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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”

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.

Impressions: 1005

VLOG #PharmaReel

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DATA COMPILATION #PharmaFlow

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US, Europe turn to advanced manufacturing, stockpiling to strengthen drug supply chains

Over the last few decades, the United States and Europe have saved trillions of dollars by importing drugs from countries like China and India. Their journey wasn’t easy, with regulatory non-compliance and drug patent scams raising their ugly heads every now and then. The Covid-19 pandemic and the accompanying lockdowns were a wake-up call for these countries to take a long, hard look at their sourcing strategies.Over the last few years, both the US and Europe have embarked on policy changes and ambitious programs to strengthen their drug supply chains. PharmaCompass takes you through US and Europe’s journeys towards more robust pharmaceutical supply chains.Biden’s executive order, CARES Act, state-backed investments strengthen US supply chainDuring the early days of the pandemic, the US government (under former President Donald Trump) had enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to address the economic fallout of the pandemic through a US$ 2.2 trillion stimulus. Through this act, the FDA had taken several drug shortage mitigation efforts. The new administration under President Joe Biden undertook more measures. Notable amongst them was Executive Order 14017 on America’s supply chains. It mandated a comprehensive 100-day review to identify vulnerabilities in key sectors, including pharmaceuticals and active pharmaceutical ingredients (APIs). The review noted that 87 percent of generic API facilities are located overseas, leaving the US healthcare system vulnerable to shortages of essential medicines.Through a Presidential Determination, Biden had also broadened US Department of Health and Human Services’ (HHS) authorities under the Defense Production Act (DPA) of 1950. HHS can now enable investment in domestic manufacturing of essential medicines and medical countermeasures under the DPA. The HHS has invested US$ 17 billion in domestic manufacturing for the medical supply chain, including US$ 500 million to support API manufacturing.Under this effort, Merck has been awarded a €121 million (US$ 132 million) government contract to set up a lateral flow membrane production facility at Sheboygan, Wisconsin. Similarly, California has launched an initiative (known as CalRx) and is working with CIVICA to make US$ 30 insulin available to all who need it.Europe encourages reshoring; EDQM develops monographs for unlicensed alternativesIn recent years, Europe has faced shortages of insulin, antibiotics, oncology drugs, corticosteroids and even paracetamol. To overcome these shortages, the European Medicines Agency (EMA) is encouraging drugmakers to enhance manufacturing capacity and diversify suppliers.There is change visible on the ground. Companies like Midas Pharma, EUROAPI, Seqens are setting up API plants in Europe. Seqens has taken steps to reshore paracetamol production in France and is constructing a new € 100 million (US$ 109 million) production unit in Roussillon. Sanofi is investing €1.3 billion (US$ 1.4 billion) in a new insulin production facility at its existing site in Frankfurt. Similarly, Sandoz has set up a new antibiotic production plant in Austria and a new biosimilar development center in Germany.That said, we know that manufacturing capacities take time to build and are often financially unviable in the developed world. Ergo, a particularly innovative initiative has come from the European Directorate for the Quality of Medicines & HealthCare (EDQM). Their project aims to develop monographs detailing the preparation and testing of unlicensed drugs that can fill the gap left when licensed medicinal products are unavailable. To facilitate this initiative, the European Pharmacopoeia Commission is recruiting experts to verify proposed production methods and analytical procedures.The other means of guarding against supply and demand fluctuations is stockpiling. The EMA has advised the European Commission (EC) and marketing authorization holders (MAH) to stockpile medicines. The regulator has also asked MAHs to establish a shortage prevention plan for critical medicines. Europe’s Health Emergency Response Authority (HERA) is taking a systematic approach to stockpile management.Despite these measures, costs and market structures pose serious challenges. Medicines for Europe, representing the generic and biosimilar medicines industry, has raised concerns about the current market structures. They argue that government purchasing practices, which prioritize obtaining the lowest prices for off-patent medicines, are jeopardizing the European manufacturing footprint and discouraging investments in supply chain resilience.FDA, EMA promote continuous manufacturing; US relies on digital stockpilesDuring the pandemic, there were acute shortages of oncology, cardiovascular, anesthesia, anti-infective, neurological and anti-allergic drugs in the US. A 2022 study undertaken by the Washington University points out that there is excess manufacturing capacity in the US that can be considered for reshoring critical and essential drugs. In fact, 49 percent of generic drug manufacturing capacity in the US is lying idle, and many others are working at less than 50 percent capacity. These capacities can be repurposed. Various advanced manufacturing technologies, such as “continuous flow and on-demand manufacturing capabilities in idled manufacturing sites offer the ability to reduce production cost,” says this report.FDA has been promoting “advanced manufacturing” technologies, such as continuous manufacturing, which are now a part of America’s overall strategy to strengthen and secure the pharmaceutical supply chain. The EMA has also released guidelines on continuous manufacturing of drug substances and drug products. Advanced manufacturing is a collective term for new or innovative medical product manufacturing technologies. Unlike batch manufacturing, which involves sequential processing and testing of material across multiple discrete stages (and often discrete facilities), continuous manufacturing combines the full manufacturing stream into a single, fully integrated flow. While continuous manufacturing may not be suitable for every drug manufacturing process, but where applicable, it tends to eliminate built-in production gaps and shortens the time taken to manufacture a drug from months to days.In the US, the Strategic National Stockpile (SNS) plays a critical role in ensuring the availability of essential medical supplies during emergencies. It now also involves a digital stockpile that does not store physical goods and products. Instead, it stores electronic plans, instructions, and methods to make and test medical products. Digital stockpiles rely on one or more trusted suppliers that can make the product from the digital information, either through methods like 3D printing or self-contained distributed manufacturing lines.Our viewThe global pharmaceutical supply chain is a complex web spanning multiple countries and continents. While advanced manufacturing and stockpiling may work to an extent, a large chunk of generic drugs and APIs will continue to come from countries like China and India.In order to reduce reliance on China, the US has been proactively expanding its collaboration with India. But this time, there is increased emphasis on quality control. While FDA is increasing the number of inspections at Indian drug plants, the Indian government, on its part, has revised rules for drug manufacturing, with higher GMP standards.Taken together, a multi-pronged approach to addressing supply chain vulnerabilities should secure drug supplies to the US and Europe in the years to come.

Impressions: 377

NEWS #PharmaBuzz

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Shandong New Time Pharmaceutical Generic Sodium Rosuvastatin Calcium Receives Approval In US

28 Apr 2018

// FDA

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