Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

	Emerging therapies are testing the capabilities of biologic drug manufacturing companies, as well as contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). As a result, these manufacturers are employing process optimization and scalable advanced technologies to produce more product in less floor space.

	“To respond to market needs for capacity, speed to manufacturing, modular platforms, and workforce training are at the forefront of any business strategy,” says Michelle Stafford, global marketing leader, BioProcess Solutions, GE Healthcare Life Sciences. “Speed to manufacturing can include in-sourcing/outsourcing analysis, which will take into account the long-term business plan, [intellectual property] IP protection, capital expenditures, time to market, and the technical capabilities of manufacturing or CDMO personnel. The result of this analysis will determine if capacity is outsourced to a CDMO or organic expansion and training is warranted.”

	“For mammalian manufacturing, there have been significant expansions in CMO/CDMO capacity over the past year with many companies announcing new facilities,” explains Charles Christy, head of commercial solutions, Ibex Dedicate, Lonza Pharma & Biotech. “Single-use technology is facilitating rapid addition of capacity, and process intensification is also playing a role in optimizing existing assets.”

	CDMOs have stepped up investments in cell therapy and gene therapy capabilities to secure a share of this market and to foster small biotechs in advancing prospective therapies. Most notably, in the first half of 2019, Thermo Fisher Scientific acquired Brammer Bio for $1.7 billion and Catalent purchased Paragon Bioservices for $1.2 billion, giving the CDMO giants capacity in viral-vector manufacturing.

	While this consolidation means there are fewer competitors in the market, industry experts see benefits including standardization of methods, simplified vendor management, and use of advanced technologies.

	“CMOs not only provide manufacturing capacity on the traditional side, but also build the capacity for novel modalities,” says Andrew Bulpin, head of process solutions, MilliporeSigma. “This enables small and virtual companies to stay independent longer.”

	“Consolidation of the contract services industry should translate into better standardization of methods and give more flexibility in scheduling capacity,” says Phil Vanek, general manager, cell and gene therapy strategy, GE Healthcare Life Sciences. “These improvements should be realized in the coming years; however, integration efforts may cause some growing pains in the near-term. As there is currently a high demand for talent in the industry, this consolidation will also likely foster better sharing of expertise and help bring the industry up to speed (technically) much more quickly.”

	“As more and more services companies take on commercial manufacturing at scale, there should be an easing of capacity demand for earlier-stage clinical activities, which is taking up much of the capacity today,” Vanek says. “The other major change will be increasing integration into the clinical workflow, with scheduling and logistics management becoming a bigger share of the manufacturing burden.”

	Working with CDMOs or CMOs that can offer end-to-end solutions can be valuable for smaller biotech companies who don’t have the resources to manufacture in house or manage complex supply chains, says Christy. “For any company, large or small, dealing with one quality system, one project manager, etc., simplifies the process. For larger companies with a range of modalities/projects, working with one CDMO can provide more leverage and they can expand across technologies quickly,” he says. “It also takes time to develop trusted working relationships with outsourcing partners. Companies working with partners that provide solutions across the modalities and value chain mean that they can hit the ground running on new projects with the same CDMO, saving time, internal resources, and leveraging synergies.”

	In addition, acquisitions have allowed contract manufacturers to invest significantly in capacity, says René Gantier, director, process R&D, Pall Biotech. “And, the rise of contract service organization acquisitions by technology suppliers is accelerating the development of fit-to-purpose bioprocess technologies and the implementation of these advanced technologies into new bioprocesses.”

	MilliporeSigma is a CDMO, as well as a developer and manufacturer of process technologies, with more than 30 years of drug manufacturing expertise and more than 250 biologics to date delivered through its three global bio development centers, says Bulpin. Looking ahead, he says, “The industry will see added capacity, development of quality and regulatory compliance standards, and the development of templates and processes for novel modalities.”

	Christy anticipates further expansion along the value chain with more focus on specialized solutions for increasingly complex medicines. “For example, some companies may choose to outsource development or manufacturing that requires very specific know-how or technology, such as bioconjugation/antibody-drug conjugates or live biotherapeutic products that target the microbiome,” he says. “Inevitably, the creation of fewer large CMO/CDMOs leaves space for smaller, niche companies to develop very specific offers.”

	Partnering and in-licensing are also important in applying new technologies to manufacturing, Christy continues, citing a transposon-based technology Lonza is developing to improve stable expression of increasingly complex proteins, which are becoming important in the development pipeline.


	Supplement: Partnering for Bio/Pharma Success
	February 2020
	Page: s8

	When referring to this article, please cite it as R. Peters, “More Capacity and Technology Translate to More Options," 

Pharmaceutical Technology Partnering for Bio/Pharma Success 

Articles

The need for manufacturing speed inspires contract manufacturers to explore advanced processing technologies.

More Capacity and Technology Translate to More Options

	In 2020, US biopharma companies face impacts from familiar business and policy issues-access to healthcare, patent protection, the cost of prescription drugs, the biosimilars debate, and the opioid addiction crisis-as the presidential and congressional election rhetoric heats up. In Europe, the United Kingdom’s departure from the European Union is certain; however, the terms of the departure are yet to be determined. Amid these political distractions, researchers and process scientists in the biopharma industry must focus on the familiar challenge of improving current processes and increasing productivity, as well as a new hurdle related to bringing emerging therapies to market.

	A more diversified biologic drug pipeline-including bispecific monoclonal antibodies (mAbs), cell therapies, gene therapies, and nucleic acids-as well as gene editing techniques and new delivery methods hold promise for patients. The tedious work to establish manufacturing processes and controls could slow progress in bringing some of these therapies to market.

	Cell therapies and gene therapies continue to generate strong research and investment interest, although investments have dropped off from 2018 levels. The Alliance for Regenerative Medicine (ARM) reports companies developing cell therapies, gene therapies, and other regenerative medicines raised $7.4 billion through initial and follow-on public offerings, upfront payments from corporate partnerships, venture capital, and private placements in the first three quarters of 2019 compared with $12.5 billion in all of 2018 (1).

	More than 1000 clinical trials for cell and gene therapies were in progress at the end of Q3 2019 including more than 570 Phase II and more than 75 Phase III trials, according to the ARM report. With a significant number of therapies in the late-stage pipeline, biopharma companies, contract manufacturers, and equipment and materials suppliers must invest in innovative development, manufacturing, and supply chain procedures and practices to deliver these therapies to patients.

	“Monoclonal antibodies have used the same manufacturing template for the past 30 years. Novel modalities currently don’t have that same foundation,” says Andrew Bulpin, head of process solutions, MilliporeSigma. “The development of reproduceable, industrialized manufacturing templates is desperately needed to provide successful and cost-effective cell and gene therapies. With that comes the need for quality and regulatory compliance standards.”

	To bridge gaps in cell and gene therapy supply-while delivering cost-effective products-continuous improvement in both upstream and downstream processing is paramount to achieve higher titers and product recoveries, says Tania Pereira Chilima, product manager, Univercells. Incorporating processes into innovative, scalable, low-footprint, low-CAPEX systems can help reduce costs, she says.

	Managing both the manufacturing process and a complex supply chain is vital. “Right now, cost-effective manufacturing is not really the primary challenge for cell and gene therapies, although costs can always be improved,” Clive Glover, director of strategy, cell and gene therapy, Pall Biotech. “What is more important is ensuring that the manufacturing process is robust and delivers a consistent product. We have seen manufacturing challenges associated with several late-stage and commercialized cell and gene therapies, which in some cases have delayed or halted their approval.”

	“On the manufacturing side, cost effectiveness will be driven by increased automation, dependence on high-dynamic range cell production, and closing systems to avoid overheads of classified environments,” says Phil Vanek, general manager, cell and gene therapy strategy, GE Healthcare Life Sciences. “For logistics, better integrated operational and supply chain data management, purpose-built manufacturing execution systems, and reducing dependence on liquid nitrogen in storage and shipping will help alleviate risk and costs.”

	Faster conventional biotherapy processing

	While cell and gene therapies have generated excitement, conventional biotherapeutics represent the majority of the biologics market. A few trends, however, are changing the processing strategies of some manufacturers of these products.

	“There is still a lot of growth around the globe in conventional biotherapies. Cost improvements are driving the need for efficiencies in smaller scale as well as manufacture in country for country,” says Michelle Stafford, global marketing leader, BioProcess Solutions, GE Healthcare Life Sciences.

	Interest in emerging therapies has been sparked by their clinical performance, says Pereira Chilima. “However, I believe that there is, and will always be, sizable investments and capacity allocation for the manufacturing of traditional/conventional biotherapeutics as these are and will continue to be standard of care for a multitude of indications,” she says. “For companies trying to diversify their product portfolio and produce both conventional and emerging biotherapeutics, investing in flexible and modular manufacturing technologies will help them cater for different product classes and efficiently respond to market fluctuations.”

	Bulpin notes that more niche therapies coming to market require smaller quantities of individual biotherapeutics. “This evolution will drive continued adoption of single-use, which will enable multi-drug manufacturing facilities,” he says. “In turn, the big thrust in manufacturing will be moving towards intensified, connected, and continuous bioprocessing, as well as Biopharma 4.0.”

	To resolve a huge shortage of viral-vector manufacturing space, specialized viral-vector contract manufacturers are rapidly building more capacity, and therapy developers are investing in their own manufacturing capabilities, say Glover. “These investments in the viral-vector manufacturing space have not shown impact [on] the investment in conventional therapeutics. In fact, several new sites are still under commission or being introduced for more conventional biologics at companies like Lonza and Servier,” he says.

	The clinical development of promising new cell and gene therapies is driving demand for capacity, says Vanek. “Capacity shortages for both [adeno-associated virus] AAV and lentivirus are being driven by the need for [current good manufacturing practice] cGMP plasmids for vector manufacturing, plus dramatic inefficiency in manufacturing yields of viral particles. As new facilities come online for cGMP-grade vector manufacturing and new manufacturing methods are developed for improving both upstream productivity and downstream recovery, these shortages will be eased,” he says.

	“There is plenty of capacity for traditional biologics manufacturing. The demand and rapid growth of novel modalities has left capacity lagging,” says Bulpin. “The standardized manufacturing templates I mentioned will bring predictable yields to inform a capacity plan. Having standardized outcomes are a key element to better capacity planning.”

	Pereira Chilima cites a combination of technology innovation and process optimization as the key to addressing capacity constraints. “Process optimization in scalable advanced technologies will enable manufacturers to exponentially increase their throughputs within the same physical perimeter,” she says.

	René Gantier, director, process R&D, Pall Biotech concurs. “This is what is driving a lot of investment and interest in the industry now by looking at ways to create a smaller footprint with an increased output to optimize efficiency, time, and money in the process,” he says. “We also see multi-product facilities enabled by single-use technologies that have flexible manufacturing approaches (e.g., manufacturing modules, ballroom manufacturing concept in controlled, not classified space).”

	“To respond to market needs for capacity, speed to manufacturing, modular platforms, and workforce training are at the forefront of any business strategy,” says Stafford. “Speed to manufacturing can include in-sourcing/outsourcing analysis, which will take into account the long-term business plan, [intellectual property] IP protection, capital expenditures, time to market, and the technical capabilities of manufacturing or [contract development and manufacturing organization] CDMO personnel. The result of this analysis will determine if capacity is outsourced to a CDMO or organic expansion and training is warranted.”

	“For mammalian manufacturing, there have been significant expansions in CMO/CDMO capacity over the last year with many companies announcing new facilities,” explains Charles Christy, head of commercial solutions, Ibex Dedicate, Lonza Pharma & Biotech. “Single-use technology is facilitating rapid addition of capacity and process intensification is also playing a role in optimizing existing assets.”

	The integration of both proven and new technologies-including continuous processing, automation, virtual reality (VR), and data management-are vital to meeting and advancing bioprocess capacity demands.

	Automating bioprocesses is a crucial factor to realizing the benefits seen for other industries such as reduced time to market and time to process, process and product safety through reduced operator errors, improved consistency and reproducibility, says Gantier. “The systematic use of quality-by-design [QbD] principles, where all process variables are characterized in detail, enables building accurate and reliable process models. Also, advancing sensing technologies and analytics from monitoring to predictive, then prescriptive and finally cognitive helps to enable highly automated bioprocesses.”

	“Data availability and mine-ability will provide us with better insights for process optimization and manufacturing efficiency improvements,” says Vanek. “While still early, the data we’re collecting as an industry can be curated to connect events with outcomes, and this, in turn, can lead to new insights and ultimately predictability of processes. Connecting sensors, biological data, and manufacturing performance in real-time will also enable improved automation and better decision making.”

	“Big data and artificial intelligence will move us to descriptive vs. prescriptive methods of manufacturing control,” Bulpin notes. “A descriptive method moves away from a traditional biologic manufacturing standard operating procedure and tunes into the needs of the living organisms used to produce a biologic. Big data will develop the ‘golden batch,’ delivering consistent and optimized outputs in each run.”

	“Although ‘Industry 4.0’ is not a totally new concept, it has taken more time to integrate new technologies into the complex and risk-averse bioprocessing world,” notes Christy. “There are many areas where advances in digital technology can and are making a difference, ranging from onboarding new operators with VR, reducing time for tech transfers and product release using more advanced data analytics, and modeling bioprocesses to optimize QbD.”

	What’s next for manufacturing processes?

	Pereira Chilima predicts that the industry will continue to focus on achieving higher production titers and move towards intensified, automated, and continuous processes to produce ‘more for less.’ This approach will enable manufacturers to dramatically reduce the footprint of operations, achieve higher productivities per production line, and install more production lines within the same footprint. “This will result in higher annual throughputs, lower CAPEX, and consequently lower cost of goods sold (COGS),” she says.

	“Although process intensification and continuous manufacturing have been a discussion point for years, joining the different elements together or focusing on hybrid processes will move us one step closer to fully joined up solutions,” predicts Christy. “Real-time release is already a reality in small-molecule manufacturing and something that will considerably speed up biologics manufacturing.”

	“The application of continuous manufacturing to monoclonal antibody production has been well studied. However, its ability to impact novel therapies such as viral vectors has not been well characterized,” says Gantier. “There are, of course, complications to applying continuous manufacturing to viral vectors, not least of which is the fact that the virus kills the cell that produces it. Nevertheless, there is the possibility for continuous manufacturing to drive unit operation intensification bringing greater process robustness and reproducibility.”

	For cell and gene therapies, Vanek expects a better understanding of biological systems and how they are impacted during manufacturing, improved process analytics to monitor that biology, and digital integration to collect data and make process decisions based on real-time biological information.

	Industrializing cell and gene therapies will continue, moving along the same commercialization and optimization curve as recombinant proteins and monoclonal antibodies, says Christy, “but hopefully faster given that the industry can apply some of the experience learned in fermentation and cell culture.”

	“We also expect a resurgence in microbial manufacturing as some of the newer complex proteins in early phase not requiring mammalian glycosylation or the linker elements for some bioconjugates become more important. Improvements to expression systems, titers, and process intensification can further reduce COGS and production times considerably in this platform, providing distinct advantages for classes of molecules such as novel vaccines, protein-linker bioconjugates, and even biosimilars,” Christy concludes.

Quarterly Regenerative Medicine Sector Report

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.


2020 Outlook for Biopharma Manufacturing

	Researchers continue to report exciting new discoveries in science and medicine that have the potential to improve life and address challenges facing society. The intersection of scientific opportunity and business profitability can, however, lead to ethical conflicts.

	Emerging scientific methods such as Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) genome editing technology, which can be used to modify genes in living cells and organisms, offer the promise of correcting genetic mutations to treat genetic causes of disease. Researchers and ethicists generally agree that gene editing methods are suitable for research applications, but not for reproductive purposes.

	Concerns about the misuse of gene-editing processes were realized when a scientist in China announced in November 2018 that he used CRISPR techniques to edit the genes in human embryos of twin girls with the intention of protecting them against the human immunodeficiency virus. This controversial work was denounced by scientists worldwide; in December 2019, a court in China sentenced the scientist to three years in prison for working outside the boundaries of scientific and medical ethics.

	This experiment illustrates the ethical, safety, and legal issues associated with promising new scientific discoveries, and many unanswered questions associated with their long-term use. FDA has pursued enforcement action against dozens of unapproved therapies and treatments based on emerging sciences. In announcing a permanent injunction against a Florida-based facility for selling adulterated and misbranded cellular products, FDA noted there are many offenders selling unproved stem-cell products, and “These actors are taking advantage of patients, many in vulnerable positions with chronic or terminal diseases, by leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations “(1).

	Beyond rooting out fraudulent efforts, FDA and industry experts also recognize the challenges with developing emerging therapies. FDA noted that while stem cell products have potential to improve human health, “… that potential will never be fully realized if careful scientific work and thoughtful clinical investigation supporting the safety and efficacy of these products are not conducted.”

	More than 1000 gene- and cell-therapy and other regenerative products are currently in the US clinical trial pipeline, illustrating the need for innovative development, manufacturing, and supply chain procedures and practices to deliver these therapies to patients. In an article in BioPharm International, experts from bioprocessing equipment manufacturers and contract development and manufacturing organizations emphasized that standardized commercial manufacturing platforms and processes are needed to ensure that these therapies can be delivered in a safe, cost-effective manner (2).

	Emerging therapies are expected to contribute to the growth in global sales of prescription drugs from an estimated $839 billion in 2019 to $1.18 trillion in 2024, a compound annual growth rate of 6.9%, according to Evaluate Pharma. For the top 100 products by sales, Evaluate Pharma analysts expect biotech product sales to overtake conventional product sales for the first time. In addition, biotech products are forecast to represent 32% of prescription drug sales by 2024, up from 28% in 2018 (3).

	Expensive, emerging therapies are becoming a larger share of the prescription drug market; however, solutions to the affordability question continue to trail rapid advances in science, threatening the success of these products. “The advances in cutting edge science are, for now, outpacing the traditional pricing and reimbursement systems the industry has been built on,” Evaluate Pharma reported. “This disconnect is leaving both patients and payers wondering how accessible these life-altering products will be.”

Statement on Stem Cell Clinic Permanent Injunction and FDA’s Ongoing Efforts to Protect Patients from Risks Of Unapproved Products

	When referring to this article, please cite it as R. Peters, “Can Policy Keep Pace with Science and Discoveries?"

The promise of new therapies is tempered by the need for affordability, safety, and ethics.

Can Policy Keep Pace with Science and Discoveries?

An employee’s view of the job market is often colored by recent work experiences-whether positive or negative-and their most recent salary increase. Professionals working in biopharma drug development and manufacturing are concerned about the size of their paychecks, but other factors-including challenging work, job security, and company stability-may be more important when making career change decisions.

	Insight provided by bio/pharma professionals from around the world responding to 

’s annual employment survey (1) indicates strong confidence in the biopharma industry (66% expect business improvement in 2020) and some confidence in prospects for their employer (52% expect business improvement in 2020). More than half of the respondents, however, expressed interest in seeking better opportunities beyond their current position. (See the infographics  for an overview of survey results.)

	Job insecurity, company restructuring, a lack of training, an unsatisfactory work/life balance, and uncertainty about the company’s performance or success were the top reasons for job dissatisfaction.

	Similar to previous surveys (2–3), more than half of all respondents said they would like to leave their jobs, given the opportunity; however, 58% said they do not expect to leave in the coming year. A significant segment, 19%, said they would like to change careers and leave the bio/pharma industry.

Survey results indicate bio/pharma professionals are on the move. More than 44% of 2019 respondents-compared with one-third in 2018-said they stayed with the same employer, on average, for five or fewer years. Respondents working in large-molecule drug development and manufacturing stayed with the same employer longer than those in the small-molecule market segment.

	More than one-quarter of the respondents said they voluntarily changed jobs in the past two years. The reasons cited-with multiple choices allowed-were to pursue a better career opportunity (72.7%), find more challenging work (40%), or to seek a better work-life balance (32.7%). Those working in the biologic drug segment valued company stability more than their counterparts in the small-molecule segment, who said job security was more important.

	Salary was the fifth most-cited single reason for job change, trailing work/life balance, professional advancement, intellectual challenge, and job security. Nearly two-thirds of the respondents were confident they could find a job similar to their current position, should they choose-or were forced-to find new employment.
	In the past two years, nearly one-quarter of the respondents said their company experienced a merger or acquisition, up from 18.1% in the previous survey; an additional one-quarter of the respondents reported that their companies had been through a downsizing or restructuring. Nearly 20% of the respondents said they left the company due to such an acquisition, downsizing, or restructuring.

	Respondents suggest there is a positive market for job seekers; 36.8% of respondents said there are few qualified candidates for open scientific/technical positions (almost 40% for biologics positions), compared with 30.3% in 2018. A smaller percentage (28% in 2019 vs. 34.2% in 2018) said there were more qualified candidates than open positions. As in previous surveys, respondents expressed somewhat negative opinions about the knowledge and skill sets of new hires; 73% said the new hires were adequately trained but not exceptional; 18% said they were poorly trained.

Salary ranked sixth on a list of 12 factors contributing to job satisfaction, up from ninth place in 2018. Compensation trailed factors such as challenging projects, intellectual stimulation, company’s potential for success, a good work/life balance, and supportive management as the “main reason I come to work.”

	Satisfaction with compensation has trended downward during the past few years. More than 39% said they were paid fairly or excessively in 2019, compared with 41% in 2018 and 46% in 2017. In 2019, more than 40% of those surveyed said their pay was at the low end of the salary range for their expertise and responsibility; 17.6% said they were paid below market value.

	The number of people reporting salary increases was stagnant from 2018 (54.1%) to 2019 (55.4%), following a drop from nearly 63% in 2017. The number of people reporting a decrease in salary ticked up from nearly 9% in 2018 to 11.4% in 2019.

	More than one-quarter of respondents said they used their full allotment of vacation, personal, and sick time while 37% said they used less than half of the available time off.

	More than 220 bio/pharma professionals from around the world responded to the survey, which was fielded in November and December 2019. Respondents primarily were from innovator bio/pharmaceutical companies (31.3%), generic-drug manufacturing companies (13.3%), and contract research and manufacturing or consulting organizations (17.6%).

	The respondents were involved in developing or manufacturing a range of drug types-with some listing multiple types-including small-molecule drugs (58.9%), large-molecule drugs (45.1%), vaccines (19.8%), cell therapies (17.8%), gene therapies (17.8%), and nutraceuticals (17.3%).

	Respondents work at small and large companies and are responsible for R&D, process development, technology transfer, validation, quality control/assurance, formulation, manufacturing, and other functions. Nearly 40% of the respondents held a doctorate or higher degree; more than one-third held at least a Master’s degree.

	Compared with previous years, the respondents had slightly less experience working in the bio/pharma industry; 26.9% had fewer than 10 years of experience, 25.6% had 10–20 years, 36.9% had 20–35 years of experience, and 12.1% have worked in the industry for more than 35 years.

	Respondents working in the small-molecule drug arena worked more hours compared with peers in the biologic-drug segment. More than 37% reported working more hours than the previous two years, compared with 30.7% for the biologics workers.

Pharmaceutical Technology/BioPharm International Employment Survey

, December 2019.
	2. Pharmaceutical Technology, 2018 

harmaceutical Technology/ Pharmaceutical Technology Europe Employment Survey

, December 2018.  
	3. BioPharm International, 2018 


	â¨Vol. 44, No. 1
	â¨January 2020â¨
	Pages: 24–27, 66

	When referring to this article, please cite it as R. Peters, “Choices for Climbing the Career Ladder," Pharmaceutical Technology 44 (1) 2020.

With a positive employment market, some bio/pharma professionals explore options for career advancement.

Choices for Climbing the Career Ladder

While the number of warning letters issued by FDA has declined slightly, recurrent violations include poorly maintained equipment and facilities, insufficient cleaning validation, inadequate written procedures for quality testing, and inadequate controls over data and computer systems. Effective, ongoing monitoring programs-for regulatory agency enforcement actions and pharmacopoeia updates-are essential for bio/pharma compliance.

Pharmaceutical Technology’s December 2019 Regulatory Sourcebook

eBook: Regulatory Sourcebook, December 2019
	December 2019
	Pages: 4–5

	When referring to this article, please cite it as R. Peters, “Warning Letters Signal Steps to Compliance," 

Pharmaceutical Technology Regulatory Sourcebook eBook

Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.

Warning Letters Signal Steps to Compliance

	Health organizations, medical professionals, caregivers, and patients mark World AIDs Day-Dec. 1, 2019-to increase awareness of this decades-long public health concern. While current statistics demonstrate that progress has been made in the diagnosis, prevention, and treatment of human immunodeficiency virus (HIV)-related illnesses, the toll the virus has taken on the world population-an estimated 32 million deaths-is still profound.

	The World Health Organization (WHO) estimates that, at the end of 2018, 37.8 million people globally were living with HIV. Of those infected, 79% had been diagnosed, 62% received treatment, and 53% had achieved suppression of the HIV virus (1). The research and development efforts of the bio/pharmaceutical scientists were instrumental in this progress in combatting the virus.

	The first AIDS cases were diagnosed in the United States in 1981. In 1987, FDA approved the first therapy against the disease, azidothymidine, a nucleoside reverse transcriptase inhibitor (NRTI) originally developed to treat cancer. Drug-resistant variations of the virus necessitated the development of other antiretroviral drug classes including fixed-dose combination drugs. In 2018, the first biologic treatment, ibalizumab, was approved (2). Currently, FDA lists 131 approved drugs for HIV/AIDS and related infections (3).

	Research continues today on antiretrovirals to treat HIV, prophylaxis drugs for HIV-negative people at risk for HIV, and vaccines to prevent HIV or provide a cure for those living with HIV. FDA lists 34 investigational drugs for HIV/AIDS and related infections (3).

	While diagnostic tools and therapies have helped make HIV a chronic condition, not a death sentence, for many infected patients, there are gaps in treatments across populations. In a statement to mark World AIDs Day, the National Institutes of Health (NIH) reported that approximately 38,000 people in the US were diagnosed with HIV in 2018; and while the rate of HIV incidence has declined significantly from a peak in the 1990s, progress on further reducing that rate has stalled (4).

	Ending the HIV Epidemic: A Plan for America is a Department of Health and Human Services initiative to reduce the incidence of HIV domestically by 75% in five years, and by 90% by 2030. Under this initiative, NIH plans to fund HIV prevention, diagnosis, treatment, and care efforts and will expand partnerships with agencies, community organizations, health departments, and other organizations to determine the best implementation of research advances.

	In particular, NIH noted that these efforts will “ensure that hardly reached communities-including the transgender, black, gay, injection drug, and sex worker communities-benefit from these strategies.” Other challenges faced by those vulnerable to HIV-“housing and food insecurity; lack of healthcare access; and pervasive stigma, discrimination, and criminalization” must also be addressed, NIH reported (4).

	On a global scale, WHO reports that in 2018, 62% of adults and 54% of children living with HIV in low- and middle-income countries were receiving lifelong antiretroviral therapy; however, there were 1.7 million new infections in 2018 and 770,000 people died from HIV-related causes (1).

	Of note, NIH and the Bill & Melinda Gates Foundation recently announced investments of $100 million over four years to develop affordable, gene-based cures for sickle cell disease and HIV (5), an example of the ongoing efforts to help those afflicted-and eradicate additional infections-that deserves year-round attention.

Antiretroviral Drug Discovery and Development

,” Press Release, Nov 25, 2019.
	5. NIH, “

NIH Launches New Collaboration to Develop Gene-Based Cures for Sickle Cell Disease and HIV on Global Scale

	When referring to this article, please cite it as R. Peters, “Fighting the Good Fight," 

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.