Spotlight on Miami - Q&A with Harpreet Smith, Senior Director of Operations
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.
1. 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.
2. 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 early phase as it’s fast paced, the projects move quickly, and customers are always so keen to see the clinical data.
3. 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.
4. 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?
5. 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 of our service offerings to support our client’s needs in the drug development process.
6. 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 which 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.
7. What benefits do clients receive by working with a development and manufacturing organization that also has clinical pharmacology expertise?
Quotient 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.
8. Since Quotient 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 to strengthen our Project Management and Data Sciences functions and adopt 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 indicate that these changes have made a really positive impact on their programs, especially with enhanced levels of project communications.
9. With all this expansion in facilities comes a need to continually increase headcount. How much has changed in terms of number of employees at the Miami location since you started up until now?
I have seen Quotient 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 which have been with us for over 10 years.
10. 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.
11. Can you tell us about the new pharmacy capabilities? How does this help customers who want to start clinical studies quickly?
Quotient is the only drug development provider who 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 to 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.
12. 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-up 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.
13. 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.