The AACR debuted at its annual conference today an informative video about the accomplishments and possibilities of cancer research. Check it out.
UCSF’s Dr. Susan Desmond-Hellmann is profiled in the Sunday, April 11, 2010 issue of the San Francisco Chronicle. The story is featured on the front page.
UCSF Chancellor Susan Desmond-Hellmann discusses the future of oncology
drug development and adaptive clinical trial design and what it means
to patients in an interview with Pharma Strategy Blog’s Sally Church. Here are excerpts from the post:
“What’s really neat about the I-SPY trial is that Laura Esserman, the PI of the trial, is a breast cancer surgeon here at UCSF and has added so much value to the project because she sees patients early and has a unique opportunity to offer neoadjuvant therapy.
Patients are getting their primary therapy before they get surgery, so for imaging and biomarkers – either established or exploratory – it is a fantastic opportunity. The endpoint is pathological complete response, so you can see if the tumor has disappeared or not.”
“It’s a fantastic rapid readout model so you can get answers much more quickly in a year, including pathological specimens, along with the answers from biomarkers and imaging, which are important.
The FDA has allowed a master IND agreement for this study, so it will be possible to move agents in and out of the trial quickly. So if agent A looks promising it can be advanced quickly and more patients put on it, but if agent B looks toxic, it can be discarded quickly. It’s not just a clinical trial but a experimental trial process that gives you a rapid readout of whether the agent works or not.”
“The hope is that you won’t wasting time and money in phase III trials, but most importantly, patients experience on that molecule. If the answer is yes on I-SPY, you then have a biomarker hypothesis for that agent and can then do a more traditional phase III trial having increased your chances of success.”
Read about the i-Spy 2 adaptive clinical trial which was launched on March 17 in Washington.
Watch the video from the Biomarkers Consortium press conference:
Dr. Laura Esserman, director of UCSF Helen Diller Family Comprehensive Cancer Center’s Breast Care Center is spearheading the development of a clinical trials model designed to accelerate and improve the efficiency with which experimental breast cancer therapies are assessed. The strategy, which involves the use of molecular markers and MRI, utilizes “adaptive design,” in which drugs are assessed over the course of months – rather than decades – and the information used in real time to direct the course of a trial.
The series of studies are known as I-SPY (investigation of serial studies to predict therapeutic response with imaging and molecular analysis) and are being carried out in patients with locally advanced i.e., aggressive – breast cancer. The goals of I-SPY are to establish a clinical trials model that supports the identification of drugs targeting the molecular profiles of aggressive cancers, and to reduce the duration of the drug-assessment process from the current 15 to 20 years down to a few years.
Dr. Esserman’s team presents several findings at ASCO today. One provocative finding shows that large, locally advanced forms of breast cancer often emerge between regular mammogram exams. These “interval” cancers present an important opportunity for doctors and patients to take advantage of neoadjuvant therapies in advance of surgery, with the hope they would be responsive. The other finding is that using molecular markers, UCSF researchers identified a subset of patients who do well regardless of how they respond to neoadjuvant treatment. They also identified a subset with poor prognosis for whom response to neoadjuvant therapy is a good predictor of long term outcome.
Read the press release:
“From Bench to Bedside to Market — Envisioning How Translational Research Will Make a Difference for Women With Breast Cancer” — UCSF’s 2009 Breast Oncology Program Scientific Retreat — was held this week. The focus was on experimental therapeutics, molecular markers, clinical trials and early detection. Among the topics discussed was “How siRNA will Change Cancer Therapy.” Here are a few take-aways:
- Many mutant proteins are not druggable. Cancer can adapt to tolerate targeted therapies.
- Current process of developing cancer drugs is not working.
- UCSF is developing a new paradigm of drug development through its pioneering siRNA research.
- Ultimately these siRNA discoveries will help eliminate the pharma industry R&D “valley of death.”
To learn more, visit UCSF’s Helen Diller Family Comprehensive Cancer Center site.
In the coming era of consumer genetics, your DNA will have much to tell you about the biological bases of your health, your physique and even your personality. But will this knowledge really amount to self-knowledge? asks Steven Pinker in his article My Genome, My Self, which appeared in the January 11, 2009 issue of the Sunday New York Times.
We've entered the age of personal genomics — where Pinker says "the plunging cost
of genome sequencing — will soon give people an unprecedented
opportunity to contemplate their own biological and even psychological
makeups". For example, 23andMe provides
a genetic report card and directs customers to a web page which
displays risk factors for 14 diseases
and 10 traits. This page also provides links additional diseases and
traits which according to Pinker, have iffier scientific substantiation.
This latest "do it yourself genomics" trend coincides with the new promise of personalized medicine – where drugs are being tailored to an individual's genetic makeup. The downside to this trend ranges from dubious companies which prey on hypochondriacs, to insurance and ethical isues.
For now, the jury is out on the benefits of personal genomics. I like Pinker's concluding thoughts:
in probabilities, by all means enjoy the fruits of personal genomics.
But if you want to know whether you are at risk for high cholesterol, have your cholesterol measured; if you want to know whether you are good at math, take a math test.
The Internet is accelerating biomedical progress in understanding and treating disease. Personally, I believe in the potential of services like 23andme — it empowers individuals to take control of their medical destinies and enables them to create virtual cohorts for clinical research and trials. With tools like these, personalized medicine will evolve even faster.