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    Quotient And Vasa Begin Human Trials Of VS-041 For Novel Heart Failure Therapy

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    Quotient Sciences Wins 2024 CRO Leadership Awards

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    With over 30 years of experience in drug development and manufacturing, Quotient Sciences serves as a drug development and manufacturing accelerator. It offers a range of integrated programs and tailored services to more than 550 customers and helps them optimize formulations, refine manufacturing processes, and plan clinical studies. Based on its experience with over 1,500 molecules at all stages of development, Quotient Sciences employs an innovative approach to formulation development that integrates drug product development with clinical evaluation. It operates seven manufacturing and clinical facilities in the UK and the US.

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    INTERVIEW #SpeakPharma

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    “We have built considerable expertise in GLP-1 drug development through our oral peptide programs”

    “We have built considerable expertise in GLP-1 drug development through our oral peptide programs”

    This week, Speak Pharma interviews Dr. Andrew Lewis, Chief Scientific Officer at Quotient Sciences, a drug development and manufacturing accelerator that offers a range of integrated programs and tailored services to over 550 customers. Lewis discusses the latest developments in the delivery of oral peptides and how Quotient Sciences is helping customers overcome drug development challenges in this exciting space. HIGHLIGHTS// latest developments in the delivery of oral peptides Why have glucagon-like peptide-1 (GLP-1) therapies become essential for treating type 2 diabetes and obesity? What makes the oral delivery of peptides such as GLP-1 challenging? GLP-1 and gastric inhibitory polypeptide (GIP) are essential incretin hormones involved in regulating glucose metabolism. Both are produced in the gastrointestinal (GI) tract in response to food intake, specifically glucose and fats. GLP-1 enhances insulin secretion from the pancreas, but only in response to elevated blood glucose levels. GIP has overlapping effects that are slightly contradictory – it promotes the production of glucagon, which can counteract its glucose-lowering effects. In people with type 2 diabetes, the body’s response to incretin hormones is impaired. However, the GLP-1 pathway remains relatively intact, allowing it to still stimulate insulin production. There is a more significant impairment for GIP, making it not as effective. This makes GLP-1 a more attractive target for treatment, leading to the development of several GLP-1 receptor agonists for managing type 2 diabetes, obesity, and potentially other conditions. Incretin analogs, like GLP-1 agonists, have traditionally been challenging to deliver orally. As a result, these medications are most often given by injection. But we know that patients generally prefer taking a tablet or capsule treatment rather than an injection. Peptides such as GLP-1 analogs go through a challenging journey before being absorbed. This is because the gastrointestinal tract functions to digest these into either small amino acids or very short pieces of polypeptides. Even if they get to the epithelium, they tend to have poor permeability, usually resulting in less than 1 percent bioavailability (the proportion of a drug that enters the circulatory system when introduced into the body, thereby having an active effect). Various technologies have been developed to overcome bioavailability issues, with permeation enhancers being the most advanced and validated. For example, SNAC is the permeation enhancer used in Novo Nordisk’s oral pill Rybelsus to promote semaglutide absorption. Mycapssa (octreotide capsules), marketed by Chiesi, employs the Transient Permeation Enhancer (TPE) technology, which utilizes the medium-chain fatty acid (MCFA) sodium caprylate (C8) to augment the absorption of the somatostatin analog octreotide. At Quotient Sciences, over the last decade, we’ve worked on over 14 oral peptide programs and tested about a dozen different permeation enhancer combinations with them. Permeation enhancers tend to be required in large amounts in formulations, and many of them are usually waxy materials with poor flow, so the tablet formulation and manufacturing process require extra attention and careful design. From an analytics perspective, a lot of the standard quality control tests for tablets have been designed for small-molecule drugs and are yet to be optimized for use with peptides. HIGHLIGHTS// permeation enhancers as the most advanced and validated technology to overcome bioavailability issues/ worked on over 14 oral peptide programs/ tested about a dozen different permeation enhancer combinations How does Quotient Sciences handle the transition from pre-clinical to clinical development? We’ve pioneered an integrated approach through our Translational Pharmaceutics platform for drug development. This platform combines drug product manufacturing with clinical testing in healthy volunteers, allowing us to be incredibly adaptive in our phase I trial design. Through a tight integration of services, we can manufacture a drug, dose it in healthy volunteers, perform bioanalysis and pharmacokinetic analysis, and use data in real time to inform our next steps. In oral peptide programs, we’ve performed numerous studies where we’ve used this capability to optimize the formulation in response to the clinical data. Typical variables we’ve evaluated are the dose of the peptide and the levels of a permeation enhancer, allowing us to identify the relationship between them to maximize human bioavailability. Through our ability to see the full spectrum of data – from preclinical to clinical – for 11 different peptides and 10 different permeation enhancers, we have built up considerable expertise in the development of oral peptide drug products. This allows us to provide a more streamlined drug development process for our clients, as common challenges across programs can be readily overcome. HIGHLIGHTS// Translational Pharmaceutics platform for drug development/ combine drug product manufacturing with clinical testing in healthy volunteers/ use data in real time to inform next steps/ 11 different peptides and 10 different permeation enhancers What innovations do you see ahead for oral peptide delivery? I see a real convergence in advances in peptide drug discovery and engineering, together with advances in drug delivery that are really pushing the field forward. Technologies such as phage display mean that vast libraries of peptides can be screened for properties of interest. These are being applied to design peptides specifically for oral delivery. From a drug delivery perspective, approaches such as ingestible devices, ionic liquids and various technologies to exploit active uptake mechanisms are showing real promise. One challenge with oral peptide delivery technologies is that their effectiveness can be significantly impacted by food intake. However, I expect that in the coming years, new methods will be developed to mitigate these food-related effects. I also expect artificial intelligence (AI) to greatly benefit oral peptide delivery. In 2021, the US Food and Drug Administration reported it saw more than 100 drug and biologic application submissions containing elements of AI or machine learning (ML) used in the development process. So three to four years later, that number has likely only increased. All these developments promise to make oral peptide therapies more effective and convenient for patients in the years to come. HIGHLIGHTS// phage display to screen vast libraries of peptides for properties of interest/ ingestible devices, ionic liquids and various technologies to exploit active uptake mechanisms/ AI will greatly benefit oral peptide delivery To learn more about this topic, watch Quotient Sciences’ latest webinar featuring Dr. Andrew Lewis and Dr. Stuart Mair, Chief Medical Officer at Quotient Sciences. Watch it here.

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    CORPORATE CONTENT #SupplierSpotlight

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    First Subjects Dosing with VS-041 a Novel Heart Failure Treatment

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    14C Human ADME Program for HTD1801

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    Oxilio & Quotient Announce Regulatory Approval for OXL001

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    Expansion of Facilities for Translational Pharmaceutics® Programs

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    Ensysce Biosciences & Quotient Announce a Partnership

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    Human ADME Studies

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    Bioanalytical Services

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    Translational Pharmaceutics®

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    Formulation Strategies for Poorly Soluble Molecules

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    Global Formulation Development & Manufacturing Capabilities

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    Commercial Manufacturing

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    Clinical Trial Manufacturing

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    Global Clinical Trial Supplies

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    GMP Certificate 2019

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    Financial Impact of Translational Pharmaceutics®

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    High Potency Handling

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    Project Management at Quotient Sciences

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    Pediatrics Services

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    Formulation Development

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    Clinical Pharmacology

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-novo-s-parent-buys-catalent-for-us-16-5-bn-fujifilm-merck-kgaa-axplora-lonza-expand-capabilities

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    NEWS #PharmaBuzz

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    Quotient And Vasa Begin Human Trials Of VS-041 For Novel Heart Failure Therapy
    Quotient And Vasa Begin Human Trials Of VS-041 For Novel Heart Failure Therapy

    11 Sep 2024

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    https://www.quotientsciences.com/news/quotient-sciences-and-vasa-therapeutics-announce-dosing-first-subjects-vs-041-novel-heart

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    11 Sep 2024
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    Quotient Sciences Wins 2024 CRO Leadership Awards
    Quotient Sciences Wins 2024 CRO Leadership Awards

    05 Jun 2024

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    https://www.quotientsciences.com/news/quotient-sciences-wins-2024-cro-leadership-awards

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    Quotient Sciences Announces New Facility Leadership in Philadelphia, PA
    Quotient Sciences Announces New Facility Leadership in Philadelphia, PA

    05 Jun 2024

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    https://www.quotientsciences.com/news/quotient-sciences-announces-new-facility-leadership-philadelphia-pa

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    Unlocking True Partnerships: Beyond Science In Outsourcing Formulation Development
    Unlocking True Partnerships: Beyond Science In Outsourcing Formulation Development

    04 Jun 2024

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    https://www.quotientsciences.com/news/unlocking-true-partnerships-going-beyond-science-outsourcing-formulation-development

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    04 Jun 2024
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    Rare Disease Insights Orphan Pediatric Drug Development Collaboration
    Rare Disease Insights Orphan Pediatric Drug Development Collaboration

    28 May 2024

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    28 May 2024
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    Highlights from CPHI North America 2024: Round-up by Life Sciences Knowledge Hub
    Highlights from CPHI North America 2024: Round-up by Life Sciences Knowledge Hub

    24 May 2024

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    https://www.quotientsciences.com/news/highlights-cphi-north-america-2024-round-life-sciences-knowledge-hub

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    24 May 2024
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