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Barbara Scott is a Master Reviewer at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients, Barbara.Scott@fda.hhs.gov.

David Green is a Senior Pharmaceutical Quality Assessor at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

Marlene Kim is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff.

Naomi Kruhlak is Scientific Lead, Computational Toxicology Consultation Service at FDA Center for Drug Evaluation and Research/Office of Translational Sciences/Office of Clinical Pharmacology/ Division of Applied Regulatory Science.

Tyler Peryea is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff.

David Skanchy was the Division Director (retired) at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

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Drug Master File (DMF) holders provide a hazard assessment for impurity classification to comply with International Council for Harmonisation (ICH) M7 (R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (1) that includes the use of (quantitative) structure-activity relationship ((Q)SAR) models. Impurities consist of starting materials, intermediates, by-products, and degradants and can total >15 for a single DMF. Currently, chemical structures for these impurities are submitted in the Electronic Common Technical Document (eCTD) (2) as unmanipulable portable data files (PDF files). Further review of the impurities using cheminformatics tools—by application of (Q)SAR models and registration in the FDA Global Substance Registration System (GSRS)—or for use in the Chemistry, Manufacturing, and Controls (CMC) review document, requires conversion of the structures to a computer-readable format. To resolve challenges with re-drawing chemical structures and to improve review efficiency, inclusion of structural information in the structure-data file (SD File) format can be very helpful in DMF reviews.

Regulating Innovation, Quality, and Risk eBook January 2024

Regulating Innovation, Quality, and Risk eBook

Barbara Scott* is a Master Reviewer at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients, Barbara.Scott@fda.hhs.gov. David Green is a Senior Pharmaceutical Quality Assessor at FDA Center for Drug Evaluation and Research/Office of
Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients. Marlene Kim is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff. Naomi Kruhlak is Scientific Lead, Computational Toxicology Consultation Service at FDA Center for Drug Evaluation and Research/Office of Translational Sciences/Office of Clinical Pharmacology/ Division of Applied Regulatory Science. Tyler Peryea is a Chemist at FDA Office of the Commissioner/Office of Digital Transformation/Office of Data, Analytics, and Research/Health Informatics Staff. David Skanchy was the Division Director (retired) at FDA Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of New Drug Products/ Division of Lifecycle Active Pharmaceutical Ingredients.

*To whom all correspondence should be addressed.

Pharmaceutical Technology/Pharmaceutical Technology Europe

Regulating Innovation, Quality, and Risk 

When referring to this article, please cite it as Scott, B. et al. Master File Submission of Structures. 

Articles

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Master File Submission of Structures

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Cliff Campbell is senior consultant at KPC.

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 This article was peer reviewed by a member of 

®’s Editorial Advisory Board and was previously published in the August 2023 issue.

A published paper, titled “Quality Quartets in Risk-Based Qualification” (1), provided a review of the International Society for Pharmaceutical Engineering’s (ISPE’s) Baseline Guide of 2019 on Commissioning & Qualification (C&Q) (2). That paper introduced a concept called “Quality Quartets” as a practical means of making use of four key concepts in the Baseline Guide: critical aspects (CAs) and critical design elements (CDEs), which were newly introduced in the 2019 Baseline Guide, and the already well-established critical quality attribute (CQA) and critical process parameters (CPP) concepts.

Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations

A Quality Quartet is essentially a documented expression of the knowledge that a company has about the relationship between CAs and CDEs and the associated CPPs and CQAs. It can be considered a knowledge management output, serving as a practical means of facilitating science and risk-based commissioning and qualification. In addition, the Quality Quartet concept represents a simple and concise means of capturing and communicating product and process knowledge and understanding.

 Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority. Cliff Campbell is senior consultant, retired.

Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

Quality Quartets in Risk-Based Qualification: 

Rick L. Friedman, MS, is Deputy Director for Manufacturing Quality, FDA Center for Drug Evaluation & Research.

David Lebo, PhD is Professor of Pharmaceutics, Temple University School of Pharmacy.

Lawrence Liberti, PhD, BPharm, RAC, is Director, The University of Southern California (USC) DK Kim International Center for Regulatory Science

GK Raju, PhD is Light Pharma CEO, and Research Affiliate, Massachusetts Institute of Technology.

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Manufacturing performance determines quality of outputs. When a company experiences significant manufacturing performance issues, improvements to production design are typically needed.Many industries have demonstrated the value gained from improving manufacturing capabilities, from both quality and business perspectives. However, in the pharmaceutical industry, the business costs and benefits that distinguish manufacturing choices are not always sufficiently understood and described when design options are weighed. When unreliable operations are used to produce medicines, the consequent lower assurance of quality can impact multiple stakeholders, including but not limited to manufacturers, the healthcare system, patients, and governments.To support selection of appropriate manufacturing technologies in accord with the principles of ICH Q9(R1) 

, the pharmaceutical industry would benefit from wide adoption of comprehensive models that better quantify the business benefits of investing in quality. 

ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable Facilities

This paper provides key insights from an extensive literature analysis and discusses the clear business case established by non-pharmaceutical industries for avoiding unreliable operations due to the risks they pose to both quality and business outcomes.

Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk eBook

Rick L. Friedman, MS, is Deputy Director for Manufacturing Quality, FDA Center for Drug Evaluation & Research. David Lebo, PhD is Professor of Pharmaceutics, Temple University School of Pharmacy. Lawrence Liberti, PhD, BPharm, RAC, is Director, The University of Southern California (USC) DK Kim International Center for Regulatory Science, and GK Raju, PhD is Light Pharma CEO, and Research Affiliate, Massachusetts Institute of Technology.

When referring to this article, please cite it as Friedman, R.L.; Lebo, D.; Liberti, L.; Raju, GK. ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable Facilities. 

Pharmaceutical Technology/Pharmaceutical Technology Europe Regulating Innovation, Quality, and Risk eBook January 2024.

This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.

Martin J. Lipa, PhD, martin.lipa@prst.ie, is a senior research fellow at Pharmaceutical Regulatory Science Team.

Anne Greene, PhD, is director PRST, Technological University Dublin.

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®’s Editorial Advisory Board and was previously published in the September 2023 issue.

The current International Council for Harmonisation (ICH) Q9(R1) Quality Risk Management (QRM) guideline is a targeted revision of the initial guidance issued in 2005, intended to address subjectivity, formality, risk-based decision-making, and other specific areas for improvement. While not a formally defined area for improvement, the revised guidance invokes many new references to “knowledge” and “knowledge management (KM)” in supporting improvement in QRM practice and, by extension, to the goals of an effective pharmaceutical quality system.

Knowledge as the Currency of Managing Risk: A Smart Investment for Patients

Recognizing that QRM and risk-based decision-making (RBDM) both depend on knowledge to be effective, it could be suggested that knowledge is the currency of managing risk. This paper presents research and perspectives on the opportunity to better connect risk and knowledge through improved integration of QRM and KM, including presenting several potential benefits of such integration. A framework is proposed, the Risk-Knowledge Infinity Cycle (RKI Cycle), which could be used to improve the connectivity of risk and knowledge along with preliminary and practical recommendations to operationalize the RKI Cycle. In addition, the paper invokes concepts of systems thinking in connecting QRM and KM as well as the opportunity to consider the role of knowledge and KM more holistically across the pharmaceutical business through application of a process classification framework.

Martin J. Lipa*, PhD, martin.lipa@prst.ie, is senior research fellow, Pharmaceutical Regulatory Science Team. Anne Greene, PhD, is professor, Technological University Dublin, and director, Pharmaceutical Regulatory Science Team.


*To whom all correspondences should be addressed.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Knowledge as the Currency of Managing Risk

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

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While his focus was on balancing personal freedom versus state power, 18th century political theorist John Locke’s following thought could arguably be applied to current pharmaceutical regulators’ attitudes when he famously declared, “the end of law is not to abolish or restrain, but to preserve and enlarge freedom” (1). While those currently reading sundry observations listed on an FDA Form 483 will feel significantly “retrained”, the intent of regulations is to allow a fair and equal access to a playing field that encourages participation by as many novel and creative solutions, as applied to disease states, as humanly possible.

Anshul Mangal, president and general counsel of Project Farma, stated, “The FDA aims to streamline the approval process for platform technologies, leveraging the Omnibus Appropriations Act of 2023 to facilitate referencing prior manufacturing data during the review process. Encouraging more gene therapies to seek accelerated approval and improving harmonization with global regulators, especially for rare diseases will be of critical importance. Additionally, the FDA is launching the START pilot to support small companies developing gene therapies for rare pediatric diseases, drawing lessons from the COVID-era Project Warp Speed. If the pilot is successful, it could become a permanent program dedicated to supporting the mission. The agency’s continued support will be paramount in propelling the therapeutic pipeline forward and teeing up the sector for another year of groundbreaking achievements” (2).

As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint. Please enjoy the following articles which, in many ways, fully embody that ethos.

Locke, J. Second Treatise of Civil Government 1690.

Mangal, A. JP Morgan Healthcare Conference Summary. LinkedIn (accessed Jan. 18, 2023).

When referring to this article, please cite it as Spivey, C. Moderating Innovation to Equipoise Risk. 

, Regulating Innovation, Quality, and Risk eBook January 2024.

As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint. 

Moderating Innovation to Equipoise Risk

Feliza Mirasol is the science editor for 

On Jan. 8, 2024, Pluri, an Israel-based biotech company, announced it launched a new business division named PluriCDMO that will offer cell therapy manufacturing services as a contract development and manufacturing organization (CDMO). The new division includes a 47,000-ft2 good manufacturing practice (GMP) cell therapy production facility.

Through this new division, Pluri will offer services relating to early preclinical development through late-stage clinical trials and commercialization. The company has expanded its experience over the past two decades to include process and analytical development, process scale-up, validation, logistics, automation, and regulatory approved comparability studies, according to a company press release.

The company operates a proprietary, patented bioreactor system that enables 3D cell expansion, allowing it to produce high-quality cells in mass quantities via an automated, fully controlled, and validated process. In addition, the company’s PluriMatrix technology enables industrial-scale production of cell-based products.

Pluri’s technology supports large-scale growth of cells and provides batch-to-batch consistency. It is also scalable, cost-effective, GMP-compliant, and has been used to support late-stage clinical trials in key jurisdictions, including FDA, the European Medicines Agency, Israeli’s Ministry of Health, Japan’s Pharmaceuticals and Medical Devices Agency, and the Ministry of Food and Drug Safety of the Republic of Korea, the company stated in its press release.

“Opening the CDMO division is a strategic move that we expect will boost revenues and cash flow utilizing our … technology and manufacturing facility,” said Yaky Yanay, Pluri’s CEO and president, in the press release. “PluriCDMO’s vision is to provide our clients with … access to valuable knowledge in cell therapy development that has been generated over the [past] two decades. PluriCDMO … can accelerate the development efforts of our partners and provide better control of the risks.”

“Pluri has an established track record of development and manufacturing in this arena and has solved many of the challenges that confront innovative companies in the cell therapy market,” said Andy Lewin, who was appointed as chief commercial officer at Pluri to lead the CDMO division, in the press release. “The [c]ompany has developed innovative production technologies, which allow it to offer large scale (and further scalable) production of cell-based products in GMP grade. Pluri’s technology, long-standing collaborations, and extensive experience enable the manufacturing of a wide range of products, including [m]esenchymal

[s]tem [c]ells (MSCs), [i]nduced [p]luripotent [s]tem Cells (iPSCs), [e]xtracellular [v]esicles (EVs) and gene-modified cells, including CAR-T [chimeric antigen receptor T] cells.”

Pluri has launched PluriCDMO, a new contract development and manufacturing organization business that will offer cell therapy manufacturing services.

Pluri Launches New Cell Therapy CDMO Division

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The Alliance for mRNA Medicines (AMM) will convene a meeting of global regulatory leaders in Washington, D.C from April 4–5, 2024. The core topic will be to assess the merits of a potential single shared regulatory streamlined platform pathway through FDA, the National Medical Products Administration (NMPA), the Ministry of Health, Labor, and Welfare

MHLW), the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA), the International Council for Harmonization (ICH), stakeholders, and others. Each jurisdiction will likely diverge—ultimately, but hopefully after having initially worked through a common “shared tree trunk” schematic for messenger RNA (mRNA) current good manufacturing practice (CGMP) compliance.

The meeting is intended to discuss what that tree trunk might look like and what it might further grow into. Realistically, a single tree trunk isn’t a good metaphor, and instead we should perhaps be thinking in terms of multiple trunks—as in a copse, thicket, spinney, or grove. Functionally, there isn’t just one type of structural modality. So be it self-amplifying RNA (saRNA) or circular RNA (circRNA), handling and manufacturing aspects vary significantly. As they also do in terms of quantities, potency profiles, or absorption, distribution, metabolism, and excretion (ADME) considerations, or when discussing a generalized vaccine versus personalized oncology vaccines, gene editing, chimeric antigen receptors (CAR-T), antibodies, or protein replacement therapies.

Still, Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, has long been supportive of the concept of a shared regulatory mRNA platform pathway, telling 

, “With over a billion doses administered, the COVID-19 mRNA vaccines have demonstrated the value proposition of this safe and effective platform in viral respiratory diseases. We anticipate that additional studies may expand the reach of mRNA vaccine technology.”

Meanwhile, activities such as mRNA vaccine production currently fall into catch-all categories like “genetic immunogens, derived from principles defined for plasmid DNA vaccines and gene therapy vectors. For vaccine development, the World Health Organization’s (WHO) guidelines around the quality, safety, and efficacy of plasmid DNA vaccines [are] regarded as a basic overarching guideline applicable for the development of RNA-based vaccines” (1). The coming meeting is timely. EMA has called for input into an mRNA regulations guideline for influenza vaccines and beyond (2).

There is now a strong trend toward taking what has worked so well in infectious disease treatment—there is a wealth of data generated during the COVID-19 pandemic response, to refer to Marks’ comment—and marrying this in a hybrid, or often combination therapy, approaches. “Having agreed upon templates to work from as a new basic starting point,” says the AMM executive director, Clay Alspach, “will serve to accelerate exciting and potentially game changing treatments.”

Alspach also noted the recent approval of ARCT-154 (from Arcturus and CSL), a sa-mRNA COVID-19 vaccine for initial vaccination and booster for adults 18 years and older, through Japan's MHLW. Alspach states, “second generation approaches, such as self-amplifying and various novel emerging methods, need to be better coordinated and their manufacturing processes optimized. Regulatory compliance is a huge part of that picture.”

Andy Geall, inaugural AMM board chair and CEO of Replicate Biosciences (working on self-replicating RNA) calls for more frequent international dialogue on both the science and also the regulations involved, due to the extreme speed with which technologies were advancing and converging. He emphasized, “there needs to be a coordinated effort to educate the public about what’s coming, because this is arriving at a speed that no one is used to. This isn’t traditional pharmaceutical development. This is coming at light speed, and with such an array of different approaches and technologies. We need to get out in front in terms of education for the public, our governments, the regulators to help de-mystify all of this for them.” Over and above combating vaccine disinformation, Geall returned to the scope and scale of impending innovation, saying, “We have people working in rare diseases. We’ve got gene editing happening,gene therapy, not forgetting vaccines in infectious diseases, oncology, and even early work in neurology. It’s not scary; it’s just an unknown to the nonscientists.And we need to communicate clearly why all of this is so positive and positively transformative” (3).

The Regulatory Environment for the Development of mRNA Vaccines during COVID-19

EMA. Concept Paper on the Revision of the Non-clinical and Clinical Module of the Influenza Vaccines Guideline. 

Geall, A.; Alspach, C.; Kuhn A. Introduction to the Alliance of mRNA Medicine, 11th International mRNA Health Conference, Berlin, Nov. 1, 2023.

Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.

A Platform for mRNA Platforms

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

Clarivate, a global information services provider, has announced, in a Jan. 8, 2024 press release, the publication of its annual 

 report, highlighting 13 potential blockbuster drugs and gamechangers that will launch in 2024.

 report provides predictive analysis of drugs set to launch with the potential to be highly commercially and/or clinically successful. In the latest edition, Clarivate analysts have identified 13 new-to-market therapeutics and drugs as potential blockbusters—drugs that are likely to achieve $1 billion in annual sales—or game-changers in terms of benefits for patients.

The drugs highlighted in the report cover a wide therapeutic base ranging from treatments for breast cancer, hemophilia A, sickle cell disease, Crohn’s disease, ulcerative colitis, respiratory syncytial virus, and multiple myeloma, among others. Additionally, the 2024 report sheds light on the growing chronic disease market in Mainland China, with the analysts picking out seven drugs that they predict as being likely to achieve blockbuster status by 2029 or as having a significant impact for Chinese patients in need of better treatment options.

“The fundamentals underpinning the biopharma sector have never been stronger, with new technologies fueling medical advancements and providing treatment options to patients with previously unmet needs,” said Mike Ward, global head of Thought Leadership, Life Sciences and Healthcare, Clarivate, in the press release. “Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year’s 

 report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes.”

The full report is available for download from Clarivate’s website, and more details will be provided in the Editor’s Comment for 

Clarivate's Drugs to Watch report highlights 13 potential blockbuster drugs and gamechangers set to launch in 2024.

Clarivate Highlights 13 Potential Drugs to Watch in Latest Report

Clinical-stage UK-based pharmaceutical company, PharmaKure, has been granted Clinical Trial Authorization (CTA) from the United Kingdom’s regulatory body, the Medicines and Healthcare Regulatory Agency, to start a Phase IIa study to assess an oral combined drug for the treatment of mild cognitive impairment (MCI) as a result of Alzheimer’s Disease.

According to a Jan. 4, 2024 press release, the CTA has been granted for PharmaKure’s PK051 oral combined drug that has been designed to target disaggregation of amyloid-β proteins—overproduction of which is being increasingly accepted as the initial event in Alzheimer’s Disease pathology. In the multi-ascending dose Phase IIa study, the company will evaluate the safety and tolerability of PK051 in patients.

"The MHRA authorization marks a major step forward in our mission to develop PK051 as a disease modifying therapy for MCI due to Alzheimer’s Disease,” said Dr. Farid Khan, CEO, PharmaKure, in the press release. “This authorization follows successful study results recently announced by the company for a novel whole blood test to quantify Alzheimer’s Disease biomarkers. PharmaKure’s proprietary ALZmetrix blood test can identify blood-based biomarkers in patients with Alzheimer’s Disease to provide early warning of cognitive decline. Used as a companion diagnostic, this could enable treatments such as PK051 to be offered earlier to provide better population-based health outcomes.”

“We are delighted to have approval to begin clinical testing of PK051,” added Dr. Bob Smith, chief clinical director, PharmaKure, in the press release. “This Phase IIa study is intended to confirm safety, tolerability, and to help us determine an appropriate dose for future efficacy studies. The trial will involve 40 patients with MCI due to Alzheimer’s Disease at a single site in the UK. The first patient is expected to be dosed in early to mid 2024, with preliminary clinical data emerging within 12 months of first dose.”

MHRA has granted a Clinical Trial Authorization to PharmaKure for its oral combined drug for the treatment of mild cognitive impairment.

PharmaKure Gets Nod from MHRA to Trial Drug Targeting Amyloid Deposits

Finnish medicine performance enhancing company, Nanoform, has announced, in a Jan. 5, 2024 press release, the completion of the First Subject First Visit (FSFV) in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.

The single-dose, randomized, comparative bioavailability study, which is being performed by a North American contract research organization, will compare Nanoform’s nanocrystalline enabled alternative to an amorphous solid dispersion (ASD) formulation of nanoenzalutamide and the FDA-approved prostate cancer androgen receptor inhibitor, Xtandi, in prostate cancer patients. The trial will compare the bioavailability of one enzalutamide 160 mg film-coated tablets (Bluepharma Farmaceutica S.A.) with that of four Xtandi 40 mg film-coated tablets (Astellas Pharma Europe B.V.). As pill burden and dysphagia are documented as common challenges for prostate patients, the development of a single tablet per day regimen could be a preferable option.

“We are pleased to have achieved [FSFV] as planned. The initiation of this trial represents a key milestone as we advance the development of nanoenzalutamide in prostate cancer for patients,” said Dr. Edward Haeggström, CEO of Nanoform, in the press release. “We continue our discussions with specialty pharma and value-added medicine partners to ensure this advance reaches the patients that need it the most. We see significant interest in nanocrystalline alternatives for [ASDs] from pharma and value-added medicine partners, for whom this platform technology offers a differentiated and improved formulation that could reduce pill burden, provide a preferred route of administration, or improve patient experience, acceptance, and adherence.”

A readout from the clinical trial is expected in the first quarter of 2024. In the event that the results of the trial are positive, Nanoform and partners have reported that they will seek one or more license and/or commercial supply agreements for nanoenzalutamide during 2024, under the proviso of maintaining 25% share of net-income.

Nanoform has completed the First Subject First Visit in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide.

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