Overcoming obstacles and advancing treatments to patients

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UC Davis GMP Manufacturing facility: Photo courtesy UC Davis

When you are trying to do something that has never been done before, there are bound to be challenges to meet and obstacles to overcome. At the California Institute for Regenerative Medicine (CIRM) we are used to coming up with great ideas and hearing people ask “Well, how are you going to do that?”

Our new 5-year Strategic Plan is how. It’s the roadmap that will help guide us as we work to overcome critical bottlenecks in bringing regenerative medicine therapies to people in need.

Providing more than money

People often think of CIRM as a funding agency, providing the money needed to do research. That’s true, but it’s only part of the story. With every project we fund, we also offer a lot of support. That’s particularly true at the clinical stage, where therapies are being tested in people. Projects we fund in clinical trials don’t just get money, they also have access to:

  • Alpha Stem Cells Clinic Network – This is a group of specialized medical centers that have the experience and expertise to deliver new stem cell and gene therapies.
  • The CIRM Cell and Gene Therapy Center – This helps with developing projects, overcoming manufacturing problems, and offers guidance on working with the US Food and Drug Administration (FDA) to get permission to run clinical trials.
  • CIRM Clinical Advisory Panels (CAPs) – These are teams put together to help advise researchers on a clinical trial and to overcome problems. A crucial element of a CAP is a patient advocate who can help design a trial around the needs of the patients, to help with patient recruitment and retention.

Partnering with key stakeholders

Now, we want to build on this funding model to create new ways to support researchers in bringing their work to patients. This includes earlier engagement with regulators like the FDA to ensure that projects match their requirements. It includes meetings with insurers and other healthcare stakeholders, to make sure that if a treatment is approved, that people can get access to it and afford it.

In the past, some in the regenerative medicine field thought of the FDA as an obstacle to approval of their work. But as David Martin, a CIRM Board member and industry veteran says, the FDA is really a key ally.

“Turning a promising drug candidate into an approved therapy requires overcoming many bottlenecks… CIRM’s most effective and committed partner in accelerating this is the FDA.”

Removing barriers to manufacturing

Another key area highlighted in our Strategic Plan is overcoming manufacturing obstacles. Because these therapies are “living medicines” they are complex and costly to produce. There is often a shortage of skilled technicians to do the jobs that are needed, and the existing facilities may not be able to meet the demand for mass production once the FDA gives permission to start a clinical trial. 

To address all these issues CIRM wants to create a California Manufacturing Network that combines academic innovation and industry expertise to address critical manufacturing bottlenecks. It will also coordinate training programs to help build a diverse and expertly trained manufacturing workforce.

CIRM will work with academic institutions that already have their own manufacturing facilities (such as UC Davis) to help develop improved ways of producing therapies in sufficient quantities for research and clinical trials. The Manufacturing Network will also involve industry partners who can develop facilities capable of the large-scale production of therapies that will be needed when products are approved by the FDA for wider use.

CIRM, in collaboration with this network, will also help develop education and hands-on training programs for cell and gene therapy manufacturing at California community colleges and universities. By providing internships and certification programs we will help create a talented, diverse workforce that is equipped to meet the growing demands of the industry.

You can read more about these goals in our 2022-27 Strategic Plan.

A year unlike any other – a look back at one year post Prop 14

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State flag of California

2020 was, by any standards, a pretty wacky year. Pandemic. Political convulsions. And a huge amount of uncertainty as to the funding of life-saving therapies at CIRM. Happily those all turned out OK. We got vaccines to take care of COVID. The election was won fair and square (seriously). And Proposition 14 was approved by the voters of California, re-funding your favorite state Stem Cell Agency.

But for a while, quite a while, there was uncertainty surrounding our future. For a start, once the pandemic lockdown kicked in it was impossible for people to go out and collect the signatures needed to place Proposition 14 on the November ballot. So the organizers of the campaign reached out online, using petitions that people could print out and sign and mail in.

It worked. But even after getting all the signatures needed they faced problems such as how do you campaign to get something passed, when the normal channels are not available. The answer is you get very creative very quickly.

Bob Klein

Bob Klein, the driving force behind both Proposition 71 (the 2004 ballot initiative that created CIRM) and Proposition 14, says it was challenging:

“It was a real adventure. It’s always hard, you have a complicated message about stem cells and genetics and therapy and it’s always a challenge to get a million signatures for a ballot initiative but in the middle of a pandemic where we had to shut down the signature gathering at grocery stores and street corners, where we had to go to petitions that had to be sent to voters and get them to fill them out properly and send them back. And of course the state went into an economic recoil because of the pandemic and people were worried about the money.”

Challenging absolutely, but ultimately successful. On November 13, ten days after the election, Prop 14 was declared the winner.

As our President and CEO, Dr. Maria Millan says, we went from an agency getting ready to close its doors to one ramping up for a whole new adventure.

“We faced many challenges in 2020. CIRM’s continued existence was hinging on the passage of a new bond initiative and we began the year uncertain if it would even make it on the ballot.  We had a plan in place to wind down and close operations should additional funding not materialize.  During the unrest and challenges brought by 2020, and functioning in a virtual format, we retained our core group of talented individuals who were able to mobilize our emergency covid research funding round, continue to advance our important research programs and clinical trials and initiate the process of strategic planning in the event that CIRM was reauthorized through a new bond initiative. Fortunately, we planned for success and Proposition 14 passed against all odds!”

“When California said “Yes,” the CIRM team was positioned to launch the next Era of CIRM! We have recruited top talent to grow the team and have developed a new strategic plan and evolved our mission:  Accelerating world-class science to deliver transformative regenerative medicine treatments to a diverse California and worldwide in an equitable manner.” 

And since that close call we have been very busy. In the last year we have hired 16 new employees, everyone from a new General Counsel to the Director of Finance, and more are on the way as we ramp up our ability to turn our new vision into a reality.

We have also been working hard to ensure we could continue to fund groundbreaking research from the early-stage Discovery work, to testing therapies in patients in clinical trials. Altogether our Board has approved almost $250 million in 56 new awards since December 2020. That includes:

Clinical – $84M (9 awards)

Translational – $15M (3 awards)

Discovery – $13M (11 awards)

Education – $138M (33 awards)

We have also enrolled more than 360 new patients in clinical trials that we fund or that are being carried out in the CIRM Alpha Stem Cell Clinic network.

This is a good start, but we know we have a lot more work to do in the coming years.

The last year has flown by and brought more than its fair share of challenges. But the CIRM team has shown that it can rise to those, in person and remotely, and meet them head on. We are already looking forward to 2022. We’ve got a lot of work to do.

A conversation with Bob Klein about the past, present and future of CIRM

Bob Klein

Anyone who knows anything about CIRM knows about Bob Klein. He’s the main author and driving force behind both Proposition 71 and Proposition 14, the voter-approved ballot initiatives that first created and then refunded CIRM. It’s safe to say that without Bob there’d be no CIRM.

Recently we had the great good fortune to sit down with Bob to chat about the challenges of getting a proposition on the ballot in a time of pandemic and electoral pandemonium, what he thinks CIRM’s biggest achievements are (so far) and what his future plans are.

You can hear that conversation in the latest episode of our podcast, “Talking ’bout (re) Generation”.

Enjoy.

CIRM Board Approves Continued Funding for SPARK and Alpha Stem Cell Clinics

Yesterday the governing Board of the California Institute for Regenerative Medicine (CIRM) approved $8.5 million to continue funding of the Summer Program to Accelerate Regenerative Medicine Knowledge (SPARK) and Alpha Stem Cell Clinics (ASCC).

This past February, the Board approved continued funding for stem cell focused educational programs geared towards undergraduate, masters, pre/postdoctoral, and medical students. The SPARK program is an existing CIRM educational program that provides for a summer internship for high school students.

To continue support for SPARK, the Board has approved $5.1 million to be allocated to ten new awards ($509,000 each) with up to a five-year duration to support 500 trainees.  The funds will enable high school students all across California to directly take part in summer research at various institutions with a stem cell, gene therapy, or regenerative medicine focus.  The goal of these programs is to prepare and inspire the next generation of scientists and provide opportunities for California’s diverse population, including those who might not have the opportunity to take part in summer research internships due to socioeconomic constraints.

CIRM’s ASCC Network is a unique regenerative medicine-focused clinical trial network that currently consists of five medical centers across California who specialize in accelerating stem cell and gene-therapy clinical trials by leveraging of resources to promote efficiency, sharing expertise, and enhancing chances of success for the patients. To date, over 105 trials in various disease indications have been supported by the ASCC Network.  While there are plans being developed for a significant ASCC Network expansion by some time next year, funding for all five sites has ended or are approaching the end of their current award period. To maintain the level of activity of the ASCC Network until expansion funding is available next year, the Board approved $3.4 million to be allocated to five supplemental awards (up to $680,000 each) in order to provide continued funding to all five sites; the host institutions will be required to match the CIRM award.  These funds will support talent retention and program key activities such as the coordination of clinical research, management of patient and public inquiries, and other operational activities vital to the ASCC Network.

“Education and infrastructure are two funding pillars critical for creating the next generation of researchers and conducting stem cell based clinical trials” says Maria T. Millan, M.D., President and CEO of CIRM.  “The importance of these programs was acknowledged in Proposition 14 and we expect that they will continue to be important components of CIRM’s programs and strategic direction in the years to come.”

The Board also awarded $14.5 million to fund three translational stage research projects (TRAN1), whose goal is to support early development activities necessary for advancement to a clinical study or broad end use of a potential therapy.

The awards are summarized in the table below:

ApplicationTitleInstitution Award
TRAN1-12245  Development of novel synNotch CART cell therapy in patients with recurrent EGFRvIII+ glioblastoma    UCSF    $2,663,144
TRAN1-12258  CAR-Tnm cell therapy for melanoma targeting TYRP-1    UCLA  $5,904,462  
TRAN1-12250HSC-Engineered Off-The-Shelf CAR-iNKT Cell Therapy for Multiple Myeloma  UCLA  $5,949,651

Month of CIRM – Our Therapeutics Team Goes Hunting

All this month we are using our blog and social media to highlight a new chapter in CIRM’s life, thanks to the voters approving Proposition 14. We are looking back at what we have done since we were created in 2004, and also looking forward to the future. Today we have a guest blog by CIRM Senior Science Officer Lisa Kadyk, outlining how she and her colleagues actively search for the best science to fund.

Lisa Kadyk, Ph.D.

Hi everyone,

This is Lisa Kadyk, a Science Officer from the CIRM Therapeutics team, here to tell you about some of the work our team does to support the CIRM mission of accelerating stem cell treatments to patients with unmet medical needs.  Our job involves seeking out and recruiting great scientists to apply to CIRM and supporting those we fund.

Therapeutics team members manage both the awards that fund the final preclinical studies required before testing a therapeutic in a clinical trial (CLIN1), and the awards that fund the clinical trials themselves (CLIN2). 

I mentioned above that we actively recruit new applicants for our CLIN1 and CLIN2 awards – which is not an activity that is typical of most funding agencies – so why and how do we do this?  

It all comes down to our mission of accelerating the development of therapies to help patients with unmet medical needs.  It turns out that there are many potential applicants developing cutting edge therapies who don’t know much or anything about CIRM, and the ways we can help them with getting those therapies to the clinic and through clinical trials.    So, to bridge this gap, we Science Officers attend scientific conferences, read the scientific literature and meet regularly with each other to stay abreast of new therapeutic approaches being developed in both academia and industry, with the goal of identifying and reaching out to potential applicants about what CIRM has to offer. 

What are some of the things we tell potential applicants about how partnering with CIRM can help accelerate their programs?   First of all, due to the efforts of a very efficient Review team, CIRM is probably the fastest in the business for the time between application and potential funding.  It can be as short as three months for a CLIN1 or CLIN2 application to be reviewed by the external Grants Working Group and approved by the CIRM Board, whereas the NIH (for example) estimates it takes seven to ten months to fund an application.   Second, we have frequent application deadlines (monthly for CLIN1 and CLIN2), so we are always available when the applicant is ready to apply.  Third, we have other accelerating mechanisms in place to help grantees once they’ve received funding, such as the CIRM Alpha Stem Cell Clinics network of six clinical sites throughout California (more efficient clinical trial processes and patient recruitment) and Clinical Advisory Panels (CAPs) – that provide technical, clinical or regulatory expertise as well as patient advocate guidance to the grantee.  Finally, we Science Officers do our best to help every step of the way, from application through grant closeout.

We now feel confident that our recruitment efforts, combined with CIRM’s more efficient funding pipeline and review processes, are accelerating development of new therapies.  Back in 2016, a new CIRM Strategic Plan included the goal of recruiting 50 successful (i.e., funded) clinical trial applicants within five years.  This goal seemed like quite a stretch, since CIRM had funded fewer than 20 clinical trials in the previous ten years.  Fast-forward to the end of 2020, and CIRM had funded 51 new trials in those five years, for a grand total of 68 trials.    

Now, with the passage of Proposition 14 this past November, we are looking forward to bringing more cell and gene therapeutic candidates into clinical trials.   If you are developing one yourself, feel free to let us know… or don’t be surprised if you hear from us!  

Month of CIRM: Battling COVID-19

All this month we are using our blog and social media to highlight a new chapter in CIRM’s life, thanks to the people of California approving Proposition 14. We are looking back at what we have done since we were created in 2004, and also looking forward to the future.

Dr. John Zaia, City of Hope stem cell researcher

The news that effective vaccines have been developed to help fight COVID-19 was a truly bright spot at the end of a very dark year. But it will be months, in some countries years, before we have enough vaccines to protect everyone. That’s why it’s so important to keep pushing for more effective ways to help people who get infected with the virus.

One of those ways is in a clinical study that CIRM is funding with City of Hope’s Dr. John Zaia. Dr. Zaia and his team, in partnership with the Translational Genomics Research Institute (TGen) in Flagstaff, Arizona, are using something called convalescent plasma to try and help people who have contracted the virus. Here’s the website they have created for the study.

Plasma is a part of our blood that carries proteins, called antibodies, that help defend our bodies against viral infections. When a patient recovers from COVID-19, their blood plasma contains antibodies against the virus. The hope is that those antibodies can now be used as a potential treatment for COVID-19 to help people who are newly infected. 

To carry out the study they are using clinical trial sites around California, including some of the CIRM Alpha Stem Cell Network clinics.

For the study to succeed they’ll first need people who have recovered from the virus to donate blood. That’s particularly appropriate in January because this is National Volunteer Blood Donor Month.

The team has three elements to their approach:

  • A rapid-response screening program to screen potential COVID-19 convalescent plasma donors, particularly in underserved communities.
  • A laboratory center that can analyze the anti-SARS-CoV-2 antibodies properties in COVID-19 convalescent plasma.
  • An analysis of the clinical course of the disease in COVID-19 patients to identify whether antibody properties correlate with clinical benefit of COVID-19 convalescent plasma.

There’s reason to believe this approach might work. A study published this week in the New England Journal of Medicine, found that blood plasma from people who have recovered from COVID-19 can help older adults and prevent them from getting seriously ill with the virus if they get the plasma within a few days of becoming infected.

We are used to thinking of blood donations as being used to help people after surgery or who have been in an accident. In this study the donations serve another purpose, but one that is no less important. The World Health Organization describes blood as “the most precious gift that anyone can give to another person — the gift of life. A decision to donate your blood can save a life, or even several if your blood is separated into its components — red cells, platelets and plasma.”

That plasma could help in developing more effective treatments against the virus. Because until we have enough vaccines for everyone, we are still going to need as much help as we can get in fighting COVID-19. The recent surge in cases throughout the US and Europe are a reminder that this virus is far from under control. We have already lost far too many people. So, if you have recently recovered from the virus, or know someone who has, consider donating blood to this study. It could prove to be a lifesaver.

For more information about the study and how you can be part of it, click here.

A Month of CIRM: Where we’ve been, where we’re going

All this month we are using our blog and social media to highlight a new chapter in CIRM’s life, thanks to the voters approving Proposition 14. We are looking back at what we have done since we were created in 2004, and also looking forward to the future. We kick off this event with a letter from our the Chair of our Board, Jonathan Thomas.

When voters approved Proposition 14 last November, they gave the Stem Cell Agency a new lease on life and a chance to finish the work we began with the approval of Proposition 71 in 2004. It’s a great honor and privilege. It’s also a great responsibility. But I think looking back at what we have achieved over the last 16 years shows we are well positioned to seize the moment and take CIRM and regenerative medicine to the next level and beyond.

When we started, we were told that if we managed to get one project into a clinical trial by the time our money ran out we would have done a good job. As of this moment we have 68 clinical trials that we have funded plus another 31 projects in clinical trials where we helped fund crucial early stage research. That inexorable march to therapies and cures will resume when we take up our first round of Clinical applications under Prop 14 in March.

But while clinical stage projects are the end game, where we see if therapies really work and are safe in people, there’s so much more that we have achieved since we were created. We have invested $900 million in  basic research, creating a pipeline of the most promising stem cell research programs, as well as investing heavily on so-called “translational” projects, which move projects from basic science to where they’re ready to apply to the Food and Drug Administration (FDA) to begin clinical trials.

We have funded more than 1,000 projects, with each one giving us valuable information to help advance the science. Our funding has helped attract some of the best stem cell scientists in the world to California and, because we only fund research in California, it has persuaded many companies to either move here or open offices here to be eligible for our support. We have helped create the Alpha Stem Cell Clinics, a network of leading medical centers around the state that have the experience and expertise to deliver stem cell therapies to patients. All of those have made California a global center in the field.

That result is producing big benefits for the state. An independent Economic Impact Analysis reported that by the end of 2018 we had already helped generate an extra $10.7 billion in new sales revenue and taxes for California, hundreds of millions more in federal taxes and created more than 56,000 new jobs.

As if that wasn’t enough, we have also:

  • Helped develop the largest iPSC research bank in the world.
  • Created the CIRM Center of Excellence in Stem Cell Genomics to accelerate fundamental understanding of human biology and disease mechanisms.
  • Helped fund the construction of 12 world class stem cell institutes throughout the state.
  • Reached a unique partnership with the National Heart, Lung and Blood Institutes to find a cure for sickle cell disease.
  • Used our support for stem cell research to leverage an additional $12 billion in private funding for the field.
  • Enrolled more than 2700 patients in CIRM funded clinical trials

In many ways our work is just beginning. We have laid the groundwork, helped enable an extraordinary community of researchers and dramatically accelerated the field. Now we want to get those therapies (and many more) over the finish line and get them approved by the FDA so they can become available to many more people around the state, the country and the world.

We also know that we have to make these therapies available to all people, regardless of their background and ability to pay. We have to ensure that underserved communities, who were often left out of research in the past, are an integral part of this work and are included in every aspect of that research, particularly clinical trials. That’s why we now require anyone applying to us for funding to commit to engaging with underserved communities and to have a written plan to show how they are going to do that.

Over the coming month, you will hear more about some of the remarkable things we have managed to achieve so far and get a better sense of what we hope to do in the future. We know there will be challenges ahead and that not everything we do or support will work. But we also know that with the team we have built at CIRM, the brilliant research community in California and the passion and drive of the patient advocate community we will live up to the responsibility the people of California placed in us when they approved Proposition 14.

A look back at 15 years of CIRM funding at UCLA

Researchers in the lab of CIRM grantee Donald Kohn, M.D.
Image Credit: UCLA Broad Stem Cell Center

Since the first grant was issued in April 2006, CIRM has funded a wide range of research conducted by top scientists at UCLA for a wide range of diseases. To give a retrospective look at all the research, UCLA released a news article that describes all this work up until this past September. During this period, UCLA researchers were awarded 120 grants totaling more than $307 million. We’ll highlight some of these findings from the article below.

51 Basic Biology CIRM Grants

Basic biology research encompasses very early stage work that focuses on the very essentials such as how stem cells work, how to successfully turn a stem cell into another type of cell, and other basic mechanisms that underly the stem cell research field. This research is critical because they inform future therapies for dozens of conditions including heart disease, genetic and blood disorders, cancer, spinal cord injuries and neurological disorders.

3 Consecutive Year-Long CIRM Training Grants

These CIRM grants are essential in training the next generation of scientists and physicians in the regenerative medicine field. The CIRM training grants supported 146 graduate students, post‐doctoral fellows, and clinical fellows working in UCLA laboratories by providing them year-long  training fellowships. This program was so successful that the UCLA Broad Stem Cell Research Center funded 26 additional fellowships to supplement CIRM’s support.

5 COVID-19 Related Grants

Shortly after the coronavirus pandemic, CIRM authorized  $5 million in emergency funding to fund COVID-19 related projects. UCLA has received a $1.02 million to support four discovery research projects and one translational project. Discovery research promotes promising new technologies that could be translated to enable broad use and improve patient care. Translational research takes it a step further by promoting the activities necessary for advancement to clinical study of a potential therapy.

1 Alpha Stem Cell Clinic (ASCC) Grant

One award was used to establish the UCLA‐UCI Alpha Stem Cell Clinic. It is one of five leading medical centers throughout California that make up the CIRM ASSC Network, which specializes in the delivery of stem cell therapies by providing world-class, state of the art infrastructure to support clinical research.

8 Clinical Trials

Out of the 64 CIRM-funded clinical trials to date, eight of these have been conducted at UCLA. Most notably, this includes a stem cell gene therapy approach developed by Donald Kohn, M.D. The approach was used in three different clinical trials for the following genetic diseases: X-linked chronic granulomatous disease (X-CGD), bubbly baby disease (also known as SCID), and sickle cell disease. The SCID trial resulted in over 50 infants being cured of the disease, including little Evie. The other five clinical trials conducted at UCLA were for corneal damage, lung damage, skin cancer, sarcomas, and solid tumors.

Wide Reach of Conditions

CIRM grants at UCLA have supported research related to many conditions, including the following:

To read the full UCLA article that discusses some of the other grants, click here.

Exploring tough questions, looking for answers

COVID-19 and social and racial injustice are two of the biggest challenges facing the US right now. This Thursday, October 8th, we are holding a conversation that explores finding answers to both.

The CIRM Alpha Stem Cell Clinic Network Symposium is going to feature presentations about advances in stem cell and regenerative research, highlighting treatments that are already in the clinic and being offered to patients.

But we’re also going to dive a little deeper into the work we support, and use it to discuss two of the most pressing issues of the day.

One of the topics being featured is research into COVID-19. To date CIRM has funded 17 different projects, including three clinical trials. We’ll talk about how these are trying to find ways to help people infected with the virus, seeing if stem cells can help restore function to organs and tissues damaged by the virus, and if we can use stem cells to help develop safe and effective vaccines.

Immediately after that we are going to use COVID-19 as a way of exploring how the people most at risk of being infected and suffering serious consequences, are also the ones most likely to be left out of the research and have most trouble accessing treatments and vaccines.

Study after study highlights how racial and ethnic minorities are underrepresented in clinical trials and disproportionately affected by debilitating diseases. We have a responsibility to change that, to ensure that the underserved are given the same opportunity to take part in clinical trials as other communities.

How do we do that, how do we change a system that has resisted change for so long, how do we overcome the mistrust that has built up in underserved communities following decades of abuse? We’ll be talking about with experts who are on the front lines of this movement.

It promises to be a lively meeting. We’d love to see you there. It’s virtual – of course – it’s open to everyone, and it’s free.

Here’s where you can register and find out more about the Symposium

Charting a new course for stem cell research

What are the latest advances in stem cell research targeting cancer? Can stem cells help people battling COVID-19 or even help develop a vaccine to stop the virus? What are researchers and the scientific community doing to help address the unmet medical needs of underserved communities? Those are just a few of the topics being discussed at the Annual CIRM Alpha Stem Cell Clinic Network Symposium on Thursday, October 8th from 9am to 1.30pm PDT.

Like pretty nearly everything these days the symposium is going to be a virtual event, so you can watch it from the comfort of your own home on a phone or laptop. And it’s free.

The CIRM Alpha Clinics are a network of leading medical centers here in California. They specialize in delivering stem cell and gene therapies to patients. So, while many conferences look at the promise of stem cell therapies, here we deal with the reality; what’s in the clinic, what’s working, what do we need to do to help get these therapies to patients in need?

It’s a relatively short meeting, with short presentations, but that doesn’t mean it will be short on content. Some of the best stem cell researchers in the U.S. are taking part so you’ll learn an awful lot in a short time.

We’ll hear what’s being done to find therapies for

  • Rare diseases that affect children
  • Type 1 diabetes
  • HIV/AIDS
  • Glioblastoma
  • Multiple myeloma

We’ll discuss how to create a patient navigation system that can address social and economic determinants that impact patient participation? And we’ll look at ways that the Alpha Clinic Network can partner with community care givers around California to increase patient access to the latest therapies.

It’s going to be a fascinating day. And did I mention it’s free!

All you have to do is go to this Eventbrite page to register.

And feel free to share this with your family, friends or anyone you think might be interested.

We look forward to seeing you there.