“bio + tech”: convergence or collision?

By Yuri A. Maricich, M.D., M.B.A.

Idea in Brief:

1. Biology and classes of medicines are undergoing a renaissance from small molecules, to biologics, to RNA/DNA/cell therapies and digital therapeutics

2. Digital technology and sensors are ubiquitous and bring tremendous scale and speed

3. Digital tech and bio are converging: software is becoming medicine and medicine is becoming software

​4. “bio+ tech” are enabling novel and hybrid delivery models, enhanced outcomes, and access to care

Question: “How” and “what” will be the impact of integration between bio + tech: when, if, and/or how will convergence occur and will they deliver improvements in outcomes, access, and value?

It’s 2022 and throughout the past 2 years of COVID-19 we have witnessed unprecedented health, economic, and social challenges, which have paradigmatically crystallized technology yields from the past two decades - digital and biologic. Digital has become ubiquitous and can be scaled in less time than prior technologies. Biological insights have expanded the categories and pace of medicine development rapidly where novel classes of “what is a medicine“ are exploding.

”Software is becoming medicine and medicine is becoming software.”

I am an internal medicine physician experienced in caring for patients across multiple clinical care settings, developed molecular therapeutics at Corixa (acquired GlaxoSmithKline), Xdynia (acq. Cavion), Cavion (acq. Jazz Pharma), and worked with digital and tech companies such as Amazon Web Services. I’ve implemented IT systems including electronic health records at multiple providers organizations.

In my current role as Chief Medical Officer and Head of Development at Pear Therapeutics (Nasdaq: PEAR) where traditional drugs, clinical drug development, and digital tech converge in our FDA-authorized PDTs: treatments for patients with serious diseases - I bring a unique leadership role and vantage point blending together traditional drug development, digital health, with clinical practice and delivery.

bio + tech

Over the last decades we have witnessed medicines originate as small molecules (pills), then expand to biologics (injectables/infusions), and now expand to genetic/cellular therapies that facilitate DNA, RNA, and cells becoming “programable” medicines. Moderna describes their class of RNA therapeutics in digital terms: The DNA - > mRNA -> Protein described by Moderna as Storage-> Software->Application.

Image source: Moderna corporate website

In the burgeoning field of synthetic biology, scientists and engineers collaborate to create programmable biological machines where medicines or their exposures to molecular targets, can be turned on/off and/or modulated in vivo. Software itself is now a medication, as prescription digital therapeutics (PDTs) treat disease either as a monotherapy, or in combination with biopharmaceuticals (combo therapy). Usually referred to as “biotech” or “biopharma” I will call this “bio”.

Digital technology, what I’ll call “tech”, has brought information exchange, communication, and automation at a speed, scale, and agility that is transformative. It has solved many problems…and created new ones. For healthcare and “bio”, “tech” raises the prospect of increased access (time, place, and opportunity), asynchrony, computing control, and automation, with the potential for healthcare ecosystem and societal cost-savings.

Historically “bio” and “tech” have maintained separation from one another. On one side, “bio” strives to discover and develop new medicines in a focused, albeit, siloed way. Molecular pathways are elucidated and chemistry targeted without primary consideration of non-biological technologies or concerns for how the drugs would fit into emerging models of care, their workflow, and “tech”.

“Tech”, particularly computing, has historically viewed biological complexity, its lack of predictability, its quality control and repercussions (life, death, morbidity), overlaid with healthcare and biopharma’s complex and expensive regulatory requirements and reimbursement pathways as too time-consuming, difficult, risky, and onerous.

Through advances in biology and digital, the expanding insights, scale and ubiquity, coupled with individual human and organizational courage and commitment, we are driving a convergence of “bio” and “tech”, or what I will call, bio+tech, the name of this blog and forum.

“Software is becoming medicine and medicines are becoming software.”

These advances, however, bring organizational, cultural, and paradigmatic differences.

Tech moves fast, learns by breaking-things, and crosses boundaries (privacy, security and regulatory) at an unprecedented scale. Biopharma is hyper-focused, controlled, non-integrative with delivery, and sequential in process with a singular focus on the biology, often ignoring delivery, “user,” and workflow considerations until late in development yet harnesses biology in incredible ways (mRNA COVID vaccines (Moderna and Pfizer/BioNTech mRNA therapeutics), gene-editing (CRISPR and base-editing), and immuno-oncology). Taken together tech and bio (exacerbated by our health insurance/payment mis-incentives) have hindered each other as they create obstacles and collisions. But, if integrated rightly, present an enormous opportunity for transformation of healthcare at scale.

Medicines are becoming software.

There are a number of emerging companies bringing bio+tech together. A selection of these include, although not limited to, are listed below::

• ConcertoAI (data + drugs)

• Insilico (AI + Drug Discovery)

• twoXAR (AI+drug discovery)

• Spring Discovery (AI + drug discovery)

• DNANexus (genomic/precision-medicine and cloud computing),

• Valo Health (AI drug discovery)

• Roche (ties up: Foundation Medicine + Flatiron)

• Deep Genomics (AI and genomic-drive drug development)

• Synlogic (Synthetic biology: programmable medicines)

• ASIMOV (programmable medicines),

• Pear (prescription digital therapeutics: molecular drugs + software like reSET-O),

• Alnylam, BioNTech/Pfizer, Moderna (RNA and RNAi)

Image Source: Asimov - Intelligent Design Corporate Website

Tech:

Software is becoming medicine.

As medicines (such as RNA) are being analogized to software, software has in fact become medicine. A renaissance in classes of medicine, software alone or in combination with existing drugs can produce a therapeutic effect. Software, mechanical delivery, and medication has been pioneered with insulin pumps, and continuous glucose monitors (Abbot CGM, Dexcom G6 CGM System and Medtronic Guardian system), yielding improved diabetic control and thus outcomes.

Not limited to software and pumps that deliver medications, the software on our phones can actually treat disease (TEDMED). Prescription Digital Therapeutics, (PDTs) are a class of therapeutics that are being integrated into clinical practice and reimbursed by payers. reSET is a software-only treatment for patients with substance use disorder (SUD) and represents the first software treatment FDA market authorized with treatment claims. While clinicians prescribe and patients receive behavioral treatment alone with reSET, there are also PDTs that are intended to be used in combination with medications. Reviewed by both CDER and CDRH of FDA and then cleared, reSET-O, working in combination with the pharmacotherapy buprenorphine/naloxone has demonstrated improvements in outcomes across RCTs, RWE, and HEOR, highlighting its performance and longitudinal, generalizable value.

In the US alone, multiple additional PDTs received FDA market authorization in 2020, including Pear’s Somryst, Akili Interactive, Nightware, and Mahana - an expansion of PDTs. Three more in 2021: AppliedVR, Luminopia, and MetaMe. Each requiring their own safety and effectiveness clinical trials and FDA authorization and label to treat disease after FDA review. I predict we’ll see expansion across disease areas, broadening coverage by payers as adoption increases: such as state Medicaid, value-based Medicaid, and Pharmacy Benefit Managers alongside expanding evidence, and increased sophistication of these therapeutics with tighter integration between molecular therapeutics and digital therapeutics.

Bringing together bio + tech can be powerful. It can also offer a false promise, when without results or where they collide without careful integration, causing waste. Whether bio + tech converge in a lasting, tight integration that transforms healthcare's outcomes and value or they chafe each other, creating friction, and value-less collision, depends on how we as leaders and developers act.

Key questions to be answered include:

1) Will convergence remain and tighten OR will bio and tech continue for some time to run in parallel silos with friction?

2) Will therapeutic companies embrace the new “bio+tech” convergence and integrate tech with molecular therapeutics? Or will pharma and drug development companies continue their development and commercialization activities relatively in isolation from tech?

3) Will healthcare organizations (particularly delivery organizations and payers) be able to adapt and harness digital and its convergence with bio or will they remain a slow adopter and/or barrier to innovation? Will healthcare delivery be able to adopt the convenience and seamless experience of tech, while maintaining rigor of bio, in serious diseases with significant morbidity and mortality, rather than health and wellness or population-approaches?

4) Will access to and equity in care increase, worsen, or be mixed?

5) Will digital work with bio to tackle serious disease and high-cost problems across all populations (including uninsured, Medicaid, etc) or continue to skim the surface and focus on issues for high socioeconomic consumers and/or "worried-well" or lifestyle patient populations?

6) Will improvements in clinical and outcomes occur, will they accelerate with convergence, and/or will step-function transformations occur?

7) Will integration of bio + tech result in improvements to costs or simply add to them?

This site will serve as a forum to explore this convergence, as well as many important topics ranging from therapeutics (and their class), evidence generation (RCTs, RWE, and health economic), clinical trials, digital health, and our healthcare delivery and reimbursement ecosystem.

I look forward to exploring as part of my work, with readers and guests of this forum, how bio + tech integrate, how organizations adapt, what platforms will develop that facilitate adoption and integration, and continued evidence generation of clinical outcomes and value, from bio+tech. Together may we strive to create a better world for patients and for ourselves.

The many topics above will be further elucidated and explored in subsequent posts by guest authors and myself.

References: are provided in hyperlinks throughout article and will be added to the reference page.