The Struggles of Our Superheroes Reveal Their Real Strength: Dr. Catalina Lopez-Correa


Seeing our superheroes struggle can be difficult. It’s a view behind the ironworks and cladding. It’s intimate. And frightening. After all, if they too stumble and fall, what fate befalls the rest of us? But seeing that struggle is something else as well: It’s revealing. And it’s there, beneath the perfect sheen, the real strength shows.

You couldn’t create a more ideal life sciences superhero than Dr. Catalina Lopez-Correa if you tried. What makes her extraordinary is that she possesses both the “I” courageous attitude AND the “us” inclusive empathy. She advocates for diversity in research AND represents it. She’s led pioneering research efforts AND implemented innovation in practice. She promotes understanding your genetics AND was among the first to explore her entire DNA sequence. She’s worked across academia, pharma, biotech, AND nonprofits. She’s catalyzed partnerships nationally AND internationally in seven countries. Catalina is the real deal, walking the walk with an aura that’s just so incredibly human.

What happens when a superhero – the one harnessing the power of science and technology to protect the rest of us – is diagnosed with breast cancer? 

“People are watching how you are facing this. Do you want to be public about this? Do you want to show that you are Superwoman, that cancer is nothing, that you can just work through it, no big deal,” Catalina sarcastically said, “or do you want to be human and show that you are really taking care of yourself and concentrating on your health?

Image of Catalina Lopez-Correa
Dr. Catalina Lopez-Correa

At the urging of her oncologist, and with deep appreciation for the personal resources and support of her employer, Catalina decided to take a one-year medical leave and focus on herself. True to Catalina’s ambitious core, she also set goals: to use this journey – as a patient – to normalize and reduce the stigma of cancer, and try to find the positive in it.

Catalina’s decision to be public and document her cancer journey took serious contemplation. As a gay, Latina, female in science, she’s experienced her fair share of being treated differently, faced barriers in how people perceive her, AND has achieved remarkably in advancing her career and visibility as a thought leader in life sciences.

“It took me three days of thinking of posting a picture on Twitter where I felt I looked very vulnerable. Sure, people say nice things, but they also say nasty things. Putting yourself out there in a completely different light, being so vulnerable… People are sending love and that’s great, but is hard to see yourself like this. But, I believe there is a need for researchers and industry to hear the voice of the patient in different way.

The patient journey has much room — and opportunity — for innovation. Despite “patient-centricity” being a phrase nearly every player in medicine regularly uses, Catalina described an experience of anxiety and ambiguity. Life science leaders often talk about a smooth flow from getting a diagnosis to defining the type of cancer through genomics, then treating precisely, successfully. As Catalina is experiencing now, what is shared from the podium at a conference is different than the reality.

“That period between getting diagnosed, testing for your biomarkers, and understanding what’s next is terrible,” she said. “You enter this black box where even doctor’s aren’t answering your questions. There’s a huge information gap filled with anxiety. When there is anxiety, people naturally look to any support they can find. The modern-day crowdsourcing through Facebook and elsewhere on social media can lead to its own problems,” according to Catalina. “There is a vastness of anecdotes, where everyone is just posting, and so much of it is just plain wrong.”

Catalina describes patient-centered care as care that is built with the mindset and goals of the individual as paramount. And it all begins with research.

“A big piece still missing in research is the patient perspective. We [researchers] say it and we keep on trying to incorporate it, but I think we are still doing it as a check box,” Catalina said. “But now I see it for myself – to understand the journeys (and not everyone will have the same journey), to understand and relate to the impact of the side effects, to understand the impact and variability of genomics, you simply need to know the patients much better.”

“Everyone is getting the same three markers – estrogen receptor, progesterone receptor, and HER2 receptor – to determine treatment. Now what?” Catalina said. “Where can the patient find decision-making support to understand how these amazing biomarkers and genomics are guiding treatment? How can treatment be personalized, and what does each treatment mean for prognosis, recurrence, their own goals as a person?”

Catalina embraces her cancer journey, specially the time to put herself first and experience the innovations in cancer care that she has helped pioneer. But, she is acutely aware that many women – without degrees in biosciences, financial resources, medical contacts, a supportive community, and more – will struggle from the myriad flaws in the system. She didn’t use the word but I heard it: injustice. The injustice is weighing on her.

Learn More and Follow Catalina

On X (formerly known as Twitter):
@clopezcorrea

On LinkedIn:
www.tlajfundforcomplexdisease.com

Medium:
Dr. Catalina Lopez-Correa On Her New Book, Barriers For Women In STEM, and The Power Of Mentoring

Click to join the Cancer Innovation community on Luna today.


About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.


Standing on the Precipice — Parents of PANS/PANDAS Patients Shunned by the Medical Establishment Unite


Alissa Johnson is a mom and an expert in public health policy. After several years working with state legislators and legislative staff on a variety of issues, Alissa started her own consulting firm, Johnson Policy Consulting, with a special interest in advancing policy solutions to promote the health and wellbeing of children and families in areas like newborn screening, heritable disorders, and insurance discrimination.

In 2019, a complex illness dramatically altered the life of her 11-year-old daughter, Louisa. In that moment, Alissa became the parent for whom she had worked to support for so many years.

“Following my professional experience, it was just astonishing for my child to become ill overnight,” Alissa said. “I had an even greater understanding and empathy for the parents who would testify to legislative committees on the horrific changes that occurred in their children that led to severe disability or death.”

Louisa, affectionately known as “Lulu” by her friends and family, was a happy, healthy, extremely social, straight A student who danced and played guitar. In second grade, Lulu had an abnormally high heart rate (tachycardia). By 6th grade, this condition progressed from being concerning to keeping her from simply walking alone in school at times, let alone running the bases in a softball game. Halfway through 6th grade, Lulu had a different body: an infection impacted her body’s ability to regulate normal functions (dysautonomia). Lulu’s heart rate swung between extremely high and extremely low, she had severe gastrointestinal issues and wasn’t eating, she had no energy, and ultimately her severe pain and difficulty swallowing led to hospitalization. Numerous tests were administered, and everything came back normal. After a week, Lulu returned home. A week later, Lulu was back in the hospital for another week. Following the second hospital stay, Alissa went to her pediatrician to address Lulu’s persistent sore throat. This test came back positive for strep throat. Just a few months later, following a flare-up of neuropsychiatric symptoms, Lulu had a diagnosis of PANDAS.

Understanding PANS/PANDAS

Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) and Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) are conditions that often affect children, causing a sudden onset of obsessive-compulsive disorder symptoms, severe anxiety, headaches, joint pain, and other neuropsychiatric symptoms. These conditions are thought to be triggered by an immune response to infections, such as strep throat or other environmental factors. PANS/PANDAS can significantly impact a child’s life, causing challenges – often severe – in daily functioning and emotional well-being.

“I really cannot express how extremely isolating and horrific the conditions of PANS and PANDAS are,” Alissa shared. “For many of the parents, the only refuge they have is the community of other families who are going through these unbelievable life circumstances.”

While there are established guidelines for PANS/PANDAS treatment, significant barriers exist, including access to care, clinical diagnosis without a physical biomarker (although, thankfully, researchers are currently working to identify candidates), and physicians’ lack of acceptance of the condition. Without access to proper, holistic care, parents find themselves in an unpredictable cycle of reacting to health changes through hospitalizations and emergency room visits.

“Going to the emergency room with a child experiencing such a complex illness like PANS/PANDAS can be really disappointing, frustrating, and sometimes frightening. All too often, the children and the parents are treated as though they are criminals,” Alissa revealed. “There is a lack of acceptance of PANS/PANDAS which seems to stem from a lack of understanding amongst the medical community. But rather than being curious and asking, ‘How can we help this child who is clearly suffering but we don’t understand it?’ Rather than wanting to dig in and say, ‘How can we improve the life of this child and this family?’ Instead, there is a tendency to blame the child and blame the parent. When physicians resist accepting these realities, it just leads to more pain and suffering beyond the pain and suffering you are already experiencing at home. It’s excruciating.”

Parents often describe teachers, doctors, caregivers, and other authorities blaming the parents or the child for the various neuropsychiatric symptoms.

The Power of Community to Drive Research

Alissa admits that she was fortunate to have resources, domain expertise, and a network of professional connections – even within her own family – that she could leverage to access care. Even then, she faced extremely challenging circumstances.

“Most hospitals will not accept these patients. Even in some highly regarded institutions, when my daughter was in complete crisis, we were told to go home and consult with a care team,” Alissa shared. “With a child that sick, even with the resources we had, it’s very difficult to get in a car and drive two states away. For single parents, people living in rural communities, families with multiple sick kids…the situation is near impossible, and we need to help them.”

“I don’t think there is a way for anyone to truly understand how devastating the circumstances are under which the children and their families are living unless the PANS/PANDAS patient community shares that with others. The most critical people who need to understand are researchers and physicians”.

Fortunately, there are growing opportunities to unite a collective voice of the community and expand research.

“Luna and Genetic Alliance provide a unique opportunity for families to engage with researchers to share their experiences, aid in raising awareness, and advance science so that we can hopefully allow these kids to go on to live healthy lives, “ Alissa said. “The great attention to privacy protection of the information patients share is really important.”

The Road Forward

In July 2021, Lulu died at 14-years-old of complications from PANS/PANDAS. Her parents founded the Louisa Adelynn Johnson Fund for Complex Disease to support the efforts of researchers studying the conditions from which Louisa suffered, including dysautonomia/Postural Orthostatic Tachycardia Syndrome (POTS), neuroimmune disease, and other comorbidities. Subsequently, Alissa joined Amanda Peel Crowley and other parents as co-founders of the National Alliance for PANS/PANDAS Action (NAPPA), a coalition which serves as a lobbying group to increase federal funding for PANS/PANDAS research. On March 23, 2023, Amanda testified on Capitol Hill to Congress about the critical need for federal funding for PANS/PANDAS, and shared some of Lulu’s story.

“What motivates me to continue to be involved in the PANS/PANDAS community is that it’s just unconscionable that this continues to go on, and so many children are affected,” Alissa said. “There is not yet reliable epidemiological data, but we know there are a significant number of families out there and, even if there were only one, we cannot accept them being continually ignored and mistreated.”

Resources and More

Alissa Johnson​, Principal Consultant, Johnson Policy Consulting
www.policyconsult.com

The Louisa Adelynn Johnson Fund for Complex Disease
www.tlajfundforcomplexdisease.com

The National Alliance for PANS/PANDAS Action (NAPPA)
www.facebook.com/NAPPANationalAllianceforPANSPANDASAction

info@panspandasaction.org 

Click to join the PANS/PANDAS community on Luna today.


About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.


Leveraging Community Voice to Bring Effectiveness Back into Efficacy


The drug development process centers on producing the desired effect, but has the process lost sight of who gets to define what the desired effect is? This got us to thinking about the difference between efficacy and effectiveness, especially in the age of calls for patient-centricity and inclusion of the patient voice.  Both terms are used in everyday language as well as technical terminology. These words are deceptively similar but, in drug development, one concerns a controlled process and environment (efficacy), while the other concerns the real world where people exist (effectiveness). Those are vastly different places, especially if you are a patient.  If a patient-centered ecosystem of individuals and advocates, pharma, and technology providers are to work inclusively in drug development, we believe it’s necessary to push for a primary focus on effectiveness so that interventions address our health priorities as we define them.

More and more entities, including regulators, biopharma companies, clinicians, policymakers, payors, and researchers, recognize the value and importance of patient reported outcomes (PROs) as an essential ingredient in developing treatments and interventions that improve people’s lives. Recently, the FDA has elevated PROs as a necessity in product validation in clinical trials and post-trials. Additionally, they have said that physical functioning MUST be measured in clinical trials. As individuals, families, and communities, it’s time to work together to ensure what is being measured aligns with what we want.

Recently, the FDA has elevated PROs as a necessity in product validation in clinical trials and post-trials. Additionally, they have said that physical functioning MUST be measured in clinical trials.

Groups can immediately act to collaborate within and across their communities and conditions to better surface and describe – quantitatively and qualitatively –common goals for treatments and overcoming the burden of disease. By preemptively establishing this – in a manner that meets the quality control and overall data rigor needed by researchers and industry to apply the information – groups can advocate for what effectiveness means to them and influence efficacy measurements.  Better yet, groups can help expand efficacy measurements beyond standard, often blunt physical measurements (e.g., reduction in number of seizures per day, increase in number of steps walked, etc.) into quality of life and other experience goals, which are increasingly becoming vital endpoints.

For example, Genetic Alliance, an organization which helps create and support advocacy groups, is launching a burden of disease study to assess the individual and population-level burden within and across diseases. The study will be administered on the Luna platform to ensure the upmost data privacy and control for all participants, and Genetic Alliance has partnered with QualityMetric, a leader in the development of validated instruments for PROs and Clinical Outcomes Assessments (COAs). The study will include QualityMetric’s SF-36v2® validated measurement instrument, a short questionnaire that measures physical functioning, bodily pain, general health, vitality, social functioning, and emotional and mental health.

Studies like this can serve to educate researchers on the burden experienced by you and people like you, drive researchers to find treatments that focus on the community’s view on critical areas of burden, identify unmet clinical needs and improper care management for your communities, and enable you to build your own custom, disease-specific surveys to the quality level required in clinical trials.

At Luna, we build technology to drive efficiency; efficiency to do the right things right the first time, and follow the fastest path to accurate answers and effective interventions for the people who need them most.

Start sharing your experiences today by joining the Cross Condition Burden of Disease study. Your experiences will form the foundation of a rigorous data set that enables researchers to focus on finding ways to ease your burden and understand the unmet medical need you and others with your disease have.
Join the Cross Condition Burden of Disease study.


About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.


Blood Donations Provide Lifesaving Treatments and Potential Research Opportunities


An ongoing partnership answers the call of blood donors by providing new clinical research opportunities. After the success of community-focused studies to develop COVID-19 vaccines and treatments, blood donors asked what more they could do as research participants to improve the health of their community.

Through an ongoing collaboration between San Diego Blood Bank and LunaPBC, blood donors are able to support health research along with providing a lifesaving donation.

“When we began collecting convalescent plasma for COVID-19 hospital patients at the height of the pandemic, donors who recovered from the virus came out in droves to donate to help those in their community and beyond,” said Nikhil Nayak, Chief Business Officer for San Diego Blood Bank. “Our blood donors often ask about additional ways they can support our mission, so we are proud to afford them the opportunity to influence the future of personalized medicine through innovative programs like this.”

San Diego Blood Bank is a platform for ensuring the community’s health by connecting its resources and diverse blood donors with research opportunities. Luna was the optimal partner because of its people-centered framework that increases participant engagement and retention, ensures interventions meet the priorities and needs of individuals, and facilitates comprehensive, longitudinal studies.

Read San Diego Blood Bank and LunaPBC Provide Blood Donors an Opportunity to Contribute to Health Research.

“Factors such as genetics, age, gender, and ethnic origin play an important role in the effectiveness of medical treatments, which is why diversity in research participants is incredibly important,” said Nayak.

Dedicated blood donor Jeff Gonka said, “One standard blood donation could save up to three lives, but one small blood sample donated for research could potentially save thousands of lives.”

Do you live in or visit the San Diego area often? Join the San Diego Research Community on Luna today.


About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.


Reflections for 2023


In 2022, Luna prioritized quality research, privacy, and community. We launched a number of studies with partner organizations, established Community Driven Innovation™, and shared our thoughts on the changing dynamics surrounding health privacy. Looking ahead, Luna reflects on the previous year to predict the important trends of 2023.

Privacy and Trust Concerns Grow in Research

Dawn Barry

Dawn Barry, Luna president and founder

Unfortunately, the health space has lost ground in consumer trust, with growing criticism in areas like pandemic response, mRNA vaccines, data surveillance and selling, and cyber breaches involving medical information. This lack of trust could further hinder people’s involvement with research, especially as the industry looks to incorporate digitalization — through real-world data, decentralized clinical trials and wearables — into next-generation trial designs. To move forward, we need to get back to basics on human trust. We need to be transparent, consistent, clear in our communications, inclusive and ethical. In other words, we need to do what’s right.

Acknowledging that individuals should control the research use of their data is only a starting point. Embracing modern data privacy laws like GDPR and CCPA is another meaningful step in demonstrating respect for study participants.

Labor-Shortage Crisis in Health Care

Joe Beery, Luna chief executive officer

The healthcare worker shortage is a significant worldwide concern, and what’s also embedded in this challenge is that many of our most experienced doctors also operate as lead researchers for new medicines and therapies. We need to ensure the funnel for vital research that feeds innovation is protected and that this population of professionals is well taken care of.

Participant-Reported Research

Ian Terry

Ian Terry, Luna senior user experience researcher

Measuring patient-reported outcomes is key to ensuring medical interventions meet the needs of the people they aim to serve. But what about patient-reported goals, lived experiences and quality-of-life desires? In 2023, I want to see more research that starts with and fully integrates the patients’ goals and measures how those outcomes were met. In establishing a full continuum that’s centered on what patients need and want, the patients win because they ideally get something that improves their life — not something industry thought they needed — and researchers and industry establish more clinically relevant outcomes to meet, thereby de-risking their development efforts.

Measuring patient-reported outcomes is key to ensuring medical interventions meet the needs of the people they aim to serve.

Balancing Life, Research, and Work

Debora Thompson

Deb Thompson, Luna vice president of operations

COVID-19 spurred the necessity of virtual work on a scale not seen before. It changed people’s perspectives on work-life balance. On the positive side, the flexibility of being able to interweave work with life means fewer missed opportunities to spend time with family, exercise, and take a breath when needed. On the negative side, missed interaction with fellow employees means more missed opportunities to brainstorm, forge bonds and connect. As always, a balance is needed to garner the best of both worlds. Why, then, do we not require the same balance with research? Tests, measurements, and doctor-patient interactions are extremely valuable to research; however, they are only one side of the story. “Real-world evidence” and “real-world data” are not things that can be fully captured in a doctor’s office or clinical site that people are forced to travel to — increasing their stress, anxiety, and other negative symptoms. What are the real lived experiences, symptoms, and behaviors of people in their normal environment? Scientists and doctors must be willing to listen to the experiences of the patients themselves; they must be willing to include data captured from patients in their normal environments. Real “real-world data” is not the electronic health record; it is the voices of the people who live with a condition. We must have REAL #LifeResearchBalance.

Protecting Privacy

Scott Kahn

Scott Kahn, PhD, Luna chief information and privacy officer

De-identification of personal data has become a myth. We live in an age of re-identification because of the proliferation of data that can be collected on individuals and the power of artificial intelligence. De-identified DNA data is an oxymoron. The world must fully embrace a rights-based approach to data control that seeks targeted informed consent for personal data use. This approach is used with the EU’s GDPR, other countries and is now expanding state-by-state across the U.S.


About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.