An interview with Martin Wing-King, Vice President and General Manager, Site Head at Quotient Sciences – Reading 

Over the last three decades, Quotient Sciences has established a reputation for efficiently accelerating to first-in-human (FIH) clinical trials through capabilities to provide integrated drug product and clinical pharmacology expertise. 

In this article, Martin Wing-King, Vice President and General Manager, Site Head at Quotient Sciences - Reading, discusses the demand for accelerated pathways to first-in-human (FiH) trials, the team's experience and capabilities offered on-site at Reading.

Martin discusses how recent equipment additions in Reading give greater flexibility for drug product manufacturing across indications and patient populations, including pediatrics drug programs, orphan drugs for rare diseases, and psychedelics drug programs. He also highlights how Reading collaborates with Quotient Sciences facilities in the UK and US to offer holistic drug program support for customers across the globe.

As part of our strategy to build Reading as a center of excellence for drug products within our global network, this year we are completing the installation and commissioning of an additional Xcelodose model 600s and a 3P Innovation model R1000 robotic capsule filler. 

What is driving the demand for accelerated pathways to first-in-human (FiH) trials, and what are some typical challenges faced in early development? 

It is well-known that developing a new drug is a long and complex process. Very few compounds make it to a licensed medicine, sometimes taking between 10 and 15 years. At any point, a new product could be rejected due to safety, effectiveness, or quality. 

Considering how the time and costs add up along the way, failure in first-in-human studies (FIH) could mean a significant setback. The enormous time and cost savings are evident if we can help our clients de-risk at this stage. Quotient Sciences has played a pivotal role in helping our customers accelerate into FIH trials, attributed largely to Translational Pharmaceutics®, a platform we have been leveraging for over 16 years. This platform enables us to obtain clinical data more rapidly, leading to a significant reduction in early development time and cost. 

Early data can be crucial in determining whether the molecule should be developed further, instilling a sense of optimism about potential outcomes, or in a worst-case scenario, allow the client to “fail fast” and move on to another program or go back to an earlier formulation or candidate if necessary. We know this is true for all customers but especially for small and midsize biotechs that may have one compound in their pipeline at the present time. They want to ensure that the clinical data is going to tell them what is working and what is not in case they need to pivot to get a more marketable formulation.

Could you share background about Quotient Sciences – Reading and its capabilities? 

Quotient Sciences - Reading was established over 25 years ago as Pharmaterials Ltd. and was acquired in 2017, creating the company that Quotient Sciences is today. The Reading site was established with teams that had deep experience in the material science behind APIs. With this foundational understanding of drug substance, we added formulation development and manufacturing capabilities. 

Our teams have always strived to understand the physical properties of APIs before commencing formulation development and manufacturing—and still do—so we can be successful as we scale drug product manufacturing without having to worry about drug substance issues. Today, the Reading site offers a wide range of capabilities, including solid oral dose, liquid, and inhalation dosage forms.

Tell us about your role at Quotient Sciences. What brought you to join the company?

I have been with the Reading, UK site for just over 16 years, including two years and counting as the facility’s site head. I was part of the commercial team at the time that Pharmaterials Ltd. was acquired. Before the acquisition, the legacy companies would compete in the early development space. I was always curious about Translational Pharmaceutics® and the combined CDMO and CRO capabilities at Nottingham. The due diligence during the acquisition showed great synergies between the two companies and the journey that we were about to embark upon.

In my current role as Vice President and General Manager, Site Head, I am accountable for ensuring that we deliver on our targets set for the facility safely, compliantly, and efficiently, and in a financially-responsible way. As one of Quotient Sciences’ subject matter experts, I also help ensure that we have the right capabilities to deliver project scopes. Prior to this, I was in the project management department for almost five years and ten years in business development roles.

What changes are being made at Reading to available equipment? 

As part of our strategy to build Reading as a center of excellence for drug products within our global network, this year we are completing the installation and commissioning of an additional Xcelodose model 600s and a 3P Innovation model R1000 robotic capsule filler. 

A Fill2Weight capsule filling machine from 3P Innovation will be installed in Q3 2024. This is a versatile robotic capsule-filling machine that can fill powder with challenging properties, such as spray-dried powders and poor-flowing APIs, whilst avoiding powder compaction. The Fill2Weight system fills to a target weight rather than dispenses a fixed volume. This allows for compensation to changes in capsule weights and powder properties. The machine also has “recipe cards” that can be used where the fill weight and API properties are typed into the machine and the machine can take over from there. 

Having access to a variety of equipment under one roof means that we can develop and manufacture the required product even faster for our customers. These pieces of equipment sit alongside the existing Xcelodose that we already have on-site, and a Harro Höfliger ‐ Modu-C LS machine, which doses powder using a vacuum drum system.

What are some of the featured departments at Quotient Sciences – Reading?

The project management team is at the heart of all the customer projects at the site, and Project managers (PMs) are the face of Quotient Sciences to the customer. They work with the customer from the very start of a project to the end and coordinate with all aspects of the business, from operational teams to finance and business development, on the delivery of a program. Kirsty Webster is currently the Head of Project Management for Quotient Sciences—Reading.

Our development team, led by Mihaela Totolici, consists of scientists who use their expertise in dosage form design to create high-quality, safe, and effective drug delivery systems. Applying technical expertise while prioritizing client needs enables the team to collaborate effectively and make significant contributions to developing marketable molecules.

The analytical teams, led by Laura Willis and George Williams, are responsible for the analytical testing of the drug product dosage forms we develop and manufacture to ensure they meet the required specifications. The department utilizes advanced instrumentation to perform the required analysis in accordance with Good Manufacturing Practice (GMP) standards.

Having access to a variety of equipment under one roof means that we can develop and manufacture the required product even faster for our customers. 

How does the team at Reading work alongside other sites in Quotient Sciences’ network?

Within Quotient Sciences, we have added capabilities for drug substance synthesis and manufacturing, along with related services like bioanalysis and 14C drug substance radiolabeling, through the acquisition of our Alnwick, UK facility, formerly Arcinova, in 2021.

Another differentiator that we have built as a company over the last two decades is direct access to Phase I clinics with our facilities in Miami, FL, and Nottingham, UK. This helps to remove hand-overs that add time to the drug programs we are working on; tech transfer time and cost can be reduced, and for the most part eliminated, by combining CRO and CDMO capabilities within one organization. 

Finally, when a drug is scaled up further downstream, we can do the Phase III work and larger-scale commercial batches in Philadelphia, PA, where we have two facilities.

In the next part of this two-part series, Martin discusses the company’s approach to formulation development, explaining the approach to “simple” as well as “complex” dosage forms, and how the Company is enabling pediatric and rare disease indication needs.
 

Quotient Sciences’ facilities in Garnet Valley and Boothwyn are located just outside of Philadelphia. 

Together, the facilities support small-molecule oral solid dose (OSD) formulation development and drug product manufacturing, with capabilities for small batches for Phase I/II trials through late-phase manufacturing and commercial product supply.

As part of recent site leadership appointments, Nichole Caparelli has joined the company as Sr. Director, Quality Operations. Ms. Caparelli has over two decades of experience in quality and operations roles with companies including Johnson Matthey, Veranova, and Flamma Group. Marlene Leuenberger has also recently joined as Vice President and General Manager of Quotient Sciences’ Philadelphia facilities.

In this interview, Nichole discusses her new role and enhancements at Quotient Sciences – Philadelphia that focus on quality.

Tell us about yourself and your background.

My career has been focused on small molecule manufacturing, including product development through commercialization. At past organizations, I have been responsible for implementing and overseeing quality management systems and driving continuous improvement initiatives that enhance overall product and process quality and operational efficiency. This involved successfully leading regulatory authority inspections and ensuring quality management systems are in place, in use, and effectively monitored to facilitate compliance with cGMP requirements. Most recently, I was a Quality Director at Flamma USA, leading the QA, QC and stability teams in the development and implementation of comprehensive quality management systems.

What initially got you interested in a career in Pharma?

My choice to pursue a career in pharmaceuticals was driven by my desire to make a tangible difference in people’s lives and my admiration for the complexity and innovation inherent in the industry.  I am eager to contribute my skills and knowledge to a field that holds such profound significance for global health.

What will your role focus on at Quotient Sciences – Philadelphia?

In my new role, I report into our global quality department and will be responsible specifically for the Quotient Sciences – Philadelphia sites. This involves leading the quality system, project quality assurance, and quality control functions at both of our Philadelphia facilities.

What developments are on the horizon this year to enhance quality and related systems or processes at Quotient Sciences – Philadelphia?

For 2024, we are focused on continuing to build Philadelphia's overall site quality culture. This will be done largely through continuous improvement and a focus on the people, processes, and systems for quality. I will be leading the site quality operations team to consistently achieve compliance targets and aid in transforming the site's approach to quality.  

Learn more about Quotient Science's facilities in Boothwyn, PA and Garnet Valley, PA.

PHILADELPHIA, PA; June 5, 2024 – Quotient Sciences, the drug development and manufacturing accelerator, has announced changes to its operational leadership team for its Philadelphia, Pa. facilities. Marlene Leuenberger has joined as Vice President and General Manager of Quotient Sciences’ Philadelphia facilities. 

Ms. Leuenberger is an established operations leader with over three decades of experience in the pharmaceuticals and consumer health industries with companies including Procter & Gamble, Wyeth Pharmaceuticals, and Novartis Consumer Health. Prior to joining Quotient Sciences, Marlene was Vice President of Operations and Site Head at Jubilant Cadista Pharmaceuticals in Salisbury, Maryland and General Manager at Catalent in Somerset, NJ. She holds a Bachelor of Science in chemical engineering from Clarkson University.

Together, Quotient Sciences’ facilities in Garnet Valley and Boothwyn, located just outside of Philadelphia, support small-molecule oral solid dose (OSD) formulation development and drug product manufacturing, with capabilities to support small batches for Phase I/II trials through late-phase manufacturing and commercial drug product supply.

“Our team in Philadelphia is pivotal to how we support our customers in delivering drug programs every day.” said Paul Ryan, Chief Operating Officer - Drug Substance & Drug Product at Quotient Sciences. “I’m looking forward to working with Marlene on a renewed commitment to operational excellence at our Philadelphia sites, as we continue to grow Quotient Sciences as a global leader and preferred CDMO/CRO partner for integrated drug development.” 
 

Alejandra Ugalde is the Screening Manager at our Miami, FL facility.

Alejandra supports volunteer screening and volunteer recruitment for our Phase I clinical trials. In this interview, she shares a day in the life of her role. 

What I enjoy most about my role is the people, including working with patients or volunteers, our screening team, and our whole Miami team. I really enjoy the patient care aspect of my nursing education and the ability to apply that here at Quotient Sciences.

-    Alejandra Ugalde

What does a screening Manager do at Quotient Sciences?

As a Screening Manager, I oversee all screening activities and volunteer recruitment on a day-to-day basis, providing guidance and support to the screening team. Our main priority is to ensure that all ongoing or new clinical trials are enrolled in full and deadlines are met on time.

What does your typical day look like?

A typical day within the screening department means that we can process around 10 to 30 volunteers a day. We are the first faces that the volunteers get to see when they come to Quotient Sciences - Miami, so we try to make their experience memorable and make sure that any issues or queries get resolved. We are also responsible for reviewing the informed consent for any trial that they’re here to participate in, conducting a thorough medical history and physical exam, and coinciding with the protocol restrictions for these screening procedures (like vital signs, ECG, and specimen collection for laboratory processing.)

How has your career progressed since joining Quotient Sciences?

At Quotient Sciences, we believe in fostering career growth. I have had the opportunity to expand my skills and responsibilities significantly since joining the company. I would say that my interpersonal skills have been sharpened, and my leadership skills have improved. I also didn’t come to Quotient Sciences with managerial experience, but I have been very hands-on and have learned on the go about what it takes to lead a successful team. My team has been so patient and understanding; I’m very thankful for all their support, especially as we’ve navigated a high influx of trials to meet enrolment deadlines and expectations of our sponsors.

What experience did you have before Quotient Sciences?

Prior to working as a Screening Manager, I worked at Quotient Sciences a few years back as a data entry coordinator. My main responsibilities were data entry and cleansing, and resolving any queries arising from the EDC or our eSource system, which we use for volunteer management and operations in Miami. I left this role and enrolled at Florida International University where I completed my Bachelor of Science in Nursing. My nursing background helped me return to Quotient Sciences in my role supporting the various aspects of volunteer screening and recruitment for our Phase I clinical trials.

What learning or qualifications have you gained since being here?

To be a Screening Manager, the qualifications were either having a registered nurse’s license or a Bachelor of Science in nursing with at least two years of clinical research experience. Since I have been with Quotient Sciences, I am grateful that the company supported my continuing education and training, and I have been able to acquire my Advanced Cardiac Life Support Certification (ACLS). Also, I have been able to apply leadership skills like conflict resolution and mentorship to ensure that the team always feels supported, motivated, or guided through any issues we encounter.

What do you enjoy most about your role?

What I enjoy most about my role is the people, including working with patients or volunteers, our screening team, and our whole Miami team. I really enjoy the patient care aspect of my nursing education and the ability to apply that here at Quotient Sciences in a lot of different ways, from conducting a medical history and assisting technicians with vitals and ECG, to doing volunteer check-in with our registration coordinators and assisting our volunteer recruiters.

What aspects do you find most challenging?

The team is comprised of many different roles including research technicians, volunteer recruiters, and front desk coordinators. Not every day is going to be easy, but we all support each other and get through our challenges. One of the more difficult aspects of being a Screening Manager is delivering bad news. That usually means telling a volunteer when they are ineligible for a trial, which can be for several reasons, such as the person may not be healthy enough to participate at this time, or trials may be moved or canceled. I’m responsible for making sure that volunteers are informed when there are changes, to let them know that they may be eligible in the future and that we can stay in touch.

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

Be prepared for a fast-paced environment—this really lives up to our manifesto at Quotient Science, “Molecule to cure. Fast.” We all need to be mindful of working efficiently while upholding the utmost quality throughout all of our clinical trials.

What do you like most about working at Quotient Sciences?

There is always an opportunity to learn, whether directly from a colleague or from learning what a department as a whole does and the impact that it has on the company, like project management, clinical, medical, database programming, data sciences—the list goes on. It’s really nice to see that we can all get together and understand each other’s roles, and how each person and function impacts a clinical trial’s success. 

The article reflects on various interviews held during CPHI North America in Philadelphia. The event took place at the Philadelphia Convention Center from May 7th to 9th, 2024. 

Unlike its overseas counterparts, CPHI NA operates on a smaller scale, creating a less hectic environment. Attendees engage in longer, nuanced conversations without the stress of constant meetings.

One notable interview was with Tim Quinn, Vice-President and General Manager Pharmaceuticals at Actylis. Actylis is a supplier and manufacturer of raw materials and performance ingredients. Quinn emphasized the company’s efforts to diversify its materials offerings by acquiring seven companies over the past four years. Actylis aims to provide any component that goes into an API product quickly, recognizing the importance of process speed.

To read more, check out the full article here on the Life Sciences Knowledge Hub website.