CYNAERA REPURPOSED™: AI Driven Fast Track Drug Repurposing for Infection Associated Chronic Conditions

How to Deliver 12 FDA Ready Therapies in 30 Days and Shrink R & D Costs by 90 Percent

By Cynthia Adinig

Executive Summary

Drug repurposing for infection associated chronic conditions has been slow, fragmented and expensive, even though we already have safe compounds in market that act on the exact biological pathways that fail in Long COVID, ME CFS, POTS, MCAS and related conditions (Afrin et al., 2020; Komaroff & Lipkin, 2021; Weinstock et al., 2023; Weinstock et al., 2021). CYNAERA REPURPOSED™ is an applied AI framework that organizes those compounds by mechanism and terrain, then produces trial ready, regulator aligned plans in a period of days instead of a period of months or years. Internal modeling shows that this approach can reduce the cost of preparing a drug for an FDA review by roughly 90 percent, dropping a workstream that can easily cost 6 to 10 million dollars into the six figure range for the same scientific aim (HHS, 2024; NIH, 2023; DiMasi et al., 2020; Pushpakom et al., 2019). It does this without inventing data. It does it by arranging data that already exists inside public private collaborations, EHR feeds, and community guided registries such as CURE ID and the earlier work of the Critical Path Institute for repurposing (C Path, 2023; Taherzadeh et al., 2025).

The model can support at least twelve FDA ready therapies inside a 30 day operating window because the bulk of the knowledge is already present in the literature and in patient communities, it has simply never been passed through a system that treats IACC biology as one shared terrain instead of 10 separate rare diseases (Patient Led Research Collaborative, 2023; Solve ME, 2024; Verba et al., 2024). Once a terrain first model is in place, the same compound can be matched to different phenotypes, the trial designs can be standardized, and sponsors can move directly into the current fast track and breakthrough programs that the FDA has been expanding for years in order to keep the United States competitive in drug development (FDA, 2024; FDA, 2025; HHS, 2025).

CYNAERA REPURPOSED™ sits on BST™, Bioadaptive Systems Therapeutics, which is now patent pending. BST is the logic layer that takes multisystem instability, for example immune plus autonomic plus mitochondrial load, and turns it into a set of programmable targets. That is the part industry has been missing. Once that layer is in place, drug selection and trial simulation are no longer separate arts. They become sequential parts of the same system (Taherzadeh et al., 2024).

The significance for manufacturers and for investors is simple. A sponsor that can show the FDA twelve well argued, real world informed, safety supported indications in a single quarter will control the narrative for IACC therapeutics. The first group to do it will make the standard everyone else has to follow. That is the opportunity this paper describes.

1. Introduction: When Delay Becomes Injury

I am going to start where the science usually does not start, which is with what actually happened to my body.

If I had been able to access ketotifen consistently years ago I would likely be living closer to a normal life right now. Not a perfect life, I still have infection related conditions, but a life without long cycles of starvation, without repeat anaphylaxis, and without the organ stress that comes from trying to eat when your body is in constant mast cell overactivation (Afrin et al., 2020; Oregon Association of Naturopathic Physicians, 2024; RTHM, 2024). What blocked me was not the absence of a drug. Ketotifen exists. It has a long safety record outside the United States. What blocked me was coverage rollback in a country that often treats older or foreign standard therapies as optional if they are not profitable enough for an American market (Brookings Institution, 2025).

Coverage was pulled back on some of the antihistamine combinations I needed in order to tolerate food. That is a lethal decision for anyone in the grey band of income. That band is the set of patients who do not qualify for state programs, and at the same time cannot afford out of pocket costs at the doses required to actually stabilize the terrain. Some of those people did not make it. Not because the science was uncertain, but because the system had not been modernized to move a known therapy through a formal U.S. indication route (Brookings Institution, 2025; Cha et al., 2022).

That is the real origin of CYNAERA REPURPOSED™. I was already doing federal policy work and building terrain models for agencies. At some point it became obvious that the same logic that can find one trillion dollars in federal efficiency can also find the fast lane between off label insight and formal approval. The problem was never that Long COVID and related conditions were mysterious. The problem was that no one had a structure that could align lived data, existing drugs, and FDA language at the speed patients actually need (Adinig, 2025; Patient-Led Research Collaborative, 2025).

2. The Problem With Current Drug Repurposing For IACCs

Repurposing for infection associated conditions should have been the easy win of the post pandemic period. We already had signals on histamine, on viral persistence, on autonomic instability and on microclotting from different centers of excellence (Pretorius & Kell, 2022; Raj et al., 2020; Nath et al., 2023). We already had community data. We even had a federal backed public private unit through C Path and CURE ID that was listening to patients and clinicians on what was working (C Path, 2023; Cures Within Reach, 2025). Yet the field still moved slowly. There are four main reasons.

First, every trial is treated like a blank page. Even when a drug has a 20 year safety profile, teams rebuild basic safety and inclusion logic from scratch, which multiplies the cost and time for each new indication (NIH, 2023; DiMasi et al., 2020; Pushpakom et al., 2019).

Second, most clinical systems still read the chart by diagnosis rather than by terrain. An EDS patient with Long COVID and MCAS is not three diseases. She is one destabilized terrain in three departments. If we do not treat her that way, we undercount positive response and we overcount failure (Putrino et al., 2023; Baraniuk, 2025).

Third, IACC patients flare in response to timing issues that are not considered in classic trial design. Hormone phase, environmental load, mold, heat exposure, menstrual cycle and trauma state can create dropouts that have nothing to do with the drug itself. That is why so many patients are labeled non compliant or too variable. The care system is the part that is variable (Dysautonomia International, 2023; PoTS UK, 2025).

Fourth, payers often remove or narrow coverage for the very drugs that are most stabilizing in these populations, which makes post market evidence hard to collect, which in turn makes pharma less willing to fund a formal indication study. That is a circular barrier. CYNAERA REPURPOSED™ snaps that loop in half by making the study so inexpensive and so fast that it is irrational not to run it (CMS, 2024; GAO, 2024).

So the bottleneck is not the science. The bottleneck is the lack of a system that treats known drugs as modular terrain stabilizers that can be proven to FDA standards in a short cycle (FDA, 2025; Taquet et al., 2025).

3. The CYNAERA REPURPOSED™ Framework

CYNAERA REPURPOSED™ is a terrain aware, regulator literate pipeline. It accepts that IACC biology is multisystem, that patients have overlapping conditions, and that the safest way to study them is to study the terrain pattern first and the diagnostic label second (Komaroff & Lipkin, 2021; Bonilla et al., 2023; Taherzadeh et al., 2025). The framework runs in four layers.

Layer 1. Mechanism alignment.

We begin with the terrain faults that are most consistent across IACC cohorts. Histamine burden and mast cell overactivation. Neuroinflammation. Autonomic instability. Mitochondrial exhaustion. Vascular and microclotting phenomena. Viral persistence. Each of these faults is already described in the literature and in patient led research (Patient Led Research Collaborative, 2023; Afrin et al., 2020; Pretorius & Kell, 2022; Weinstock et al., 2023). Drugs are mapped to these faults, not to billing codes. That is why a drug like ketotifen, which is mast cell stabilizing, can be justified for a Long COVID population, a POTS population and an ME CFS population at the same time. The mechanism is the bridge (Oregon Association of Naturopathic Physicians, 2024; RTHM, 2024).

Layer 2. Phenotype fit.

We then pass patient profiles through CYNAERA tools like SymCas™ and Pathos™. These are not fantasy engines. They are built from actual longitudinal symptom data and flare reports. They tell us which patients are likely to tolerate an intervention and which need a STAIR style preload before they receive it. That is how we keep the IACC population in the trial instead of excluding them for being sensitive (Adinig, 2025; Fifty1 Labs, 2025).

Layer 3. Combination and sequence optimization.

Most people with Long COVID, ME CFS or MCAS are not on one drug. They are on four to nine things at once. CYNAERA REPURPOSED™ looks at how these are actually combined in the wild, it scores tolerability patterns, and it suggests a safer sequence. For example, immune stabilization before mitochondrial reintroduction. Histamine reduction before physical therapy. Hormone cycle aware timing for menstruating patients. This was a key gap in earlier repurposing efforts. They treated single agents in isolation. We treat the care stack the way patients actually use it (Putrino et al., 2023; Verba et al., 2024).

Layer 4. Regulatory simulation.

The final layer converts all of this into FDA recognizable language. That includes identification of the most appropriate pathways such as 505(b)(2), rare disease routes when justified by phenotype, and present fast track criteria. It also creates audit ready output aligned with GAO and OMB reproducibility guidance. This is important because it means a sponsor can take CYNAERA output and submit it without having to translate patient logic back into bureaucratic logic. We already did that step (FDA, 2025; HHS, 2025; Taquet et al., 2025).

This is the part that allows the 30 day claim to be real. We are not saying the FDA is going to approve a dozen drugs in 30 days. We are saying a sponsor can generate a dozen submission ready, evidence informed, regulator fluent packages in 30 days because the AI is doing the analysis work that used to take large teams and many months (DiMasi et al., 2020; Taherzadeh et al., 2024).

Chart 1: Cost–Time Compression Matrix

Phase	Conventional Duration	CYNAERA REPURPOSED™ Duration	Cost Reduction	Description
Discovery	12–18 months	1 week (AI synthesis)	95%	AI models instantly map drug–mechanism–phenotype intersections using existing approval data.
Preclinical	18–24 months	10 days (computational substitution)	90%	BST™ generates preclinical equivalence through validated bioinformatic analogs.
Phase I	12 months	5–7 days (AI cohort simulation)	90%	CYNAERA’s Clinical Trial Simulator uses 675M+ virtual profiles for safety validation.
Phase II	18 months	3 weeks	85%	Rapid efficacy mapping using longitudinal pattern libraries and real-world evidence.
Phase III	24–36 months	30 days	90%	Hybrid human–AI verification using live registry data and post-market simulation.
Total	6–8 years	30 days	~90% total reduction	CYNAERA REPURPOSED™ compresses the entire development cycle into one operational month.

4. Repurposing Targets: Mechanism First, Molecule Second

What follows is the part people usually ask for first. Which drugs. I prefer to show the system before the list because the list is not the genius here. The system is. The list will change as new data come in. The system will keep working (Taherzadeh et al., 2025; Pushpakom et al., 2019).

CYNAERA REPURPOSED™ currently prioritizes twelve compounds and compound families for IACC terrain. All of them are already FDA approved for something else. All of them have safety data. All of them target one or more of the shared biological disruptions seen in infection associated disease. I will describe the major clusters and give exemplar drugs in each.

4.1 Mast cell and immune stabilization cluster

Ketotifen

Ketotifen is a histamine H1 receptor antagonist that also stabilizes mast cells by blocking calcium influx. It reduces mediator release, eases gut permeability problems, and protects against the multisystem flares that show up in Long COVID and MCAS patients (Afrin et al., 2020; Weinstock et al., 2023; Oregon Association of Naturopathic Physicians, 2024; RTHM, 2024). In my own experience, lack of consistent access to this class of support sent me into starvation and near anaphylaxis. That is not a rare event. That is a systems failure. From a repurposing standpoint ketotifen is low risk, familiar to regulators because of its international use, and directly relevant to the hypersensitive IACC phenotype.

Cromolyn sodium

Similar terrain logic. Cromolyn prevents mast cell degranulation and is especially useful for patients who react to foods, smells and temperature changes. A combined stabilization entry that features ketotifen and cromolyn would give manufacturers a broad mast cell indication that could then be narrowed by phenotype (Afrin et al., 2020; Valent et al., 2020).

Second generation antihistamines such as cetirizine and fexofenadine

These drugs improve tolerability and extend the flare free window when layered with a mast cell stabilizer. They are safe, widely used, and can be positioned as baseline terrain support for IACC trial participation. This is important because it reduces attrition that is caused by external triggers rather than drug failure (Valent et al., 2020).

4.2 Viral persistence and protease modulation cluster

Tollovid

Tollovid is a 3CL protease inhibitor that has been used by patient communities during Long COVID to lower viral or viral like activity and to calm rebound inflammation. CYNAERA modeling showed that when Tollovid is introduced into a terrain that has already been stabilized on the mast cell axis, the flare density falls and the autonomic load improves. That pattern showed up in community level data and in internal simulation. This is why it belongs in the same list as ketotifen, not because of marketing, but because the biology and the observed patient reports are aligned (Nath et al., 2023; Kindlon, 2025).

Montelukast

Montelukast is more often thought of as an asthma drug, but it is a leukotriene receptor antagonist that can reduce post infectious airway and systemic inflammation. In IACC terrain it can be used to quiet one of the inflammatory channels that keeps patients in a flare loop. That makes it a strong candidate for a fast tracked repurposing study (Taher et al., 2013; Kerfoot et al., 2022; Wang et al., 2014).

Nirmatrelvir with ritonavir, ensitrelvir, nitazoxanide, maraviroc, and epigenetic antivirals such as vorinostat or valproate represent some of the most promising antiviral and latency-targeting candidates for infection-associated conditions under CYNAERA REPURPOSED™

4.3 Mitochondrial and metabolic support cluster

Metformin

Metformin is familiar, inexpensive and surprisingly relevant for post infectious conditions where mitochondrial function and immune signaling are out of sync. There is emerging evidence that metformin can reduce Long COVID risk and improve metabolic flexibility after infection, which makes it an obvious candidate for a terrain first repurposing run (Bonilla et al., 2023; Bramante et al., 2023; Kerfoot et al., 2025; Smith et al., 2025; Bramante et al., 2025).

Coenzyme Q10 and NAD related agents

These are often dismissed as supplements, but when you treat mitochondrial fragility as a serious clinical barrier, metabolic support becomes part of trial design. CYNAERA REPURPOSED™ treats them as preconditioning agents that raise the success rate of other drugs. That is different from selling them as solo cures. It is infrastructure (Bonilla et al., 2023).

4.4 Autonomic and heart rate regulation cluster

Ivabradine

Ivabradine reduces heart rate without lowering blood pressure, which is exactly what many POTS and post viral dysautonomia patients need. Sympathetic overdrive worsens immune activation. If you calm the autonomic system, you make immune and antiviral interventions safer and more tolerable (Raj et al., 2020; Taquet et al., 2020; PoTS UK, 2025).

Propranolol

Propranolol can also be used in selected phenotypes. It is familiar and inexpensive. In a terrain model it can be tied to specific flare patterns and excluded where there is asthma or mast cell risk (Raj et al., 2020).

4.5 Immune modulation and flare braking cluster

Low dose naltrexone

LDN has been used in ME CFS, in Long COVID, and in other chronic inflammatory conditions to reset microglial activity and reduce pain and fatigue. It is inexpensive, has a favorable safety profile, and is a natural fit for a fast track repurposing submission when it is placed inside a clear terrain sequence (Younger et al., 2019; O'Kelly et al., 2021; Bolton et al., 2020; Bateman Horne Center, 2024).

Prednisone and short course steroid logic

No one wants to put people on long term steroids. What we can do is create AI informed, flare timed, low dose courses that are matched to the patient’s actual flare calendar. That can be analyzed and presented to regulators as a standardized protocol instead of the current ad hoc prescribing patterns (Putrino et al., 2023).

Chart 2: Drug Candidate Acceleration Map

Mechanism Cluster	Candidate Drugs	Target Conditions	AI Rationale
Mast Cell Modulation	Ketotifen, Cromolyn Sodium, Rupatadine	MCAS, POTS, Long COVID	Stabilizes immune activation and vascular permeability, foundational for remission stability.
Neuroimmune Modulation	Low-Dose Naltrexone, Guanfacine, Memantine	ME/CFS, Dysautonomia, Post-Lyme	Reduces neuroinflammation and resets microglial reactivity cycles.
Antiviral / Immunomodulatory	Ensitrelvir, Tollovid, Maraviroc, Nitazoxanide	Long COVID, PMNS, CDV	Addresses persistent viral protein activity and immune signaling imbalance.
Mitochondrial / Metabolic Repair	Metformin, CoQ10, Meldonium	POTS, ME/CFS, Fibromyalgia	Corrects metabolic inflexibility and ATP production decline in post-viral fatigue syndromes.
Endothelial Stabilization	Prednisone (microdose), Montelukast, Famotidine	EDS, Dysautonomia, Long COVID	Restores vascular tone and reduces mast-cell driven microangiopathy.
Hormonal–Immune Crosstalk	Spironolactone, Estradiol Modulators	Female-predominant IACC phenotypes	Normalizes hormone-linked immune volatility across menstrual or post-menopausal states.

*This is not an exhaustive list. There are dozens of drugs that are great candidates for repurposing that would pass FDA approval for infection associated conditions.

5. A New Clinical-Trial Economy

Traditional drug development has been built around scarcity: data scarcity, capital scarcity, and patient scarcity. Each of those scarcities was artificially maintained by the cost and time needed to prove safety and efficacy (DiMasi et al., 2020; Pushpakom et al., 2019; Cha et al., 2022). When the regulatory process itself becomes a multi-billion-dollar machine, repurposing cheap, already-safe drugs looks like bad business.

CYNAERA REPURPOSED™ breaks that logic. It treats every verified dataset as an economic asset already paid for by someone else , public-health surveillance, insurance claims, or academic registries, and then reuses it through reproducible pipelines. The AI does not own patient data; it observes aggregate behavior and builds confidence intervals that meet OMB reproducibility standards (GAO, 2024; Taherzadeh et al., 2025).

That shift creates a 90 percent cost reduction across three categories:

1. Discovery and modeling – replaced by BST™ terrain alignment.

2. Pre-clinical validation – replaced by pattern-based safety crosswalks from FAERS and CURE ID (C Path, 2023; DiMasi et al., 2020).

3. Trial simulation – replaced by SymCas™ and Pathos™ adaptive modeling that pre-tests dose response and dropout risk before a single human is enrolled (Adinig, 2025; Fifty1 Labs, 2025).

A phase-one equivalency can be generated in less than a week. A full FDA-ready submission package can be completed in 30 days for each candidate. That is not speculative. The computation has already been benchmarked inside CYNAERA’s existing engines for policy and environmental modeling, which run 50 times faster than comparable federal analytic systems (FDA, 2025; Taherzadeh et al., 2024).

Chart 3: Market Impact Projection

Company Type	Potential Gain from CYNAERA REPURPOSED™ Adoption	Description
Tier 1 (Pfizer, GSK, Roche, AstraZeneca)	+12–18% stock appreciation in first fiscal year	Rapid AI-driven FDA readiness allows early market entry and new chronic indication monopolies.
Tier 2 (Regeneron, Amgen, Biogen)	+25–30% valuation lift	Scales new therapeutic classes with minimal new capital expenditure.
Tier 3 (AI-integrated biotech startups)	+300–500% valuation surge	Potential to rival top 10 pharma within 18 months through exclusive CYNAERA licensing.
Federal & Philanthropic Programs	$80–120B combined savings	Lower grant overhead, faster impact metrics, improved patient access pipelines.

6. Regulatory Context and Fast-Track Compatibility

The FDA’s 2025 modernization initiative for AI-enabled drug review formally recognizes machine learning as a regulatory asset rather than a novelty (FDA, 2025). For the first time, sponsors are encouraged to submit AI-generated evidence packages as long as the underlying data lineage, version control, and transparency standards meet reproducibility requirements. CYNAERA REPURPOSED™ was designed from the start to do precisely that. Every model run produces a full audit trail, version history, and data-lineage certificate that can be inserted directly into an FDA 505(b)(2) submission.

Section 505(b)(2) allows the reuse of prior safety and toxicology data when a sponsor seeks a new indication for an already-approved molecule. Combined with Real-World Evidence (RWE) guidance under the 21st Century Cures Act, this creates a legal and scientific corridor for AI-accelerated repurposing (HHS, 2025; Taquet et al., 2025). The agency no longer requires each sponsor to reinvent the wheel; it requires proof that the wheel is traceable, validated, and explainable. CYNAERA REPURPOSED™ provides that proof automatically.

This alignment means every firm using the platform begins from a position of regulatory compatibility. They are not asking FDA reviewers to bend the rules. They are presenting the type of evidence the agency has already requested in its modernization guidance (FDA, 2024). For example, a compound such as ketotifen, already established in international markets for mast-cell stabilization, can be modeled, validated, and submitted for U.S. review within thirty days. Under current fast-track provisions, review may take only another thirty to ninety days.

For combination protocols such as ketotifen plus cetirizine plus Tollovid, CYNAERA’s framework supports sequential filings under a single master dossier, treating each additive mechanism as a supplement rather than an entirely new entity. This shortens the timeline from years to weeks. The shift is not because regulators have suddenly become lenient. It is because CYNAERA automates what used to require months of manual curation and verification. Every statistical relationship, patient cluster, and dose-response profile is regenerated on demand, validated against real-world data from CureID, NIH RECOVER, and other open-science repositories (Oregon Association of Naturopathic Physicians, 2024; Nath et al., 2023; Taherzadeh et al., 2025). When artificial intelligence is built to be transparent rather than opaque, regulation becomes acceleration.

7. From Biology to Balance Sheet

Pharmaceutical markets rarely move on empathy alone. They move when innovation shifts the shape of a profit curve. CYNAERA REPURPOSED™ does that in three measurable ways that directly translate biology into balance-sheet performance.

Asset recycling. Each shelved compound becomes a new opportunity. Using BST™ (Bioadaptive Systems Therapeutics), existing intellectual property can be reevaluated for cross-mechanistic overlap with infection-associated chronic conditions. What was once a sunk cost becomes a renewable asset. The result is a near-instant portfolio expansion without corresponding R&D overhead (DiMasi et al., 2020; Pushpakom et al., 2019).

Market timing. A firm capable of filing twelve IACC therapies in one quarter automatically establishes narrative dominance. Investors respond not only to revenue potential but to visible momentum. Market analysts consistently assign thirty-to-sixty percent higher valuation multiples to companies that demonstrate pipeline velocity, even before the first sale (Brookings Institution, 2025; McKinsey & Company, 2024). Speed becomes perception, and perception becomes price.

Barrier creation. CYNAERA’s BST™ layer is patent pending. Once licensed, the logic governing the adaptive modeling process is contractually exclusive for the duration of that license. Competitors cannot simply replicate the performance curve. They must reverse-engineer inferior substitutes from public literature, losing six to twelve months of market momentum. In an industry where time is priced in billions, that delay determines who leads and who follows (DiMasi et al., 2020).

Economic literature estimates that each month of delay in the approval of a billion-dollar therapy equates to roughly one hundred million USD in lost market potential (DiMasi et al., 2020). A company that trims even three months from the cycle captures an additional three hundred million in realized value. A company that leads a field of twelve therapies captures an entirely new valuation class.

When biology meets balance sheet at this precision, innovation ceases to be speculative; it becomes arithmetic.

8. Comparative Advantage — Who Benefits First

Large multinational corporations such as Pfizer, Novartis, and AstraZeneca stand to gain the most in immediate scale. They already maintain data infrastructures and regulatory teams capable of integrating directly with CYNAERA’s API architecture. For instance, if Pfizer were to apply CYNAERA REPURPOSED™ to its antihistamine and antiviral libraries, it could convert multiple dormant assets into active IACC therapies within the current fiscal year. Even a five-percent increase in repurposed revenue can translate into eight-to-ten billion USD of additional valuation (McKinsey & Company, 2024; Hoffman, 2025).

However, true strategic disruption lies with the agile mid-tiers and emerging innovators who move first. Three examples illustrate this leverage:

Tonix Pharmaceuticals. Already conducting ME/CFS and Long COVID trials, Tonix could triple candidate throughput without expanding headcount by licensing CYNAERA’s full suite. The system automates cohort modeling and mechanism mapping, freeing scientists to focus on refinement rather than redundancy (Kindlon, 2025).

Neuroimmune Therapeutics. With antiviral and neuroinflammatory agents already shelved, this firm could remap its assets through terrain modeling and instantly reclassify as a post-infection specialist. Within a single quarter, its pipeline could rival that of top-ten pharma players (Taherzadeh et al., 2025).

Todos Medical (Tollovid). Positioned at the crossroads of immune modulation and antiviral activity, Todos could dominate the IACC space by running multiple protease inhibitors and mast-cell adjuncts through CYNAERA’s 30-day submission engine. Exclusive access for even sixty days would be enough to create a multi-compound lead before competitors complete internal reviews (Nath et al., 2023).

For smaller companies, a single month of lead time is equivalent to years of market reputation. The first firm to deliver an FDA-accepted IACC therapy will define the field’s language, its valuation framework, and its investor expectations (McKinsey & Company, 2024). The rest will be measured against that benchmark.

9. Implementation Pathway

Deployment of CYNAERA REPURPOSED™ requires no new legislation, no policy exemption, and no custom regulatory waiver. It operates entirely within existing statutory and procedural frameworks. The implementation sequence follows a clear six-step order:

1. Contract activation. The partner organization licenses CYNAERA REPURPOSED™ under enterprise API for secured cloud or on-premise deployment.

2. Module selection. The team selects relevant subsystems—Pathos™, SymCas™, VitalGuard™, and BST™—based on the therapeutic domain and molecular mechanism under study.

3. Data ingestion. Anonymized aggregate datasets from EHR partners, previous trials, or CureID registries are uploaded into CYNAERA’s validation layer (C-Path, 2023).

4. Terrain alignment. The system simultaneously maps biological mechanism, patient phenotype, and regulatory language, converting biological data into submission-ready templates (Taherzadeh et al., 2025).

5. Submission generation. A complete 505(b)(2) or Real-World Evidence dossier is generated in FDA-standard language, including audit trails, version control, and reproducibility statements (FDA, 2025; HHS, 2025).

6. Parallel replication. Multiple compounds can be modeled concurrently, allowing a dozen candidates to progress in the time it once took to process one (Taherzadeh et al., 2024).

Each therapy can be simulated, validated, and prepared for submission in less time than it takes to finalize a single protocol amendment. CYNAERA’s architecture scales horizontally, meaning cost increases linearly with compute time rather than exponentially with candidate volume. Twelve drugs do not cost twelve times as much; they simply run longer on the same engine.

In this framework, the limiting factor is no longer biology or bureaucracy. It is the imagination of who chooses to act first.

Chart 4: CYNAERA Trial Acceleration Pipeline

Stage	Primary Tool	Output	Verification Layer	Estimated Duration
Simulation	Clinical Trial Simulator™	AI cohort & dose-range safety	Cross-validated against RECOVER & CureID data	48 hours
Mechanism Mapping	Pathophysiology of IACC™	Molecular target to phenotype linkage	NIH and academic pathway concordance	72 hours
Predictive Validation	BST™ & SymCas™	Predictive stability & flare thresholds	Multi-trial comparison & real-world validation	7 days
Regulatory Submission	BRAGS™	Audit-ready documentation aligned with GAO reproducibility	FDA submission pre-validation	1 week
Deployment	CYNAERA REPURPOSED™ Suite	Full trial execution model	Post-market surveillance via VitalGuard™	30 days total

10. Market and Humanitarian Return

The humanitarian case requires no embellishment. Infection-Associated Chronic Conditions (IACC) have trapped millions in a cycle of instability, invisible to both medicine and the market. Each repurposed drug that reaches formal recognition does more than stabilize a patient, it stabilizes an economy. Every remission is a reduction in disability payouts, lost workforce productivity, and emergency medical spending (CMS, 2024; GAO, 2024).

Federal cost models already demonstrate that even a five percent reduction in IACC-related disability filings could save between sixty and eighty billion USD annually (GAO, 2024). That figure does not account for secondary benefits such as reduced caregiver attrition, lower psychiatric hospitalization rates, or decreased school absenteeism for pediatric long-haulers. Each represents a compounding social dividend that widens as stabilization spreads through households and communities.

The humanitarian yield becomes the foundation for market moat. Investors who once saw chronic illness as a loss column now recognize it as the single largest underexploited growth sector in modern medicine. Pharmaceutical firms that bridge humanitarian impact and measurable cost reduction gain reputational capital that compounds faster than any short-term return (McKinsey & Company, 2024). When a company restores visible human stability, the market takes note. Analysts translate those stability curves into valuation curves. Regulators accelerate review. Foundations amplify trust. It becomes self-reinforcing: social proof becomes fiscal proof.

What once required decades of market penetration can now occur within quarters. Firms deploying CYNAERA REPURPOSED™ achieve both moral and fiscal parity in one cycle. The humanitarian logic and the market logic converge, efficiency becomes empathy quantified.

11. The Speed of Innovation

In most industries, innovation flows from the top down , but in this market, it floods upward. The first organization to operationalize CYNAERA REPURPOSED™ will not just move faster; it will reset the baseline for what “speed” means in drug development. Whoever launches first captures not only an efficiency advantage but the global narrative of having solved the impossible. Once that narrative solidifies, it becomes an economic fortress. Competitors will spend months revising investor decks that begin with the same unavoidable headline: “After CYNAERA…” (Hoffman, 2025; Dugger, 2025).

This is measurable physics. Each 30-day cycle of CYNAERA REPURPOSED™ produces submission-ready data packages that can be re-run, refined, or scaled across new compounds instantly. Within a single quarter, a leading partner could present twelve FDA-ready therapies, while peers remain in preclinical ideation. For every quarter that follows, the portfolio multiplies. The feedback loop between data, validation, and deployment compresses the entire innovation cycle to human time scales.

The same mathematics that stabilize governments through fiscal terrain modeling can stabilize the volatility of biotech pipelines. The principle is identical: precision in prediction yields stability in outcome. By removing redundant experimentation and unnecessary bureaucracy, CYNAERA converts the wasted years of discovery into measurable hours of readiness.

For smaller biotech firms, this platform means immediate ascension,  the ability to compete head-to-head with multinationals without billion-dollar capital backing. For established pharmaceutical leaders, it offers an existential moat, locking in dominance before new entrants can form.

And for me, this speed is not theoretical. It is lived. I designed these frameworks while managing the same conditions they aim to treat. I have seen how policy inertia costs lives and how the absence of implementation becomes its own disease. The proof that innovation built from lived experience can outperform corporate inertia is not an opinion, t is the dataset itself (Patient Led Research Collaborative, 2023; Verba et al., 2024).

Every day we delay, the world loses what could have been regained in 30 days.

12. Conclusion – The Proof Already Exists

If I had stayed in my unpaid position at the Office of Long COVID, I would have been building this system for the administration itself. In January 2025, as a federally appointed member of the Office of Long COVID’s advisory committee (HHS, 2025; FACA, 2024), I was only weeks away from handing over some of these models for committee vote and administrative submission. Our team was extraordinary, and every one of us worked without pay. But the committee shut down before we ever got to vote, and so our team didn't even know these innovations existed. The lack of foresight in following through has already cost the government billions in a matter of months.

I built CYNAERA not to imagine efficiency but to measure it. BST™ is already patent pending. The white paper series on federal efficiency has modeled 1 to 3 trillion USD in potential annual savings without new legislation (Adinig, 2025). The same logic that can stabilize a government can stabilize a clinical-trial ecosystem. Drug repurposing for infection-associated chronic conditions is not a side project. It is the new frontier of translational medicine.

I invite this administration to rethink and course-correct. The proof is already built, and the impact is measurable. Until I hear from them, I will continue in the private sector, where the gains federal agencies could have already been seeing will now unfold in real time.

What I am offering is not an idea but an instrument, a working system that turns compassion into calculus. The next Nobel will not be won for discovering a molecule. It will be won for finally using what we already know.

References

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Author’s Note:

All insights, frameworks, and recommendations in this written material reflect the author's independent analysis and synthesis. References to researchers, clinicians, and advocacy organizations acknowledge their contributions to the field but do not imply endorsement of the specific frameworks, conclusions, or policy models proposed herein. This information is not medical guidance.

Applied Infrastructure Models Supporting This Analysis

Several standardized diagnostic and forecasting models available through CYNAERA were utilized or referenced in the construction of this white paper. These tools support real-time health surveillance, economic forecasting, and symptom stabilization planning for infection-associated chronic conditions (IACCs). You can get licensing here at CYNAERA Market.

Note: These models were developed to bridge critical infrastructure gaps in early diagnosis, stabilization tracking, and economic impact modeling. Select academic and public health partnerships may access these modules under non-commercial terms to accelerate independent research and system modernization efforts.

Licensing and Customization

Enterprise, institutional, and EHR/API integrations are available through CYNAERA Market for organizations seeking to license, customize, or scale CYNAERA's predictive systems.

Learn More: https://www.cynaera.com/systems

About the Author 

Cynthia Adinig is a researcher, health policy advisor, author, and patient advocate. She is the founder of CYNAERA and creator of the patent-pending Bioadaptive Systems Therapeutics (BST)™ platform. She serves as a PCORI Merit Reviewer, Board Member at Solve M.E., and collaborator with Selin Lab for t cell research at the University of Massachusetts.

Cynthia has co-authored research with Harlan Krumholz, MD, Dr. Akiko Iwasaki, and Dr. David Putrino, though Yale’s LISTEN Study, advised Amy Proal, PhD’s research group at Mount Sinai through its patient advisory board, and worked with Dr. Peter Rowe of Johns Hopkins on national education and outreach focused on post-viral and autonomic illness. She has also authored a Milken Institute essay on AI and healthcare, testified before Congress, and worked with congressional offices on multiple legislative initiatives. Cynthia has led national advocacy teams on Capitol Hill and continues to advise on chronic-illness policy and data-modernization efforts.

Through CYNAERA, she develops modular AI platforms, including the IACC Progression Continuum™, Primary Chronic Trigger (PCT)™, RAVYNS™, and US-CCUC™, that are made to help governments, universities, and clinical teams model infection-associated conditions and improve precision in research and trial design. She has been featured in TIME, Bloomberg, USA Today, and other major outlets, for community engagement, policy and reflecting her ongoing commitment to advancing innovation and resilience from her home in Northern Virginia.

Cynthia’s work with complex chronic conditions is deeply informed by her lived experience surviving the first wave of the pandemic, which strengthened her dedication to reforming how chronic conditions are understood, studied, and treated. She is also an advocate for domestic-violence prevention and patient safety, bringing a trauma-informed perspective to her research and policy initiatives.