Each year, we ask industry leaders to share their predictions with us. For predictions related to therapeutic advances and manufacturing technology, read part 1.
Laws and regulations
Pharma companies will lose sleep over the IRA
“The Inflation Reduction Act will keep pharmaceutical company leaders up at night in 2024. Medicare drug price negotiation will impact more than just the 10 drugs on the current negotiation list by creating competition in those therapeutic categories and could force price adjustments, including higher commercial drug prices. Pharmaceutical manufacturers must navigate this complex market to maintain revenue for research and development of new medications.”
— Jesse Mendelsohn, Senior Vice President, Model N
The pandemic has shifted regulatory focus
“In the wake of Covid-19 ramifications that have permanently altered the industry landscape, and in the face of groundbreaking advancements fueled by AI/machine learning, pharma organizations and regulatory bodies must balance rapid development with holistic risk management. The FDA’s collaborative support for digital initiatives and AI/ML integration will continue to promote data security as a compliance touchpoint. Permanent adoption of Remote Regulatory Assessments, coupled with expiration of the Covid-19 PHE and transition away from EUA for Covid-19 products, signals the agency’s shifting focus toward the future. Decentralization of manufacturing activities will be amplified by persistent labor shortages and supply chain uncertainty, along with regulatory pressure from the unannounced foreign facility inspections pilot program. The way 2024 unfolds will point the trajectory for the coming era of medicine.”
— Jennifer Chang, Quality Assurance Intelligence Specialist, Blue Mountain
Manufacturing and regulations will become more adaptable and collaborative
“I anticipate an uptick in the adoption of advanced manufacturing technologies, leading to smaller batch sizes and a more adaptable manufacturing approach to cater to the demands of personalized medicine and clinical trials. Simultaneously, the increasing integration of digital technologies, automation and data analytics is expected to play a pivotal role. Moreover, I foresee continued industry investment in bolstering supply chain resilience post-Covid. Additionally, I hope for increased regulatory adaptations and collaborations to keep pace with technological advancements and escalating costs. For example, consider the Mutual Recognition Agreement signed in July 2023 between Switzerland's SwissMedic and the USA's FDA, validates inspections conducted by each other's regulatory authorities. I hope this kind of collaboration between trusted regulatory bodies will shape the manufacturing of the future.” —Michael Altorfer, Chief Executive Officer, Swiss Biotech Association
Drugmakers will push for a more streamlined regulatory approach
“2023 was a year of firsts for the advanced therapy community, culminating with the approval of the first CRISPR-Cas treatment for sickle-cell disease by the UK and US. I believe that 2024 will continue this trend with an increasing number of market applications and approvals in this dynamic and fast evolving drug development area. With this comes the need for a streamlined approach to our regulatory procedures, ensuring that patients receive access to these novel, life-changing therapies in a timely manner, without compromising control over patient safety and drug quality and efficacy. Currently our regulatory systems favor those drug developers working with orphan drug designation status, with expedited review times and more accessible support from the regulators. We need to consider how we can support SMEs working with therapies for more commonplace diseases and establish reimbursement and pricing procedures in Europe that makes market authorisation in the EU commercially attractive.”
— Lindsay Davis, Chief Executive Officer, NextCell
Regulatory teams will adopt an agile project delivery mindset
“Challenged by the pace of global regulatory change, sweeping initiatives such as the move to data submissions and the general directive to do more with less, more regulatory operations and affairs departments will adopt an agile 'DevOps' mindset. Signs of significant culture change and a new emphasis on continuous improvement are already visible. While they work to speed approvals in more product areas and regions, regulatory teams will also take a closer look at how internal operations can be improved. More will use the same data they send to regulatory agencies to spot trends, solve problems, and improve business performance. Continuous publishing will receive particular attention, as fully end-to-end platforms enable savings and efficiency. Another focus will be using technology to enhance manufacturing change control, traditionally handled using time-consuming manual processes that often delay the availability of treatments.”
–Marc Gabriel, Head of global RIM strategy, Veeva
Sustainable processes and facilities
The industry will embrace sustainability
“Whilst it is essential to focus on patient disease management and providing safe, effective, high quality and well usable treatment options, pharma manufacturers and CDMOs must re-design the way they work, to ensure the sector is operating sustainably. My prediction (and hope) for 2024 is that the industry will focus on sustainability by: developing formulations and medicines with sustainability as one key criterion (beyond compliance, stability and usability); building lab and manufacturing operations that focus on energy efficiency and savings and considering quick wins (e.g., motion controls, energy controls, LEDs, waste reduction and management, implementation of circular solutions etc.); operating using self-generated (renewable) energy; focusing on research on alternative options for pharma, e.g., moving away from single-use disposable plastics to biodegradable components or circular solutions. There is a lot to do and #weHaveNoTime to wait until 2030, 2040 or 2050.”
— Hanns-Christian Mahler, Chief Enablement Officer, ten23 health
Manufacturers must integrate digital transformation into facilities
“In 2024, ‘operational readiness’ will be on the tip of pharma’s tongue. Ensuring facilities are ready to expedite the delivery of lifesaving medicine will truly be a top priority. Some would say: well, what’s revolutionary about that? The reality is that many facilities are designed and built but aren’t ready, often for months, to make medicine. It is an unspoken and unequivocal fact in the industry. In order to thrive in an increasingly fast-paced drug development environment, manufacturers must embrace digital transformation by the realistic integration of AI and digital twin technologies, while staying attuned to regulatory changes, and fostering resilient and sustainable supply chains."
— Jennifer Lauria Clark, Vice President, Sales and Account Management, CAI
The industry will need to design sustainability into the manufacturing processs
“Sustainability is a key priority for biopharma companies. As we look to develop products and solutions that will help accelerate the development of novel therapeutics, we must ensure that we ‘design in sustainability’ at every part of the manufacturing process. Some suggestions include: •Moving to circular economy: Drug manufacturers are changing from a take-make-waste model to a circular model where waste is minimized, and resources used more efficiently. This starts by rethinking product design and embedding sustainability throughout a product’s life cycle. •Transitioning to renewable energy: Many manufacturing sites are converting to renewable energy such as solar, wind and hydro-electric energy as another method of reducing carbon emissions.
•Rethinking materials: Sourcing is discovering and testing eco-friendly materials, including recycled or new bio-based materials.
•Using less water: Manufacturers are reducing water use, optimizing water treatment systems, and reuse/recycling water where possible.
All of this helps lessen the environmental impact of operations. We can’t do this alone. Increasingly we need collaboration all along the value chain. Customers are asking for it, and we need to work with suppliers to provide product composition data and ethically sourced materials, while meeting customer demand for quality and on-time delivery.”
— Ryan Walker, Sustainability Program Leader, Cytiva
The facilities of the future will be sustainable
“The life sciences market will continue to grow this year, driven by a strong pipeline in diabetes, weight loss and oncology treatments and an increased focus on Advanced Therapy Medicinal Products. With more products coming onto the market, pharma companies will need to adopt a flexible approach to manufacturing. In response to these dynamic marketplace shifts, solutions providers are delivering ‘facilities of the future’ that adhere to cost and schedules while meeting the highest safety standards. Additionally, this next generation of pharma facilities aspire for the highest sustainability certification. To achieve this, the entire project life cycle, from design and construction to operation must be considered. Best practice in this regard focuses on: Significant reductions (of at least 40%) in water use; On-site renewable energy generation, such as rooftop solar panels and use of electric boilers; Efficient LED lighting fixtures and less electric power use for lighting; Reduction strategies for embodied carbon used in construction materials (like concrete); Diverting on-site construction waste from landfills to recycling facilities. Sustainability is not just about making energy and water savings. These facilities of the future will also promote biodiversity through the delivery of pollinator gardens, vegetation projects and reforestation plans. These facilities are also people-centric spaces that promote employee well-being, empowering them to innovate and collaborate to fulfil their potential. Ultimately, this approach will attract top talent to enable scientific discovery, thus, the emerging treatments and therapies will be developed and delivered to patients, faster.”
— Lindsay Gerding, Vice President, Life Sciences, Jacobs
Sustainability will spill into the entire supply chain
“For most organizations, 75% to 90% of a company’s footprint sits within their supply chain, making this a key focus area in decarbonization efforts. Many large pharmaceutical and life science organizations have recognized the impact of indirect emissions generated by their suppliers, distributors and customers and are actively working to reduce their impact. However, doing so at scale remains a huge challenge. It is imperative to solve, as this will multiply the effect of supply chain sustainability across the industry. In 2024, I see momentum building for collaboration and learning, helping accelerate this critical piece of the sustainability puzzle."
— Jeffrey Whitford, Vice President of Sustainability and Social Business Innovation, Life Science, at MilliporeSigma
Accountability and authenticity will be key
“Sustainable operations, drug shortage mitigation strategies, and AI integration will face substantial changes/will continue to be under the microscope in 2024. In the midst of a climate emergency, our industry will continue to be under the microscope. Last year, one of COP27’s core themes was around the need to move from negotiations through actual implementation. This year, COP28 will focus on actionism. Accountability and authenticity will be key to seeing real progress, and part of that accountability will arise from employee-led sustainability initiatives and inter-industry collaboration. We’ll also see an attempt to mitigate drug shortages via improved communication through new technology. The FDA’s mobile app and web portal dedicated to reporting drug shortages allow for early communication with the FDA regarding potential manufacturing disruptions. Finally, there will be a rise in AI consultants assisting biopharma as companies seek guidance on integration, regulation, and more."
— Tom Hartman, President and Chief Executive Officer, International Society for Pharmaceutical Engineering (ISPE)
Pharma must increase cleanroom capacity
“The ongoing growth of the global market for advanced therapy medicinal products will present both an opportunity and a challenge for pharmaceutical manufacturers in 2024. Valued at $8.4 billion in 2022, the segment is on track to be worth $20.63 billion by 2031. To benefit from this expansion in 2024, pharma companies must source new or upgrade existing sterile cleanroom space urgently, since ATMPs are overwhelmingly administered parenterally. Traditional 'stick-built' cleanroom systems are no longer fit for purpose. They have long project timelines and unpredictable costs, rely on outdated technology, and lack the flexibility companies need to meet changing market demand. Pharmaceutical companies should explore alternative approaches. Modular cleanroom design provides flexibility and helps to accelerate project timelines and reduce costs. The pre-manufacturing and validation offered by modular cleanrooms mean they can provide the needed capacity at the right speed to keep up with the fast-rising ATMP demand in 2024.”
— Grant Merrill, Chief Commercial Officer, AES
People and culture
Companies will integrate people and technology
“When organizations acquire technology and are unaware of how to use or properly leverage it, they can end up in large amounts of data and not know how to appropriately apply it to improving solutions. Organizations need to remember that technology requires a workforce that supports integration and is onboard to learn and train to effectively use the technology. Not enough attention is given to supplying people with the appropriate support and training to feel comfortable with technology. Especially if people are pushing back on the implementation of technology, that can be a huge deterrent to the success of an organization. Moving forward, organizations that can create a culture that embraces change across people, processes and technology will benefit in the coming years. Those who can jump into and embrace new innovations while supporting their staff and internal processes to fully understand and integrate new technologies will take full advantage of any change.” — Philip Johnson, Senior Principal, Quality and Compliance Solutions, IQVIA
“In the coming year, we’ll see the impact of these ‘fourth industrial revolution’ technologies step up pharmaceutical manufacturing even further, helping facilities to make the most of their workforce talent. Robotics and automation will extend the capabilities of teams, helping to deliver on the industry’s commitment to excellence and to operating facilities that are leading technological innovation through advanced manufacturing. The use of digital twins will become more widespread in product testing and optimization as well as the reduction of material waste and storage costs. We’ll also see more adoption toward Gen AI and robotics in factories; humans working side by side with machines to drive new ideas and innovation – making the industry safer, more efficient and more connected.”
— Karan Singh, M.D., ACG
“Organizations, amidst the groundbreaking advancements in AI, including language learning models, natural language processing, and generative AI, are recognizing that success extends beyond the latest technology. Despite the potential of AI, factors such as regulations, data availability, and commercial viability pose limitations in life sciences. In health care and life sciences, technology isn't a universal solution; its effectiveness hinges on proper implementation guided by people and supported by processes. Neglecting these aspects hinders technological advancements. The increasing complexity of quality management in life sciences, driven by regulations and standards, requires organizations to deliver improved results with constrained resources. Efficient, compliant business operations demand a strategic combination of consulting services, outsourced services, and technology, offering value that goes beyond deploying off-the-shelf solutions, adapting to evolving organizational needs and challenges.”
— Michael King, Senior Director, Product and Strategy, Technology Solutions, IQVIA
AI will revolutionize training
"In 2024, AI's role in workforce training will evolve into a more dynamic, interactive partner in the learning process. Gone are the days of passive data crunching. AI is set to revolutionize how knowledge is captured and shared, turning raw data into customized, interactive learning experiences. This will not only enhance learning outcomes but also revolutionize how industries approach training and knowledge retention.” — Sam Zheng, Chief Executive Officer and Founder, Deephow
Drug development
AI will supercharge drug development
“In the next few years, we will see a surge in highly effective, multipurpose drugs. Pharmaceutical companies will leverage AI to supercharge drug design with greater precision, specificity, and speed, resulting in more effective treatments with fewer side effects. Very soon, more new medications will move from treating the symptoms to fixing the root problem.”
— Jesse Mendelsohn, Senior Vice President, Model N
“The discovery of the Covid-19 vaccines showed what is possible when organizations work together, pooling resources and data to enable quick identification and development of novel therapies. In addition, the streamlining of the regulatory processes made it possible to bring lifesaving vaccines to the market. The current drug discovery process is complicated and inefficient: bringing a single drug to market costs around $2.5 billion dollars, takes 10 years, and for every drug that gets approved, ten thousand compounds will fail. Industry research has found that over the past 20 years, large pharmaceutical companies have spent an average of $6.16B per drug approval. Technology and innovation is now helping life science companies shorten the drug discovery funnel and reduce the costs of drug therapy R&D from billions to millions of dollars.”
— Alister Campbell, Vice President, Global Head of Science, Dotmatics
“AI's revolutionary impact on gene therapy in 2024 is evident across multiple fronts. Rapid identification of therapy targets, driven by AI, transforms drug development. Predictive modeling, powered by AI, optimizes gene therapy constructs, ensuring economic viability. Personalized treatment plans, increasingly common by 2024, leverage AI tools to tailor interventions to each patient's unique genetic profile. AI transforms data analysis, interpreting complex genomic data and guiding clinicians in selecting precise gene therapy interventions. Optimized drug delivery, AI-predicted effective vectors, dosages, and delivery methods improve treatment efficiency and safety. AI systems streamline regulatory approval, aiding safety and efficacy evaluations. AI accelerates clinical trial designs, identifying biomarkers, optimizing patient recruitment, and predicting treatment responses. AI-powered real-time monitoring enhances patient care, providing continuous data for prompt treatment adjustments. Paramount to AI's role is robust data security and privacy measures, safeguarding sensitive genetic information in gene therapy advancements." — Kent Wakeford, Chief Executive Officer, Form Bio
Drugmakers will need to address clinical limitations
“2024 will undoubtedly see more cell and gene therapies reach clinic. The acceleration of these trials will necessitate additional cell processing and cryopreservation services for autologous apheresis materials and for participant blood processing to ensure timely and successful manufacturing and delivery of the drug to patients and to maintain sample integrity for accurate clinical readouts. The current limitations around co-location of these capabilities to clinical sites will need to be addressed urgently for the continued success of the industry.”
— Priya Baraniak, Chief Business Officer, OrganaBio
Quality management
AI will advance quality management
“Quality management has traditionally been cautious about integrating AI tools into their processes, given the sensitivity of information in quality management systems. However, a shift is occurring as more organizations embrace large language models and other AI capabilities, a trend expected to continue in 2024. The use of recommendation engines, combining AI with personal experience for augmented intelligence, is on the rise, enhancing responsiveness, cycle times, accuracy, and efficiency. Public generative AI adoption may take longer due to intellectual property concerns in life sciences, but private GPT is gaining traction. These trends drive increased investment in predictive and preventative analytics. Additionally, breaking down siloes between quality and other departments using AI fosters connectivity, benefiting overall productivity and efficiency. This connectivity facilitates data access across disciplines like enterprise resource planning (ERP), supply chain management (SCM), and product lifecycle management (PLM), reducing errors and duplication of effort.”
— Kari Miller, Senior Director of Product Management, IQVIA
Pharma will take a holistic approach to quality
“One realization that life science organizations will hopefully make in the coming year is to gain perspective on trends in quality (e.g. CAPAs, investigations, complaints etc.). Often, organizations view singular issues or urgent matters and work to resolve them one by one but lack the ability to view the problem as a reflection of the work as a whole due to the nature of their software. Organizations are too often missing the forest for the trees and falling victim to their own software by neglecting to examine complaints in a holistic manner, understanding the reasoning behind the issues. In the coming year, organizations that can take these issues highlighted by the software and apply them to high-level trends will reap the benefits. Another trend necessary for the advancement of the industry is improvement in broad-based system connectivity. Organizations are still struggling with a siloed approach to management and software systems. Successful quality management will require a combination of quality management software, product life cycle management and enterprise resource planning to not only connect and harmonize systems but to ensure that the correct system is being utilized to perform certain tasks. Organizations that can optimize and connect their management systems will succeed moving forward.”
— Michael Hidock, Director Quality and Compliance Services, Pharmaceutical Consulting Services, IQVIA
Quality management will drive continual improvement
“Although there has been an increase in automation, streamlining the process of triage, evaluation, complaint determination and reportability decisions will be the determining factor in organizational success. Their access to data and data quality will be much more indicative of how far technology can take us. As quality is better understood and valued, organizations that approach quality management as a tool to drive continual improvement, as opposed to one that looks at quality as a nuisance and cost burden, will be more successful at improving outcomes. A few organizations are already doing this through automation of key quality management processes to drive efficiency and to provide a system-wide view of quality process performance, reviewing trends and intervening where necessary. Those who can transform their thinking to look at quality as an incredibly beneficial steering tool while embracing automation will be those who succeed.”
— Anthony Hudson, Senior Principal, Technology, IQVIA
Access to connected quality assurance and QC data will drive efficiency
“A growing data review burden that stresses quality operations caused by the volume of QA and QC data generated across today’s quality operations. To make this data readily accessible across functions, quality leaders will deepen their understanding of how different stakeholders need and prefer to use it. Rather than consider each data point from a single user group’s perspective, access will reflect multiple points of use and bring it to each decision point to drive speed. More accessible quality data will enable greater use of novel approaches, such as real-time batch release, which involves diverse areas, including jurisdiction, deviations, manufacturing, quality control, and batch genealogy. Overall, making end-to-end quality data readily available to all decision-makers will support “right-first-time” results and help speed the adoption of automation within quality.”
–Jason Boyd, Senior Director, Veeva Vault LIMS strategy
Supply chain partners
Partnerships and technology will help advanced therapies grow
“The cell and gene therapies sector will continue its growth in 2024, with a focus on finding the best therapeutic results in the oncology and rare disease. However, improvements in regulatory and manufacturing challenges are a must, focusing on key solutions for process automation, enabling AI tools and allowing faster market access. As recent years demonstrated, partnership between key stakeholders will continue to be the main model of moving innovation cycles faster and ensuring meaningful (effect-wise) and patient-relevant approaches. Working together within industry, academia and regulators to create change in policies, cost-reduction and unmet needs will be goal for advance therapy developers.”
—Agnė Vaitkevičienė, Chief Executive Officer, Memel Biotech
Pharma will expand partnerships, with an eye on efficiency
“Companies will continue to look for ways to nearshore and build localized, flexible delivery capacity to mitigate global supply chain disruptions, ensure efficiency, and minimize regulatory duplications. Pharma companies will continue focusing and specializing, expanding partnerships with CMOs and automation companies to drive more efficient operations in core competencies and accelerate pipelines. Regulatory bodies will begin discussions on how to bring drugs safely to market using digitized validation information and look at multiple ways to regulate therapies based on intended patient pools — ATMP smaller batches versus API large batches versus personalized medicine.” — Nathan Pettus, President, process systems and solutions, Emerson
The specialized CDMO sector will grow
“We see a growing range of therapeutic modalities in the biopharma sector that are synthesized with a wide variety of manufacturing platforms — for example cell- and gene therapies, radiopharmaceuticals, ADCs, monoclonal antibodies, peptides, oligonucleotides. Single (even larger) companies can’t always cater for all these technologies and smaller companies or start-ups do not have the scale and means to build up the competencies. For these reasons, we will likely keep seeing growth in the CDMO sector allowing for accessible availability of specialized capabilities and capacities at affordable prices.” — Anne Marie de Jonge, board member, Swiss Biotech Association
Fill-finish capacity will be tight
“We will see increases in scale due to specific molecules, such as glucagon-like-peptides (GLP-1) reaching broader therapeutic indications (e.g. diabetics and obesity). This will require massive investments to increase scale in, for example, peptides’ manufacturing, sterile fill-finish operations as well as devices. The developments will result in tighter capacity situations in fill-finish and devices in the coming years, potentially affecting other therapeutical areas as well.” — Anne Marie de Jonge, board member, Swiss Biotech Association
Manufacturing will become more adaptable, digital and collaborative
“I anticipate an uptick in the adoption of advanced manufacturing technologies, leading to smaller batch sizes and a more adaptable manufacturing approach to cater to the demands of personalized medicine and clinical trials. Simultaneously, the increasing integration of digital technologies, automation and data analytics is expected to play a pivotal role. Moreover, I foresee continued industry investment in bolstering supply chain resilience post-COVID-19. Additionally, I hope for increased regulatory adaptations and collaborations to keep pace with technological advancements and escalating costs. For example, consider the Mutual Recognition Agreement signed in July 2023 between Switzerland's SwissMedic and the USA's FDA, validates inspections conducted by each other's regulatory authorities. I hope this kind of collaboration between trusted regulatory bodies will shape the manufacturing of the future.”
—Michael Altorfer, Chief Executive Officer, Swiss Biotech Association
