Navigating Expedited Drug Development Pathways Globally: Q&A with Quotient Sciences Experts

As the demand for faster access to life-saving therapies grows, regulatory agencies around the world have introduced expedited approval pathways to accelerate drug development without compromising safety or efficacy.

Programs like the FDA’s Fast Track and Breakthrough Therapy designations offer sponsors a strategic advantage when developing treatments for serious or rare conditions.

Recently, a new type of designation, the Commissioner's National Priority Voucher (CNPV) program, was announced by the FDA. The CNPV aims to prioritize therapies that meet one of the following criteria:

• Addressing a U.S. health crisis
• Offering innovative cures for U.S. patients
• Meeting U.S. public health needs
• Boosting U.S. domestic drug manufacturing

Compared to current Fast Track, Breakthough Therapy, and similar FDA programs, CNPV vouchers are non-transferable and must be used within two years.1

Quotient Sciences experts address CMC challenges

Navigating these pathways bring CMC challenges requiring regulatory knowledge, technical agility, and a collaborative approach to development to solve.

In this Q&A, Brad Rowe, Senior Director of Integrated Development, and Robert Cornog, Senior Director of Product Development at Quotient Sciences, share insight on how clients can successfully leverage accelerated approval pathways.

From regulatory strategy and clinical manufacturing to risk mitigation and global alignment, they explore the critical elements that drive success in today’s fast-paced drug development landscape and how Quotient Sciences helps clients meet these needs.

What are expedited drug approval pathways and why do they matter?

Brad Rowe: Expedited approval pathways are regulatory mechanisms that allow drug developers to bring therapies to market faster—especially when treating serious or life-threatening conditions. Agencies including the FDA, EMA, PMDA, and others offer programs to support this.

Robert Cornog: These pathways are designed to balance speed with safety and efficacy. In 2024, 75% of novel drugs approved by the FDA used one or more of these designations. That shows how critical they’ve become in modern drug development.

How can pharma/biotech companies determine if their drug qualifies for an accelerated pathway?

Brad: There are several criteria that a company needs to meet to qualify for an expedited status and it varies by region. In the U.S., we often work with clients that have FDA Fast Track or similar. We have seen that between the different regulatory agencies, some qualifying questions are universal, like:

• Does the drug treat a life-threatening condition?
• What’s the global patient population?
• Is it significantly better than current treatments? Or is there an unmet need?

Robert: The principles we apply in the U.S. often translate to these global programs. Also, understanding the age of onset and diagnosis is key. For example, pediatric or geriatric populations may require different formulations. These factors shape early regulatory conversations and development strategies.

Why is choosing the right CDMO critical for accelerated development?

Brad: It has long been our standpoint that a CDMO should be more than a vendor—it should be a strategic partner. That is exactly what we aim to do at Quotient Sciences for our clients. You need a partner who really understands the stakes and is experienced.

Robert: And one who’s flexible, especially when working on a program for a rare disease where batch sizes are small and maintaining the same quality is paramount. Also, a smaller biotech company may also be navigating this process for the first time, possibly looking to license or divest the asset. A good CDMO can help build a roadmap that ensures continuity, even if the asset changes hands.

How does Quotient Sciences help manage compressed timelines and limited resources?

Robert: It’s all about alignment of resources—technical, financial, operational. They must match the program’s phase and risk profile. For example, late-stage development often overlaps with clinical and regulatory work. That means you need to identify and de-risk gaps early. 

In part, that’s why we advocate for integrated development—combining formulation, manufacturing, and clinical dosing, like we do with the Translational Pharmaceutics® platform. It allows for rapid iteration and smarter decision-making.

Brad: I would agree that the challenge isn’t entirely about how to manage the risk, but failing to prepare for it. Our Drug Development Consultants (DDCs) and project managers help our clients navigate decision points, clarify trade-offs, and keep programs on track.

For more insight, download our recent whitepaper and contact us about your next accelerated development program.

References: 1- https://www.pharmaceutical-technology.com/newsletters/fda-creates-new-priority-review-voucher-scheme-to-boost-us-interests

Summary: Victoria Hustler works as a Senior Director within Quotient Sciences’ Legal Affairs team in Nottingham, UK. She discusses her career with the company and what she enjoys most about her role.  

Get to know the people behind Quotient Sciences in our colleague Q&A series. 

What does a Senior Director, Legal Affairs do at Quotient Sciences?

As a Senior Director in Legal Affairs, I support the business by negotiating contracts and advising on a wide range of legal matters. I also help lead Quotient Sciences’ ESG initiatives, which is a rewarding way to contribute to our broader impact beyond the legal function – and it is something that I am passionate about.

Describe a typical day in Legal Affairs.

My day usually starts by checking emails and our group inbox to respond to any urgent queries. From there, I might be reviewing master service agreements, advising colleagues on legal risks, or collaborating with teams across the business. No two days are the same, which keeps things interesting.

How has your career progressed since joining us?

I joined Quotient Sciences in October 2023 after a decade in private practice as a corporate lawyer. Although I haven’t been here long, I’ve already had fantastic opportunities to grow. I’m currently taking part in Quotient Sciences’ “Developing Great Leaders” program and have recently started a part-time MBA at Nottingham Business School. The support I’ve received to pursue both has been incredible—it’s made the transition into an in-house role both exciting and rewarding.

What experience did you have before you worked at Quotient Sciences?

I worked in private practice as a corporate lawyer, where I advised businesses on things like setting up companies, buying or selling businesses, and raising investment. It gave me a solid grounding in how businesses operate, but moving in-house has added a whole new dimension—now I’m part of the decision-making process from the inside.

Did you require any qualifications for the role you applied for?

Yes, a law degree and a practising certificate were essential for the role.

What learning or qualifications have you gained in this role?

I’ve gained a much deeper understanding of how businesses operate, especially from the client’s perspective. Being on the other side of the table when instructing external counsel has been eye-opening and has helped me become a more commercially minded lawyer.

What do you enjoy most about your role?

What I enjoy most about my role at Quotient Sciences is the variety of work, the opportunity to collaborate with brilliant colleagues, and the supportive culture. I also really value the flexibility, which allows me to balance a fulfilling career with life outside of work—I have a young family, so that balance is incredibly important to me.

What aspects do you find most challenging?

Quotient Sciences operates in a highly technical and scientific space, so there’s always something new to learn. It can be challenging, but it’s also one of the things that makes the role so interesting.

What’s the team like?

I’m lucky to be part of a fantastic, supportive team. We work collaboratively, share ideas freely, and genuinely look out for one another. It’s a great environment to grow and thrive in.

What advice would you give to someone applying for a role in your team?

Do your research - make sure you understand what Quotient Sciences does and how your role would contribute to the bigger picture. And be yourself. We value authenticity and a collaborative mindset.

What do you like most about working at Quotient Sciences?

The people, the culture, and the sense of purpose. It’s inspiring to work for a company that’s making a real difference in the world of drug development, and to do so in an environment that supports both professional growth and personal well-being. 

“What I enjoy most about my role at Quotient Sciences is the variety of work, the opportunity to collaborate with brilliant colleagues, and the supportive culture.”

– Victoria Hustler

Advisory board will contribute to driving innovation and technology aligned with company strategic priorities

Inaugural board participants include established pharma & biotech executives, academics

NOTTINGHAM, UK; July 15, 2025–Quotient Sciences, a leading integrated CRDMO (contract research, development and manufacturing organization) for the pharmaceutical and biotech industry, is pleased to announce the formation of its Scientific Advisory Board (SAB) and appointment of inaugural members​ from the US, UK and Europe​. 

The Quotient Sciences SAB was formed to enhance the Company’s commitment to scientific innovation and excellence in drug development, with members providing a diverse range of views and specialisms.  

The SAB will work closely with Quotient Sciences' scientific and executive leadership to provide input on research and development priorities, technology investments, and scientific strategy.  

The founding board members are distinguished leaders from pharma, biotech, and academia with decades of experience in drug development, pharmaceutical manufacturing and drug delivery technologies. They are:  

Dr. Dominique Demolle, CEO of Cognivia: Dr. Demolle has held leadership roles at Eli Lilly, including Associate Director of Global Early Phase Operations. She co-founded Cognivia in 2013, leveraging machine learning and patient psychology to enhance clinical trials. Dr. Demolle was honored as one of the Most Inspiring People in Life Sciences by the 2022 PharmaVoice 100 awards. She earned her Ph.D. in Biochemistry from the University of Brussels.

Dr. Alastair Coupe, Independent CMC Consultant: Dr. Coupe brings deep expertise in drug development, regulatory strategy, and pediatric formulation from over 30 years of experience across senior scientific roles at Pfizer and 3M Health Care. Notably, he directed the cross-industry Innovate UK project focused on accelerating pediatric drug development, played a key role in securing funding for the UK’s National Formulation Centre, and led Pfizer’s efforts in addressing nitrosamine risk across its portfolio. Dr. Coupe earned his B.Pharm. and Ph.D. in drug delivery both from the University of Nottingham.  

Dr. Colin Rowlings, SVP of CMC at Actio Biosciences: Dr. Rowlings has led CMC teams across biotech companies including Gossamer Bio, Ardea Biosciences, and in his current position with Actio Biosciences. He has contributed to the development of oral, inhalation, nasal, and parenteral dosage forms, including enabling technologies such as ASDs and modified-release formulations, assisting over 30 biotech companies as an independent consultant. Dr. Rowlings earned his B.Pharm. in pharmacy from the University of Queensland, Australia and Ph.D. in pharmaceutics from the University of Iowa.

Professor Yvonne Perrie, Chair in Drug Delivery at the University of Strathclyde: Professor Perrie is an expert in drug and vaccine delivery systems, with prior academic appointments at Aston University. She has authored over 150 peer-reviewed papers, holds multiple patents, and is a Fellow of several scientific societies including the Royal Society of Chemistry and the Royal Pharmaceutical Society. In 2024, she was appointed a Member of the Order of the British Empire (MBE) in His Majesty the King’s New Year Honours List 2024 for services to pharmaceutical innovation and regulation. Professor Perrie earned her Ph.D. from the University of London.

"The collective experience and insight of the SAB​ will​ be invaluable as we continue to expand our technology and service offering.” commented Dr. Andy Lewis, Chief Scientific Officer, Quotient Sciences. “I’m looking forward to working closely with our Scientific Advisory Board members and seeing the positive impact their contributions make to our company’s future.”  

About Quotient Sciences

Quotient Sciences is an integrated CRDMO (contract research, development and manufacturing organization) providing services across the entire drug development pathway.  Our flagship platform for drug development, Translational Pharmaceutics®, has been trusted for integrated drug product formulation development and manufacturing with clinical testing activities for over 17 years. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. To learn more, visit quotientsciences.com.