FDA Publishes New Paper on KASA: Why Knowledge Management is Critical to the Drug Industry

Last week the FDA published a paper on its pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA) in the International Journal of Pharmaceutics: X. With our focus on QbDVision, we see KASA as a significant advancement by the FDA and believe its goals and structure reveal a model which can be replicated for overcoming current industry challenges with quality and cost.

Background on KASA

Last year Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) first shared that the FDA was prototyping KASA at the annual meeting of the US Association for Accessible Medicines in Orlando, Florida. In June of 2018, KASA was formally announced by former FDA Commissioner Scott Gottlieb as a program to “modernize generic drug review from a text-based to a data-based assessment”. The program requested $37.6 million and 5 FTEs for a “one-time platform investment” that would “result in more consistent drug product evaluations and seamless knowledge management across generic and brand-name drugs”. Both of these announcements were significant and drew media attention, in part due to the Agency publicly acknowledging its challenges with submissions.

In September of 2018, we were encouraged by the FDA’s discussion at the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee, where the committee unanimously agreed (10-0) upon the need for KASA. Just one day before the meeting, we launched QbDVision to the market after extensive development. As you can imagine, we were thrilled to learn how closely their thinking aligned with ours.

We suspect things are accelerating internally following last week’s publication and a recent announcement that the agenda for the upcoming 4th FDA/PQRI Conference on Advancing Product Quality will now include a Special Plenary Session to discuss KASA. We’ll be at the meeting in person and are excited to hear an update.

Why is KASA important?

KASA highlights one of QbDVision’s key observations on the pharma industry: we’ve outlived the age of the document. Here are the FDA’s words directly.

“The lengthy unstructured text narrative with dispersed information and the lack of efficient knowledge management make it difficult for the FDA to compare relative quality and relative risk across drug products and facilities. This makes it difficult to capture the ‘state of quality’ for a product at any given time. This becomes especially evident when assessing residual risks with post-marketing quality changes during the drug product lifecycle. These challenges may lead to late interventions to prevent or address drug shortages or quality failures of marketed drugs. To meet the above challenges, the FDA is developing the KASA system to modernize the quality assessment of drug applications to include structured information. This will promote consistency and enable a much-needed knowledge management tool that will improve efficiency and the overall quality assessment process.”

The agency further highlights three key challenges with today’s Quality-by-Documentation approach:

  1. “When a quality assessor picks up a regulatory application, it is not possible to easily locate historical data about similar products, processes, or the facilities.”
  2. “Risk assessment and control can be subjective, leading to inconsistency in regulatory actions and outliers in risk when compared to similar products.”
  3. “The assessment is a freestyle text narrative that often includes exhaustive documentation of information already provided in the application, and the assessments rely heavily on the knowledge and expertise of the assessor.”

Said simply: if we want to improve the quality of new drugs and speed to market, we must adopt a knowledge-based approach.

And, despite best efforts, today’s approaches are anything but that. Organizations that go out of their way to be thorough in their testing and approach ultimately lose connectivity and traceability to their information, especially when it ends up in a free-form document. On the other side of the equation: the FDA sifts through endless pages of information when reviewing documents in order to understand the drug application.

In today’s time-strapped world, it’s the document that’s holding us back.

What’s new with KASA?

KASA is a new paradigm for performing quality assessments of applications. It’s a move toward a structured assessment rather than a text document. It allows for knowledge management throughout the product lifecycle AND higher efficiency processing by the FDA.

Conceptually, the system’s three core pillars remain unchanged. We performed a structural analysis of the content between the publication and the PSCP September document and found only minor changes following two themes:

  1. More formal linkages and references to past publications, for example, linking to Q8(2) Pharmaceutical Development for Quality-by-Design.
  2. More positive or moderated language. For example, calling for “structured assessment that minimizes text-based narrative” as opposed to one that “radically eliminates text-based narratives”.

Based on the information made available to date, it appears that KASA will be a tool used by FDA regulators, not the industry itself. The industry will most likely be impacted by KASA through new FDA submission protocols and data formats.

Overall, the paper pushes KASA along the open publication route that other FDA standards have undergone and serves as an important milestone.

Predictions about KASA

While we have no inside information as to how KASA will progress, as industry observers and builders of the first commercial knowledge management tool for pharma, we offer four predictions to help further shape the conversation.

  • Generics as a starting point. The past two administrations have pushed the FDA to promote generic drug entry as a way to foster competition and lower drug prices. And, as noted above, KASA funding comes from an initiative tied to promoting generics. Therefore, we expect the first pathways for using KASA will be with generic applications, but further predict that will quickly expand. The definition and scope of KASA so far appear to be intentionally broader from the onset.
  • QbD at the core. At the heart of any knowledge management system are its organizing principles of information. For KASA, we suspect that to be the Quality-by-Design framework adopted by the FDA. KASA publications so far are strongly-linked to patient-centered approaches that are inherent to the framework. QbD seems like a perfect fit for the job.
  • Data integration will be tricky. Disparate commercial systems, to which many are homegrown, and vast data organization principles out in the wild will make getting data integration right tricky. We’ve seen this in practice today across the industry – data is all over the place. And, given KASA’s rule and algorithmic based assessments, this part will be all the more important to get right. The publication directly addresses this, referencing calls for unification in Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data and terminologies and eCTD. We’ve previously shared that we feel eCTD has outlived its usefulness, and recent delays add insult to injury. We hope that the industry will join forces here to help drive standardization and normalization around common data.
  • Internationalization. In September of 2018, the PSCP Advisory Committee recommended engaging the international community on KASA, similar to other frameworks (e.g., QbD). Publishing a paper is the first step in that process. We know the topic is being discussed internationally. For example, this week our CEO, Yash Sabharwal, is in the UK speaking on the topic of structured knowledge management at De Montfort’s Quality by Design Symposium.

What happens next?

We hope to hear a lot more about KASA this year. We’ll be active participants at the 4th FDA/PQRI Conference on Advancing Product Quality next month, where the KASA initiative will be outlined by an expert FDA panel moderated by Dr. Lawrence Yu, Deputy Director of CDER’s Office of Pharmaceutical Quality, along with distinguished presenters from the FDA including Dr. Susan Rosencrance.

Explore what knowledge management can do for you

QbDVision is the first cloud-based, Structured Knowledge Management Solution (SKMS) for the Pharmaceutical industry. Unlike KASA, it’s built for the industry (by industry insiders). QbDVision is available today for your exploration. Sign-up for our Sandbox environment and explore example case studies, or try your own project. Contact us directly or use the feedback button and tell us what you think.

Mark Fish

Managing Director, Scientific Informatics, Accenture

Mark Fish is Managing Director and Global Lead for Accenture’s Scientific Informatics Services Business. Mark has over 25 years of experience in leadership roles in Accenture, Brooks Life Sciences and Thermo Fisher Scientific delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and manufacturing transformation. Mark has extensive experience in agile software development, data strategy, process engineering and robotic automation for research, analytical development and quality control in Life Sciences.

Chris Puzzo

Solution Architect, Digital & Data, Zaether

Chris is a Solution Architect with Zaether, focusing on delivering next-generation digital and data solutions for GxP Life Sciences customers. Chris has previously held technical operations roles within multiple gene therapy manufacturers, including Thermo Fisher Scientific’s CDMO organization where he supported various capital projects including the design, build, and startup of new GxP manufacturing capacity.

Victor Goetz, Ph.D

Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company

Victor Goetz, Ph.D. is the Executive Director of Technical Services New Modalities and Data Strategy at Eli Lilly and Company. He has over 35 years of industry experience in developing and commercializing nine novel medicines to enhance the exchange of knowledge needed to speed the delivery of new medicines to patients. Dr. Goetz holds a BS in chemical engineering from Stanford University and a PhD in chemical and biochemical engineering from the University of Pennsylvania.

Rachelle Howard

Director of Manufacturing Systems Automation and Digital Strategy, Vertex Pharmaceuticals

Rachelle is the Director of Manufacturing Systems Automation and Digital Strategy for Vertex’s Small Molecule Manufacturing Center. She oversees the site Automation Engineering function and has co-led Vertex’s global Digital Manufacturing Transformation program since 2019. She leads several initiatives related to data integrity, data management, and employee education. Rachelle is a graduate of Tufts University and the University of Connecticut where she has degrees in Chemical Engineering and a PhD in Process Control.

Vijay Raju

Vice President, CMC Management, Flagship Pioneering

Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.

Greg Troiano

Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence, Sanofi

Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.

Pat Sacco

Senior Vice President Manufacturing, Quality, and Operations, SalioGen

Pat is a Biotechnology technical operations executive with 30+ years of experience leading and managing technical operations functions at numerous innovative companies in the biotech and life sciences industries. He has a passion for advancing and implementing best practices in pharmaceutical manufacturing.

Diana Bowley

Associate Director, Data & Digital Strategy, AbbVie

Diana is the Associate Director, Data & Digital Strategy in S&T-Biologics Development and Launch leading the organization’s Digital Transformation since October 2021. She joined AbbVie in 2012 in the R&D-Discovery Biologics group focused on antibody and multi-specific protein screening and engineering, leading multiple programs to the cell line development stage. In 2017 she joined Information Research and led a team of IT professionals who supported AbbVie’s Discovery Scientists in Biotherapeutics, Chemistry, Immunology and Neuroscience. She has a PhD in Molecular Biology from The Scripps Research Institute and Bachelor of Science in Chemistry from The University of Northern Iowa.

Robert Dimitri, M.S., M.B.A.

Director Digital Quality Systems, Thermo Fisher Scientific

Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.

Devendra Deshmukh

Global Head, Digital Science Business Operations, Thermo Fisher Scientific

Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.

Grant Henderson

Sr. Dir. Manufacturing Science and Technology, VernalBio

Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.

Ryan Nielsen

Life Sciences Global Sales Director, Rockwell Automation

Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Board Director, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is a Senior Director in the Flagship Digital, IT, and Informatics team, where he leads and manages the digital evolution for Pioneering Medicines. His role is pivotal in ensuring that digital strategies align with the overall goals and objectives of the Flagship Pioneering initiative.

His robust background in digital life sciences includes expertise in applications, informatics, data management, and IT/OT management. He previously spearheaded Digital Biomanufacturing Applications at Resilience, a CDMO start-up backed by Arch, where he established a team responsible for implementing global manufacturing automation systems, Quality Assurance applications, laboratory systems, and data management applications.

Matt holds a B.S. in Biology and Biotechnology from Worcester Polytechnic Institute and an M.B.A. from the Boston University Questrom School of Business, where he focused on Strategy and Innovation.

Daniel R. Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Senior MSAT Scientist at Viralgen, Process and Knowledge Management Scientist at Bayer AG

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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