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USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide.

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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.

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2024 US Elections: Harris, Trump differ on abortion rights, ACA, public health spends; agree on need to cut drug prices

The US is in the midst of yet another, or perhaps the most, polarizing Presidential election. The two candidates have highly divergent personas, records, visions and views. That gets reflected in their starkly different visions for the healthcare system.Healthcare is the second most important issue for voters in the 2024 US elections, with only the economy ranking higher, according to the Pew Research Center.In this week’s PharmaFlow, we look at the past approaches of both the contenders — Democratic presidential nominee Kamala Harris and Republican contender Donald Trump — towards healthcare, and what the two presidencies could mean for the US healthcare industry.Both Harris and Trump have a rare point of agreement — that the US government should act on reducing high drug prices. But have they spelt out how they will make healthcare more accessible? Our analysis should give you some answers.Abortion remains a pivotal issue, may shape broader discussions on healthcareTrump takes pride in the fact that he played an important role in overturning Roe v. Wade, a ruling that protected the abortion rights of women across America. Trump did that by selecting Supreme Court justices who were instrumental in overturning it. Two and a half years after Roe v. Wade was overturned, Trump faces an electorate that largely seems to favor abortion rights — according to Pew Research, 63 percent respondents say abortion should be legal in all or most cases, while 36 percent say it should be illegal in all or most cases.Candidates’ stances on abortion access, including the regulation on medications like mifepristone, are being scrutinized by both supporters and opponents of abortion rights. In June this year, the US Supreme Court had unanimously rejected a case to restrict access to the abortion drug mifepristone. The demand for its ban had been raised by an anti-abortion group in Texas.Of late, there have been reports of Republicans trying to distance themselves from aggressive anti-abortion ideas coming from its party men and allies. Aiming to carve-out a political middle ground, Trump has said that abortion policy should be made by the states. Despite Trump’s softening of stance, abortion rights is likely to not only affect voter turnout, but also shape broader discussions on healthcare and women’s rights.Affordable Care Act: Harris to strengthen it, Trump has ‘concepts of a plan’ to replace itHarris has been all for expanding and strengthening the Affordable Care Act (ACA). She has promised to “make affordable healthcare a right, not a privilege.”Trump, on the other hand, had made attempts during his presidency to repeal and replace the ACA, arguing that it provided “lousy healthcare.” While those efforts ultimately failed in the Senate, Trump succeeded in weakening the ACA by eliminating the individual mandate penalty through the 2017 Tax Cuts and Jobs Act.In a potential second term, Trump might renew efforts to dismantle or significantly alter the ACA. Although he has not presented a comprehensive replacement plan, he said during the Presidential debate held on September 9 that he has “concepts of a plan.”Drug prices: Harris to accelerate Medicare price cuts; Trump to focus on genericsHarris has had an aggressive stance on reducing prescription drug costs. Her tie-breaking vote on the Inflation Reduction Act gave Medicare the power to negotiate lower drug prices with pharmaceutical companies.Harris has pledged to accelerate those negotiations, once she becomes President, to cover more drugs and further lower prices for Americans. She also intends to extend the US$ 35 cap on insulin and the US$ 2,000 cap on out-of-pocket spending for seniors to all Americans, not just those on Medicare.Harris plans to make permanent the Biden-Harris tax credit enhancements that have already lowered healthcare premiums by an average of about US$ 800 a year for millions of Americans. This move would ensure continued accessibility to health insurance for a broader segment of the population.However, her stance on insurance companies and Big Pharma, including her support for “march-in” rights, might face resistance from pharmaceutical companies concerned about maintaining incentives for innovation.On the issue of drug pricing, Trump’s record is mixed. While he took credit for some decreases in prescription drug prices during his presidency, his administration’s most significant regulatory changes often favored pharmaceutical companies.Trump did issue a rule setting up a path to import drugs from Canada and other countries, but this initiative has faced significant hurdles, including pushback from Canadian authorities.Trump’s stance on drug pricing for a potential second term appears to focus on increasing generic and biosimilar competition, importing drugs made in the US but sold overseas back to the US, and capping out-of-pocket insulin costs. While he has criticized Big Pharma for putting profits above people, his administration’s policies had often aligned with industry interests.Harris appears committed to drug control; Trump had cut public health fundsMental health and substance abuse are the other areas where Harris has shown strong commitment. Having prosecuted drug traffickers, she has demonstrated her commitment to curbing the opioid epidemic.In the White House, she helped direct more than US$ 150 billion to disrupt the flow of illicit drugs and delivered billions of dollars in investments to states to fund lifesaving programs. Under a Harris administration, we might see increased funding for addiction treatment programs and continued efforts to make overdose-reversal drugs like naloxone more accessible.During his presidency, Trump had significantly reduced funding for public health programs. His administration had suggested budget cuts to the Centers for Disease Control and Prevention (CDC) and other public health agencies, justifying them as measures for fiscal responsibility.Our viewGiven her record, a Harris presidency could lead to increased insurance coverage. However, it might also come with increased regulation and price controls. More aggressive drug price negotiations could pressure pharmaceutical companies’ profit margins, potentially affecting R&D budgets. Stricter vigilance on the pharmaceutical industry could lead to more litigation and regulatory challenges for drug companies. But in the long run, this might also improve public trust in drug companies and in the healthcare systems.Under a second Trump term, reduced public health funding could create challenges for community health providers and public health initiatives. An emphasis on generic competition could pressure brand-name drug manufacturers, but create opportunities for generic drug makers.