Sit back and listen to 23andMe CEO and Co-Founder <a href="https://blog.23andme.com/articles/23andmes-anne-wojcicki-among-the-best-ceos-for-women">Anne Wojcicki, </a>along with 23andMe board member and founder of 23andMe Therapeutics division <a href="https://blog.23andme.com/articles/richard-scheller-named-to-national-academy-of-medicine">Richard Scheller</a>, speak to Roelof Botha of Sequoia Capital about the company&#8217;s critical moments in history.



Botha, who is also on the 23andMe Board of Directors, discusses how the company weathered early criticism, even at its founding in 2006, from the 2013 FDA letter that ordered 23andMe to stop selling health testing products to customers to downturns in consumer interest.



The episode is part of a series called <a href="https://www.cruciblemoments.com/episodes/23andme" target="_blank" rel="noreferrer noopener">Crucible Moments,</a> produced by Sequoia Capital. In this series, Roelof explores moments in every start-up business journey in which a company can succeed or fail. How a company responds often defines its future.



Listen to <a href="https://www.cruciblemoments.com/episodes/23andme">Anne&#8217;s Crucible Moments</a> and learn a little about <a href="https://blog.23andme.com/articles/23andme-turns-16">23andMe&#8217;s history</a>.

Crucible Moments in 23andMe’s History

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.

<iframe loading="lazy" width="650" height="366" src="https://www.youtube.com/embed/xrWYJgkGcec" frameborder="0" allowfullscreen="allowfullscreen"></iframe>

23andMe’s CEO Featured On The Today Show

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

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://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04272015_BioPhoto_Robert_2x-229x300.jpg 229w, https://blog.pub.us-west-2.prd.23andme.us/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.

23andMe Therapeutics

23andMe, Pfizer, Inc. and the <img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2015/05/04092015_communityBadge_lupus-300x300.png" alt="04092015_communityBadge_lupus" class="alignright size-medium wp-image-22440" height="300" width="300" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-300x300.png 300w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-150x150.png 150w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-768x768.png 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-880x880.png 880w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-271x271.png 271w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-372x372.png 372w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-574x574.png 574w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus-980x980.png 980w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/05/04092015_communityBadge_lupus.png 1000w" sizes="auto, (max-width: 300px) 100vw, 300px" />on the genetics of the autoimmune disease known as lupus.


The aim is to quickly enroll 5,000 people with the disease, which affects about 1.5 million people in the United States alone.


“The ability to effectively personalize treatments for lupus patients is limited, due in large part to our incomplete understanding of the disease,&#8221; said 23andMe CEO and co-founder Anne Wojcicki. &#8220;We hope to change that by studying human genetics alongside environmental and health history factors to ultimately help inform better treatment options for lupus patients.”
Recruitment for the study begins this month, which is also Lupus Awareness Month.
The disease is characterized by the body’s immune system attacking normal, healthy tissues almost anywhere in the body. People with lupus might have symptoms that include inflammation of the joints, or skin rashes, sores or damage to the kidneys, or heart or lungs.
While there is no cure for the disease and it isn’t very well understood, researchers know some factors linked to the disease. They know that there are both environmental and genetic factors involved, and hormones also play a role. 
The research to be lead by 23andMe will focus on genetic factors, but it will also incorporate data from participants’ medical records and look at how the disease progresses over time. The hope is that this research will uncover some of the genetic causes for lupus that could indicate onset of the disease, how it progresses and how patients respond differently to different treatments.
“Pfizer is committed to bringing forward new treatments for patients suffering from lupus,” said Belen Carrillo-Rivas, D.Phil., Head of Research &amp; Development Innovation Projects, BioTherapeutics Research &amp; Development, Pfizer. “By enhancing our understanding of the underlying biology of the disease, we hope to better support our clinical research activities and development programs.”
For the lupus study, 23andMe will recruit new participants as well as conduct outreach to existing customers, who once determined eligible, will be required to provide consent to participate in this new project. Recruitment of eligible study participants is expected to be completed by mid 2016.
For more information, including eligibility requirements for joining the study, please visit https://www.23andme.com/lupus/.

23andMe Launches Lupus Research Community

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://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/01/Global-Drug-Dev-Spending-300x223.jpg 300w, https://blog.pub.us-west-2.prd.23andme.us/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://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/01/Time-in-years-to-FDA-approval-300x211.jpg 300w, https://blog.pub.us-west-2.prd.23andme.us/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://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2015/01/Examples-of-Drugs-Approved-300x241.jpg 300w, https://blog.pub.us-west-2.prd.23andme.us/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.

Pfizer