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

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Closing the Gap in Modern Process Control and Automation for QC/QA

Drug Digest December 2025

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Cheryl Barton is director of PharmaVision, 

On 5 May 2023, the World Health Organization (WHO) declared that COVID-19 was no longer a public health emergency following a decrease in COVID-19 deaths, hospitalizations, and intensive care unit admissions across the globe over the past several months (1). On 6 July 2023, the European Medicines Agency (EMA), the European Commission (EC), and the Heads of Medicine Agencies (HMA) announced they would be phasing out the extraordinary COVID-19 regulatory flexibilities introduced in August 2022 in response to the pandemic (2).

Extraordinary regulatory flexibilities introduced during COVID-19

The extraordinary regulation encompassed several different aspects to ensure the continuity of supplies of medicines during the public health emergency. These included greater flexibility for:

good manufacturing practice (GMP) and good distribution practice (GDP) issues

issues related to marketing authorization (MA) and MA procedures

manufacturing and importation of finished products and APIs (3).

EMA’s quick response to the crisis highlighted the need for rapid and coordinated feedback to developers and the importance of continued dialogue with them, to ensure that adaptions to the regulatory environment were workable for the industry (4).

From this point onwards, the regulatory flexibilities that were introduced jointly by the EC, EMA, and HMA during COVID-19 will no longer be granted (3). For products that have already received approved labelling flexibilities, such as COVID-19 vaccines with English-only labelling, the application will be extended until the end of 2023 to prevent any disruptions to supplies; after which time, manufacturers will revert to the original legislations on product labelling (3).

Conversely, on-site GMP and GDP inspections have been reinitiated following their postponement or implementation of remote visits performed during the pandemic (3). GMP and GDP certificates have been extended until the end of 2023, and the GMDP inspectors working group will provide further details over the coming months following a review of information gleaned from remote working of qualified persons during the pandemic (5).

Future regulation, preparedness, and response tools

The COVID-19 pandemic highlighted the importance of deploying a coordinated EU-wide strategy and revealed some vulnerabilities in the current system, including limitations in the regulations, preparedness, and response tools (6). In November 2020, the EC proposed a series of measures, including a revised regulation on serious cross‑border threats to health and proposals to extend the mandates of EMA and the European Centre for Diseases Prevention and Control (ECDC) in public health emergencies, to create a European Health Emergency Preparedness and Response Authority (HERA) (7). In February 2021, the EC also announced that it may consider targeted amendments to the pharmaceutical legislation including developing new regulatory tools to introduce an emergency authorization of vaccines at the EU level with shared liability among member states, during public health threats (6).

On 26 April 2023, EMA published two legislative proposals—a new regulation 2023/0131 and a new directive 2023/0132—to replace the current European Union (EU) regulatory framework for all medicines (8,9). As part of the overhaul, EMA plans to introduce some contingency planning procedures including the compilation of an EU-wide list of critical medicines and recommendations to companies to strengthen the supply chains should the need arise. Under the new proposal, all MA holders will need to put in place a shortage prevention plan for each medicine on the market, any critical shortages would need to be reported to EMA. In addition, the new regulation provides temporary measures such as emergency MA for crisis‑related medicines allowing the EU to take control of drug manufacturing in response to an emergency, this controversial point has raised concerns amongst some pharma industry leaders (10).

The new regulatory framework is currently being reviewed by the European Parliament and the European Council and a decision on the proposed reform is unlikely to take place before the 2024 EU parliamentary elections. In the meantime, data are being gathered by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products regarding manufacturers’ experience of the COVID-19 regulatory flexibilities (11). EMA will then reflect on how lessons learned during the pandemic can inform best practices for confronting medicine shortages in the presence of new and emerging health challenges in the future (2).

Statement on the Fifteenth Meeting of the IHR (2005) Emergency Committee on the COVID-19 Pandemic

Phasing out of Extraordinary COVID-19 Regulatory Flexibilities

Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic

, 11 Aug. 2022.
4. Cavaleri, M.; Sweeney, F.; Gonzalez-Quevedo, R.; Carr, M. Shaping EU Medicines Regulation in the Post-COVID-19 Era. 

, 9, 100192.
5. Taylor, N.P. Euro Roundup: EMA Starts Phasing Out Regulatory Flexibilities Provided During the COVID-19 Pandemic. 

, RAPS, 13 July 2023.
6. Beaussier, A.; Cabane, L. Strengthening the EU’s Response Capacity to Health Emergencies: Insights from EU Crisis Management Mechanisms. 

HERA Incubator: Anticipating Together the Threat of COVID-19 Variants

Reform of the EU Pharmaceutical Legislation

Proposal For a Regulation of the European Parliament and of the Council Laying Down Union Procedures for the Authorization and Supervision of Medicinal Products for Human Use And Establishing Rules Governing The European Medicines Agency, Amending Regulat

. Regulation, 26 April 2023.
10. Barton, C. 

EMA Overhauls the Medicine Legislative and Regulatory Framework

Executive Steering Group on Shortages and Safety of Medicinal Products

Cheryl Barton is director at PharmaVision, Pharmavision.co.uk.

When referring to this article, please cite it as Barton, C. Phasing Out COVID-19 Regulatory Flexibilities. 

Articles

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Phasing Out COVID-19 Regulatory Flexibilities

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

US Capital Building. | Image Credit: © W.Scott McGill - © W.Scott McGill - stock.adobe.com

As the federal government began to roll out the rules and procedures for negotiating prices of drugs reimbursed by Medicare Part D plans, biopharma companies launched an attack on the legality of the controversial program. Merck took the lead in filing a detailed lawsuit on June 6, 2023 in the Washington, D.C. federal district court, claiming that the negotiation process established by the Inflation Reduction Act (IRA) violates the constitutional rights of manufacturers (1).

Merck and Bristol Myers Squibb (BMS), which filed a similar lawsuit a few days later in New Jersey, charged that the Medicare price setting program would involve a “taking” of private property for public use without just compensation, in violation of the Fifth Amendment to the US Constitution (2). In addition, these companies claimed that the IRA also is unconstitutional under the First Amendment right to free speech because the process would coerce a manufacturer to sign an agreement it opposes: any company that wants to walk away from a price negotiation deal it doesn’t agree with would have to pay an onerous fine for doing so and thus is denied free speech. Both manufacturers have much to lose under the new pricing program, as lead targets for the scheme include Merck’s Januvia and Keytruda and BMS’ Eliquis and Opdivo, which would undermine company efforts to test and reformulate these therapies for new life-saving and profitable uses.

Similar to the Merck and BMS suits and to subsequent filings by Johnson & Johnson and Astellas Pharma, the US Chamber of Commerce filed a complaint in Ohio also charging that the price negotiation program violates the manufacturers’ constitutional rights. It additionally claims that Congress lacks the power to levy the specified excise tax for noncompliance because that would “compel” commerce (3).

Next up, on June 21, 2023, the Pharmaceutical Research and Manufacturers of America (PhRMA) joined a lawsuit filed by National Infusion Center Association (NICA) and the Global Colon Cancer Association (GCCA) challenging the constitutionality of the price negotiation provisions in the IRA (4). The plaintiffs take issue with the IRA’s excise tax—the provision that sets an 18% fine or more on a drug’s annual revenues for refusing to comply with the negotiated rate. Such a penalty, they claim, is an “excessive fine” and violates the constitution because there is no provision for judicial review of the many decisions involved in determining negotiated prices under the program. The plaintiffs also argue that the new law breaches due process by denying public input on the how the program will be implemented.

Beyond the specific legal issues raised in these lawsuits, which ultimately may end up before the Supreme Court, biopharma companies continue to claim that the administration’s price negotiation scheme will discourage investment in more risky research and development programs for new cures, particularly for rare diseases. Although the program exempts orphan drugs from negotiations, manufacturers note that this applies only to the first approved indication, and not to additional uses of the therapy. That provision is expected to undermine manufacturers’ plans to test additional uses for therapies hit by negotiated prices, cutting off industry’s main strategy for discovering and developing new treatments for cancer and rare diseases.

The Centers for Medicare and Medicaid Services (CMS) meanwhile is working to implement the drug price negotiation program, as mapped out in a final guidance published June 30, 2023 (5). That document made some changes from its initial memorandum issued on March 15, 2023, responding partially to the industry lawsuits challenging CMS’ planned process for reaching agreement on negotiated prices by 2026 (6).

The documents outline what information CMS will require from manufacturers in order to select the first 10 drugs for negotiations by Sept. 1, 2023. The agency then will propose “maximum fair prices” in February 2024 and final prices by August 2024, which would become effective Jan. 1, 2026.The June advisory allows for more public discussion of the negotiation process and provides leeway for manufacturers to disclose proposed prices if they choose to do so.

The bottom line will be whether Medicare price negotiations actually reduce program outlays for drugs, as promised by the Biden administration alongside critics of high drug prices. Congressional approval of the program represented an unprecedented defeat for the pharmaceutical industry’s long-time efforts to block government price control initiatives. Pharma companies claim that they have long tried to facilitate patient access to needed medicines, but through individual discounts and other strategies that maintain market share. Industry also points to health insurers and pharmacy benefit managers for thwarting these efforts and limiting opportunities to reduce patient outlays for medicines. The legal challenges are only just beginning, and much can happen in Washington between now and 2026.

Wilson, M. R. Merck Sues HHS Over Drug Negotiation, Claims Program ‘tantamount to extortion’. 

BMS. Impact of the Inflation Reduction Act on Innovative Medicines for Patients. 

Stempel, J. US Chamber of Commerce Sues Over Government’s Drug Pricing Power. Reuters.com. June 9, 2023.

PhRMA, NICA, GCCA, PhRMA Litigation Asserts Price Setting
Provisions in the Inflation Reduction Act are Unconstitutional. Press
Release. June 21, 2023.

Medicare Drug Price Negotiation Program: Revised Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026

edicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026, and Solicitation of Comments

Jill Wechsler is Washington reporter for 

When referring to this article, please cite it as Wechsler, J. Industry Challenges Medicare Price Negotiation Scheme. 

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

Industry Challenges Medicare Price Negotiation Scheme

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

The term microbiome may have first been used in an agriculture paper (1), but widespread traction was sparse until Francis Collins (then head of the National Human Genome Research Institute) talking through upcoming funding limits for simply sequencing yet another organism, with Broad Institute head, Eric Lander, had a true eureka moment, to seize upon sequencing the human microbiome—skin, gut, hair, and so forth, for multiple funding projects going forward. Suddenly all things microbiome became in vogue. However, as recently as February 2020, scientific papers were still proposing vague notions that, “The mechanisms by which microbiomes impact on cancers can yield new diagnostics and treatments, but much remains unknown” (2). What had seemed administrative legerdemain at that time of Collins eureka moment is, in 2023, absolutely a therapeutic window to drill down on. The tumor microenvironment as therapeutic approach has come of age, and the tool of the hour is messenger RNA (mRNA).

Acknowledging that bacteria and fungi form complex colonies with solid tumors, an approach to unravel this microbiome community was developed with mRNA molecules encoded to produce a toxin lethal to cohabitating bacteria. In this experiment, pseudomonas exotoxin A domain III was packaged into lipid nanoparticles and injected into the tumor bed. “We hypothesized that encoding the active domain only, without the binding and translocation domains of the original toxin, will allow potent intracellular effect upon mRNA translation, while reducing the risk of side-off effects in case of toxin release from target cells,” related professor Dan Peer, co-lead author of the study (3). Unlike chemotherapy where resistance gathers pace during extended exposure, this approach is easily amenable to simply switching to a different natural toxin. The study goes on to describe that most of the lipid nanoparticles reached cancer cells, destroying 44–60% of them.

While the history of drug discovery science is replete with false dawns, it is encouraging to see mRNA make an alliance with deeper understanding of the mechanics of the tumor microbiome. mRNA may be a modality whose chief advances are yet to come.

2. Xavier, J.; Young, V.; Skufca, J., et al. The Cancer Microbiome: Distinguishing Direct and Indirect Effects Requires a Systemic View. 

March 6(3), doi: 10.1016/j.trecan.2020.01.004.

3. Granot-Matok, Y.; Ezra, A.; Peer, D.; et al. Lipid Nanoparticles-loaded with Toxin mRNA Represents a New Strategy for the Treatment of Solid Tumors. 

When referring to this article, please cite it as Spivey, C. New Magic from mRNA. 

mRNA may be a modality whose chief advances are yet to come.

New Magic from mRNA

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Question mark background | Image Credit: © Leigh-Prather - © Leigh Prather - stock.adobe.com

Q: I work for a virtual company that outsources our manufacturing. We recently made a regulatory filing, and I wonder what information we need to share with our contract manufacturing organization (CMO)?

A: This is an easy question. Share everything you can. Whether you filed an investigational new drug application, a new drug application, an abbreviated new drug application, a biologics license application, or a marketing authorization application, the more information you share with your contract provider(s) the smoother the approval process will be for your organization. Because you are a virtual company, your approval inspections will most likely be at your designated manufacturing facility. If you are using a different facility to test your product, the contract testing laboratory also needs to have critical information to provide the best service because they might also be audited. So, in my opinion, the contract provider(s) need to know as much as the applicant.

In today’s regulatory environment, it is important for organizations to know the regulations with the same depth of knowledge and understanding as regulators. If an organization happens to be a contract manufacturer, it might also find itself in the position of providing that in-depth regulatory expertise to customers. In either case, the contract manufacturer and its customers must be able to work with each other and within the regulatory requirements to assure that the product manufactured and released for patients is of the highest quality. The partnership between the contract provider and contract giver must reflect the requirements and time commitments as defined in the regulations. The most efficient way to establish a transparent relationship where you have the freedom to share the necessary information is to establish a robust quality agreement with your contract provider(s). If you are using a contract manufacturing organization and a different contract testing organization, it is important for you to have quality agreements with both organizations. It is ideal if you can encourage your two contract providers to enter in a quality agreement with respect to your product filing.

Because you are using contract providers, complaints are an area where the more information that is shared between all parties, the sooner a resolution to the complaint investigation can be achieved. Another area where it is necessary for all parties to have access to critical information contained in your filing is investigations for out-of-specification (OOS) results. Whether you are using multiple contract organizations or just one, those organizations should have the information needed to perform a thorough investigation into complaints or the OOSs. The complaint standard operating procedure (SOP) and the quality agreements should address the turnaround requirements needed to investigate complaints associated with adverse or serious unexpected adverse events. For these complaints, the turnaround time must be able to accommodate tighter regulatory requirements. The license holder (i.e., the client) is required to submit a Field Alert within three working days after becoming aware of a reported problem either through a complaint or internal testing. In these cases, the complaint must be investigated quickly by the contract manufacturer and/or the contract test laboratory. The turnaround time for these types of investigations must be more expeditious than the timelines for handling routine investigations. OOS reports also require an expedited timeline for communicating confirmed results to the client because of the potential impact to product already distributed for use. When there are agreements in place that allow the sharing of information that can potentially be used for resolving investigation and ensuring they are completed in a timely manner, the stronger your compliance posture will be when it comes time for your pre-approval inspection.

In today’s environment, all parties must take responsibility for product quality and regulatory compliance through clear delineation and communication of responsibilities through quality agreements and internal SOPs.

Susan J. Schniepp is distinguished fellow with Regulatory Compliance Associates.

When referring to this article, please cite it as Schniepp, S.J. Sharing Critical Information for the Best Outcome. 

The more information shared, the smoother the approval process, says 
Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates. 

Sharing Critical Information for the Best Outcome

Mike Hennessy Jr. is the Chairman and CEO of 

In June 2021, the Biden–Harris administration announced a task force to address “short term supply chain discontinuities” (1). This included strengthening Executive Order 13944, a list of essential medicines, medical countermeasures, and critical inputs (2). A report published in May 2022 highlights fundamental pillars one would expect (3).

A proposed bill by US Senator Gary Peters (MI), Chairman of the Homeland Security and Governmental Affairs Committee, building off several reports he released in the past few years, proposes to assess national security vulnerabilities in the pharmaceutical supply chain by the Mapping America’s Pharmaceutical Supply (MAPS) Act. This database will include key information about critical drugs such as the country of origin and quantity so supply chain weaknesses can be identified (4). While this might seem duplicative of other database systems such as North American Industry Classification System codes, it can be seen as part of a macro trend for government, to take further action in an already highly regulated industry. The Inflation Reduction Act (IRA) and the National Biotechnology and Biomanufacturing Initiative are cut from the same cloth.

Rumors have swirled about an under-the-radar White House initiative to gather pharmaceutical supply feedback to present potentially radical options. On this initiative, but specifically commenting on generics, Elisabeth Reynolds, a Massachusetts Institute of Technology lecturer and former special assistant to Biden for manufacturing and economic development at the National Economic Council, said, “There’s a lot of resistance in the industry to more transparency or anything that requires more cost in this low-margin business. We have to find ways to provide incentives to invest in quality, or put in place requirements to make them responsible for quality” (5).

Tom Kraus, VP government relations for the American society of health-system pharmacists, strongly supports MAPS, saying, “By requiring HHS to coordinate with other agencies and the private sector to map the pharmaceutical supply chain, threats to the US pharmaceutical supply chain can be identified and addressed before they place patients at risk” (5).

1. White House. FACT SHEET: Biden-Harris Administration Announces Supply Chain Disruptions Task Force to Address Short-Term Supply Chain Discontinuities. 

2. FDA. Reports, Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs. August 2020.

3. The Advanced Regenerative Manufacturing Institute (ARMI). 

Essential Medicines Supply Chain and Manufacturing Resilience Assessment

. BioFabUSA Roadmap Reports, Special Reports.

4. Senator Gary Peters Office, Peters Introduces Bipartisan Bill to Assess National Security Vulnerabilities in the Pharmaceutical Supply Chain. Press Release. July 20, 2023.

5. Griffin, R.; Edney, A.; Swetlitz, I. Secret White House Team Tackles Drug Shortages, Quality Woes. 

Mike Hennessy Jr. is the President and CEO of 

When referring to this article, please cite it as Hennessy, M. 
Supply Chain Securities. 

Mapping America’s Pharmaceutical Supply (MAPS) Act aims to establish a database including key information about critical drugs so supply chain weaknesses can be identified.

Supply Chain Securities

Customized for shear-sensitive applications with low to medium viscosity, the ROSS Model CDA-200 features a two-wing anchor agitator and two medium-speed agitators, each fit with five rows of three-blade pitched turbines. The mixer was supplied with two portable stainless-steel mixing vessels and transport covers for semi-continuous operation, a four-gallon charging hopper for introducing ingredients to the batch, and a thermoprobe for accurate temperature readings.

All three agitators are driven independently by explosion-proof inverter-duty motors. The two-wing anchor includes Teflon scrapers that contact the jacketed sidewall and bottom surfaces. Double FlexiLip seals and silicone O-rings enable vacuum operation up to 29.5 Hg for creating air-free pastes, slurries, gels, and suspensions.

Designed for heavy-duty use, the ROSS line of Multi Shaft Mixers standardizes on precision bearings with large bearing spans that reduce agitator shaft deflection and vibration, contributing to the quality and longevity of these machines. With no bearings and seals in the product zone, ROSS Multi-Shaft Mixers are designed to offer better protection against contamination compared to other designs with bottom-entering agitators

The ROSS Model CDA-200 is fitted with multiple agitators for semi-continuous operation. 

ROSS Multi-Agitator Low-to-Medium Viscosity Mixer

Sphere Fluidics’ Cyto-Mine is an automated cell line platform that integrates single cell screening, sorting, dispensing, imaging, and clone verification into one solution. Intended for use in various research areas, including antibody discovery, cell-line development, cell engineering, and synthetic biology, the device uses a unique microfluidic picodroplet technology that is designed to enable screening of up to 40 million cells over the course of several hours.

Recent software updates to the Cyto-Mine have been made to ensure compliance with current good manufacturing practice regulations. These updates include 21 

 Part 11, FDA’s regulation for electronic documentation and electronic signatures, and a full installation qualification/operation qualification package, which is intended to support quick and easy equipment qualification.

Sphere Fluidics’ Cyto-Mine is an automated cell line platform that is designed to enable screening of up to 40 million cells over the course of several hours. 

Versatile Cell Line Platform

transcription (IVT) messenger RNA (mRNA) synthesis service is designed to offer a comprehensive solution for researchers seeking high-quality, customizable mRNA synthesis with fast turnaround times. The synthesis service is intended for use in molecular biology, drug discovery, vaccine development, and gene therapy, among other fields.

The IVT mRNA synthesis service is designed to handle various applications and includes customizable mRNA synthesis capabilities to meet specific research needs. Researchers can customize mRNA transcripts in various ways, including modifying the sequence, length, and purity of the mRNA.

Eurofins Genomics Blue Heron IVT mRNA synthesis service is designed to provide researchers a customizable solution. 

Customizable mRNA Synthesis Service

Thermo Fisher Scientific’s Gibco OncePro Tumoroid Culture Medium Kit

Thermo Fisher Scientific’s Gibco OncePro Tumoroid Culture Medium Kit is a commercially available culture medium specifically developed for the expansion of patient-derived tumoroids, or cancer organoids, from multiple cancer indications.

As an off-the-shelf modular tumoroid culture medium kit, this product is designed to make it easier for cancer researchers to use patient-derived tumoroids to better model disease and predict patient response to therapeutics 

. In an effort to improve ease of use, the kit includes a scalable, automation-compatible suspension culture method.

In addition to the kit, Thermo Fisher Scientific offers Tumoroid Assay Development Services to support outsourced screening and characterization. Customers may also access seven unique OncoPro Tumoroid Cell Lines, representing four different cancer indications including colorectal, lung, endometrial, and breast.

Thermo Fisher Scientific’s Gibco OncePro Tumoroid Culture Medium Kit was specifically developed for the expansion of patient-derived tumoroids from multiple cancer indications. 

Tumoroid Culture Medium Kit

Caroline Phares is Global Head of Health and Life Sciences at Domino Data Lab.

In the biomedical and pharmaceutical industries, speed to market of safe and effective new therapies is everything—both for patients who need them and for the life sciences companies that develop them. As companies look to accelerate R&D, there has been an increasing focus on clinical development, where the availability of efficiency-enabling technology is currently outpacing workforce enablement.

Biostatistics leaders, in particular, are aiming to modernize the skillset of their current statistical programming organizations. The prevailing approach has been to get established Statistical Analysis System (SAS) programmers proficient in R and eventually in Python, two open-source programming languages that are constantly evolving due to thriving communities of active contributors who are continually expanding the languages’ toolsets.

However, having all SAS programmers proficient in R or Python may not be necessary to take advantage of all the functionality that these languages offer. Novel, flexible statistical computing environments (SCEs) can solve the unique challenges that biostatistics leaders face in enabling diverse teams to effectively collaborate and accelerate study submissions.

A rift appears in the biostatistics workforce

Although FDA has long held to the principle of language independence, SAS has until recently been the predominant statistical computing language used for study submissions. This is because both the expertise and infrastructure within the industry have long been SAS-based.

However, SAS is a closed-source language, it is not extensible, and it requires licensing. Because of the availability and extensibility of open-source alternatives, such as R and Python, the speed at which these latter two languages have evolved to meet the statistical and data science needs of the user community has far outpaced SAS in recent years.

New talent entering the field of biometrics has a clear preference for using R and Python over SAS, leaving pharmaceutical organizations with an interoperability challenge. Consequently, a schism is widening between more experienced biostatisticians, who tend to prefer SAS, and those who are entering or have just recently entered the field, who are more likely to be proficient in R or Python.

This fluency gap has placed an added burden on the emerging workforce to develop SAS proficiency in addition to business domain expertise—an expensive and time-intensive operation for both workers and their employers. It also puts stress on experienced statistical programmers, forcing them to choose between relying on the SAS expertise they have spent years developing or moving to a new language they are not comfortable with, all while remaining productive and efficient in their jobs. For biostatistics organizations, the challenge is acute as the need for statistical programmers is greater than the number of jobseekers, contributing to resource shortages and delays.

All of this is unfolding at a pivotal moment in the broader evolution of technology. Recent advances such as rapidly expanding graphic processing unit compute power, the emergence of generative artificial intelligence, and increased efficiency of solid-state data storage are poised to radically transform all aspects of R&D.

A different approach to enabling the biostatistics workforce

Biostatistics leaders understand that opportunities exist to maximize the impact of available data. However, the challenge lies in enabling statistical programming teams to collaborate on studies as effectively as possible with minimal disruption, particularly when something as fundamental as the SAS and R/Python proficiency schism is so pronounced.

Biostatistics leaders have been thinking that the first step in this process is unifying the skillsets of their teams. However, this isn’t necessarily a prerequisite to be able to take advantage of today’s available open-source technologies. Instead, biostatistics organizations can adopt readily available SCE systems that enable all team members, regardless of their programming language expertise, to collaborate on studies and individually upskill with minimal disruption. Neither group needs to focus precious time and effort solely on learning a new language that can realistically require an entire career to master.

These new SCE systems allow tremendous flexibility in how individuals can contribute to team efforts:

Good Practice (GxP) and non-GxP work can be performed on the same platform without compromising on flexibility or compliance.

Each team member can use their language and integrated development environment software of choice to analyze data and create outputs within one organized project.

Each team member has the flexibility to choose the right tool for each individual deliverable.

The platform provides automatic versioning, traceability, and reproducibility of results.

Organized batches of SAS, R, and Python jobs can be executed from one command.

Organizations can leverage data for multiple purposes without having to make copies from one system to another.

In the author’s experience, the availability of these systems is most welcome news for biostatistics leaders struggling to build out and enable biostatistics teams that can accelerate R&D. There is a pool of candidates out there who have statistical programming expertise, but not in SAS: however, that is okay. When facilitated by the right technical infrastructure, these candidates can contribute meaningfully to the work at hand without needing as much additional training. Meanwhile, experienced SAS programmers don’t need to divert their effort and focus away from current deliverables to learn new languages. Biostatistics leaders finally have an easy solution to the challenge of the talent gap.

When the most important choice to make is the choice to empower team members to do their innovative work in the way they want to, biostatistics leaders will not only solve their workforce enablement challenges, but also enable their teams to move at the speed that their business and the life sciences industry require.

Interoperability difficulties resulting from discrepancies in preferred programming languages can be resolved via statistical computing environments.

Featured Content

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

Behind the Headlines Episode 28

Ask the Expert

Drug Digest December 2025

A “Plan, Prevent, Prove” Approach