Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Patrick Lavery

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A January 2025 report from Vector, a United Kingdom-based recruitment process outsourcing (RPO) partner for pharmaceutical contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), defined five main trends to watch for regarding outsourcing within the bio/pharmaceutical industry itself (1). Skill specialization, regulatory complexities, the perpetuance of remote and hybrid work, the meteoric rise of artificial intelligence (AI) technologies, and talent retention were all given their place in the pharma workforce of the future.

At least one of these factors—a continued reduction in in-office work—is a stubbornly lingering aftereffect of the COVID-19 pandemic. Erik Wiklund, CEO of Circio, called it the “COVID bubble,” a “nuclear winter” of sorts for smaller biotech companies that made capital difficult to access and caused massive layoffs in the United States and Europe (2).

However, Wiklund sees the winds of change shifting for Circio, and believes the experiences his company has been through in the past five years mirror those of countless industry peers.

“Many companies launch great ambitions, large valuations,” Wiklund explained (2). “People flow into the industry, and then the breaks set in, but then what happens is that the companies that survive, they then suddenly have access to a broad talent pool, and then the capital comes back.”

Central to that broadening of talent, opined Sheryl Johnson, pharma application development manager at Orbia Fluor & Energy Materials, should be endeavoring to continue the strides the industry has made toward diversity, equity, and inclusion—keeping in mind that the pharmaceutical world encompasses far more than the US, where those buzzwords have come under political scrutiny (3).

Johnson says Orbia is taking a variety of proactive approaches to improve gender-diverse representations within their workforce, but full diversity will take ongoing cooperation throughout the field.

“Women, in particular, can bring unique perspectives, talents, [and] approaches that can drive innovation, particularly in the pharma industry,” Johnson said (3). “Female leaders can often excel in collaborative and inclusive leadership styles, which I feel can help foster creativity and new ideas. I find women are very open to sharing of new ideas and provide supportive attitude to research management and development through considered and empathetic communication.”

As part of its coverage of both the International Day of Women and Girls in Science on February 11 and International Women’s Day on March 8, 

® conducted a series of interviews with leading women in the bio/pharma space, Johnson included, explaining some reasons for a gender gap in science, technology, engineering, and math (STEM) that has skewed the balance of skilled workers heavily to the male side, and offering potential ways the industry can foster and incentivize female involvement (4).

While Sabine Gölden, eLearning & Training Lead at the European consulting firm MAIN5, said educational STEM programs aim to provide equal access to all without being gender-specific, she added that persistent stereotypes of what are traditionally seen as gendered career paths should be understood by females at a young age—especially when programs exist that challenge them to break out of those norms (5).

“Scientific research shows that there are cognitive differences and varying talents between men and women,” Gölden said (5). “As a result, some individuals may naturally have advantages in this or that topic or might suit better in a specific position. These talents follow a Gaussian (‘normal’) distribution, and men are more likely to have cognitive advantages for STEM-related work—but women are still underrepresented in these fields.”

Yet to return to another of the Vector report’s key points, talent retention remains a major hurdle. And it may not always be, as in Wiklund’s “COVID bubble” example, the sole burden of the industry, or any specific company.

Gölden said the “work-motherhood challenge” is still one that women are fighting, even within themselves, across various workforces (5). She calls it a “leaky pipeline,” one that may have an unconventional fix.

“Even today, it’s still uncommon for women to be the primary breadwinners and men to take on the role of caretakers,” she said (5). “From my perspective, this is where the biggest challenge lies. It’s not just about providing opportunities and empowerment for women; it’s about breaking down the barriers for men, who often face potential career and reputation impacts when they take on caretaker roles."

The reputations of human workers of all backgrounds could figure to be at stake in the next several years as AI impacts more corners of the industry. Wiklund is in lockstep with the Vector report in theorizing that AI’s most likely usefulness in the near term will be in the earliest stages of the R&D process, such as drug development (1,2). But as far as human decision-making, Wiklund believes the technology’s intrusion is still a long way off.

“Maybe the area which appears most obvious is in diagnostics and prognostics, where an artificial intelligence can start utilizing information and colliding information in a more systematic way, using radiology and other types of scans to give better and more reliable interpretations,” he said (2). “That probably is where artificial intelligence will make an impact first. But again, the business models are not really established yet. The regulatory frameworks are not there yet. So ... I think it’s going to take longer than 2025 for us to start really seeing [the] big impact of this when it comes to therapeutic development, or the real impact on treatment decisions.”

Doing the best to keep a step ahead of the latest AI innovations can only benefit human professionals, and gender diversity plays a distinct role in that as well. Programs such as Girls Who Code, which helps girls build coding and AI skills, are gateways for women in healthcare industries who now must compete against machine as well as man, according to Jean Redmond, chief operating officer at Biologit (4). But there’s a higher purpose here, too: preparing those women to be the decision-makers that Wiklund said AI is not yet ready to usurp.

“By increasing representation in STEM fields, these initiatives help drive diversity in leadership and innovation in pharma and biotech,” Redmond said (4). “Additionally, mentorship, networking, and industry partnerships further support women in transitioning from education to impactful careers.”

As the US rewrites its tariff policies early in the second Trump Administration, companies in Europe and other parts of the world may look elsewhere for development opportunities, according to Wiklund. So even as access to talent is improving five years post-COVID, where people are looking for new work, and which companies will partner with them, and each other, remain question marks.

“Increasing cost levels in the US in particular, [a] strong dollar, and increasing inflation [have] driven up prices,” Wiklund explained, also adding that “it’s become cheaper by comparison to develop drugs in Europe, Asia, [and] Australia, and I think maybe if that trend continues with a strong US economy and increasing prices, then you may see that that kind of European, eastward-oriented trend continuing” (2).

Will the geopolitical climate, artificial intelligence, gender imbalances, or the flexibility of working environments prove to be headwinds or tailwinds for finding, developing, and retaining talent? Finding a definitive answer that fits any of those factors is neither easy nor certain. Skilled workers are out there to be had, but how bio/pharmaceutical companies treat them and encourage their career growth is a destination to which there are many different paths.

1. Kelly, N. The Future of Pharma Outsourcing: Trends Reshaping the Talent Landscape in 2025. 

, Jan. 23, 2025.
2. Thomas, F. and Haigney, S. Industry Outlook 2025: Talent Up for Grabs. 

, April 10, 2025.
3. Thomas, F. International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma. 

, March 8, 2025.
4. Haigney, S. Leaving STEM Skills on the Table. 

, Feb. 13, 2025.
5. Haigney, S. International Day of Women and Girls in Science 2025: Inspiring and Supporting Women in STEM. 

®
Vol. 49, No. 4
May 2025
Pages: 30–31

When referring to this article, please cite it as Lavery, P. Authentic Intelligence: Finding Diverse Talent in the Age of AI. 

Articles

The pandemic made it daunting for companies to retain talent and then find it anew, but just as that cloud is lifting and workforce diversity is being embraced, AI beckons as a new challenge.

Authentic Intelligence: Finding Diverse Talent in the Age of AI

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Q32 Bio, of Waltham, Mass., announced on April 30, 2025 that its human anti-IL-7Rα antibody, bempikibart (ADX-914), has been given fast track designation by FDA for the treatment of alopecia areata (AA) (1).

According to the National Alopecia Areata Foundation (NAAF), a California nonprofit, AA is a common, autoimmune skin disease characterized by hair loss, often in circular, coin-like patches, on the scalp as well as other areas of the face and body (“alopecia” means bald, and “areata” means patchy) (2). In severe cases, total hair loss is possible. NAAF said about 2% of the world population will experience AA, meaning approximately 700,000 people in the United States currently have AA in some form. More than 80% of those with the disease exhibit signs before age 40, with women more likely to develop it than men, and Asian, Black, and Hispanic populations having higher odds than whites.

As a fully human antibody, bempikibart re-regulates adaptive immune function, according to Q32 Bio, by blocking the IL-7 and TSLP pathways that have been genetically and biologically implicated as forces behind T cell-mediated pathological processes in various autoimmune diseases (1). Q32 Bio’s ADX-914 candidate, currently in development, is being evaluated in a Phase II trial.

FDA’s fast track process facilitates development and expedites review of new drugs that are intended to treat serious diseases and fill an unmet need, all with the goal of getting those drugs to patients faster (1). Drugs that receive a fast track designation may also be eligible for accelerated approval and priority review from FDA if certain criteria are met.

"The fast track designation granted by the FDA recognizes the seriousness of AA and the significant current unmet medical need while underscoring bempikibart's potential as a novel, differentiated therapy for patients needing new options," said Jodie Morrison, chief executive officer of Q32 Bio, in a company press release (1). "This fast track designation follows the encouraging clinical activity observed in Part A of our SIGNAL-AA clinical trial and the recent initiation of dosing in the Part A open-label extension and Part B portions of the SIGNAL-AA trial. We look forward to continued collaboration with the FDA as we work to deliver this potentially paradigm-shifting treatment to patients."

Alopecia areata was one of the diseases addressed at the March 2025 meeting of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use. At that time, 

an application for an initial marketing authorization

 was withdrawn for Cinainu (liquid ethanolic extract 30% [W/W] of Allium cepa fresh bulb and citrus limon fresh fruit/dry aqueous extract of paullinia cupana seed/dry hydroethanolic extract of theobroma cacao seed), an herbal medicine developed by Switzerland-based Legacy Healthcare for treatment of moderate-to-severe AA (3). No further details on the withdrawal were given, except for that Legacy took the action in February 2025 following a re-examination, according to EMA.

1. Q32 Bio. Q32 Bio Announces FDA Fast Track Designation Granted to Bempikibart (ADX-914) for the Treatment of Alopecia Areata. Press Release. April 30, 2025.
2. Alopecia Areata. National Alopecia Areata Foundation | NAAF. 

 (accessed April 30, 2025).
3. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

Thousand Oaks, Calif.-based Capsida Biotherapeutics (Capsida) has announced its slate of seven scientific presentations, three oral and four in poster form, that have been accepted for the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), which will be held in New Orleans from May 13–17, 2025 (1).

In a press release, Capsida said the presentations would show new data demonstrating the company’s positive progress across its wholly owned pipeline, proprietary capsid engineering, and manufacturing (1).

More specifically, the three oral presentations will highlight advances in Capsida’s intravenously (IV)-delivered genetic medicines—including its first-in-class IV administered gene therapy CAP-002, designed to achieve brain-wide neuronal expression while simultaneously detargeting the liver—which are enabled by the company’s engineered capsids and cargo (1,2).

The first, to be presented by Celeste Stephany, PhD, Capsida director of CNS (central nervous system) and Ophthalmology Preclinical Research, is entitled “Systemic AAV (adeno-associated virus) Gene Therapy with Next Generation Engineered Capsid Demonstrates Expression Levels Supporting Potential Therapeutic Benefit for CNS, Cardiac, and Sensory Symptoms in Friedreich’s Ataxia” (1). The second is closely related: “Systemic Gene Therapy CAP-002 Demonstrates Potential for Disease-Modifying Treatment of Seizures and Motor and Cognitive Deficits of STXBP1-DEE Using an Engineered, CNS-Targeted AAV,” to be presented by one of Capsida’s founders and Chief Research and Innovation Officer Nick Flytzanis, PhD.

A third oral presentation will be made by founder and Chief Technology Officer, Nick Goeden, PhD, entitled “Identification of Multiple Novel Blood-Brain-Barrier Receptors for CNS Gene Therapy and Other Drug Modalities via an Integrated AAV Capsid Engineering Platform” (1).

All oral presentations will be made on Wednesday, May 14, as will two of the four poster presentations; the other posters will be exhibited during evening sessions on Tuesday, May 13 and Thursday, May 15 (1). Capsida said the data contained in each presentation will be embargoed until the morning of May 13 for posters, and the morning of May 14 (the presentation day) for oral sessions.

“These data reflect the significant progress we are making in translating Capsida’s innovative capabilities into differentiated clinical therapies,” said Peter Anastasiou, Capsida chief executive officer, in an April 28, 2025 press release (1). “We are on track to enter the clinic with our STXBP1-DEE and PD-GBA programs this quarter, with the potential to bring disease-modifying and possibly curative treatments to these communities who so desperately need them.”

Capsida presented preclinical evidence for CAP-002 

“This study built upon our previous proof-of-concept study and represents a significant advancement in our understanding of the therapeutic potential of engineered AAV gene supplementation therapy in the treatment of genetic epilepsy and developmental disorders due to STXBP1 mutations. These data are encouraging and emphasize the potential for CAP-002 to meaningfully improve outcomes in patients with this disease,” Mingshan Xue, PhD, associate professor, Department of Neuroscience, Department of Molecular and Human Genetics at Baylor College of Medicine and the Cain Foundation Laboratories, Jan and Dan Duncan Neurological Research Institute at Texas Children's Hospital and an ASGCT 2024 presentation co-author, said at the time (2).

1. Capsida Biotherapeutics. Capsida to Present Progress Updates at the ASGCT Annual Meeting, Including NHP GLP Toxicology Study Results for its Potential First-in-Class STXBP1 Developmental and Epileptic Encephalopathy Program (CAP-002 STXBP1-DEE). Press Release. April 28, 2025.
2. Capsida Biotherapeutics. Capsida Biotherapeutics Presents New Preclinical Evidence Indicating Novel First-in-Class IV-Administered Gene Therapy Effectively Treats Genetic Epilepsy Due to STXBP1 Mutations. Press Release. May 7, 2024.
3. American Society of Gene & Cell Therapy. ASGCT Annual Meeting. 

The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.

Capsida Previews Its Oral and Poster Presentations for ASGCT 2025

Netherlands-based argenx has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended its efgartigimod alfa treatment, brand name Vyvgart, in 1000-mg subcutaneous injection, as a monotherapy for adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) who have been previously treated with corticosteroids or immunoglobulins (1).

According to a press release from argenx, efgartigimod is an antibody fragment that reduces pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor, thereby blocking the process by which IgG is recycled (1). The company’s efgartigimod alfa treatment is the first and only targeted IgG Fc-antibody treatment for CIDP, argenx said, and if approved, it would be the first novel mechanism of action for treatment of CIDP in more than 30 years.

CIDP is a serious, though rare, autoimmune disease of the peripheral nervous system (1). People diagnosed with CIDP report symptoms of fatigue, muscle weakness, and a loss of feeling in their arms and legs that may come and go or may worsen over time. In those cases, the symptoms can impair a person’s ability to function in everyday life; more than one-third of those diagnosed with CIDP will need a wheelchair if they are not treated. Estimates say there are more than 31,000 people living with CIDP in the European Union (1).

In the United States, FDA approved a form of the argenx treatment, efgartigimod alfa and hyaluronidase-qvfc (under the brand name Vyvgart Hytrulo), in June 2024, for treatment of adult patients with CIDP in a once-weekly, 30- to 90-second subcutaneous injection (2).

“Our mission is to develop innovative, targeted treatments for patients with rare and severe autoimmune diseases, who continue to face significant unmet needs,” Luc Truyen, MD, PhD, and chief medical officer of argenx, said in the April 2025 release (1). “The positive CHMP opinion for Vyvgart in CIDP brings us one step closer to providing patients across Europe with a transformational new treatment option that provides meaningful functional improvement.”

As with the FDA approval, CHMP’s recommendation was based on results from a clinical trial (ADHERE) that involved the largest number of CIDP patients to date; updated data from this trial show that 66.5% of patients (214 out of 322) treated with efgartigimod alfa demonstrated evidence of clinical improvement—particularly improvements in mobility, function, and strength—regardless of prior treatment (1).

"For the patient population represented by the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN) and for those affected by CIDP, this is excellent news," said Jean-Philippe Plançon, president of EPODIN (1). "There are still considerable unmet medical needs in the management of CIDP, and CHMP’s recommendation brings renewed hope for improved treatment options and quality of life."

The European Commission is expected to make a decision on the marketing authorization application for Vyvgart within approximately two months (1).

1. argenx. argenx Announces Positive CHMP Opinion for Vyvgart (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Press Release. April 28, 2025.
2. argenx. argenx Announces FDA Approval of Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy. Press Release. June 21, 2024.

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

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The Switzerland-based biopharmaceutical company Debiopharm Research & Manufacturing has announced a license agreement with Oncodesign Services, of Dijon, France, for the use of a technology known as AbYlink for preclinical services (1). In a press release on April 24, 2025, Debiopharm explained that AbYlink is a rapid, regio-selective bioconjugation technology designed for use in therapeutic and non-invasive diagnostic applications.

Under the terms of the agreement, Oncodesign will use the technology to prepare antibody chelator conjugates for use in preclinical studies, hoping to gain insights about the predictive effectiveness of novel treatments for molecular radiotherapy, and in particular, radioimmunotherapy for cancer treatments (1).

Debiopharm further describes AbYlink as a one-step method that results in stable conjugation at defined and invariable sites on the Fc domain of an antibody, with no impact on antigen-binding regions, enabling a seamless, reproducible conjugation of payloads to antibodies or antibody-drug conjugates (ADCs) (1).

“We have demonstrated the effectiveness of this powerful technology to rapidly and covalently conjugate any off-the-shelf antibody in a single step with an imaging agent,” Frédéric Lévy, chief scientific officer at Debiopharm, said in the press release (1). “Our strategic collaboration with Oncodesign Services allows broader access to and usage of non-invasive imaging applications and provides an innovative solution to biotech and pharma partners to integrate imagery in the development of new antibody- and ADC-based therapeutics.”

“We are pleased to integrate this cutting-edge technology into our portfolio for our clients,” said Aidan Synnott, CEO of Oncodesign Services, in the release (1). “The AbYlink technology gives the advantage of generating reproducible batches of bioconjugated antibodies and ADCs that secure specificity and efficacy of targeted radiotherapy.”

In announcing their agreement, Debiopharm and Oncodesign said a joint poster is scheduled to be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25–30, 2025 in Chicago, that will illustrate a demonstration of the use of the non-invasive AbYlink technology in radioimmunotherapy, targeting animal models with human epidermal growth factor receptor 2-positive (HER2+) tumors (1).

In other radiopharmaceuticals news, Sydney, Australia-based AdvanCell 

 that it had successfully completed an oversubscribed, $112 million round of Series C financing (2). The mission of AdvanCell was originally built around targeted alpha-emitting radionuclides for cancer therapy, and, to that end, the company currently operates a 40,000-square-foot manufacturing facility. AdvanCell plans to expand manufacturing capacity even further and accelerate clinical development of its radionuclide therapy pipeline with the new funding.

As for ADCs, Christian Morello, vice-president and head of the Bioconjugates Business Unit at Lonza, highlighted some challenges 

“The technology is now at the level of maturity that enable a lot of different things,” Morello said, referencing Lonza’s acquisition of Synaffix, which presents a type of linker technology in which the developer can define how many payloads it wants to have per monoclonal antibody (3). “That is another possibility that will enable [the developer] to fine tune the benefits/risk ratio for the patient,” Morello added. “We can see [that] today for some cytotoxic compounds for oncology, for sure, but we also have radiolabeled compounds to facilitate diagnosis. [This is] also oncology treatment, but with a different approach.”

1. Debiopharm Research & Manufacturing. Debiopharm and Oncodesign Services Launch Strategic Collaboration to Propel Radiopharmaceuticals in Preclinical Research. Press Release. April 24, 2025.
2. AdvanCell. AdvanCell Successfully Completes an Oversubscribed US$112M Series C Financing. Press Release. Feb. 3, 2025.
3. Mirasol, F. Advancing ADCs to the Next Level. 

The AbYlink technology enables a seamless, reproducible conjugation of payloads to antibodies or ADCs.

Debiopharm, Oncodesign Agree to Use Non-Invasive Technology for Preclinical Research

Switzerland-based pharmaceutical process development and API manufacturing company CARBOGEN AMCIS announced on April 22, 2025 that its facility in the Shanghai Chemical Industry Park, which is used for early-stage R&D, pilot scale production, and commercial good manufacturing practice (GMP) manufacture, has obtained its first drug manufacturing license (DML) from China’s National Medical Products Administration (NMPA) (1).

“This achievement underscores our team's commitment, disciplined execution, and the robustness of our Quality Management System, which has been rigorously aligned with both corporate and Chinese regulatory requirements,” said Simone Maggi, quality head, CARBOGEN AMCIS Shanghai site, in a company press release (1).

The Shanghai facility, which CARBOGEN AMCIS said is fully self-supporting, offers services ranging from raw materials to APIs, including high potency material handling and micronization (1). Equipment is located in four segregated units; reactor capacities range from 50 to 6300 liters. The site employs more than 140 workers.

“In addition to our core manufacturing capabilities, we’re proud that the Shanghai site is equipped to handle highly potent compounds up to category 3 and provide full GMP product release and analytical support,” said Harry Wong, country manager, CARBOGEN AMCIS Shanghai, in the press release (1). “This license is a testament to the strength of our team and demonstrates our ability to execute seamless technology transfers and align with the highest quality standards across CARBOGEN AMCIS’ global network.”

The DML from NMPA comes one month after CARBOGEN AMCIS was granted a GMP certificate, the company announced on March 24, 2025, for its state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, by the French regulatory authority Agence nationale de sécurité du médicament et des produits de santé (ANSM). The certificate was achieved following a routine inspection process conducted by ANSM to gauge GMP compliance. It permits the facility to manufacture and release clinical and commercial sterile drug products; ANSM had granted the site authorization to manufacture, test, and release drug products upon its February 2023 opening, with the first clinical batch released in January 2024 (2).

“The successful ANSM inspection reaffirms CARBOGEN AMCIS as a reliable partner in the drug product manufacturing market,” Helen Caddy-Leach, head of Business Development, Drug Product, said in a press release at the time (2). “With our extensive expertise and a state-of-the-art GMP-certified facility, we are well-positioned to support customers’ drug product projects with excellence.”

In similar fashion to that inspection, CARBOGEN AMCIS said the most recent review by NMPA, which focused on GMP compliance and operational readiness, found that the Shanghai site met all regulatory expectations successfully, reflecting the strength of the facility’s quality systems (1).

“Securing the [d]rug [m]anufacturing [l]icense not only demonstrates the operational readiness of our Shanghai site but also reflects the strength of our global quality culture,” Stephan Fritschi, CEO of CARBOGEN AMCIS, said in the April 22 press release (1). “This achievement strengthens our long-term goal of becoming a trusted partner in the Chinese pharmaceutical market.”

1. CARBOGEN AMCIS. CARBOGEN AMCIS Shanghai Site Awarded Drug Manufacturing License from Chinese NMPA. Press Release. April 22, 2025.
2. CARBOGEN AMCIS. CARBOGEN AMCIS Secures GMP Certification After Successful ANSM Inspection for its Aseptic Drug Product Manufacturing Site. Press Release. March 24, 2025.