Grant Playter

Dr. Ulrike Lemke, Head of Sterile Fill Finish at Recipharm, sat down with Grant Playter, associate editor, to discuss drug delivery forms. Topics of discussion include drug storage, drug dosage, and the greater supply chain. 

A full transcript of the conversation can be found below.

What are some of the benefits of prefilled syringes?

: Prefilled syringes are a subset of the dosage forms that currently enjoys a lot of growth, and there are multiple reasons for that, and for an increasing preference, particularly in the high value markets, to go to prefilled syringes. One of the facts is, of course, the lower risk at the point of care to misdose.

The second very important advantage of prefilled syringes is, when it comes to filling a high-value API, you don't need to overfill. So in vials, you have single-dose, multi-dose vials, and then you need to extract, at the point of care, the volumes that you want to deliver to the patient. In the prefilled syringe everything is preset, so the risk of doing any mistakes is lower, and you can fill the exact volume that you need. In that regard, you preserve valuable API as well.

Now, what is a disadvantage of prefilled syringes versus other fill forms? Of course you need to have the storage space available for that, and that's why every technology has its pros and cons and you really need to understand, in the end, markets how your patient will need to be treated. There's no need of specific preparation of material or so, the prefilled syringes ready to go, that makes it a preferred option today,

Can you illuminate the process behind lyophilization a bit for our readers? What are some of the factors that we might not be considering?

: First of all, lyophilization is really freeze drying of formulations to make them more stable. The main advantage of this is you can keep sensitive compounds and materials stable for a longer period of time. So lyophilized products can often be maintained at ambient temperature, so you're avoiding cold chain requirements, and also the degradation in the dry form for sensitive product is much slower if at all present. And with that, you increase the shelf life of products. It is not suitable for every product as well, but often chosen for a really long term stability and storage reasons.

: You have seen this during the COVID crisis, so there are certain products, particularly in the vaccine space that right now need ultra cold storage, and when you want to hit less developed markets such as the African markets, it really puts constraints on how you can deliver these dosage forms. There are routes around this, and we have seen improvements also with ultra cold storage.

For example, the elongate shelf life of these products after freezing for a couple of days, in two to eight, but generally for markets that don't have these elaborate cold chains very well developed, I think a lyophilized product would be advantageous. At Recipharm we have done this in the mRNA space, for example in lyophilization, and that would circumvent some of the disadvantages of ultra cold storage. It's also costlier and you have to establish the -70, -80 degree storage, and then the question is the access to energy at point of care, so this makes lyophilization easier.

Now, here we come to a counter argument when you look to prefilled syringes versus fill form in vial, for example. In markets where you where you want to deliver to patients also cost effectively, storage space is a limitation. And then, of course, also the way that you want to deliver to the patient. So often you see multiple dosage forms -- or multiple doses in a vial, not multiple dosage forms, to just make that clear -- and it's advantageous to do that. Because it is simpler at the point of care or at the delivery to the patient you reduce the space that is needed. So prefilled syringes, for example in Africa would put a constraint on storage spaces in different countries.

I do think there's opportunity in the lyophilization space, especially given the supply chain disruptions we got from COVID. I know there was so much talk about vaccines expiring in storage, it was just very unfortunate.

: That's unfortunate. It's a waste of a high value API. But again, I would also like to stress the point that there are different ways of tackling it, lyophilization is one. But I think the other thing is to make the formulation more stable after thawing which were routes that we have seen customers taking, and we can support both. In the end there's always a good solution to it. I think we have alluded to lyophilization, but ultracold storage is something that we should not unnecessarily exclude, but it has constraints.

I'll refrain myself for getting further in the weeds, this is all very interesting. In the parenterals market, can you talk about some technologies whose impact might be overlooked? Because I know there's these heavy hitters of things that dominate the headlines, but I'm curious about the lesser known things.

: When you think of the market today, first of all, the market has moved a bit from terminal sterilization and to aseptic filling, and we're all talking about the standard dosage forms, which is liquid vial, lyophilized vial, and BFS.

One thing that we take a particular interest in, and that can offer new opportunities, is blow fill seal. We see some first applications in the vaccine space coming up. It's a cost efficient technology, but it is, as the name says, you blow the device, you fill it with the medicine, and then you seal it. There's certain energy or heat involved, so it doesn't lend itself to all kinds of applications. But we think that there is a potential, particularly in the vaccine space, but possibly also other applications in biologics that would be suitable. We're very interested in how this market is going to develop.

We're looking also into the early stages and are very happy to test formulations for customers that want to have a cost-efficient delivery form. One specialty in this is not necessarily a sterile delivery, but when you think about how you need to administer, particularly to children, is an oral route of a liquid into children, and that is another element where BFS could play a role.

Can you tell me about some of the key factors that you would take into consideration when deciding on a form of drug delivery specifically?

: Well, I think for every medicine, the first element that is really important is how do you want to deliver to your patient, and what is the dosage scheme? So how often does he get it, and what is the point at which the customer will receive the medicine? It's the self-administered, for example, or is this given at a point of care in a hospital or so. Then based on this, of course, you need to design your ideal dosage forms.

Other elements, and we alluded to this earlier in this conversation, is really also which markets are you targeting? How mature are they? What is the training status of the caregiver? How do you avoid any mistakes in the formulation? For example, when you look into a lyophilized product, you need to bring it back into the liquid phase at some point in time. So that requires a caregiver or the patient itself to mix the final medicine again. These types of considerations are what you want to look through before you're defining what your delivery form is going to be. So it's really patient centric, and also understanding what is the health system that you go into. There's a lot of constraints – I mean, we’re talking supply chain, we're talking training centers of the caregiver, we're talking the convenience for the patient itself — you want to avoid pain, so that's one important thing.

And this is physical chemical parameters really, is what kind of a drug substance do you have? Is this stable under certain conditions or not? How can you stabilize it? How can you elongate the shelf life of it? How can you improve the bioavailability of it due to your formulation? So, these are the technical considerations.

Last but not least, and this is also where we were focusing on a lot, is you want to think about the efficacy of the manufacturing process itself. So though we want to do this, we don't want to lose a lot of API in our manufacturing process. We want to make sure that when the dosage forms are being delivered, that this works from a distribution perspective. We have touched upon this when we looked into COVID and when we looked into what cold chain, for example, requires, what kind of space do you have available to store? What kind of customs borders do you have to do? So all these things matter because, for example, when you're very sensitive drug substance or drug product in the end, and you cannot break the cold chain, how do you make sure that this is happening?

All these considerations go in, that's not necessarily only considerations that we do for ourselves, but our customers, the pharmaceutical companies, the biotechs, the innovators, come with this thought process already, and we aid them in it. It's not a one fits all approach, that's why we see them mixing the different dosage forms, and there is always a question of how to serve the market that is a mix of multiple factors.

How would you evaluate the current state of the market in terms of drug delivery, specifically? I'm so curious, because I was talking with Gregor and I feel he does a lot of market instability in the greater biopharma space. But do you think that is being mirrored here?

: I would not call it, "This is an unstable market." If anything, what I would say is, first of all, due to COVID there was an increasing demand. I think there was an over focus on liquid vial manufacturing and speed of lines. I see that there is still a need for serving the mid-size market segments, so companies that don't have large volume expectations, but have smaller products for global demand and in smaller indications, and I think they need to be served really well and have maybe gotten a little less attention during the COVID years but now we're coming back.

I think there are market segments in which we see that there is a bit of an imbalance between supply and demand, and that is really in the high volume, large throughput liquid vial segment, where we have seen lots of investments coming in. And of course, we see a couple of new players appearing on the market that have yet to prove that they can work under aseptic conditions and can bring the sterile products to market at the required quality.

Last but not least — and I mean this keeps our industry on our toes, and rightly so — the continued expectations from regulatory authorities to push for more patient safety led to the annex one compliance framework that comes into place in August 2023, this year, and this is really to make the market rethink about what does it mean to handle a aseptic products? So what does it mean from a patient safety perspective, and that requires of course investments. I think this is all good, as long as the cost for the patients do not explode while we're managing continuous increase in safety for these types of medicines.

Without going into who these new players are, how would you say they’re affecting the industry?

: They have a large capacity they have filled during the COVID crisis, and there's a certain mindset also with these companies. I think it's good that new competitors are coming in, it puts pressure on the industry to also rethink. There's a lot of new lines that are coming in, but I think that the point is not about lines alone, it's about the service model that you have to your customers, and it is about resilience in these situations.

I think one of the things, for example, that in this industry for us was very important was to learn how our supply chain really worked, because our suppliers were constraining us to some degree as well. So how do you manage packing material that is relatively consolidate in the industry? How do you make sure that you get access to filters? That was a significant problem during the COVID crisis. And again, there's a consolidated industry on the supplier base, and to manage your supply chain effectively, is a capability that will also affect your customers and the delivery ultimately to patients. So these are the nuances that you need to think through in addition to having manufacturing capacity.

This might be a bit of a blasé question, I guess. But would you say there's a surplus of lines existing from the COVID pandemic, or is it just a matter we haven't thought of how to best use the existing ones?

: Not everywhere, I think it depends really on the dosage form that you look at. We have not done the full analysis of this, but my impression at this point in time is when you're really looking to large scale high throughput liquid vial aseptic, there seems to be a certain surplus. In other areas, absolutely not, lyophilization I don't see that at all, prefilled syringes, I don't see it at all. And I see in smaller lines, liquid aseptic vial filling also no surplus. So it's really an a specific segment that actually targeted vaccines and large volume biologics, if you will.

Now, conversely, can you say there are any segments you think of a shortage like that need to be start ramping it up?

: I said that lyophilization -- I don't see it, I see prefilled syringes and market that continues to increase. I believe there's more capabilities and also capacity coming on stream in the years to come and rightly so. Because what drives it is a very vivid pipeline in biologics with new needs.

I think the one unknown for me is going to be what's happening with single use technologies and different ways of handling liquids that are not the classical sterile fill forms that we discussed here, but when it comes in bags. So there are elements in gene therapy that I observed with interest and we'll see how this goes. But I think there's more to be done because the underlying innovative growth for new molecules coming just sustains the trend of growth and sterile fill finish.

Is there anything you would want to point out to advances that might be on the horizon, in addition to what you've already stated in this segment?

: As I said, one thing for me that that I watch with interest is liquid handling technologies in ATMPs that may not be glassware based. I think we touched upon the BFS technology, we touched upon single use bags for point of care applications -- we need to see to which volumes this will come down.I think then some minor elements will be how much will be glass versus plastic, and let's see how this goes.

And there's one element that of course we also look into, and this is the combination of cartridge, and then devices where a point of care could shift from a hospital-based model to an auto-injector, for example, where the patient treats himself. So lots of things to observe, I think we're in a very dynamic industry and I really enjoy being here.

I can clearly tell your enthusiasm for what you're saying. Do you have any final thoughts you want to share?

: I think for me, it's really a good point to be in this industry. I think the underlying growth in biologics and innovation will continue to fuel it. I think competition is good for the business, and I like it. I think what I would like to take a focus on in the coming years is not only the dosage angle and the modality angle that we looked for, but the angle of how will we serve markets that are underserved today? So Africa comes to mind in this, and how can we make sure that some of the learnings that we had in the pandemic will be applied so that we can avoid future shortages, particularly of medicines that prevent pandemics or stop them?

Absolutely. Thank you so much for taking the time to speak with us.

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

Articles

Dr. Ulrike Lemke, Head of Sterile Fill Finish at Recipharm, sat down with Grant Playter, associate editor, to discuss drug delivery forms.

Exploring Drug Storage, Drug Dosage, and the Supply Chain with Ulrike Lemke (DCAT Week)

FDA announced the approval of GSK’s Biologicals’ Arexvy, a respiratory syncytial virus (RSV) vaccine, on May 3, 2023. The vaccine is the first to be approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and older, according to an agency press release.

FDA based its approval on analysis of data from an ongoing, randomized, placebo-controlled clinical study in individuals aged 60 and older. The study, which had 12,500 participants receive the vaccine and 12,500 receive placebo, showed that the vaccine reduced the risk of developing RSV-associated LRTD by 82.6% and severe RSV-associated LRTD by 94.1%. Data from the first RSV season of the study was made available to FDA, but participants will remain in the study through three RSV seasons to assess the duration of effectiveness and safety, as well as the effectiveness of repeat vaccines.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in the press release. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects [FDA’s] continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

Results from two other studies were also considered. One of these studies saw two patients develope acute disseminated encephalomyelitis (ADEM), one of whom died. In the other, a single patient developed Guillain-Barré syndrome. According to the release, FDA is requiring GSK to conduct a post-marketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. In addition to this, GSK has independently committed to assess atrial fibrillation in the post-marketing study

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.

FDA Approves First RSV Vaccine

Baxter, a global medical technology company, announced its agreement to divest its BioPharma Solutions Department (BPS) on May 8, 2023. Advent International, a private equity firm, and Warburg Pincus, a global growth investor, will pay approximately $4.25 billion in cash for the BPS manufacturing facilities and 1700 employees in Bloomington, Ind., and Halle, Germany. The transaction is expected to close in the second half of 2023.

Baxter plans to use the cash from the deal to reduce its current debt. Advent and Warburg plan to operate BPS as an independent full-service contract development and manufacturing organization (CDMO) specializing in sterile contract manufacturing solutions, parenteral delivery systems, and customized support services to the pharma and biotech industries. According to a company press release, BPS is expected to generate approximately $600 million in revenue in 2023.

“Today represents an important step in Baxter’s ongoing transformation journey as we continue to execute against our strategic priorities, enhance our focus, and create additional value for all our stakeholders,” said José E. Almeida, chairman, president, and CEO, Baxter, in the press release. “I am confident that under their stewardship, BPS will continue to build on its leadership position, foster world-class talent, invest in new capabilities and capacity, and provide leading-edge, high-quality solutions for its clients.”

“BPS is a premier asset at the forefront of the biopharma industry, and one we’ve been closely following for a number of years,” said John Maldonado, a managing partner at Advent. “Leveraging our deep sector expertise and significant strategic resources, we believe this partnership can unlock multiple opportunities for growth and help the business realize its full potential by serving blue-chip customers, including Baxter, with high-value, specialized, and end-to-end capabilities as a standalone company. We're thrilled to partner with BPS to alleviate critical pain points for its customers and to help them provide life-changing therapies to patients around the world.”

Private investors from Advent International and Warburg Pincus will operate the assets as an independent CDMO.

Baxter Divests BioPharma Solutions Department in $4.25 Billion Deal

Ginkgo Bioworks, a US-based biotech company, announced a drug discovery partnership with Boehringer Ingelheim on May 8, 2023. Ginkgo will receive upfront research fees and potential R&D, regulatory, and commercial milestone payments totaling $405 million, plus unspecified royalties on any products commercialized through this collaboration.

Under the agreement, the companies will work together on the discovery and development of novel therapeutic molecules for diseases with high unmet patient needs that are considered out of reach of conventional drug discovery. According to a company press release, they will mine Ginkgo’s metagenomic sequence database, composed of structurally novel bioactive molecules, as a means of identifying potential lead molecules.

"Ginkgo is well-positioned to help partners like Boehringer Ingelheim complement their drug discovery efforts particularly when it comes to natural product discovery," said Jason Kelly, CEO and co-founder, Ginkgo Bioworks, in the press release. "We are thrilled to work with Boehringer Ingelheim leveraging our Foundry and Codebase to unlock new possibilities in biopharma innovation."

Boehringer Ingelheim will use Ginkgo’s metagenomic sequence database to identify potential lead molecules for diseases with high unmet patient needs.

Ginkgo Bioworks and Boehringer Ingelheim Sign $405 Million Drug Discovery Deal

Roger Viney, chief commercial officer at ICE Pharma, sat down with Grant Playter, associate editor, to discuss the history and current use of bile acid therapeutics.

Pharmaceutical Technology: Can you explain for our audience what exactly bile products are? What is the market like?

Bile acids have been used for thousands of years in traditional Chinese medicine. It was not until the 1970’s that ursodexoycholic acid (UDCA) was prescribed in western medicine. The last 20 years have seen a huge growth of medicinal research in bile acids. As recently as 1999 the scientific community recognised that bile acids are metabolic regulators—and this opened a whole new area of research into bile acid based medicines.

UDCA represents ICE Pharma’s most important API, as this is a key active ingredient in drugs treating liver and gallbladder diseases. Our range of products also includes cholic acid, deoxycholic acid, chenodeoxycholic acid, their salts and taurine and glycine conjugates, which find diverse uses from nutraceuticals to excipients and APIs.

PharmTech: Can you talk a little bit about ICE Pharma’s recent publication with the Ferrier Research Institute concerning treatments for Parkinson Disease?

: Recent research has revealed the role of bile acids as metabolic regulators and uncovered their potential to treat a variety of diseases. It was discovered in 1999 bile acids and their salts act as hormones and are essential in the homeostasis of metabolic activities. This makes bile acids an excellent class of molecules to target metabolic conditions such as type 2 diabetes, obesity, and nonalcoholic fatty liver disease.

Bile acids are now shown to act on a number of nuclear receptors and it is becoming clear that bile acid signalling properties are complex and extend beyond that of FXR and TGR5, where most of current bile acid research has been conducted. One growing area of interest for bile acids is with neurodegenerative disease where UDCA is showing promising results in current clinical studies.

One of the research papers with the Ferrier Institute, to which we contributed, relates to Parkinson’s Disease. Mitochondrial dysfunction is a well-documented mechanism in both sporadic and familial Parkinson’s Disease. UDCA has been identified as a bile acid which leads to increased mitochondrial function in multiple 

 models of Parkinson’s Disease. Our study indicates that modified novel bile acid molecules could lead to the development of more efficacious bile acids which increase mitochondrial function and ultimately cellular health so proving attractive potential novel therapeutics for Parkinson’s Disease.

PharmTech: Last year, ICE Pharma acquired an API manufacturing site from Mitsubishi in Japan. Can you talk a bit about the strategy behind this decision? What factors led you to acquire a site in that region specifically?

: Tokyo Tanabe, who became Mitsubishi Tanabe, was the originally developer of UDCA in Japan in the 1950’s and since that time the benefit of UDCA in treating a range of diseases has been recognised worldwide. The Iwaki manufacturing unit is a high-quality facility with a long heritage of stable supply focusing on Japan. The Japanese and wider Asian demand for UDCA is large and increasing and the integration of the Iwaki facility and its employees into the ICE manufacturing network helps us strengthening the company’s position by providing it with a fourth UDCA API facility and a base in Asia.

Under the new ownership, and by taking advantage of ICE’s expertise, the new facility continued and improved delivery of our UDCA API. The acquisition of the Iwaki plant is a fantastic occasion to provide customers with further capacity and to strengthen ICE’s position as a global bile acids player.

: Taken from a 10,000 ft. level, what is your perspective on the state of the global bio/pharma market?

: The big talking point I have noticed at DCAT are the problems with pricing in the US market for the generic drug product manufacturers. The consolidation of the distribution channel to three main players in the US has led to an imbalance in the distribution of the value from the business. The drug product manufacturers have seen further price erosion recently and face additional business risks of late delivery penalties and unsold stock returns. Many companies that had previously been focused on the US and filing new ANDAs are looking at new markets particularly in Asia. These changes may not be in the long-term interests of the US patients.

: Do you have any bold predictions on where the bio/pharma industry will be a year from now? How about ten?

: In 2022 we saw Amylyx launch the first treatment for motor neuron disease based on a bile acid. I am expecting to see that the large amount of scientific research into bile acids will lead to further discoveries of their biological functions and potential to treat diseases. lCE Pharma has developed a library of over 500 novel bile acid compounds that we expect to license to partners who will bring these molecules through clinical trials and ultimately to market.

Roger Viney, chief commercial officer at ICE Pharma, discusses the history and current use of bile acid therapeutics.

Exploring Bile Acid Therapeutics with Roger Viney (DCAT Week)

Sarah Stevens, senior vice-president and head of Drug Product Development & Manufacturing at Quotient Sciences, sat down with Grant Playter, associate editor, to discuss various facets of the modern outsourcing industry.

Sarah, thank you so much for taking time to speak with us today.

What are some of the latest drug developments in the larger biopharma industry? How is Quotient looking to capitalize on them?

 Sure, we see across our customer base and our network, really, trying to double down and find ways to accelerate on the drug development pathway. And we see that from the larger pharma companies through to some of the smaller biotech, you spin out to establishment. So, for Quotient, this aligns well to our core strategy of eliminating the whitespace and operating in a more disruptive nontraditional drug development approach.

So, we have our platform technology, which is translational pharmaceutics. And this essentially captures our ability to accelerate along the drug development pathway, really integrating our formulation development, clinical manufacturing, and dosing in our own in-house clinics, in a really accelerated and real time fashion.

Can you tell me a little bit more about the platform? What sort of use cases have you been using it?

 Translational pharmaceutics, as a concept, has been utilized by Quotient Sciences now for over 15 years; we have conducted over 400 clinical studies that have been designed in this way. For us, it really comes down to, as I say, having the in-house capability from that early formulation development.

Drug substance manufacturing is the latest addition to our capability portfolio, really building knowledge of a molecule and using that to guide the drug development approaches. So, we can rapidly reduce time and therefore, significantly reduce cost for our customers by essentially adopting this make dose test approach. And we know it's kind of a real time response, that we can adopt gathering data on humans, as opposed to animal models to inform those decisions.

What are some of the considerations that go into developing your company's overall drug development plan?

 For us, we tend to develop our strategy very much in response to what we see as a need for our customer – less of of a “build it and they will come” and much more responding and evolving as we work with a whole kind of spectrum and range of customers. And so, one of the key recent developments for us was the introduction of drug substance manufacturing, with some real strength around materials characterization. What that has allowed us to do is expand that translational pharmaceutics offering, really capturing the customer's needs much earlier in that process. And again, it just allows us to build that molecule knowledge and develop a real pathway for our customers.

In addition to that, we've expanded in recent years across into the US market, and of course, originated in the UK and Nottingham. And has grown considerably over recent years and introducing the translational pharmaceutics concept into the US market also.

Are there any special considerations that can be made for the orphan disease product development, given scarcity relative to more common conditions like say diabetes or whatnot? How does this affect that manufacturing process?

 Yes. it’s funny. For orphan indications, typically there may be a smaller target patient population. Some of the accelerated regulatory progression that you see with orphan or other fast track indications fits very well, actually, with what I've described around translational pharmaceutics and the fact that we can accelerate, we can be nimble, and as far as the manufacturing piece goes, we can work at very small scale. So essentially, very much I can give material speeding approach, which in turn saves money for the customer. It allows us to be very nimble in that make and dose approach that I've described.

How do you promote manufacturing agility at Quotient?

 It's interesting. So again, it's dependent on customer needs — we operate at a range of different scales across different facilities within the business. So we can very much adopt a GMP, small scale manual approach — perhaps you're only looking for a small number of tablets, small number of capsules, all the way through to several kilogram scale batch sizes across our facilities from the UK and the US. Regardless of scale, we adopt operational excellence, lean manufacturing approach, and really drive a kind of continuous improvement, culture and strategy around all of our manufacturing operations.

How would you evaluate the current state of the broader biopharma market? Are there any technologies or practices you're keeping a close eye on?

 Recent years have been fairly disruptive, I think —we see the kind of the aftermath, the learnings from COVID and a lot of focus on more advanced medicines, whether that be the mRNA space, lipid nanoparticles, more advanced drug delivery systems to support these peptides and proteins. So, certainly a lot of growth in the biologics side. We also have some sterile manufacturing capability within Quotient Sciences, and that really plays to that part of the market, it’s probably an area of future growth for us. But, certainly seeing that trend around the more advanced biologics.

With regard to COVID, in America, we declared the state of emergency in March 2020, but it’s set to lapse in May. But I've been talking with many people throughout the DCAT week, and a lot of people talking about how disruption and supply chain is still here. And that just in time, while it may not be completely out, seems to be losing favor in lieu of on-shoring. What's your take on all that?

 It’s really interesting. I think that there certainly are some supply chain challenges, materials, supplies, whether it be coming from an engineering perspective all the way through to even supply capsule shells. I think that, in very general terms, that COVID has brought an acute focus to supply chain.

And again, it's all about planning, and maybe just in time isn't the right approach, and maybe it's thinking more carefully about forecasts, from a commercial manufacturing perspective, and just the materials management part of any business where you're dealing with businesses it CDMO spaces. I think we've got the attention that has been needed, and brought acute focus and a much clearer view. Planning has become all the more important.

Do you have any bold prediction about where we'll be five years from now? How about ten?

 Oh, my goodness. Thinking about it from the CDMO and pharmaceutical services perspective, I think we will see this continuing direction of travel towards offering a fully integrated end-to-end service. I think almost all CDMOs will be at least claiming to offer the kind of integrated, end to end, services, as well as some venturing into biologics to match the small molecule capabilities. And again, that advancement, as I mentioned, some of the more complex or advanced drug delivery systems, polymeric, nanoparticles, liposomes powders, all those things that play well, along with protein delivery. So, I suspect we'll see that continued momentum in that space.

Sarah Stevens, senior vice-president and head of Drug Product Development & Manufacturing at Quotient Sciences, discusses various facets of the modern outsourcing industry.