Summary: Dr. Helen Baker, Director of Formulation Design, and Dr. Vanessa Zann, VP of Scientific Consulting - U.S. Translational Pharmaceutics® & Clinical Pharmacology at Quotient Sciences, discuss the difference Translational Pharmaceutics® makes in drug development. Translational Pharmaceutics® integrates drug product formulation, manufacturing, and clinical testing, reducing timelines and costs. They explain how Quotient Sciences U.S. facilities in Philadelphia and Miami conduct these programs, giving options to clients who choose to work with a Quotient Sciences Translational Pharmaceutics® program in either the U.S. or in the U.K.

How does Quotient Sciences conduct Translational Pharmaceutics® from our U.S. facilities?

For nearly 20 years, Quotient Sciences has been at the forefront of integrated CRDMO solutions through Translational Pharmaceutics®. This pioneering approach merges operational efficiency, scientific rigor, and clinical insights into a seamless program—managed under a single organization with a dedicated program manager. 

Collectively, we’ve completed more than 500 Translational Pharmaceutics® programs worldwide for more than 100 customers. While the Translational Pharmaceutics® platform has been used in the U.K. for over 17 years, Quotient Sciences has also been successfully running Translational Pharmaceutics® programs in the United States for over eight years, with significant growth and investment in recent years. 

Q&A with Dr. Helen Baker and Dr. Vanessa Zann on Quotient Sciences’ U.S. Translational Pharmaceutics® Capabilities

To discuss the evolution and impact of using Translational Pharmaceutics® programs to accelerate drug development for pharma and biotech clients in the U.S., we spoke with Dr. Helen Baker, Director of Formulation Design at Quotient Sciences, and Dr. Vanessa Zann, Vice President, Scientific Consulting, U.S. Translational Pharmaceutics® & Clinical Pharmacology.

Q: Translational Pharmaceutics® has been a core part of Quotient Sciences’ approach to drug development for nearly two decades. How has the U.S. offering evolved in recent years?

Dr. Baker: Our U.S. Translational Pharmaceutics® offering has developed significantly since we started our first programs, which are a partnership between our Philadelphia, PA and Miami, FL facilities to fully execute. Effectively, we have rebuilt our operations for Translational Pharmaceutics® in the U.S. to operate independently from traditional early and late-stage development or patient supply programs, such as clinical trial materials manufacturing.

Unlike traditional drug development, where drug product manufacturing and clinical testing are performed by entirely separate entities, Translational Pharmaceutics® maintains full control of the supply chain. Our CMC, quality, regulatory and clinical teams are fully integrated. 

Dr. Zann: Translational Pharmaceutics® requires a different way of working to conventional CDMO or CRO approaches. We have a dedicated team focused on U.S. Translational Pharmaceutics® and have expanded the capabilities of our U.S. sites to support Translational Pharmaceutics® projects that includes:

• Dedicated CMC and project management leadership
• Dedicated formulation, QA, and analytical support
• Expanded R&D lab spaces with cutting-edge equipment

Additionally, we’re coming up on the five-year anniversary of the expansion of our Miami pharmacy compounding capabilities. Our Miami site is a clinical pharmacology facility specializing in Phase I clinical studies but also contains an integrated research pharmacy department with the ability to perform sterile pharmacy compounding for the in-house Phase I clinic. This includes several formulation types, such as drug in capsule steriles for IV, IM and SC administration, solutions and suspensions. Compounding of non-sterile drug products is performed in accordance with USP<795>. Pharmacy compounding gives added flexibility in how we can manufacture drug product to support FIH trials at our Miami clinic.

Q: How does Translational Pharmaceutics® benefit drug developers when compared to traditional approaches?

Dr. Baker: Translational Pharmaceutics® streamlines drug development by integrating drug product formulation and cGMP manufacturing with clinical testing into a single program. 

Overall development timelines are accelerated and emerging clinical data is used to guide formulation and dose selection in real-time, improving decision making along the way. Translational Pharmaceutics® also allows for greater control of the supply chain and eliminates vendor management complexity for our clients when compared to having multiple, CRO and CDMO partners to coordinate.

Drug product batch sizes also have reduced stability requirements. We make smaller, 100- to 300-unit drug product batches with stability requirements of typically 7-14 days. The stability generated covers the clinical dosing period but also allows rapid progression into clinical testing and reduces API requirements. We don’t have a large batch of drug product manufactured and waiting to be dosed, at risk of being wasted if it is not needed. 

Dr. Zann: For most customers, we’ve seen Translational Pharmaceutics® save an average of 12 months of time in drug product development and Phase I clinical testing. When factoring in the extra steps, time, and cost removed from the lifecycle of a drug, the actual savings using Translational Pharmaceutics® can be far greater—as the Tufts Center for Drug Development saw when they conducted their assessment.

We know other providers offer programs to integrate similar services, but they are not replacements for what Translational Pharmaceutics® can offer. In all cases, we have found these to be separate programs of work, with separate project managers coordinating services. These programs are not nearly as integrated as a Translational Pharmaceutics® program, with the different teams and capabilities we assemble to make these possible. In addition, not all companies are able to see the formulation development through to the in vitro characterization and clinical outcomes—with Translational Pharmaceutics®, we can. 

Dr. Baker: With Translational Pharmaceutics®, everything is coordinated under one team, and there’s one program of work and one program manager who leads it. Our project managers are a lynchpin that make Translational Pharmaceutics® programs run the way they do, in the U.S. and in the U.K. They ensure that timelines are set and adhered to, monitoring client feedback along the way, so we can always ensure we are delivering against project milestones

Q: What investments have been made in the last 12-18 months to enhance Translational Pharmaceutics® capabilities in the U.S.?

Dr. Baker: We have made significant changes to our Philadelphia facilities (in Boothwyn and Garnet Valley, PA) to streamline our ways of working with dedicated teams and operational improvements as mentioned, which has taken place over the last year. Changes have also been made to what equipment and spaces are available for conducting U.S. Translational Pharmaceutics® programs to increase capacity and efficiency. Key investments include:

• Two dedicated R&D lab spaces for U.S. Translational Pharmaceutics® projects
• New equipment, including tablet presses, mills, and blenders and solubility enhancement technologies, including micronization and spray drying
• Semi-automated tablet presses, which has doubled our capacity compared to last year

These investments mean that we can develop and manufacture the full range of oral solid dosage forms—from simple, powder in bottle (PIB) formulations to more complex modified release formulations, or enabled formulations.

Q: How do Quotient Sciences’ U.S. Translational Pharmaceutics® programs support regulatory requirements?

Dr. Zann: Regulatory compliance is critical and our U.S. facilities have recently undergone successful regulatory inspections from multiple agencies, including the U.S. FDA, ANVISA (Brazil), and CFDI (China). This ensures that we can support both domestic and global development programs. 

Also, as part of a Translational Pharmaceutics® program the Quotient Sciences team will author the IND module 3 drug product section for the IND opening/update.

Q: Can you share examples of recent Translational Pharmaceutics® projects?

Dr. Baker: We’ve had many exciting Translational Pharmaceutics® projects, particularly in modified release formulation optimization and solubility-enhanced formulations. One standout program that we conducted as a Translational Pharmaceutics® project between our U.S. facilities was a first-in-human study for a top five global pharma company, where we developed a granulate-in-capsule formulation for a SAD/MAD and food effect study. Among the benefits included a three-month acceleration to the clinic and significant API savings. This program demonstrated the power of the Translational Pharmaceutics® platform by enabling real-time formulation refinements based on emerging clinical data.

Dr. Zann: We’re also proud of our recent work with Ensyce Biosciences, where a clinical program was completed in Miami, supported by our U.K. sites for drug product formulation development and manufacturing.

Lynn Kirkpatrick, the company’s CEO, approached us to address formulation challenges for their modified release product, PF614-MPAR, in development as a potential breakthrough in treating severe pain. After consulting a traditional CDMO, Ensyce Biosciences was told by that provider that it would take over 8 months for an initial drug product prototype. In Part 1 of the study, we assessed 10 different formulation combinations to identify the unit dose.

Realistically, the company would have faced years of development to optimize its formulation and determine the required dose for the PF614-MPAR drug product, if multiple iterations needed to be manufactured sequentially, and the traditional formulation development approach was undertaken.

We were able to complete the work in a fraction of the time that was quoted by the other provider. The company has since moved forward with Phase II/III trials and is scaling for commercial manufacturing. We are proud to see what the product will go on to achieve and the impact it may have in addressing the ongoing opioid crisis.

Q: Who benefits most from U.S. Translational Pharmaceutics® programs?

Dr. Baker: We work with a range of clients, from large pharma to emerging startups. The simple answer is that many clients can benefit from the time and cost savings that Translational Pharmaceutics® brings to early stage drug development. We’ve applied it across indications and patient groups - in drugs that are targeted for use in oncology, rare diseases, and pediatrics, just to name a few. 

We see many cases, like with Ensyce Biosciences, where clients want to move rapidly into formulation optimization in a more efficient, controlled way. 

We also see many clients who have limited API availability, or cases where it is very costly to produce. As I noted before, Translational Pharmaceutics® puts us in control of the full supply chain, including the amount of drug product needed - and thereby, API used - for a clinical study. 

Endevica was a peptide sterile formulation developed at Nottingham and then tech transferred to Miami for compounding, and according to the client due to small batch compounding with limited stability, the Translational Pharmaceutics model saved the client over 1 million dollars on the API synthesis cost. 

Having the flexibility to conduct Translational Pharmaceutics® programs in the U.S. can be particularly valuable when an organization has U.S.-based grant funding, for example from the National Institutes of Health (NIH). In nearly all cases, this mandates that studies must be conducted in the U.S. 

Dr. Zann: There are also significant benefits of using Translational Pharmaceutics® when a client has a challenging molecule, such as poor solubility or permeability. Our scientific team includes experts in formulation, biopharmaceutics, modelling and simulation, and clinical pharmacology so we can select the best strategy to overcome these challenges and design a development program to maximize the probability of success. 

Likewise, using Translational Pharmaceutics® is ideal when a client aims to develop a complex drug product, such as a modified release (MR) formulation or an oral peptide. The correlation between preclinical animals and humans for immediate release products can be poor (Grass and Sinko, 20XX) and in the case of MR or oral peptides can be even greater, therefore the opportunity to optimize these drug products based on  clinical testing with healthy volunteers is the preferred approach and likely to give the best opportunity for success.

Q: Can you tell us more about the wider team of scientific experts at Quotient Sciences? 

Dr. Baker: Globally, we have a group of very talented drug development experts and apply our experience across a range of areas. 
Ultimately, no matter where a customer chooses to work with us on a Translational Pharmaceutics® program, they benefit from our collective knowledge and an accelerated path to meet development milestones.

Meet the Team & Learn More at DCAT Week

For those interested in learning more about Translational Pharmaceutics®, we invite you to download our one-page summary to read more about the benefits of Translational Pharmaceutics®.

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. 

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. 

Spotlight Interview with Harpreet Smith, Vice President & General Manager at our Miami, FL facility

Joining a great company like Quotient Sciences is a competitive effort on the part of new hires and we select only the top candidates to join our team.

-Harpeet Smith

What do you enjoy most about your role and why?

Knowing that we are helping to develop new medicines and get them to patients faster is exciting and very rewarding. What better mission can one have?

For any qualified candidates looking for a position at Quotient Sciences, what can they look forward to? 

Teamwork. Joining a great company like Quotient Sciences is a competitive effort on the part of new hires and we select only the top candidates to join our team. Team members can expect a collaborative and hands-on approach to delivering projects and a leadership team that encourages working together, driving for results, and operational excellence.

What else do you think differentiates Quotient Sciences from other drug development organizations?

Our clients rely on our expertise accelerate their drug development programs in a variety of ways. Uniquely, we provide both clinical pharmacology & research (CRO) services and pharmaceutical contract development & manufacturing (CDMO) services to the pharmaceutical and biotech industry. These services can be provided individually, or as an integrated service which has been shown to dramatically shorten development times, reduce outsourcing costs, and significantly simplify supply chains for customers. 

As Sr. Director of Operations at Quotient Sciences, Miami, Harpreet is responsible for the day-to-day running of the clinical pharmacology unit. She oversees an experienced team of nurses, clinical, and laboratory staff to deliver healthy volunteer studies successfully, on time, and to the highest quality standards.

You mentioned that you started off in nursing, so why did you pursue a career progress into the pharmaceutical industry?

Early in my career as a dialysis nurse, I took care of patients with major health problems. I saw firsthand the benefits they received from newly marketed treatments and this made me determined to develop my career in clinical research. I earned a Master of Science degree in Nursing with a specialty in Clinical Research Management from Duke University and my role at Quotient allowed me to use my clinical background and education to set up and run early-phase studies.

I am passionate about using new technologies in drug development and have spearheaded our transition from paper to electronic source documentation and managed the start-up of an on-site laboratory within our Miami clinic.

Have you always worked in the Clinical Pharmacology space?

After working as an acute dialysis nurse, I moved into early-phase clinical research and have worked in the clinical pharmacology space for the last 21 years.  I love working in the early phase as it’s fast-paced, the projects move quickly, and customers are always keen to see the clinical data.   

As the Senior Director of Operations, what does your day-to-day look like?

No two days are the same and with a global client base, I have to work flexibly to provide support across different time zones.  A typical workday may include making rounds in the clinic, reviewing new protocols with our Sr. Medical Director, and discussing continuous improvement plans with operational colleagues. The one constant, however, is working side by side with my team, to overcome any challenges in the delivery of projects for our customers.

What do you enjoy most about your role and why?

Knowing that we are helping to develop new medicines and get them to patients faster is exciting and very rewarding. What better mission can one have?

How do you see your role evolving over time as the business grows?

In recent years I have been working with Quotient’s senior leadership to strengthen and expand the capabilities in Miami.  For example, we have just finished a huge project to build a new industry-leading compounding pharmacy, capable of preparing a broad range of dosage forms for first-in-human and early-phase clinical studies.  This project took nearly 9 months to complete and was a considerable investment for our organization.  We now have state-of-the-art cleanroom suites meeting USP 797 and USP 800 standards to prepare sterile and non-sterile dosage forms and handle both hazardous and non-hazardous compounds.

As the company grows, my role will continue to evolve as we broaden our service offerings to support our client’s needs in the drug development process.

Tell us about the Miami facility and what role it plays within Quotient’s early development network

The Miami site specializes in clinical pharmacology studies with a proven track record of almost a thousand studies over the past 25 years. With 144 beds and a large recruitment database of 20,000 healthy volunteers, we’re known for being able to rapidly start up new studies in record time and complete studies quickly with full cohorts of subjects.

We also work closely with our Quotient teams in Philadelphia (US), Nottingham, Reading, and Edinburgh (UK) to deliver highly bespoke programs of work that save clients considerable time and money. Translational Pharmaceutics® is our unique platform which integrates formulation development, manufacturing, and clinical testing to deliver exceptional benefits to clients. A recent white paper from Tufts CSDD concludes that Translational Pharmaceutics® reduces development times by 12 months on average and creates significant financial gains ($ multi-million) for biotech/pharma companies.

What benefits do clients receive by working with a development and manufacturing organization that also has clinical pharmacology expertise?

Quotient Sciences has development, manufacturing, and clinical pharmacology expertise across multiple sites in the US and UK.  Our clients are therefore able to place projects at any of our sites and Quotient can integrate different activities to accelerate their drug development plan. For example, our Philadelphia team can develop and manufacture new drug products (e.g. tablets or capsules) which can then be rapidly tested in clinical studies at our Miami clinic. This tight integration helps us get new medicines to patients faster.

Since Quotient Sciences acquired the Miami facility back in 2017, what additions and improvements have been made to better support our client’s needs?

Until the recent addition of our new pharmacy, a lot of our focus has been on strengthening our Project Management and Data Sciences functions and adopting a multidisciplinary team structure for project delivery.  We have also recruited and trained many new employees to increase our overall capability and capacity and laid the framework for continued growth and development. Feedback from client questionnaires indicates that these changes have made a really positive impact on their programs, especially with enhanced levels of project communications.

With all this expansion in facilities comes a need to continually increase headcount.  How much has changed in terms of the number of employees at the Miami location since you started up until now?

I have seen Quotient Sciences Miami grow significantly during my tenure. We have dedicated a lot of time towards becoming efficient and ensuring that our new employees become capable and experienced in supporting our existing team.  We also have great employee engagement and retention, and as such, I am surrounded by many dedicated and long-serving team members, many of whom have been with us for over 10 years. 

For any qualified candidates looking for a position at Quotient Sciences Miami, what can they look forward to?

Teamwork. Joining a great company like Quotient Sciences is a competitive effort on the part of new hires and we select only the top candidates to join our team.  Team members can expect a collaborative and hands-on approach to delivering projects and a leadership team that encourages working together, driving for results, and operational excellence.

Can you tell us about the new pharmacy capabilities? How does this help customers who want to start clinical studies quickly?

Quotient Sciences is the only drug development provider that can offer pharmacy compounding, GMP drug product manufacturing, and clinical testing all under the same organization.  Our experienced pharmacy team and new cleanrooms enable us to prepare low, medium, and high-risk compounded products for dosing in the Miami clinic. Using the formulation and manufacturing capabilities across the Quotient Sciences network, we can then help our clients seamlessly transition from simple first-in-human pharmacy formulations to a robust solid oral product for their downstream patient trials.  By simplifying the supply chain with an integrated project team and a single development partner this offering enables our clients to achieve proof-of-concept up to 15 months faster.

Tell us how the Miami facility can support our client’s clinical pharmacology needs and deliver studies with quality service and speed.

Our clinical pharmacology expertise encompasses first-in-human (SAD/MAD), DDI, food effect, TQT, and BA/BE studies. Our experienced and dedicated project managers work closely with the IRB and screening team to ensure timely enrollment. We are accustomed to helping clients with rapid study start-ups and with an on-site CLIA-certified laboratory for fast turnaround times, we work to get clinical data to our clients quickly – but not at the expense of quality. Our excellent regulatory inspection history speaks to the high-quality delivery by our project and clinical teams.

What else do you think differentiates Quotient from other drug development organizations?

Our clients rely on the expertise of Quotient Sciences to accelerate their drug development programs in a variety of ways. Uniquely, Quotient provides both clinical pharmacology/research (CRO services) and pharmaceutical development & manufacturing (CDMO services) to the pharmaceutical and biotech industry. These services can be provided individually, or as an integrated service which has been shown to dramatically shorten development times, reduce outsourcing costs, and significantly simplify supply chains for customers.

The ability to move quickly and cost-effectively from candidate selection to first-in-human clinical trials is a theme that comes up often from clients. One way which we strive to do this is through services offered from our compounding pharmacy in Miami, FL.  

The compounding pharmacy is part of our clinical pharmacology services in Miami, FL, where we conduct Phase I trials with healthy volunteers.  

In this article, learn about the capabilities of our Miami, FL on-site compounding pharmacy, and ideal uses for pharmacy compounding to accelerate FIH to POC trials.

What are the advantages of choosing pharmacy compounding for FIH trials?

Quotient Sciences simplifies the drug development supply chain, acting as a single partner with integrated project team and services. We can help through all stages of development.  

At our Miami site, fit-for-purpose pharmacy preparation can be used to quickly start FIH trials. In this approach, a FIH trial using a simple and cost-effective dosage form, such as powder- in-capsule or bottle (also called PIC or PIB, or drug in capsule/bottle), solution or suspension, has the benefit of improving timelines to the clinic while still providing maximum dose flexibility to achieve Phase I objectives of obtaining PK and safety data.  

Emerging clinical data within the FIH study itself can be used to inform formulation technologies (such as solubility enhancement) enabling selection of a technology and/or drug product to move forward with. This means that simultaneously, we can develop and manufacture solid oral drug product, like a tablet, for Phase 2 patient trials within the same program. This allows for POC patient trials to begin with immediate GMP clinical trial material supply.  

The ability to manufacture and dose multiple formulation types in real-time, coupled with the ability to use smaller batch sizes and abbreviated data packages, ensures that we can carefully manage CMC investments and minimize API usage.  

Are there certain programs that benefit from choosing pharmacy compounding?

We have used compounding for a range of drug candidates including small molecules, peptides, fusion proteins, and monoclonal antibodies. These have been across oral and intravenous dosage forms, and for a range of therapeutic areas.  

As discussed, compounding delivers significant benefits for accelerating to FIH programs and when transitioning from FIH to POC. A simple drug in capsule or drug in bottle for reconstitution at bedside is the quickest route to clinic with compounding and dosing occurring within 24 hours.  

Compounding is beneficial on any early clinical program where there is a desire to get data rapidly and keep dose flexibility throughout the trial. In addition to FIH single and multiple ascending dose (SAD/MAD) studies, pharmacy compounding has used in other study types, including:

• Absolute Bioavailability and Relative Bioavailability studies
• Drug Drug Interaction (DDI) studies
• TQT studies
• Food Effect and PK studies
• Studies in special populations (e.g. Elderly)
• Device trials
• Formulation screening studies

Sterile compounding with sterilization by aseptic filtration is another quick route to clinic as proof of concept especially for chronic indications such as HIV infections, CNS indications, oncology, viral infections, certain rare diseases, and metabolic conditions.  

Another advantage of pharmacy compounding is its adaptability in dose-finding studies for combination therapies, where precise modulation of each active pharmaceutical ingredient (API) is essential. This approach is well suited to drug delivery systems requiring an initial burst release followed by sustained drug exposure. By systematically varying the proportions of immediate-release and modified-release components, the optimal formulation for therapeutic efficacy can be efficiently identified.  

In molecules with limited stability, compounding allows for early assessment of their potential for further development.

For small molecules that have solubility and bioavailability challenges, we help clients select the right formulation technology for their poorly soluble molecules. We apply a data-driven process based on the physicochemical and biopharmaceutic properties of the API with a full range of solubility enhancement technologies including lipidic systems, micronization, spray drying, and hot melt extrusion.

Finally, the best formulation, with accompanying formulation technology, can be selected and a new solid oral dosage form manufactured, ready for packaging and shipment for patient trials.

When was the compounding pharmacy at Quotient Sciences – Miami last renovated?  

In 2020, we upgraded the Miami compounding pharmacy to add more IP storage space, including refrigerated storage space at 2 to 8°C and freezer storage at -20°C.  

Clean rooms in the facility were built to ISO Class 7 air quality standards with ISO Class 5 Primary Engineering Controls (PEC), which include laminar airflow workbenches (LAFWs) and biological safety cabinets (BSCs), allowing us to handle potent APIs and Hazardous investigational products  

The laboratory space also expanded to support our new pharmacy and provide efficient processing of higher volumes of biological samples.  

What dosage forms can be handled at Quotient Sciences – Miami?

Within the pharmacy and clinic, we can handle a variety of dosage forms including active pharmaceutical ingredients (APIs) or processed intermediates in oral solutions, suspensions, powder-in-capsule (PIC) or powder-in-bottle (PIB), and sterile preparations for parenteral delivery.  

More about Quotient Sciences – Miami pharmacy compounding and clinical pharmacology  

Learn more about our pharmacy compounding capabilities in our info sheet and see a preview of the Miami pharmacy in this video.