into:
- The challenges associated with immunotherapy and stimulating the immune system
- How are next generation immunotherapies making waves in cancer research?
- How recent papers in NEJM and Science & Translational Medicine have described this novel approach and what the preliminary data shows
- Some of the potential challenges or hurdles for registration of CTL019, the CART therapy being developed by Novartis.
CART is emerging as potential new exciting leukemia treatment – impressive results have been reported in a small cohort of adults with CLL and children with ALL who received the Novartis CTL019 therapy.
We expect there will be more data available at the 2013 annual meeting of the American Society of Hematology (ASH) later this year in New Orleans.
If you have an interest in understanding the potential of CART technology, then please sign up at Pharma Strategy Reports to download a complimentary executive summary. You will also be the first to know about future reports when they are published, such as what the new FDA Breakthrough designation means?
October 10th, 2012
It is a great pleasure to announce that Sally Church, PhD has accepted an invitation to join the Board of Directors of the non-profit organization Fight Colorectal Cancer.
Fight Colorectal Cancer supports patient education, advocacy and research funding for a cancer that can be cured if detected early, yet remains the second leading cause of cancer deaths in the United States.
Earlier this year, Carlea Bauman, President of Fight Colorectal Cancer rang the NASDAQ market closing bell and spoke about the need to raise awareness of CRC, and provide ease of access to screening:
Icarus Consultants looks forward to supporting Sally’s participation on the Board. Further information on how to make a donation or offer support can be found on the Fight CRC website. You can also follow Fight CRC news on Twitter (@FightCRC).
November 10th, 2011
November 10, 2011 is the second worldwide neuroendocrine (NET) cancer awareness day. Pancreatic NET is what Steve Jobs sadly succumbed to.
In recognition of NET Cancer Day, Sally Church has written an insightful post on Pharma Strategy Blog about pancreatic neuroendocrine tumors and new treatment options. It is well worth reading!
Sally highlights two new therapies for pNET approved by the FDA this year:
- everolimus (Afinitor) from Novartis that targets mTOR, downstream of the PI3K/AKT pathway
- sunitinib (Sutent) from Pfizer, a multikinase inhibitor
Both showed a benefit over placebo with an increase in progression free survival (PFS). They do, however, have some challenges associated with their side effects.
Sally concludes that “in the future, we may well see sequencing studies emerge as well as other targeted therapies to prolong outcomes for patients with this rare disease.”
We hope that the Neuroendocrine Cancer Awareness day achieves its goal of raising awareness about this disease. You can read more on Pharma Strategy Blog.
October 5th, 2011
Making a Difference to the Lives of Cancer Patients
Sally Church has written over 900 blog posts on Pharma Strategy Blog about oncology and hematology new product development.
One series of posts stands out, and that is the “Making a Difference” interviews with thought leaders and business visionaries who are making a difference to the lives of cancer patients.
The latest in the series has just been published – a video interview with Dr Gordon B. Mills MD, PhD of MD Anderson Cancer Center.
Sally interviewed Dr Mills in Stockholm at the European Multidisciplinary Cancer Congress where he gave a keynote presentation on personalized medicine in the presidential, plenary session of the meeting.
Anyone interested in cancer drug development strategy, personalized medicine and how industry and academia can collaborate together in drug development should watch this video.
We look forward to many more in the future.
September 27th, 2011
2011 European Multidisciplinary Cancer Congress Breast cancer news
There were two noteworthy breast trials with new data at the 2011 ESMO ECCO oncology congress in Stockholm this past weekend:
1) The phase III BOLERO-2 study for everolimus (Afinitor) plus exemestane is according to Sally Church, “probably the biggest single advance in breast since the Herceptin data was announced way back in the 1990’s,” with an improvement in progression free survival (PFS) from 4.1 to 10.6 months, a six and a half month extra benefit.
2) The other trial that returned good solid data was a phase II study that compared T-DM1 to trastuzumab plus docetaxel in women with HER2+ breast cancer who were previously untreated. The median PFS improved from 9.2 to 14.2 months, an improvement of 5 months before the disease worsened. The side effect profile, including cardiotoxicity, was also superior in the T-DM1 arm compared to the control arm. We still need to wait for the phase III results before drawing definitive conclusions on the safety and efficacy of T-DM1, but the results so far are promising.
Although there are multiple therapies are available for the treatment of different types of metastatic breast cancer, many of them sadly only advance progression by a few months at a time, meaning patients must cycle through multiple lines of therapy.
The good news is that these agents are being tested in different patient populations, meaning we will have new and potentially better options for more patients. It is hoped both everolimus and trastuzumab will be approved for breast cancer in the not to distant future.
You can read more about the impressive breast cancer results in the BOLERO-2 study on Pharma Strategy Blog. This data was Sally Church’s HOT NEWS of the Stockholm cancer congress!
Icarus Consultants will be at the San Antonio Breast Cancer Symposium (SABCS) later this year, where we expect more insights and new data in breast cancer new product development.
August 29th, 2011
It is a pleasure to announce that Sally Church, PhD has been invited to be a speaker in the Distinguished Lecturer Student Seminar Series held at the Science Park campus of the University of Texas, MD Anderson Cancer Center.
The Science Park located at Smithville, just outside of Austin, TX is the location of the Victoria Harris Cockrell Cancer Research Center, where basic science research is undertaken in the Department of Molecular Carcinogenesis.
The mission of the center is “to investigate the molecular biology of cancer and to develop means for cancer prevention and detection.”
Sally’s seminar on October 5, 2011 to the graduate students in cancer research is entitled, “On Science, Blogging and Drug Development.”
We look forward to reading more about Sally’s visit and seminar on Pharma Strategy Blog.
August 29th, 2011
Late last friday afternoon, Pfizer received FDA approval for Xalkori® (crizotinib) in non-small cell lung cancer (NSCLC). The companion diagnostic test from Abbott was approved at the same time. Sally Church on Pharma Strategy Blog has written about the Xalkori approval and the “wonderful news” this represents for those affected by this disease.
Sally notes that the Xalkori® story “represents another major advance for targeted therapy in a clearly defined subset of patients.” The cost of treatment is $9,600 per month. In addition there will be the cost of screening the majority of NSCLC patients who do not have an abnormal anaplastic lymphoma kinase (ALK) gene. “ALK aberrations typically occur in the order of 4-7% of NSCLC patients.”
Sally in her informative Pharma Strategy Blog post also shares the story from Dr Jack West in Seattle of one patient who has been on the drug for 2 years and is now coaching soccer!
Post Glivec/Gleevec, which Sally helped bring to market while at Novartis Oncology, it’s good to see two new highly targeted therapies that will have a major impact on the lives of patients.
Not withstanding the excellent results, it remains to be seen whether the high price of recently approved oncology drugs such as Zelboraf, Adcetris and Xalkori represents a sustainable business model in the long-run. Drug companies argue that how society spends its healthcare dollars is a matter of public policy and choice by the taxpayers, rather than an issue of how they choose to price their products.
As Pieter Droppert noted on Biotech Strategy Blog last week while writing about the Google/Department of Justice Settlement, many prescription drugs are cheaper in Canada than in the United States. Is it inevitable that the continued rise in the price of oncology drugs in the United States will eventually force some form of price regulation or costing model based on performance metrics such as Quality-Adjusted Life Years (QALY)?
In the meantime, the Xalkori approval is one that Pfizer can be proud of. Despite all that’s been said about the lack of innovation in the pharmaceutical industry, it’s an example of how knowledge of the underlying biology and mechanism of action of a disease can be leveraged in drug development. The result is a new product brought to market within a relatively short period of time.
In addition to Sally Church’s recent post on Pharma Strategy Blog about the crizotinib FDA approval, she previously posted an excellent interview with Dr Ross Camidge on “crizotinb and ALK rearrangements in lung cancer.“ This is well worth reading if you missed it the first time.
August 26th, 2011
The prostate cancer market is dynamic, with a lot of news happening. One of the many new treatments in development worth watching is custirsen (OGX-011).
Sally Church on Pharma Strategy Blog recently wrote about Custirsen from OncoGeneX. This drug inhibits the production of clusterin, a protein associated with the development of treatment resistance. As Sally notes it is in essence a “chemo enhancer.”
Phase 3 trials with custirsen are currently underway in castrate resistant prostate cancer patients receiving docetaxel in the first and second line setting.
The potential to improve the efficacy of docetaxel may be of commercial interest as more generic versions become available. According to IMS Health, sales of generic and branded docetaxel were approximately $1.1 billion for the year from June 2010 to June 2011.
This week Sandoz entered the market with their announcement of the FDA approval and launch of their generic version of Taxotere®.
It will be interesting to see whether use of custirsen with docetaxel increases overall survival (OS) in the phase III CRPC trials, and if it does how this compares to other recently approved CRPC treatments such as Zytiga™ (abiraterone acetate).
As Sally noted in her video blog post from the annual meeting of the American Urological Association (AUA), there is also preliminary scientific data to suggest that custirsen may improve the efficacy of androgen receptor antagonists such as MDV3100 from Medivation/Astellas.
We expect there will be new data on prostate cancer new products in development at the ESMO/ECCO European Multidisciplinary Cancer Congress in Stockholm in late September. The possibility of new treatment options is good news for prostate cancer patients. It is a market definitely worth watching.
August 24th, 2011
Earlier this summer, the Food and Drug Administration (FDA) Oncology Drugs Advisory Committee (ODAC) announced a positive decision for Seattle Genetics’ Adcetris™ (brentuximab vedotin) in Hodgkin Lymphoma (HL) and Analplastic Large Cell Lymphoma (ALCL).
As Sally Church on Pharma Strategy Blog reported earlier this week, Seattle Genetics has just received fast track approval from the FDA for Adcetris™, a CD30-directed antibody drug-conjugate.
Using the company announced price of $13,500 per dose, Sally in her blog post analyzed the clinical trial data and treatment regimens to come up with a likely cost for a course of treatment in the range of $94,500 – $121,500.
Sally goes on to note that the “overall treatment cost will therefore be typically less than the $120K cost of treatment for BMS’s ipilimumab (Yervoy) in metastatic melanoma.”
The clinical data for Adcetris™ is impressive, and patients will most certainly benefit from the availability of this new treatment. Adcetris™ is the first antibody drug conjugate (ADC) technology to come to market.
You can read more about Sally’s analysis of the Adcetris™ price and other ADC products in the pipeline such as Roche’s T-DM1 on Pharma Strategy Blog.