Collaborating on Quality Risk Management for New Drugs at IFPAC 2021

We are excited to be back at IFPAC 2021 this year!

IFPAC 2020 was the last in-person conference we attended before the COVID-19 pandemic reshaped our industry’s major global conferences. In an effort to keep the dialog going, most conference venues are trying to reproduce their events virtually. Our experience so far with virtual events has been relatively selective. We prefer in-person collaboration and ad hoc engagement with industry representatives and regulators when we attend conferences. So, far that’s been all too difficult in the virtual setting.

But, our experience at IFPAC last year brought us back. At the last conference, we had a chance to participate in a spirited discussion with our industry and regulatory colleagues about knowledge management benefits. Our experiences over the past year have only reinforced these conclusions.

This year we’re back at IFPAC to focus the discussion on Risk Assessment. I will be speaking during the IFPAC Thursday afternoon session on Quality Risk Management for New Drugs, specifically about Quantitative Risk Assessment Methodologies for Pharma 4.0.

Have you noticed how most risk assessment examples are filled with subjective terms such as “likely,” “probable,” “moderate,” etc.? How are accurate assessments made when this level of subjectivity drives the discussion? No wonder everyone gets confused and finds the overall exercise to be frustrating!

It doesn’t have to be this way. And, it doesn’t mean you need a team of statisticians either. Risk assessments can help assess the key areas of a product or process where development activities should be focused.

As the maker of a software platform that integrates knowledge, risk, and quality management for product and process development, we work to provide clarity and consistency around these topics, which is often lacking.

My talk focuses on straightforward ideas and methods for using science, data, and analytics to develop a more rigorous and quantitative understanding of manufacturing processes and associated risk assessments. Many of you have spent time conceptually working with Impact, Uncertainty, Occurrence, Detectability, etc., but have likely struggled to create more objective assessments around these concepts.

For many of these layers of risk, practitioners often don’t realize that they can be estimated quantitatively as more process understanding with underlying data is generated. These estimates can feedback into the risk analyses iteratively to show how process improvements and analytical method development are mitigating the risk over time. Severity estimation should utilize sensitivity analyses to form model-based, empirical, or statistical estimates of how changes in an input variable affect an associated output variable. Occurrence estimation should be based on a statistical analysis of process control. The probability that an input variable will be out-of-specification (OOS) can be estimated by transforming standard Z-scores derived from process performance metrics into probability distributions. Combining these two estimates provides an estimate of the variable’s total risk under analysis based on “sound, scientific rationale” under the Quality-by-Design principles outlined in ICH Q8(R2).

We’re excited to present to the audience at IFPAC and our peers presenting in our session. That’s one of the primary reasons we’re attending. Last year we benefited significantly from our presentation structured data frameworks to enable efficient knowledge management. As part of the session entitled The Future is Now: Advancing Data, Information and Knowledge Management in Pharmaceutical Industry” we participated in a great discussion, and we were able to share our thoughts alongside other participants from Amgen, Eli Lilly, Biogen, Emerson, and Merck as well as representatives from the FDA. One of the key takeaways from the session was that structured formats are inevitable as they will be critical to reducing the inefficiencies with today’s document-heavy processes.

Not only did we collaborate during the conference and the panel, but we also kept the discussion going virtually throughout the year to further our shared ideas and conclusions.

This year, our session includes representatives from AstraZeneca, FDA (CDER OMQ), DFE Pharma, and Light Pharma. We’re delighted not only to present but also to listen and engage on their topics. The sessions include:

  • QRM: Closing the loop between Risk/Benefit and the Patients, Sarah Miksinki, AstraZeneca
  • QRM: GMP Perspective, Tara Gooen, FDA, CDER, OMQ
  • QRM: QMS and Cost of Poor Quality, Rick Friedman, FDA, CDER, OMQ
  • Dynamic Controls for Dynamic Systems, Brian Carlin, DFE Pharma
  • 21st Century Cures and 21st Century Quality, GK Raju, Light Pharma

We hope you can join us live and actively participate in the conversation (it’s not too late to register). If you can’t join us, don’t worry, we’ll share our presentation and conclusions after the conference.

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 currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

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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