Precision Medicine: The Right Treatment at the Right Time for Every Patient

Early-stage biotech founders are navigating a rapidly evolving healthcare landscape where precision medicine is emerging as a game-changer. In a recent episode of talk is biotech! featuring host Guru Singh and guest Negin Ashouri, the conversation centered on why the future of medicine isn't one-size-fits-all.

Guru Singh, Founder and CEO of Scispot, brings extensive expertise in biotechnology and data infrastructure. Scispot provides life science laboratories with an industry-leading AI-powered technology stack that enables researchers to make their data AI-ready for analysis and decision-making. The platform serves as a comprehensive lab operating system that streamlines research workflows and enhances data management capabilities.

Negin Ashouri, CEO of FemTherapeutics, leads the Montreal-based company that's revolutionizing women's healthcare through precision medicine approaches. FemTherapeutics specializes in creating customized medical devices using 3D printing technology and AI-driven design to address unmet needs in gynecological care.

Together, Singh and Ashouri highlighted how diseases like diabetes and endometriosis demand more nuanced approaches, setting the stage for a new era of tailored therapies that move beyond traditional one-size-fits-all treatments.

The End of One-Size-Fits-All Medicine

For decades, standard medical practice has treated complex diseases as if they were uniform conditions. The reality is very different: common illnesses are often heterogeneous, with significant variation from patient to patient.

Understanding Disease Complexity Through Diabetes

Take diabetes, for example. Over 590 million people worldwide, approximately 1 in 9 adults, currently live with diabetes. However, not all diabetes is the same. Researchers have identified at least five distinct subtypes of adult-onset diabetes, each with different underlying mechanisms and risk profiles.

What medical professionals commonly categorize as "type 2 diabetes" might actually represent multiple diseases in disguise. This complexity explains why a treatment that works wonders for one patient may fail completely for another, leaving both patients and physicians frustrated with unpredictable outcomes.

The Endometriosis Challenge in Women's Health

A similar story unfolds in women's health, particularly with endometriosis. Long considered a single disorder, endometriosis is now understood as a complex condition with varied presentations. It affects approximately 10% of women and girls globally, representing roughly 190 million individuals worldwide, yet its causes remain poorly understood.

Currently, there is no known cure for endometriosis, and treatment typically focuses on controlling symptoms rather than providing permanent solutions. The complexity becomes evident when examining how the condition manifests differently across patients.

One patient's endometriosis might present with superficial lesions on pelvic organs, while another might develop ovarian cysts or deep invasive nodules. These variations in presentation mean that a therapy providing significant pain relief for one woman could prove completely ineffective for another with the same diagnosed condition.

When One-Size-Fits-All Falls Short

The traditional one-size-fits-all approach in drug development reveals clear limitations that impact millions of patients worldwide. Studies demonstrate that the top ten highest-grossing drugs in the United States benefit only 4% to 25% of the patients who take them.

This statistic represents a sobering reality: millions of people receive prescriptions for blockbuster medications that may provide no therapeutic benefit whatsoever. This shortfall isn't due to poor science or inadequate medicine, but rather reflects fundamental biological differences. Genetic and environmental variations mean that the "average" patient, for whom most drugs are designed, often doesn't exist in real-world clinical practice.

The Human Cost of Treatment Variability

The consequences of this biological variability extend far beyond statistics. Patients frequently endure trial-and-error prescribing approaches, cycling through multiple medications until they find one that works, if they ever do. This process can take months or years, during which patients may experience continued symptoms, side effects, and mounting healthcare costs.

Adverse drug reactions represent a significant portion of healthcare complications, with approximately 5% of all hospital admissions attributed to negative drug responses. Much of this stems from genetic differences in how individuals metabolize medications, process active compounds, and respond to therapeutic interventions.

In women's health specifically, conditions like endometriosis and pelvic organ prolapse demonstrate high rates of symptom recurrence and unnecessary surgical interventions when treatments aren't properly tailored to individual patient needs and anatomical variations.

The traditional medical model, which treats patients as biologically identical, clearly leaves too many individuals without effective treatment options, highlighting the urgent need for more personalized approaches.

Precision Medicine: The Right Treatment for the Right Patient

Precision medicine offers a fundamentally different paradigm that transforms healthcare delivery. Often summarized as delivering "the right treatment to the right patient at the right time," this approach represents a radical departure from population-based medicine.

Rather than basing therapy decisions on broad population averages, precision medicine leverages detailed patient-specific data to guide clinical decisions. This includes genetic markers, biomarkers found in blood or tumor tissue, lifestyle factors, environmental exposures, and other individual characteristics that influence treatment response.

Transforming Cancer Treatment Through Precision Approaches

The impact of precision medicine is already visible across multiple medical specialties. In oncology, precision medicine has catalyzed an explosion of targeted therapies that have transformed cancer treatment outcomes.

Nearly 43% of all new cancer drugs approved between 1998 and 2022 represent precision therapies guided by specific biomarkers. This shift allows oncologists to treat cancers based on the tumor's molecular profile rather than solely on its anatomical location.

The clinical impact proves tangible and significant. For instance, adding targeted HER2-specific drugs to breast cancer therapy can reduce the risk of recurrence by over 50% for patients with HER2-positive tumors. By identifying the right subset of patients through genetic signatures, physicians can dramatically improve outcomes while sparing other patients from ineffective treatments and unnecessary side effects.

Prevention and Early Intervention Through Genetic Insights

Precision medicine also enables a fundamental shift toward prevention and early intervention strategies. Genetic testing and genomics can reveal individual risk profiles that inform proactive healthcare decisions.

For example, women carrying harmful BRCA1 gene variants face up to an 85% lifetime chance of developing breast cancer, compared to approximately 13% risk in the general population. Armed with this knowledge, these individuals can pursue intensive screening protocols or consider prophylactic measures well before any tumor develops.

Similarly, genetic and biomarker profiling in diabetes management may identify patients at higher risk for complications, enabling more aggressive early management strategies for those individuals who need them most.

Precision medicine not only matches treatments to patients but also helps healthcare providers get ahead of disease progression by using personal risk profiles to inform preventive care strategies.

A Growing Opportunity for Startups

The rise of precision medicine presents a massive opportunity for biotech startups willing to embrace this paradigm shift. The convergence of biotechnology with big data analytics and artificial intelligence has created exceptionally fertile ground for innovative new ventures.

Technological Enablers Driving Growth

Several key technological advances serve as enablers driving the precision medicine revolution. The cost of genome sequencing has plummeted dramatically over the past decade, making genomic data more accessible than ever before. The global next-generation sequencing market continues growing at over 21% annually, reflecting increasing adoption across research and clinical settings.

Simultaneously, healthcare organizations are rapidly embracing data-driven decision-making tools. Industry projections suggest that approximately 90% of payers and healthcare providers will adopt big data analytics capabilities within the next five years to inform care decisions and improve patient outcomes.

These trends indicate that both the technological infrastructure and organizational appetite for precision approaches are expanding rapidly across the healthcare ecosystem.

Market Growth and Investment Trends

Market indicators strongly reflect this momentum toward precision medicine approaches. Globally, the precision medicine market demonstrates an impressive growth trajectory, with projections suggesting it will reach approximately $470 billion by 2034, up from roughly $120 billion in the mid-2020s.

This represents a robust double-digit annual growth rate that significantly outpaces traditional pharmaceutical sector growth, indicating sustained investor and market confidence in precision approaches.

Investment patterns tell a complementary story of growing enthusiasm. Venture capital funding is flowing into precision medicine ventures at record levels, particularly targeting areas like AI-driven drug discovery, genetic testing platforms, and digital health solutions.

Recent analyses indicate that venture capital funding for precision medicine and personalized health startups more than doubled from 2023 to 2024, jumping from approximately $1.4 billion to $3.6 billion in a single year. This dramatic increase reflects growing investor recognition of the commercial potential in personalized healthcare approaches.

Even in historically overlooked domains like women's health, investors are taking notice of precision medicine opportunities. Funding for women's health-focused startups surged 55% in 2024, far outpacing growth rates in the broader healthcare sector and indicating increasing recognition of unmet needs in this market.

Pharmaceutical Industry Transformation

Large pharmaceutical companies are also pivoting toward precision strategies, recognizing the limitations of traditional blockbuster drug models. Many of the newest high-revenue therapies are actually targeted treatments, sometimes called "nichebusters," aimed at genetically defined patient subsets rather than broad populations.

This industry trend opens significant doors for startups to either partner with established pharmaceutical companies or carve out specialized markets that were previously considered too small to be commercially viable.

Regulatory environments also support this transition. The FDA has implemented comprehensive frameworks for approving drugs alongside companion diagnostic tests, ensuring that novel therapies are prescribed specifically to patients who will actually benefit from them, rather than broad patient populations.

Emerging Tools and Technologies

Biotech entrepreneurs entering the precision medicine arena have access to an expanding toolkit of advanced technologies and methodologies. Several key technological trends are enabling breakthrough innovations in this field.

Multi-Omics and Advanced Biomarker Discovery

Beyond traditional genomics, the analysis of proteomics, metabolomics, and microbiome data is uncovering new biomarkers that help stratify patients by risk profiles or likely treatment responses.

Advanced diagnostic tests, including minimally invasive "liquid biopsies," can now detect circulating tumor DNA and other disease markers directly from blood samples. These tests reveal which specific therapies a cancer patient is most likely to respond to, enabling physicians to spare other patients from unnecessary treatments and associated side effects.

Multi-omics approaches combine data from multiple biological layers to create comprehensive patient profiles that guide treatment selection with unprecedented precision and accuracy.

Artificial Intelligence in Research and Development

Artificial intelligence and machine learning technologies are fundamentally transforming how researchers identify patterns in vast biomedical datasets. Platforms like Scispot's Lab Operating System help make laboratory data "AI-ready" for sophisticated analysis, enabling scientists to quickly derive actionable insights from complex experimental data.

Machine learning models can predict patient outcomes, identify optimal drug-target interactions, and significantly accelerate the discovery of targeted therapies. In clinical settings, AI-driven decision support tools are beginning to assist physicians in choosing optimal treatments by analyzing patient-specific variables against millions of comparable data points from previous cases.

These AI applications reduce the time from discovery to clinical application while improving the precision of treatment selection for individual patients.

Personalized Devices and Advanced Manufacturing

Precision medicine extends beyond pharmaceuticals to encompass medical devices tailored to individual patients. Advances in 3D printing technology and materials science now enable the creation of patient-specific implants, prosthetics, and therapeutic devices.

This capability proves particularly transformative in fields like orthopedics for custom implants, cardiology for personalized stents, and gynecology for anatomically matched devices.

A prime example is FemTherapeutics' innovative use of 3D printing to create bespoke pessaries for pelvic organ prolapse treatment. This approach replaces traditional one-size-fits-all devices with completely customized solutions designed specifically for each patient's unique anatomy and clinical needs.

Cell and Gene Therapies

The advent of gene editing technologies like CRISPR and advanced cell engineering capabilities has enabled ultra-personalized treatments that modify patients' own cells for therapeutic purposes.

CAR-T cell therapies for cancer represent a powerful demonstration of precision medicine in action. Each patient's T-cells are genetically reprogrammed to specifically attack their individual tumor characteristics, creating a truly personalized therapeutic approach.

Gene therapies are being developed to correct or compensate for specific genetic defects in individual patients. As these technologies continue maturing, startups have unprecedented opportunities to deliver cures for conditions once considered untreatable, with treatments tailored to the specific genetic profiles of even small patient populations.

FemTherapeutics: Precision Medicine in Action

FemTherapeutics exemplifies how precision medicine principles can transform traditional medical device approaches, particularly in women's healthcare where innovation has historically lagged behind other medical specialties.

Addressing a Century-Old Problem

The company, co-founded by CEO Negin Ashouri, tackles a classic one-size-fits-all problem in gynecological care: the standard vaginal pessary used to treat pelvic organ prolapse. Pessaries are medical devices inserted into the vagina to support pelvic organs, and they have remained largely unchanged for over a century.

Traditional pessaries typically come in a limited range of standard shapes and sizes, forcing patients to find the "least bad" fit among available options. Many women struggle to find comfortable, effective fits with off-the-shelf pessaries, leading to high discontinuation rates and often pushing patients toward more invasive surgical interventions.

A Technology-Driven Solution

FemTherapeutics has developed a comprehensive platform that applies cutting-edge precision medicine principles to solve this persistent problem. The company uses artificial intelligence, cloud computing capabilities, and advanced 3D printing technology to design the world's first truly customizable pessary system.

Instead of offering a few standard options, their approach begins with each patient's unique anatomy and specific clinical needs. Following a standard pelvic examination or medical imaging, FemTherapeutics' proprietary software generates a detailed 3D model of the patient's vaginal canal and prolapse geometry.

Their sophisticated algorithms then design a pessary device specifically tailored to that individual patient, optimizing both shape and size to ensure proper fit and optimal therapeutic support. Each device is 3D-printed using biocompatible materials to precisely match the patient's anatomical requirements.

The Vision Behind Personalization

The mission driving FemTherapeutics underscores the broader value proposition of personalized medicine approaches. As the founders explain their company's genesis: "We thought, 'we have custom dental appliances, we have custom orthotics, we have custom hearing aids, why don't we have something custom in gynecology?'"

This observation highlights how women's health had remained stuck with archaic, one-size-fits-all solutions for far too long, despite technological advances enabling personalization in numerous other medical fields.

Clinical Impact and Future Potential

By redesigning the traditional approach to women's healthcare, FemTherapeutics aims to significantly improve patient outcomes and comfort while reducing unnecessary surgical interventions. When a properly tailored pessary successfully manages a woman's prolapse symptoms, she can avoid the risks, costs, and recovery time associated with surgical procedures.

Comfortable, well-fitting devices also improve patient compliance and long-term management of the underlying condition, leading to better quality of life outcomes.

Though still in relatively early stages, FemTherapeutics has already demonstrated the promise of its approach through pilot studies and ongoing collaborations with practicing gynecologists. Healthcare providers can now offer truly personalized medical devices for prolapse management, an option that was completely unavailable just a decade ago.

As more patient data is collected and analyzed, the company's AI algorithms can continue refining device designs and potentially predict which patients will respond optimally to pessary treatment versus those who might eventually require surgical intervention.

This example illustrates how precision medicine startups create entirely new solution categories while generating valuable data and insights that continuously improve patient care over time.

The Road Ahead: Building the Future of Personalized Healthcare

The convergence of these technological and market trends creates clear implications for today's biotech startup founders. The future of medicine will increasingly belong to organizations that can master personalization at scale while maintaining clinical efficacy and economic viability.

The Interdisciplinary Advantage

Success in precision medicine requires convergence of multiple disciplines including biology, data science, engineering, and clinical insight. Startups are uniquely positioned to innovate at these intersections, unencumbered by legacy systems and traditional organizational silos that often constrain larger institutions.

Entrepreneurs can identify specific niche patient populations with significant unmet medical needs and develop targeted solutions, as FemTherapeutics demonstrated in women's health. Alternatively, they can create enabling technologies that make personalized care approaches possible at scale, similar to Scispot's work in AI-driven laboratory workflows and data management.

An Ecosystem Ready for Innovation

The broader healthcare ecosystem is increasingly prepared for precision medicine innovations. Physicians are becoming more comfortable incorporating genomic testing results and AI-driven decision support tools into their clinical practice routines.

Health insurance providers are recognizing the economic value proposition: paying for a $250 genetic test today can potentially prevent a $250,000 hospitalization or surgical intervention in the future. This shift in payer perspective creates more favorable reimbursement environments for precision approaches.

Regulatory agencies have demonstrated flexibility and support for clinical trials focused on biomarker-defined patient groups, streamlining approval pathways for targeted therapies and companion diagnostics.

Perhaps most importantly, patients themselves are beginning to expect treatments tailored to their individual genetic and clinical profiles. This cultural shift toward personalized healthcare represents a fundamental change that should not be underestimated by entrepreneurs building in this space.

Overcoming Implementation Challenges

Significant challenges remain in scaling precision medicine approaches. Developing targeted therapies or diagnostics for smaller, genetically defined patient subpopulations can prove both scientifically complex and financially challenging compared to traditional broad-market approaches, particularly for drug discovery initiatives.

Data privacy concerns surrounding genetic information require careful management with transparency and robust security measures. Patients need assurance that their personal genetic data will be protected and used only for their direct therapeutic benefit.

Healthcare providers will require ongoing education and training to fully implement personalized treatment approaches in their clinical practice. Modern laboratory information management systems (LIMS) and data infrastructure must also ensure equitable access to precision medicine innovations, preventing these advances from becoming available only to affluent patient populations.

Strategic Recommendations for Founders

Despite these challenges, history demonstrates that when medical approaches demonstrably improve patient outcomes, they eventually become standard care regardless of initial implementation obstacles.

For early-stage biotech founders, the strategic mandate is clear: integrate precision medicine principles into your company mission from the very beginning. This integration might involve designing clinical studies that specifically identify which patients benefit most from your product and, equally importantly, which patients do not benefit.

Successful precision medicine companies leverage artificial intelligence to inform research and development decisions while building comprehensive databases that accumulate insights about patient variability and treatment responses over time. Computational biology integration becomes essential for bridging wet lab and dry lab workflows.

Building winning teams in precision medicine often requires interdisciplinary collaboration that extends beyond traditional biology and chemistry expertise. The most successful companies typically include data scientists, software engineers, clinical specialists, and regulatory experts working together from the early stages.

The Personal Future of Medicine

As the conversation between Guru Singh and Negin Ashouri on talk is biotech! highlighted, medicine's next chapter will be deeply personal and individually tailored. The era of blockbuster drugs designed to treat millions of patients identically is giving way to an era of bespoke interventions, where therapeutic success is measured one patient at a time.

For entrepreneurs ready to embrace this fundamental shift, precision medicine offers unprecedented opportunities to deliver transformative value to patients while building commercially successful companies. The convergence of advancing technology, supportive regulatory environments, favorable investment climate, and changing patient expectations creates ideal conditions for breakthrough innovations.

In precision medicine, doing what's right for individual patients isn't just good ethics and responsible healthcare practice. It represents sound business strategy and defines the future direction of the entire healthcare industry. The companies that master this personalized approach will shape medicine for decades to come.