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Articles by Mark Witcher
09.17.26 -- A Much-Improved Approach For Managing Safety Risks
Get more biosimilar development insight with our FREE newsletter Newsletter | September 17, 2026 Performance Characteristics Of ADC Reactor For Conjugation Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid. Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.
08.31.26 -- Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
Join Cell & Gene Live for "Scaling Next-Gen MSC Therapies Without Scaling Risk." Chief Editor Erin Harris hosts CEOs from Kiji Therapeutics, Mesoblast, and MEDIPOST to explore scaling cell production without losing therapeutic efficacy. Learn practical strategies for minimizing donor variability, preserving potency, and building commercially viable platforms.
08.30.26 -- CSV Assumes The AI System Sits Still — It Doesn't.
CSV Assumes The AI System Sits Still — It Doesn't. The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance. A Much-Improved Approach For Understanding And Managing Safety Risks Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the medical device industry. Connect With Med Device Online:
08.28.26 -- A Much-Improved Approach For Understanding And Managing Safety Risks
Why Spray Drying Is Gaining Attention As A Biologics Lifecycle Management Strategy As biologics face a looming $300bn patent cliff, pharmaceutical companies are exploring new ways to extend the value of established assets. This paper examines why spray drying is emerging as a powerful lifecycle management strategy, enabling novel delivery routes, enhanced patient convenience, and new intellectual property opportunities.
08.27.26 -- New Insights For Safer, Smarter Medtech
Successfully Navigating Opportunities With On-Body Delivery Systems – Common Questions And Answers Container Closure Integrity (CCI) is essential to ensure sterile drug products remain safe, effective, and contamination-free throughout their shelf life. USP <1207> recommends evaluating package integrity from development through commercialization by defining the Maximum Allowable Leakage Limit (MALL) and selecting validated, application-specific test methods.
A Much-Improved Approach For Understanding And Managing Safety Risks Original
Guest Column | August 18, 2026 By Mark F. Witcher, Ph.D., biopharma operations subject matter expert Safety is an essential part of every enterprise, including the pharmaceutical and medical device industries. This article describes how causal mechanism and effect analysis (CMEA)1 and its principles can be used to develop and maintain safer working environments. CMEA provides two complementary analysis methods for keeping everyone safe.
08.13.26 -- Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis
Speed Meets Precision With Process Development Services Explore strategies to accelerate biosimilar development that help manufacturers reduce timelines, optimize workflows, and meet regulatory standards while delivering cost-effective therapies. Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.
08.06.26 -- Analyzing And Managing CDMO Project Risks Using Causal Mechanism And Effect Analysis
Redefining Prefillable Syringe Systems A prefillable syringe platform streamlines early drug product development by providing an integrated, system-level approach to accelerate clinical fill. Built around a single verification package, compatibility assessments, aligned shipping formats, and system-level testing, it reduces development complexity and unnecessary testing.
08.01.26 -- Med Device Online Best Of July
Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities. The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.
07.21.26 -- Analyzing And Managing CDMO Project Risks Using Causal Mechanism And Effect Analysis
CDMO Live Americas - Where External Manufacturing Partnerships Are Made Benchmark your outsourcing strategy, take part in exclusive peer roundtables and make high-value connections with leading biopharma manufacturers. Powered by PartnerMatch 1-2-1 meeting program. 20–21 October 2026, Boston.
07.17.26 -- Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed?
Webinar: Nitrite and Nitrosamine Testing in Pharmaceutical Risk Assessment Nitrosamine regulations are evolving, and manufacturers must adapt their risk assessment strategies. Join this webinar to explore NDSRI requirements, understand how nitrosamines form in drug products, and learn practical approaches for developing sensitive analytical methods.
07.17.26 -- South Korea's Turn: CDMO Powerhouse Adds Biotech Innovation
CDMO Live Americas - Where External Manufacturing Partnerships Are Made Benchmark your outsourcing strategy, take part in exclusive peer roundtables and make high-value connections with leading biopharma manufacturers. Powered by PartnerMatch 1-2-1 meeting program. 20–21 October 2026, Boston. Download Agenda. Choosing The Right Pharma CMO: The 3 Cs That Matter Most Choosing a CMO is a strategic decision that shapes long‑term quality and scalability.
Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis Original
Guest Column | July 8, 2026 By Mark F. Witcher, Ph.D., biopharma operations subject matter expert CDMOs are a vital part of the pharmaceutical and medical device industries. Building, executing, and maintaining an effective sponsor/CDMO working relationship is critical to developing, commercializing, and manufacturing many important therapies and products.
06.26.26 -- Causal Mechanism And Effect Analysis: FMEA's Simpler, Effective Alternative
Tailoring Formulations To Meet Precision‑Medicine Needs Precision‑medicine formulation requires a thoughtful approach to improve performance, support patient needs, and help therapies advance successfully. Clinical Innovation Meets Manufacturing Excellence Discover how our ClinDMO model transforms early drug development with on-demand manufacturing, adaptive formulation, and real-time decision-making to accelerate timelines and optimize API use.
Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? Original
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert One of the pharmaceutical industry’s best examples of risk-based decision-making is the FDA’s decision to approve a new therapy.
06.13.26 -- Pharmaceutical Online Newsletter - Best Of May
MAY'S BEST FEATURED EDITORIAL Why Isolators Do Not Automatically Ensure Annex 1 Compliance Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is how it is applied.
05.12.26 -- Advancing Quality And Risk Management In MedTech
Webinar: 2026 Critical Manufacturing Trends Reshaping Life Sciences in Pharma & Medical Device Discover how life sciences manufacturers are preparing for 2026 with smarter, more connected operations and scalable innovation. In this MasterControl webinar, explore how unified digital threads, AI-driven manufacturing, and adaptable supply chain strategies are transforming production, quality, and compliance.
Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative Original
Guest Column | May 1, 2026 By Mark F. Witcher, Ph.D., biopharma operations subject matter expert The risk analysis method most widely used in the pharmaceutical and medical device industries is FMEA (failure mode and effect analysis).
01.15.26 -- SUS Insufficient For 40% Of Biopharma
Speed Meets Precision With Process Development Services Explore strategies to accelerate biosimilar development that help manufacturers reduce timelines, optimize workflows, and meet regulatory standards while delivering cost-effective therapies. Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.
01.14.26 -- Europe In 2026: Resilience Through Uncertainty
Spray-Drying Biologics: An alternative to freeze-drying. Explore how spray-drying technologies can enhance the stability and efficacy of biologics, improving formulations and producing powders for nasal and pulmonary dosage forms. Click to read the whitepaper.
01.09.26 -- Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
Webinar: The mRNA Journey: From Design to LNP-Ready Molecules for Research Discover an optimized end-to-end workflow for producing high-quality IVT mRNA for research applications.
12.17.25 -- Top 10 Of 2025
Connect With Pharmaceutical Online:
Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis Original
Guest Column | December 17, 2025 By Mark F.
Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
Guest Column | December 17, 2025 By Mark F.
11.01.25 -- October's Most Popular Articles & Solutions
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators. Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events.
10.03.25 -- Why Pharma, Medical Device Risks Must Be Analyzed By Their Risk Mechanisms
Webinar: From First-in-Human to Proof-of-Concept — Quicker, Smarter, Streamlined Unlock the keys to successful First-in-Human studies with Quotient. This webinar reveals how expert-designed SAD/MAD trials, flexible CMC strategies, and smart regulatory planning accelerate proof-of-concept while avoiding costly setbacks. Gain insider insights on biomarkers, patient recruitment, and data integration—plus real-world case studies across rare diseases, obesity, CNS, and inflammation.
Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms Original
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert The pharmaceutical and medical device industries are composed of a wide variety of systems, equipment, instruments, procedures, people, and processes that must be designed and operated to have a very high probability of successfully achieving their objectives for safely and effectively treating patients.
Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert The pharmaceutical and medical device industries are composed of a wide variety of systems, equipment, instruments, procedures, people, and processes that must be designed and operated to have a very high probability of successfully achieving their objectives for safely and effectively treating patients.
09.06.25 -- August's Most Popular Articles & Solutions
FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers can analyze to strengthen compliance and drive operational excellence. Explore how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting medical device risks.
08.27.25 -- Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection
Webinar: Strategic Approaches to Controlled Release Formulation: Polymer Screening and Case Study Insights Join Bend Bioscience for an insightful webinar on controlled release (CR) formulations—designed to optimize drug performance, enhance patient compliance, and reduce dosing frequency. Learn how to streamline CR development using efficient polymer screening methods and real-world case studies. Don’t miss this opportunity to gain actionable strategies and elevate your formulation expertise.
08.14.25 -- Minimizing The Impact Of Human Errors Using Relational Risk Analysis
This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks. What Kind Of Capacitors Does Knowles Make? Discover capacitors for everything from medical implants to fusion experiments, covering energy storage from millijoules to kilojoules with tailored, high-performance solutions. What Is A Bowie-Dick Test And Why Is It Important?
Minimizing The Impact Of Human Errors Using Relational Risk Analysis Original
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert People can make mistakes – you should plan on it. This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks. Minimizing the impact of human errors remains one of the industry’s most vexing and challenging objectives.
Mejora de métodos prospectivos de desarrollo de productos derivados de lineamientos regulatorios basados en la gestión
INVESTIGACIÓN ARBITRADA Mark Witcher Para lograr rápidamente procesos de fabricación farmacéutica de alta calidad, la industria debe centrarse en desarrollar enfoques prospectivos basados en la gestión en lugar de medidas retrospectivas basadas en el desempeño que son demasiado lentas para impulsar la innovación necesaria y la mejora continua.
07.18.25 -- Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis
Webinar: Unlocking Global Oncology Success: The Strategic Advantage of Australia & Asia for U.S. Biotechs The oncology clinical trial landscape is evolving, and U.S. biotech companies are increasingly seeking innovative solutions to accelerate their drug development programs. Join us as we explore how Australia, Taiwan, and South Korea provide a strategic advantage in conducting early, mid, and late-phase oncology trials, offering speed, cost efficiency, and global scalability. Register now.
07.03.25 -- How APBio Builds Multispecific Analytical Target Profiles
Some attributes require an elevated level of attention, in particular when it comes to analyzing chain pairing, folding fidelity, and aggregation. The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?
06.24.25 -- Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis
Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | June 24, 2025
06.10.25 -- Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis
Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient. Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation The following insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.
Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis Original
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert A bow tie risk analysis (BT) is an intuitively appealing approach used in many fields, including the pharmaceutical and medical device industries, for identifying, understanding, and modelling risks.1 This article describes how relational risk analysis (ReRA) can be used to enhance and expand a BT to more effectively analyze risks as relationships between mechanisms and events.
05.29.25 -- Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis
Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | May 29, 2025 Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.
Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis Original
Guest Column | May 5, 2025 By Mark F. Witcher, Ph.D., biopharma operations subject matter expert Health Canada recently released a new guideline for managing patient risks of a new or significant drug or therapy that provides an opportunity to better describe and understand a patient’s benefit/harm risks.1 The guidance describes the submission of a risk management plan (RMP) for identifying and managing adverse reactions (ARs).
02.27.25 -- A New Approach For Minimizing Human Errors In Medical Devices And Biopharma
Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | February 27, 2025 Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
02.27.25 -- A New Approach For Minimizing Human Errors In Biopharmaceuticals
Get more biosimilar development insight with our FREE newsletter Newsletter | February 27, 2025
02.24.25 -- CDMOs Bet Big On Asia Expansion. Can Trump Reverse The Tide?
Webinar: Get $mart: 1 Year Out from Phase 1 Injectable Trials, Avoid 3 Expensive Mistakes Join us on March 6th with Singota to explore strategies for scaling up drug development from bench to Phase 1 clinical trials. Learn how to navigate cold chain logistics, develop robust analytical methods, and avoid compromising your core values. Discover insights from Singota’s 20+ years of experience helping early-stage biopharma teams succeed. Click here to learn more.
Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis Original
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges.
02.18.25 -- Business Of Biotech Newsletter
In the business of Precigen, Ethris, Capsida, 3T Biosciences, Acumen Pharmaceuticals, and more! What a time we had in San Francisco last month at the JP Morgan Healthcare Conference, the bellwether of the biotech year to come, where an uncommon abundance of January sunshine may have contributed to the confirmation bias inherently present when thousands of wealthy people get together to determine where and how the money flows.
A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices Original
By Mark F. Witcher, Ph.D., biopharma operations subject matter expert Controlling human errors is one of every organization’s greatest challenges. Human errors account for a majority of failures in executing many complex activities in aviation, nuclear, and many other industries.1 The same is true for biopharmaceuticals and medical devices.
12.07.24 -- Nobember's Most Popular Articles & Solutions
This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks. In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.
A New Approach To ISO 14971 For Better Medical Device Risk Analysis
Guest Column | October 23, 2024 By Mark F. Witcher, Ph.D., biopharma operations subject matter expert ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry.1 The guidance’s influence sometimes extends well beyond just medical devices.
08.10.24 -- Pharmaceutical Online Best Of July
JULY'S BEST FEATURED EDITORIAL ChatGPT-4: Practical Applications For The Biopharma Laboratory AI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver? Making Good Decisions When FDA Investigators Come Knocking Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.
08.10.24 -- Cell & Gene Best Of July
Hello Cell & Gene readers, I'm happy to bring you July's most-clicked articles. Enjoy! Erin Harris, editor-in-chief Follow me on X JULY'S BEST FEATURED EDITORIAL System Failure Mode & Effects Analysis: Intuitive Risk Analysis Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
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