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The pandemic continued to affect supply chains, inflation was at a recent all-time high, and FDA approvals hit a five-year low. The Inflation Reduction Act was signed into law back in August, promising to limit the pharma industry’s pricing power.
Despite these tests, the industry experienced pivotal moments. Humira’s patent expiration led to CDER’s 40th biosimilar approval — with more to follow. There was a surge of gene therapy approvals, including the first gene therapy for hemophilia B.
Even though pharma’s bar for eventful years was set incredibly high after 2020, the industry is set up for a busy 2023. Here’s a glimpse at what industry leaders are predicting for the coming year.
MANUFACTURING TECHNOLOGIES
Pharma’s insight will be crucial for tech improvements
"Pharma manufacturing needs are in part restricted by the available technology manufacturers have access to in the marketplace. As the world population increases, the demand for innovative medicines and increased understanding of genetics, cancer therapies and infectious diseases are driving the need for accurate, repeatable and reliable instrumentation. Going forward, pharma manufacturers will need increased capacity, response time and accuracy — and repeatable instruments will help. Pharma companies partnering with their suppliers to design the products of the future will be critical. As we come from what was once an analog industry to what is now the digital era, it will be the vision of the pharmaceutical industry that drives the technology of tomorrow."
— Jeff Gulla, Sales Manager, Scientific MEMS Product Line, Sierra Instruments
"Encouraged by technology advancements that permit seamless access and granular control over information, more biopharmas and CDMOs will invite suppliers to participate in key processes within their quality management systems. CDMOs will also increasingly invite their customers directly into their QMS, quality documentation, and training systems for better visibility and real-time sharing of information. This approach will make it easier for smaller innovators to accept products, sign off and approve batches, review quality events, and share quality data. Over time, companies will develop distinct information-sharing strategies, training programs, and new processes tailored to each CDMO or supplier."
— Ashley Wentworth, Senior Director, Vault Quality, Veeva Systems
Digitalization will help pharma streamline
“Part of a digital transformation strategic solution will be to ‘find the hidden plant’ within a company’s global pharmaceutical manufacturing operations. That is to identify those processes that represent the untapped efficiencies of each manufacturing line and to make the most of capacity and productivity as sourcing needs continue to change throughout the year. Accessing auditable and traceable communication helps to ensure compliance as well as streamline workflows, reducing operational risk and increasing efficiencies."
— Andreas Eschbach, CEO and Founder, Eschbach
"This year, drug developers will embrace cognitive computing to streamline the safety signal process, positioning themselves to increase their strategic contributions and drive growth. Teams that don’t move forward will struggle with raising case volumes, noisy signals and manual tasks."
— Elizabeth Smalley, Director of Product Management and Data and Analytics, ArisGlobal
Companies that digitize will reap benefits
"We are continuing to see digitalization become a major trend in the pharma manufacturing industry as proper implementation can lead to higher quality products, improved performance, increased customization, and time savings. Pharma companies should keep in touch with the latest trends, while partners focus on supporting customers in adopting new technologies and integrating them into production processes. At Stevanato Group, we witness first-hand how AI can help reduce parametrization and production costs, supporting pharma companies in leading a robust root analysis and moving to a predictive method, exploiting a large amount of data."
— Raffaele Pace, Vice President, Engineering, Stevanato Group
"Historically, companies have been hesitant to invest in technologies like AI and IoT, and simply tested the waters with small pilot programs. But in recent years, these technologies have matured tremendously, and have proven successful and scalable in global manufacturing environments of all kinds. Companies will ramp up their own digital transformation with confidence now, putting resources into smart technologies to keep a competitive edge. Those leaning into predictive and prescriptive analytics will lead the pack, using data-driven insights to understand and act on the risks posed by increased competition, tight labor markets, higher costs, new product quality standards, and emerging regulations. Lastly, we’ll see areas like maintenance and reliability be recognized as strategic opportunities to eliminate waste. "
— Zach Gilula, Team Leader, Pharmaceutical, Life Sciences and Medical Products, Augury
"We are seeing the industry beginning to show signs of moving towards more paperless solutions, including electronic batch records. The cost of the daunting number of systems and changes to consider is the most restrictive factor. Sites that adopt a robust digital platform and operating culture will be more successful in attracting and retaining a higher percentage of the workforce."
— Cheryl Bondurant, Principal Consultant, CAI
"The pharma industry is up against a complex landscape, including supply chain disruptions that are causing a shortage of antivirals and antibiotics, as well as gaps in global medicine access. In addition, the expectations for increased speed to market are higher than ever. In 2023, we can expect to see pharma manufacturers increase digital technology investments in order to help overcome these challenges. The development of smarter manufacturing strategies, powered by automation, AI, and advanced analytics, will drive progress and create new capabilities crucial to maximizing operational agility and efficiency—a major strategic goal for 44% of pharma manufacturers’ digital transformation journeys, according to a recent survey from AspenTech. Equipped with the right tech, pharma companies can make strides toward improving their global access to medicine strategies and ensuring resilient supply chains that can better address medicine shortages."
— Kelly Doering, Sr. Director of Pharma, AspenTech
Policy will drive adoption of advanced technologies
“The Inflation Reduction Act (IRA) will have a profound impact on R&D investment as well as on overall industry earnings for innovator companies. With it, look for pharma to finally get the push they need to adopt more efficient, effective advanced manufacturing technologies like continuous manufacturing, designed to provide lower cost, high-quality drug manufacturing. Small molecule development will be hit hard as they are exempted from negotiation under the IRA for only nine years post-approval, compared to thirteen years for large molecule drugs.”
— Bikash Chatterjee, CEO, Pharmatech Associates
SUSTAINABILITY EFFORTS
Pharma companies will get serious about their environmental impact
“The mission of improving lab sustainability is quickly becoming a top priority in both private and public sectors. As the industry shifts toward more sustainable practices, more responsibility will fall upon private businesses and individuals to enact and meet sustainability goals. The financial and environmental benefits of sustainable practices are prompting leaders in the scientific community to embrace these changes and move initiatives forward. While the requirement for sterility makes using single-use plastics unavoidable in many cases, there are basic adjustments — such as reducing energy and water consumption, conserving materials and properly disposing waste — that labs can make to reduce overall environmental impact without affecting workflow.”
— Marwan Alsarraj, Biopharma Segment Manager, Bio-Rad
“The life science community and the pharmaceutical industry need to re-double their commitments to long-term sustainability. Today’s innovations can only provide their anticipated impact if we protect them from the consequences of environmental damage. Our community has an opportunity to lead by example as a climate-conscious industry, and we have the scientific chops needed to make it a reality. We need to go beyond carbon offset programs by developing new technologies that significantly improve the sustainability of research workflows and bioprocesses."
— Chris Fisher, Ph.D., Scientific Affairs Manager, Provectus Algae
"Health care has a substantial carbon footprint, approximately 4% of global emissions, and medicines generate up to one third of that. Additionally, human health is directly impacted by rising temperatures. Health care providers should be motivated to reduce their carbon footprint — and they are. Twenty country health systems have pledged to achieve net zero with target dates between 2030 and 2050. To accomplish this, they will look to medicines suppliers among others, to respond with similar net zero commitments. So far, only eight of the top 100 pharma companies have made a net zero commitment in the same date range. This disparity between goals of health care purchasers and suppliers isn’t sustainable – 2023 might be the year in which the pressure on large pharma to get serious about carbon footprint becomes significant."
— Aurelio Arias, Director, Thought Leadership, IQVIA
“2023 will continue to pave the way towards sustainable manufacturing, with a growing number of organizations placing focus on creating long-term solutions. Now is the time for new manufacturing sites to adopt and implement new technologies; to transform pharma manufacturing from being reliant on costly legacy processes. Digital technology will speed up processes by enabling early detection of wear and tear on machinery lines. It will also help to reduce wastage and recalls by effectively tracking defective batches, allowing for timely interventions. Inclusion, innovation, and integration will be keywords for the pharmaceutical industry in 2023.”
— Karan Singh, Managing Director, ACG
"The best route to achieving sustainability goals is through manufacturing and operational efficiency. Securing those objectives requires process data, automation, and systems control, as well as other tools to create smarter manufacturing environments. Although the industry’s integration of digital technologies and its journey to Pharma 4.0 operating models is accelerating, the ability to do so successfully is one challenge I believe the industry will struggle to overcome. Regardless of what is being manufactured, these integrations will never be ‘plug and play’ because every organization, process and operation has unique attributes. Fortunately, accessing this valuable enterprise and operational data to achieve higher-order goals like efficiency and sustainability are becoming easier with the support of the industry’s digital technology and integration solutions providers."
— Jim Lehane, Global Leader of Life Sciences Manufacturing, Cognizant
A look to used equipment
“More companies will start to realize the benefits of redeploying equipment within their own network in terms of sustainability and cost savings. Not only is it the most prudent way to save money, but it will also make better use of their existing resources. And the best part, it's a great way to be more environmentally friendly, by reducing the need for new equipment purchases, companies can lower their carbon footprint. This can be a great way to showcase their commitment to sustainability. It's a win-win situation, and I think we'll see more businesses catching on to this trend this year.”
— Justin Kadis, Business Development & Operations, Federal Equipment
DRUG DEVELOPMENT
Companies will use the COVID model to drive agility
“COVID-19 saw multiple vaccines reach patients in less than a year without compromising safety or scientific integrity. Leading companies will use this blueprint to drive agility into the drug development cycle value chain. Disruptors in the industry will employ different ways of working or reallocating resources to revolutionize processes and decision-making. In certain areas, companies will experiment with smaller, agile teams that work in parallel to drive speed and innovation. This process will also result in increased collaboration with external partners where there is strong alignment, driving exclusive partnerships in certain areas.”
— Stephan Ohnmacht, Vice President, Global R&D Business Consulting Lead, Veeva Systems
Plant-based platforms will speed clinical development
"Biologics are taking the world of medicine by storm and are being used for an ever-increasing number of therapeutic purposes. However, manufacturing biologics cannot occur by inorganic means; drug manufacturers must use live cells such as mammalian to produce the drug in question and then purify it and package it for use. Still, the process has a flaw: engineering mammalian cells to produce large amounts of a biological drug leads them to produce toxic proteins in the cells, inhibiting their ability to make the biologic and slowing down overall production. The use of plant-based platforms to quickly manufacture clinical-grade materials can shift the balance from mammalian cell platforms, which can often take a few months to produce target clinical-grade materials. Plant-based platforms can produce the same, less toxic proteins in a matter of weeks, allowing for multiple targets to be tested simultaneously and allowing clinical trials to get moving more quickly."
— Bill Brydges, CEO, Phylloceuticals
Drug discovery will move to the cloud
"Life sciences companies must keep processes and discoveries out of the wrong hands. In the coming year, more providers of cloud-based life science services will direct the cloud lab conversation to protecting vital scientific data. Carnegie Mellon University is doing pioneering work on a $40 million plan for an internet-accessed cloud lab. This will enable undergraduates, graduates and researchers to perform life sciences experiments without ever setting foot in the lab. Only 10% of rare diseases have treatments, but one in 10 Americans suffer from them. With the ability to experiment in the cloud 24/7/365, rare diseases won’t have to be prioritized downward in pharma development."
— Toby Blackburn, Head of Business Development and Strategy, Emerald Cloud Lab
Pharma will looks for ways to streamline development
"We're seeing real momentum in demand for fully integrated drug development services offerings that span ‘end-to-end’, all the way from candidate development through to late stage and commercial drug product manufacturing. Additionally, where customers can streamline and partner with a single outsourcing provider to meet all key development milestones, this eliminates the non-value add white space traditionally created by working across multiple vendors. Our customers validate these significant benefits, citing real risk reduction, reduced time and reduced expenditure. It is genuinely advantageous to embed deep molecule and program knowledge in a single, truly integrated outsourcing partner. Indeed, this advantage extends beyond the early development space into enabling readiness for commercial product launch."
— Sarah Stevens, SVP & Head of Early Development & Late-Stage Commercial, Quotient Sciences
"This year, drug developers will embrace cognitive computing to streamline the safety signal process, positioning themselves to increase their strategic contributions and drive growth. Teams that don’t move forward will struggle with raising case volumes, noisy signals and manual tasks."
— Elizabeth Smalley, Director of Product Management and Data and Analytics, ArisGlobal
SUPPLY CHAIN
Workforce pools will widen
"Due to the high number of promising transferred therapies in 2023, the pharmaceutical industry as a whole is going to be busier than ever and will therefore need to expand sites and staff. Biopharma sites will be widening their staffing pool. We see more sites hiring more people without GMP experience and/or without a college degree. With this trend emerging, now training, leadership and emphasis on quality culture is more important than ever from onboarding to full position engagement. "
— Ellyn Ludden, Principal Consultant, CAI
Companies will reinvest in domestic manufacturing capacity
"The biotech industry has been historically good in maintaining dual sourcing; however, has not paid particular focus to where in the globe those multiple sources have been located, i.e. frequently for key materials, all commercially available sources are outside of the U.S. This should bring opportunities for re-investment in domestic manufacturing capacity as plants are pulled back from overseas and to win increased volume for smaller domestic manufacturers. Cost increases in biomanufacturing should be muted relative to the broader industry. Biomanufacturing costs are not particularly sensitive to changes in materials cost, and the expected economic downturn will help contain labor costs. Energy/fuel surcharges, particularly in the transportation sector, are here to stay."
— Lisa Sellers, CEO, Vector Laboratories
"The prevalence of drug shortages caused by reactions to the pandemic raised a difficult question: what's the real cost of no supply and the patient not getting what they need? Businesses are now looking at cost more holistically and acknowledging that the price for low-risk, reliable and quality supply may be higher upfront, but it could have serious advantages in the longer term. So, as a result, we've seen an increased interest in localized outsourcing and demand for our US manufactured APIs and intermediates. Pharma and biotechs sourcing APIs and intermediates are taking a harder look at their CDMO relationships and looking for partners that they trust will deliver against their development and manufacturing milestones. For CDMOs, a demonstrable ability to protect their customers’ patient bases through reliable supply is going to be paramount to growing their business."
— Andy Anderson, Global Head of Strategic Account Management, APIs and Intermediates, Pfizer CentreOne
Bridge facilities will gain traction
"Keeping up with market forces will require an increase in demand for advanced therapies that will outstrip current means of production. Building facilities requires validation that can delay the manufacturing process while CDMOs are already operating at capacity; neither alternative will satisfy growing demand. New approaches are being introduced to bridge the gap between building facilities and outsourcing capacity. These so-called ‘bridge facility’ scenarios have yielded a variety of alternatives, including cleanroom licensing. The facilities are being introduced across the country in areas with the greatest pharma and life sciences manufacturing capabilities. Bridge facilities are becoming a cost-effective way for pharma manufacturers to scale their operations to meet demand without building facilities that may remain largely vacant. "
— Ravi Samavedam, Chief Innovation Officer, Azzur Group
THERAPEUTIC INNOVATION
Alzheimer’s disease will be a key focus
"Biopharma desperately needs to deliver clinical successes in 2023, to help remind investors why this sector can be worth the risks. Areas of focus next year include Alzheimer’s disease, where Eisai and Lilly are hoping to succeed where Biogen failed. "
— Evaluate Vantage 2023
CGT will continue to grow
"In 2023, new platform technologies addressing current limitations in CGT will be a key growth area. Cell therapy 2.0 will continue to deliver innate immune cells such as natural killer cells and macrophages as an alternative to T-cells for engineering chimeric antigen receptors. In vivo cell therapy is an emerging field as well. Within gene therapy, alternatives to CRISPR-Cas9 gene editing technology to improve the range and specificity of gene editing will continue to be a focus area."
— Sigma Mostafa, Senior Vice President and Site Head, KBI Biopharma
"For the year ahead, key growth drivers will include the expanding diabetes and weight-loss market and a strong project pipeline in contract manufacturing, especially with regards to monoclonal antibody production capacity. The outlook for ATMP/personalized medicine will also remain positive. Increasingly, this sector is diversifying to focus on genetic and metabolic conditions, neurodegenerative disorders and cardiovascular disease. Similarly, the year ahead will see messenger RNA continue to evolve at a rapid pace, with more vaccines and therapeutics in the pipeline. mRNA manufacturing remains highly specialized, with each facility requiring specific responses. To address these complex challenges, collaborations between biopharma companies and solutions providers will become more commonplace."
— John Noble, Vice President & General Manager, Life Sciences, Jacobs
Changes will be needed to enable advanced therapies
“As commercial approvals continue to occur, for larger patient populations and with potentially long-term efficacy, pharmacoeconomics will loom large. Price and cost bases will have to start trending in a downward direction, or the long-term sustainability of the cell and gene therapy field will be questioned. From a technical perspective, cell and gene therapy needs to enter into an era of deeper product characterization. We will see old analytical methods applied in new ways and new methods applied to current and future products. This will also help with manufacturing cost: you can’t improve what you can’t control, you can’t control what you can’t measure. The volume of potentially successful gene and cell therapy programs is threatening to overwhelm the FDA and indeed the world’s regulators. A paradigm shift is needed in how advanced therapies are regulated if this is not to become an unacceptable bottleneck”
— Anthony Davies, Dark Horse Consulting Group, CEO and Founder
"To address the enhanced need for viral vectors, a manufacturing trend moving into 2023 will be the broader development and adoption of stable producer cell lines – enabling manufacturers to maintain the production of a consistent and high quality product while expanding output. Although the upfront development time can be extensive, the overall benefits of stable producer cell lines are advantageous in the long run and will continue to have developers switching to this from transient transfection methods. More specifically, a stable producer cell line will facilitate reduced vector variability, improved scaling, lower cost of goods, and remove the need for plasmid manufacturing."
— Laura A. Kerepesi, Associate Director, Preclinical Manufacturing, Andelyn Biosciences
Neuropsychiatric disorders pipeline will advance
"In 2023, the industry will see innovation in next generation medicines for neuropsychiatric disorders that we haven’t seen for decades. Soon, companies will start sharing data from the pipeline of clinical trials gaining momentum for patients with disorders such as schizophrenia, treatment-resistant depression, and Alzheimer’s Disease from companies like Sunovian’s phase 3 clinical trial of Ulotaront, COMPASS Pathways’ phase 2 psilocybin trial, and Lilly’s donanemab and Roches’s gantenerumab phase 3. Decentralized clinical trials (DCT’s) and simplification of studies will help accelerate clinical trials, and more companies will cut pipelines in response to the Inflation Reduction Act."
— David Bleakman, President of Drug Discovery & Development, PsychoGenics
REGULATORY COMPLIANCE
The use of AI for regulatory operations will explode
“Today’s regulatory technology solution uses center around gathering data to analyze and use in submissions. However, the use of AI for regulatory operations in life science is about to explode in 2023. Regulatory technology of the future will do much more than gather data – it will also use smart automation and predictive analytics to provide intelligent, actionable insights. Instead of simply inputting data for reporting purposes, intuitive solutions will guide the entire regulatory process while reducing associated risks. Connecting historical data, typically stored in silos, is the big caveat to achieving this next step in AI-driven regulatory capabilities. That’s where cross-functional integration comes in to provide massive amounts of data for regulatory analysis. By starting cross-functional integration with regulatory affairs and drug development, organizations can immediately see the impact of eliminating data silos and effectively managing valuable data across the enterprise. In addition, the comprehensive nature of now-connected data sources will enable more in-depth AI-driven analysis – leading to valuable, actionable insights that improve not only RADDS operations but enterprise success as a whole.”
— Michelle Gyzen, Senior Director, Strategic Solutions, Regulatory Affairs & Drug Development Solutions, IQVIA
Companies will align AI initiatives with data privacy regulations
"In 2023, companies will enact policies that standardize how data is cleaned, managed and approved for AI analysis. Translations of data will be certified by human reviewers, and limitations will be put in place around personal patient information and how it’s stored. This will not only push AI initiatives to success, but will ensure IT landscapes and data analytics comply with regional regulations for data privacy."
— Andrew Mitchell, Senior Director, Pharmacovigilance & Regulatory Technology, IQVIA
Data-based regulatory submissions will take hold
“Increasing regulatory pressure will lead to more agile, connected data management approaches that enable companies to ensure compliance globally. In addition, the long-anticipated shift from document to data-based regulatory submissions will soon take place, starting with new FDA and industry initiatives that will use data management approaches for manufacturing CMC submissions. In 2023, more companies will focus on developing the systems, infrastructure, and skill sets required to work with data-based submissions. Far from a trivial effort, this will require an entirely new operating model and substantial organizational change.”
— Marc Gabriel, Vice President, Vault RIM, Veeva Systems
Source: https://www.pharmamanufacturing.com/home/article/21548855/2023-pharma-predictions