Dr. Chou is the President, CEO and a member of the Board of Directors of AltruBio, Inc. a clinical stage biotech company that is focused on developing novel antibody therapeutics for the treatment of immune inflammatory diseases.
“I am excited to join the ICOC leveraging my experience both as a scientist in the the biopharmaceutical industry and as a corporate executive to support the research and funding of life changing medicines for patients in need,” said Dr. Chou.
Dr. Chou has more than 20 years experience in drug development and biomanufacturing. Before joining AltruBio she headed the global Biotech organization at Bayer Pharmaceuticals. At Bayer she oversaw the development, manufacturing and distribution of the company’s more than $3 billion product portfolio. She also oversaw more than 2,000 employees and led the drug development and launch activities for the biologics pipeline. In addition, she also served as the site head for Bayer’s facility in Berkeley, California, the company’s largest manufacturing site in the U.S.
“We are honored and delighted to have Dr. Chou take a seat on the Board,” says Jonathan Thomas, Ph.D., J.D., Chair of the CIRM Board. “She has a remarkable career in academia, industry and in promoting diversity, equity and inclusion and will be an invaluable addition to the ICOC. We are very much looking forward to working with her.”
Dr. Chou also has had leadership roles at Pfizer, Medivation Inc., Genentech and Wyeth Biopharma. She has won several awards and in 2018 was the recipient of the Most Influential Women in Business award by the San Francisco Business Times. She is currently an advisor at the UC Berkeley Engineering School and is working to promote diversity and inclusion through her advisory board position at Silicon Valley Women in Engineering.
Dr. Chou obtained her Ph.D., at Yale, her post-doctoral training at the Max-Planck Institute in Germany and was a research faculty member at Harvard University Medical School focusing on cell biology and neuroscience.
Dr. Chou was appointed to the CIRM Board by State Treasurer Fiona Ma, as the Executive Officer of a Commercial Life Science entity. She replaces Dave Martin.
At the California Institute for Regenerative Medicine (CIRM) we are fortunate in having enough money to fund the most promising research to be tested in a clinical trial. Those are expensive projects, often costing tens of millions of dollars. But sometimes the projects that come to our Board start out years before in much more humble circumstances, raising money through patient advocates, tapping into the commitment and ingenuity of those affected by a disease, to help advance the search for a treatment.
That was definitely the case with a program the CIRM Board voted to approve yesterday, investing more than $11 million dollars to fund a Phase 2 clinical trial testing a cell therapy for dysphagia. That’s a debilitating condition that affects many people treated for head and neck cancer.
Patients with head and neck cancer often undergo surgery and/or radiation to remove the tumors. As a result, they may develop problems swallowing and this can lead to serious complications such as malnutrition, dehydration, social isolation, or a dependence on using a feeding tube. Patients may also inhale food or liquids into their lungs causing infections, pneumonia and death. The only effective therapy is a total laryngectomy where the larynx or voice box is removed, leaving the person unable to speak.
Dr. Peter Belafsky and his team at the University of California at Davis are developing a therapeutic approach using Autologous Muscle Derived Progenitor Cells (AMDC), cells derived from a biopsy of the patient’s own muscle, elsewhere in the body. Those AMDCs are injected into the tongue of the patient, where they fuse with existing muscle fibers to increase tongue strength and ability to swallow.
The $11,015,936 that Dr. Belafsky is getting from CIRM will enable them to test this approach in patients. But without grass roots support the program might never have made it this far.
Ed Steger is a long-term survivor of head and neck cancer, he’s also the President of the National Foundation of Swallowing Disorders (NFOSD). In 2007, after being treated for his cancer, Ed developed a severe swallowing disorder. It helped motivate him to push for better treatment options.
In 2013, a dozen swallowing disorder patients visited UC Davis to learn how stem cells might help people with dysphagia. (You can read about that visit here). Ed says: “We were beyond thrilled with the possibilities and drawing on patients and other UCD contacts our foundation raised enough funds to support a small UCD clinical trial under the guidance of Dr. Belafsky in mouse models that demonstrated these possibilities.”
A few years later that small funding by patients and their family members grew into a well-funded Phase I/II human clinical trial. Ed says the data that trial produced is helping advance the search for treatments.
“Skipping forward to the present, this has now blossomed into an additional $11 million grant, from CIRM, to continue the work that could be a game changer for millions of Americans who suffer annually from oral phase dysphagia. My hat is off to all those that have made this possible… the donors, patient advocates, and the dedicated committed researchers and physicians who are performing this promising and innovative research.”
Our hats are off to them too. Their efforts are making what once might have seemed impossible, a real possibility.
UC Davis School of Medicine Dean, Dr. Allison Brashear: Photo courtesy UCD
We have a new member on the CIRM Board – Dr. Allison Brashear is the Dean of the UC Davis School of Medicine, overseeing one of the nation’s top research, academic and medical training institutions.
Dr. Brashear is an internationally known researcher in movement disorders and an expert in ATP1A3-related diseases, a spectrum of rare neurologic disorders.
Before joining UC Davis, Dr. Brashear was professor and chair of the Department of Neurology for 14 years at Wake Forest School of Medicine.
She serves on the American Board of Psychiatry and Neurology, and has served on the boards of the American Neurological Association and the American Academy of Neurology, where she was instrumental in crafting a leadership program for women, now expanded to include leadership development for minorities.
You can read more about her background in this news release. But we wanted to get a sense of what motivates and inspires Dr. Brashear. So we asked her. And she told us.
Dean Brashear being sworn in – virtually – on the CIRM Board. Top left, James Harrision CIRM General Counsel; Jonathan Thomas, CIRM Board Chair; Dr. Brashear; and Dr. Jim Kovach, Director of Industry Alliances at UC Davis, alternative Board member.
When did you get interested in science? Was this always something you knew you wanted to do?
I loved math and science in middle school and continued with science in college. I grew up hearing my parents talk about caring for patients and the impact you could have on them and their family’s lives. My father is a pulmonologist and my mother was a Ph.D. in marriage and family therapy. Together they taught me the value of patient-centered care.
My mother was a tremendous advocate for women. When I was in middle school she took my friend and I to the state legislature and we watched the ERA (Equal Rights Amendment) debates. It’s a powerful memory but not always flattering about what people thought at the time. So, from an early age I really became a strong advocate for women, to make sure women had opportunities and that we were an inclusive culture wherever I was.
As a woman going into a male dominated field, how did you manage to push past the skeptics and doubters to succeed?
Early on I recognized the need to work with senior faculty who would give me an opportunity to lead and learn. I became a chair of neurology at Wake Forest when I was 44 and was the only woman chair for 4 years. When I was appointed to the Wake Forest Baptist Medical Center Board of Directors as one of two faculty, I was the only woman. I learned early on that it was important to have sponsorship from senior leaders to succeed. I learned that, when opportunities presented themselves, to say “yes.” This is how I became the lead investigator into ATP1A3 related diseases in 1991. That project, now 11 years funded by the NIH, is one that is led by me and three other women.
It’s still not uncommon for me to walk into a room and be the only woman. And so, making sure that there is appropriate support for women leaders is really key.
Did you have mentors to help you along the way – what was their advice to you?
I prefer the term sponsorship. Mentors advise – which is important, but more important is the role of the sponsor. A sponsor goes out of their way to advance another career. This can be a public call-out, a well-placed phone call or giving a resident what ends up being a new pathway of research. I appreciate the many sponsors in my life, and that includes men and women. I aspire to be a similar sponsor. This is my way to pay it forward.
How do you sponsor others to help them overcome barriers, etc.?
I advise women to get extra leadership training, learn about money and to make sure to have a network of advocates. I also remind them to say thank you to those who pave the way.
I think it goes down to the message that you meet these key people in your life and they go the extra mile to help you and you, as a leader, need to take that opportunity and really just launch from it. Along the way I found I really wanted to bring people in and grow them and that was the best part of being chair of the department and one of the reasons I wanted to be a dean. When faculty join our health system I want to set them up to succeed. Celebrating others’ success with them is a great feeling. Fostering these successes is how we can be a catalyst to research and care innovations that improve health, which is at the heart of our work.
These are interesting times to head a major university, what advice and encouragement do you have for students just starting out who face their first year “at university” at home?
Every change brings opportunity. University at home is hard – interpersonal relationships are so important to learning and we miss that when we are on Zoom. I advise students and faculty to nurture those social connections.
When you are not working what do you do for fun?
I hang out with my husband and our two rescue dogs. We are making plans to go explore California when the COVID-19 pandemic settles down. We had our two adult children home during the shutdown, but both are back at school on the East Coast.
Ysabel Duron, a pioneering award-winning Latina journalist, and a leading figure in cancer education in the Latino community in the US, has been appointed to the governing Board of the California Institute for Regenerative Medicine.
State Controller Betty Yee made the appointment saying: “Ms. Duron’s personal perspective as a (cancer) survivor and her commitment to equity will serve the institute’s mission well.”
Ms. Duron was a journalist and TV news anchor for more than 43 years winning numerous awards, including two EMMYS. She has been inducted into the Hall of Fame of the National Association of Hispanic Journalists and given the Living Legacy Award by the Chicana/Latina Foundation.
As a journalist she covered her own battle against Hodgkin’s Lymphoma, using her reporting to help raise awareness about the disease and the health disparities involved in treating it in communities of color.
In 2003, as a result of her own experience, she founded Latinas Contra Cancer, a non-profit organization that advocates for and serves the Latino community. She is now the President of the Latino Cancer Institute, a national network of Latino cancer service agencies addressing the community’s cancer disparities.
“As a veteran journalist, I like to think I am as curious as a scientist, I just frame the question differently,” says Ms. Duron. “Usually I am looking for the best return for the public health! This appointment gives me a new learning opportunity to understand a very complex issue, and, make it bite size so the public, patients and advocates will understand how these scientific revelations will impact lives in the short term and the long run. As a steward of taxpayer dollars, I also want to make sure there is equity for communities across California, and that the research serves all of us”
We are delighted to welcome Ysabel to the Board,” says Jonathan Thomas, CIRM Board Chair. “She has a well-deserved reputation as a champion for patients and an activist committed to breaking down barriers that prevent people in the Latino community accessing quality care. She will add a powerful voice to our Board.”
Ms. Duron replaces Sherry Lansing as the CIRM Board patient advocate for cancer.
“It is impossible to overstate Sherry’s importance and contributions to CIRM over her long tenure on the Board,” says Thomas. “Sherry was one of the original Board Members and a towering presence who played a central role in the formulative years of the Agency, including co-chairing the Standards Working Group, which set the ethical guidelines for the future research CIRM would enable. Since that time, she has been a commanding voice of reason and an unrelenting positive force on behalf of all patients. She will be sorely missed.”
The newest member of the CIRM Board is a researcher who wasn’t always sure she would have a career as a scientist. Suzanne Sandmeyer, PhD, says at the start of her career she had a lot of doubts.
“During my postdoc, I was developing the impression I would struggle to survive in my career as a scientist. I had a female mentor at the time and I shared this idea with her. She told me that was ridiculous: I was not going to starve, and I believed her. Turns out, she was right. Today, I enjoy the independence that comes with academia.”
We’re delighted she changed her mind. Dr. Sandmeyer, is now the Vice Dean for Research at the University of California at Irvine (UCI) School of Medicine, and has been appointed to CIRM’s Board.
She was recommended for the position by UCI Chancellor Howard Gillman who called her “an outstanding researcher who has contributed significantly to the field of molecular genetics.”
Dr. Sandmeyer said she was honored to be chosen.
“It is a privilege to be involved in this new era of stem cell research and clinical trials. We have only just begun to understand the potential of our discoveries and the impact we can have on human health by advancing stem cell therapies.”
Jonathan Thomas, Ph.D., J.D., the Chair of the CIRM Board, welcomed the appointment saying:
“Dr. Sandmeyer will be a great addition to the Board. She has a distinguished career, not just as a highly regarded scientist but also as a leader in helping UC Irvine become the great research institution it is today.”
Dr. Sandmeyer’s career as a scientist had an early beginning.
“My Dad was an engineer, so science always seemed like a very natural thing to pursue. Growing up I liked to be outdoors and loved the diversity of living things, so I eventually gravitated toward biology.”
That sense of curiosity and love of biology has helped her build a bustling and productive research lab at UC Irvine. Her research focuses on molecular genetics and biochemistry of retrovirus-like elements called retrotransposons (which make up almost half the human genome but are not well understood) and metabolic engineering in yeast. Although she has had amazing success in academia, she was not always sure that this would be her path.
As a member of the CIRM Board, Dr. Sandmeyer will provide important insight and perspective into advancing stem cell therapies.
“Our country has one of the most expensive systems of medical care and yet we don’t have the longest-lived population. I want to work toward reducing the burden of medical expenses for people. I am very excited about the potential of stem cells to treat many disorders and the potential for new technologies like CRISPR to further empower that approach.”
When not making important scientific discoveries in the lab, you can find Dr. Sandmeyer pursuing one of her many and varied hobbies.
“I go through phases like everyone. There is never enough time. My favorites are astronomy, bird photography, guitar, biking, kayaking, reading and of course German shepherd dogs.”
The CIRM Board discusses the future of the Stem Cell Agency
Budgets are very rarely exciting things; but they are important. For example, it’s useful for a family to know when they go shopping exactly how much money they have so they know how much they can afford to spend. Stem cell agencies face the same constraints; you can’t spend more than you have. Last week the CIRM Board looked at what we have in the bank, and set us on a course to be able to do as many of the things we want to, with the money we have left.
First some context. Last year CIRM spent a shade over $306 million on a wide range of research from Discovery, the earliest stage, through Translational and into Clinical trials. We estimate that is going to leave us with approximately $335 million to spend in the coming years.
A couple of years ago our Board approved a 5 year Strategic Plan that laid out some pretty ambitious goals for us to achieve – such as funding 50 new clinical trials. At the time, that many clinical trials definitely felt like a stretch and we questioned if it would be possible. We’re proving that it is. In just two years we have funded 26 new clinical trials, so we are halfway to our goal, which is terrific. But it also means we are in danger of using up all our money faster than anticipated, and not having the time to meet all our goals.
Doing the math
So, for the last couple of months our Leadership Team has been crunching the numbers and looking for ways to use the money in the most effective and efficient way. Last week they presented their plan to the Board.
It boiled down to a few options.
Keep funding at the current rate and run out of money by 2019
Limit funding just to clinical trials, which would mean we could hit our 50 clinical trial goal by 2020 but would not have enough to fund Discovery and Translational level research
Place caps on how much we fund each clinical trial, enabling us to fund more clinical trials while having enough left over for Discovery and Translational awards
The Board went for the third option for some good reasons. The plan is consistent with the goals laid out in our Strategic Plan and it supports Discovery and Translational research, which are important elements in our drive to develop new therapies for patients.
Finding the right size cap
Here’s a look at the size of the caps on clinical trial funding. You’ll see that in the case of late stage pre-clinical work and Phase 1 clinical trials, the caps are still larger than the average amount we funded those stages last year. For Phase 2 the cap is almost the same as the average. For Phase 3 the cap is half the amount from last year, but we think at this stage Phase 3 trials should be better able to attract funding from other sources, such as industry or private investors.
Another important reason why the Board chose option three – and here you’ll have to forgive me for being rather selfish – is that it means the Administration Budget (which pays the salaries of the CIRM team, including yours truly) will be enough to cover the cost of running this research plan until 2020.
The bottom line is that for 2018 we’ll be able to spend $130 million on clinical stage research, $30 million for Translational stage, and $10 million for Discovery. The impact the new funding caps will have on clinical stage projects is likely to be small (you can see the whole presentation and details of our plan here) but the freedom it gives us to support the broad range of our work is huge.
Every day at CIRM we get calls from people looking for a stem cell therapy to help them fight a life-threatening or life-altering disease or condition. One of the most common calls is about osteoarthritis, a painful condition where the cartilage that helps cushion our joints is worn away, leaving bone to rub on bone. People call asking if we have something, anything, that might be able to help them. Now we do.
At yesterday’s CIRM Board meeting the Independent Citizens’ Oversight Committee or ICOC (the formal title of the Board) awarded almost $8.5 million to the California Institute for Biomedical Research (CALIBR) to test a drug that appears to help the body regenerate cartilage. In preclinical tests the drug, KA34, stimulated mesenchymal stem cells to turn into chondrocytes, the kind of cell found in healthy cartilage. It’s hoped these new cells will replace those killed off by osteoarthritis and repair the damage.
This is a Phase 1 clinical trial where the goal is primarily to make sure this approach is safe in patients. If the treatment also shows hints it’s working – and of course we hope it will – that’s a bonus which will need to be confirmed in later stage, and larger, clinical trials.
From a purely selfish perspective, it will be nice for us to be able to tell callers that we do have a clinical trial underway and are hopeful it could lead to an effective treatment. Right now the only alternatives for many patients are powerful opioids and pain killers, surgery, or turning to clinics that offer unproven stem cell therapies.
Targeting immune system cancer
The CIRM Board also awarded Poseida Therapeutics $19.8 million to target multiple myeloma, using the patient’s own genetically re-engineered stem cells. Multiple myeloma is caused when plasma cells, which are a type of white blood cell found in the bone marrow and are a key part of our immune system, turn cancerous and grow out of control.
As Dr. Maria Millan, CIRM’s President & CEO, said in a news release:
“Multiple myeloma disproportionately affects people over the age of 65 and African Americans, and it leads to progressive bone destruction, severe anemia, infectious complications and kidney and heart damage from abnormal proteins produced by the malignant plasma cells. Less than half of patients with multiple myeloma live beyond 5 years. Poseida’s technology is seeking to destroy these cancerous myeloma cells with an immunotherapy approach that uses the patient’s own engineered immune system T cells to seek and destroy the myeloma cells.”
In a news release from Poseida, CEO Dr. Eric Ostertag, said the therapy – called P-BCMA-101 – holds a lot of promise:
“P-BCMA-101 is elegantly designed with several key characteristics, including an exceptionally high concentration of stem cell memory T cells which has the potential to significantly improve durability of response to treatment.”
Deadly infections
The third clinical trial funded by the Board yesterday also uses T cells. Researchers at Children’s Hospital of Los Angeles were awarded $4.8 million for a Phase 1 clinical trial targeting potentially deadly infections in people who have a weakened immune system.
Viruses such as cytomegalovirus, Epstein-Barr, and adenovirus are commonly found in all of us, but our bodies are usually able to easily fight them off. However, patients with weakened immune systems resulting from chemotherapy, bone marrow or cord blood transplant often lack that ability to combat these viruses and it can prove fatal.
The researchers are taking T cells from healthy donors that have been genetically matched to the patient’s immune system and engineered to fight these viruses. The cells are then transplanted into the patient and will hopefully help boost their immune system’s ability to fight the virus and provide long-term protection.
Whenever you can tell someone who calls you, desperately looking for help, that you have something that might be able to help them, you can hear the relief on the other end of the line. Of course, we explain that these are only early-stage clinical trials and that we don’t know if they’ll work. But for someone who up until that point felt they had no options and, often, no hope, it’s welcome and encouraging news that progress is being made.
Caleb Sizemore speaks to the CIRM Board at the June 2017 ICOC meeting.
Having been to many conferences and meetings over the years I have found there is a really simple way to gauge if someone is a good speaker, if they have the attention of people in the room. You just look around and see how many people are on their phones or laptops, checking their email or the latest sports scores.
By that standard Caleb Sizemore is a spellbinding speaker.
To say his talk was both deeply moving and inspiring is an understatement. I could go into more detail but it’s so much more powerful to hear it from Caleb himself. His words are a reminder to everyone at CIRM why we do this work, and why we have to continue to do all that we can to live up to our mission statement and accelerate stem cell treatments to patients with unmet medical needs.
An addition to the family is always a cause for celebration, whether it be a new baby, a puppy, or, in our case, a new Board member. That’s why we are delighted to welcome City of Hope’s Linda Malkas, Ph.D., as the newest member of the CIRM Board.
Dr. Malkas has a number of titles including Professor of Molecular and Cellular Biology at Beckman Research Institute; Deputy Director of Basic Research, Comprehensive Cancer Center, City of Hope; and joint head of the Molecular Oncology Program at the Cancer Center.
Her research focus is cancer and she has a pretty impressive track record in the areas of human cell DNA replication/repair, cancer cell biomarker and therapeutic target discovery. As evidence of that, she discovered a molecule that can inhibit certain activities in cancerous cells and hopes to move that into clinical trials in the near future.
California Treasure John Chiang made the appointment saying Dr. Malkas is “extraordinarily well qualified” for the role. It’s hard to disagree. She has a pretty impressive resume:
She served for five years on a National Cancer Institute (NCI) subcommittee reviewing cancer center designations.
She has served as chair on several NCI study panels and recently took on an advisory role on drug approval policy with the Food and Drug Administration.
She has published more than 75 peer-reviewed articles
She sits on the editorial boards of several high profile medical journals.
In a news release Dr. Malkas says she’s honored to be chosen to be on the Board:
“The research and technologies developed through this agency has benefited the health of not only Californians but the nation and world itself. I am excited to see what the future holds for the work of this agency.”
With all this in her work life it’s hard to imagine she has time for a life outside of the lab, and yet she does. She has four horses that she loves to ride – not all at the same time we hope – a family, friends, dogs and cats she likes spending time with. And as if that wasn’t enough to make you want to get to know her, she’s a huge fan of Star Trek, vintage sci-fi movies and Harry Potter.
Now that’s what I call a well-rounded individual. We are delighted to have her join the CIRM Team and look forward to getting her views on who are the greater villains, Klingons or Death Eaters.
Christian & Alysia Padilla-Vaccaro with daughters Annabella and Evangelina, Randy Mills, Isabelle Javier and son Jake, CIRM Board Vice Chair Art Torres, Vita Trede, Karl Trede, Brenden Whittaker, Becky Whittaker, CIRM Board Chair Jonathan Thomas ,
It’s not an easy thing to bring an entire Board of Directors to tears, but four extraordinary people and their families managed to do just that at the last CIRM Board meeting of 2016.
The four are patients who have undergone life-saving or life-changing stem cell therapies that were funded by our agency. The patients and their families shared their stories with the Board as part of CIRM President & CEO Randy Mill’s preview of our Annual Report, a look back at our achievements over the last year.
The four included:
Jake Javier, whose life changed in a heartbeat the day before he graduated high school, when he dove into a swimming pool and suffered a spinal cord injury that left him paralyzed from the chest down. A stem cell transplant is giving him hope he may regain the use of his arms and hands.
Karl Trede who had just recovered from one life-threatening disease when he was diagnosed with lung cancer, and became the first person ever treated with a new anti-tumor therapy that helped hold the disease at bay.
Brenden Whittaker, born with a rare immune disorder that left his body unable to fight off bacterial or fungal infections. Repeated infections cost Brenden part of his lung and liver and almost killed him. A stem cell treatment that gave him a healthy immune system cured him.
Evangelina Padilla Vaccaro was born with severe combined immunodeficiency (SCID), also known as “bubbly baby” disease, which left her unable to fight off infections. Her future looked grim until she got a stem cell transplant that gave her a new blood system and a healthy immune system. Today, she is cured.
Normally CIRM Board meetings are filled with important, albeit often dry, matters such as approving new intellectual property regulations or a new research concept plan. But it’s one thing to vote to approve a clinical trial, and a very different thing to see the people whose lives you have helped change by funding that trial.
You cannot help but be deeply moved when you hear a mother share her biggest fear that her daughter would never live long enough to go to kindergarten and is now delighted to see her lead a normal life; or hear a young man who wondered if he would make it to his 24th birthday now planning to go to college to be a doctor
When you know you played a role in making these dreams happen, it’s impossible not to be inspired, and doubly determined to do everything possible to ensure many others like them have a similar chance at life.
We will have more extraordinary stories to share with you when we publish our Annual Report on January 1st. 2016 was a big year for CIRM. We are determined to make 2017 even bigger.
Brenden Whittaker
Evangelina Padilla Vaccaro
The Stem Cellar 