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Colleague Stories: Kate Foster

Careers , Nottingham

Colleague Stories: Kate Foster

Kate Foster discusses her career at Quotient Sciences, and her experiences working at our Nottingham, UK facility.

"Quotient Sciences provides an exciting, fast paced environment to work in. The company understands individual needs and allows flexibility and is good at adapting in an ever-changing world."

-Kate Foster

What does a Clinical Performance & Compliance Manager do at Quotient Sciences?

In my role, I have responsibility for scheduling, training, compliance, and continuous improvement in our clinic. One of my goals is to ensure everyone is set up to deliver our studies confidently and in compliance with good clinical practices (GCP) and Quotient Sciences’ clinical protocols and standard operating procedures (SOPs).

I have direct line management of our scheduling manager as well as our training and compliance team to ensure we are getting the best out of our team, to meet the needs of the business and our people. I also directly manage a team of Clinical Data Coordinators with oversight of data collection and transcription into client databases and study set up.

I have a passion for continuous improvement and seek opportunities that allow us to work smarter, not harder, in the clinic. In my role, I am always looking at where we can apply principles of Lean Six Sigma to make improvements in how we deliver projects, whether that is to reduce waste and variation in our processes, increase the quality of our programs, or to improve colleague or volunteer wellbeing and engagement.

Describe a typical day in the clinic.

No two days are the same in our clinic!

On a typical day, there is a buzz of activity starting at 7am when the early shift starts and prepares our volunteers for dosing or study procedures. Some days, we take blood samples and perform safety procedures, such as ECGs and vital signs, regularly throughout the day. Other times, volunteers will just have one set of procedures in the morning.

Once the peak of activities are completed in the morning, our team are busy looking after volunteers, setting up and preparing the clinic for the next day, taking time for training, attending study meetings, or catching up on other day-to-day tasks.

In my role, a typical day for me includes work on various improvement projects or plans for what’s coming up in the weeks and months ahead, and meetings with my immediate and wider team to provide support and advice.

How has your career progressed since joining us?

I’ve held various roles since joining Quotient Sciences initially in 2012 as a Clinical Scientist. I worked closely with volunteers on our wards and was trained up to perform procedures such as taking blood samples, ECGs, vitals, and dosing volunteers. I later took a keen interest in getting involved in preparing study documentation and progressed to my next role as a Clinical Deputy. In this role, I supported the Clinical Lead with oversight of studies, preparing documents, attending study meetings, and delivering study training to the wider team.

To expand my knowledge even more, I took a role within the Project Management team as a Clinical Project Coordinator in 2015. It was interesting to get involved in projects from start up to completion and archiving, but I really did miss working with the volunteers. I returned to the clinic in 2016 as a Clinical Lead, where I managed a team of technicians and nurses responsible for delivering studies.

I built a wealth of experience in delivering all types of studies and was later promoted to a Senior Clinical Lead with oversight of a larger team. I was also a key leader in driving more general clinic improvement projects, which led me to pursue a role focused on continuous improvement as an Operational Excellence and Performance Specialist. My main focus became driving improvement projects within the clinic, and that has led me to my current role.

What experience did you have before you worked at Quotient Sciences, and what learning or qualification have you gained in your time with the company so far?

Over the years and within the different roles that I’ve held at Quotient Sciences, I have learned so much about clinical trials and the pharmaceutical industry. I pursued a Bachelor of Science degree in Psychology and following graduation, I started in my first role at Quotient Sciences in 2012 as a Clinical Scientist. For this role, a science degree was desirable but not mandatory.

I have completed training in Good Clinical Practice (GCP) protocols. GCP is critical for how trials are designed and conducted, and there are regulatory standards that must be upheld and involving areas such as documentation for the clinical protocol, record keeping, and training. I am also certified in providing Immediate Life Support (ILS). Most recently, in relation to my interests in continuous improvement, I have gained a Green Belt in Lean Six Sigma.

At Nottingham, we also have implemented a Mental Health First Aider program, which is an internal program for colleagues. I have also completed training to be part of this program so I can aid colleagues who may need support.

What do you enjoy most about your role? And what is most challenging?

I love working in an exciting, fast paced environment. No two studies are the same and it is great to be such an integral part of the molecule journey. That said, sometimes, there’s just not enough hours in the day to achieve all that I want to achieve! But it’s great to keep busy and stay motivated, just need to be good at prioritizing!

What’s the team like?

We have a great team here who always rally to help each other and achieve great things! Our clinical team is a large team, and many of our team members work shifts so it is often challenging to get everyone together. The wider team, although we don’t often cross paths, when we do, everyone is always really friendly and approachable, and people will often go out of their way to make time for you even when they have a busy schedule.

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

Work hard, stay focused, ask lots of questions and push yourself outside your comfort zone. Take every opportunity you get to learn new skills, listen to experts in other areas and observe what people do in other departments to gain a full understanding of the business.

What do you like most about working at Quotient Sciences?

It is a great company to work for, they understand individual needs and allow flexibility and the company is good at adapting in an ever-changing world.

Tufts CSDD Demonstrates Multi-Million Dollar Benefits of Translational Pharmaceutics®

Articles & Publications , Translational Pharmaceutics®

Tufts CSDD Demonstrates Multi-Million Dollar Benefits of Translational Pharmaceutics®

Tufts Center for the Study of Drug Development (CSDD) today published a white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.

The Tufts CSDD study assessed development cycle times and their financial benefits by using data compiled on completed Translational Pharmaceutics projects to benchmark against industry drug development durations. On average, Translational Pharmaceutics was shown to accelerate development by more than 12 months, with each month of development time saved resulting in a $9.5 million reduction in R&D costs per approved new drug. Further gains are achieved from products reaching the market sooner, translating into total financial benefits to drug sponsors of more than $200 million per approved new drug.

Translational Pharmaceutics is a platform that integrates formulation development and real-time adaptive manufacturing and clinical research to accelerate drug development. It has been used widely by pharmaceutical and biotech companies to advance molecules from first-in-human to proof-of-concept and accelerate the development and optimization of clinical formulations.

“Our own studies have demonstrated significant benefits, and we are pleased that Tufts CSDD has accurately quantified the time and cost benefits of our unique Translational Pharmaceutics approach to drug development,” said Mark Egerton, Ph.D., Quotient CEO. “Quotient Sciences has worked hard over the past decade to develop this innovative platform to help our customers lower costs, accelerate development, and improve R&D productivity.”

"Despite long-standing efforts by the pharma industry to operate more efficiently, traditional drug development paradigms and outsourcing models still present a number of challenges for today’s drug developers," said Joseph A. DiMasi, Ph.D., director of economic analysis at Tufts CSDD and principal investigator for the study. "The outcomes from this research indicate that Translational Pharmaceutics can create substantial time savings and financial benefits to pharma and biotech companies."

Peter Scholes, Ph.D., Quotient CSO, said, “Translational Pharmaceutics accelerates the development timeline by integrating drug product manufacturing into the clinical research program. Emerging clinical data are then used in real time to inform the optimization of a clinical formulation and maximize the potential for the drug to achieve its desired therapeutic effect.”

Read the full PDF version here

Quotient Sciences Expands UK Formulation and Analytical Capabilities

News & Announcements

Quotient Sciences Expands UK Formulation and Analytical Capabilities

NOTTINGHAM, UK; August 24,2022 – Quotient Sciences, a drug development and manufacturing accelerator, has completed a £1.5 million expansion of its early development and manufacturing facility in Reading, UK.

The investment has doubled formulation development and analytical capabilities at the site, increased office space, and created 40 new technical and scientific jobs including formulators and analytical chemists.

“Our investment in Reading is in response to strong market demand, direct feedback from our customer base, and to maximize utilization of our UK-based operational footprint,,” said Mark Egerton, CEO of Quotient Sciences.

“As well as increased formulation development and analytical capabilities, the expansion increases our capacity to support  programs as they progress through development phases, providing our customers with further improved services.”

Quotient Sciences employs more than 1,300 talented individuals across six operating sites in the UK and US. The 48,000 sq ft Reading facility currently employs 75 people across a range of scientific disciplines.

Egerton added: “We are committed to a growth strategy that supports our customers on both sides of the Atlantic, with stand-alone development and manufacturing services, or fully integrated Translational Pharmaceutics® programs that deliver substantial time and cost benefits.

“We will continue to liaise with existing and potential customers to ensure we are meeting their current and future needs and expect to announce further expansions of both UK and US operations in the near future.”

Acquired in 2017, Quotient Sciences tripled the manufacturing footprint of the Reading facility in 2018, increasing the total number of manufacturing suites to 13. The site focuses on small-molecule drug products from the pre-clinical stage through to Phase I-III clinical trials, with significant expertise in poorly soluble compounds and a broad range of technologies including spray drying, hot-melt extrusion, lipidic systems, and particle size reduction methodologies.

View the press release here

Ensysce Biosciences and Quotient Sciences Announce a Partnership on the Development and Clinical Testing of Ensysce’s PF614-MPAR

News & Announcements

Ensysce Biosciences and Quotient Sciences Announce a Partnership on the Development and Clinical Testing of Ensysce’s PF614-MPAR

Ensysce Biosciences and Quotient Sciences logos

Partnership further expedites Ensysce’s development pipeline

NOTTINGHAM, UK; August 31, 2022 – Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety, and Quotient Sciences, a drug development and manufacturing accelerator, today announced a partnership to support the development and clinical testing of PF614-MPAR.

PF614-MPAR is a novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose.

Quotient Sciences is currently using its integrated Translational Pharmaceutics® platform to identify a PF614-MPAR formulation that allows conversion into oxycodone within the prescribed dose range but reduces conversion to oxycodone at higher than prescribed dose levels in an overdose scenario.

The formulation will be an optimized composition that balances dose and release rate, with the candidate formulations being tested in the clinic having been selected from emerging clinical data in order to achieve the desired exposure profile, allowing formulation optimization in humans rather than preclinical species. 

Mark Egerton, PhD, CEO of Quotient Sciences, said: "We are pleased to be partnering with Ensysce to accelerate the development of their PF614-MPAR program. Quotient Sciences’ ability to integrate formulation and clinical services under a single organization will expedite Ensysce’s development timeline and provide patients who are suffering with a safer option for pain relief faster.”

Lynn Kirkpatrick, PhD, CEO of Ensysce Biosciences, commented: “Opioids have been a longstanding and important type of treatment for moderate to severe pain, but they are prone to abuse and overdose. This widespread problem for patients and society results in significant costs to the healthcare system, which we are trying to address with our two proprietary technology platforms.”

“The PF614-MPAR program is designed to fill a great unmet need for effective pain medications that reduce the risk of abuse and specifically prescription drug overdose. This partnership serves as validation of our mission and ultimately our platforms. We continue to make strong progress towards our clinical development of PF614 and are excited to partner with Quotient Sciences to develop PF614-MPAR, as we believe we will be bringing to market important therapeutic options for those in severe pain.”

About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. For more information, please visit quotientsciences.com.

About Ensysce Biosciences

Ensysce Biosciences San Diego, CA is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR™) platforms, the Company is in the process of developing a unique, tamper-proof treatment option for pain that minimizes the risk of both drug abuse and overdoses. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse, reducing the human and economic cost. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.

Ensysce Biosciences Company Contact
Lynn Kirkpatrick, PhD
Chief Executive Officer
(858) 263-4196

Ensysce Biosciences Investor Relations Contact
MZ Group North America
Shannon Devine
(203) 741-8811
[email protected]

SOURCE: Ensysce Biosciences Inc.

Click here to access the official release

HighTide Therapeutics and Quotient Sciences Announce Agreement to Conduct a 14C Human ADME Program for HTD1801

News & Announcements , Customer Milestone , Synthesis-to-Clinic® , ADME

HighTide Therapeutics and Quotient Sciences Announce Agreement to Conduct a 14C Human ADME Program for HTD1801

Quotient Sciences

Integrated Quotient Sciences Synthesis-to-Clinic® Program Will Support HTD1801’s Clinical Development and Regulatory Submission Package

ROCKVILLE, USA; SHENZHEN, CHINA; and NOTTINGHAM, UK: December 15, 2022 – HighTide Therapeutics, Inc. (“HighTide”), a globally integrated clinical-stage biopharmaceutical company focusing on novel multifunctional therapeutics for metabolic and digestive diseases, and Quotient Sciences, a drug development and manufacturing accelerator, have signed an agreement to support HighTide’s HTD1801 program.

The agreement will see Quotient Sciences perform a 14C human absorption, distribution, metabolism, and excretion (ADME) study for HighTide’s lead drug candidate, HTD1801, to generate data to support HTD1801’s clinical development.    

HTD1801 is a first-in-class new molecular entity. HighTide’s continued clinical progress with HTD1801 includes an ongoing Phase 2 study for the treatment of type 2 diabetes (T2DM), the initiation of a global Phase 2b study for the treatment of nonalcoholic steatohepatitis (NASH), and the successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for primary sclerosing cholangitis (PSC).      

The U.S. FDA has granted HTD1801 Fast Track designation in both NASH and PSC.

Quotient Sciences will be providing a fully integrated Synthesis-to-Clinic® program, from radiosynthesis of the 14C-labeled drug substance to the design and conduct of the human ADME study and delivery of the final clinical study report. The company is currently commencing radiochemistry activities and finalizing the clinical study design.

Mark Egerton, PhD, CEO of Quotient Sciences, said: “We are excited to share our expertise in 14C-enabled drug development with HighTide to support their HTD1801 program, which has the potential to help many patients suffering from T2DM, NASH, and PSC worldwide. Our unique Synthesis-to-Clinic offering streamlines the entire human ADME process by integrating radiolabeled formulation development, real-time drug product manufacturing, and clinical testing in a single program of work led by a single project manager, reducing timelines and getting new medicines to patients faster.”

Liping Liu, PhD, Founder and CEO of HighTide, added: “We are very pleased to enter this collaboration with Quotient Sciences. Both parties have extensive expertise and experience in their respective fields. The study will help us better understand the ADME properties of HTD1801 to continue to advance our global clinical development programs. We expect the alliance to greatly facilitate our clinical progress by completing the ADME program in a more streamlined, time- and cost-effective manner.”


About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

About HighTide Therapeutics
HighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of innovative multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), and primary sclerosing cholangitis (PSC). HTD1801 has received Fast Track designation from the U.S. FDA for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program.

HighTide Therapeutics Company Contact
Jeffrey Dao
[email protected]
+1-650-580-3872

Quotient Sciences Celebrates Grand Opening of New Alnwick Drug Substance Facility With Official Ribbon Cutting

News & Announcements , Alnwick

Quotient Sciences Celebrates Grand Opening of New Alnwick Drug Substance Facility With Official Ribbon Cutting

ALNWICK, UK; DECEMBER 8, 2022–Quotient Sciences, the drug development and manufacturing accelerator, will hold an official ribbon cutting event in celebration of the grand opening of their new drug substance manufacturing facility in Alnwick, Northumberland, on Friday, December 9, from 2:00pm to 4:00pm.

The event will be hosted by the CEO of SCI (Society of Chemical Industry), Sharon Todd, and Quotient Sciences’ SVP and Head of Candidate Development, Paul Ryan, at the Taylor Drive facility and will include tours of the newly built facility.

Sharon Todd, CEO of SCI, said: “This new drug substance manufacturing facility showcases the North-East region as one of the UK’s key clusters for innovation. I am honored to be there to support the opening of this new facility – especially with the local connections I have to this area. Quotient Sciences is one of SCI’s corporate partners, and this launch resonates with SCI’s core charitable purpose of helping our community to accelerate science out of the laboratory – for the benefit of society. Quotient Sciences is accelerating science out of the lab to bring new drugs to market more quickly, to improve global health.”

“The Alnwick facility is also a shining example of the latest technologies, industry growth, and job creation – the multi-million investment will bring new highly skilled roles. I am certain this manufacturing site will not only benefit the region and the UK in the long term but also the world.”

Quotient Sciences completed the £6-million state-of-the-art building expansion in October 2022, with the overall goal to deliver comprehensive integrated support for customers bridging from candidate selection to early clinical development and beyond. The newly expanded space features multi-purpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 liters up to 150 liters and deployment of both batch or continuous flow chemistry technologies.

SVP and Head of Candidate Development at Quotient Sciences, Paul Ryan, said: “Expanding our drug substance capabilities was a necessary step in allowing us to better support our customers’ programs as they progress through the development pathway. Our Alnwick facility was perfectly placed for expansion with available space and a wealth of local talent.” 

“This new facility delivers agile capacity to manufacture multi-kilogram quantities of new, novel drugs for medical research, which will allow us to get medicines to patients faster.”

“Plus, this celebratory occasion also marks an important milestone for our Alnwick pharmaceutical development site, which celebrated its 40th anniversary in 2022. We have a long and successful history in Alnwick, and we fully intend for that to carry on with our continued investment and support in the town.”

The completion of this facility will create an additional 80-100 new scientific and technical jobs at the Alnwick site, which currently employs 200 people across a range of scientific disciplines, including process chemistry, solid-state characterization, radiosynthesis, bioanalysis, and formulation development.

The company will continue to expand its capabilities, capacity, and headcount at the site to meet the growing demand for outsourced drug substance, product development, and manufacturing services. In 2021, the site was presented an award for “Most Inspirational North-East (UK) Science Employer” from STEM Learning as part of the STEM Ambassadors program.
 


About Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. 

About SCI

SCI is a unique global multi-disciplinary innovation network bringing together scientists, inventors, and entrepreneurs to develop scientific solutions to the biggest challenges facing society today. SCI works across crucial sectors as diverse as renewable energy, sustainability, and new forms of cancer treatments.

Quotient Sciences Contributes to Clinical Pharmacology in Drug Development article, "A Phase 1 Study of Savolitinib"

Articles & Publications

Quotient Sciences Contributes to Clinical Pharmacology in Drug Development article, "A Phase 1 Study of Savolitinib"

Som Menakuru, Senior Clinical Research Physician at Quotient Sciences, recently contributed to an article published in the American College of Clinical Pharmacology® Clinical Pharmacology in Drug Development journal, "A Phase 1 Study to Evaluate Absolute Bioavailability and Absorption, Distribution, Metabolism, and Excretion of Savolitinib in Healthy Male Volunteers."

This open-label, two-part, phase 1 clinical study used a radiolabeled micro-tracer approach to evaluate absolute bioavailability and a traditional approach to determine the ADME of savolitinib in healthy male adult volunteers.

 

Article Summary

Aberrant activation of MET (hepatocyte growth factor receptor) signaling is associated with tumorigenesis and in many cancers, such as that of the kidney, liver, stomach, lung, and breast, an aggressive phenotype with poor clinical outcomes. Rapid disease progression and shortened survival have been linked to MET dysregulation. MET dysregulation has also been linked to acquired resistance to targeted therapies, limiting their therapeutic efficacy and leading to treatment failure. Savolitinib is an oral MET tyrosine kinase inhibitor and is under global clinical development outside of China as a monotherapy or combination therapy in additional disease areas.

Previous pharmacokinetic (PK) assessments of savolitinib in patients with advanced solid tumors and drug–drug interaction (DDI) studies in healthy volunteers have shown that savolitinib is rapidly absorbed, with a relatively short time of maximum observed concentration (tmax) of approximately 2–4 hours.  Apparent terminal half-life (t½) is also short (approximately 4–7 hours), resulting in no accumulation of savolitinib after once-daily or twice-daily dosing. Mean plasma exposure of a pharmacologically active metabolite (M2; N-desmethyl savolitinib, M2 is approximately 3–4-fold less potent than savolitinib) and a nonactive metabolite (M3; hydroxy savolitinib) are approximately 33% and 12% of the exposure of savolitinib, respectively, based on area under the plasma concentration–time curve (AUC) (from time 0 to infinity) after a single oral dose of savolitinib.

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About Savolitinib

Savolitinib is an oral MET (hepatocyte growth factor receptor) tyrosine kinase inhibitor, with demonstrated preliminary efficacy in several cancer types. Previous pharmacokinetics assessments showed that savolitinib is rapidly absorbed but there are limited data on the absolute bioavailability and absorption, distribution, metabolism, and excretion (ADME) of savolitinib.

Quotient Sciences Expands Formulation Development Capabilities at Nottingham, UK

News & Announcements , Nottingham, UK

Quotient Sciences Expands Formulation Development Capabilities at Nottingham, UK

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NOTTINGHAM, UK; February 8, 2023 – Quotient Sciences, the drug development and manufacturing accelerator, today announced that it has completed an expansion of its early-phase formulation development capabilities for oral dosage forms at its Nottingham, UK, facility. The expanded services build upon the site’s existing formulation capabilities and increase capacity to support fully integrated drug development programs through the company’s flagship platform, Translational Pharmaceutics®.

Over the past 30 years, Quotient Sciences has built a strong reputation for developing both simple and complex, fit-for-phase formulations for small molecules and peptides. With this latest investment, the company has expanded its high containment laboratory capacity to support oral drug programs including immediate release, modified release tablets and multi-particulate dosage forms for highly potent compounds.

Andy Lewis, Global Vice President of Integrated Pharmaceutical Sciences at Quotient Sciences, said: “At Quotient Sciences, our expertise in formulation development is underpinned by our unique track record in clinical research. Having both biopharmaceutics and clinical knowledge in-house, coupled with our experience from formulating over 1,500 molecules, enables us to accelerate the development process for our customers.”

“With these expanded capabilities, we can start formulation development work even earlier for our customers, allowing for projects to start faster and turnaround times to be reduced, which in turn will speed up development timelines. Importantly, the new equipment and process trains are fully integrated with our existing capabilities, so at the appropriate point we can quickly transition drug programs downstream into GMP clinical trial manufacturing, saving our customers precious time in advancing innovative medicines into the clinic.”

Mark Egerton, CEO of Quotient Sciences, added: “Quotient Sciences’ mission is to help get new medicines to patients faster and over the course of the last decade we’ve been investing in capabilities to support that. We place great importance on supporting customer demand and will continue to actively increase our formulation tool kit to provide more integrated solutions under a single organization to streamline the outsourcing paradigm for our customers.”

John McDermott contributes to roundtable article with Drug Development & Delivery

Articles & Publications , John McDermott

John McDermott contributes to roundtable article with Drug Development & Delivery

Reflections - Quotient Sciences

During a recent round­table discussion, Drug Development & Delivery posed this question to life science leaders: Which Trends Will Have the Most Impact on Drug Development in 2023? In response, John McDermott, Vice President of Scientific Consulting at Quotient Sciences, shares the benefits that a single, common serv­ice platform can have on drug development.

"The pharmaceutical industry is constantly seeking ways to accelerate the drug development process and shorten timelines to reduce costs and deliver medicines to patients earlier – ‘trends’ which are followed annually in the industry." said Mr. McDermott. "The integration of drug manufacturing and program strategy management works to streamline key stages of drug development and fast-track a molecule from first-in-human to proof-of-concept."

Read the rest of John's response and see more insight from other experts in the Drug Development & Delivery article. Continue reading.

Ensysce Biosciences' PF614-MPAR Enters Final Stage of Phase 1 Study

News & Announcements , Customer Milestone , Translational Pharmaceutics®

Ensysce Biosciences' PF614-MPAR Enters Final Stage of Phase 1 Study

Ensysce Biosciences and Quotient Sciences logos

Ensysce Biosciences' PF614-MPAR could become the industry's first overdose protection pain product. 

Quotient Sciences are partnering with Ensysce Biosciences on the final Phase I study for PF614-MPAR at our Miami, FL, facility. Read Ensysce's announcement regarding the initiation of the final stage of the Phase 1 study.

SAN DIEGO, CA / ACCESSWIRE / January 25, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), (OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced the initiation of the final stage of the Phase 1 study of PF614-MPAR. PF614-MPAR is the overdose protection version of its lead product, PF614, and this key study is being conducted in healthy subjects by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.

PF614, a TAAPTM prodrug of oxycodone, has a number of safety features designed to reduce abuse, including its extended-release profile that has been shown to reduce ‘drug liking' in recreational drug users. Additionally, its requirement for exposure to the enzyme trypsin to release oxycodone reduces the ability of recreational users to chew, crush and snort, or manipulate and inject to change the opioid release profile. The combination product PF614-MPAR has another layer of safety, with an added trypsin inhibitor to prevent overdose.

The recently completed initial stage of the trial sought to optimize PF614-MPAR (the PF614/nafamostat combination) for both release rate and ratio of the combination. Data from the trial demonstrated that PF614-MPAR could deliver oxycodone similarly toPF614, which was the goal of the study. In line with expectations, the results of the study demonstrated that an overdose of PF614-MPAR would result in diminished oxycodone release and uptake as compared to an equivalent amount of PF614. In the final stage of the study, the selected PF614-MPAR formulation will be evaluated by measuring oxycodone release from increasing dose units delivered to a group of healthy subjects.

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