Bethanne Lee is a Project Manager working with our Miami, FL and Philadelphia, PA facilities. 

In her role, she helps streamline the implementation of Translational Pharmaceutics® programs in the US. She shares more about her role with Quotient Sciences and day-to-day in this interview. 

“The business lives by its manifesto, which is another aspect I like about working at Quotient Sciences. Decision-making is built around this, our culture fosters this, and our efforts in innovations are piloted by this.”

-Bethanne Lee

What does a project manager do at Quotient Sciences?  

In my role as a project manager at Quotient Sciences, my responsibility is to ensure the successful delivery of projects within set timelines, budget, and quality standards. A crucial part of my role involves leading and coordinating project activities with both my project team and the customer’s team to ensure seamless collaboration.

Describe a typical day in project management at Quotient Sciences.

Any typical day in project management can include preparing for upcoming customer meetings, issuing minutes, finishing follow-up activities from previous customer meetings, and meeting internally to track important activities within the project team. As a project manager, we work internally to find de-risking measures for the program, resolutions to any unforeseen issues that have arrived, and making decisions to progress a customer’s program. From time to time, project managers also support writing change orders.

How has your career at Quotient Sciences progressed?  

The Philadelphia site was previously QS Pharma and was acquired by Quotient Sciences in 2017. At this time, I was a financial analyst working part-time and previously held full-time positions as a laboratory scientist and business development manager since 2004.  

In 2020, I applied for and accepted a full-time position as a client services associate. This role had a global reach where our department supported services across all of Quotient Sciences’ sites in the UK and US. This role enabled me to expand my knowledge from drug product development and manufacturing to other areas of pharmaceutical development such as clinical pharmacology, bioanalysis, 14C ADME studies, and drug substance synthesis and manufacturing.  

In 2022, a project management position opened at the Philadelphia site. With previous technical, sales, and key account experiences, I wanted to take this knowledge and apply it to successfully manage projects. I was eager to do so with a passion for customer and team interactions that foster a healthy teamwork environment.

What experience did you have before you started in your role?

I’ve been with Quotient Sciences since 2004, after graduating from the University of Delaware with a Bachelor of Science degree in Laboratory Science. Prior to Quotient Sciences’ acquisition of QS Pharma in 2017, I held roles as an analytical scientist, project coordinator, business development manager, and financial analyst.

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

I joined Quotient Sciences after graduating with my Bachelor of Science degree. In later roles with the company, I went on to obtain a Master of Science degree in Biomedical Science & Engineering from Drexel University and an MBA from Wesley College. These qualifications, congruent with experience in pharmaceutical development from a contract development and manufacturing organization (CDMO) perspective over the course of many years, have been very beneficial for the project manager role.

What learning or qualifications have you gained in this role?

In a typical drug product CDMO setting, a project manager might manage early-stage programs (Phase I and II), late-stage programs (Phase III, registration, validation, commercial), or be able to see a project through the whole process. Here, I have had the opportunity to manage our Translational Pharmaceutics® programs, a platform that touches all stages and truly lives our manifesto: Molecule to Cure. Fast. 

What is unique about Translational Pharmaceutics® is the real-time, adaptive, clinical manufacturing at our Philadelphia site based on emerging clinical data between cohorts, regimens, or periods being conducted at our clinic in Miami. In this setting, we learn the clinical pharmacology aspects of clinical trials and partner very closely with our clinical team throughout the project to manufacture and release the clinical supply for each dosing.

What do you enjoy most about your role?

A project manager is involved in various aspects of the business, which is what I find most enjoyable. They have a broad understanding of the operations and procedures across different departments, which is crucial for the success of a project. Additionally, they have financial responsibilities and must possess or be able to develop a strong business acumen, including the ability to effectively communicate with different teams.  

What aspects do you find most challenging?  

During some aspects of a program, an important activity or milestone may rely on individuals or departments that are not aware of the objectives of the project. The importance of meeting the milestone is, therefore, not an accountable action. This is what I find most challenging. Sometimes this is anticipated, making it crucial to be a step ahead and work with those individuals or departments so they also understand the objectives that the team is working towards. Sometimes this is not anticipated, making timely and effective communication key in bringing everyone on board with the goals the team is putting their efforts toward.  

What’s the team like?  

The project management department is a wonderful group of colleagues at all different levels of our careers. While we don’t work together within our project teams, as a department we rely on each other for support, meet frequently as a group, and create an environment to share best practices and structure for continual improvement. The project teams I work with are simply outstanding. I could not ask for a better group of extremely smart, scientifically-sound, motivated, and accountable team members to work with. We all share similar passions for bringing molecules to cures. Fast.

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

Do you like being an integral part of developing treatments and cures for patients? Does the word communication spur thoughts of opportunity and teamwork? Is customer satisfaction just as rewarding to you as it is for them? If yes to these questions, you would thrive in the project management team at Quotient Sciences.

What do you like most about working at Quotient Sciences?  

As a project manager, you start to build your team camaraderie and effectiveness by ensuring all members understand the project's purpose, objectives, and expectations. We have a great teamwork environment where we all hold each other accountable through support and motivation.  

The business lives by its manifesto, which is another aspect I like about working at Quotient Sciences. Decision-making is built around this, our culture fosters this, and our efforts in innovations are piloted by this. It is a rewarding feeling after every day knowing that what was accomplished daily was achieved through a business structured in integration and adaptiveness, enabling our projects to run better and ultimately achieving our manifesto in the process. 

Summary: In July 2024, the FDA released final guidance on human radiolabeled mass balance (ADME) studies, outlining expectations for study design, including the number of evaluable subjects and criteria for mass balance recovery. This guidance affects drug developers and CROs, necessitating updated compliance strategies. These measures align with FDA requirements and aim to streamline ADME study processes.

The FDA issued its final guidance on the clinical pharmacology considerations for human radiolabeled mass balance studies (ADME, or hADME) in July 2024. 

The draft guidance, published in May 2022, had an immediate impact on the expectations of the study design and conduct of ADME studies, such as the expected number of evaluable subjects, while other parts, such as expectations around the criteria for mass balance recovery and the recognition of the different approaches to metabolite characterization by AMS-enable investigations, were still being evaluated.  

With the finalization of this guidance, drug developers, clinical research organizations (CRO’s), and other outsourcing partners are establishing new compliance strategies for conducting ADME programs in 2024 and beyond. In this article, Dr. Adam Robinson-Miller, Senior Manager, 14C Enabled Drug Development, shares thoughts on the newly approved guidelines' impact for the industry.

What are human ADME studies?  

Conventional ADME and AMS-enabled mass balance (also called microADME) studies are usually straightforward in their design. In these programs, single-dose studies are typically conducted in a small cohort of healthy volunteers to help drug companies generate data to support drug development and registration. 

The goals of an ADME study are to understand of the recovery of the radioactivity administered as the parent drug, identify the routes and rates of elimination, and generate samples of plasma, urine, and feces to allow for metabolite profiling and identification. 

At Quotient Sciences, our ADME studies utilize 14C radiolabeled drug substances.

When is an ADME study typically conducted?

A human mass balance/ADME study is a requirement prior to submitting a New Drug Application (NDA). These studies are typically performed before the end of Phase II, although they may be done sooner depending on the indication or in cases where there is fast track or orphan drug designation which may shorten the overall development timeline.

What is the FDA guidance on mass balance?

The FDA’s guidance has described for the first time the agency's expectations for conducting these studies. Many of the expectations reflect the design and conduct of these studies over many years. There are some differences between the traditional approach to conventional and microADME studies that have been significant and have been translated into the final guidance document. 

Key topics of interest include:

• An increase in the number of evaluable subjects
• Consideration around the target % radioactivity recovered from the radiolabeled dose
• Best practice with respect to pooling and profiling methodology across different study designs
• Guidance around the design of AMS enabled studies

Quotient Sciences have described our approach to address potential changes, from the draft guidance in a poster presented at ISSX Boston 2023 and video.

What is Quotient Sciences’ approach to ADME studies?

Quotient Sciences have evaluated the new guidance to ensure that our ADME programs can remain compliant with the new requirements, including: 

• Recommendation to dosing increase to n=8. This allows us to de-risk the likelihood of completing an ADME with an incomplete data set. There will be situations when we must consider restricting dosing. For example, when administering a higher dose than 1mSv or administering an oncology molecule in healthy volunteers, which may make recruitment challenging. In those scenarios, we would discuss the suitability of dosing n=6 subjects only and strategies to maximize the resultant dataset.
• Discharge criteria greater than 90% and less than 1% on 2 consecutive days. Challenges may be faced when recovery does not reach 90% but remains greater than 1% each day; we might be obligated to continue collecting until 90% is achieved. This could result in extended residency periods for drugs with very long terminal half-life. This risk is mitigated by ensuring appropriate wording to allow flexibility and investigator discretion, with robust discussions with our partners.
• Greater than 80% radioactivity in excreta to be identified. This ensures compliance in our metabolite profiling and identification scope.

How will ADME studies be conducted in the future?

We know that ADME studies are critical to adequately describe the metabolism of their study drug and, therefore, to their program’s success in meeting its milestones to reach the market. These changes underscore the FDA’s commitment to rigorous scientific evaluation, a value that is also core to our mission as a company. 

As the technology is now firmly established, there is also an increased demand for AMS-enabled microADME studies. Both approaches allow the generation of critical data to support new drug registration. Quotient Sciences can adopt either methodology as reflected by the specific needs of the molecule. 

Quotient Sciences can support conducting human mass balance studies that meet the highest regulatory standards. Contact us to discuss your next ADME program. 

In the rapidly evolving bio/pharmaceutical industry, integrating advanced technologies and patient-centric strategies is crucial for formulation success. This article by Pharma Tech explores how digitalization, artificial intelligence (AI), and machine learning (ML) are revolutionizing drug development. 

By leveraging these technologies, companies can enhance efficiency, predict outcomes, and minimize formulation failures, ultimately leading to more effective and patient-friendly therapies. 

Dr. Asma Patel, vice president of Integrated Development Services at Quotient Sciences, points out that patient centricity is a growing need for pediatric patients as these patients require age-appropriate and palatable dosage forms.

Continue reading the article on Pharma Tech.

In this article by the Manufacturing Chemist, Dr Andy Lewis, Chief Scientific Officer at Quotient Sciences reviews the trends driving the adoption of oral peptide products and considers the strategies to overcome the development challenges associated with effective delivery.

The article explores the future of GLP-1s and oral peptides, as advancements in drug delivery are transforming treatment options for patients.

Recent innovations are enabling the development of oral peptide products, which offer a more convenient and non-invasive alternative.

Given that approximately 90% of drugs fail during the clinical trial phase, developing strategies to address this is imperative.

Continue reading the article on Manufacturing Chemist.