Susan Haigney

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, Google introduced its new artificial intelligence (AI) system created to help scientists generate novel hypotheses and research proposals. AI co-scientist is a multi-agent AI system that can help scientists navigate information and insights from scientific publications and other resources.

Built on Gemini 2.0, it is intended to be used as a collaborative tool by scientists and was designed to mirror the reasoning process of the scientific method. The tool can “uncover new, original knowledge [and] formulate demonstrably novel research hypotheses and proposals, building upon prior evidence and tailored to specific research objectives,” according toJuraj Gottweis, Google Fellow, and Vivek Natarajan, Research Lead (1).

AI co-scientist uses a combination of Generation, Reflection, Ranking, Evolution, Proximity, and Meta-review that use automated feedback to “iteratively generate, evaluate, and refine hypotheses, resulting in a self-improving cycle of increasingly high-quality and novel outputs.”It also uses web search and specialized AI models to enhance the quality of the hypotheses. Scientists can interact with the system by directly providing seed ideas or feedback on generated outputs.

The tool analyzes the assigned goal into a research plan configuration that is managed by a supervisor agent that assigns specialized agents and allocates resources. This enables the system to “flexibly scale compute and to iteratively improve its scientific reasoning towards the specified research goal” (1). It then leverages test-time compute scaling to reason, resolve, and improve outputs. It uses self-play-based scientific debate to create novel hypothesis and ranking tournaments for hypothesis comparison. The system self-improves by using the Elo auto-evaluation metric.

“Due to their core role, we assessed whether higher Elo ratings correlate with higher output quality. We analyzed the concordance between Elo auto-ratings and GPQA benchmark accuracy on its diamond set of challenging questions, and we found that higher Elo ratings positively correlate with a higher probability of correct answers. Seven domain experts curated 15 open research goals and best guess solutions in their field of expertise. Using the automated Elo metric we observed that the AI co-scientist outperformed other state-of-the-art agentic and reasoning models for these complex problems. The analysis reproduced the benefits of scaling test-time compute using inductive biases derived from the scientific method. As the system spends more time reasoning and improving, the self-rated quality of results improve and surpass models and unassisted human experts,” Gottweis and Natarajan stated in the blog post (1).

End-to-end laboratory experiments in drug repurposing, proposing novel treatment targets, and elucidating the mechanisms underlying antimicrobial resistance were done using the AI co-scientist to assess the validity of the system’s novel predictions. The tool was used to assist the prediction of drug repurposing to validate predictions through computational biology, expert clinician feedback, and 

“Notably, the AI co-scientist proposed novel repurposing candidates for 

 (AML). Subsequent experiments validated these proposals, confirming that the suggested drugs inhibit tumor viability at clinically relevant concentrations in multiple AML cell lines,” Gottweis and Natarajan stated in the blog post (1).

The system does have some limitations and areas of improvement, according to Gottweis and Natarajan, such as enhancing literature reviews, fact-checking, cross-checking with external tools, and larger-scale evaluation with subject matter experts.

“The AI co-scientist represents a promising advance toward AI-assisted technologies for scientists to help accelerate discovery. Its ability to generate novel, testable hypotheses across diverse scientific and biomedical domains—some already validated experimentally—and its capacity for recursive self-improvement with increased compute, demonstrate its potential to accelerate scientists' efforts to address grand challenges in science and medicine. We look forward to responsible exploration of the potential of the AI co-scientist as an assistive tool for scientists. This project illustrates how collaborative and human-centered AI systems might be able to augment human ingenuity and accelerate scientific discovery,” Gottweis and Natarajan stated in the blog post (1).

1. Gottweis, J. and Natarajan, V. Accelerating Scientific Breakthroughs with AI Co-Scientist. Blog Post. Google Research. 

https://research.google/blog/accelerating-scientific-breakthroughs-with-an-ai-co-scientist/

Articles

The AI co-scientist is a multi-agent AI system that can work as a virtual scientific collaborator.

Google Launches AI Co-Scientist System

Ask the Expert: Complying with 21 CFR 211.110

In January 2025, FDA published a draft guidance document that provides considerations for complying with 21 

) 211.110 (1). This specific section of the 

 focuses on production and process controls for sampling and testing of in-process materials and drug products. The guidance, 

Considerations for Complying With 21 CFR 211.110, Guidance for Industry, Draft Guidance

, applies to human drug products and biologics, but not to the manufacture of APIs. The guidance document also discusses how process models can be incorporated into commercial manufacturing control strategies.

 video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of this draft guidance and best practices for complying.

“What [the guidance document] really seems to be aimed at is new manufacturing techniques that are coming on board and some flexibility for biopharmaceuticals as we get into, you know, personalized medicines, continuous manufacturing, and the use of artificial intelligence (AI) to identify some of the key process parameters for new manufacturing and processes … giving manufacturers more flexibility in that arena,” explains Schniepp.

“FDA is trying to look to the future, is trying to address what's current, what's happening now. And as you said, use of AI; although, I don't think a lot of companies are really, really implementing this yet in day-to-day operations. Perhaps another aspect here of this guidance is it speaks a lot about continuous manufacturing, which, again, in my experience, is a process that's rarely applied in most of manufacturing because the vast majority of processes are still back by batch,” says Schmitt.

Click the video above to watch Sue and Siegfried answer the following question:

"I saw that FDA posted a new draft guidance for complying with 21 

) 211.110. How will this impact how my company performs batch uniformity testing?"

https://www.fda.gov/media/184825/download

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

The European Medicines Agency (EMA) announced on Feb. 17, 2025 that it has been certified with the Eco-Management and Audit Scheme (EMAS) for its commitment to environmental sustainability. EMAS is an environmental management and auditing standard in the European Union that organizations use to evaluate, report, and enhance environmental performance. It also provides a framework for improving these efforts.

“The EMAS certification is an important acknowledgment of our efforts to strive for continuous improvement and reduce our environmental footprint. As an EU body, EMA takes its responsibility seriously to protect the environment for current and future generations,” said Emer Cooke, EMA’s executive director, in a press release (1).

EMA’s office building is certified BREEAM Excellent and Energy Label A++, and the agency practices eco-conscious procurement. 

“This is for example reflected in the requirement of EU Ecolabel for consumables, and use of sustainable materials. The implementation of digital workflows throughout the agency reduces the need for printing. When selecting replacement of electronic equipment such as laptops and other small electrical devices, products and appliances, the energy rating is included in the evaluation,” the agency stated in the press release. EMA also promotes environmental awareness to its employees.

Sustainability is a hot topic for the pharmaceutical industry, with many pharma companies, biotechs, and contract manufacturers working toward sustainability goals. Contractors are having to match the sustainability requirements of sponsor companies and adjust to the myriad global regulations.

“When we’re negotiating and contracting with our partners, they’re wanting to work with companies who do have ESG [environmental, social, and governance] sustainability policies in place,” said Andy Burns, vice president, MDI (Metered Dosed Inhaler) Business Development at Kindeva, in an

“We used to see only Big Pharma or large generic drug companies having specific sustainability requirements. But now a lot of small to mid-sized biotech companies are talking to us and evaluating us on our sustainability-related practices,” said Saharsh Davuluri, vice-chairman and managing director, Neuland Laboratories, in an

(3). “One of our largest generic customers has required us to apply for the SBTi [Science Based Targets initiative] validation, which is something that we are seeing other companies follow as well. On the innovator side, we’re seeing some of the large innovators enquire about our EcoVadis rating, beyond the standard frameworks of assessments that are available."

“European regulations are particularly stringent on emissions and product lifecycle sustainability, and they have guided a lot of our initiatives such as a co-design, or carbon offset partnerships,” said Charles Ruban, president and CEO, Verdot, in an 

(4). “We're partnering with suppliers committed to systemic sustainability, so our carbon-neutral initiative reflects the commitment of overcoming those models while enabling appliances to globally reduce their environmental footprint,” said Ruban.

EMA. EMA Earns Certification for its Environmental Efforts. Press Release. Feb. 17, 2025.

Haigney, S. Sustainability in Inhalation and Small-Molecule Drugs. 

Haigney, S. Sustainability in Pharmaceutical Outsourcing. 

Haigney, S. Sustainability in Pharmaceutical Manufacturing. 

The agency has received certification with the Eco-Management and Audit Scheme for its commitment to environmental sustainability.

EMA Earns EMAS Certification

International Day of Women and Girls in Science: Fostering STEM Careers for Women

As part of our coverage of theInternational Day of Women and Girls in Science,

® sat down with Agnes Cwienczek, director of Product Management at ArisGlobal, to talk about how women can be supported in the pharmaceutical industry and other science, technology, engineering, and mathematics (STEM) fields.

 Is there sufficient investment in promoting STEM career paths for girls? Should the pharma industry invest in these types of promotions?

: A science-led, R&D-intensive pharmaceutical industry is host to a wealth of opportunities for STEM professionals, with a continuous upward trend, in my opinion. Looking at the ever-growing competitive and global environment, it seems to me to be crucial to further foster science, technology, engineering, and mathematics education and careers to secure our technological growth and future innovation. While more and more pharma companies have established dedicated STEM programs and are fostering related career paths, men continue to outnumber women in this field across the globe, particularly at the higher levels.

It should be in our collective interest to invest further in these kind of promotions—not only for purposes of equality but also to capitalize on the skills and significant contributions made by women to science and research.

 Artificial intelligence (AI) is a fast-growing technology in the pharmaceutical industry. Are there unique and specific skills and/or viewpoints women in STEM jobs bring to this area?

 Personally, I prefer not to gender-stereotype, but if pressed to emphasise specific areas, I would say women bring emotional intelligence, resilience, approach to problem-solving, critical thinking, [and] creativity. While some of these are perhaps less directly relevant to defining and developing AI-based solutions, they can be important to the implementation of those solutions within an organization.

 How can access to grants for women scientists and to jobs for women working in STEM fields be increased and/or nurtured?

 I believe that everything starts at an early age. So early exposure to scientific options, early provision of opportunities, as well as continuous encouragement and support while we learn, study and grow along the way, are essential.

Secondly creating a supportive workplace is vital, with active promotion, by example. Also, ensuring a degree of flexibility and allowance for a heathy work-family balance—though this is not relevant only for STEM fields.

It’s worth noting that this is viewpoint is from someone who grew up and lives in Europe. The situation might look different in developing countries, where access to education is hindered by limitations with funding or other resources, so that financial support becomes key.

Click the video above to watch the full interview.

Agnes Cwienczek, director of Product Management at ArisGlobal

Agnes Cwienczek is director of Product Management at ArisGlobal, specializing in Regulatory Information Management, Document Management, Submission Management, and Labeling Management. 

Agnes Cwienczek, director of Product Management at ArisGlobal, talks with Pharmaceutical Technology® about how careers for women in STEM fields can be nurtured.

International Day of Women and Girls in Science 2025: Inspiring and Supporting Women in STEM

 coverage of the International Day of Women and Girls in Science, we sat down with Sabine Gölden, eLearning & Training Lead at MAIN5, a European consulting firm, about her experience working in the pharmaceutical industry and her perspective on gender equality in STEM (science, technology, engineering, and mathematics) fields.

 What are some of the benefits of STEM programs for girls in school? How do these programs translate to women building careers in the pharmaceutical industry?

 From my perspective, the primary goal of STEM programs is to provide equal access to all fields for everyone, without labeling specific areas as gender-specific.

As a mother of two, I observe with great interest how societal expectations continue to shape role models. A clear example is toy advertisements—on many popular websites, you can filter toys by ‘Boys’ or ‘Girls,’ resulting in distinctly different suggestions. And this is just one of many examples. That’s why I strongly believe STEM programs in schools are a valuable opportunity to challenge stereotypes and give every student the chance to discover whether STEM is the right fit for them.

Scientific research shows that there are cognitive differences and varying talents between men and women. 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.

Gender should never be the basis for deciding which field of study is right for you, regardless of any evolutionary advantages or disadvantages. Ultimately, someone’s path should be determined by their unique talents, passion, dedication and interests—not by their gender.

It’s crucial for every girl to understand this. Since gender-based stereotypes persist, programs that encourage girls and women to explore subjects traditionally overlooked due to outdated role models are essential.

 While there a many ongoing initiatives and activities at schools and from the pharma industry promoting STEM career paths and there is progress in closing the gender gap. One of the most burning topics is the effect of the ‘leaky pipeline’. This term describes how women are more likely to leave STEM fields at various stages of their careers, leading to a significant gender gap in these professions.

From my perspective the leak arises mostly from the challenge of ‘working motherhood’. There are already great set-ups as maternity leave, that jobs are held, more and more flexible working models and so on, but it is not yet enough to fully enable mothers to be able to master the work-motherhood challenge.

I recently listened to a TED Talk about NASA's pioneering women, such as Barbara Paulson and Helen Lane, who balanced motherhood and work by fostering a culture of working motherhood. They shared childcare responsibilities with their husbands, enabling them to contribute to the space race.

Even today, it's still uncommon for women to be the primary breadwinners and men to take on the role of caretakers. 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.

I am fortunate to be able to focus on my job because my partner works for an organization where he doesn't fear negative repercussions for working part-time. However, we know that this isn't true for all organizations. We need to work on more role models for men who are caretakers!

Sabine Gölden, eLearning & Training Lead at MAIN5

Sabine Gölden is eLearning & Training Lead at MAIN5, a European consulting firm delivering digitally enabled change in Life Sciences. She is based in the Frankfurt Rhine-Main metropolitan area of Germany.

Pharmaceutical Technology® spoke with Sabine Gölden, eLearning & Training Lead at MAIN5, about her experience working in the pharmaceutical industry. 

This year marks the 10th anniversary of the International Day of Women and Girls in Science, which was recognized on Feb. 11, 2025. There has traditionally been an unbalanced gender gap in the areas of science, technology, engineering, and mathematics (STEM) that is limiting the potential of skilled workers in the pharmaceutical industry. According to the United Nations, fewer than 30% of engineering graduates are women (1). Women also face unique challenges in these fields, including a lack of opportunity in senior positions. With the demand for highly skilled personnel high, what is the bio/pharmaceutical industry doing to encourage girls to enter STEM fields and women to pursue higher level jobs in pharma?

Michelle Bridenbaker, COO, Unbiased Science, stresses the critical nature of STEM programs in developing talent and ensuring a sustainable, and relevant, workforce. “In terms of the pharma industry specifically, a strong scientific background is a solid foundation for the rigor, discipline, and critical as well as innovative thinking that modern pharma success is built on,” says Bridenbaker. “As employers, pharma companies need to actively encourage women through mentorship and leadership preparation, so that they see and realize their full potential.”

Opportunities for STEM-related jobs in the pharmaceutical industry are abundant and are continuing to grow, according to Agnes Cwienczek, director of Product Management at ArisGlobal. It is crucial to foster education in these fields to meet the growth of technology.

“While more and more pharma companies have established dedicated STEM programs and are fostering related career paths, men continue to outnumber women in this field across the globe, particularly at the higher levels,” says Cwienczek. “It should be in our collective interest to invest further in these kind of promotions—not only for purposes of equality but also to capitalize on the skills and significant contributions made by women to science and research.”

Gender ‘norms’ often inhibit girls from entering what are traditionally seen as school subjects that are ‘for boys’. Pushing back on these stereotypes is crucial, not just for girls, but also for boys. Equal access to STEM fields without labeling specific areas as ‘gender-specific’ is important for STEM programs, says Sabine Gölden, eLearning & Training Lead at MAIN5.

“Gender should never be the basis for deciding which field of study is right for you, regardless of any evolutionary advantages or disadvantages,” says Gölden. “Ultimately, someone’s path should be determined by their unique talents, passion, dedication, and interests, not by their gender. As a mother of two, I observe with great interest how societal expectations continue to shape role models,” remarks Gölden. “A clear example is toy advertisements—on many popular websites, you can filter toys by ‘Boys’ or ‘Girls,’ resulting in distinctly different suggestions. And this is just one of many examples. That’s why I strongly believe STEM programs in schools are a valuable opportunity to challenge stereotypes and give every student the chance to discover whether STEM is the right fit for them.”

To foster interest in science and engineering for girls, exposure to these fields at an early age is imperative. “STEM programs for girls in school play a crucial role in fostering interest, confidence, and skills in science, technology, engineering, and mathematics,” explains Jean Redmond, the chief operating officer at Biologit. “These programs provide early exposure to a wide range of career possibilities, helping to break down stereotypes and encourage more girls to pursue STEM fields. Given that technology and data-driven roles are often male-dominated, targeted initiatives can help bridge the gender gap and ensure that young women feel supported in pursuing these careers.”

Bridenbaker concurs. “Everything starts at school in terms of cultivating ambition and a sense of what you can achieve,” she says. “When I was at school and passionate about science, I was at times discouraged from pursuing this as a specialist subject and career on the basis that this would be a tough path for a woman and for raising a family; it was suggested instead that being a teacher was more realistic. Actively promoting STEM subjects to girls from an early age is essential to cultivate their passion, talent, and ambition, first so they have a vision and then so that they believe in themselves enough to pursue it.”

For example, a passion for science led Alex Tabbitt, quality control microbiologist at SERB Pharmaceuticals to study biology and chemistry and pursue a degree in forensic investigation. “I think there could be more done to encourage girls through school,” says Tabbitt. “The sciences can be hard and inaccessible, which could be tackled. I was always most engaged by the practical side of my studies—the experiments and the chance to see science in action. Perhaps more could be done to link what is learned in the classroom to its significance in the real world.”

Redmond points to programs like Girls Who Code, which helps girls build coding and AI skills, as gateways for women in healthcare industries. “By increasing representation in STEM fields, these initiatives help drive diversity in leadership and innovation in pharma and biotech,” Redmond says. “Additionally, mentorship, networking, and industry partnerships further support women in transitioning from education to impactful careers.”

Ensuring women have access to grants and jobs in STEM fields requires a ‘multi-faceted approach’ of financial support, mentorship, and changes in cultural norms, asserts Redmond. Having dedicated funding and education opportunities, including internships, for women can increase access to these STEM areas.

“Mentorship plays a key role, and many companies have established internal or external mentorship programs,” says Redmond. “Professional networks play a key role. I have personally benefitted from the incredible network of women from the IQVIA WIN ERG that has lasted over many years, and engaging in these groups can lead to many opportunities such as exposure to networking events, conferences, collaboration, and job opportunities.”

“The pharma industry should absolutely be investing in and promoting STEM career paths for girls,” says Bridenbaker. “It’s incumbent on them to do so. It’s about investing in a sustainable talent base, and about doing the right thing by half of the population. Not to mention accessing the many inherent leadership qualities that women bring to the table, and as drivers of technology-based process innovation.”

Gölden points to the concept of the "leaky pipeline", which describes how women are more likely to leave STEM fields at various stages of their careers, as a factor for the lack of women in these job positions. “From my perspective the leak arises mostly from the challenge of ‘working motherhood’,” says Gölden. “There are already great set-ups as maternity leave, that jobs are held, more and more flexible working models and so on, but it is not yet enough to fully enable mothers to be able to master the work-motherhood challenge.”

While Bridenbaker believes the advancement of women in STEM fields is improving, more could be done. She points to countries, such as the United Kingdom, Ireland, France, and Nordic countries, that actively protect women in the workplace by providing maternity and paternity leave and good work-life balance practices as having a head start in creating, and maintaining, STEM jobs for women. “Without good policies here, economies and employers are putting at risk a significant proportion of their workforce and future talent base, and by extension their long-term sustainability,” she says.

“Creating a supportive workplace is vital, with active promotion, by example,” says Cwienczek. “Also, ensuring a degree of flexibility and allowance for a heathy work-family balance; though, this is not relevant only for STEM fields.”

“In particular for women, a focus on supporting a return to work following maternity leave is a crucial area where women can benefit from support in their careers,” agrees Redmond. “Finally, increasing visibility of successful women in STEM provides role models and helps shift industry norms. Providing remote work, flexible hours, and parental leave options helps retain women in STEM careers.”

 for more coverage on the International Day of Women and Girls in Science.

1. UN. International Day of Women and Girls in Science, 11 February. 

https://www.un.org/en/observances/women-and-girls-in-science-day/

Investing in STEM programs for girls in an education setting and then supporting women as they excel in their professional careers is key to ensuring that vital highly skilled personnel are not left behind. 