Mental illnesses, such as depression and post-traumatic stress disorder (PTSD), are a leading cause of disability worldwide. Conventional anti-depressants have a high rate of partial or no response, often fail to improve symptoms, and can cause unpleasant side effects, thus identifying a great need to expand the range of available treatments. Could psychedelics provide a solution?

In the 1950s and 1960s, psychedelics were intensively studied and seen as a breakthrough in psychiatry, but their ban in 1970 under the United States’ Controlled Substances Act put a stop to most research. Over the past few decades, there has been a gradual change in perspective, owing to a lack of innovation in conventional psychiatric medications and expanding knowledge of how psychedelics work.       

In the last 10 years, there has been a surge of interest in psychedelics within the pharmaceutical industry, and there is growing evidence from scientific studies that psychedelics could be effective treatments for a variety of mental illnesses. Examples of psychedelic drugs that have been studied include: psilocybin, N,N-dimethyltryptamine (DMT), lysergic acid diethylamide (LSD), and 3,4-methylenedioxy​methamphetamine (MDMA).

At Quotient Sciences, our scientists are experienced at handling controlled substances and actively working on drug development projects with psychedelic compounds in both the laboratory and the clinic, including psilocybin, psilocin, DMT, and analogues. 

In this article, we explore what psychedelics are, how they are thought to work, and what scientific research is currently being done on them. We also discuss the challenges of conducting clinical research on psychedelics and handling them in the laboratory and in the clinic, and what the future holds for this somewhat controversial research area.

What are psychedelics?

Psychedelics are a class of psychoactive substances that produce changes in perception, mood, and cognitive processes. They have been known to cause different types of both visual and auditory hallucinations, including seeing or hearing things that do not exist or that are distorted. Psychedelics also have a high potential for misuse as recreational drugs and are classed as controlled substances, making them illegal to possess, produce, and supply without a license in most parts of the world.

How are psychedelics thought to work?

There is a belief that psychedelics could help to treat depression, possibly more effectively than the current marketed treatments, because they may target different areas of the brain that current methods do not access.

Currently, the most common category of anti-depressants is selective serotonin reuptake inhibitors (SSRIs). Serotonin is a neurotransmitter that is thought to help regulate your mood, and SSRIs work by increasing the amount of serotonin available to bind to serotonin receptors in the brain. SSRIs are typically taken as tablets 1–3 times a day. It can take up to 6 weeks to tell if an SSRI is working, and if it does not work, the patient must taper off the drug and try a different treatment.

In contrast, it is thought that psychedelics may be able to impart neuroplasticity, which is the ability to reorganize connections in the brain’s synapses. This may provide longer-lasting effects than conventional treatments and require less frequent doses, but more research and data is needed to obtain a deeper understanding of how psychedelics work.

LSD and MDMA are synthetic psychedelics, whereas psilocybin and DMT are naturally occurring psychedelics. DMT is one of the key active ingredients in the hallucinogenic drink ayahuasca. Psilocybin is the active ingredient in “magic mushrooms”, and it is a prodrug that is converted by the body to psilocin. Psilocin, DMT, and LSD have similar chemical structures to serotonin, so they are able to cross the blood-brain barrier and activate serotonin 2A receptors. This is thought to be what produces the psychedelic effects. MDMA has a different type of chemical structure, and it is thought to act by increasing the reuptake and release of serotonin, dopamine, and norepinephrine.

What scientific research is currently being done on psychedelics?

The US Food and Drug Administration (FDA) has designated psilocybin and MDMA as “breakthrough therapies”, which is a priority status given to promising drugs targeting an unmet need. This means that companies receive ongoing support from the FDA throughout the clinical trial process and priority review when data is available. There are currently hundreds of clinical trials registered on clinicaltrials.gov to test the effects of psychedelics on a variety of mental illnesses.

While some pharmaceutical companies are focusing on first-generation psychedelic compounds, others are tweaking the chemical structures to see if they can improve safety and effectiveness. Some companies are even hoping to create new chemical entities (NCEs) that remove all hallucinogenic effects while retaining the features responsible for therapeutic benefits. However, it is not yet known whether this is possible, and many scientists argue that the psychedelic “trip” brings about a change in perspective that is critical for treating mental illnesses. There is also the potential to look at fundamentally different molecules that can act on the same targets as psychedelics.

Recent notable breakthroughs in this field include the 2019 FDA approval of Spravato, developed by Janssen Pharmaceuticals, for treatment-resistant depression [1]. Spravato is a nasal spray with the S enantiomer of ketamine. While ketamine is not technically a psychedelic compound, this approval lent credibility to the idea of using a controlled substance to treat mental illness. In May 2021, the Multidisciplinary Association for Psychedelic Studies (MAPS) published results of a Phase 3 clinical trial on PTSD, where MDMA combined with psychotherapy showed sustained improvement in symptoms 2 months after treatment compared to placebo [2]. In November 2022, Compass Pathways published encouraging results from the Phase 2b clinical trial of Comp360, a patented polymorph of psilocybin, for treatment-resistant depression, which is the largest trial of psilocybin reported to date [3].

What are the challenges with conducting clinical research on psychedelics?

Conducting clinical research on psychedelics presents many challenges. In clinical trials, a synthetic form of the drug is tested on healthy volunteers or patients with specific mental illnesses under strict medical conditions, and expert psychological support must be provided before, during, and after the drug is taken.

It is difficult to conduct a truly double-blind trial with a psychedelic drug, as it is likely that participants will know whether they have received the active drug or a placebo. This raises the question of whether people are truly seeing therapeutic benefits, or if they just think they are because they know they received the active drug.

Currently, clinical trials of psychedelics typically exclude vulnerable populations, such as people with bipolar disorder, who might be vulnerable to psychotic episodes when taking psychedelics. However, these people would be exposed to the drug when it reaches the market, so it is important to include vulnerable populations in clinical trials to assess safety.

In addition, depression and anxiety can sometimes last for many months and can also recur in susceptible individuals. For this reason, long-term studies in different patient populations will ultimately be required to assess if the potential benefits in early trials can be sustained over time. 

Quotient Sciences has recently started performing clinical trials with psychedelic investigational medicinal products (IMPs) on healthy volunteers for customers. As a precaution, a trained psychologist is present during the clinical trial to manage any adverse events and to help the volunteer manage the experience in a calm and relaxed environment.

How do you legally and safely handle psychedelics in the laboratory?

There are stringent regulations in place for handling controlled substances like psychedelics, which presents many challenges for drug developers. Pharmaceutical companies need to be licensed to handle controlled substances, and strict security is required for production and storage. Safety is a critical consideration in order to protect employees and the facility from cross-contamination. While acute toxicity is typically low with psychedelics, they can exhibit observable effects at very low doses. The main risks are altered perception, poor decision-making, and subsequent accident or injury in the laboratory. Therefore, ensuring containment and minimizing exposure of staff is important. Capabilities and facilities for handling controlled substances can be prohibitively expensive for small pharmaceutical companies, so this creates opportunities for contract development and manufacturing organizations (CDMOs) that are licensed to handle controlled substances.

Quotient Sciences is licensed by the UK Home Office to possess, produce, and supply Schedule 1–4 controlled substances under the Misuse of Drugs Regulations 2001. Psilocybin, DMT, LSD, and MDMA are all classed as Schedule 1 drugs, which means they have no currently accepted medical use and a high potential for abuse. To ensure security, controlled substances are stored in a defined locked cabinet, and key access is restricted. All usage and production are recorded on controlled substance usage forms, and all activities are signed and witnessed. To ensure safety, a specific risk assessment is conducted for all laboratory activities involving psychedelics. All dispensing, packaging, and weighing of materials is done in a Class 3 isolator, and personnel must wear appropriate personal protective equipment (PPE). To avoid cross-contamination, there is a dedicated project-specific high-performance liquid chromatography (HPLC) and rotary evaporator for each psychedelic project, and use of the house vacuum is forbidden. Additionally, the transfer of material between laboratories requires double containment in high-density polyethylene (HDPE).

What does the future hold for psychedelics?

Psychedelics are a rich and fertile research area. While results from scientific studies appear promising, most research is still in the early stages, and there are many challenges to overcome before medications can become widely available.

Even if pharmaceutical companies can succeed in formulating psychedelics into effective drugs, commercial success will heavily depend on overcoming pre-conceived opinions of regulatory authorities, doctors, and patients on the use of recreational drugs as safe and effective medications.

There is also the question of how scalable psychedelics could be to meet the high occurrence of mental illnesses. How do you make treatment convenient, controllable, accessible, and affordable? With the current generation of potential medicines necessitating close medical supervision, it would only be possible to administer psychedelics at a doctor’s office. Treatments would be time-consuming, taking patients away from work and other responsibilities. Access to treatments may also be difficult for patients living in rural locations. While the potentially long-lasting effects of psychedelics might make them more cost-effective than conventional treatments in the long term, there could be large, up-front costs, which insurance companies may be reluctant to cover.

As an organization with a culture focused on science and innovation, the team at Quotient Sciences is excited to see how developments will progress in this space.

References

1. https://www.spravato.com

2. Mitchell JM, Bogenschutz M, Lilienstein A, et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine 2021;27:1025–1033.

3. Goodwin GM, Aaronson ST, Alvarez O, et al. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med 2022;387:1637–1648.

Find out more about Quotient Sciences’ drug substance and clinical pharmacology services.

Pharmaceutical products are subject to several rigorous quality controls to guarantee their identity, strength, quality, and purity. 

Microbiological quality controls are requirements that have been put in place by global regulatory bodies to prevent the risk of adverse effects to patients. These controls monitor the presence of pathogens and their toxins in the treatments that are administered to patients in order to ensure their safety. 

Failing to establish and follow appropriate written procedures designed to avoid microbiological contamination of drug products can cause delays in the development process, out-of-specification occurrences, non-compliance during audits, and, of course, potentially significant safety concerns. Hence, it is vital that these controls are adequately validated for their intended purpose and followed meticulously to ensure compliance with the current Good Manufacturing Practice (cGMP) guidelines for non-sterile and sterile products.

In this article, we discuss the important role that microbiological quality controls play in the drug development process.

What are microbiological quality controls?

Microbiological quality controls must include but are not limited to:

• environmental monitoring of the facilities, equipment, materials, and personnel
• adequate design of testing laboratories and processes
• establishment of scientifically sound and appropriate specifications, sampling plans, and test procedures to ensure the microbiological quality and the safety of the final product

Microbiological tests are performed throughout the whole drug development process, from the release testing of the active pharmaceutical ingredient (API) and excipients, through to the testing of in-process samples (IPC) and bioburden (the number of microorganisms present in a product/sample), and up to the final drug product release. Risk assessments must be performed for each drug substance and drug product to determine which tests are required for each phase of development according to the source, administration route, manufacturing process, and type of product. Testing programs must be designed to assess the stability of the drugs at specific storage conditions, and the results of these stability tests are used to determine appropriate storage conditions and expiration dates for the product.

Why the horseshoe crab is the unsung hero of endotoxin testing

If you have been vaccinated, know anyone with a knee replacement, or have received intravenous (IV) antibiotics, you are indebted to the horseshoe crab. Bacterial endotoxin testing is performed on drugs and medical devices that will come in contact with the blood stream using a reagent that comes from the blood of a horseshoe crab. Humans that are exposed to harmful levels of endotoxins can suffer severe illness, so products like vaccines, injectable drugs, IV solutions, and implantable medical devices are quality tested to ensure that they do not contain unsafe levels of endotoxins.

The horseshoe crab has an immune and blood coagulation system that protects it against infections. The horseshoe crab’s blood cells contain proteins that are released in response to the presence of unwanted organisms, such as Gram-negative bacteria (endotoxins are structural components of the Gram-negative bacteria that are released when the cell is destroyed), and cause its blood to clot around the injury and bacteria, protecting the animal from further harm.

In the 1960s, Frederik Bang and Jack Levin developed a test from Limulus polyphemus (Atlantic horseshoe crab) blood that detected the presence of endotoxins. This test, based on the fact that the blood of the horseshoe crab clots when it comes in contact with endotoxins, was called the Limulus amebocyte lysate (LAL) test and was commercialized in the United States in the 1970s. 

The LAL test methods have advanced since the early days, all with the purpose of helping to make injectable drugs, vaccines, and medical devices safer for humans and animals. In addition to the use of their blood for endotoxin testing, the horseshoe crab's DNA has been used to develop a recombinant test method for endotoxins. Even as alternatives are being developed that will retire or reduce the use of horseshoe crab blood, we will always be indebted to the horseshoe crab's contribution to our health.

Manufacturing facilities, like ours at Quotient Sciences, are the first layer of defense to prevent opportunistic microorganisms from colonizing pharmaceutical products that will be reaching patients in the clinic, at home, and at hospitals. Controlling the entry of unwanted microorganisms into pharmaceutical manufacturing facilities and performing validated tests on the products before releasing them significantly reduces the number of outbreaks and product recalls and increases the safety of the treatments. Otherwise, unsuccessful contamination control strategies can cause negative consequences, both economical and human. This approach must be established from the beginning of the drug development process to ensure that the product can be used safely during the clinical trials and must be followed once the product is approved for commercial release.

What is enumeration testing? Why is enumeration testing done?

For APIs and raw materials, for oral products, and for products before the final sterilization process, it is necessary to quantify the amount and the type of microorganisms present in the product. This is to ensure that the flora in the product is not hazardous, and the levels are within the defined safe limits zone. Not all products must be sterile – for example, some are administrated orally, where the drug must pass through our natural microbial defense system. However, the contamination control strategy is still important to maintain the microbiological quality of products.

To quantify the microorganisms in a product, we use enumeration testing, known as total aerobic microbial count (TAMC) and total yeast and mold count (TYMC). These are quantitative tests that check the number of aerobic microorganisms and the yeasts and molds present in a sample. We use different types of media that are full of nutrients, and we incubate the samples at ideal temperatures for the growth of the microorganisms. If present, microorganisms are visually countable (in colony-forming units) after a determined period of time.

How is microbiological testing done at Quotient Sciences?

At Quotient Sciences, we employ microbiological testing as part of our integrated Translational Pharmaceutics® programs. Our microbiology laboratories and experienced microbiologists are capable of performing several types of testing to cover all the microbiology needs of our customers under one roof. 

For non-sterile and sterile drug substances and drug products, a full method development and validation service is offered to support the application of key microbiological techniques. As method development, validation, and testing can all be performed at one facility, there is no need for time-consuming material and technology transfer activities. In addition, we are equipped to perform microbiological testing on radiolabeled, high-potency, and some cytotoxic and controlled substances.

Our microbiologists are not only involved in the testing of the samples, but they are also an integral part of the manufacturing process, including:

• ensuring the facilities, equipment, materials, and personnel are monitored using settle plates, contact plates, air samples, and swabs
• performing gowning validation for the personnel working in the classified cleanroom areas
• assessing aseptic techniques
• supporting media fill simulations

At Quotient Sciences, our expert team of microbiologists pride themselves on applying their knowledge and skills to ensure that pharmaceutical drug substances and drug products are safe and meet today’s rigorous quality specifications and regulatory standards. To find out more about Quotient Sciences’ microbiology services, take a look at our info sheet.

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Continuous flow manufacturing is becoming increasingly popular across the pharmaceutical industry as an alternative to traditional batch manufacturing for active pharmaceutical ingredients (APIs), providing significant benefits for rapid and robust delivery of drug substances to support downstream drug product development. Through a collaboration with the University of Nottingham funded by Innovate UK, Quotient Sciences is actively focused on flow chemistry research and has developed a modular continuous manufacturing technology platform.

As part of this collaboration, Felicity Roberts, Flow Chemist at Quotient Sciences, presented a poster at the American Association of Pharmaceutical Scientists (AAPS) 2022 PharmSci 360 Meeting, investigating a continuous flow process for the kilo-scale synthesis of norketamine from 2-chlorophenylcyclopentyl ketone using daisy-chained reactors. Norketamine is an intermediate in the synthesis of (2R,6R)-hydroxynorketamine, a pharmaceutical undergoing trials as an antidepressant.

While manufacturing of norketamine had previously been carried out in batch, converting to a continuous flow process could provide several advantages, including safer handling of hazardous reagents on scale-up, access to process conditions that are difficult to achieve in batch, and reduced time between stages to minimize the risk of impurity formation.

A system of four daisy-chained flow reactors was constructed for the synthesis of norketamine from 2-chlorocyclopentyl ketone, including bromination, amination, solvent swap, and thermal rearrangement stages. The process was run at steady state for over 24 hours, producing over 1 kg of norketamine at good purity.

Overall, this project demonstrated that continuous flow approaches continue to present time, cost, and quality benefits for small-molecule drug substance synthesis.

Poster authors
Felicity Roberts, Rowena Howie, Rory MacDonald, Gareth Jenkins, Marcos Veguillas Hernando, Jonathan Moore, Peter Licence, Martyn Poliakoff, and Michael George

Find out more about Quotient Sciences’ drug substance manufacturing capabilities.

With a draft FDA guidance on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies currently under review, there is considerable interest in the design and conduct of human absorption, distribution, metabolism, and excretion (ADME) studies. At the International Society for the Study of Xenobiotics (ISSX) conference in September 2022, Quotient Sciences presented a poster reviewing the approximately 200 radiolabeled studies the organization has performed over the past decade.

The poster included examples where study designs have been adapted to address specific challenges presented by new drug candidates such as:

• Molecules with a long half-life: When the half-life of a drug would make a main residency period too long to be practical, a main residency period of 14–21 days and then several 24-hour return visits can be scheduled to enable the collection of excreta samples for total radioactivity analysis. The recovery curve can then be extrapolated to demonstrate what the likely outcome would have been if a full residency period had been feasible.
   
• Integrated intravenous microtracer (IVMT)/ADME studies: Integrating an IVMT with a conventional human ADME study is a highly efficient method to assess absolute bioavailability, mass balance, routes and rates of excretion, and metabolite characterization. Extending the overall sample analysis to assess intravenous (IV) mass balance can enable an understanding of key parameters impacting bioavailability, such as fraction absorbed (f_a), fraction surviving gut metabolism (f_g), and fraction surviving hepatic elimination (f_h).
   
• Potent drugs: Given the challenges of completing the synthesis of the radiolabeled drug at the required specific activity and/or the limitation on the sensitivity of methods and instrumentation for sample analysis, potent drugs often require a hybrid approach to sample analysis, involving both conventional methods and accelerator mass spectrometry (AMS)-enabled methods.
   
• ADME at steady state: ADME can be investigated at a steady state by administering a single radiolabeled dose after establishing a steady state by multiple dosing of the non-radiolabeled drug. This approach only evaluates the clearance pathway of the radiolabeled drug after a single administration, but it is a practical compromise. An alternative approach is to divide the radiolabeled dose across the multiple doses required to achieve a steady state, but this can result in more challenging analysis requirements.
   
• Particular study populations: While most human ADME studies can be conducted in healthy male volunteers, occasionally different subject populations may be required (e.g. female subjects, target patient populations, or healthy volunteers with a specific genotype status). Having to identify and recruit patients or provide additional characterization of healthy subjects before they can be recruited adds complexity to the subject recruitment process for the study.

Human ADME study designs should be adapted to address the particular challenges of each molecule under investigation. The approaches described to obtain human ADME data demonstrate the advances in technology available to investigate and understand the disposition of drugs in development. 

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At the International Society for the Study of Xenobiotics (ISSX) conference in September 2022, Quotient Sciences [1], AB Science [2], the Netherlands Organisation for Applied Scientific Research (TNO) [3], and Pharmaron-UK [4] presented a poster investigating the absorption, metabolism, and excretion of masitinib, an oral tyrosine-kinase inhibitor that targets mast cells and macrophages and is currently in development as a potential treatment for neurology, inflammatory diseases, oncology, and viral diseases.

The key objectives of the open-label, single-period, radiolabeled study were to assess mass balance recovery, determine routes and rates of elimination, and enable metabolite profiling and identification for masitinib.

Six healthy male volunteers received a single oral dose of ¹⁴C-masitinib in the fasted state. Blood, plasma, urine, and faeces samples were collected until 168 hours post-dose and analyzed for total radioactivity (TRA) by accelerator mass spectrometry (AMS). Samples collected during the study were pooled across time points and subjects, and metabolite profiling and identification were performed using an ultra-performance liquid chromatography (UPLC) system coupled to a high-resolution accurate mass spectrometer (HRMS).

On average, 69% of the radioactive dose was recovered by the end of the sampling period, with the majority recovered in faeces. The main metabolites were identified, and the study results led to a hypothesis that there may be covalent binding of some masitinib metabolites to plasma proteins.

Overall, this study provided valuable insights on the absorption, metabolism, and excretion of masitinib, which informed the drug development program and regulatory filings.

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Poster authors

1. Quotient Sciences: I Shaw, S Mair

2. AB Science: F Pitré, F Bellamy

3. TNO: W Vaes, R de Ligt

4. Pharmaron-UK: R Cooke

Summary: Michael Astle, Vice President of Legal Affairs at Quotient Sciences, outlines how the company’s legal team streamlines drug development partnerships by eliminating unnecessary delays. Quotient Sciences' in-house legal team emphasizes responsiveness, clarity, and collaboration, helping clients navigate regulatory complexities while protecting all parties. 

The legal function plays a major role in the drug development process, especially when it comes to partnering with an outsourcing provider.

Legal documentation is commonly put in place between sponsor companies and outsourcing vendors to protect all parties who are entering into an agreement, to ensure that deliverables are achieved. From confidentiality agreements (CDAs) to master service agreements (MSA), these important documents, among others, are necessary to kick off project discussions and to agree on the scope of work that will be conducted on a program. The process of putting documentation in place is standard to any drug development program, however, each company can have its own approach which can make the process lengthy and cumbersome.

At Quotient Sciences, we have our own unique philosophy when it comes to the legal aspects of working with our customers and their programs. Our in-house legal team supports our colleagues and our customers by being helpful, responsive, and jargon-free. They understand that the overall goal is to develop products and deliver clinical trials in a safe and timely manner, so they do their very best to truly support Quotient Sciences' mission of molecule to cure, fast.

Streamlining the project kick-off

Having alignment with the customer is key when trying to start a development program.  By taking a modular contracting approach, we ensure that our legal processes are fully aligned with the customer’s own journey for their molecule.  This allows customers to do business based on the stage of development or services that they need at that time.

For example, if a customer needs formulation development and clinical manufacturing support but may not be ready to begin clinical testing for their program, they can contract specifically for the services they need, then add a simple short module to the agreement later.  This enables them to sign their clinical program when they are ready to do so, without lengthy or repetitive legal negotiations. Conversely, if the initial contract is for a clinical pharmacology study but later on the project develops a need for manufacturing support or evolves into an integrated Translational Pharmaceutics® program, it is a simple step to add on a short module to the existing agreement to facilitate this.

Protecting customers & the organization

At Quotient Sciences, our legal team helps protect all parties by having a clear delineation of risks and responsibilities, adherence to regulatory guidance, and a willingness to help customers from other countries navigate local complexities, such as UK or EU privacy rules. This collaborative approach helps protect our customers, our study volunteers, and our organization. 

Benefits of close collaboration

In a business where time and speed are critical, every function, including legal, is focused on how they can streamline processes to get new medicines to patients faster. As their objective, our legal team works in close collaboration with our customers and is responsive to their needs. They are focused on removing the red tape and achieving our mutual goals of signing and starting projects in a safe and timely manner.

They deliver on this in three ways:

• Speed of response: we aim to review all project agreements in 1 week – allowing our customers to progress their projects quickly. No disappearing into a legal black hole here.
• Ease of understanding: our contract templates are designed to be easier to use and understand than most legal documents – for example in our last major update, compared to the prior version of our core template we removed 52% of paragraphs, 31% of the word count and made a 40% improvement on ease of reading on the Flesch scale
• Helpfulness of colleagues: our contract edits are intended to help reach a resolution – we provide comments with context and solutions where possible, not just endless rejections without any rationale. We’re also always happy to talk – no hiding in the background or endless emails, we’d rather pick up the phone to address any challenging topics.

Our legal approach is just one of the many ways that Quotient Sciences is focused on streamlining and accelerating the drug development process for our customers. Contact us to learn more about how we can help accelerate your program to its next milestone.

"Continuous flow technology is particularly suitable for fast, challenging chemistries that are difficult to control."

This article explores the benefits of continuous flow chemistry in synthesising pharmaceutical products. Our Science & Technology Director, Gareth Jenkins, and Head of Drug Substance, Paul Quigley, describe the recent advances in the area of continuous flow chemistry, including the development of modular systems and real-time analytics. The significant impact of this rapidly evolving technology is also explored, particularly its use in the production of personalised medicine. 

Read the full article on the Chemistry Knowledge Hub website

The Medilink East Midlands Business Awards' "Deal of the Year" award recognizes the entrepreneurship of an individual or team in executing a truly transformational and high-value deal for both the company and the East Midlands Life Sciences sector. 

Quotient Sciences won the award in recognition of securing a new private equity partner, Permira, with the investment providing substantial new funding to fuel the next stage of the Company's growth.

Mark Egerton, CEO of Quotient Sciences, commented: “We are delighted to win the Medilink Business Award which gives recognition to Quotient Sciences alongside our new partner, Permira, as we continue to drive the business forward."

"The Deal of the Year award is a great honor for our team, and achievements like this come from the hard work and dedication of all our staff. The investment by Permira will support our continued growth plans, which include broadening our core services portfolio and capabilities globally in order to meet the demands of our growing customer base.” continued Egerton.

Tufts Center for the Study of Drug Development Demonstrates Multi-Million Dollar Benefits of Quotient Sciences’ Translational Pharmaceutics Platform

San Francisco, CA/December 2019: Quotient Sciences, today announced plans to present the latest Tufts CSDD White Paper assessing the timeline reductions and multi-million dollar cost savings of Translational Pharmaceutics® at Biotech Showcase 2020™, to be held January 13-15, during the most important week in healthcare at the Hilton San Francisco Union Square.

Peter Scholes, Quotient Sciences’ Chief Scientific Officer, will be presenting the talk entitled: Analysis from the Tufts CSDD study to Assess the Financial Benefits from Translational Pharmaceutics®:  A Platform for Accelerating Product Development

Date: January 14, 2020
Time: 4:45 (PST)
Room: Franciscan C (Ballroom Level)
Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San Francisco, CA (United States)

Quotient Sciences is an innovative drug development and manufacturing organization supporting clients across the full development cycle from candidate selection through to commercial supply. The unique Translational Pharmaceutics® platform accelerates development by integrating formulation development, real-time manufacturing, and clinical testing. 

At Biotech Showcase, Dr. Scholes will present a summary of the recent Tufts CSDD study, comparing the Quotient Sciences Translational Pharmaceutics® platform to traditional development programs, which concluded that Translational Pharmaceutics®, on average, reduced development timelines by more than 12 months and delivers financial gains of more than $200 million per approved new drug. Dr. Scholes’ presentation will also describe client case studies of Translational Pharmaceutics programs, demonstrating how the platform can either be applied to accelerate molecules from first-in-human (FIH) to proof-of-concept (POC) or to develop and optimize clinical formulations for downstream patient trials and commercialization.

“Biotech Showcase is the perfect venue for Quotient Sciences to present on the recent Tufts CSDD findings on our Translational Pharmaceutics platform. Biotech companies, and the biotech community as a whole, are major beneficiaries of the time savings and financial benefits that Translational Pharmaceutics offers, relative to traditional drug development paradigms,” said Dr. Scholes. “At Quotient Sciences, we’re focused on accelerating the development of new medicines for patients by helping our customers improve their R&D productivity.”

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry's largest gatherings and busiest weeks.

“We are delighted that Quotient Sciences will be presenting at Biotech Showcase this year,” said Sara Demy, CEO of Demy-Colton. “Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery.”

About Quotient Sciences

Quotient Sciences, a global pharmaceutical development, clinical and commercial manufacturing organization, delivers innovative, customized solutions for pharmaceutical and biotech customers through both individual and integrated services. Quotient’s Translational Pharmaceutics® platform integrates formulation development, real-time adaptive GMP manufacturing, and clinical research for the continuous improvement of drug development programs — and is proven to accelerate timelines and reduce cost.  

About Biotech Showcase

Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year. Now in its 12th year, this well-established, highly respected conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.