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Fast-Tracking Innovation: Navigating Global Expedited Review Pathways

News & Announcements , Articles & Publications

Fast-Tracking Innovation: Navigating Global Expedited Review Pathways

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This article from Outsourced Pharma, offers a comprehensive roadmap to understanding key designations like Fast Track, Breakthrough Therapy, and Accelerated Approval, while highlighting the strategic questions sponsors must ask to determine eligibility.

It also emphasizes the critical role of experienced CDMO partners in managing technical, regulatory, and operational challenges, especially for rare and orphan diseases. 

With the right collaboration, sponsors can align resources, mitigate risks, and bring life-changing therapies to patients faster.

Read the full article on the Outsourced Pharma.

Tailored clinical manufacturing provides flexibility

Colleague Stories: Charlotte Hannigan

Careers , Nottingham

Colleague Stories: Charlotte Hannigan

Charlotte Hannigan

Summary: Charlotte Hannigan works as a Director within Quotient Sciences’ Business Development 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 Director of Business Development do at Quotient Sciences?  

In my role as a Director of Business Development, I support all accounts across the UK, Ireland and Japan, known as my ‘territory’. I focus on supporting accounts with the delivery of studies which involve a clinical component. This could be a standalone clinical pharmacology study or a study utilizing Quotient Sciences’ Translational Pharmaceutics® platform.  

My role involves identifying and engaging new clients, facilitating discussions between clients and our Drug Development Consultants (DDCs) to shape effective scopes of work, and supporting ongoing projects in collaboration with Project Management. I work closely with our legal team to ensure project readiness regarding key contracting activities including CDAs, MSAs and work orders.  

I also represent Quotient Sciences at industry events to enhance visibility and drive new business opportunities which involves working closely with the marketing team.  

Describe a typical day in Business Development.  

There’s really no such thing as a typical day in Business Development – it’s one of the things that makes the role so dynamic and engaging. My time is split between working from home, visiting Quotient Sciences sites for internal meetings or to host both prospective and existing clients, and being out on the road meeting clients at their facilities or attending industry events.

On any given day I might be digging into our CRM system to identify new opportunities within my territory, hosting kick off meetings alongside our project management and operational teams, driving from science park to science park to host onsite meetings, or exhibiting at events with thousands of people in attendance.  

Everyday brings a different set of priorities, challenges and conversations – no two days are ever the same.  

How has your career progressed since joining us?  

I joined Quotient Sciences in 2018, creating the role of Client Engagement Manager, a role in which I was responsible for implementing and establishing the Inside Sales function within the business. At the time, this was a new function for the company, so I had the opportunity to shape what Inside Sales looked like, defining our processes, identifying how we could best support the broader commercial team, and driving early engagement with potential clients. Over time, Inside Sales successfully grew to a team of four, building a strong foundation that continues to support the business today.

Following that role, I transitioned into the role of Associate Director of Business Development in 2021, where I was able to apply that commercial insight in a more client facing capacity. After deepening my client facing skills and contributing more directly to project scoping and delivery, I ultimately progressed into my current position of Director of Business Development in 2024.  

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

Before joining Quotient Sciences, my career began in a scientific role following University, where I worked as an analytical chemist. After a year, I progressed to become Team Leader of the stability department, gaining valuable experience in both laboratory operation and team management. I also learned I preferred spending my time outside of the laboratory and speaking with clients. This led me to pursue a new role, where I transitioned to another company moving into a Business Development role.  

In that role, I was responsible for implementing and coordinating sales and marketing activities. My work involved client management, generating new business opportunities, developing and executing a marketing plan, and conducting performance analysis with a strong awareness of industry trends. This combination of scientific and commercial experience laid a strong foundation for my move to Quotient Sciences.  

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

I didn’t need any additional qualifications for the role I applied for at Quotient Sciences as my industry experience was more than sufficient. However, my academic background is in Forensic Biology with Criminology, so a career in the pharmaceutical industry wasn’t something I had originally planned. As my career progressed, I chose to enhance my understanding of the sector by undertaking a Master of Science in Pharmaceutical Industrial Advanced Training with the University of Manchester, alongside my full-time work. This program gave me a comprehensive view of the industry, including the different functional areas, the requirements at each stage of drug development, and the journey from early research to commercial launch. It also deepened my understanding of the commercial functions that support pharmaceutical businesses, which has been incredibly valuable in my current role.  

What learning or qualifications have you gained in this role?

While Quotient Sciences supported me in gaining my Master’s degree, much of the most impactful learning I’ve experienced in my current role has been non-qualification, and honestly, it’s hard to put into words just how much I’ve gained over the last 7 years. The breadth of learning has been vast, covering everything from sales, marketing, and negotiation tactics to deeper skills like stakeholder management, strategic thinking, and relationship building. Beyond the technical or commercial knowledge, the role has also played a huge part in my personal development – helping me grow in confidence, adaptability, and resilience.  

What do you enjoy most about your role?

What I enjoy most about my role is the variety – no two days are ever the same, which keeps things fresh and engaging. I genuinely enjoy building strong relationships with potential clients, earning their trust, and helping them feel confident in Quotient Sciences’ ability to deliver or support their projects. There’s a real satisfaction in seeing those relationships turn in to successful collaborations. I also really value the travel aspect of the role. It’s a great opportunity to meet clients face to face, experience different cultures, and represent Quotient Sciences on a global level.  

What aspects do you find most challenging?  

What I find most challenging is the same thing I enjoy most – the variety. Because no two days are ever the same, that requires a high level of flexibility and adaptability, which can be both exciting and demanding. At home, I have a family with three young children so balancing the demands of a dynamic role with a busy home life means I must be exceptionally organized. I constantly need to plan and manage my time carefully to make sure everything is covered – both professionally and personally – depending on what each day or week brings.  

What’s the team like?  

The Business Development team at Quotient Sciences is incredibly supportive and approachable – everyone is always willing to share their experience and lend a hand when needed. There’s a strong depth of knowledge across the team, which makes it a great environment to learn and grow. That said, in my day to day work I probably collaborate most closely with the Drug Development Consultants, Project Management, and Marketing teams. These functions are central to the work I do-whether that’s building scopes of work, supporting study delivery or helping to shape external messaging and outreach. It’s a highly collaborative environment across the board, and that something I really value.  

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

My advice to anyone applying for a role in Business Development at Quotient Sciences would be to stay curious and ready to learn. It’s a fast paced, varied role where no two days are the same, so adaptability and a proactive mindset are key. Don’t worry about having all the answers on day one – what’s more important is being open to building relationships, asking questions, and understanding how Quotient Sciences’ unique offering supports our clients. Collaboration is a big part of the role, so being a strong communicator and team player will take you far. If you’re someone who enjoys problem solving, relationship-building, and being party of a supportive, dynamic team, then Business Development at Quotient Sciences is a great place to grow.  

What do you like most about working at Quotient Sciences?  

What I like most about working at Quotient Sciences is the variety my role offers – every day brings something new, which keeps the work engaging and fulfilling. I also really value the supportiveness of the people I work with, there’s a strong sense of collaboration across teams, and it’s a genuinely positive environment to be part of. The pharmaceutical industry is constantly evolving, and that dynamic nature means I’m always learning and adapting-my approach to the role continues to grow in response to both external trends and internal developments. On top of that, I appreciate the opportunities I’ve been given at Quotient Sciences to develop professionally and take on new challenges as my career progresses.  

“I genuinely enjoy building strong relationships with potential clients, earning their trust, and helping them feel confident in Quotient Sciences’ ability to deliver or support their projects.”

 – Charlotte Hannigan  

Jane McGuffog - Director, Modelling and Simulation

Jane McGuffog

Jane McGuffog

Director, Modelling and Simulation

Subject Expert
About

Jane McGuffog has over 30 years of experience in Drug Discovery and Development. She brings extensive expertise across the pharmaceutical R&D spectrum, with roles at companies including Parke Davis, Pfizer, Millennium Pharmaceuticals and Proximagen. In her last 7 years at BenevolentAI, she led DMPK, Safety, and Modelling functions, while also managing projects through Phase I and Phase II clinical development. Her deep knowledge spans DMPK, PBPK, and Translational Science, underpinned by a strong track record of project and people leadership.

At Quotient Sciences, she heads a seasoned team of modellers dedicated to advancing drug development through the application of Physiologically Based Biopharmaceutics Modelling (PBBM) and Physiologically Based Pharmacokinetic Modelling (PBPK)

She holds a BSc (Hons) in Applied Chemistry from the University of Portsmouth.

Quotient Sciences’ John McDermott Contributes to Pharmaceutical Outsourcing Oral Solid Dosage Roundtable

News & Announcements , Articles & Publications , John McDermott

Quotient Sciences’ John McDermott Contributes to Pharmaceutical Outsourcing Oral Solid Dosage Roundtable

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In this article from Pharmaceutical Outsourcing, John McDermott, Vice President of Scientific Consulting at Quotient Sciences, talks about the evolving landscape of oral solid dosage (OSD) manufacturing.

While 3D screen printing is revolutionizing drug formulation with its precision and customization, John emphasizes the continued relevance of batch manufacturing. 

John also talks about the increasing industry focus towards rare and orphan diseases and highlights the importance of small, agile CDMOs and a balanced approach to technology adoption to meet the diverse demands of modern drug development.

Speaking about trends that are driving the growth of the OSD contract manufacturing market, John notes: "Controlled-release formulations can provide an option for a more effective treatment and better patient compliance and offer an ideal life-cycle management solution. Careful development and control of these formulations is necessary to ensure the optimal pharmacokinetic profile is achieved."

Read the full article on the Pharmaceutical Outsourcing.

"Controlled-release formulations can provide an option for a more effective treatment and better patient compliance and offer an ideal life-cycle management solution."
-John McDermott

Q&A with Quotient Sciences’ John McDermott: Exploring the Benefits of Partnering with a CRDMO

News & Announcements , Articles & Publications , John McDermott

Q&A with Quotient Sciences’ John McDermott: Exploring the Benefits of Partnering with a CRDMO

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European Pharmaceutical Manufacturer speaks with John McDermott, Vice President of Scientific Consulting at Quotient Sciences, to explore the strategic advantages of partnering with a CRDMO.

John explains how CRDMOs—by integrating the capabilities of CROs and CDMOs—streamline the drug development process, reduce handoffs, and accelerate timelines. He highlights Quotient Sciences’ Translational Pharmaceutics® platform, a pioneering approach that unifies formulation, manufacturing, and clinical testing into a seamless process.

This integration not only enhances efficiency and reduces costs but also enables real-time decision-making and adaptive development strategies, ultimately bringing new therapies to patients faster.

Read the full article on European Pharmaceutical Manufacturer.

"CRDMOs offer a number of strategic and operational benefits for pharmaceutical and biotech companies... By consolidating services under one roof, CRDMOs eliminate the need for multiple handoffs between vendors."
-John McDermott

Dr. Asma Patel and Matt Pa­terson contribute to Drug Development & Delivery's special feature, 'Outsourcing Formulation Development & Manufacturing'

News & Announcements , Articles & Publications , Translational Pharmaceutics® , Dr. Asma Patel , Matt Paterson

Dr. Asma Patel and Matt Pa­terson contribute to Drug Development & Delivery's special feature, 'Outsourcing Formulation Development & Manufacturing'

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Translational Pharmaceutics® platform enhances drug development efficiency and decision-making, as highlighted as part of commentary from Quotient Sciences in recent Drug Development & Delivery's special feature on outsourcing.

Dr. Asma Patel, Vice President of Integrated Development Services, and Matt Pa­terson, Chief Strategy Officer and Head of Translational Pharmaceutics® platform, recently contributed to Drug Development & Delivery's special feature: "Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure."

When speaking on our Translational Pharma­ceutics® platform, Paterson says it is a disruptive approach to drug development that integrates drug product formulation and manufacturing with clinical testing, setting us apart from other industry providers. "The integration of services im­proves decision-making while reducing time and white space, so milestones can be achieved as efficiently as possible, shortening drug development timelines as a whole.”

Dr. Patel discusses how the platform ad­dressed a product development challenge for one client. She explains, “We worked on a project for Rigel Pharmaceuticals, which was develop­ing R552, a small molecule RIPK1 inhibitor for autoimmune and inflammatory disor­ders. Preclinical data showed potential sol­ubility issues and, therefore, the client wanted to evaluate a range of formula­tions for the first-in-human (FIH) study. Leveraging the Translational Pharmaceu­tics® platform, we conducted an adaptive FIH study to develop lipid and solid disper­sion (SDD) formulations to enhance solu­bility. These formulations underwent rapid, iterative testing, allowing for immediate adjustments and optimization.”

Read the full article here on Drug Development & Delivery's website.

"The integration of services [with the Translational Pharma­ceutics® platform] im­proves decision-making while reducing time and white space, so milestones can be achieved as efficiently as possible, shortening drug development timelines as a whole.” 
-Matt Pa­terson

Clinical and Formulation Strategies for Targeted Peptide Drug Development: Q&A with Dr. Andrew Lewis

Whitepapers , Peptide Drug Development , Oral Peptides

Clinical and Formulation Strategies for Targeted Peptide Drug Development: Q&A with Dr. Andrew Lewis

1 June 2025
Overview

Rapid innovation in drug discovery, peptide engineering, and drug delivery is expanding the boundaries of peptide-based therapeutics.

Novel technologies and therapies are helping drug developers to overcome challenges associated with the development of injectable and oral peptide formulations, including rapid clearance, poor permeability, and instability in some drug product solutions, in plasma, and in the gastrointestinal (GI) tract.

Dr. Andrew Lewis, Chief Scientific Officer at Quotient Sciences, examined how chemistry, manufacturing, and controls (CMC) and clinical strategies for peptide drugs can be further improved, answering questions on the challenges and potential solutions associated with development of injectable and oral peptide drugs.

Download "Clinical and Formulation Strategies for Targeted Peptide Drug Development: Q&A with Dr. Andrew Lewis" to read the interview.

Download
Date
1 June 2025

Dr. Helen Baker and Dr. Richard Castledine contribute to Pharmaceutical Technology's 'Poor API Quality Threatens a Healthy Supply'

News & Announcements , Articles & Publications , Dr. Helen Baker , Dr. Richard Castledine

Dr. Helen Baker and Dr. Richard Castledine contribute to Pharmaceutical Technology's 'Poor API Quality Threatens a Healthy Supply'

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Dr. Helen Baker, Director of Formulation Design, and Dr. Richard Castledine, Head of Drug Substance Operations, contribute to Pharmaceutical Technology's issue, 'Poor API Quality Threatens a Healthy Supply'.

The API is, one might say, the most important element in a pharmaceutical product. Poor API quality may often lead to delays in production and a shortage of supply.

Dr. Castledine emphasizes that poor quality API presents several risks to the drug product, supply chain, and ultimately patients, ranging from a lack of efficacy to the possibility of toxicity.

Dr. Baker explains how more drugs than ever are now classed as highly potent, discussing how HPAPIs present additional CMC challenges due to the containment requirements to protect both the operators and manufacturing facilities. 

Read the full article on Pharmaceutical Technology's website here.

Alaa Hosny - Head of Development

Alaa Hosny

Alaa Hosny

Head of Development

Subject Expert
About

Alaa Hosny has over 15 years of experience in the pharmaceutical industry, specializing in drug product development from early formulation design through clinical implementation. In his role as Head of Development, Alaa leads development teams and collaborates across functions to deliver complex projects efficiently and on time, driving results through strategic planning and technical expertise.

Alaa’s experience spans enabling technologies such as lipid-based formulations and spray drying, as well as modified-release dosage forms. He has a strong track record in developing innovative solutions for challenging molecules, optimizing bioavailability, and ensuring robust product performance. Prior to Quotient Sciences, Alaa gained experience in development and scale-up of generic formulations for commercial manufacturing.

Alaa holds an MSc in Drug Delivery from Aston University and has a deep interest in advancing formulation strategies that accelerate the path from concept to clinic.

Nick McEntee - Executive Director and Head of UK GMP Operations

Nick McEntee

Nick McEntee

Executive Director and Head of UK GMP Operations

Subject Expert
About

Nicholas McEntee has over 20 years of experience in pharmaceutical manufacturing and clinical trial supply. As Executive Director and Head of UK GMP Operations at Quotient Sciences, he oversees formulation development, GMP manufacturing, and global clinical trial supply. His expertise spans facility expansion, process optimization, and cross-functional capability development.

Nick holds a B.Sc. in Chemical and Pharmaceutical Sciences from the University of Sunderland and an HND in Chemistry from Staffordshire University.

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