Getting Leaner, Going Digital: 4 Ways Drug Developers Are Adapting to a New Market

For the last year or so, it’s been… well… a bit of a rough patch for our drug development industry.

So many layoffs. A record run of bankruptcies and closures. A painfully tight capital market. You name it, we’ve suffered it. As we get deeper into 2024, some sparks of hope are beginning to glimmer: deal activity is finally starting to rebound after a long funding winter. But for drug developers on a cash runway today, the message is inescapably clear. For the next few quarters, going the distance will likely require some serious belt-tightening. 

As our industry gets leaner, workforces get stretched, and costs get fiercely scrutinized, everyone’s feeling the pressure to get more efficient and accelerate time-to-market. In today’s drug development landscape, that can take some serious out-of-the-box thinking. How else do you get things done faster, do more with less, and do it all with fewer people… all at the same time? 

Believe it or not, it’s possible – but only with the right tools and strategies. For drug developers racing to gain efficiency, compress development timelines, and streamline operations, now’s the time to take a long, strong look at how Digital CMC solutions: how they can help organizations adapt to a challenging market, and how they can unlock new value from within those organizations.

Let’s take a look at 4 ways QbDVision can make that possible.

1. Amplify resources to accelerate timelines

There’s a confounding paradox at the heart of today’s drug development industry: the global pipeline is bursting with novel and sometimes near-miraculous drug products, yet much of R&D remains in a major productivity slump. As McKinsey recently reported, R&D spending increased 44% from 2012-2022. But the number of US novel drug approvals has stayed flat.

Of course there are many, many factors that contribute to that development bottleneck – from persistent inefficiencies in the clinical trial process, to persistently low trial success rates, to pervasive reliance on outdated and inefficient processes. But for drug developers struggling through the current downturn, one challenge looms particularly large: widespread cost-cutting means R&D teams rarely have the resources they need to efficiently develop new products.

For drug developers racing to gain efficiency, compress development timelines, and streamline operations, now’s the time to take a long, strong look at how Digital CMC solutions: how they can help organizations adapt to a challenging market, and how they can unlock new value from within those organizations.

For more than a year now, one company after another has downsized their labs to the tune of “the challenging economic environment.” Drug developers fighting to advance their development programs face a stark new reality: the margin for error in R&D is slimmer than ever, while the pressure to “get it right the first time” has become intense – along with the urgency to get it there as fast as possible.

So where does that leave companies struggling to stretch their acutely finite development budgets?

We hope it leaves them asking how they equip their leaner R&D teams to work more efficiently, collaboratively, and data-centrically. A pullback period is no time for R&D teams to be struggling with all-too-familiar silos, manual processes, and tedious data-chasing tasks. Now, perhaps more than ever, it’s time for them to investigate and deploy solutions that empower R&D teams to work smarter and faster – using frameworks and principles that magnify the value of each development step. 

That’s precisely what Xeris Pharma was able to achieve by unifying their CMC programs on QbDVision. Our structured knowledge platform helped their team escape a time-sucking array of spreadsheets, SharePoints, and PDFs, and free their experts to focus on critical development tasks – rather than gathering data, documents, and inputs scattered across their organization. 

The result: 6-12 months shaved off their tech transfer timelines, with all that time and all those resources added back to their operational capital.

2. Create digitally native R&D infrastructure

Despite many “economic headwinds”, some positive signals are beginning to appear in the drug development landscape – especially when it comes to M&A. Dealmaking momentum is slowly starting to ramp back up, driven by enterprises looking to prime their pipelines with promising candidates.

This trend will no doubt have many stakeholders reviving sweet dreams of an exit and payout. But it also puts up-and-coming drug developers on notice: today’s savvy acquisition hunters want to see a valuable molecule, compelling science, and robustly managed data to back them both.


What they don’t want to see is more of the notoriously fragmented, unstructured, and siloed CMC data that our industry is (in)famous for. 

Few things ding asset valuation like “that analysis is definitely on our server somewhere,” “we may need to reconstruct that data,” or other signs that onboarding that new asset will be a major lift. To agree to premium valuations, enterprise buyers increasingly want to see well-kept information resources that can be leveraged with minimal friction.

An M&A upswing will have many stakeholders reviving sweet dreams of an exit and payout. But it also puts up-and-coming drug developers on notice: today’s savvy acquisition hunters want to see a valuable molecule, compelling science, and robustly managed data to back them both.

For innovators like Flagship Pioneering, the solution to messy data is simple: centralize, organize, and structure it from the start. When they generate new companies for their portfolio, they equip them with digital CMC infrastructure from inception – proactively preparing them to produce data assets in the most leverageable, value-supporting way possible. 

With QbDVision, drug developers like Flagship’s portfolio companies can establish effective knowledge management with every keystroke. ICH guidelines and QbD principles are built into the framework of our structured platform, so adding necessary taxonomies and ontologies is as simple as entering the data. 

QbDVision is also purpose-built to enable a FAIR approach for CMC data and data quality. So when a potential deal partner needs to see that critical process information – and understand how easily they can leverage it – that data will already be in a Findable, Accessible, Interoperable, and Reusable form. No scrambling to find or generate the reports. Just click and show.

Without that kind of structure, it can take 15 people 10 days to a month to complete a painstaking process like FMEA – inefficiency that no global organization wants to absorb. With QbDVision, it can be completed in as little as 10 seconds.

And that’s the kind of performance enterprises want to see in an acquisition target.

3. Prepare to unlock the full value of AI

For today’s drug developers, effective knowledge and data management isn’t just an M&A must-have. It’s a crucial gateway to something even more powerful: the AI applications that have taken drug development by storm in the last year. 

As McKinsey recently reported, generative AI has the potential to produce 60 billion to $110 billion a year in economic value for the pharma and medical-product industries. That potential transformative impact has captured imaginations across the industry, along with the promise of spectacular efficiencies and operational enhancements in drug discovery, clinical development, marketing, and more.

There’s just one pesky little catch. 

As McKinsey also notes, Gen AI “cannot deliver results unless a proper data architecture is in place.” To deliver their much-hyped impact, AI models need consistently structured, high-quality training data – and that’s often in short supply for CMC programs, even in R&D enterprises swimming in petabytes of information.

To deliver their much-hyped impact, AI models need consistently structured, high-quality training data – and that’s often in short supply for CMC programs, even in R&D enterprises swimming in petabytes of information.

The size, strength, and depth of that data architecture will be one of – if not the biggest – rate limiting factor for any drug developer hoping to capture some of that eye-popping new value. So where should they start building it?

For CMC programs, QbDVision can be a perfect starting point. It’s an off-the-shelf solution for structuring, integrating, and stewarding drug development data – “architecture in a box” for businesses that are thinking ahead to how they’ll leverage that data through an AI model. 

By centralizing and rationalizing CMC information, QbDVision also provides a valuable way to facilitate the multidisciplinary collaboration that’s vital to successfully developing and deploying new data models. With all CMC data in one structured platform, it’s readily accessible for both data scientists and process scientists alike.

And that makes it an upfront investment that can deliver major, AI-powered dividends for future programs.

4. Streamline your CMC tech stack

While the right technology can deliver immense value, “too much of a good thing” is still a very real risk for drug developers in today’s tough market. A unified knowledge management hub can help reduce fragmentation, inefficiency, and data sprawl. A profusion of point solutions can drive those challenges right back up. 

Not surprisingly, as many organizations look to lean out their operations, one key priority is often consolidating tech stacks – which are frequently bloated with siloed tools for managing risk, process knowledge, product knowledge, tech transfers, and more. Consolidating an array of these narrow solutions is often a critical goal for businesses of any size that are aiming to operate more efficiently

QbDVision can facilitate that important effort as well. It’s purpose-built to handle a much broader range of development activities, with comprehensive quality risk management baked into every workflow or dataset. It provides a centralized, fully integrated hub for all product and process information, eliminating the need for separate systems to store and manage either set of knowledge. And it can now integrate with a growing range of MES systems.

Not surprisingly, as cash gets tight and timelines get tighter, many drug developers are racing to consolidate their tech stacks – which are often bloated with siloed tools for managing risk, process knowledge, product knowledge, tech transfers, and more.

As major players like Sanofi and Bayer have already discovered, these capabilities can make QbDVision a lynchpin for information systems that span the product lifecycle – as well as a valuable solution to tech stack sprawl. Using the platform’s open API and fast-growing range of integrations, these organizations have leveraged QbDVision to unify an array of disparate data sources and fully connect their CMC ecosystems from discovery to commercial manufacturing.

Doing so has enabled them to work more efficiently, manage risk more comprehensively, and harness their data at a much greater scale – and do so with a right-sized tech stack. That can be a transformative shift for drug developers navigating today’s choppy market waters, and it’s one that QbDVision can readily support.

No matter your goals, now’s the time to prepare for a better market

As we get further into 2024, we all hope today’s sparks of hope will kindle an upswing in the drug development market – one that will reignite investment, deal activity, and industry productivity. Until then, doing more with less will be a critical goal for today’s up-and-coming drug developers. 

At the same time, those organizations need to be ready for positive traction whenever it arrives – whether that means implementing effective knowledge management, consolidating and integrating their development data, or pre-packaging key information assets for sale. When buyers come – and they will – drug developers with handoff-ready assets will be the ones who can claim standout valuations. 

QbDVision can facilitate both these critical goals: optimizing operational efficiency for lean organizations and proactively turning development data into value-generating assets. To find out how, reach out any time. We’d be thrilled to show you how our platform can help bring a new level of efficiency and resilience to your development program.


Ready to pullback-proof your CMC operations?

Connect with our team to learn more about QbDVision and how it can streamline critical workflows across your programs.

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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