Challenges, Sustainability, and Big Trends in Outsourcing Today

Drug Solutions

Understanding is crucial to ensure the right balance in manufacturing technologies and proccesses is achieved.

Balancing Change and Certainty in Manufacturing

Obstacles remain before broader application of intensified processes can be implemented.

Formulating Drugs for Continuous Processing

Limitations in production platforms have impeded continuous manufacturing for advanced therapies.

Small Footprint Automated Closed Production Platforms

Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.

Considerations for Analytical Testing for E&L

Fundamental Constriction Points in Emerging Therapies

Drug Digest

Shabbir Mostafa, head of Business Development — Advanced Delivery Systems, Recipharm, sat down with Grant Playter, associate editor, during DCAT week to discuss the current state of inhalations forms and drug delivery. The full interview transcript can be read below.

Broadly speaking, if you had to isolate one overwhelming drug delivery trend, whether that's in development, regulatory approvals, or even commercial markets, what would you say is the most impactful at this moment?

: I think for inhalation in particular its sustainability. So at the moment, we, within the metered dose inhaler (MDI) marketplace, use propellants for the user, for the formulations. And these propellants have high global warming potential. And now, these propellants have kind of been slowly phased out from the regulatory side. And they're looking to replace those propellants with low GWP, or low global warming, potential propellants, which are at quite an early stage in terms of their development.

But the environmental, the carbon footprint isn't going away. So there's a real problem at the moment of changing, of moving from high GWP to low GWP propellants. Because the expectation is it's going to be a lot of cost in terms of your development, your clinical batches, and also modifications to your facilities.

So, a number of the big companies that are big players within the inhalation market have already started to move over and started to transition. But there's a lot of other companies behind at the moment that haven't transitioned yet, and are looking to see what the regulatory side will be in terms of what they will have to do as they move across. And so it's quite an important area within innovation, because it's such a large market.

Just building on that a little bit, you say the low GWP are early in development, and some companies are beginning to transition. Can you expand on that, do we have any sort of timetable?

: The phase down is starting to happen now. The high-GW propellants — the products that are currently used today in formulations — they're going to be transitioning sort of to a lower point. They can only sell a certain amount, as it goes. And it's a step down process over a number of years, so by ‘25, ‘26, the amount of propellant available will be very low.

The proponents are used in lots of different markets. And actually in the medical side of it, the medical use is very low, but there was an exemption for medical use for these propellants. However, that exemption has been now taken away, so this step down process is now affecting also propellants for the medical use as well.

Are there any other sustainability measures you want to highlight, anything you can point to as a big trend?

: I think everything comes to sustainability. So they look at the carbon footprint of the factories. Are we doing things like solar power, how are we doing recyclables, etc. is huge. Actually, within Recipharm, in general, sustainability is a huge, huge area, we have people dedicated to that to look at how we can get become a net zero company. So it's huge within the pharmaceuticals.

Can we talk a little bit about like nasal delivery and just broadly inhaled biologics, what's going on in that space?

: So nasal delivery, I think, is becoming more and more popular. Traditional nasal delivery was multi-dose delivery, just your normal nasal spray that you'd use for anti-allergies, etc. But now as you've probably seen, there's what we call one shot unit dose delivery devices, which basically shoots one dose into your nose, and that's been used for things such as rescue medicines and immediate pain relief.

As Recipharm, we've developed a device for single-dose delivery, and it's going to be used in those areas, and as you know, with rescue medicines — its for people overdosing on things like fentanyl — so they need to have this straightaway rescue medicine. Just gives you one shot and you get hopefully relieved from the overdosing of the fentanyl.

What are some observations you’re seeing in terms of inhaled biologics?

: So, from an inhaled biologics side, we're starting to see more and more customers looking for that development. There's two areas which you can go in; the biologics one is either a nebulizer or dry powder inhaler. But the nebulizer, which is a solution, it tends to be quite high-shear, so it can destroy the large molecules as it's being inhaled. So, there's a challenge using nebulizers for biologics.

We've developed a soft mist inhaler, which is one of our newest devices, in partnership with Medspray, where we have a company called Resyca. This soft mist inhaler is very gentle. And we're working with a number of customers biologics, large molecules, for mimicking of the nebulizer route.

The other preferred route is through DPI, dry powder inhaler, where you can spray dry your active or your biologic onto something, a carrier. And that's starting to show some popularity now. The issue with DPI has always been reproducibility. And so that's the challenge with inhaled biologics at the moment, making sure we still get reproducibility of the active.

From a development perspective, can you talk about some of the considerations that go into selecting a drug delivery system? Like what's the discussion when you're selecting between like, say, a nasal inhalant versus an inhalant one would use for asthma?

: So asthma disease is straight into the lungs, so it's looking for respiratory delivery, so you would use an inhaled, so either an MDI or a DPI delivered, or a nebulizer delivery. If you are looking for something for an immediate sort of pain relief in the head like a migraine, you'd probably go through your nasal delivery, because you've got the delivery faster.

Pfizer just had the migraine nasal spray approved the other day, I believe. 

[Editor's Note: This interview was recorded on March 18th, 2023.]

: Yes, it has been, Pfizer. So that's why I'd say the difference is, if you're looking for a sort of respiratory, you'd go inhalation; if you're going for nasal things like pain relief, or as I said, rescue medicines, etc., for the nose to brain delivery.

Can you give me a bold prediction for the future of drug delivery five years from now?

: I think the market for inhalation is definitely going to change. I think we're going through this huge change, as I said with the MDIs, we don't know where that's going to be in five years' time, whether there actually is going to be a business for it, or whether everything is going to transition across the DPIs.

My suspicion, I think, is that there's going to be a hybrid, I think there'll be less of MDIS and I think there'll be more of DPI formulations out there in the marketplace. We, part of our business is huge, is MDIs and valves. So we still see a value for it, but we don't know what the market will be like because of the transition from high GWP to low GWP propellants. We don't know what the market will be like in five years' time. So I think that's the big thing for us. And looking at that and seeing where, you know, what will happen in the future.

: Ten years? That's difficult. I think that it'll definitely be the growth of inhaled biologics, I think, over a ten-year period. I think that biologics will be a lot more in the next five to ten years. I think for nasal delivery, again, I said it went through the uni-dose, so single dose shot for things such as rescue medicines, and it's quite big in America, in Europe, etcetera requirements. So that's where I see the market in ten years' time.

For more of our coverage on DCAT in 2023, viewers can visit 

Articles

Shabbir Mostafa, head of Business Development — Advanced Delivery Systems, Recipharm, sat down with Grant Playter, associate editor, during DCAT week to discuss the current state of inhalations forms and drug delivery. 

Investigating Inhalation Forms and Drug Delivery with Shabbir Mostafa (DCAT Week)

While the world may have marched on from the halcyon days of the mid-20th century where the United States was the undisputed center of the global economy, the country’s continual impact should not be understated. Particularly as it concerns the biopharmaceutical industry, the US remains a powerful influencer; not only has it proved to be fertile ground for the growth of pharmaceutical powerhouses such as Pfizer and Johnson & Johnson, the country’s 330+ million population is a substantial target for overseas pharmaceutical companies.

That is not to say that powerful players, including the likes of China, Japan, and the European Union (EU) member countries are of lesser importance. Rather, it stresses the reality that the US, for the foreseeable future, is the largest pharmaceutical market; Fortune Business Insights valued the US at a world-leading $534 billion in 2020 and anticipated strong growth to $861 billion by 2028 (1). Correspondingly, a comprehensive understanding of the global biopharmaceutical market is contingent on thorough knowledge of the US landscape and ongoing events in the country. In this vein, while the ink has long dried on the Inflation Reduction Act, the bill must be examined with close scrutiny to understand its full impact on the global bio/pharmaceutical market.

Following narrow votes in both chambers of the US Congress, President Joe Biden signed The Inflation Reduction Act of 2022 (IRA) into law on Aug. 14, 2022 (2). While the $740 billion bill was a compromise among senate Democrats following failure to reach a consensus on a proposed $2.2 trillion framework (colloquially referred to as the “Build Back Better” bill), which aimed to have a transformative “cradle to casket” impact on American healthcare, IRA is nonetheless set to have a discrete impact on the healthcare throughout the country.

While the bill does not solely focus on healthcare, it introduces several key reforms that are set to introduce price controls on medicines. The bill will limit out-of-pocket costs for Medicare beneficiaries at $2000 a year beginning in 2025, passing additional costs onto drug manufacturers. Additionally, starting in 2026, the US government will also be able negotiate Medicare prices on 10 widely-used, costly medicines; this number will be expanded to 20 in 2029. If this price is rejected by the manufacturer, they will be charged a significant fee (3).

One aspect of the bill that has raised a few eyebrows is the difference in the negotiation window between small molecules and biologics; small molecules sit at nine years following FDA approval, whereas biologics are 13 years (4). This variation has led to many outspoken critics of the bill, including John Stanford, executive director of the Incubate Coalition. Incubate is an organization representing various venture capital organizations that seeks to “educate policymakers on the role of venture in bringing promising ideas to patients in need” (5).

“The bill shows a misunderstanding of the basic science—we shouldn’t be incentivizing biologics or small molecules,” says Stanford. “If the cure for Alzheimer’s is a biologic infusion, great. If it’s a small molecule, that’s great too. But now, from an investment perspective, I’m more interested in 13 years than nine years, and that’s a big flaw that’s going to have pretty damning consequences over the next couple of decades.”

According to Stanford, the discrepancy may have arisen from an existing misconception that small molecules were already disadvantaged from an investment perspective. The existing framework for exclusivities is five years for small molecules and twelve years for biologics, but this understanding does not factor additional factors, such as the role of the 20-year patent and possible add-ons.

However, while most agree that some amount of innovation will be lost as profit margins slim and investment risk increases, there is little consensus as to what that will look like. For instance, the US Congressional Budget Office estimated that the drug negotiation provision would ultimately result in a 1% decline in new drugs being introduced to the US market over the next 30 years (6). Others, such as Stanford, feel strongly that this will have broader consequences.

“Capital flows like water. I don't think tomorrow life sciences funds are going to dry up. But there's more barriers, more risk, now going to be associated with it,” says Stanford. ““We have dramatically decreased the perceived reward while increasing the risk.”

Stanford’s argument is that companies will look to diversify and mitigate risk. If $100 million in investment capital would have completed seed funding for 10 life science companies in the past, after these changes, that amount might only fund five life sciences companies as investors look to segments such as banking or technology for alternative investment opportunities. The inherent complexity of the biopharmaceutical development process already makes it a risky bet for venture capitalists; increasing the burden placed on them has a strong possibility of decreasing investor interest in innovations that would otherwise be seen as interesting.

In a similar vein, one could argue that there are already potential knock-on effects from the bill impacting the industry. For instance, the IRA attempted to codify a $35 price cap on insulin for recipients with Medicare and private healthcare coverage. However, because regulating private insurers fell outside the purview of reconciliation (a legislative process that allows for certain bills to pass with a simple majority of votes) that portion of the provision was put to a vote and axed from the bill (7). However, the provision remained intact for Medicare recipients, and arguably set a precedent for Eli Lilly and Company’s decision to cap their insulin prices in the United States at that price in March 2023 (8). Regardless of whether one believes Lilly would have set the cap independent of the bill, it remains prudent for industry experts to acknowledge its potential downstream impacts on bio/pharmaceutical businesses.

Of course, the US doesn’t operate in a vacuum—it’s just one part of the greater global biopharmaceutical market. A market which, as discussed in the 2022 CPHI annual market report, has effectively bottomed out in terms of investment, with hundreds of billions sitting in parked capital (9). Investment, however, is cyclical, and the authors of the report acknowledged that this money will likely have to enter the industry at some point within the next 18 to 24 months. In this regard, of note are the findings of 

s annual survey where approximately half of industry respondents felt that cell and gene therapies presented the biggest avenue for growth (10). However, if the IRA does have a negative impact on investment in US biologics, it begs the question: where will this money go?

“If the US has been degrading its investment appetite through policy, threats to intellectual property, and price controls, China has been going the other way,” says Stanford. “China has extended intellectual property. China is trying to make a warm investment environment.”

China’s rapid economic growth has been the story of the 21st century, and the biotechnology market is no different. The Chinese biotechnology market had total revenues of $23.2 billion in 2020, representing a compound annual growth rate (CAGR) of 8.5% between 2016 and 2020 (11). If the disincentive is strong enough for investors to take pause, it’s entirely possible that looser regulations and the potential for greater profits could bring them to China.

Another contender is Europe, which, as of 2021, had a pharmaceutical market valuation of $282.75 billion (12). Stanford suggested that if the EU were to relax various price controls, à la China’s recent efforts or the US’ implementation of measures such as the Bayh-Dole Act in the 1980’s (13), the EU could easily pick up many of the investment dollars being left on the table in the US.

However, where the capital ultimately ends up is largely moot in terms of US interests: while the government would certainly prefer these dollars go to strongly aligned countries, any investment outside of the US is obviously not preferred. Congress has aggressively pursued bipartisan measures at keeping industry in America; the Creating Helpful Incentives to Produce Semiconductors (CHIPS) and Science Act (14), which aimed to take semiconductor business from countries such as China, was passed shortly before the IRA. If the bio/pharmaceutical provisions in the IRA move an equal or greater amount of investment out of the US, then Congress’ efforts at keeping industry housed within the US would be hampered.

The question regarding the IRA isn’t necessarily what will happen regarding investment funding, but, rather, how big of the pie will be leaving the country, and where is it going? No one, including Stanford and his contemporaries, is expecting a mass exodus of biotech funding from the US. If the Congressional Budget Office’s number sticks, most businesses wouldn’t bat an eye. If the impact is more in line with the expectations of Stanford and company, it could severely stifle market growth.

Unfortunately, while it would be courteous of investors to kindly explain why they chose one option over another in detail, oftentimes the downstream effects of decisions such as this are hard to isolate—investors themselves might not fully appreciate the various confounding factors that led them to a decision. However, as competition continues to build in the global bio/pharmaceutical market, tracking where biotech investments in totality are occuring could perhaps give at least a glimpse into the answer.

US Pharmacy Market Size, Share & COVID-19 Impact Analysis, By Type (Branded and Generics); By Therapy Class (Oncology, Anti-diabetics, Autoimmune Diseases, Respiratory, Pain, Nervous System Disorders, Dermatology, Antihypertensive, Mental Health, HIV Antivirals, Multiple Sclerosis, Anticoagulants, Other Cardiovascular, ADHD, GI Products, Viral Hepatitis, Sex Hormones, Antibacterial, Hormonal Contraception, Ophthalmology, and Others), By Setting (Retail Pharmacies, Mail Order/Online Pharmacies, Others), Regional Forecast, 2021-2028

H.R.5376, US House of Representatives, 117th Congress, 130th Session (Washington, DC), Sept. 27, 2021.

Wechsler, J. New Legislation Overhauls Medicare Drug Pricing and Benefits. 

Ferrechio, S. Biotech Investors Sound Alarm on Senate Drug-Pricing Bill. 

Congressional Budget Office. How CBO Estimated the Budgetary Impact of Key Prescription Drug Provisions in the 2022 Reconciliation Act. 

cbo.gov/system/files/2023-02/58850-IRA-Drug-Provs.pdf 

Luhby, T. Democrats Lose Effort to Cap Insulin at $35 for Most Americans Before Passage of Senate Reconciliation Bill. 

Eli Lilly and Company, Lilly Cuts Insulin Prices by 70% and Caps Patient Insulin Out-of-Pocket Costs at $35 Per Month. Press Release, March 1, 2023.

CPHI Annual Report 2022: Psychedelic Approvals, VC Driven Contract Services Boom and Next Generation Manufacturing

Playter, G. Crossing the Same River Multiple Times. 

Biotechnology in China - Market Summary, Competitive Analysis and Forecast to 2025

Europe Pharmaceutical Market Size, Share & Trends Analysis Report by Product (Branded, Generic), by Type (Prescription, OTC), by Therapeutic Category, by Region, and Segment Forecasts, 2021 - 2028

H.R.6933, US House of Representatives, 96th Congress (Washington, DC), March 26, 1980.

H.R.6933, US House of Representatives, 117th Congress (Washington, DC), July 1, 2021

Context surrounding the Inflation Reduction Act is necessary for a comprehensive understanding of the global biopharma market.

The United States and the Global BioPharma Market

Chris Spivey is the editorial director of 

Chris Spivey, editorial director, speaks with Jane True, vice-president of mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer. In this interview, True shares her perspective on how mRNA will shift commercial models in the pharmaceutical industry, including changes to the "just-in-time" supply chain, pandemic preparedness, and more.

Jane True, vice-president of mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, shares her perspective on how mRNA will shift commercial models in the pharmaceutical industry.

How mRNA will Shift Pharma Commercial Models with Jane True, Pfizer

ProBioGen, a Berlin-based company specializing in the development and manufacture of APIs, announced its new lentivirus packaging cell line on May 17, 2023. Lenti.RiGHT is a lentivirus production platform based on human embryonic kidney 293 packaging cells.

According to a company press release, the new line is capable of producing lentiviral particles with titers between 107 and 108 transducing units per mL. It includes stable integration of gag-pol, rev, and vesicular stomatitis virus-G proteins.

"With our Lenti.RiGHT platform we have developed a new standard for efficient large-scale lentivirus production and CAR–T [chimeric antigen receptor T cell] manufacturing,” said Volker Sandig, chief scientific officer, ProBioGen, in the release. “It enables an inducible, scalable, and efficient production of high-titer lentiviral particles for gene transfer applications.”

ProBioGen’s Lenti.RiGHT is a lentivirus production platform for use in gene transfer applications.

ProBioGen Launches Lentivirus Packaging Cell Line

ChargePoint Technology, a company specializing in powder transfer, and Famat Sampling, a company specializing in sampling devices, announced a collaboration technology on May 16, 2023. According to a company press release, the companies’ new integrated valve solution allows operators to take a product sample for quality analysis during the course of production while maintaining optimal containment and sterile integrity.

The new product, a combination of ChargePoint’s split butterfly valve and Famat’s 125-Threaded Cap/Occupational Exposure Limit valve, is designed to create a secure and sterile environment for high-potency and sterile powder samples to be taken. According to the release, the interconnected system forms an airtight seal that prevents a dead zone and allows for sampling of highly potent, toxic, or sterile powders to be transferred while maintaining Occupational Exposure Band 4 (OEB4) and OEB5 level compliance.

“During processing, manufacturers must prioritize sampling so that the quality of drug products can be assessed at various stages of the production process,” said Christian Dunne, head of Sterile Solutions, ChargePoint Technology, in the release. “Famat Sampling shares our high standards for quality. Joining forces as two recognized industry leaders in our respective fields was a no-brainer for our team.”

ChargePoint Technology and Famat Sampling’s combination technology is designed to allow for product sampling during the course of production.

ChargePoint Technology and Famat Sampling Collaborate on Novel Sampling Technology

Feliza Mirasol is the science editor for 

Sania Therapeutics, a new UK-based startup focused on developing genetic medicines for neural circuit dysfunction, has launched itself from stealth mode at the American Society of Gene & Cell Therapy (ASGCT) conference, held in Los Angeles, Calif., on May 16–20. On May 17, 2023, the company unveiled its suite of proprietary patented platforms at ASGCT.

The company’s technology combines the evolution of adeno-associated viruses (AAVs) in human neural circuits—the fundamental components of the nervous system—with tuneable, conditionally activated ion channels. This combination permits breakthrough efficacy by correcting dysfunctional neural excitation, which unlocks a broad range of diseases both within and beyond neurology, according to a company press release.

The company’s foundational technology platforms were first developed at University College London. The launch at ASGCT follows the closing of a series seed financing. Proceeds from the seed financing have been applied to platform development, the advancement of a lead program in motor disorders, and the initiation of additional undisclosed programs that leverage the company’s platform capabilities.

Sania’s R-Scan platform enables human-centric precision delivery. R-Scan leverages the combination of microfluidics with a diverse population of human-induced pluripotent stem cells to recreate human neural circuits in a dish. This recreation 

 enables directed evolution of human-centric AAVs. R-Scan is complemented by a second platform, called Gre-Scan, which is a novel and proprietary technology for the high throughput screening of gene regulatory elements.

Both R-Scan and Gre-Scan are combined with Neu-Scan, which facilitates tuneable genetic neuromodulation via testing and validation of the overexpression of conditionally activated ion channels. The company’s proof-of-concept data, which were presented at ASGCT, demonstrate that the Neu-Scan platform has identified ion channels, deliverable by AAV, that enable the treatment of dysfunctional neural excitation.

“We formed Sania with a simple yet powerful vision: to be the first in developing medicines that treat disorders of neural circuits selectively. Today we are excited to demonstrate proof-of-principle data and unveil our platforms,” said Andy Murray, CEO and co-founder of Sania Therapeutics, in the press release.

Sania Therapeutics has emerged from stealth mode and launched its technology platforms for enabling the development of novel therapeutics to treat neural circuit dysfunction.

Launch of Sania Therapeutics Expected to Advance Development of Novel Therapeutics for Neural Circuit Dysfunction

Connect in Pharma announced on May 16, 2023 that for every visitor who attends their event, five Swiss francs will be donated to Global Health Security (GHS) Fund, which is a non-profit organization driving local innovation and global programming to address threats to health security.

The event, which takes place on June 14-15, 2023 in Geneva, Switzerland, aims to bring together key industry players across the pharmaceutical pipeline and biotechnology community. It will also host an exhibition booth for the Global Health Security Fund.

The new partnership hopes to increase funding and awareness of global health security challenges and highlight the role of the pharmaceutical industry in increasing access to medicines and improving health worldwide, according to a press release.

The Global Health Security Fund is made up of innovators who help to create, develop, and scale sustainable solutions to global health security challenges with a specific focus on less developed nations and emerging innovation ecosystems. Health equity and access, public health solutions, and infectious diseases are just a few of the issues that the organization focuses on.

“We welcome the opportunity to lead conversations on global health security challenges at this year’s Connect in Pharma conference,” said Lisa McDonald, MD, president of the Global Health Security Fund, in a press release. “GHS Fund is committed to supporting the growth of Geneva as a hub for pharmaceutical innovation. We look forward to meeting with industry experts from across Europe to ensure the future of pharma has a global perspective.”

Edward Kelley, MD, chief global health officer for ApiJect Systems, and Magali Bischof, secretary general at BioAlps Association, are set to deliver keynote talks addressing related global health issues and share their experience working on the global deployment of COVID-19 vaccinations.

The new partnership hopes to increase funding and awareness of global health security challenges and highlight the role of the pharmaceutical industry in increasing access to medicines and improving health worldwide.

New Partnership Launched by Connect in Pharma for Global Health Innovation

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

FDA sent a warning letter, dated April 28, 2023, to Pharmedica USA, after an inspection of the company’s Phoenix facility found drug products meant to be sterile being prepared, packed, or held under insanitary conditions. The company also lacked International Organization for Standardization (ISO) classified areas for sterile drug manufacturing.

In addition, a variety of current good manufacturing practice violations were found, including failure to establish and follow written procedures to prevent microbiological contamination. “During the inspection, you informed us that you were unaware that ophthalmic drug products are required to be sterile and acknowledged that your facility is not designed and equipped to handle or manufacture sterile drug products, even though your drug products are intended for use as ‘eye drops,’” the agency stated in the letter.

The company also failed to establish adequate procedures for production and process control. “You failed to adequately qualify the equipment and validate the processes used to manufacture your drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an ongoing program for monitoring process control, to ensure stable manufacturing operations and consistent drug quality for products in US distribution,” the agency stated.

These and other quality control problems led to a product recall and a cease of production at the Phoenix facility.

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

FDA Sends Warning Letter to Arizona Facility

Editor of Pharmaceutical Technology Europe

The United Kingdom and Switzerland have kicked off negotiations on a modern free trade agreement (FTA), it has been revealed in a May 15, 2023 press release issued by the UK government.

Such a deal will boost trade between the two countries, which are both high service economies. The current FTA between the two countries is based on a deal made more than 50 years ago, prior to any digital or electronic services even being available.

“As two of the world’s leading service economies, there’s a huge prize on offer to both the UK and Switzerland by updating our trading relationship to reflect the strength of our companies working in [numerous] areas,” said Kemi Badenoch, Business and Trade secretary, UK Government, in the press release. “The UK and Switzerland are natural trading partners and today’s launch will play to our strengths as services superpowers, while also boosting investment in emerging technologies, data innovation, and digital trade.”

In terms of the life sciences sector, a new trade deal could provide significant opportunities for innovation and will strengthen the relationship the countries already have within the field. Additionally, the new FTA should open up greater opportunities for the countries to enhance their research and innovation offerings, furthering the work started in 2022 when a memorandum of understanding was signed to encourage cooperation in science and technology.

“Negotiation of an Enhanced Trade Agreement between the UK and Switzerland provides a pivotal opportunity for a world-leading agreement between two life science superpowers,” said Claire Machin, executive director, International Policy, Association of the British Pharmaceutical Industry, in a press release issued in response to the government news.“Prioritization of life sciences in negotiations could help to boost the growth of our two innovation-intensive economies and set world-leading standards to encourage the creation and adoption of the next wave of scientific technologies.”

The UK and Switzerland are negotiating a modern free trade agreement.

Negotiations Between UK and Switzerland are Underway

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced, in a May 18, 2023 press release, that the United Kingdom’s National Institute for Heath and Care Excellence (NICE) has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.

The recommendation from NICE follows from the authorization made by the Medicines and Healthcare products Regulatory Agency in April 2022 and has been based on positive data from two Phase III trials. Additionally, data from 32 clinical studies have been used to support the regulatory decisions on Kapruvia.

“The recommendation of Kapruvia by NICE is a key step on our journey to bring this breakthrough treatment to in-center hemodialysis patients living with moderate-to-severe CKD-associated pruritus in the UK,” said Fabio Dorigotti, head Global Medical Affairs of CSL Vifor, in the press release. “We look forward to continue working with the National Health Service to ensure access to this important medicine for patients as quickly as possible.”

“We are pleased that Kapruvia will be available to CKD patients in England, Wales, and Northern Ireland who are undergoing hemodialysis and suffering from moderate-to-severe CKD-associated pruritus,” added Christopher Posner, president and CEO of Cara Therapeutics, in the press release. “Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus is managed.”

“Chronic kidney disease-related itch is common for people on hemodialysis and represents a significant unmet need; leading to poor sleep and reduced quality of life for patients,” said Kieran McCafferty, consultant nephrologist, Barts Health NHS Trust, in the press release. “We now have an option to help reduce the burden of CKD-related itch.”

UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.