Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

The bio/pharma industry, despite being renowned as a slow adopter of novel technologies, is experiencing a boon in innovation—be that in the therapeutic modalities under investigation, the techniques being employed for drug development and manufacturing, or advances in materials used for packaging and drug delivery devices. A major driver for innovation within the bio/pharma sector has been the COVID-19 pandemic, which propelled advances such as the approval of messenger RNA (mRNA) vaccines at record-breaking speeds and led to many companies pivoting to deal with the urgent requirements for capacity and supply chain flexibility needed to overcome pandemic challenges.

A major contributor in the efforts to combat COVID-19 was the European bio/pharma industry, with players from European countries providing key services and making important development breakthroughs. However, despite the various life sciences and biotech hubs and clusters located within the European region, there has not necessarily been a translation of expertise into commercial success, particularly in terms of biotech (1).

Exhibitions and conferences are potential avenues for companies within the bio/pharma industry to showcase their expertise and broaden their potential commercial reach. In line with this type of entrepreneurial opportunity, event organizer Easyfairs is launching the Connect in Pharma event in September 2022 in Switzerland. “We’re really excited to be launching this event in Geneva, Switzerland, as we think it’s the ideal meeting place to bring together leading pharmaceutical companies, biotechs, and suppliers,” explains Josh Brooks, marketing & community director, Packaging at Easyfairs.

“Before deciding on a location, we conducted extensive market research, and it quickly became clear, just by the sheer proximity of so many biopharmaceutical companies, associations, and research centres, that the event had to be in Geneva. This city is at the heart of a number of leading European pharma and biotech clusters in France, Switzerland, Italy, and Germany,” Brooks continues. “There was nothing serving this market already in the centre of Europe, and we thought the Easyfairs team, with our deep experience in running events in the packaging world, could serve this segment of the market well. The event is perfectly placed to bring together key influencers from leading pharmaceutical groups, biotechs, industry clusters, and suppliers.”

To gain a greater understanding about this new event, 

 spoke in more detail with Brooks about the event’s main areas of focus, things for visitors to look out for, the reasoning behind the formation of the event, and the prospects for the future.

 Why have you chosen the four key areas—Innovative Packaging, Drug Delivery Systems, contract manufacturing organizations/contract development and manufacturing organizations (CMO/CDMO), and Filling & Assembling Processes—for the event?

 The pharmaceutical and biotech markets are experiencing incredible advances across the sector. With an array of new developments in the field, including personalized treatments, biologics, nanotechnology, and increasing digitalization across the supply chain, to name just a few, we knew this was the right time to launch an event that would be geared towards looking at the future of innovation in the sector. Understanding the shifting landscape of European regulations and trends in innovation of drug design and delivery systems has never been more important.

What we’re doing is creating an event that looks at everything downstream of the molecule. In other words, once the science has been done, there’s a lot of resources that need to go into getting that molecule into a form that can be delivered in a safe way to a patient. Having the right drug delivery system, filling and finishing vials in a sterile environment, packaging, and outsourcing are all important components that are part of that process.

There’s a vibrant community in Europe making extraordinary advances in all these areas. Businesses are looking for the most effective way to bring their products to market against the backdrop of shifting regulations and an expanding and ageing population. We believe this biotech and pharmaceutical community is underserved, and we’d like to help bring key players together.

We’re very focussed right now on working with our newly formed advisory board to put together the details of the programme, but participants can expect to hear from experts on a range of subjects, from sustainability to patient-centred design to the impact of industry 4.0 on production and supply chains, to name just a few.

 What can visitors experience while at the show?

 After more than two years of cancelled events, we think it’s a really exciting time to be bringing people together. First and foremost, it will be an opportunity for visitors to discover the latest products and services that will help them solve their packaging and production challenges. Many of the world’s leading suppliers of devices, packaging, and CMO/CDMO services will be exhibiting—companies like BD, Gerresheimer, Catalent, Unither, Essentra, and many more—so it will be a perfect opportunity to meet these companies in one place.

Connect in Pharma aims to ensure that people have multiple opportunities to meet and network—like a champagne bar right in the centre of the event, VIP areas, and we’re planning a party on the evening of the first day. It’s about fun, but it’s also about making new connections and seeing old colleagues and friends—all in the interest of driving new collaborations, ideas, and innovations.

We’re also very happy to be able to share that we will be hosting the presentation of the inaugural Sustainable Medicines Packaging Awards, which are given by the Sustainable Medicines Partnership. It’s a new awards programme from a new organization that is aiming to drive a reduction in the environmental footprint of the whole pharmaceutical industry supply chain—more details can be found on the event website.

In addition to all that, visitors will find a conference programme that includes a range of opportunities to see and hear about advances and trends through plenary talks and workshops.

The plenary conferences aim to help the market think about the pharmaceutical Europe of tomorrow. This high-level and non-commercial conferences programme will give the floor to experts from labs including Roche, as well as consultants, corporates, and manufacturers at the forefront of future developments in the world of biopharmaceuticals. Organized as four half-days, they will each address a theme related to the four main areas of the supply chain present in the exhibition area: pharmaceutical packaging (primary and secondary), medical devices, pharmaceutical sub-contracting, and pharmaceutical equipment.

Visitors can also register for 45-minute workshops where experts in packaging, medical devices, pharmaceutical equipment manufacturers, and CMO/CDMO will provide insights and advice. These workshops are all about finding technical solutions to problems. It will be less of a product pitch, and more solution focused. This part of the programme is intended to provide representatives from pharmaceutical and biotech companies with the opportunity to interact with different suppliers to better understand best practices and challenges of their suggested solutions.

Furthermore, we are dedicating a portion of exhibit space to highlight innovation. This will allow participants to hear from exhibitors who will be demonstrating their latest innovation or technology within short, 15-minute segments. We think this will be a great tool to learn about the latest innovations in the market and find new suppliers and partners. 

The event is taking place at Palexpo, the international exhibition and congress centre located within a two-minute walk from the Geneva airport in Switzerland, between 14 and 15 September 2022 Registration for the event is free.

More information about the event, exhibitors, and how to sign up to receive updates by email can be found at 

 What are you hoping to achieve with this inaugural event? Are there any particular targets/outcomes you have in mind?

 As this is the first edition of this event, our biggest challenge and measure of success will be around the extent to which we bring this community together. It will take a few years to build the brand so that Connect in Pharma becomes associated with connecting people and is recognized as the place to go to discover new clients and suppliers.

The dream scenario, the real measure of success, is when a product comes to market that happened as a result of a meeting or discussion that took place at our event. That can take a long time, but we’ve seen it happen time and again with our other trade shows, and that’s when you really know you’ve succeeded.

If we can create a new platform where people can meet, build their business, feel inspired and come away with new ideas, then we’ve done our jobs. For exhibitors, that means new business opportunities and new clients. For others, it will mean finding inspiration for what the future looks like and discovering new solutions.

 Have you already started planning future events? Will the event be an annual occurrence or a different frequency perhaps? Will you expand the exhibition or change location, etc?

 We have created Connect in Pharma as the first edition of an annual event. It is our ambition to grow the event in terms of scale. We expect to have about 100 exhibitors this year, but the venue at Palexpo has the capacity to accommodate larger exhibitions, and we expect the event to grow in the future. The location of Geneva will be maintained for any future events. We are always looking at ways to build our community. That means we will be looking at opportunities to develop the digital offering and exploring other meaningful and useful information services around the event.

1. J. Smyth, “Finance, Culture, Talent: Why Europe Struggles to Commercialize its Biotech Expertise,” 

Felicity Thomas is the senior editor/European editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as F. Thomas, “Connecting the Dots for Pharma,” 

Articles

The inaugural Connect in Pharma event will take place on 14 and 15 September in Geneva, Switzerland.

Connecting the Dots for Pharma

In May 2022, the World Health Organization (WHO) received reports of monkeypox cases in countries where the virus is not endemic and that have no direct travel links to endemic countries, which is ‘highly unusual’ (1). Despite the recent outbreak, it is considered unlikely that monkeypox will become a pandemic threat (2).

Preparations into ways of tackling the current monkeypox outbreak have already begun. The therapeutic options that are on the table to help in this outbreak have been, for the most part, originally developed for smallpox (3).

So far, at the time of writing, there are four main players working and making deals to ensure treatments and vaccines are available for the monkeypox outbreak. These companies are Bavarian Nordic, Siga Technologies, Emergent BioSolutions, and Moderna.

 has already signed several supply contracts for its smallpox vaccine (MVA-BN, IMVANEX) with deliveries expected to start immediately to try to curb the current outbreak (4).

 has received requests for its antiviral treatment (TPOXX [tecovirimat]), which is a treatment for smallpox and can be used to treat monkeypox and cowpox in the European Union (5).

 has entered into a definitive agreement with Chimerix for the acquisition of the worldwide rights to TEMBEXA (brincidofovir)—an antiviral treatment for smallpox (6).

 has announced via Twitter that it is investigating potential monkeypox vaccines at a preclinical level (7).

Additionally, other companies, such as Roche and Abbott Laboratories, are working to develop diagnostic tests.

The silver lining of this recent and unusual outbreak, however, must be the fact that the bio/pharma industry and regulatory bodies have indeed learnt from the COVID-19 pandemic and are capable of acting rapidly to mitigate the potential risks associated with a viral concern.

1. WHO, “Multi-Country Monkeypox Outbreak in Non-Endemic Countries,” Press Release, 

, 21 May 2022.
2. M. Kortepeter and Coronavirus Frontlines, “Will Monkeypox be the Next Deadly Pandemic? It’s Unlikely,” 

, 19 May 2022.
4. Bavarian Nordic, “Bavarian Nordic Enters Additional Vaccine Contracts with Governments in Response to Monkeypox Outbreak,” Press Release, 30 May 2022.
5. M. Mishra, “Siga Gets Requests for Smallpox Drug in Europe as Monkeypox Spreads,” 

, 19 May 2022.
6. Emergent BioSolutions, “Emergent BioSolutions to Acquire from Chimerix its Exclusive Worldwide Rights to TEMBEXA (brincidofovir), the First FDA-Approved Smallpox Oral Antiviral for All Ages,” Press Release, 16 May 2022.
7. Moderna, “Our Official Statement on Monkeypox,” Posted on Twitter 23 May 2022 [Accessed 1 June 2022].

When referring to this article, please cite it as F. Thomas, “An Unusual Threat,” 

Cases of monkeypox are rising around the world, but it is unlikely the virus will become a pandemic problem.

An Unusual Threat: Pharma is Already Tackling the Monkeypox Outbreak

editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

Steven Lynn, Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates (RCA

), has 24 years of quality and regulatory compliance related experience, is an expert in Current Good Manufacturing Practices compliance related matters and has significant experience with other GxP quality compliance and regulatory issues.



Alexander Natz, Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

, advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective.


This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

 editors, who interview experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

: Biopharmaceutical drug development and manufacturing

Automating pharma and biopharma processes

Videos

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

Drug Digest: Emerging Therapies in All Shapes and Sizes

Traditionally, drug delivery approaches were primarily aimed at the oral administration of a therapeutic substance that was released immediately. However, as drug molecules have progressed and newer modalities have been investigated, the ‘conventional’ routes of drug delivery proved limiting for formulators as a result of the requirement for higher doses, the need for frequent administration, and the fact that the release of the therapeutic is not controlled. Therefore, novel drug delivery systems (NDDS) that can help overcome the limitations of more conventional approaches have been a key area of focus for bio/pharmaceutical companies (1).

This industry focus is reflected in the market trajectory for NDDS, which, according to research, is projected to grow at a compound annual growth rate of 20.8% between 2021 and 2026, reaching an estimated value of $28.1 billion by the end of the forecast period (2). It is anticipated that this growth will be driven by multiple factors, such as the benefits offered by controlled-release drug delivery, the presence of in-vivo biological barriers that impact various properties of a drug substance, and the increased adoption of controlled-release drug delivery systems by specific patient populations because of non-adherence to treatment regimens.

Between 1950 and 1980, the fundamentals of understanding how drugs are released were underpinned (3). This period saw the first generation of development, with controlled-release mechanisms being approved by regulatory bodies, such as the approval of Spansule (Smith, Kline, & French Laboratories) in 1952—the first controlled-release drug delivery system (4).

In the first generation of drug delivery development, four main drug-release mechanisms were employed—dissolution-control, diffusion-control, osmotic-pressure control, and ion-exchange control (3). Other mechanisms were investigated, but for most commercial products between the 1950s and 1980s, the release-mechanism was based on dissolution or diffusion-control, or a mixture of the two (4). These delivery systems were mainly employed for oral or transdermal administration of therapeutic products.

Moving over to injectables, the first long-acting formulation was approved in 1989 by FDA, forming part of the second generation of drug delivery development (3). The poly(lactic-co-glycolic acid) (PLGA) microparticle formulation—an injectable depot formulation—was designed initially to deliver peptide and protein drugs for a month. This duration of drug release expanded to a period of six months with some ratio and molecular weight adjustments (4). As a result of the known safety of PLGA polymers, approvals of all other polymer-based long-acting injectable formulations have been based on PLGA.

Another significant second-generation development is the process of attaching poly(ethylene glycol) (PEG) to protein molecules—PEGylation (4). Through this process, it is possible for protein molecules to stay in the systemic circulation for longer. However, a potential limitation was realized in subsequent studies where antibodies were produced in the body against the PEG molecules, which led to accelerated blood clearance (5,6). Ultimately, greater understanding of PEGylation is required to ensure this process is used more effectively (4).

Most recently, PEGylation, more specifically lipid nanoparticles containing PEGylated lipid, has been imperative in the messenger RNA (mRNA) vaccines used against COVID-19, a development that has renewed research into the field of lipid nanoparticles (4).

A notable progression, brought to the fore of global attention thanks to the COVID-19 pandemic as mentioned previously, has been the ability to deliver mRNA vaccines (7)—something that was not possible when the medical use of mRNA vaccines was first proposed, approximately 30 years ago (8).

To enable the safe delivery of the sensitive and unstable mRNA, it is first necessary to encapsulate the vaccine molecules in lipid nanoparticles so that they are shielded from destructive enzymes (9). Once the vaccine is
appropriately protected, however, it is then necessary to ensure it can be delivered effectively and escape the endosome to have a therapeutic effect (4). The ability for formulators to rapidly create a functional mRNA delivery system using lipid nanoparticles, as was seen in the COVID-19 pandemic, was only possible thanks to decades of prior research in the area.

Staying with the basic concept of encapsulation, scientists from Nanyang Technological University, Singapore, published a study into the utility of conjugated peptide coacervates—protein-based microdroplet—as a drug delivery vehicle for the intracellular administration of a broad range of macromolecular therapeutics (10,11). Through the use of the protein-based microdroplets, which act as a ‘Trojan Horse’, the therapeutics are able to sneak into the cells. Once inside the cells, the droplets dissolve, allowing the release of the drug-carrying biomolecules.

According to the Singapore-based researchers, the microdroplets are a promising platform for delivery of a variety of therapeutics, including proteins, peptides, and mRNAs (10). Additionally, the scientists report that it would be possible to recruit and deliver a single or a combination of macromolecular therapeutics using the microdroplets.

In June 2021, a global specialist HIV company that is majority owned by GlaxoSmithKline, ViiV Healthcare, announced its partnership with biopharmaceutical company, Halozyme Therapeutics, for the development of “ultra long-acting” medicines to treat HIV (12). The collaboration agreement granted ViiV Healthcare exclusive access to Halozyme’s ENHANZE drug delivery technology—recombinant human hyaluronidase PH20 enzyme (rHuPH20)—for four specific HIV medicine targets.

The technology works through the PH20 enzyme, which has the ability to break down hyaluronan (HA)—a substance found under the skin. Once HA is broken down, a greater volume of fluid can be injected subcutaneously and dispersed, which has the potential to reduce treatment burden (12).

Another partnership, this time between Janssen Biotech, a Pharmaceutical Company of Johnson & Johnson, and Bioasis Technologies, has been formed to develop drugs that can traverse the blood-brain barrier (BBB) (13). Under the terms of the agreement, Janssen will have access to Bioasis’ proprietary xB3 platform technology, which is based on a human transport protein that can be found in low levels in blood.

According to Bioasis, the platform has shown efficacy in its ability to shuttle molecules of varying sizes and types, such as monoclonal antibodies, enzymes, small molecules, and gene therapies, across the BBB. Once the molecules have traveled into the brain, it is possible for them to reach the appropriate targets through a process called receptor-mediated transcytosis (14).

Finally, BioNTech has linked up with Matinas BioPharma to evaluate novel delivery technology for mRNA-based vaccines (15). The exclusive research collaboration will assess the combination of mRNA formats and Matinas’ proprietary lipid nanocrystal (LNC) platform technology.

The companies are hopeful that, through the collaboration and the promising capabilities of the LNC delivery platform, they will potentially have the opportunity to develop mRNA vaccines that can be delivered orally.

, 590, 119912 (2020).
2. Research and Markets,

 Novel Drug Delivery Systems (NDDS)—Global Market Trajectory and Analytics, Market Report

 (February 2022).
3. Y.H. Yun, B.K. Lee, and K. Park, 

, 219, 2–7 (2015).
4. H. Park, A. Otte, and K. Park, 

 287, 257 (2018).
7. G. Quaglio with M. Fernández. Álvarez, “What If New Drug Delivery Methods Revolutionized Medicine?” European Parliamentary Research Service, 

, 14, 274–283 (2022).
11. Nanyang Technological University, Singapore, “Sneaking Large Drug-Carrying Biological Molecules into Cells,” Press Release, 

, Mar. 16, 2022.
12. GSK, “ViiV Healthcare and Halozyme Enter Global Collaboration and License Agreement for ENHANZE Drug Delivery Technology to Enable Development of ‘Ultra Long-Acting’ Medicines for HIV,” Press Release, June 22, 2021.
13. Bioasis, “Bioasis Enters into Research Collaboration with Janssen,” Press Release, April 11, 2022.
14. Bioasis, “Platform,” Science Information Page [Accessed April 22, 2022].
15. BioNTech, “BioNTech and Matinas BioPharma Announce Exclusive Research Collaboration to Evaluate Novel Delivery Technology for mRNA-Based Vaccines,” Press Release, April 11, 2022.

Felicity Thomas is senior editor of Pharmaceutical Technology.


Volume 46, Number 5
May 2022
Pages: 26–27

When referring to this article, please cite it as F. Thomas, “An Evolving Approach to Drug Delivery,” 

Advances in therapeutic modalities and an increase in molecular complexity have led to the need for an evolution in drug delivery approaches over the years.

An Evolving Approach to Drug Delivery 

As the industry enters a phase where the patents of many major drugs will expire and the use of more novel therapeutic modalities is increasing, the desire to partner up with a company that can offer significant expertise is also rising. According to market research, the global formulation development outsourcing market is predicted to grow at a compound annual rate of 8.19% between 2020 and 2028 (1).

“Outsourcing formulation activities provides sponsor companies with the opportunity to unlock the entire commercial potential of new therapeutic approaches,” confirms Cornelius Pompe, vice-president R&D at Leukocare. “The most obvious advantage of outsourcing is the opportunity to increase the likelihood of success. Thereby, the sponsor’s specific knowledge about the drug is combined with the formulation expertise of the service provider that is able to leverage from a high project throughput.”

“With more molecules in development than ever before, huge productivity challenges are arising. Consistent increases in molecules with challenging drug properties have created hurdles when trying to achieve successful delivery, which also aids in the high attrition rates of molecules before Phase II,” notes Vanessa Zann, senior drug development consultant, Quotient Sciences. “If accelerating development timelines is the goal, drug developers must characterize their compounds sufficiently to allow intelligent formulation strategies to be adopted, and for contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) to be able to provide meaningful data quickly.”

When moving away from traditional industry silos and using an integrated approach for projects with a single outsourcing partner, it is possible to gain significant cost and time savings, explains Zann. “Outsourcing to a fully integrated service provider also allows for the opportunity to access the specialist knowledge of drug substance, drug development, and clinical experts that are dedicated to the provision of these services, often having experienced many valuable case studies that can provide great benefit for the customer,” she says. “This integrated consultancy approach can offer additional value when accelerating formulation strategies to achieve first-in-human and proof-of-concept milestones.”

In addition to a lack of expertise, which creates a hurdle to successful formulation strategies by pharmaceutical companies, other common issues include the appropriate amount of resources and time to be able to choose and apply orthogonal approaches to understanding the formulation design space, specifies Paul Kippax, Pharmaceutical Sector director at Malvern Panalytical. “Working in partnership with a contract service provider that provides both expertise and instrumentation can add exponential value to any formulation development workflow,” he says. “By offering consultancy on and access to the plethora of analytics and associated methods available, an experienced team will supply the clarity needed to answer your questions and accelerate your development.”

A best-case scenario, when outsourcing a project to a CRO, would be for
the sponsor company to gain rapid access to the wide range of instrumentation and experience that is required for an orthogonal approach, Kippax emphasizes. “[This scenario would] allow sponsors to effectively define the design space without introducing noise and unnecessary complexity,” he adds. “And selecting a services provider with deep experience developing the dosage forms most relevant to your product can be the ultimate fast-track to success.”

“Accelerating a formulation strategy is all about continually asking and answering the questions that enable you to narrow the design space,” Kippax states. “Like the beams of two torches crossing in the dark, applying the right combination of analytics to validate—or even dismiss—a particular formulation will quickly shine a light on the optimal product preparation.”

Alexander Faude, director Process Science, downstream processing,
Rentschler Biopharma concurs that sponsors can benefit from the expertise that a CDMO can bring to the table, as well as the flexibility a partnership can offer. The reasoning being that not only are CDMOs, such as Rentschler Biopharma, experts in high-quality manufacturing, but they also follow holistic approaches to product development, he notes.

“At the same time, [a holistic] approach is tailored to the needs of the client and molecule in question,” Faude continues. “The collaborative exchange between the sponsor and service provider continuously enhances this foundation of knowledge and can be leveraged for project success.”

“The experience and track record of outsourcing providers plays a defining role in contributing towards the success of accelerated formulation strategies,” specifies Marvin Kadisch, director Process Science, upstream processing, Rentschler Biopharma. “[These attributes] ensure the alignment of material supply and quality with formulation development activities that are critical to the success of the strategy. Moreover, expertise, especially with respect to in-silico approaches but also wet-lab activities, is a defining factor.”

Particularly for accelerated formulation strategies, partnering with an outsourcing service provider that has formulation expertise for a great variety of modalities is advantageous because the partner will be agile toward the specific needs of the client’s molecule, adds Pompe. “Accelerated formulation strategies are largely built on cutting-edge technologies like machine learning, which require skillsets (e.g., software development experience) that are not necessarily available on the sponsor’s side,” he notes.

“High-throughput, automated analytics have been critical to enabling strategic formulation development, providing extensive and detailed measurements that rapidly expand understanding of critical material attributes,” emphasizes Kippax. “Combining a highly automated approach with visualization and data analytics that provide high data density can really catalyze the sample-centric workflow. And to ensure your data [are] relevant, precise, repeatable and connected, it’s important to have the right expertise available at the right time, to interpret analytics, support with data interpretation, and oversee the overall picture painted.”

Firstly, Pompe emphasizes that the decision as to whether or not new molecules may even be eligible for accelerated formulation strategies, partially depends on the molecules’ intrinsic liabilities. “At very early project stages, these liabilities can be addressed during developability assessments aiming for the identification of most promising lead molecules. Here and during later development phases, in-silico tools like molecular modeling, biostatistics, or machine learning are increasingly leveraged,” he says. “In combination with predictive time-independent analytics (e.g., biophysical methods), these tools are able to expedite informed decisions on final formulations and allow for a more efficient utilization of lab resources.”

Partnering with a service provider that encompasses the whole bandwidth of aforementioned technologies and is highly experienced in applying them to a broad range of modalities is beneficial, stresses Pompe.

A method that can be employed to accelerate both small and large-molecule formulation development is the integration of clinical trial manufacturing and clinical testing, points out Chris Roe, senior research fellow, Quotient Sciences. “With this approach, a number of formulations can be rapidly manufactured in small batch sizes with limited stability, and assessed in the clinic in quick succession (sequential dosing in a small cohort of subjects) to inform of the best performing formulation to move forward with,” he says.

Furthermore, the use of modeling and simulation software has added another tool to assist in accelerating formulation optimization, continues Roe. “Future innovations from artificial intelligence and machine learning tools, will enable organizations to leverage a prior experience to enhance formulation design and selection, based on input molecule properties and a target pharmacokinetic profile,” he states.

“Outsourcing accelerated formulation strategies in the context of process development and manufacturing is a collaborative process that brings together the right mix of knowledge, expertise, and experience to guarantee project success,” concludes Faude. “Ultimately, acceleration programs for highly coordinated process development and manufacturing followed by sophisticated approval strategies enable shortest clinical and commercial entering.”

Formulation Development Outsourcing Market: Information by Services (Pre Formulation Services [Formulation Discovery, Pre-Clinical Services, Analytical Services], Formulation Optimization [Phase I, Phase II, Phase III, Phase IV]), by Dosage Form (Injectable, Oral, Topical, Inhaled, Others), by Application (Oncology, Genetic Disorders, Neurology, Infectious Disease, Respiratory, Cardiovascular, Others), by End User (Pharmaceutical and Biopharmaceutical, Government and Academic Institutes), and Region (Americas, Europe, Asia-Pacific, and the Middle East & Africa)—Forecast till 2027


Volume 46, Number 5
May 2022
Pages: 46–47

When referring to this article, please cite it as F. Thomas, “Unlocking Formulation Expertise,” 

Partnering with an experienced service provider can help companies unlock the commercial potential of new therapeutic approaches.

Unlocking Formulation Expertise

As the world’s media is focusing on the high-profile, celebrity defamation case currently underway between Johnny Depp and Amber Heard, the pharmaceutical industry is also witnessing some further developments in a long-running criminal case, concerning trade secrets. The case, which has been ongoing for six years, was brought to court by pharma giant, GlaxoSmithKline (GSK), against several people, including employees.

To get to the beginning of this specific trade secrets case, it is necessary to go back to early 2016, when Philadelphia federal prosecutors indicted five people on charges of stealing trade secrets (1). The people accused included two research scientists who had worked at one of the company’s research facilities. Four of the five indicted have already pleaded guilty—some in 2018 and others in 2022—the fifth person is currently a fugitive, residing in China (2–4).

However, another offender in the case was recently convicted in May 2022 (5). The new offender, formerly a Swiss resident, had worked at the Friedrich Miescher Institute for Biomedical Research (FMI), which is affiliated with Novartis.

Confidential and proprietary data were shared between the offenders involved in this case, and two new business entities were set up—one in China and the other in Switzerland—through which, those involved would sell and market the pilfered information. The data that was stolen mainly pertained to anti-cancer drugs that were purported to be extremely valuable (5).

“When a company like GSK spends billions on research and development to bring new drugs to market, the theft of valuable trade secrets poses a significant operational threat,” said Jacqueline Maguire, special agent in Charge of the Federal Bureau of Investigation’s Philadelphia Division—who had investigated the criminal activity—in a press release (5).

1. K. Thomas, “5 Accused of Stealing Drug Secrets from GlaxoSmithKline,” 

, 20 Jan. 2016.
2. The United States Attorney’s Office, Eastern District of Pennsylvania, “

Former GlaxoSmithKline Scientist Pleads Guilty to Stealing Trade Secrets to Benefit Chinese Pharmaceutical Company

, Press Release, 31 Aug. 2018.
3. The United States Attorney’s Office, Eastern District of Pennsylvania, “

Second Former GlaxoSmithKline Scientist Pleads Guilty to Stealing Trade Secrets to Benefit Chinese Pharmaceutical Company

, Press Release, 14 Sept. 2018.
4. The United States Attorney’s Office, Eastern District of Pennsylvania, “

Fourth Defendant Pleads Guilty to Stealing Trade Secrets from GlaxoSmithKline to Benefit Chinese Pharma Company

, Press Release, 3 Jan. 2022.
5. The United States Attorney’s Office, Eastern District of Pennsylvania, “

Swiss Scientist Convicted by Federal Jury of Conspiracy to Steal Trade Secrets Belonging to GlaxoSmithKline

When referring to this article, please cite it as F. Thomas, “Law and Pharma,” 

A long-running criminal case involving the theft of confidential data from a pharma giant is still unravelling, as more convictions are made.