Summary: Kaustubh Gawde works within Quotient Sciences’ Formulation team in Philadelphia, PA. He discusses his career with the company and what he enjoys most about his role.

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

What does a Formulation Group Leader do at Quotient Sciences?  

My role as a Formulation Group Leader includes a variety of tasks. One side of this job is technical. I am a group leader as well as a SME for all the projects my team is working on. A group leader has to be responsible for all the troubleshooting that can occur during the execution of project. A group leader works with different departments such as Operations, QA, Material Management, Analytical Development, QC, PM, and BD to successfully execute each project. A group leader has to interact with a client whenever required if they have any formulation or development questions. As manager, I have to be responsible for all the actions of my team members. My team needs to be productive members of our organization, achieving personal growth, as well as growth in their overall career.

Describe a typical day in the Formulation Department.  

Morning starts with coffee and checking email and Teams messages. At the start of the day, we have a daily meeting to discuss manufacturing activities from the day before and provide an overview of activities for the current day. In a day, typically I have one internal meeting and a couple of project meetings to a give weekly updates on projects to clients. I make different kinds of documents and review already made by documents by my team. I also troubleshoot any problems that my department may have for various projects. The day ends with a meeting to summarize the day’s manufacturing activity.

How has your career progressed since joining us?  

I joined Quotient Sciences almost three years back. I started as a staff formulator. I worked on various projects over the last three years. With each project, I learned a lot about both manufacturing and formulation development. This is my first time working in a CDMO setting. I had never worked with a client facing organization prior. It was a brand new experience. For the past three years, I have worked on multiple projects at different stages of project lifecycles. I have worked on clinical phases 1, 2, 3, and late stage commercial projects. Skills required for each project were different and I had to adapt as needed to meet each project’s requirements. We also need different temperaments to deal with different clients. I learned how to work on multiple projects at the same time, perform multiple tasks such as manufacturing, documentation, client visits, and quality events. I became efficient at my job in staff formulation and gained a lot of technical skills/knowledge in a short period of time.

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

I used in work in a generic drug product manufacturing company which made potent control substance products.  

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

I had a Master’s degree in Pharmaceutical Sciences as well as three years of experience working with large scale manufacturing equipment. I was also part of various ANDA filling projects and had experience making product development reports.

What learning or qualifications have you gained in this role?

I transitioned from a scientist role to a group leader role last year. Both roles have different requirements. As a scientist, you only need to be good at your job. As a group leader, you have to be responsible for all the people in your group. As a group leader, I had to be up to date on the latest formulation and manufacturing techniques as well as perform my manager duties.

What do you enjoy most about your role?

As a group leader, I get to work on multiple projects that are assigned to my team. I work with BD to strategize the development work and scope of manufacturing. I also like working on different projects as it gives me new challenges and keeps me on my toes.

What aspects do you find most challenging?  

Time management at times becomes very difficult when we get multiple projects at same time. Also, some clients can be difficult to deal with as they are set in their own ways. Some clients have a difference of opinion with us which can be challenging to deal with at times.

What’s the team like?  

I report to the Senior Director of Formulation Development and Technical Services. Two staff formulators and two manufacturing scientists are in my team. My team is mix of experienced and inexperienced people. We train new hires with experienced team members.

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

Quotient Sciences is great place to learn and grow. Quotient Sciences gives you space to reach your career goals at your own pace. We have lot of new technologies and we are consistently looking to progress in the field.

What do you like most about working at Quotient Sciences?  

Quotient Sciences has lots of new technologies. I like my team. Quotient Sciences also promotes internal promotions. I like the core leadership team at my site. We have a visual representation of progress at Quotient Sciences. 

Quotient Sciences is great place to learn and grow.
– Kaustubh Gawde

Yaribey Rodriguez works within Quotient Sciences’ Quality Assurance team in Miami, Fl. She discusses her career with the company and what she enjoys most about her role. 

What I like most about working at Quotient Sciences is to know that I am making a difference in the field of medical care. To know that I took part in the development of future treatments that can save lives, and that it was done with the outermost passion, dedication, and with the best team.

– Yaribey Rodriguez

What does a Senior Director GCP QA do at Quotient Sciences?

A Senior Director GCP QA is responsible for implementing, maintaining, and continuously improving Good Clinical Practice (GCP) compliance programs and the Quality Management Systems (QMS) to support the clinical trial activities at Quotient Sciences Miami.  This role provides QA oversight to assure clinical trial activities are conducted in compliance with applicable regulations, ICH GCP guidelines, and internal policies and procedures.  Other tasks include managing and conducting internal and supplier audits, hosting client audits, and serving as the point of contact and host for all regulatory inspections.  

Describe a typical day in the Quality Assurance Department.  

The Quality Department always has exciting and interesting days. Typically, it includes both required meetings and also daily firefighting activities to ensure the site is complaint and audit ready. These are accompanied by constant multitasking and rapidly shifting priorities to ensure the business continues to run smoothly. You would never be bored!

How has your career progressed since joining us?  

I joined Quotient Sciences under the tile of Director, GCP QA for the Miami site. Since then, I have developed to be a Senior Director, GCP QA.  

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

Before Quotient Sciences, I was an Operational Excellence Leader with more than 10 years of experience and 40+ direct reports in the medical device industry under title 21 CFR Part 211 and 820 FDA/ISO 9001 environment, regulations, and compliance.

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

Yes, for my role, necessary qualifications include knowledge of good clinical practices and ICH guidelines paired with FDA regulations that govern the clinical research field.

What learning or qualifications have you gained in this role?

I obtained the certifications of ISO 27001 auditor while in Quotient Sciences as well as have been able to attend several FDA seminars.

What do you enjoy most about your role?

The constant learning about clinical research is what I enjoy most about my role. Every study is different and brings new questions that spark my curiosity to know more. I also enjoy the people I work with. They make my job purpose absolutely amazing. My amazing team is always so supportive, effective, organized, and constantly in a state of development and collaboration.

What aspects do you find most challenging?

In my field, sometimes it is necessary to align to new regulations that require rapid modifications to our processes or procedures. This poses a challenge since it needs to be done while keeping the business running. But, this is a good challenge to have!

What’s the team like?  

I could not ask for a better team. Each of them shows an extreme dedication to the job, a genuine passion for what they do, and enjoyment for all of our accomplishments. I have the best team!

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

To have an open mind. To seek to understand others’ points of view, to always be hungry to learn more, and to aspire to be better each day.

What do you like most about working at Quotient Sciences?  

What I like most about working at Quotient Sciences is to know that I am making a difference in the field of medical care. To know that I took part in the development of future treatments that can save lives, and that it was done with the outermost passion, dedication, and with the best team. I love that Quotient Sciences is unique for its people and its vision! 

In this article by The Medicine Maker, Dr. Asma Patel, VP of Integrated Development Services at Quotient Sciences discusses how accelerating first-in-human (FiH) clinical trials is crucial in drug development, especially for orphan drugs treating rare diseases.

Asma points out how a simplified formulation approach, such as a drug-in-capsule method, can streamline the process.

Continue reading the full article on The Medicine Maker

Summary: Dr. Vanessa Zann is featured in Drug Development & Delivery, discussing strategies for transitioning from immediate-release to modified-release formulation. She highlights how challenges like poor solubility, permeability, and fluctuating drug concentrations can be addressed through modified-release approaches to enhance compliance, maintain therapeutic levels, and reduce side effects.

Simple, immediate release and once-a-day (QD) formula­tions are desired not only by the patient for rapid onset and im­proved compliance, but also by the pharmaceutical industry due to ease of development and cost benefits. 

However, many small molecules in today’s pipelines have sub-optimal properties for QD immediate-release formulations. Challenges, including poor solubility or per­meability, can lead to reduced absorption (input in the body) or high clearance (output from the body) that causes a short dura­tion of therapeutic effect. This results in more frequent dosing reg­imens, which may not be suitable for patient compliance. 

Another challenge comes from the significant peaks and troughs in circu­lating drug concentrations. Using immediate-release formulations, the drug im­mediately enters the bloodstream, and if dosing is not optimized, this could lead to side effects for the patient and variation in ther­apeutic efficacy. 

For immediate-release formulations that require more than once-a-day dos­ing, a modified release formulation, which delivers the drug to the lower GI tract over a sustained period, can be a better choice to achieve the desired therapeutic effects.

The following article discusses opportunities and challenges when transitioning from an immediate-release to modified release formulation, therapeutic ben­efits and challenges associated with modified release formulations, considerations related to GI physi­ology environments and API physicochemical properties, and modified release technology choices to help drug developers achieve trans­lation success. 

To continue reading, visit Drug Development & Delivery.

Following approval in November from the UK Medicinal and Healthcare Products Regulatory Agency (MHRA), Nanomerics Ltd., a private speciality pharmaceutical company, and Quotient Sciences have commenced dosing the first volunteers for the Phase I trial of OC134.

OC134 is an eye drop medicine candidate indicated for the topical treatment of moderate to severe allergic conjunctivitis, a condition for which a suitable non-steroidal topical ocular treatment, does not currently exist.

The clinical testing of Nanomerics’ eye drop assets is being done by Quotient Sciences - Nottingham, UK.

Dr Nand Singh, Medical Director at Quotiexnt Sciences commented, “We are excited to begin clinical testing at our Nottingham, UK clinic for Nanomerics’ OC134 Phase 1 Sunlight trial. This marks an important step forward in developing advanced treatments for moderate to severe conjunctivitis.”  

Continue reading the announcement from Nanomerics 

Summary: Iain Shaw, Senior Director of 14C Enabled Drug Development, highlights a collaborative project advancing acoziborole, a single-dose treatment for sleeping sickness. Presented in a scientific poster, the study showcases how Quotient Sciences performed radiosynthesis and GMP repurification of 14C drug substance of oxaborole-6 carboxamide along with an ADME study in healthy male volunteers, demonstrating the benefits of integrated development in accelerating global health solutions.

At the 26th North American ISSX and 39th JSSX Meeting in September 2024, Quotient Sciences presented three posters showcasing significant advancements in the pharmacokinetics and metabolism research of acoziborole. 

Acoziborole is a potentially transformative investigational treatment for Human African trypanosomiasis (HAT), commonly known as sleeping sickness. This is an illness caused by protozoan parasites transmitted by infected tsetse flies. It is endemic in sub-Saharan Africa and without treatment is typically fatal. Most people impacted by HAT live in rural areas and depend on agriculture, fishing, animal husbandry, or hunting. 

Continue reading to see how Quotient Sciences supported the radiosynthesis and GMP repurification of 14C drug substance of oxaborole-6 carboxamide, followed by the ADME studies in healthy subjects. 

Poster 1: Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C]Acoziborole – Preparation of GMP [14C]Acoziborole Drug Substance 

This poster outlines the radiolabelling and purification process for [14C]acoziborole, a radiolabelled drug produced under GMP standards to support human metabolism studies. It outlines the synthesis process, including the initial non-GMP preparation from barium [14C]carbonate and the subsequent GMP repurification conducted in a dedicated radiosynthesis laboratory. 

This process ensures that the final product meets regulatory standards through thorough quality control and assurance measures. As a result of the careful synthesis and purification, the final product is a GMP-compliant [14C]acoziborole, now ready for use in human studies.

Access the full poster for more on the process and outcomes. 

Poster 2: A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C]Acoziborole in Healthy Male Subjects 

A Phase 1 open-label clinical study was conducted to examine the mass balance, pharmacokinetics, metabolism, and excretion (ADME) of acoziborole. The study involved six healthy male participants and provided key insights into how the drug is processed in the body. 

This study, funded and sponsored by DNDi in Geneva, Switzerland, was conducted by Quotient Sciences at our integrated drug product formulation development, drug product manufacturing, and clinical pharmacology facility in Nottingham, UK.

In this study, participants received a single oral dose of 960 mg [14C]-acoziborole. Over the next 120 days, researchers collected samples of blood, plasma, urine, and faeces to evaluate the drug's absorption and elimination. However, the study encountered challenges due to the COVID-19 pandemic, which restricted urine collections to just 16 days post-dose.  

Key findings indicate that acoziborole was well tolerated, demonstrating good absorption with predominantly slow biliary-faecal elimination and minimal urinary excretion. Notably, acoziborole was the most abundant circulating component in plasma. This poster describes the mass balance and clinical safety assessments from the human ADME study.  

Download the full poster to explore the detailed methodology and findings. 

Poster 3: Investigation of the Metabolite Profile of Acoziborole in Plasma, Urine, and Fecal Homogenate Samples Using UPLC-MS Fractionation Followed by AMS Analysis 

This poster focuses on the analysis of metabolites following a human ADME study that used a microdose of [14C]-acoziborole. To accurately assess the metabolites present at such low doses, Accelerator Mass Spectrometry (AMS) was employed. The research involved preparing pools of plasma, urine, and faeces homogenates to investigate the metabolites. 

Using a sophisticated analysis method called data-dependent acquisition, the study detected metabolites in these samples and assigned them to specific fractions where their activity exceeded baseline levels, based on their molecular mass. This research contributes to our understanding of the drug’s metabolic pathway, its safety profile in humans, and its potential as an effective treatment for HAT.

For a breakdown of the methodology and results, access the full poster.