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Revolutionizing Treatment: The Promising Future of GLP-1s and Oral Peptides by Dr Andy Lewis

Articles & Publications , Dr. Andrew Lewis

Revolutionizing Treatment: The Promising Future of GLP-1s and Oral Peptides by Dr Andy Lewis

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In this article by the Manufacturing Chemist, Dr Andy Lewis, Chief Scientific Officer at Quotient Sciences reviews the trends driving the adoption of oral peptide products and considers the strategies to overcome the development challenges associated with effective delivery.

The article explores the future of GLP-1s and oral peptides, as advancements in drug delivery are transforming treatment options for patients.

Recent innovations are enabling the development of oral peptide products, which offer a more convenient and non-invasive alternative.

Given that approximately 90% of drugs fail during the clinical trial phase, developing strategies to address this is imperative.

Continue reading the article on Manufacturing Chemist.

Daniel Dennehy - Director, Business Development

Daniel Dennehy

Daniel Dennehy

Director, Business Development

About

Daniel Dennehy is an accomplished Business Development Director with over 10 years’ experience in sales to healthcare, pharmaceutical, and academic institutions. I have a proven track record of increasing sales, breaking into new markets, and building relationships with clients. My experience includes business to business relationships as well as business to consumer.

Daniel holds a degree in Microbiology from University of New Hampshire.

Expertise & focus areas

Jennifer Lattimer - Executive Director & Head of Global Inside Sales Management

Jennifer Lattimer

Jennifer Lattimer

Executive Director & Head of Global Inside Sales Management

About

Jennifer Lattimer is a motivated, outgoing and experienced Sales Executive with a demonstrated history of global business closure, B2B selling, cold calling and leadership in the CDMO/CRO industry. My professional experience began in highly regulated, GMP laboratories, and that has aided greatly in my transition into the commercial segment of the business. I am skilled in cold calling, lead generation and prospecting, as well as building and growing the client relationship. Knowledgeable in project oversight, onboarding and have an eye for process improvement and efficiency.

Jeniffer holds a bachelor's degree in biology from University of Louisiana Monroe, as well as Master of Business Administration from University of Louisiana Monroe.

Expertise & focus areas

AAPS PharmSci 360 2024

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AAPS PharmSci 360 2024

Salt Lake City, United States | 21 October 2024 - 23 October 2024
Overview

Join us for AAPS 2024 in Salt Lake City

Quotient Sciences drug development experts will be back for another great year at AAPS PharmSci 360 in Salt Lake City, UT in October. Join us at booth #2419 to discuss your drug development needs and be sure to join us for our various presentation within the AAPS PharmSci conference.    


Attend our conference presentations

Rapid Fire Talk: "Design Space Approach to Optimize Formulation Based on Clinical Data"

Date: Monday October 21, 2024  
Time: 3:00 PM - 3:15 PM 
Presented by: Dr. Vanessa Zann
Room: 255 EF, Salt Palace Convention Center 

Main Stage: "Your hired! Selecting the right pre-IND compound"

Date: Monday October 21, 2024  
Time: 9:00 AM - 10:00 AM
Presented by:
Darren Matthews, Associate Science Director, UK Small Molecule Drug Discovery at Charles River Laboratories
Eleanor Row, VP, Global Commercial Drug Substance at Quotient Sciences
Room: Stage 3, Exhibit Hall 


See our poster presentation

Predicting Belumosudil Drug-Drug Interactions Using a Physiologically Based Pharmacokinetic Model

Presented by: Kevser Sevim, Senior Modelling and Simulation Research Fellow


Join us for our seminar 

RapidFACT® Overcoming the Poor Predictability of Preclinical Models to Accelerate Formulation Optimisation.

Tuesday, October 22

Breakfast & registration beginning at 7:30 AM

Join us during AAPS for our breakfast seminar at the Hyatt on October 22nd.  Vanessa Zann, PhD, Executive Drug Development Consultant will share how Translational Pharmaceutics platform integrates formulation development, on-demand GMP manufacture and clinical testing to accelerate dug development programs.  

Click here to read more and register.  

Advanced registration is required, and spaces are limited!  

Register now
Location
Salt Palace Convention Center
90 S W Temple St
Salt Lake City, United States

Optimizing API Synthesis: Balancing Quality, Speed, and Safety in Pharmaceutical Development

Articles & Publications , Richard Castledine

Optimizing API Synthesis: Balancing Quality, Speed, and Safety in Pharmaceutical Development

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In this article by the Medicine Maker, Richard Castledine discusses how to identify a safe, cost-efficient, and sustainable route to scalable API synthesis.

The article explores the complexities of developing Active Pharmaceutical Ingredients (APIs) and offers strategies to optimize their synthesis. Balancing the need for quality with the speed of development is crucial during the transition from candidate selection to first-in-human clinical trials. Deploying data-driven API development strategies early in a drug program can mitigate downstream development risks.

Continue reading the article on Medicine Maker.

Leveraging Real-Time Clinical Data to Deliver Certainty in Formulation Development: Case Studies from Across 300 Delivered Programs

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Leveraging Real-Time Clinical Data to Deliver Certainty in Formulation Development: Case Studies from Across 300 Delivered Programs

London, United Kingdom | 27 September 2024
Overview

Drug product optimization is a critical development step that is common for most drugs that are progressing through today’s development pipelines to respond to suboptimal exposure profiles, to transition from an early development formulation to one suitable for chronic administration in patients, or as part of a life-cycle management strategy.

Traditional drug product optimization processes take 12-18 months to complete and place significant emphasis on the predictive power of laboratory and preclinical assessments. This approach is a non-optimal working model necessitated by the multiple disciplines required to develop, make and test new formulations in humans.

In this presentation, John McDermott will describe the application of Quotient Sciences’ Translational Pharmaceutics to re-engineer and streamline the drug product optimization process, using clinical data to improve decision-making and halve development timelines.

Learning Objectives:

  • Develop an understanding of Translational Pharmaceutics when applied to drug product optimization
  • Hear case studies on reformulation programs 
     

Date 27th September - Agenda

Arrival: 1 - 1.30pm
Seminar: 1.30 - 2.30pm
Cocktail making class: 2.30 - 3.30pm

 

*This is an in person event that will not be recorded. A virtual option to attend is not available.

**We reserve the right, at our sole discretion, to deny registration or remove any individual who is not a confirmed current or potential client/partner of Quotient Sciences.

 

Register
Location
Friday September 27th, 2024 Drake and Morgan, Kings Cross
6 St Pancras Square
London, United Kingdom

Microwave Digestion to Support ICP-MS Sample Analysis

Bioanalysis

Microwave Digestion to Support ICP-MS Sample Analysis

Two scientists working in a laboratory

What is Microwave Digestion?  

Microwave digestion is a technique that is achieved by subjecting a sample to a strong acid in a closed vessel followed by an increase in pressure and temperature through microwave irradiation. The rapid pressure and temperature increase causes the sample to break down much faster than traditional methods like an oven or a simple acid or alkaline digest. The increase in pressure and temperature of the acidic sample amplifies both the speed of thermal decomposition of the sample as well as the solubility of metal elements in solution. Once the samples are in solution, it is possible to quantify the metal elements by ICP-MS analysis.

What Microwave Digester do Quotient Sciences use?

Quotient Sciences' facility in Alnwick has an ultraWAVE digester that has been used successfully in many regulated studies for the digestion of complex biological matrices and elements.

What are the Benefits of using the ultraWAVE Digester?

The use of the ultraWAVE digester is less labor intensive. The alternative approach Quotient Sciences use is an overnight digest in a concentrated acid which takes more time for the analyst to set up and digest. This digest occurs overnight whereas the ultraWAVE digester cycle lasts approximately 30 minutes from start to finish. This process can be done in much less time due to a few reasons. Sample rack inserts can hold up to 26 samples that are all digested simultaneously in one cycle. In addition, disposable vials are used to contain the sample when in the digester. This means there is no additional cleaning step between cycles and no carryover observed. Another benefit is that different biological matrices can be digested together. Difficult matrices can also be digested. For example, bones and nails. Due to the benefits listed above, Quotient Sciences observed an increased sample throughput when using the ultraWAVE digester.

Has Quotient Sciences used the ultraWAVE Digester for regulated studies?

Yes, we have used our ultraWAVE digester for validation work and regulated sample analysis studies. The digester was used during a GLP study in which our team analyzed over 600 tissue samples. The team digested and analyzed bone marrow, brain, GI tract, liver, ovaries, testes, spleen and uterus tissue samples.

What are alternatives to this method/way of working?

The alternative approach Quotient Sciences use is an overnight digest in a concentrated acid or base. This process is a lot more labor intensive and takes a lot more time to digest the samples. Depending on the sample that is being digested, an acid/base digest can take longer than overnight. This can cause delays to sample analysis and impact timelines.  

In what situations would we recommend using the ultraWAVE Digester?

We would recommend using the ultraWAVE digester for the following: metallic nanoparticle solids, challenging matrices such as bone that do not easily digest, large clinical and non-clinical studies that require analysis of a vast amount of samples, and clinical and non-clinical studies that have more than one tissue type requiring digest as the ultraWAVE digester can digest multiple tissue types in one cycle.

*the ultraWAVE digester is a patented technology under Milestone. 

RapidFACT® – Overcoming the Poor Predictability of Preclinical Models to Accelerate Formulation Optimization

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RapidFACT® – Overcoming the Poor Predictability of Preclinical Models to Accelerate Formulation Optimization

Belmont, CA 94002, United States | 15 October 2024
Overview

Conventional formulation development uses preclinical models to assess formulation performance to select prototypes to study in humans. It is well understood that there is often a disconnect between preclinical and human bioavailability, hence relying on animal data carries risk of selecting suboptimal formulations. 

Translational Pharmaceutics® platform integrates formulation development, on-demand GMP manufacture and clinical testing to accelerate drug development programs. It enables clinical assessment with GMP manufacturing, release and dosing possible in less than seven days, allowing clinical assessment to proceed with only short term stability data, and significantly reduced batch sizes. 

Flexible formulation design spaces can also be evaluated to enable critical formulation attributes to be studied allowing multiple formulation variables to be assessed and optimized based on emerging clinical PK data. Current talk describes the Translational Pharmaceutics® platform, its applications within the development cycle during first in human (FiH) studies giving an overview of a case study covering integrated formulation development, compounding and a FiH study with a novel synthetic peptide compound and also formulation platform selection within a FiH study. 

The presentation also covers RapidFACT® (rapid formulation development and clinical testing) application for solubility enhancement for DCS class 2 compounds, modified release and gastroretentive formulation optimization.  

Learning objectives 

  • Gain and understanding of how exposure in preclinical species doesn’t not always predict human performance, and hence risks misleading development activity.
  • See how integration of GMP manufacturing (CDMO) and clinical testing (CRO) industrial silos via Translational Pharmaceutics® can accelerate drug development
  • Develop an understanding of how Translational Pharmaceutics® can be applied to perform Rapid Formulation development And Clinical Testing (RapidFACT®) to facilitate formulation selection and optimization within a clinical study increasing chances of success and delivering better outcomes
Date/AgendaLocation

Tuesday, October 15, 2024

Registration & Networking: 5:00 PM
Seminar  with Dinner: 5:45 PM
Dessert/Coffee/Q&A: 6:30 PM

Divino Restaurant
968 Ralston Avenue 
Belmont, CA 94002

*This is an in person event that will not be recorded. A virtual option to attend is not available.

**We reserve the right, at our sole discretion, to deny registration or remove any individual who is not a confirmed current or potential client/partner of Quotient Sciences.

Register now
Location
Tuesday October 15, 2024 Divino Restaurant
968 Ralston Avenue
Belmont, CA 94002, United States

On-Demand: Development of Orally Delivered GLP-1 Therapeutics …From Diabetes to Obesity and Beyond

On-Demand Webinar , GLP1 , Oral Peptides , Dr. Andy Lewis , Dr. Stuart Mair

On-Demand: Development of Orally Delivered GLP-1 Therapeutics …From Diabetes to Obesity and Beyond

18 July 2024
Overview

Dr. Andrew Lewis, Chief Scientific Officer, and Dr. Stuart Mair, Chief Medical Officer explore the latest developments in orally delivered GLP-1 agonists and take a look at potential future innovations. 

Our expert speakers examine obesity as a global health issue, discussing its profound impact on healthcare; guide us through the discovery of GLP-1 agonists and the potential for these therapeutics outside diabetes; and explore the challenges and potential solutions for orally-delivered GLP-1 products. 

You'll learn about:

  • Drivers for oral incretin analogues and the CMC and clinical challenges in their development
  • How Quotient Sciences' Translational Pharmaceutics® platform has enabled the accelerated development of both orally delivered peptides and small molecules in the incretin family
  • Future innovation in GLP-1 agonists and oral peptides

Watch our on-demand recording and stay at the forefront of treatment advancements in this quickly evolving category.

Watch
Date
18 July 2024

How Translational Pharmaceutics® Supports Drug Product Optimization (Video)

Translational Pharmaceutics , Drug Product Optimization , Dr. Aruna Railkar

How Translational Pharmaceutics® Supports Drug Product Optimization (Video)

How Translational Pharmaceutics® Supports Drug Product Optimization (Video)

It is well known that traditional drug product optimization processes take significant time.

Great emphasis is placed on laboratory and preclinical assessments to identify human formulations. Even though data do not adequately capture the performance of the dosage form in vivo, and the translation from the preclinical species to humans is suboptimal, drug developers often invest a significant amount of time and resources at this stage.

There is a critical need to rapidly enter clinical testing of new chemical entities (NCEs) in humans, assess their performance, and optimize as needed.

What is Translational Pharmaceutics®?

Translational Pharmaceutics® is an integrated approach to drug development. It is an innovative platform proven to shorten development timelines by 12 months or more. First applied in 2008, the platform uses clinical data to improve decision-making and halve development timelines.

How is Translational Pharmaceutics® used?

Quotient Sciences Translational Pharmaceutics® is a powerful solution to address the challenges of drug product optimization, in particular, which is one main application. 

In a recent client example, we supported the development of an extended-release drug product for overdose protection of a prescription drug. It was a complex program using a prodrug that requires activation by trypsin in the gastrointestinal tract and an inhibitor that requires delivery over an extended duration due to its short duration of action. We were able to help the customer adjust the release rate and dose for the immediate and extended-release beads across a two-part clinical study to support our client in meeting their goals. This was done using the concept of a "design space" to test ranges of doses and other critical to performance parameters in a clinical program. 

Video: Our expert discusses applying Translational Pharmaceutics® to drug development 

Translational Pharmaceutics® has been successfully applied to over 300 drug product optimization programs, delivering significant benefits in areas including solubility enhancement and modified release drug development activities. 

In this video, watch Aruna Railkar, Senior Drug Development Consultant, speak on this topic at the 2024 Controlled & Modified Drug Release Summit in New Jersey about how we apply Translational Pharmaceutics® to drug product optimization.

Want to discuss your next program and how we might be able to help? Contact us today.

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