As part of a series on cutting edge women, The Today Show featured Anne Wojcicki, 23andMe&#8217;s CEO and co-founder.


The NBC crew followed Anne as she hustled through a typical day, juggling family life, and work meetings. The crew also got a glimpse of 23andMe&#8217;s Therapeutics lab, and sat down with her to talk about her vision for the future.


Check out the segment.

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23andMe Blog

23andMe Blog Team

23andMe’s CEO Featured On The Today Show

23andMe scientists will be at the annual American Society of <img loading="lazy" decoding="async" class="alignright size-full wp-image-24281" src="https://blog-api.23andme.com/wp-content/uploads/2016/09/microscope.jpg" alt="microscope" width="131" height="166" />Human Genetics meeting in Vancouver this month, sharing a wide spectrum of interesting data, including more on the genetics of Parkinson’s disease, promising new methods for drug discovery, and even some fun findings around traits like nail biting and the ability to carry a tune.
These conferences, which attract thousands of geneticists and include hundreds of scientific presentations over four days, are tough to encapsulate in one article. But each year, ASHG does a good job of keying in on the most interesting current issues in the field of genetics, creating forums for some of those big ideas, and then offering scientists a chance to show off their latest work in those areas.
This year is no different, with talks on gene editing, strategies for incorporating health records into genetic research, and panel discussions on the genetics of cancer and aging.
<h2>Therapeutics</h2>
Along with presenting some of our findings, 23andMe also has the honor of having two of our scientists speak at this year’s conference.
Richard Scheller, 23andMe’s chief science officer and head of the therapeutics group, will speak on Wednesday during a session on using genome-wide association studies to help develop drug targets. Richard will be one of four speakers during a session titled “From GWAS and Mendelian Genes to Therapeutic Drug Targets.” 23andMe’s therapeutics group is using human genetic data as the starting point for identifying new therapies for both common and rare diseases.
<h2>Associations with Nail Biting</h2>
23andMe senior statistical geneticist Chao Tian will also speak at the four-day conference. Chao is no stranger to the conference, having<a href="https://blog-api.23andme.com/wp-content/uploads/2013/10/GWAS-for-Susceptibility-to-Infection.pdf"> presented a poster in 2013</a> that used genome-wide association studies to classify HLA alleles associated with infectious diseases. This year, Chao will speak in a short “platform session” on Saturday, Oct. 22, focused on Neuropsychiatric Disease in the Young and Old. She will present data on genetic and phenotypic associations for<a href="https://ep70.eventpilot.us/web/page.php?page=IntHtml&amp;project=ASHG16&amp;id=160121314"> nail biting</a>. Among her findings were that some of the variants associated with the trait are in genes or gene regions that have also been associated with certain psychiatric disorders.
Along with talks, panel discussions, and plenary sessions, scientists will also highlight their findings in poster sessions – which usually consist of vast halls where researchers literally post their work on boards and stand by to answer questions posed by anyone who happens to walk by. This informal question and answer session – involving attendees, most of whom are scientists – can be the most stimulating part of the conference, where researchers are sometimes forced to explain their methods and defend their findings in real time.
Below is the list of some poster presentations 23andMe will present at ASHG. We’ll provide more details during the conference.
<div style="float: center; text-align: justified; width: 600px; background-color: #eee; padding: 15px; margin-left: 10px;">
<h2 style="text-align: center;">23andMe&#8217;s Presentations at ASHG</h2>
• Genetic variation underlying self-reported weight-loss success in the presence of a dietary intervention – Authors: J.F. Shelton; N.A Furlotte; R. Smith; C. Wheldon; M.N. Johnson; C. Wilson; G. Benton; R. Gentleman
• Interrogating gene-by-environment interactions using genetic risk scores – Authors: Furlotte; V. Vacic; G. Benton; A. Auton; D. Hinds
• Generalized polygenic risk prediction for direct-to- consumer genetic testing of non-medical traits – Authors: M.L. Multhaup; R.P. Smith; D. Hinds; N.A. Furlotte
• GWASs of ability to carry a musical tune and mathematical educational attainment – Authors: R. Bell; D. Hinds; C. Tian
• GWAS of levodopa-induced dyskinesia in Parkinson’s disease – Authors: O.V. Sazonova; I. HallgrÃ­msdÃ³ttir; J. Shelton; P. Cannon
• Phenome-wide association study of 28 variants associated with Parkinson’s disease in a web-based cohort – Authors: K. Heilbron; B. Alipanahi; P. Cannon
• Leveraging PheWAS to Fine Map Complex Trait GWAS Loci – Authors: F. Sathirapongsasuti; P. Fontanillas; V. Vacic; A. Auton
• Efficient calculation of genetic correlations across 700,000 pairs of diverse phenotypes – Authors: A. Kleinman; N. Furlotte; A. Auton; D. Hinds
• The impact of personal experience with direct ­-to- ­consumer genetic testing on physician readiness – Authors: E.S. Gordon; E. Kim; J. Cintron; R. Gold; J. Pollard; E. Nelson
</div>

23andMe Scientists To Present New Findings at ASHG

The sobering fact about drug development is that it takes too long and costs too much money. 23andMe wants to change all that.<img loading="lazy" decoding="async" class="alignright size-medium wp-image-23144" src="https://blog-api.23andme.com/wp-content/uploads/2015/10/Slide3-e1445883959527-300x115.jpg" alt="Slide3" width="300" height="115" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/10/Slide3-e1445883959527-300x115.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2015/10/Slide3-e1445883959527.jpg 678w" sizes="auto, (max-width: 300px) 100vw, 300px" />
At the annual meeting of the American Society of Human Genetics this month, 23andMe computational biologist Fah Sathirapongsasuti offered some insight into how this is being done.
“It’s a well-appreciated fact among drug developers that genetic evidence can indicate success of a drug program, but until now, genetic data was hard to come by.”
In his presentation, Fah explained 23andMe’s unique drug discovery model, which has the promise of lowering the cost and accelerating the pace of drug discovery. This new model is also what is behind <a href="https://blog.23andme.com/news/23andme-therapeutics/" target="_blank" rel="noopener noreferrer">23andMe&#8217;s Therapeutics group</a>.
The current industry model isn’t working well, he said. Nine out of ten drugs deemed successful in animal studies fail in human clinical trials. And all that time and all those failures add up to staggering costs. Although there’s a<a href="http://www.nejm.org/doi/full/10.1056/NEJMp1500848"> dispute</a> about just how many hundreds of millions or billions it costs to develop a drug, no one disputes that finding new drugs is too slow and costs way too much.
But there’s another way, as Fah explained.
Simply using genome wide association studies can help improve success.
A<a href="https://www.nature.com/ng/journal/v47/n8/full/ng.3314.html"> recently published study</a> showed that starting with a GWAS could double the success rate of drug development. Another approach is to identify genetic variants that are protective and use those variants to zero in on promising drug targets. A well-known example of that approach is the work done by Amgen and Sanofi in the development of two recently approved drugs that target cholesterol-lowering variants in the gene PCSK9, Fah said.
But what makes 23andMe research model unique is its customers. So far we have more than a million, and 80 percent of them have chosen to participate in our research. They are also engaged and have shared more than 300 million data points about themselves that inform research. Our scientists can gather that information about health history, or drug sensitivity or ancestry and traits, into specific “phenotypes.”
We have more than a thousand phenotypes to work with such as phenotypes for cardiovascular and autoimmune diseases, as well as different forms of cancer and metabolic conditions, giving our researchers a tremendous resource to compare genetic information against.
That gives 23andMe researchers a huge head start, said Fah. Using that data, researchers first look at phenotypic information to find a candidate indication for genes that, in turn, can be easily targeted by antibodies. &nbsp;23andMe recently did just that with, studying 255 genes that code for cytokines and receptors, and focusing on those genes that have not yet been targeted by industry. About half of that total have not yet been used for drug targeting.
Finally screening those targetable variants in our database, our researchers found about two-dozen potential targets.
There’s a lot of additional work that goes into the process, for instance just determining whether these targets offer a plausible biological pathway that’s relevant to treating a disease.<img loading="lazy" decoding="async" class="alignright size-medium wp-image-23143" src="https://blog-api.23andme.com/wp-content/uploads/2015/10/Slide2-300x169.jpg" alt="Slide2" width="300" height="169" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/10/Slide2-300x169.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2015/10/Slide2.jpg 720w" sizes="auto, (max-width: 300px) 100vw, 300px" />
Fah illustrated this by looking at IL13, a gene that encodes a cytokine secreted by T helper cells that in turn mediate allergic inflammation. Looking at the phenotypic associations for variants in IL13, 23andMe researchers found a clustering of associations around asthma, certain types of food and animal allergies as well as skin conditions like psoriasis. &nbsp;And indeed IL13 is a known target for several drugs that are currently in phase II and phase III clinical trials.
“At 23andMe, we are turning the drug discovery process on its head,&#8221; said Fah. &#8220;Traditionally a pharmaceutical company starts with a disease of interest and combs the disease pathways for drug targets. &nbsp;We start from a set of druggable molecules and use our genetic database to guide us to the disease indications. &nbsp;Because we scan across a wide spectrum of disease and traits, we can choose the most promising targets to work with.”
This is still early in this new drug discovery approach, he said.
&#8220;We feel incredibly blessed to be working with this powerful database, with our customers as partners,” Fah said.
<div style="float: center; text-align: justified; width: 640px; background-color: #eee; padding: 15px; margin-left: 10px;"><img loading="lazy" decoding="async" class="alignright size-medium wp-image-23151" src="https://blog-api.23andme.com/wp-content/uploads/2015/10/ASHG-15-Posters.001-300x225.jpg" alt="ASHG 15 Posters.001" width="300" height="225" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/10/ASHG-15-Posters.001-300x225.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2015/10/ASHG-15-Posters.001-768x576.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2015/10/ASHG-15-Posters.001-880x660.jpg 880w, https://blogcms.23andme.com/wp-content/uploads/2015/10/ASHG-15-Posters.001.jpg 1024w" sizes="auto, (max-width: 300px) 100vw, 300px" /> 
Fah was not the only 23andMe scientist at American Society of Human Genetics this year. As we do each year, 23andMe had a strong showing, and our data was included in a number of presentations. This year we had two posters that were part of the conference.</div>
<div style="float: center; text-align: justified; width: 640px; background-color: #eee; padding: 15px; margin-left: 10px;">
&#8211; &#8220;<a href="https://blog-api.23andme.com/wp-content/uploads/2015/10/nfurlotte_ASHG_2015_final_approved.pdf" target="_blank" rel="noopener noreferrer">Deep Learning and the prediction of human disease risk</a>,&#8221; by Nicholas Furlotte, Babak Alipanahi and David Hinds
&#8211; <a href="https://blog-api.23andme.com/wp-content/uploads/2015/10/ASHG2015_AaronFinal.pdf" target="_blank" rel="noopener noreferrer">&#8220;Improving haplotype phasing accuracy using many short IBD segments,&#8221;</a> By Aaron Kleinman, Eric Durand and Cory McLean
</div>

23andMe And Drug Discovery

Growing up 23andMe’s chief science officer Richard Scheller, Ph.D., had classmates in his elementary school, who wanted to be a firemen, police officers and astronauts.
Richard always wanted to be a scientist.
<div id="attachment_22312" style="width: 305px" class="wp-caption alignright"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-22312" class="size-full wp-image-22312" src="https://blog-api.23andme.com/wp-content/uploads/2015/03/Headshot-Richard-Scheller.jpg" alt="Dr. Richard Scheller" width="295" height="197" />Dr. Richard Scheller</div>
“My classmates had posters of rock bands or cars on the walls in their bedrooms,” he said. “I had the periodic table of the elements.”


That singular focus and a lifetime of scientific accomplishments was recognized this week when Dr. Scheller was named to the<a href="http://www.national-academies.org/"> National Academy of Medicine</a>.


“I’m honored to join such a prestigious group of scientists,” Dr. Scheller said after learning of his nomination.


Considered one of the highest honors in the field of health and medicine, membership to the academy is given to those recognized for outstanding professional achievements who also have had a commitment to service. More than 300 of its members are also Nobel laureates.
For Dr. Scheller, membership adds to the long list of accomplishments he’s made over his distinguished career that includes achievements not just in business, but in academia and research.
Dr. Scheller joined 23andMe to lead the new therapeutics group, which is tasked with leveraging the company’s innovative research model to find and develop new treatments for diseases. When he came on board, 23andMe’s president Andy Page, noted how fortunate the company was to have him, calling Dr. Scheller a “visionary.”  
Even in his short time with the company,  Scheller and his team have made great progress, Page said.
Before coming to 23andMe, Dr. Scheller served as executive vice president for research and early development at Genentech for almost 15 years. Prior to that he spent almost two decades at Stanford University serving as a professor in the Department of Biological Sciences and in the Department of Molecular and Cellular Physiology as well as working as an investigator at the Howard Hughes Medical Institute at the Stanford University Medical Center.
Two years ago, Dr. Scheller received the Albert Lasker Basic Medical Research Award for his discoveries concerning the molecular machinery and regulatory mechanism that underlie the<a href="http://blogs.nature.com/spoonful/2013/09/lasker-awards-go-to-rapid-neurotransmitter-release-and-modern-cochlear-implant.html"> rapid release of neurotransmitters</a>. Considered one of the most respected science prizes in the world, the Lasker Award is sometimes referred to as “America’s Nobel.”
Last year, Dr. Scheller received a CalTech Distinguished Alumni Award for his work, and in 2010 he received a<a href="http://www.kavliprize.org/prizes-and-laureates/laureates/richard-h-scheller"> Kavli Prize</a>, and he has a U.S. National Academy of Sciences Award in Molecular Biology.
Along with now being part of the National Academy of Medicine, Dr. Scheller is also a member of the National Academy of Arts &amp; Sciences, and the National Academy of Sciences.
He serves on the board of trustees for the California Institute of Technology and as an adjunct professor in the Department of Biochemistry and Biophysics at the University of California, San Francisco. He has published more than 280 research studies.

Richard Scheller Named to National Academy of Medicine

Anne Wojcicki, 23andMe&#8217;s CEO and co-founder, spoke recently with Kai Ryssdal, the host and senior editor at 
<img loading="lazy" decoding="async" class="alignright size-medium wp-image-22084" src="https://blog-api.23andme.com/wp-content/uploads/2015/01/Anne_Color_-Seated-250x300.jpg" alt="Anne_Color_ Seated" width="250" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/01/Anne_Color_-Seated-250x300.jpg 250w, https://blogcms.23andme.com/wp-content/uploads/2015/01/Anne_Color_-Seated-768x923.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2015/01/Anne_Color_-Seated-852x1024.jpg 852w, https://blogcms.23andme.com/wp-content/uploads/2015/01/Anne_Color_-Seated-732x880.jpg 732w, https://blogcms.23andme.com/wp-content/uploads/2015/01/Anne_Color_-Seated-982x1180.jpg 982w" sizes="auto, (max-width: 250px) 100vw, 250px" />Marketplace, about the company, genetics, and the future of health care.


It&#8217;s a good overview of some of what we&#8217;ve been doing lately here at 23andMe.
Anne takes time to explain some of 23andMe&#8217;s core mission about helping people access and benefit from their genetic information, as well as explain how this information will become increasingly important in the future.


Genetic information is already changing health care, but it is also changing drug development and discovery. 23andMe recently announced the creation of its new therapeautics group, lead by renowned scientist Richard Scheller, Ph.D. Anne talked a little bit about this effort and how it aligns with 23andMe&#8217;s overall mission.


It&#8217;s worth taking a few minutes to listen to the piece.

The Future of Health Care

Over the last few months 23andMe has assembled a virtual dream team to make up its therapeutics group.<img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2015/05/04272015_BioPhoto_Robert_2x-229x300.jpg" alt="04272015_BioPhoto_Robert_2x" class="alignright size-medium wp-image-22511" height="300" width="229" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/05/04272015_BioPhoto_Robert_2x-229x300.jpg 229w, https://blogcms.23andme.com/wp-content/uploads/2015/05/04272015_BioPhoto_Robert_2x.jpg 650w" sizes="auto, (max-width: 229px) 100vw, 229px" />


Starting with the appointment of Richard Scheller, Ph.D. as chief science officer and head of therapeutics, 23andMe has filled out the team with some top-notch talent including another luminary Robert Gentleman, Ph.D., as vice president of computational biology.
The two have talked about the potential for using 23andMe’s novel research model to make some real breakthroughs and bring better treatments to people who really need them. As Robert recently said in an interview with Bio-IT World, most of us have friends or family who have suffered from illness.
“And the motivation for doing some of this stuff is really not personal in the sense [of being] about you yourself, but it’s about your family, it’s about your friends, it’s about people around you,” Robert said.

It’s hard not to hear these men talk about their work, as Robert did earlier this month with a writer from Bio-IT World, and not feel a sense of excitement about the future.
“I also want to emphasize, this is just a fantastic time to be a computational biologist,” he said.


Check out his interview <a href="http://www.bio-itworld.com/2015/3/17/23andme-therapeutics-wont-change-drug-discovery.html" target="_blank" rel="noopener">here</a>.

A Computational Biologist And A Gentleman

By Anne Wojcicki

It is with great pleasure that we are announcing an addition to the 23andMe executive team and a new initiative for the company.
<div id="attachment_22312" style="width: 305px" class="wp-caption alignright"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-22312" src="https://blog-api.23andme.com/wp-content/uploads/2015/03/Headshot-Richard-Scheller.jpg" alt="Dr. Richard Scheller" class="size-full wp-image-22312" width="295" height="197" />Dr. Richard Scheller</div>
Renowned scientist, Dr. Richard Scheller, will be joining 23andMe as our Chief Science Officer and will lead the development of a new research and development group, 23andMe Therapeutics.


The same way we are transforming the way people access and understand their genomes, we hope to transform the way we discover and develop novel therapies. By starting with genetic information and understanding the basics of disease, we hope we can make discoveries that will have a meaningful impact on society. 
Dr. Scheller joining is a testament to the power of 23andMe and what our customers have come together to build. 23andMe is the largest database in the world of genetic information, with almost 900,000 customers.
Customers have contributed over 250 million datapoints of information. All that information powers research that helps us understand how to prevent and treat disease.
Our mission is to help people access, understand and benefit from the human genome. With Dr. Scheller joining the team, we believe we will be putting our best efforts into helping customers and society benefit from the human genome.
Participating in research is completely voluntary and customers can opt-in or out at any time.
Over 80 percent of customers chose to opt-in to research and answer questions. We believe we have the potential to be the source of new discoveries that transform the health and lives of our friends and family. Our customers should be proud that they make this research possible.

Anne Wojcicki

23andMe Therapeutics

Before a medicine reaches pharmacy shelves, it goes through extensive and rigorous evaluation to prove it is safe and <img loading="lazy" decoding="async" class="alignright size-full wp-image-21214" src="https://blog-api.23andme.com/wp-content/uploads/2014/07/IBD-IMage-.jpg" alt="IBD IMage" width="240" height="160" />effective.
We want to shed some light on a few of the steps involved in drug development and highlight how the work being done by 23andMe with the <a href="https://www.23andme.com/ibd/" target="_blank" rel="noopener noreferrer">Inflammatory Bowel Disease Study</a> can help inform this process in the future. 

<h6>
The basics 
</h6>

On average, it takes somewhere between 11 and 14 years for a drug to go through development. This extensive process can cost up to $5 billion. Of all the medicines that start the clinical development process, less than 10 percent make it through all the stages of clinical trials and through Food and Drug Administration (FDA) approval. The majority of the drug
<div id="attachment_22135" style="width: 310px" class="wp-caption alignright"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-22135" class="size-medium wp-image-22135" src="https://blog-api.23andme.com/wp-content/uploads/2015/01/Global-Drug-Dev-Spending-300x223.jpg" alt="Image: The Center for Information and Study on Clinical Research Participation " width="300" height="223" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/01/Global-Drug-Dev-Spending-300x223.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2015/01/Global-Drug-Dev-Spending.jpg 548w" sizes="auto, (max-width: 300px) 100vw, 300px" />Image: The Center for Information and Study on Clinical Research Participation</div>
development timeline is taken up by conducting the clinical trials (6-11 years), and one of the most time-intensive parts of running clinical trials is finding study volunteers. Only 7 percent of Americans say their doctor has ever suggested they consider participating in a clinical research study.

<h6>
What happens before clinical trials? 
</h6>

Before a medicine enters clinical development, it goes through years of testing in the laboratory, using cell culture and animals to better understand how the drug works and to ensure it’s safe.

<h6>
Clinical Trials: Phase I to Phase III 
</h6>

The very first study of a new medicine in people is called a “phase I” study. This type of study is very small – just a handful of volunteers are given the drug, starting at very low amounts. The dose is increased incrementally until they find a dose that is safe and also high enough to be considered active.
<div id="attachment_22136" style="width: 310px" class="wp-caption alignright"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-22136" class="size-medium wp-image-22136" src="https://blog-api.23andme.com/wp-content/uploads/2015/01/Time-in-years-to-FDA-approval-300x211.jpg" alt="Image: The Center for Information and Study on Clinical Research Participation " width="300" height="211" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/01/Time-in-years-to-FDA-approval-300x211.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2015/01/Time-in-years-to-FDA-approval.jpg 566w" sizes="auto, (max-width: 300px) 100vw, 300px" />Image: The Center for Information and Study on Clinical Research Participation</div>
The next study, a “phase II” trial, is larger and looks for safety as well as efficacy. Essentially this phase looks at whether the drug does what it is meant to do. Does it improve the symptoms or alleviate the disease?
A “phase III” study is the largest still and often includes a “control” group – volunteers who are given the standard-of-care medications (not the experimental drug) for comparison.  The FDA then reviews the data collected from these trials. The FDA can then request additional studies, or it can “clear” the drug for use (meaning the manufacturer can go ahead and sell the drug.)
<h6>
How can genetics impact the drug development process?</h6>
Newly approved medicines provide benefits to many people. They alleviate symptoms, or sometimes cure a disease. However, they don’t work well for everyone. Many people take medicines which don’t help their condition, or sometimes lead to unacceptable side effects. There is no way to know which medicines will work for which patients. The method of finding the right treatment for any patient is still very much a “trial and error” process – the doctor keeps prescribing different medicines until he or she finds one that works.


This is where genetics may play a role in improving the process. We know that genetics can influence how people respond to drugs. By studying the genetics underlying diseases, such as Inflammatory Bowel Disease (IBD), we hope to provide more insights into how IBD differs between people. It is possible that there are certain genetic variants which can predict what type of drug would be most effective, or cause the least side effects.
A better understanding of the genetics of IBD can change how clinical trials are done, which can in turn bring medicines to the market faster and provide guidance to physicians about which patients will most benefit from which drugs.
<div id="attachment_22134" style="width: 310px" class="wp-caption alignright"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-22134" class="size-medium wp-image-22134" src="https://blog-api.23andme.com/wp-content/uploads/2015/01/Examples-of-Drugs-Approved-300x241.jpg" alt="Image: The Center for Information and Study on Clinical Research Participation " width="300" height="241" srcset="https://blogcms.23andme.com/wp-content/uploads/2015/01/Examples-of-Drugs-Approved-300x241.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2015/01/Examples-of-Drugs-Approved.jpg 528w" sizes="auto, (max-width: 300px) 100vw, 300px" />Image: The Center for Information and Study on Clinical Research Participation</div>
Patients who enroll in clinical trials of new medicines must meet several specific eligibility criteria. For IBD, right now those criteria may involve a list of medications the person must have taken (and failed) and/or a specific range of acceptable lab results.
In the future, the eligibility criteria for an IBD trial may include lists of specific genetic variants that participants need to have in order to enroll in the study along with other precise measures of disease such as the composition of their microbiome (the types of bacteria in their gut). In this way, only those patients who would most benefit from the experimental medicine would be enrolled, sparing patients with no hope for efficacy the potential side effects of the drug and allowing them to find other clinical trials better suited for their IBD.


Precision medicine (prescribing the right medication for the right patient at the right time) is already a reality in the treatment of many cancers. Examples of such drugs are: trastuzumab (Herceptinâ“‡) for the treatment of HER2 positive breast cancer, cetuximab (Erbituxâ“‡) for the treatment of colorectal cancer which carries a mutation in the EGFR gene but not the KRAS gene, or crizotinib (Xalkoriâ“‡) for the treatment of lung cancers with an ALK gene fusion.
The reality of genetically targeted medicines is still not yet realized for IBD, but we are helping lay the groundwork through our research efforts and collaboration with Pfizer, a manufacturer of new treatments for IBD.
Observational studies (where no drugs or treatments are involved) such as our IBD study play an important role in providing a basic understanding of the disease. We hope the results of this study will directly inform Pfizer’s drug development efforts and help us move just a step closer to the future of precision medicine approaches in IBD.

Therapeutics — Page 3