Our 501(c)(3) nonprofit prioritizes global patient access to life-changing therapies by connecting scientific breakthroughs, regulatory pathways, and real patients in need by collecting observational data of international research to enhance treatment options and outcomes. We champion compassionate use to ensure innovative treatments reach those who need them most.
Our Mission: Accelerating Access to Life-Saving Therapies
As a 501(c)(3) charitable organization, we are committed to making a meaningful difference in patients' lives through innovative approaches to treatment access.
Scientific Breakthroughs
Identify cutting-edge therapies with potential to save lives and improve quality of life.
Regulatory Navigation
Guide treatments through complex approval pathways and compassionate use requests.
Patient Access
Ensure life-changing therapies reach those with urgent medical needs when standard options fail.
Data Collection
Collect observational data from international research to improve treatment efficacy and inform future innovations.
Our Approach: Strategic Regulatory Navigation
Global Expertise
Specialized knowledge of regulatory frameworks across major markets and emerging regions.
Strategic Partnerships
Collaborations with industry, hospitals, and advocacy groups to develop comprehensive access strategies.
Regulatory Intelligence
Continuous monitoring of evolving regulations in the US, EU, and developing markets.
Innovative Solutions
Creative approaches to overcome access barriers through established and novel pathways.
International Research Data
Collection and analysis of observational data from international research to inform treatment access strategies and regulatory approaches.
501(c)(3) Charitable Status
Operating as a tax-exempt nonprofit organization dedicated to expanding patient access to life-saving therapies through philanthropic support.
Compassionate Use: Making Hope a Reality
Patient Identification
Work with physicians to identify candidates who could benefit from unapproved therapies when standard treatments have failed. Partner with 501(c)(3) charitable organizations to extend reach to underserved communities.
Documentation & Advocacy
Prepare comprehensive requests, coordinate with manufacturers, and advocate with regulatory authorities. Leverage 501(c)(3) patient advocacy groups to strengthen cases for access approval.
Access Management
Facilitate treatment delivery, monitor outcomes, and provide ongoing support to patients, families and healthcare providers. Collaborate with 501(c)(3) organizations to establish financial assistance programs for eligible patients.
Data Collection
Collect observational data through international research networks to build evidence supporting treatment efficacy and safety profiles. This valuable real-world evidence helps improve future access pathways and informs regulatory decisions globally.
Our team has successfully navigated access for numerous patients including a groundbreaking pediatric gene therapy not yet commercially available. Through strategic partnerships with 501(c)(3) charitable organizations, we ensure treatments reach those in need regardless of financial circumstances.
Global Market Access Programs
Multinational Projects
Operating pilot programs spanning North America, Europe, Asia, and Africa to establish access models that work across borders. As a 501(c)(3) charitable organization, we can partner directly with governments and NGOs without profit constraints.
Clinical Development
Coordinating cross-border clinical trials and data sharing for orphan drugs and breakthrough therapies with limited market incentives. We also collect observational data of international research to identify patterns and optimize treatment protocols across diverse populations. Our 501(c)(3) status enables us to channel 100% of funding into research and patient support.
Ethical Approvals
Working directly with local regulatory bodies to ensure ethical, timely review and approval processes that respect cultural contexts. Our charitable organization structure promotes transparency and accountability in all approval processes.
Clinical Research: Long COVID Immunodeficiency Study
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Study Focus
Observing relationship between RXRA gene expression and neuroinflammation in Long COVID patients with immunodeficiency.
Real-World Data
Collecting outcomes from patients receiving intranasal immunoglobulin therapy through international clinical programs.
Biomarkers
Monitoring immunological markers and RXRA expression to identify patterns in recovery and symptom persistence.
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Global Impact
Developing ethical frameworks for medical tourism while advancing knowledge of post-viral immune dysfunction.
As a 501(c)(3), we're uniquely positioned to conduct this observational research without commercial bias. Our findings will inform compassionate use protocols and support patients seeking innovative care options worldwide. Learn more here
Leadership & Expert Team
Regulatory Veterans
Our leadership includes former senior officials from FDA, EMA, and international regulatory bodies with decades of combined experience navigating approval pathways.
Clinical Experts
Physicians and researchers specializing in rare diseases, oncology, and gene therapies provide medical expertise and clinical trial design guidance.
Patient Advocates
Board members with lived experience as patients or caregivers ensure our work remains centered on real human needs and ethical considerations.
Research Analysts
Our dedicated team collects and analyzes observational data from international research initiatives, identifying patterns and insights that inform global treatment approaches.
501(c)(3) Status
As a recognized charitable organization, we maintain strict compliance with nonprofit regulations while maximizing the impact of every donation through transparent fiscal management.
Get Involved: Support Our Mission
Volunteer Your Expertise
We welcome regulatory specialists, medical writers, patient navigators, and translators to join our global network of dedicated volunteers making access possible.
Donate to Fund Access
Your contributions directly support urgent compassionate use applications, educational resources, and advocacy campaigns for policy reform. As a 501(c)(3) charitable organization, all donations are tax-deductible to the fullest extent allowed by law.
Become a Partner
Corporate sponsors, foundations, and healthcare organizations can amplify our impact through financial support, expertise sharing, and collaborative programs.
Contribute to Research
We also collect observational data of international research to improve treatment access pathways. Your participation helps build a comprehensive database that informs future policy and practice in compassionate use programs.
Meet Our Principal Investigator: Dr. Jonatha Leicher
Clinical Expertise
Board-certified Adult-Gerontology Acute Care NP with specialized training in cardiopulmonary, renal, and critical care medicine. Her comprehensive approach integrates traditional medical interventions with evidence-based complementary therapies for complex cases.
Education
Doctor of Nursing Practice from University of Arizona with continued education at Harvard, Stanford, and Mayo Clinic. Her advanced certifications include critical care medicine, neurological assessment, and regulatory clinical trial management.
Experience
Over a decade in emergency, trauma, cardiovascular, and intensive care units across premier health systems. She has served as principal investigator on multiple IRB-approved studies and compassionate use programs for novel therapeutics.
Research Focus
Develops integrative care models for neurologic injury, ischemia, transplant complications, and immune dysregulation. Her innovative protocols have improved patient outcomes in treatment-resistant conditions where conventional approaches have limited efficacy.
Dr. Leicher brings her expertise in AI healthcare applications and regenerative medicine to our mission. Her holistic approach combines clinical excellence with compassionate care for patients without traditional options. Throughout her career, she has pioneered innovative treatment protocols that bridge conventional medicine with emerging therapeutic approaches.
As our Principal Investigator, Dr. Leicher leads our clinical research initiatives with meticulous attention to scientific rigor while maintaining a deep commitment to patient-centered care. Her collaborative leadership style fosters interdisciplinary approaches that have resulted in groundbreaking treatment access for patients with limited options. She regularly presents at international medical conferences and has published extensively on regulatory pathways for experimental therapies.
Dr. Leicher's vision for Healing Hope International centers on creating sustainable models for compassionate use that can be replicated globally, particularly in underserved communities. Her dedication to ethical research practices and patient advocacy has established her as a respected voice in the complex intersection of regulatory science, clinical innovation, and patient rights.
Meet Our Latin American Clinical Operations Director: Selene Guido
Selene brings specialized expertise in pediatric medical tourism for cellular therapies across Latin America.
Registered Nurse with advanced training in cross-border healthcare coordination
Pioneered streamlined access protocols for international patients seeking experimental treatments
Champions culturally-sensitive care models that respect diverse family needs
Builds vital partnerships with regional healthcare providers and regulatory agencies
Meet Our Regulatory Affairs Director: Tamara C Tamas
Tamara bridges cutting-edge cellular therapies with patient care as our regulatory strategist and biochemist. With over 15 years of experience in biopharmaceutical regulation, she navigates complex regulatory frameworks to create viable pathways for innovative treatments to reach patients in need.
Scientific Foundation
MS in Biopharmaceutical Regulatory Affairs and Chemistry degree with biochemistry focus. Her specialized training enables her to understand the molecular mechanisms of cellular therapies while developing regulatory strategies that satisfy scientific and safety requirements across multiple jurisdictions.
Manufacturing Expertise
Specialized in cGMP-compliant cell therapy production and cleanroom operations. Tamara has implemented quality management systems for cellular manufacturing facilities in three countries and trains teams on maintaining regulatory compliance throughout the production process.
Global Access
Coordinates international therapy delivery through compassionate use frameworks. She has successfully facilitated treatment access for over 200 patients across 14 countries through expanded access programs, special access schemes, and hospital exemptions.
Tamara's comprehensive approach integrates regulatory strategy with practical implementation, ensuring that promising therapies can overcome administrative barriers to reach patients with urgent medical needs. Her work includes developing regulatory documentation, navigating Ethics Committee approvals, and creating patient-specific access plans for complex cases.
As a recognized expert in her field, Tamara regularly consults with regulatory agencies and contributes to policy discussions about improving access pathways for experimental treatments. Her patient-centered philosophy drives her commitment to finding creative solutions within existing regulatory frameworks.
Our goal is to connect over a thousand patients with life-saving therapies through compassionate use by 2030.
25+
Global Reach
Expanding our network to cover more than 25 countries and all major therapeutic areas requiring urgent access.
100%
Research Impact
We collect observational data from international research to improve treatment outcomes and drive policy reforms for more equitable, accelerated patient access to innovative treatments worldwide.