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Dr. Christine Allen - Co-Founder & CEO Intrepid Labs

Christine Allen Headshot Oct 2025

Dr. Christine Allen

Co-Founder & CEO Intrepid Labs

Guest Expert
About

Dr. Christine Allen is CEO and co-founder of Intrepid Labs Inc., a company leveraging AI, automation, and deep pharmaceutical expertise to accelerate drug formulation and develop proprietary delivery technologies. Intrepid’s approach helps bring transformative medicines to patients faster, improving therapeutic outcomes and enhancing patient care.

Christine is also a full professor at the University of Toronto (U of T), internationally recognized for her contributions to drug formulation and development, with over 180 peer-reviewed publications. She is a distinguished fellow of both the American Institute for Medical and Biological Engineering and the Canadian Academy of Health Sciences. Christine has held significant leadership roles, including President of both the Controlled Release Society and the Canadian Society for Pharmaceutical Sciences, and Editor-in-Chief of the Journal of Controlled Release.

Her academic leadership includes serving as the inaugural Associate Vice-President and Vice Provost Strategic Initiatives and Interim Dean of the Leslie Dan Faculty of Pharmacy at U of T. 

Seminar: Accelerating Formulation Development with AI

Seminar: Accelerating Formulation Development with AI

San Antonio, United States | 11 November 2025
Overview

Join Quotient Sciences and Intrepid Labs for an exclusive breakfast seminar exploring how artificial intelligence (AI) is transforming formulation development. Learn how AI platforms are helping reduce development timelines, optimising formulation strategies and improving predictability of clinical performance. 

This session will highlight real-world applications, including how Intrepid’s proprietary AI algorithm, AndromedaTM, can be combined with Translational Pharmaceutics® - a disruptive approach to drug development - to accelerate entry into the clinic, reduce API consumption, and enhance formulation decision-making in clinical development.  

Key Learnings for Attendees

  • Understand the role of AI in formulation development
  • Learn how formulation design has been streamlined for modified release products.  
  • Discover the potential benefits of combining AI with Translational Pharmaceutics®
  • See how this integration accelerates clinical timelines and improves formulation lock-in.
  • Gain insights into future applications and research     

Engage in open discussion and participate in a Q&A session to explore what the future of drug development may look like. 

Time/DateVenue

7:30 AM - 9:00 AM

Tuesday, November 11th 2025

Grand Hyatt San Antonio River Walk 

600 E Market St, San Antonio

TX 78205, United States 

Register
Location
Grand Hyatt San Antonio River Walk
600 E Market St, TX 78205
San Antonio, United States

First-in-Human Trials to Proof of Concept Info Sheet

Info Sheets , Clinical Pharmacology , First-in-Human , Proof-of-Concept , Patient Trials

First-in-Human Trials to Proof of Concept Info Sheet

14 October 2025
Overview

The transition from preclinical to clinical testing is a pivotal moment in drug development. It’s also one of the most challenging. 

Unknown risks, complex protocols, and regulatory hurdles can delay progress and put your investment at risk.

Partnering with an experienced first-in-human specialist such as Quotient Sciences is the key to navigating this critical phase with confidence. Through our work with small molecules and biologics, we provide the expertise, infrastructure, and agility needed to move your novel therapy forward, faster. 

Download
Date
14 October 2025

Quotient Sciences and Biorasi Partner to Accelerate Early Phase Clinical Trials to Patient Proof of Concept

News & Announcements

Quotient Sciences and Biorasi Partner to Accelerate Early Phase Clinical Trials to Patient Proof of Concept

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NOTTINGHAM, UK; October 14,2025: Quotient Sciences, a leading global drug development, research and manufacturing accelerator, and Biorasi, a global clinical research organization (CRO), today announced a strategic partnership to deliver fully integrated early phase clinical trial solutions. 

The partnership will combine Quotient Sciences’ expertise in early clinical development with Biorasi’s global patient recruitment capabilities to provide biotech and pharma Sponsors with a simplified, efficient pathway from Investigational New Drug (IND) to proof of concept (POC) with seamless transitions from healthy volunteers into patient groups within first-in-human (FIH) Phase I/IIa clinical trials.

Sponsors will benefit from Quotient Sciences’ clinical pharmacology expertise, with facilities in Miami (US) and Nottingham (UK) comprising 230 beds and supported by a large database of trial participants. This is complemented by Biorasi’s global patient recruitment network, which spans a wide range of therapeutic areas including dermatology, neurology, nephrology, cell therapy, and other specialty fields.  

The partnership will provide sponsors with a single provider model for FIH to POC programs, with the option of a single contract and a unified protocol and regulatory submissions to reduce the outsourcing complexity and accelerate development timelines.  

Quotient Sciences is a recognized leader in early clinical development, with deep expertise in Phase I healthy volunteer studies and early patient proof of concept (POC) trials. To meet growing industry demand for patient assessments and biomarker integration in first-in-human (FIH) studies, the company is expanding its patient access framework through a network of academic and commercial collaborators.  

These hybrid or multi-part protocols—combining healthy volunteer and patient cohorts within a single integrated design—offer speed, flexibility, and scientific rigor and a seamless pathway for generating early clinical data. 

​​​Thierry Van Nieuwenhove, CEO of Quotient Sciences, commented:​ “This partnership reflects our 35-year commitment to helping customers accelerate drug development to proof of concept by reducing complexity and breaking down traditional barriers. By combining Quotient’s clinical expertise with Biorasi’s global patient access network, we enable Sponsors to efficiently conduct early-phase studies under a single operational and contracting model, while maintaining the highest standards of clinical research and data quality. We take your molecule to the next stage of its journey—faster and more cost-effectively than anyone else.”

​​“Biotech and pharma innovators need flexible, reliable solutions to succeed in today’s evolving clinical trial environment,” added​​ Chris O’Brien, CEO of Biorasi. “Through this collaboration with Quotient Sciences, we are providing Sponsors with a simplified, scalable model that supports everything from FIH studies to patient POC, helping new therapies reach patients faster.”​​​

​​​The expansion into patients is a natural extension of Translational Pharmaceutics®, Quotient’s disruptive approach to drug development which seamlessly integrates formulation development, drug product manufacturing, and clinical testing, saving up to 12 months and accelerating data-driven decision making. ​​

The venture also expands opportunities for adjacent services including comprehensive CDMO offerings such as pharmacy compounding, drug product manufacturing, data sciences, and regulatory support. 

Poster Spotlight: Taste Assessment Study of Bivamelagon Pediatric Solution Formulations from EuPFI 2025

Pediatrics , Formulation Development

Poster Spotlight: Taste Assessment Study of Bivamelagon Pediatric Solution Formulations from EuPFI 2025

Poster Spotlight Taste Assessment Study of Bivamelagon Pediatric Solution Formulations from EuPFI 2025

Summary: At the 17th Annual Conference of the European Paediatric Formulation Initiative (EuPFI),  researchers from Quotient Sciences and Rhythm Pharmaceuticals presented a poster titled “Taste Assessment Study of Bivamelagon (MC72) Pediatric Solution Formulations.”  

Poster Spotlight: Taste Assessment Study of Bivamelagon Pediatric Solution Formulations from EuPFI 2025 

Read highlights from the poster below and download the poster to see additional findings.   

Bivamelagon (MC72; LB54640) is an investigational small molecule agonist of the melanocortin-4 receptor (MC4R), developed for once-daily oral administration to treat MC4R pathway disease-related obesity.

The poster highlighted a collaborative effort to improve the palatability of oral liquid formulation of Bivamelagon for pediatric patients. Quotient Sciences authors Amit Sawant, Nazim Kanji and Phil Evans, along with Rhythm Pharmaceuticals authors Joe Shulman and Anthony Frank contributed to the poster.

Clinical taste assessment study with healthy volunteers

The primary objective was to evaluate the taste profile of  Bivamelagon solutions and establish the viability of age-appropriate oral liquid formulations for pediatric use. The current Bivamelagon oral formulation consists of a hydrochloride salt with a bitter taste.  

The team aimed to identify simple flavoring and sweetening strategies to mask bitterness and improve acceptability for children. A taste assessment study was conducted with a panel of healthy adult volunteers at Quotient Sciences – Nottingham, UK.

Twelve adult volunteers participated in a randomized, controlled taste assessment where each person sampled oral solution formulations—one reference (Regimen A) and seven test solutions (Regimens B to H)—all containing 10 mg/mL Bivamelagon. The test solutions varied in different levels of sweetener used (sucralose) and different flavors (orange, strawberry, and raspberry).

Participants rated overall acceptability and taste attributes using a 9-point Likert scale. Statistical analyses were performed to compare each test regimen to the reference. 

A more palatable formulation for further clinical study 

The study found that the reference formulation (Regimen A) was poorly rated for taste and acceptability.

In contrast, all seven test regimens (B to H) showed statistically significant improvements in overall acceptability and palatability attributes. The addition of sucralose, either alone or combined with flavors, consistently improved taste masking.

The median overall acceptability scores for test regimens ranged from 4.5 to 5.5, compared to 3.0 for the reference. A statistical analysis confirmed significant improvements (p < 0.02 for all comparisons vs. reference.

These results demonstrated that simple sweetening and flavoring strategies can effectively mask bitterness and enhance the palatability of Bivamelagon oral solutions. The study concluded that formulations containing sucralose, alone or with fruit flavors, are suitable for further development and progression to pediatric patient studies. 

Download the poster

Browse more about our pediatric offering 

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Colleague Stories: Catherine Wilkes

Careers , Nottingham

Colleague Stories: Catherine Wilkes

Catherine Wilkes

Summary: Catherine Wilkes, Quotient Sciences’ longest serving colleague of over 30 years, works as an Executive Director within our Environmental Health & Safety (EHS) team in Nottingham, UK. She discusses her career with the company and what she enjoys most about her role.  

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

Describe a typical day in EHS

Describing a typical day is difficult as no two days are the same. As an EHS team member at Quotient Sciences, you could arrive at work planning to do one thing, like reviewing safety assessments, developing and delivering EHS training programs, coordinating incident investigations, or leading one of our Safety Champion meetings…but then ending up in a meeting helping to find a safe solution to an unexpected operational issue, advising on safe ways of working, or following up on safety observations as they are reported. It’s never dull! 

How has your career progressed since joining us?  

My career has progressed significantly since I joined the business in 1995 when I was recruited into the role of Research Technician supporting laboratory, manufacturing, and clinical activities. Since then, my career path has been a mixture of sideways moves and upward promotions. Having gained well-rounded experience within the operational areas of the business, I moved into a full-time EHS role in the 2003, responsible for implementing H&S management systems at the Nottingham site from scratch. Fast forward to today and my current role includes developing global EHS policy and procedures and working with EHS and management teams across all sites to support harmonization activities, where this is beneficial.  

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

My only relevant work experience was one year working in the Virology department of an hospital as part of my BTEC HND sandwich course. I spent that academic year working in the lab processing biological samples for diagnostic testing. Aside from that, various part-time positions I held in retail as a student taught me the importance of good customer service.

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

The Research Technician role just required a scientific qualification, so the BTEC HND in Applied Biology which I had just achieved was perfect. 

What learning or qualifications have you gained in this role?

When I moved into EHS, Quotient Sciences supported me in studying for and gaining my Level 6 Diploma in Occupational Safety & Health. This was the stepping stone to being able to join two professional EHS bodies (IOSH & IIRSM) and subsequently, through a program of continued professional development (CPD) and assessment, I successfully achieved IOSH Chartered Safety Practitioner status in 2013 which I’m very proud of. CPD continues to be important for me to retain my credibility by keeping my professional knowledge and skills up to date. 

What do you enjoy most about your role? 

I enjoy most that my role gives me the opportunity to positively promote EHS at Quotient Sciences, working with colleagues across all sites and at all levels within the organization. The ultimate goal is to achieve a positive and proactive safety culture with all colleagues actively engaged in supporting safe working at all our sites. While every single colleague has a part to play in that, it’s my main motivator and has been since I first became involved in EHS.  

What aspects do you find most challenging? 

I’m a firm believer that EHS procedures should be kept as simple, comprehensive, and efficient as practicable, as this ultimately make life easier for everyone. Overcoming resistance to change, especially when proposing improvements to legacy systems or inefficient ways of working, can be a challenge but this also presents great opportunity to work collaboratively with colleagues to really understand their concerns and to ensure these are properly considered in the planning process.

What’s the team like?  

While the small site-based EHS teams focus on managing the EHS hazards and risks relevant to their site, we still come together as an EHS Community. We are regularly in contact with each other, benefitting from the experience among the wider pool of knowledge. One of the key attributes all our EHS colleagues have is their approachability and friendly supportive manner…this is of paramount importance to our mission to foster and maintain a positive safety culture within the global business. It also helps that they are a lovely bunch with a good sense of humor! 

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

If you are looking for a role where you are able to plan your day meticulously and don’t like to deviate from that plan, then EHS will probably not be for you. To thrive in an EHS role, you need to be adaptable, able to juggle a range of tasks simultaneously, an advocate of continuous improvement, able to accept the inevitable interruptions to your day with a smile, keep calm under pressure, and be a true team player. 

What do you like most about working at Quotient Sciences?  

I’ve worked for Quotient Sciences for a long time…I’ve stayed so long because I genuinely enjoy working here. I continue to be motivated by and interested in both the work we do as an organization (developing new medicines for patients) and the people I work with every day. There is now, and always has been over the years, brilliant people working at Quotient Sciences and I enjoy doing my bit to keep them all safe and healthy while they are at work. 

“One of the key attributes all our EHS colleagues have is their approachability and friendly supportive manner…this is of paramount importance to our mission to foster and maintain a positive safety culture within the global business.” 

– Catherine Wilkes 

 

Formulation Optimization of EVX-101, A Novel Gastro-Retentive Prolonged-Release 5-HTP/Low-Dose Carbidopa Tablet

Scientific Posters , EVX-101 , Translational Pharmaceutics , 5-HTP

Formulation Optimization of EVX-101, A Novel Gastro-Retentive Prolonged-Release 5-HTP/Low-Dose Carbidopa Tablet

8 October 2025
Overview

Inadequate response to antidepressant treatment is a significant issue for many patients with depression. Enhancing brain extracellular serotonin (5-HT) levels beyond those produced by serotoninreuptake inhibitors may treat depression more effectively. Adjunctive treatment with 5-hydroxytryptophan (5-HTP), the natural precursor to 5-HT, can amplify brain serotonin. 

However, 5-HTP absorption is restricted to the upper intestine, bioavailability is low, and 5-HTP has a short half-life (t½), making 5-HTP a poor drug. To overcome these pharmacokinetic (PK) limitations, a gastro-retentive (GR) sustainedrelease (SR) formulation is required to maximize absorption producing sustained exposure. Carbidopa inhibits amino acid decarboxylase, the enzyme that converts 5-HTP to 5-HT in the intestine, resulting in decreased first pass metabolism and increased 5-HTP bioavailability. 

The development and optimization including PK and safety assessment, of EVX-101 a novel GR SR 5-HTP/carbidopa tablet formulation is described.

Download
Date
8 October 2025

A First-in-Human Assessment for TQS-168, Including Safety, Tolerability, Pharmacokinetics, Formulation Selection, and Food effect in healthy volunteers

Scientific Posters , First-in-Human , Translational Pharmaceutics , TQS-168

A First-in-Human Assessment for TQS-168, Including Safety, Tolerability, Pharmacokinetics, Formulation Selection, and Food effect in healthy volunteers

8 October 2025
Overview

TQS-168, a first-in-class peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1α) inducer in development for the treatment of amyotrophic lateral sclerosis (ALS) and Parkinson’s disease. 

TQS-168 is a Biopharmaceutics Classification System (BCS) Class II compound, and preclinical data have indicated solubility limited absorption, hence solubility enhancement is likely required to achieve adequate exposure in humans. 

The purpose of the first in human (FIH) study was to establish safety, tolerability and pharmacokinetics (PK) for TQS-168, but also to assess performance of solubility enhanced formulations, allowing selection of an appropriate technology for Phase II progression. The food effect was also assessed on the selected formulation technology.

Download
Date
8 October 2025

Development of an Extended Release Nafamostat Formulation for Prescription Drug Overdose Protection

Scientific Posters , Nafamostat Formulation , Translational Pharmaceutics

Development of an Extended Release Nafamostat Formulation for Prescription Drug Overdose Protection

8 October 2025
Overview

Prescription opioid abuse and overdose are major society burdens, resulting in significant costs, illnesses, and deaths.

PF614, an oxycodone-derived prodrug, was designed to reduce abuse as it requires exposure to trypsin in the small intestine to release oxycodone. Injection, insufflation, plugging, and dose dumping are not possible means of abuse of PF-614 due to its molecular design.

MPAR® (Figure 1) is a combination of Trypsin Activation Abuse Protection (TAAPTM) (Figure 2) prodrug platform (PF614) and a protease inhibitor (nafamostat) that provides overdose protection at a molecular level.

The short half-life of nafamostat required development of an extended release (ER) formulation to ensure trypsin inhibition is maintained for the duration that PF614 prodrug is transiting the small intestine.

Optimization of the PF614-MPAR formulation with evaluation of several variables including ER nafamostat release rate (modified by bead coating), ER and immediate release (IR) nafamostat dose ratio, and PF614:nafamostat dose ratio, is described.

 

Download
Date
8 October 2025

Taste Assessment Study of Bivamelagon (MC72) Paediatric Solution Formulations

Scientific Posters , Bivamelagon , Paediatric Solution Formulations

Taste Assessment Study of Bivamelagon (MC72) Paediatric Solution Formulations

8 October 2025
Overview

The melanocortin-4 receptor (MC4R, OMIM:155541) is a G protein-coupled receptor that is predominantly expressed in the hypothalamus and has a pivotal role in the regulation of satiety, feeding behaviour, and energy homeostasis through the leptin-melanocortin pathway.

Hyperphagia (insatiable hunger and abnormal food-seeking behaviours) and obesity may result from pathway impairment caused by genetic variants or hypothalamic injury.

Current treatment options for these forms of obesity are limited due to the failure of conventional weight management interventions, such as lifestyle modifications, to address the underlying hyperphagia and specific molecular mechanisms leading to continued weight gain.

Bivamelagon (MC72; LB54640) is an investigational small molecule agonist of MC4R and is being developed for once daily (QD) oral administration to treat MC4R pathway disease-related obesity. The current bivamelagon oral formulation consist of a hydrochloride salt that has a bitter taste.

The overall objective of this study was to evaluate the tasteprofile of reconstituted bivamelagon solutions to establishthe viability of simple flavouring and sweetening methodsfor taste masking an acceptable, age-appropriate oral liquid formulation for administration to paediatric patients.

 

Download
Date
8 October 2025
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