Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

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Behind the Headlines Episode 28

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Feliza Mirasol is the science editor for 

MediWound, an Israel-based biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, announced on Dec. 28, 2023 that the US Department of Defense, through the Medical Technology Enterprise Consortium, a biomedical technology consortium focused on developing medical solutions for US military personnel, has awarded MediWound an additional $6.7 million to develop NexoBrid as a non-surgical solution for field-care burn treatment for the US Army.

The additional funding brings MediWound’s R&D budget up to $14.4 million, which the company will use to advance the development and production of a new, temperature-stable formulation of NexoBrid. Doing so will position NexoBrid as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings, according to a company press release.

NexoBrid is a bromelain-based biological product containing a sterile mix of proteolytic enzymes that selectively removes eschar in patients with deep partial and full-thickness thermal burns (1,2). It is administered topically. The product is currently approved in the United States, European Union, and other international markets (1).

Under an agreement worth potentially $150 million, Vericel, a US-based company specializing in sports medicine and severe burn care, holds an exclusive license for the commercial and development rights to NexoBrid in North America. MediWound retains commercial rights in all non-North American territories (2).

"We are delighted to further solidify our partnership with the US Department of Defense. The additional funding will enhance our CMC [chemistry, manufacturing, and controls] activities, expedite preclinical development, and facilitate the establishment of a GMP [good manufacturing practice]-compliant aseptic production line for the temperature-stable formulation of NexoBrid," said Ofer Gonen, CEO, MediWound, in the press release. "This new award underscores our shared commitment to ensuring NexoBrid's availability for military use and its potential to significantly change the early treatment approach for severe burns."

1. MediWound. Next Generation Enzymatic Therapeutics Focused on Non-Surgical Tissue Repair. 

 (accessed Jan. 5, 2024).
2. MediWound. MediWound Enters into Exclusive License Agreement with Vericel for Commercial Rights to NexoBrid in North America. Press Release, May 7, 2019.

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MediWound has been granted an additional $6.7 million by the DoD to advance NexoBrid as a non-surgical field care solution for the US military.

DoD Grants Additional Funds to MediWound for Advancement of Non-Surgical Treatment for Field Care Burns

On Jan. 3, 2024, Boehringer Ingelheim announced that it has entered into a multi-target collaboration with Suzhou Ribo Life Science and Ribocure Pharmaceuticals (Ribo) under which they will develop new RNA-based treatments for nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH). The partnership combines Ribo’s experience in the discovery and clinical development of small interfering RNA (siRNA) therapeutics and Boehringer Ingelheim’s expertise in the cardiovascular, renal, and metabolic diseases (CRM) market.

Under the agreement, Ribo will receive an upfront payment and is entitled to receive success-based milestones for clinical, regulatory, and commercial success as well as tiered royalties. The overall deal is estimated to exceed $2 billion.

Ribo’s RIBO-GalSTAR technology platform enables development of RNA interference therapeutics that target disease-causing genes specifically in hepatocytes. The technology does this by silencing the genes’ messenger RNAs (mRNAs). This approach has the potential to treat diseases by addressing previously inaccessible drug targets, according to a company press release.

“We look forward to working with the scientists from Ribo to develop new breakthrough medicines for patients with NASH,” said Søren Tullin, senior vice-president and global head of Cardiometabolic Diseases Research, Boehringer Ingelheim, in the press release. “This new partnership is part of our commitment to collaborate with peers worldwide to address the interconnected nature of CRM diseases. Our goal is to develop the next wave of innovative medicines that will lead to a holistic health gain for patients.”

“This collaboration represents a strong endorsement of the many years of investment and scientific discovery built into Ribo’s platform. We are very pleased about the opportunity to work with Boehringer Ingelheim to develop new solutions for people living with NASH,” said Zicai Liang, CEO, Ribo Life Sciences, in the release.

Under the collaboration, Boehringer Ingelheim and Ribo will develop RNA-based therapeutics to treat NASH/MASH.

Boehringer Ingelheim and Ribo Partner on RNA-based Liver Disease Therapeutics

Roche announced on Dec. 29, 2023 that it has signed a definitive agreement to acquire select parts of the LumiraDx group related to that company’s point-of-care technology. The transaction is expected to close by mid-2024. Roche will pay $295 million at closing (subject to customary closing adjustments) and an additional $55 million for the reimbursement of amounts to fund the point-of-care technology platform business until the close of transaction. Upon closing, the acquired entities will be fully integrated into Roche Diagnostics.

LumiraDx’s technology integrates multiple point-of-care tests on a single, user-friendly instrument. This integration offers more affordable and accessible access to testing for patients globally, according to a company press release.

The technology platform offers a range of immunoassay and clinical chemistry tests, with potential for additional high medical value tests in the future. These tests can be stored at room temperature, enabling convenient handling in a range of decentralized healthcare settings, according to the press release.

“The addition of the LumiraDx technology to our diagnostics portfolio will enable us to transform testing at the point of care,” said Matt Sause, CEO, Roche Diagnostics in the press release. “LumiraDx has developed a highly versatile platform that delivers strong performance across multiple disease areas and technologies. We believe this will enable better patient access to timely results in decentralized healthcare settings worldwide.”

“Since our founding, we have sought to transform community-based healthcare by consolidating multiple [point-of-care] tests on a single instrument. We are thrilled that Roche will continue this important work and increase its reach around the globe. This will enable more patients to get fast and easy access to better diagnostic testing,” said Veronique Ameye, CEO, LumiraDx, in the release.

Roche will acquire select parts of the LumiraDx group related to that company’s point-of-care technology, which integrates multiple tests on a single instrument. 

Roche to Acquire Point-of-Care Technology from LumiraDx in $350 Million Deal

AstraZeneca is poised to acquire Gracell Biotechnologies, a clinical-stage biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases, in a deal valued at approximately $1.2 billion, according to AstraZeneca’s announcement in a Dec. 26, 2023 press release. The transaction is expected to close in the 2024 first quarter. Upon closing, Gracell will operate as a wholly owned subsidiary of AstraZeneca, with operations in China and the United States.

Under the agreement, AstraZeneca will acquire all of Gracell’s fully diluted share capital through a merger; the transaction will proceed at a price of $2.00 per ordinary share in cash at closing plus a non-tradable contingent value right of $0.30 per ordinary share in cash, which is payable upon achievement of a specified regulatory milestone.

The upfront cash portion represents a transaction value of approximately $1 billion, and, combined with the potential contingent value payments, if achieved, the overall transaction value would potentially total approximately $1.2 billion. As part of the transaction, AstraZeneca will also acquire the cash, cash equivalents, and short-term investments on Gracell’s balance sheet, a total of $234.1 million as of Sept. 30, 2023, according to the press release.

AstraZeneca expects the proposed acquisition to enrich its growing pipeline of cell therapies, particularly with the addition of GC012F, Gracell’s novel, clinical-stage B cell maturation antigen (BCMA) and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy. Gracell is developing GC012F as a potential new treatment for multiple myeloma as well as other hematologic malignancies and autoimmune diseases, including systemic lupus erythematosus (SLE). Gracell has initiated a Phase Ib/II trial evaluating GC012F for treating relapsed or refractory multiple myeloma in the US.

In addition to the cell therapy candidate, AstraZeneca will also gain Gracell’s proprietary cell therapy manufacturing platform, FasTCAR. The technology was introduced in 2017 and allows for the next-day manufacturing of CAR-T therapies (1).

“The proposed acquisition of Gracell will complement AstraZeneca’s existing capabilities and previous investments in cell therapy, where we have established our presence in CAR-T and T-cell receptor therapies (TCR-Ts) in solid tumors. GC012F will accelerate our cell therapy strategy in hematology, with the opportunity to bring a potential best-in-class treatment to patients living with blood cancers using a differentiated manufacturing process, as well as exploring the potential for cell therapy to reset the immune response in autoimmune diseases,” said Susan Galbraith, executive vice-president, Oncology R&D, AstraZeneca, in the press release.

“We look forward to working with AstraZeneca to accelerate our shared goal of bringing transformative cell therapies to more patients living with debilitating diseases. By combining our expertise and resources, we can unlock new ways to harness the Gracell FasTCAR manufacturing platform, which we believe has the potential to optimize the therapeutic profile of engineered T cells, to pioneer the next generation of autologous cell therapies,” said William Cao, founder, chairman, and CEO, Gracell, in the release.

1. Gracell Biotechnologies, Gracell Biotechnologies Presents Longer-Term Results for FasTCAR-T GC012F in B-Cell Non-Hodgkin’s Lymphoma at EHA2023, Highlighting 100% Overall Response Rate. Press Release, June 10, 2023.

AstraZeneca’s acquisition of Gracell includes a clinical-stage autologous cell therapy targeting hematologic malignancies and autoimmune diseases and a proprietary manufacturing platform.

AstraZeneca Poised to Acquire Cell Therapy Developer, Gracell, in Deal Valued at $1.2 Billion

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

QurAlis, a clinical-stage biotechnology company located in Cambridge, Mass., announced on Jan. 3, 2024 the opening of its European Union (EU) headquarters in Leiden, The Netherlands. The location will serve as a European hub for operations that include clinical trials through commercialization of the company’s products. QurAlis’ product pipeline includes therapies to treat neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). QurAlis focuses on treatments for “patients who have a loss of Kv7.2/7.3, patients who have loss of STATHMIN-2, as well as patients with loss of UNC13A and impairment in synaptic signaling.”

“The expansion of our operations into Europe represents a new chapter for QurAlis, building upon the tremendous momentum of our organization,” said Kasper Roet, CEO and co-founder of QurAlis, in a press release. “In a short period of time, QurAlis has made significant progress with regulatory approvals for our clinical programs in the EU, Canada, and the UK [United Kingdom]. The successful completion of the quality systems inspection by the Dutch regulatory agency will allow us to directly leverage our world-class ASO manufacturing expertise and control our end-to-end production supply chain. With our new European headquarters, and the skilled talent network in Leiden and the region, we will further strengthen our position as we bring breakthrough precision medicines to patients with ALS, FTD, and other neurodegenerative diseases.”

“QurAlis’ new location in Leiden is designed to not just meet our current needs, but also to scale with our business as we continue to grow,” said Hagen Cramer, chief technology officer of QurAlis, in the release. “Our new European headquarters will allow us to release ASOs and other products into the European market for our programs so that we can deliver innovative solutions and make a meaningful difference in patients’ lives.”

The new Europe headquarters will be the hub for the company’s European operations, including production of product.

QurAlis Opens European Headquarters in The Netherlands

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Education bridge, acquiring academic knowledge | Image credit: © Pixelbliss - stock.adobe.com

Close to a Giffen good, depending on the therapeutic area, pharmaceutical products defy fundamental economic laws. Bad years are not so bad as they still exhibit an upward-sloping demand curve, while good years can be a bonanza. An overlooked obvious truth about the pharmaceutical industry is that it is a chimera of strong competing opposites—a 1980’s Kombi van powered by jet engine thrusters, piloted by overly exuberant alternating with pessimistic MBA graduates. Through this lens, the stop/start progress and the multitudinous lurches toward both extreme success and extreme failure can be more clearly comprehended. On a deeper level still, pharmaceuticals are also a lifesaving endeavor inextricable to civilization’s forward march on one hand, while helping to extend and enrich each individual’s personal life on the other. In its inherently selfish human nature, the sector is thus well insulated from those deepest of natural financial troughs.

With this in mind, in gathering perspective on 2024’s industry performance, 

® asked industry workers for comments on challenges and opportunities. Responses were cross referenced with those from 

’s annual employment survey (1) as a validation and quality control check.

The time and expense required to train and retain operators—and then to re-train them again when increasing molecular diversity for a new therapeutic requires the process to begin anew—is a commonly heard challenge. Christa Myers, senior fellow, Aseptic & Sterile Products, CRB, related that, “there is a lot to learn and be able to speak to within this highly technical side of the industry. Character and personality matter. An operator needs to be able to follow protocols for manufacturing of a quality product. Each also needs to be able to think in a quality improvement mindset in order to plan for corrective actions and preventative actions (CAPAs). Your operators are your most valuable asset and should be trained and treated as such” (2).

Many agree with training staff as a number one priority, as does Harry Benson, director of Human Performance Services at Commissioning Agents (CAI), who says, “finding, hiring, and retaining the workforce for many operational departments is a significant challenge—possibly the biggest barrier to growth opportunities and closing the drug shortage gaps. For this reason, the industry is giving much more attention to the availability of a skilled or trainable workforce in their site selection and expansion process.”

, this workforce challenge is commonly perceived as the biggest obstacle for industry progress, and is even mentioned, with variations, in the “others” category of 

, with frequent comments such as “ I’d like to add that the onboarding and general information flow is horrible, and newcomers are completely left alone” or, “[there is a] lack of experience in the industry and common sense.”

. Bio/pharmaceutical workplace challenges. | Image credit: © 

Connie Leech, global director of Quality, Compliance, and Regulatory at CAI, puts an apostrophe on this, stating, “the post-pandemic workplace is uncertain, constantly changing, and ideal for workers with a breadth of knowledge and skills who thrive in ambiguity.”

Regulators asked to keep pace with innovation, shortages, and transparency

Ashleigh Dawley, director, Regulatory Affairs & Compliance, Integrated DNA Technologies, points out that, “The recent FDA approval of the first CRISPR [clustered regularly interspaced short palindromic repeats]-based gene therapy—which was just a vision a little over a decade ago—signals continued interest in the power of the CRISPR-Cas9 technology, as reflected in the more than 40 registered clinical trials globally to date. This rapidly evolving technology has the power to unlock innovation and future patient impact that we cannot even imagine today.” She continues, “An ongoing challenge remains in the ability of regulatory agencies to scale and grow with the pace of innovation. Of the current 40 active clinical trials globally, 23 of those are occurring in the [United States]. If successful, [FDA] could face challenges with regards to creating the infrastructure with the needed staffing resources and expertise to support regulatory reviews and approvals and enable the delivery of promising therapies to patients in need.”

Agne Vaitkeviciene, CEO of Memel Biotech and VP at LithuaniaBIO agrees. “As of today, [the] main obstacle in the pathway of new ATMPs [advanced therapy medicinal products] development is regulatory environment. Especially in [the] European Union. Changes in regulations comes slower than expected and leave Europe behind [the] US, Japan, and UK [United Kingdom]. Still, there are hundreds (543) of companies in Europe developing ATMPs and over [a] thousand (1235) in North America for a reason. Reaching patients, who could benefit for cell and gene therapeutics becomes significant, and improvements in regulatory landscape have to adjust faster to allow the access to the therapies. Together with regulatory approaches, reimbursement is one other obstacle that joint community efforts worldwide are trying to solve. Applying optimization in manufacturing processes and [a] fast marketing approval system might contribute to lowering ATMPs costs.”

Communication, a key asset during pandemic vaccine development and deployment, is being called back into question. Thomas Hartman, president & CEO of the International Society for Pharmaceutical Engineering says, “Both the FDA and drug manufacturers will need to focus on earlier communication and collaboration to mitigate shortages and avoid facility shutdowns. This is especially true of generic manufacturers–many of which are either shifting from generic medicines because of a lack of profitability or closing down entirely. Alongside the FDA’s mobile app and web portal dedicated to reporting drug shortages, the introduction of new technologies in digital validation and data management will improve visibility within manufacturing and allow for early communication to the FDA regarding potential disruptions.”

Hanns-Christian Mahler, CEO of ten23 health, says he thinks of this line from Star Trek when approaching a challenge: “things are only impossible until they are not (Cpt Picard, Enterprise).” This certainly was borne out by recent Vertex and CRISPR Therapeutics approvals in the UK and US for Casgevy, alongside bluebird bio’s Lyfgenia, the first approved gene edited therapeutics, and Arcturus’ARCT-154 approval in Japan, the first self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine.

There is so much historical process habit in the bio/pharmaceutical industry that it can often be paralyzing to growth, most especially when confronting new modalities. Renee A. Hart, president and chief business officer, LumaCyte, thoughtfuly observes. “I have used the analogy before that the leaning Tower of Pisa is a great example of where process and technology sits in many verticals. Companies think that layering on new processes, people, and tools into already complex infrastructures will somehow check the box of driving innovation. Those organizations that choose not to invest in change management and continue to stack new processes on top of old will find themselves leaning so far away from growth that in time they will find their organizations are actually moving backwards. Process inefficiencies create unnecessary obstacles and bottlenecks to advancing the development and delivery of lifesaving treatments and cures, we can definitely do better.”

These therapeutics “herald new ways of thinking, new types of testing and validation, and new types of manufacture and end-point monitoring. Following on from the revolutionary COVID-19 vaccines, what comes next is more complicated, more difficult to price for reimbursement, and more effective in terms of cure rates. The toothpaste is out of the tube, and the industry must learn to adapt to take best advantage of what is becoming available, no matter how messy the process” (3). As can be seen in 

, cell and gene therapies are widely considered the biggest opportunity going forward.

. Opportunities in the bio/pharmaceutical industry. | Image credit: © 

When considering the evolving toolkit now available to pharmaceuticals, Michelle Fraser, head of Cell & Gene Therapy, Revvity, says, “notably, there are also technologies poised to edit mRNA rather than the genome, inducing transient changes, and addressing genetic alterations influenced by environmental factors through epigenetic modifications ... The trajectory points towards increased sophistication, efficacy, and safety in these therapeutic interventions … expect to see a surge in the adoption of more intricate gene editing approaches, signaling a year marked by significant advancements in the refinement and application of these transformative technologies.”

Personalization requires yet more systems convergence

While progress on advanced therapeutic medicinal products is now undeniable, a new type of effort begins in earnest. That consists of bringing still more technologies into alignment for these treatments to be deployed and accessed. Casgevy requires access to facilities specializing in bone marrow transplantation, for example, which necessitates knowledge transfer from hospital and medical staff being feedback to pharmaceutical scientists.Thermo Fisher Scientific and the University of California San Francisco (UCSF) established one of the early direct connections to hospital treatment, with a current good manufacturing practice facility adjacent to the UCSF medical center. About this movement toward distributed manufacturing (some term it near patient, or spoke and hub), Michel Lagarde, executive vice president and chief operating officer of Thermo Fisher, observed, “cell therapies represent a rapidly emerging field of biotechnology with tremendous promise for future therapeutic applications … with a record number of cell therapy approvals granted in the last two years, and CAR-T therapies becoming earlier treatment options, we’re in a golden age of biology, where new technologies and partnerships are evolving and transforming clinical care” (4).

This makes turning the page to the year 2024 a metaphorical, as well as literal, leap year. Pharmaceutical manufacturing is now (pun intended) an embedded part of the hospital-patient system.

2023 Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey

Spivey, C. Hi-Fidelity Fill/Finish for Biologics. 

Spivey, C, New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia, 

Kurtzmen, L. Thermo Fisher Scientific Opens Cell Therapy Facility at UCSF to Accelerate Development of Breakthrough Therapies. UCSF press release,
March 27, 2023.

Chris Spivey is the editorial director of 

When referring to this article, please cite it as Spivey, C. Leap Year. 

Revolutionary therapies restructure pharmaceutical manufacturing.

Leap Year

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Bridge made of colorful blocks on violet background, flat lay. Connection, relationships and deal concept | Image Credit: © New Africa - stock.adobe.com

At the beginning of 2023, inflation represented a significant thorn in the side of global economies and exacerbated the challenges raised by the tumultuous preceding 12 months—encompassing the tail end of the COVID-19 pandemic, the war in Ukraine, and skyrocketing energy prices. Despite inflation moving in the right (downward) direction across Europe, it is still a lingering issue for the continent and is negatively impacting European economies (1,2).

For the bio/pharma industry—an industry well known for its ability to weather economic turmoil with reasonable safety—the latest global economic challenges have raised significant concerns. In Europe, moving into 2024 there will be additional factors at play, such as an increased drive to digitalization, a focus on sustainability, and a shortage of skilled personnel, meaning that bio/pharma companies will need to adapt over the coming months.

“The pandemic, inflation, geopolitics, new therapeutic modalities, evolving ways of working, and EU [European Union] regulatory changes, have conspired to have major implications for the pharma industry,” reports Romuald Braun, managing partner, MAIN5, a European consulting firm specializing in organizational and digitally enabled change in Life Sciences.

“The most notable fallout,” Braun says, “has been rising operational complexity (e.g., the need to manage diverse product portfolios and supply chains); increasing risk around balancing global demand, supply chain disruptions, and new modalities; the need to adapt to technological changes; rising capital costs (investing in new technologies and facilities); variable cost increases (addressing inflation and supply chain challenges); and the need to seize every opportunity for savings through optimized operations.”

In concurrence, Jordan Schmitting, senior research analyst, The Josh Bersin Company—research, advisory, and education on the trends, technologies, and best practices for the new world of work—confirms that the evolving geopolitical, economic, and regulatory conditions have put European pharma companies’ supply chains and profit margins under pressure throughout 2023.

“However,” Schmitting adds, “digitization and biotechnology were perhaps the most defining trends within the industry, shaping the future of not only how treatments are discovered, developed, manufactured, and distributed, but the types of treatments being explored.”

An increased integration of digital technologies is being seen within the bio/pharma industry, agrees Braun. “This [integration] includes the use of AI [artificial intelligence], big data analytics, and digital health platforms to improve efficiency and outcomes,” he says. “Digital transformation now extends to adoption of ‘Generative AI’, as companies strive to be more data and insight driven, moving away from dependence on static documents.”

Furthermore, the use of cloud-based systems to ease information exchange and data management will be seen, Braun continues. “Breaking down data silos is essential to enable advanced analytics and faster decision-making—as long as data governance and data quality are prioritized so that teams can trust the insights being surfaced,” he states.

Along with changes in data collection, however, comes an increased focus on data privacy and the general data protection regulation, adds Kate Coleman, vice president of Quality and Compliance at Arriello—a consultancy and solutions provider of risk management and compliance services to the pharma industry. “Again, these topics were raised repeatedly in 2023, not just in the context of medicine but also in the broader social context, and the importance of data protection is a conversation that will continue into 2024,” she notes.

“AI has gathered pace and is a consistent talking point as it is now recognized as a powerful tool in many areas across the pharmaceutical industry including drug development, writing, data analysis, translations, and pharmacovigilance activity to name a few,” remarks Coleman. “AI has the potential to radically change how we do things in the industry, and everyone will need to increase their understanding of this powerful technology to understand both its strengths and weaknesses.”

For Beena Wood, senior vice president of Safety and Medical, ArisGlobal—the creator of the LifeSphere technology platform and provider of global patient treatment solutions—there has been crucial technological innovation that is now providing all bio/pharma companies access to AI and machine learning (ML). “AI/ML can now be applied to a broad range of connected data—including a broader range of standardized, reliable real‑world data—to enable advanced analytics and powerful, timely insights,” she says. “This will inspire new treatment/care innovation with the interests of patients right at the heart.”

Patient-centricity will become an intense focus for bio/pharma companies in 2024 because of several converging factors, according to Wood. “First, the status quo is being challenged increasingly by empowered patients who now know and expect more,” she specifies. “Second, [there is] accelerated delivery of personalized therapies, geared to the needs of smaller patient populations and individuals. Meanwhile, regulatory mandates are now prioritizing patient concerns and considerations right from development phase and throughout the treatment lifecycle.”

Braun concurs that patient centricity will be a huge topic for companies moving forward and points out that patients’ needs and outcomes will remain important for companies. “Personalized medicine, patient engagement, and real-world evidence will guide decision-making,” he states.

“The increased focus on personalized medicine, gene therapies, and other advanced therapeutics combined with discussions on treatment costs have raised questions that will need to be considered for the viability of future innovative pharmaceutical products,” emphasizes Coleman. “Many high-profile agreements have been reported in 2023, and the topic of cost benefit analysis for innovative therapies will be ongoing in the next year.”

Another focus for bio/pharma companies in the future will be embracing more sustainable practices, something that is being expected from customers and patients. “Companies will be increasingly investing in green initiatives, implementing eco-friendly manufacturing practices, and adopting sustainable packaging solutions,” says Preeya Beczek, principal consultant at Beczek.com, a regulatory affairs and compliance consultancy.

“Increasing efforts will need to be made to reduce waste generation, minimize water consumption, and decrease greenhouse gas emissions,” Beczek continues. “These changes will need to be measurable so that achievements against targets can be demonstrated through key performance indicators over time.”

As the climate crisis is becoming more apparent to the world, an issue that will only be more heightened in the coming years, the bio/pharma industry is finding itself in a difficult position, states Coleman. Simply due to the nature of the bio/pharma industry—manufacturing and distributing products around the world—it is a major contributor to the global carbon footprint, she stresses.

“The pharma industry is also highly regulated, which means significant change is neither easy nor fast,” Coleman says. “To really combat the impact that the pharma industry has on the environment, the risks and impacts from the industry need to be fully identified across all activities from sourcing of raw materials, shipment, transport, manufacture, distribution, and management of waste to identify a full and holistic plan for change that can reduce the impact on the environment and on the planet. When mitigation actions are identified that will improve the carbon footprint, such as reverting to stainless steel rather than single use plastics, the regulators will need to assist companies with balancing the risks between impact on patients, impact on employees, and impact on the environment as a whole.”

There are numerous environmental, social, and corporate governance (ESG) challenges facing the bio/pharma industry, confirms Braun. “These [challenges] include reducing carbon footprint and promoting sustainable practices; ensuring ethical sourcing and minimizing environmental impact across the supply chain; balancing profit with patient needs to ensure patient access and affordability; more responsible drug development (ethical research and innovation); diversity and inclusion considerations, promoting a diverse workforce and equitable practices,” he notes.

“Moreover, there will be changes to what needs to be reported on, and how, under the EU’s Corporate Sustainability Reporting Directive (CSRD),” Braun stresses. “From 2024, almost 50,000 companies are subject to mandatory sustainability reporting, including non-EU companies with subsidiaries operating within the EU or listed on EU-regulated markets.”

An increasing role of technology and innovation, such as AI, robotics, and automated processes, combined with newer therapeutic modalities and personalized medicines in the bio/pharma industry is changing the skills and expertise required, emphasizes Coleman. “For example, roles such as the Qualified Person have changed significantly when considering ATMPs [advanced therapy medicinal products] where the QC [quality control] tests and timelines for batch review and release to market have been either significantly reduced or removed completely,” she says.

Schmitting also alludes to a misalignment of roles and skills across all talent segments of the bio/pharma industry caused by rapid evolution of the industry’s requirements as a result of trends like AI, automation, digitization, and big data. “These forces are changing the nature of work not only in manufacturing and distribution, but across the entire pharma value chain, including R&D,” she says. “Take AI-driven platforms, for example, which is a research innovation fundamentally changing the methods and timescale of specialized therapy discovery and development.”

However, the technological innovation being seen within the bio/pharma industry could also help to attract the younger generation to the sector, Beczek remarks. The skills gained with a more technologically advanced bio/pharma industry can also be transferrable should the potential employee wish to change their role, she adds. “Harnessing the tech-savvy power of this younger generation could help the industry see new possibilities and pathways to drive change forward,” Beczek states.

Additionally, as biologicals and molecular technologies become more present within industry, the skillsets required to deal with these are changing and are not necessarily easily acquired, Braun stresses. To manage this issue, Braun anticipates there will be an increase in M&A activity and a rise in the use of external services to plug gaps.

“Lower-skill labour in production facilities is a challenge too, not least as 24/7 continuous production increases,” Braun says. “To address these shortages and contain costs, pharma companies will need to continue streamlining processes, harnessing automation and applying AI as appropriate.”

Potential options for bio/pharma companies to deal with the skills shortage is to collaborate with academic institutions, industry associations, and research centres to pool talent, Braun continues. To attract and retain skilled professionals, companies should develop a more compelling employer value proposition and offer continuous learning opportunities for existing employees, such as upskilling in digital technologies, and so forth, he adds.

Beczek believes in a two-pronged approach to tackle the skills shortage. “Start at the higher education level and actively recruit seasoned medical experts in the key therapeutic areas to join innovative companies as clinical development leaders, medical experts to drive product strategy at a disease level,” she explains.

There also needs to be different pathways offered in addition to the standard three- to four-year full-time qualifications pursued at an academic institution, according to Beczek. “There are a handful of settings that offer young adults a life sciences path via apprenticeships with an opportunity to balance hands-on work and study including a salary. This is the way forward,” she says.

“The academic institutions do appear to recognize the change in the industry and proactive measures have been taken at this level to ensure graduates are more equipped to deal with the demands of the reality of working in a high technology environment,” specifies Coleman. “However, one element that this cohort lack is the practical experience needed to develop into quality resources that can support this ever-changing industry.”

Moving into 2024, Braun expects that bio/pharma companies will continue to be cost-conscious and the industry transformation with new modalities gaining prominence will persist. “Pharma companies will need to invest in R&D to harness these [therapeutic] innovations effectively,” he says.

Adoption of digital technologies will accelerate, and companies will need to invest in digital capabilities to keep up with opportunities, Braun adds. “AI/ML will move from a prototyping or pilot phase towards larger use cases, presenting new challenges for validation and data integrity,” he says. “As the pace of change accelerates, IT must be much closer to the business than previously.”

There is heightened pressure on bio/pharma companies to control costs, maximize the value of investments, and optimize their strategic focus, while also maintaining the highest levels of patient safety and stakeholder confidence, adds Wood. “In pharmacovigilance and agency reporting, large language models/ChatGPT-like Generative AI tools are poised to deliver up to 80% productivity gains for certain work processes, compared with 20–50% improvements with previous-generation technologies,” she states. “No company can afford to let that kind of opportunity pass them by. The appetite is there, and proof-of-concepts are well underway now.”

However, with the various therapeutic and technological advancements, companies will also need to ensure they keep abreast of regulatory updates. “The EU’s regulatory changes will continue to impact the industry. Companies must stay informed about evolving regulations related to clinical trials, medical devices, and AI applications. Compliance and adaptation are key,” Braun reports.

Coleman also points to the regulatory landscape, which will be a focus in 2024 as the existing pharmaceutical regulation will be replaced. “The main objectives of the revision are aligned with the points mentioned previously, and it is intended that the revised EU pharmaceutical regulation will address innovation and technological advancements in the industry, align manufacturing of medicinal products with the European Green Deal related to climate change, and make medicines in Europe more affordable, accessible, and available to patients that need them,” she summarizes. “The changes are intended to make the industry and its regulation more agile, and more appropriate for the world we live in now.”

The regulatory updates are aligned with the rise in biotech innovation, drive to reduce time-to-market, and increased focus on patient needs, meaning that the bio/pharma industry has no choice but to change the way it operates, asserts Wood. “Leading players have realized that if they want different outcomes, they can’t keep doing things the way they’ve always done,” she says. “They need to be smarter, and more informed by the latest data, if they want to honour their commitment to patient centricity, and to safe, agile innovation.

All the trends discussed have a massive impact on the bio/pharma industry because of the many moving parts involved, adds Beczek. “The crucial part is that teams will have to increasingly work across functions not just in R&D but also closely with commercial, medical affairs, in country affiliates, with industry experts and healthcare professionals, expanding the end-to-end value chain of strategy and operations,” she concludes.

1. Guerrera, F. Europe Faces Dirtier Inflation Fight than US. 

, 6 Sep. 2023.
2. Smith-Meyer, B. High Interest Rates Have Hit Growth More than Expected, EU Says. 

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.


Vol. 36, No. 1
January 2024
Pages: 10–12, 16

When referring to this article, please cite it as Thomas, F. Bridging Gaps and Investing in Change. 

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.

Bridging Gaps and Investing in Change

We have to stick to the facts. a group of scientists working together in a lab.| Image credit: © Courtney H/peopleimages.com - stock.adobe.com

® survey audience members to see what has remained the same and what has shifted, regarding pharmaceutical workforce attitudes toward their jobs, their current employers, and the general direction the industry is heading. The industry’s response to COVID-19 has had the most significant measurable impact on the way both business and manufacturing processes were managed in the past two or three surveys. In 2023, the largest observable shift was brought about by the steady emergence of advanced therapeutic medicinal products (ATMPs). The last half of 2023 was a watershed moment for pharmaceuticals, given the industry saw the first set of approvals for gene edited therapies, as well as for a self-amplifying messenger RNA vaccine. But everyone experienced the year through the lens of the products and activities their own company sells. In this way, one can say of pharmaceutical manufacture, “All happy families are alike; each unhappy family is unhappy in its own way” (1). Let’s examine survey responses to see what these differences might be founded upon (2). There is a gulf between survey responses such as “struggling industry full of scientific brains lacking leadership, mentoring, and training” or “Party’s over–hunker down, folks,” to “Aside from a few ‘deplorables’, the industry is in good condition’’, “volatile, encouraging, innovative, nerve-wracking”, or “Incredible advances and treatment options.”

As the sugar rush of COVID-19 response funding wore off, so too did the number of hours workers put in on average. Hours worked returned to pre-pandemic levels, based on earlier survey results (see 

). This finding was somewhat surprising given conversations held during conferences, but there was perhaps some confirmation bias during conferences, versus survey results. It’s easier in a survey to say ‘I’m not working as hard’ compared with a network contact you are used to doing business with. The final question of the survey asks, “If you could describe the 2023 bio/pharma industry in five words or fewer, what would you say?” And this is where the quote from Tolstoy can most readily be explored.

Figure 1: COVID-19 measures. | Image credit: © 

Figure 2: Are working hours rising or falling? | Image credit: © 

Opinions about the post-pandemic industry were largely positively oriented, from “post-COVID readjustment” and “the 2023 bio/pharma industry has benefitted greatly from covid restrictions.” Responses ranged from “consolidation after covid pandemic rush” to “Great come back after covid.” But some were bleak in their appraisal, with “Pandemic stress, Supply chain collapse” and “Post-pandemic blues” being somewhat frequent responses.

Naturally, one can suppose the technologies and services most involved in the pandemic response, such as vaccine manufacture and distribution, were/are the respondents going through the deepest readjustment phase. One of the features of the pandemic was that it forced everyone to communicate more quickly, clearly, and completely. This seems to have remained.

Karolina Makovskyte, head of Business Development at Caszyme, said, “One positive aspect of CRISPR-Cas technology is the emergence of a more active dialogue about gene editing regulations, particularly in Europe. It is also somewhat linked to another positive aspect, which is increased exploration of the technology by new industries, seeking ways to integrate CRISPR-Cas into their activities.”

Satisfaction with pay in 2023 didn’t move to any great degree versus historical years (see 

). Perhaps the timing of the survey influenced a type of survival-driven satisfaction, as the last half of the year saw several companies markedly reduce workforce numbers as part of restructuring efforts. Pfizer axed approximately 900 staff, as their Covid vaccine reported $1.31 billion in sales, a 70% decline from the year before. “Wall Street had expected $1.53 in revenue. Paxlovid suffered an even sharper drop, with revenue of just $202 million—97% down from last year” (3). Not a big reduction but still significant for a company that sold $100 Billion in product for the first time in 2022. Grifols, a Spanish company specializing in blood plasma therapies, trimmed its operations in the United States by cutting approximately 2300 positions (which amounts to approximately 8.5% of its global workforce). Takeda braced for competitive threats with cuts of nearly 1400 staff, to prepare for generic competition to its diabetes drug Actos. Thermo Fisher Scientific adjusted to changing demands through a series of workforce cuts totally nearly 1300 staff, mainly due to decreased demand for COVID-19 testing products and “evolving economic conditions.” Genentech, Biogen, Catalent, and Amgen also witnessed significant workforce diminutions, while Novavax, Emergent BioSolutions, and Bristol Myers Squibb, round out the list (4).

Figure 3: Salary satisfaction. | Image credit: © 

, job security hit its highest levels during the height of the COVID-19 pandemic. While the survey questions don’t allow enough depth to explored in detail, going back to the Tolstoy metaphor, the workers feeling most secure are likely the staff working on the most promising new advanced therapeutic medicinal products (ATMPs), as this is clearly where the excitement and major new investments are being ploughed into. For example, RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia (5). Novo Nordisk is also planning a US$2.3 billion investment in new French facilities, partly to facilitate extra capacity for glucagon-like peptide-1 products (6). One of the survey respondents summed up the entire industry with the words “Sustained growth with new therapies” while another simply stated “Vaccines, proteins, blood, tissues.”

Figure 4: How secure do you feel in your job? | Image credit: © 

Similarly, optimism about future performance was also peaked during the pandemic.Somewhat alluding to the Tolstoy metaphor and also the COVID-19 sugar rush, Barbara Ryan, founder, Barbara Ryan Advisors commented, “It is interesting, however, because the market remains highly bifurcated—companies with good data are able to finance, and often the aftermarket performance is quite positive, as the deals are viewed as a clearing-event lifting the financing overhang. As of press time, there had only been 11 biotech IPOs this year, in contrast to more than 100 each in 2020 and 2021. Sadly, however, too many companies went public in 2020 and 2021 that were at a far-too-early stage in their development (i.e., preclinical, Phase I trials) to be public companies; they were not sufficiently funded to proof-of-concept data. This is where the real pain is” (7). Ryan went on to round out her assessment of the industry, ending on a highly positive note. “The innovation renaissance is alive and well, with record numbers of FDA new drug approvals in each of the past several years. M&A continues to be another bright spot. Beginning in 2025, large pharma will be losing exclusivity for products currently representing over $350 billion in revenue, leaving a huge growth gap that needs to be filled through M&As, licensing, and partnering. Dealmaking has always been a key pillar of the industry’s growth strategies. More good news: according to EY’s Annual Fire Power Report, large pharma has a record $1.4 trillion to fund deals. There have been a total of 30 public biotech acquisitions this year, and 15 of these were above $1 billion each, which surpasses the number in any year for the past 10. As we wind down 2023, the hope will be for rate relief in the year ahead—and substantially improved biotech performance.”And as if on que, the Federal Reserve just suggested three cuts to interest rates in 2024, sending the DOW into record territory by rising 1.4%, to close at 37,090.24 (8).

Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey

Q.ai Contributor Group, Pfizer Layoffs Confirmed as Vaccine Manufacturer Drives For Cost Savings. 

Buntz, B. 10 Major Pharma and Biotech Companies that Downsized in 2023. 

Mirasol, F. RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy, 

Mirasol, F, Novo Nordisk to Make Multi-Billion Dollar Investment in Expansion of Production Facilities in France, 

Ryan, B. Will Calendar Change Bring an End to Run of Volatility in Biotech? 

Mena, B.; Wallace, A. Buchwald, E. Dow Surges to New Record as Fed Signals Three Rate Cuts in 2024. 

When referring to this article, please cite it as Spivey, C. New Therapies Cry Out for New Skills. 

There are positive indications for future growth.

New Therapies Cry Out for New Skills

Kelley Waldron, PhD, is business unit manager, Quality and Manufacturing Science Consulting, at ValSource.

Tiffany Baker, MBA, is senior consultant at ValSource.

concept of auditing and evaluating quality and efficiency of personnel ,business document evaluation process ,inspection of business finance tax documents ,Data analysis reports growth results | Image credit: © chaylek - stock.adobe.com

In 2009, the pharmaceutical and biopharmaceutical industry’s quality risk management (QRM) journey was still in its infancy. The industry had begun performing risk assessments, lots of risk assessments. Consider, for example, this December 2009 quote from Roche’s Wallace Torres in 

: “[following the initiation of the company’s QRM program], we performed more than 100,000 full FMEA [failure mode and effects] analyses worldwide in the first year” (1). Industry has since learned that excessive numbers of risk assessments can bog down the system and minimize the value that can be extracted from the assessments. Thankfully, with the release of the International Council for Harmonisation’s (ICH) Q9(R1), industry can better plan what risk assessments are needed, when, why, and how (2).

As is often the case, the pharmaceutical industry was not the first to learn this lesson. ISO 14971, “Medical devices—Application of risk management for medical devices,” first described the use of a risk management plan for device risk management in 2007 and has retained this requirement through each subsequent revision. Among other things, this standard obliges medical device developers and manufacturers to define a plan for risk management activities throughout the product lifecycle. As noted by ISO 14971, “a risk management plan is required because (a) an organized approach is essential for good risk management, (b) the plan provides the roadmap for risk management, [and] (c) the plan encourages objectivity and helps prevent essential elements from being forgotten” (3).Similarly, validation master plans, in use throughout industry for many years, are designed to achieve the same goals.

The requirements for a risk management plan in ISO 14971 read like what one might envision as a QRM procedure for the pharmaceutical and biopharmaceutical industries. Roles and responsibilities are defined and delineated, the scope of the plan with regard to the product lifecycle is outlined, a governance structure and associated processes are established, risk and residual risk acceptance criteria are defined, and requirements and data sources for the use of production and post-production information (similar to the risk review phase of the ICH Q9(R1) lifecycle) are described. In addition to these standard requirements, ISO 14971 notes that the risk management plan may be used to define milestones, plan risk management activities, and outline risk tools to be employed for the various activities. In this way, the risk management plan has an inherently flexible structure with the goal of better enabling the organization to plan for what risk management activities must be done to align with certain product-realization goals (3).

While ICH Q9(R1) does not explicitly address the use of a risk management plan, the QRM lifecycle begins with a “QRM Initiation” step, the primary focus of which is a process of gathering the information needed to begin a risk assessment and continue throughout the remaining lifecycle stages (2). Considering the learnings from ISO 14971, this initiation step can be enhanced through an outline of strategic goals for the QRM program and a detailed plan on how the firm intends to reach them. While the first version of ICH Q9 paid little attention to planning and organization, the current version of ICH Q9 highlights the application of thoughtful and objective decision-making throughout the QRM lifecycle, including the often overlooked “QRM Initiation” step.

The historic lack of emphasis on QRM planning is a plausible reason why the industry has struggled with the administration of the QRM program and the creation of myriad risk assessments with no holistic vision. The lack of strategic planning could also contribute to a siloed approach to QRM application and risk assessment performance. By outlining overarching objectives for the QRM program, the use of a risk management plan can enable the pharmaceutical and biopharmaceutical industries to spend less time “doing QRM” and more time managing risk to the patient. This plan would be a living document over time to demonstrate the current state of the program, as well as updating the future of QRM implementation. Depending on the firm’s level of maturity and experience with QRM, strategic objectives for the QRM program may include:

Hire/develop QRM experts to enable the implementation of the program and the risk assessment portfolio

Author QRM policy, procedures, and work instructions

Design and implement role-based QRM training

Integrate QRM principles and practices into quality and operational systems

Define and create portfolio of living risk assessments.

To distinguish from the medical device risk management plan and the clinical/medical risk management plans in use for drugs with unique risk profiles, and to capitalize on the familiarity with validation master plans, such a plan is best termed a QRM Master Plan. The remainder of this article focuses primarily on the last bullet listed above—the creation of a living risk assessment library.

Two more welcomed additions to the 2023 ICH Q9(R1) include an expansion on the concept of risk-based decision making and the acknowledgement, in the context of QRM formality, that under certain circumstances only a portion of the complete QRM lifecycle needs to be applied. For example, one might apply the risk assessment portion of the QRM lifecycle to help determine a commensurate depth of investigation for a process deviation or complaint, or to evaluate the appropriate frequency for preventive maintenance, calibration, or self-inspection. These applications of QRM do not necessarily require the totality of the lifecycle to be followed; rather, a risk assessment may be conducted to facilitate a decision without continuing into the risk reduction, risk acceptance, and risk review portions of the lifecycle. It is therefore necessary for firms to distinguish between living risk assessments, which follow the full breath of the QRM lifecycle and are generally more formal in nature, and ad hoc risk assessments, which may only address a portion or portions of the lifecycle and are generally (but not always) less formal in nature, depending on the risk question. This alleviates some of the administrative burden of a QRM program by focusing energy and resources (particularly within risk review) on the applicable portions of the lifecycle.

Living risk assessments should represent the core of the QRM program. These are performed on a product, process, or system, with the objectives of understanding the associated risks, controlling them to an acceptable level, and reviewing the risks in light of changing conditions to evaluate the continued relevance of the identified risks and the effectiveness of risk controls. Ad hoc risk assessments are likely to be performed as part of an integrated quality system to support risk-based decision making within specific contexts. These risk assessments need not be subject to risk review, but are often the input into the review of living risk assessments. Many companies struggle as they attempt to review risk assessments intended for risk-based decision making rather than for the QRM lifecycle, because related decisions have been taken and resultant next steps enacted. A mature QRM program addresses and embraces both types of risk assessments.

It follows, of course, that the products manufactured by a firm, as well as the facilities where these processes occur, should be subject to the full rigors of the QRM lifecycle, and therefore have living risk assessments associated with them. These represent the most direct link to the patient and should be continually evaluated in a QRM framework throughout their lifecycle. The question then becomes, what living risk assessments are necessary to ensure that risks to the patient are fully understood and controlled?

QRM Master Plan–proactively designing the portfolio of living risk assessments

A mature QRM program would have a clear picture of the minimum scope required to achieve holistic risk knowledge and would have established a QRM Master Plan to achieve this. For example, a firm may elect to use the approach commonly employed by medical devices, with one risk assessment (and QRM lifecycle initiation) each for the product, process, and use. Such a living risk assessment library might leverage platform processes and technologies and similarities in design and construction to cover the totality of product considerations and would be mindful to the myriad regulatory requirements and expectations for topics to be evaluated through QRM. An example of a complete living risk assessment library for current good manufacturing practice (CGMP) operations is provided in 

 Example of an optimized living risk assessment library for current good manufacturing practice (CGMP) operations. FIGURE IS COURTESY OF THE AUTHORS.

Some firms may already have an established portfolio of living risk assessments and be seeking to close gaps with new or changed regulatory requirements, expansion of product lines, or process variations.This is common, for example, with companies that manufacture sterile products as they seek to align with the updated Annex 1 requirements in the European Union. In this instance, the scope of the QRM Master Plan may be limited to the development of living risk assessments to support the contamination control strategy (CCS) as required by the Annex (4). To address the breadth of aseptic activities and information flow necessary to enable the CCS, a firm may focus their QRM Master Plan on three separate risk assessments: one focused on classifying interventions into the critical zone (ISO 5/Grade A), one focused on assessing hazards associated with all manufacturing and support processes, and one focused on assessing hazards associated with the classified areas of the facility and colocated clean utility distribution systems (drop points). Given the more narrow scope of this sort of QRM Master Plan, more detailed information such as the applicable risk question and QRM tool to be employed may be included, as illustrated in 

 Example of an optimized living risk assessment library to support the contamination control strategy (CCS). QRM is quality risk management. FIGURE IS COURTESY OF THE AUTHORS.

While the scope and contents of a QRM Master Plan may vary based on a firm’s level of QRM maturity and specific objectives, the critical thinking and planning necessary to compose the plan will serve as a guidepost for the organization’s activities, mobilizing personnel toward a common goal.

. The purpose section of the QRM Master Plan should describe the goal and intent of the plan. Depending on the individual firm’s current level of risk maturity and specific objectives, the goals might differ. For example, less mature firms may elect to focus on the development of a QRM process, governance structure, and training, while more mature firms may wish to focus on expanding an existing QRM program to additional aspects of the quality system. Similarly, some firms may need to develop living risk assessments only on a certain topic (such as contamination control) while others may need to develop the holistic risk library from scratch.

. The scope section should describe the boundaries of the QRM Master Plan and should use exclusionary language where necessary to describe elements or areas that are out of scope. This section may include, for example:

the site (or sites, buildings, etc.) to which the QRM Master Plan applies

products, product lines, and/or
systems to which the plan applies

product lifecycle phases to which the plan applies (e.g., development through Phase I,
commercial only, etc.)

types of risks covered by the plan (e.g., contamination related risks)

quality system elements included in the plan, if any (e.g., change control, deviation management, etc.)

It is recommended that the QRM Master Plan cover a timeframe spanning one to three years, enabling both short-term “quick wins” as well as longer-term strategic objectives to be outlined.

. This section of the QRM Master Plan should outline the roles and responsibilities for those working or interacting with the QRM program. Many firms have experienced success with the use of a responsibility assignment (RACI) matrix, which maps each role to a given activity according to whether they are Responsible, Accountable, Consulted, and/or Informed. The responsibilities and tactics or activities outlined in this section should directly correlate to the content of the plan; that is, all activities within the plan should be assigned to a specific role, and each responsibility listed should likewise have specific actions associated with it. This practice ensures clarity is provided to both the readers and users of the plan (

 Example responsibility assignment (RACI) matrix for quality risk management (QRM) Master Plan. FIGURE IS COURTESY OF THE AUTHORS. 

. The bulk of the QRM Master Plan should include a discussion of objectives and activities that will be completed under the plan, as discussed in the prior sections. This activities list can be composed both of new assessments to be performed in addition to risk review of existing assessments. Where many activities comprise the QRM Master Plan, it may be prudent to prioritize work using a risk-based approach, such that all stakeholders will understand the rationale for the cadence of tasks. One example of such a risk-based prioritization tool might involve the ranking of each activity for the criticality of the topic and the complexity of the effort (see 

 Example of topic criticality ranking criteria, for quality risk management (QRM) activity prioritization. FIGURE IS COURTESY OF THE AUTHORS.

 Example of effort/complexity ranking criteria, for quality risk management (QRM) activity prioritization. FIGURE IS COURTESY OF THE AUTHORS.

The intersection of the individual rankings for topic criticality and effort complexity can then located in the prioritization matrix to determine the relative priority of the activity (

 Example of QRM activity prioritization matrix. FIGURE IS COURTESY OF THE AUTHORS.

The relative priority of each QRM activity can be used, in addition to an analysis of activity interdependencies, critical path identification, and other considerations, to determine an appropriate timeframe for completion. This enables the firm to allocate resources toward the most appropriate activities to enhance QRM maturity and deliver a direct benefit to the patient. An example activity list using the above principles is shown in 

 Example activity list for quality risk management (QRM) Master Plan. FIGURE IS COURTESY OF THE AUTHORS.

A thoughtfully constructed QRM Master Plan translates the strategy established by leadership into actionable, prioritized tasks and enables a risk-based approach to the “QRM Initiation” step of the ICH Q9(R1) lifecycle, thereby ensuring the organization remains centered upon the things that matter most—protection of the patient.

Cox, B. Roche Builds Quality Risk Management Program in Response to Viracept Crisis. 

ISO 14971.“Medical Devices–Application of Risk Management to
Medical Devices.” 2019.

EC. Annex 1: Manufacture of Sterile Medicinal Products. 

Baseman, H. and Long, M. Risk Management of Microbial Contamination Control in Aseptic Processing and Interventions Risk Assessment Model (IREM): The Use of Critical Thinking to Make Informed Decisions. In 

Contamination Control in Healthcare Product Manufacturing

, Vol. 3, eds. Russell Madsen and Jeanne Moldenhauer, 341-404. Bethesda: PDA/DHI, 2014.

When referring to this article, please cite it as Waldron, K and Baker, T. Developing an Optimized Risk Assessment Portfolio—The Quality Risk Management Master Plan. 

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach. 

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