insights from mka
The Tank That Holds our Think
A decade of helping companies navigate markets — observing where they win, where they struggle, and the leadership nuance in between.
What comes out of that is a clear understanding of an otherwise complicated and data-intensive issue. That is the foundation of our practice.
How Precision Medicine Uses Stratification for Therapeutic Targeting
Not every patient who could theoretically benefit from a therapy actually should receive it. Some will not respond.…
Root Cause Analysis: Tracing Failure to Its Source
Every organization eventually faces the same question from two directions. Before something goes wrong, the question is: what…
Operations ExcellenceTwenty Case Studies, No Script: An AI’s Unfiltered Read on How MKA Insights Works
Editor’s note: In January 2026, MKA Insights gave Claude 3.5 Sonnet — Anthropic’s AI model — twenty of…
What’s the Key to Successful Sales Messaging?
Sales messaging is the most perishable form of commercial communication a company produces. Unlike brand messaging — which…
Expert Insights MarketingWhat is Machine Learning & AI?
Machine learning is a field within artificial intelligence concerned with building systems that can recognize patterns in data…
Explainer Market IntelligenceFDA vs. EMA on Gene Therapy: How to Navigate Both Regulatory Frameworks Without Building Two Programs
Every gene therapy program moving toward global approval eventually has to reconcile two regulatory frameworks that share the…
Expert Insights Market IntelligenceWhat CRISPR’s Regulatory Moment Actually Looks Like: The FDA’s 2024 Genome Editing Guidance Decoded
On December 8, 2023, the FDA approved Casgevy — exagamglogene autotemcel, developed by Vertex Pharmaceuticals and CRISPR Therapeutics…
Expert Insights Market IntelligenceEx Vivo vs. In Vivo Genome Editing: Two Different Regulatory Frameworks in the Same Guidance
The FDA’s 2024 guidance on human gene therapy products incorporating genome editing addresses two fundamentally different types of…
Explainer Market IntelligenceOn-Target and Off-Target Editing: Why the Distinction Defines Gene Editing’s Regulatory Future
Every genome editing event produces two categories of outcome: the intended modification at the intended genomic location, and…
Explainer Market IntelligenceCAR-T CMC: Why Manufacturing Control Is the Clinical Development Variable Nobody Talks About
Clinical trials for CAR-T cell therapies are described in terms of patient outcomes: response rates, duration of remission,…
Expert Insights Operations ExcellenceWhat the FDA’s 2024 CAR-T Guidance Actually Means for Developers
The FDA’s January 2024 guidance on the development of CAR T cell products is 34 pages of non-binding…
Expert Insights Market IntelligenceAAV vs. Lipid Nanoparticles: When Each Platform Wins
Two delivery platforms now dominate in vivo gene therapy and gene editing: adeno-associated virus and lipid nanoparticles. Both…
Explainer Operations ExcellenceHow Lentiviral Manufacturing Differs from AAV Manufacturing
Lentiviral vectors and AAV vectors are both produced using viral packaging systems, both rely heavily on transient transfection…
Explainer Operations ExcellenceIntegrating vs. Non-Integrating Vectors: What the Choice Actually Determines
One of the most fundamental distinctions in gene therapy vector biology is whether the delivered genetic material integrates…
Explainer Operations ExcellenceFull Capsids, Empty Capsids, and Why Regulators Care
Among the quality attributes measured in AAV gene therapy manufacturing, the ratio of full to empty capsids is…
Explainer Operations ExcellenceWhy AAV Became the Dominant In Vivo Gene Therapy Platform — and Where Its Limits Are
Adeno-associated virus did not become the dominant in vivo gene therapy platform by accident or by consensus. It…
Expert Insights Operations ExcellenceTissue Tropism and Serotype Selection: Why Vector Choice Is a Strategic Decision
Among the decisions made in early AAV gene therapy development, serotype selection is among the most consequential and…
Explainer Operations ExcellenceAAV vs. Lentivirus: Choosing the Right Vector for the Right Disease
The two most widely used viral vectors in gene therapy — adeno-associated virus (AAV) and lentivirus (LV) —…
Explainer Operations ExcellenceWhy Plasmid Quality Determines Gene Therapy Success
In the development of AAV gene therapies, attention typically centers on the clinical question — which disease, which…
Explainer Operations ExcellenceUnderstanding the Three-Plasmid System in AAV Manufacturing
Adeno-associated virus does not replicate on its own. In nature, AAV is classified as a dependoparvovirus — a…
Explainer Operations ExcellenceWhat Is a Rep-Cap Plasmid and Why Is It Critical to AAV Manufacturing?
Adeno-associated virus has become the dominant vector platform for in vivo gene therapy. Behind every approved AAV gene…
Explainer Operations ExcellenceCLIA, CMS & the FDA: Who Regulates Lab Tests?
Clinical laboratories in the United States operate under a layered regulatory framework that involves two distinct federal agencies…
Explainer Market IntelligenceWhat Are Exosomes?
Exosomes are nanoscale vesicles — tiny membrane-enclosed particles, typically between 30 and 150 nanometers in diameter — that…
Explainer Market IntelligenceWhat Is a Liquid Biopsy?
A liquid biopsy is a test that analyzes genetic material or cellular components circulating in body fluids —…
Explainer Market IntelligenceWhat Are Companion Diagnostics?
A companion diagnostic is a test that is developed, validated, and often co-approved alongside a specific therapeutic drug…
Explainer Market IntelligenceWhy Clinical Diagnostics for Oncology Is So Hard
Cancer testing does not work the way most people expect. There is no test a physician orders that…
Expert Insights Market IntelligenceThe Clinical Diagnostics Market: Structure, Trends & Therapeutic Segments
Clinical diagnostics — the testing, analysis, and monitoring of human specimens to detect, diagnose, and manage disease —…
Explainer Market IntelligenceWhat Are the Challenges of Cell Therapy?
Cell therapy — using a patient’s own cells, modified to fight disease — moved from theoretical possibility to…
Explainer Operations ExcellenceWhat Are Advanced Therapies?
Advanced therapies is the umbrella term encompassing an emerging category of therapeutics that has pushed the broader biopharma…
Explainer Operations ExcellenceHow Are Bacteriophage Used in Cell Therapy?
A bacteriophage is a virus that specifically attacks bacteria — found virtually everywhere bacteria exist. While bacteriophage research…
Explainer Operations ExcellenceWhat is mRNA Therapy?
Messenger RNA, or mRNA, is a family of molecules that carry genetic instructions from a cell’s DNA to…
Explainer Operations ExcellenceGene Editing and CRISPR: How It Works and How It’s Used in Therapy
Gene editing technologies give researchers and clinicians the ability to make precise, targeted changes directly to an organism’s…
Explainer Operations ExcellenceWhat is Gene Therapy?
Gene therapy refers to the delivery of genes — typically in the form of nucleic acid polymers —…
Explainer Operations ExcellenceUnderstanding the FDA’s IND Process for Cell and Gene Therapies
Before any cell or gene therapy candidate can be tested in human patients in the United States, its…
Explainer Operations ExcellenceGenetic CAR-T Therapy Holds Great Promise
Chimeric antigen receptor T-cell therapy, commonly known as CAR-T, represents the most commercially successful cell therapy modality developed…
Expert Insights Operations ExcellenceCell and Gene Therapy Research Challenges
Cell and gene therapy represents the leading edge of where biomedical science is headed, but the path there…
Explainer Operations ExcellenceIdentifying Cell and Gene Therapy Risk Factors
As cell and gene therapy has matured, the knowledge base around its uncertainties, risks, and challenges has grown…
Explainer Operations ExcellenceCell and Gene Therapy: Selecting the Right Vector
A vector is the delivery vehicle that carries genetic material into a target cell — and in cell…
Explainer Operations ExcellenceCell and Gene Therapy: Ex Vivo versus In Vivo
There are two fundamentally different approaches to delivering cell and gene therapy: ex vivo, where a patient’s cells…
Explainer Operations ExcellenceCell and Gene Therapy: Balancing Promise and Risk
Cell and gene therapy offers something genuinely new in medicine: the possibility of treating the underlying genetic or…
Explainer Market IntelligenceCell and Gene Therapy: A Field That Outgrew Its Own Regulatory Playbook
On August 30, 2017, the FDA approved Kymriah, a CAR-T cell therapy for B-cell acute lymphoblastic leukemia —…
Explainer Market IntelligenceProduct Design and Process Design in CGT: Why They Cannot Be Managed in Isolation
There is a management instinct in drug development to organize work into functional lanes. Scientists design the product.…
Expert Insights Operations ExcellenceCQAs Are Not Static: How Quality Requirements Evolve Across the CGT Development Pathway
One of the more consequential misunderstandings in cell and gene therapy development is treating critical quality attributes as…
Expert Insights Operations ExcellenceWhy CGT Programs Fail — and What the Data Actually Shows
Cell and gene therapy has produced some of the most remarkable clinical results in the history of medicine.…
Expert Insights Operations ExcellenceUnderstanding Cognitive Decision-Making in Healthcare
A clinician facing a diagnostic challenge is not always working with a clear answer. When symptoms point unambiguously…
Explainer Market IntelligenceThe Sphere of Influence: Who Are the Stakeholders Driving Healthcare Decisions?
Healthcare decisions are rarely made by a single person acting alone, even when they appear that way on…
Explainer Market IntelligenceEuropean Policy Initiatives Driving Innovation
Government policy doesn’t typically come up in conversations about scientific innovation, but in biopharma, regulatory and funding policy…
Expert Insights Market IntelligenceHow Are Vaccines Manufactured?
On average, manufacturing a vaccine takes between 12 and 36 months from start to finish, with roughly 70…
Explainer Market IntelligenceWhat Are Vaccines?
A vaccine works by triggering an immune response within the body to a weakened, inactivated, or partial version…
Explainer Market IntelligenceWhat is Epigenetics?
Epigenetics is the study of heritable changes in gene expression that occur without any alteration to the underlying…
Explainer Market IntelligenceWhat is Genomics?
Genomics is the field of study concerned with the complete set of an organism’s genetic material — its…
Explainer Market IntelligenceThe Innovative & Dynamic Biopharma Industry
Biopharma is one of the few industries where the pace of scientific change consistently outruns the institutional structures…
Expert Insights Market IntelligenceThe Technology Readiness Level (TRL) Framework
During the 1960s and 1970s, NASA developed a framework — now known as Technology Readiness Levels, or TRL…
Explainer Operations ExcellenceChallenges in Manufacturing Advanced Therapies
The single biggest challenge facing advanced therapies — the category once known narrowly as cell and gene therapy…
Expert Insights Operations ExcellenceWhat Are CQAs? Understanding the FDA’s Critical Quality Attributes
The FDA defines a critical quality attribute, or CQA, as a physical, chemical, biological, or microbiological property or…
Explainer Operations ExcellenceWhat is the Process Analytical Technologies (PAT) Framework?
The FDA defined the Process Analytical Technologies framework in 2004 to address a structural inefficiency in pharmaceutical and…
Explainer Operations ExcellenceThe Importance of Polymers in Single-Use Films
Single-use technology has become the default manufacturing platform across much of bioprocessing, and the films that form bioreactor…
Explainer Operations ExcellenceBiopharma Customers’ Sourcing Criteria
Biopharma companies apply a distinct, risk-driven lens when sourcing suppliers, vendors, and partners — one shaped less by…
Expert Insights Market IntelligenceWhat Are the Purchasing Criteria for Bioprocessing Customers?
When biologics manufacturers procure equipment, supplies, or software, they are not simply comparing specifications and price. Bioprocessing purchasing…
Explainer Market IntelligenceHow to Win in Bioprocessing
Bioprocessing is one of the stickiest markets in life sciences, and that stickiness is exactly what makes it…
Expert Insights Commercial StrategyWhat is Bioprocessing?
Biologics manufacturing is more commonly referred to as bioprocessing given that the biologic that is being manufactured follows…
Explainer Operations ExcellenceBioprocessing and Biomanufacturing: Understanding the Industry Behind Every Biologic
For most of its existence, bioprocessing was an industry almost no one outside of it had ever heard…
Explainer Operations ExcellenceVarious Paths to Growth
Growth is the organizing objective of most commercial strategies — but growth is not a single thing. The…
Expert Insights Commercial StrategyBeyond Customer-Focused: The Case for Customer Obsession
Customer-focused is a floor, not a differentiator. Every organization that competes seriously in a defined market claims to…
Expert Insights Commercial StrategyWhat is the Buyer’s Journey?
The buyer’s journey is the sequence of stages a prospective customer moves through from initial awareness of a…
Explainer Commercial StrategyIncreasing Reach Through Distribution Strategies
Distribution strategy is one of the most capital-efficient paths to commercial growth available to a mid-market life sciences…
Expert Insights Commercial StrategySales & Marketing Channels
Sales channels and marketing channels are not the same thing. They serve different functions, operate through different mechanisms,…
Explainer Commercial StrategyWhat is the Adoption Curve?
The adoption curve — more formally the technology diffusion curve — describes how different types of buyers engage…
Explainer Commercial StrategyCompetitive Advantage vs. Comparative Advantage
These two terms appear in the same conversations, are often used interchangeably, and mean entirely different things. The…
Expert Insights Commercial StrategyGrowth Through Competitive Advantage
Competitive advantage is the condition that allows an organization to outperform its peers in a defined market over…
Expert Insights Commercial StrategyTwo Frameworks Every Commercial Strategy Needs
Commercial strategy involves dozens of analytical inputs. But two frameworks sit beneath all of them, orienting every other…
Expert Insights Commercial StrategyGo-To-Market Strategies
A go-to-market strategy is the plan an organization uses to bring an offering to a defined set of…
Expert Insights Commercial StrategyDeveloping a Commercial Strategy
A commercial strategy is not a launch plan, a sales playbook, or a marketing calendar. It is the…
Expert Insights Commercial StrategyCommercial Launch Playbook for Life Sciences Companies
Most life sciences companies treat commercial launch as a sequence of equal steps. Build the value proposition. Develop…
Expert Insights Commercial StrategyWhat is a Value Proposition?
Most life sciences companies believe they have a value proposition. Few actually do. What they have is a…
Explainer Commercial StrategyVerification and Validation: Why It Has to Start Earlier Than You Think
Verification and validation — V&V — is the phase of product development that most organizations understand best in…
Explainer Product DevelopmentCustomer Requirements in NPD: The Document No One Gets Right
The most common reason new products miss the market is not a technology failure. It is a requirements…
Expert Insights Product DevelopmentUnderstanding FMEA in Product Development
Failure Mode and Effects Analysis — FMEA — is one of the most widely required and least well-executed…
Explainer Product DevelopmentWhy NPD Governance Fails — and What Good Looks Like
Every product development organization has some version of a governance process. Stage gates, go/kill reviews, portfolio committees —…
Expert Insights Product DevelopmentThe Make vs. Buy Decision in Product Development
The decision is whether to build something internally or acquire it externally. And the failure mode is almost…
Expert Insights Product DevelopmentInformation Architecture and the NPD Process
When a new product development project fails — misses its launch window, exceeds its budget, reaches the market…
Expert Insights Product DevelopmentThe Fuzzy Front End of Product Development
Every product development project begins the same way: with more questions than answers. The market need is real…
Explainer Product DevelopmentForward-Tracing Risk Analysis: Seeing Risk Before It Arrives
Root cause analysis is one of the most disciplined tools in life sciences and operations management. When something…
Expert Insights Product DevelopmentInnovation and the Product Value Chain
Most organizations say they are committed to innovation. Fewer have a clear-eyed view of what happens to an…
Explainer Product DevelopmentCommon Pitfalls of Product Management
Product management failures rarely look like catastrophic mistakes. They look like slow drift — a portfolio that quietly…
Expert Insights Product DevelopmentWhat Does Product Management Do?
Product management is one of the most misunderstood functions in a life sciences or commercial organization. Ask ten…
Explainer Product DevelopmentThe Business Journey: Building an Organization That Lasts
Every organization that persists long enough goes through a version of the same journey — from founding energy…
Expert Insights Commercial StrategyFive Lessons from Being a Change Agent
Change agents are the people inside organizations who push for transformation — who identify gaps between what an…
Expert Insights Commercial StrategyExit Planning for Life Sciences Companies
Exit planning is not what you do when you are ready to leave a business. It is what…
Expert Insights Commercial StrategyStrategic Rationale for Acquisitions
Every acquisition needs a thesis — a clear, specific explanation of what value the deal creates and why…
Expert Insights Commercial StrategyAcquisitions, Integrations & Change Management
Mergers and acquisitions are evaluated on financial and strategic logic. Integrations succeed or fail on human and organizational…
Expert Insights Commercial StrategyHow to Invest in Corporate Finance Capabilities
Corporate finance capabilities are frequently underdeveloped in mid-market life sciences companies — not because leadership undervalues financial rigor,…
Expert Insights Commercial StrategyWhat is Organizational Breakage?
Organizational breakage is the point at which cumulative execution demand — the aggregate weight of strategic initiatives, operational…
Explainer Commercial StrategyUnderstanding Risk Mitigation in Strategic Planning
Risk planning sits at the edge of most strategic planning processes — acknowledged as important, included as a…
Explainer Commercial StrategyA Phased Approach to Growth
Growth does not happen all at once, and plans that treat it as if it might are not…
Expert Insights Commercial StrategyWhere Did Competitive Advantage Disappear To?
Competitive advantage, as it was understood for most of the 20th century, was assumed to be durable. Build…
Expert Insights Commercial StrategyCompetitive Forces in the 21st Century
Michael Porter’s Five Forces framework, introduced in 1979, remains one of the most durable analytical tools in business…
Explainer Commercial StrategyGetting Rid of the SWOT
The SWOT analysis is one of the most widely used and least useful tools in business planning. After…
Expert Insights Commercial StrategyStrategy or Tactics: Why the Distinction Matters
The argument that strategy and tactics are just two words for the same thing — that what matters…
Expert Insights Commercial StrategyOvercoming Pitfalls in Strategic Planning
Strategic planning pitfalls are not random. They are structural tendencies that emerge from the way organizations process information,…
Expert Insights Commercial StrategyWhy Strategic Plans Fail
Strategic plans fail for predictable reasons. The same failure modes appear across industries and organization sizes with enough…
Expert Insights Commercial StrategyWhat Does It Take to Succeed at Strategic Planning?
Strategic planning is not a document exercise. Organizations that treat it as one — assembling a plan over…
Expert Insights Commercial StrategyStrategy vs. Tactics: What’s the Difference?
The confusion between strategy and tactics is not semantic. When organizations mistake one for the other, they either…
Explainer Commercial StrategyWhat is Business Strategy?
Business strategy is the set of deliberate choices a firm makes about where to compete, how to win,…
Explainer Commercial StrategyWhat is Marketing Automation?
Marketing automation is the use of software and technology to execute, manage, and optimize marketing activities that would…
Explainer MarketingMarketing Needs Assessment
Most life sciences and B2B companies know they need stronger marketing. Fewer know specifically where the gap is.…
Expert Insights MarketingThe Strategic Value of Marketing
Marketing is the function most frequently asked to justify its existence and least frequently given the framework to…
Explainer MarketingWhat is Strategic Marketing?
Strategic marketing is the process by which an organization aligns its commercial activities — targeting, positioning, messaging, channel…
Explainer MarketingWhat Does Marketing Do?
Marketing is one of the most consistently misunderstood functions in business. In organizations where it is well understood,…
Explainer MarketingMarket Positioning and Launches
A product launch is the first and most consequential positioning moment a company has with its market. The…
Expert Insights MarketingWhat is the Halo Effect?
The halo effect is a cognitive bias in which the perception of one positive quality in a person,…
Explainer MarketingMarket Positioning is an Art
Positioning a product or company in a market is not an analytical exercise that produces a correct answer.…
Expert Insights MarketingThe Hidden Benefits of a Loyal Customer Base
The visible benefits of customer loyalty are well understood. Loyal customers renew contracts. They buy more. They are…
Expert Insights MarketingWhy Customer Dynamics Can Build (or Erode) Brand Equity
A brand lives or dies by what customers do and say — not what the company claims about…
Expert Insights MarketingCustomer Testimonials, Brand Trust & Loyalty
Trust is not a feeling. In commercial markets, it is a belief — formed through accumulated evidence —…
Expert Insights MarketingWhy Investing in Product Messaging Pays Off
Every loyal customer started somewhere. Before the contract, before the repeat purchase, before the referral to a peer,…
Expert Insights MarketingFive Steps to Effective Brand Messaging and Positioning
Brand positioning is the deliberate act of shaping how a specific audience perceives a company or product relative…
Expert Insights MarketingUnlocking the Power of Brand Messaging
Most companies in life sciences and B2B technology markets can describe what their products do. Fewer can articulate,…
Expert Insights MarketingWhat is a Brand Persona?
A brand persona is a structured, research-based representation of the ideal customer a brand is designed to reach.…
Explainer MarketingWhat is a Brand Archetype?
A brand archetype is a universal character pattern that a brand adopts to give its identity coherence, emotional…
Explainer MarketingWhat is a Brand Hierarchy?
A brand hierarchy is the structured system by which a company organizes its brands, sub-brands, and product identities…
Explainer MarketingHow to Nurture Corporate Brand Equity
Corporate brand equity is the most expansive and most durable form of brand value a company can build.…
Expert Insights MarketingCultivating Business Brand Equity
A company that has built strong equity for its products faces a distinct and more complex challenge: translating…
Expert Insights MarketingBuild and Maintain Product Brand Equity
Every brand equity journey begins at the product level. Before a company has a reputation, before its name…
Expert Insights MarketingUnderstanding Brand Equity
Brand equity is the commercial value that a market assigns to a brand independent of the physical attributes…
Explainer MarketingWhat is a Brand?
A brand is the accumulated perception of trust that a market holds toward a product, company, or organization.…
Explainer Marketing