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

Felicity Thomas

In February 2022, Russia commenced its invasion of neighbouring country Ukraine, in the largest military attack on the continent of Europe since World War II. Shortly thereafter, business leaders from the life sciences industry called on their peers to take immediate action by stopping work with any Russian companies and rejecting investments from Russian funds (1). The open letter garnered a monumental response and currently features, at the time of writing, 860 signatories.

Globally, sanctions—considered to be the toughest actions possible before going to war—have been placed on Russia by numerous governments. Although these sanctions, which include the removal of Russian banks from the international financial system and bans on Russian flights, are not applicable to medicine and medical equipment, there are concerns that there will still be significant disruptions to supply (2).

Of course, the bio/pharma industry has a duty of care to ensure medicines and vaccines are delivered to those in need, a point that was emphasized by the European Federation of Pharmaceutical Industries and Associations (EFPIA): “Our first priority is to ensure that medicines reach the patients that need them in Ukraine, in the neighbouring [European Union] EU Member States, in Russia, and in other countries where access to medicines may be negatively impacted. We call on all parties to facilitate the safe passage of medicines and vaccines to those in need,” EFPIA said in a news release (3).

As was demonstrated by the recent COVID-19 pandemic, the bio/pharma industry has the capacity to act quickly in crisis situations, and this recent emergency is proving no different. Many companies have already made donations and committed their support to humanitarian efforts (2). EFPIA explained the reaction of industry well in their release, which stated, “The research-based pharmaceutical industry in Europe stands in solidarity with the people of Ukraine. We condemn the invasion of their country and express our sorrow at the suffering it has caused. As an industry dedicated to saving and improving lives, we stand for peace” (3).

The thoughts of all at Pharmaceutical Technology Europe and MJH Life Sciences are with those affected, and we hope that a peaceful resolution to this situation will be swift.

1. Business Leaders for Ukraine, “Call for Business Leaders to Economically Disengage from Russian Industry,” 

, Open Letter, 27 Feb. 2022.
2. F. Guarascio, M. Erman, and S. Jacobsen, “Drugmakers, Device Companies Say Sanctions May Hinder Medical Supplies to Russia,” 

, News, 3 March 2022.
3. EFPIA, “Pharmaceutical Industry Response to the War in Ukraine,” 

, News Release [last updated on 11 March 2022].

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as F. Thomas, “Standing in Solidarity,” 

Articles

As Russia’s invasion of Ukraine continues, industry leaders speak out in condemnation of the actions taking place and pledge to provide aid to those in need.

Standing in Solidarity

As the world becomes increasingly data-driven and the need for standardization and transparency between the various sectors of the bio/pharma industry heightens, Europe’s implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) continues to progress apace under the European Medicines Agency’s (EMA’s) substance, product, organization, and referential (SPOR) programme (1). To learn more about the ISO IDMP and the way that data and documents will need to be addressed in the future for bio/pharma companies, 

 spoke with James Kelleher, CEO of Generis; and Frits Stulp, managing director, and Remco Munnik, associate director, both of Iperion Life Sciences, a Deloitte company.

 Could you provide some key details about the ISO IDMP standards and how these will impact bio/pharma companies within Europe (as well as those seeking to do business in the region)?

 The ISO IDMP standards were designed to allow structured data exchange on medicinal products. These standards will ensure consistency of data collected, enabling comparisons, traceability, and that updates to constituent parts are harmonized (for example, update on manufacturer or substance information).

As with any such standard, there is effort required by all companies, small and large, in meeting it. EMA has published an EU IDMP Implementation Guide (EU IG) (2), with several updates, to guide along this process, but while it might seem an easy task, and a goal that will provide a considerable benefit to companies, agencies, and, therefore, ultimately to patients, getting ready for IDMP is not straightforward.

 It is expected that IDMP data standards will be implemented as part of the SPOR programme, which will be used directly by the Digital Application Dataset Integration (DADI) project. Existing electronic application forms (eAFs) will be replaced by this project. This will trigger a huge step forward in the submission of structured data within the regulatory processes.

This change requires companies to control their regulatory data in accordance with the ISO IDMP standards and controlled vocabularies.

 What, in your opinion, could be significant bottlenecks for bio/pharma companies in the future in terms of data and documents?

 ISO IDMP requires data from different departments. For this reason, data governance—clear rules on rights and accountabilities for the data—must be considered and provided for. Due to the tie-in of the submission of structured regulatory data and the regulatory process, companies need to have processes and systems in place to access structured data from the get-go. Authors contributing to the supporting documents for product registration will need direct access to the latest and agreed terms to ensure consistent use. Although this may sound challenging, this requirement provides an opportunity to control the regulatory data end-to-end—from development and across the regulatory process and pharmacovigilance—and achieve benefits (e.g., cross-divisional reporting), harnessing that data as the definitive source for authoring.

 Much of the data required is, of course, already present within company databases—but frequently in multiple databases, which have different data owners and stewards, and are not linked or synchronised. Additionally, data [are] quite often in the wrong format—one key example being items such as dosage strength, where some companies might have a dosage strength as a single value (‘10 mg/100 mL’) and others might have four data items (‘10’, ‘milligrams’, ‘100’, ‘millilitres’). These data items might even be free text in some systems internally, leading to a need for a substantial exercise in data cleaning/consolidation.

As companies look to do business in Europe and meet these standards, they will also find two basic types of vendors on the market: those who provide a dedicated IDMP database (yet another database of separate information), meaning users have to enter data that is potentially duplicated in other systems, and potentially in different formats and not linked to the regulatory documents and applications/registrations; and those who provide regulatory systems where the data [are] captured and applied, in the right format, to documents and submissions as part of the regulatory operations processes, and can then be compiled/extracted to provide the required IDMP submissions, without duplication.

 Do you believe there will be an increased demand for digital provisions post-pandemic, and if so, how might this impact the volume of data to be processed by companies?

 The use of digital/virtual solutions will absolutely increase—having been forced to accelerate the implementation of such capabilities during the pandemic, companies are really seeing the benefits in both the speed with which they can perform business processes (and therefore being able to do more in the same time) as well as the consistency of data that it brings, improving compliance, reducing rework and errors.

One emerging trend is the desire to increase automations—having a system that acts as a ‘dump’ of data or documents is no longer sufficient, and companies are looking at systems that have capabilities to automate repetitive processes into a single button click. One great example is around the audits and inspections: previously, setting up an audit, requesting particular documents ahead of time, choosing dates, receiving pre-audit documents, and so on, was all done back and forth by emails. Now, a single audit object can be created which automates the process of notifications, uploads of documents, setting of meetings, and also generating a final audit report.

 Digitalization is the future—to optimize existing processes and data flows. With increased demands as well as expectations around healthcare, the competent authorities will need to be able to do more with the same resources. It’s essential, then, to be able to leverage the potential of digital data/processes. This can only be achieved by adopting standards. The use of standardized and structured data will not only ensure data quality and consistency; it will also help accelerate regulatory processing and assessment by the health authorities. The sky is the limit, and the time is right to shape the future. What’s more, society will expect no less.

 What tools are currently available for companies to deal with this potential increased volume of data?

 Most companies are still struggling with the legacy of data captured and held in documents. For large parts of the portfolio, consistency between the regulatory information and the data stored in documents needs to be checked, extracted, and aligned with ISO IDMP/SPOR data.

Tools exist that can alleviate the burden of the data extraction, and which make use of artificial intelligence (AI). However, experts in the interpretation of the regulatory data have an important role to play too, to assess the data extraction and data transformation requirements.

Biotech companies (with a smaller portfolio) have a potential advantage in being able to leverage processes and systems that work with structured data in a shorter timeframe.

 There is a move towards ‘platforms’ which leverage technology such as Elasticsearch for very rapid searching in massive volumes of data. The concept of data lakes is being married to document/data repositories—for example, our platform can contain all enterprise data, documents, and business processes in a single ‘Information Lake’ to allow the enter-one-and-reuse that ensures data consistency for purposes such as IDMP and digital automations. There are two key aspects to this: to have a platform that does actually consist of a single data source—rather than the older-style platforms that are multiple silos built with the same technology and need connectors and even then, still duplicate data; and to have a platform that doesn’t just act as a data store but provides the place where users can do their entire business process, guided by wizards/automations, and where they have access to all supporting data required, regardless of its provenance or data owners within the company.

 Do you feel industry’s cautious approach to technology advances is changing?

 Interestingly, we have seen a major change in this since the pandemic—the rate at which companies are reaching out for the kinds of automations, AI, single ‘Information Lake’ solutions has really accelerated, and the fear of newer technologies, moving to the cloud, and taking ‘out of the box’ pre-configured solutions has dramatically decreased—companies are looking for ready-made solutions (with pre-packaged validation thrown in) that can set them up for the coming five-year explosion in industry digital requirements and the faster pace of drug development that we have seen start during the pandemic.

 Many bio/pharma companies are looking into ways in which AI might support and increase efficiency internally. Within the regulatory field, the administrative burden has only increased over the last few years, with fewer people having to do more work. We believe that the time is right to do things smarter, quicker… to optimize existing processes via a more data-driven way of working.

1. EMA, “Data on Medicines (ISO IDMP Standards): Overview,” 

 [Accessed 2 Feb. 2022].
2. EMA, “Substance and Product Data Management Services,” 


Vol. 34, No. 2
February 2022
Pages: 31–32

When referring to this article, please cite it as F. Thomas, “The Data Relationship,” 

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

The Data Relationship

Drug pricing has long been a contentious issue within the bio/pharma industry and has, in fact, provided politicians with good fodder for campaigns. Currently, with some countries ahead of the curve in terms of COVID-19 treatment programmes and others lagging way behind, the issue of pricing is once again peaking.

 An evidence report from the Institute for Clinical and Economic Review (ICER) has found that the prices of four COVID-19 treatments for mild-to-moderate disease were ‘reasonably aligned’ with the benefits they offer patients (1). In the ICER report, cost-effectiveness of the COVID-19 treatments was projected by estimating the relative treatment effectiveness from the pivotal trials of each therapy and then applying those estimations to a common ‘usual care’ comparator arm.

None of the four treatments evaluated (sotrovimab [Xevudy, GlaxoSmithKline and Vir Biotechnology], molnupiravir [Lagevrio, Merck & Co.], nirmatrelvir/ritonavir [Paxlovid, Pfizer], and fluvoxamine [Luvox/Fevarin, Upsher-Smith Laboratories]) had base-case results that exceeded US$100,000 (€87,400) per quality-adjusted life year gained and equal-value life year gained (1). Furthermore, the report authors specify that there may be other benefits afforded by the treatments that could not be fully accounted for within the economic model used.

However, the report authors also note that there are disadvantages to each treatment to be considered and that the cost-effectiveness of the treatments would be reduced significantly if used in populations with a lower-risk of infection (1).

 Looking at the other side of the argument, and in light of recent announcements of company profits, there has been patter about the potential of ‘pandemic profiteering’ (2). Pfizer has been singled out most recently by the democratic social justice organization, Global Justice Now, after the release of the company’s annual revenue information, which has been stated as being larger than the gross domestic product value of most countries (2).

In a press release, Global Justice Now revealed that Pfizer’s annual revenue has doubled to US$81 billion (€70.8 billion), which has been largely driven by the sales of the vaccine, Comirnaty (2). “It’s nothing short of pandemic profiteering for Pfizer to make a killing while its vaccines have been withheld from so many,” said Tim Bierley, pharma campaigner at Global Justice Now, in the release (2).

1. K. Yeung, et al., Special Assessment of Outpatient Treatments for COVID‑19, 

, Draft Evidence Report, 3 Feb. 2022.
2. Global Justice Now, “Pfizer Accused of ‘Pandemic Profiteering’ Amid Bumper Revenue,” Press Release, 8 Feb. 2022.

When referring to this article, please cite it as F. Thomas, “The Price Debate,” 

As company revenues are gaining a boost from COVID-19, the issue of pricing is being debated once more.

The Price Debate

Toxicology studies are employed in drug development to evaluate the safety and viability of potential drug candidates, and the data from such studies are used to support regulatory submissions. As it is widely known that toxicity is a contributing factor to drug candidate attrition and with demand for faster and cheaper drug development increasing, researchers are looking at ways to perform toxicology studies as efficiently as possible.

To learn more about toxicology studies, including how accelerated timelines impact these studies, the expectations and requirements of regulatory bodies, issues surrounding animal models, and possible alternative assays, 

 spoke with Steven Bulera, PhD, DABT, corporate vice-president, global head of Toxicology, Charles River Laboratories.

 Could you elaborate on the importance of toxicology studies?

 When developing a new therapeutic, the new therapy must demonstrate two simple criteria. First, the therapy must be efficacious: it must treat the disease or improve the quality of life of the patient. Second, the therapy must be safe and not cause additional and/or unacceptable harm to the patient. Toxicology studies are designed and conducted to identify and characterize any potential adverse events or toxicities prior to the new drug being administered to patients or volunteers participating in clinical trials (1). To accomplish this task, a variety of nonclinical toxicology studies are performed in non-human 

 models. Additionally, these studies are required for regulatory submissions around the world and support ‘first-in-human’ clinical trials and clinical trials needed to bring the drug to the market and to patients in need.

In addition to characterizing potential adverse events, toxicology is important in that the studies conducted help identify and remove potentially ‘bad’ drugs from development, which protects patients from potentially harmful drugs and removes drugs from development before large financial investments are made in drugs that have limited or no potential to be a successful new therapy.

 What type of toxicology studies are performed in drug development?

 The types of studies run include general toxicology (various durations), genetic toxicology, safety pharmacology, reproductive toxicology, and carcinogenicity bioassays. Additionally, other specialty studies may be run to identify abuse/seizure liabilities, musculoskeletal toxicities, neuro-toxicities, ocular toxicities, and/or phototoxicities that could potentially be caused by the new therapeutic. The 

 studies are run in a variety of cell types, and the 

 studies are typically run in two species (a rodent and nonrodent species). In general, regardless of the new drug modality (small molecule, monoclonal antibody, gene therapy, oligonucleotide, protein, etc.), the study designs and endpoints are similar.

Where differences are seen are with the specific biomarkers that are included in the study and are based on the specific type of molecule and the target of the new drug. It is important to mention and acknowledge that while many of the toxicology studies use animals, the studies are designed with the 3Rs (reduce, refine, and replace) in mind and that the animals are treated humanely with the highest standards of animal welfare in mind.

 How might accelerated development timelines impact toxicology studies?

 When there is an unmet medical need, the question that is always on a researcher’s mind, is ‘how fast can we get this drug to the patients that need it?’ A common trend in drug development is ‘how do we go faster?’ To support accelerated programs, toxicology has developed faster ways to generate, analyze, and interpret data, as well as faster ways to create the reports needed for regulatory submission. Additionally, some of the best practices that can be called upon involve strong partnerships between clients and contract research organizations (CROs) so that both parties are working together to remove white space from study initiation and reporting timelines. Milestones can then be reached more rapidly.

Also, companies have developed paradigms that require decisions to be made at risk or in parallel with the reporting process to move to the next steps faster. Often, companies wait for final reports to make decisions. To accelerate the toxicology program, companies are encouraged to make decisions on data, and then start the next study/phase before the previous study report is finalized. This [method] can remove weeks if not months from a toxicology program.

 What are the regulatory expectations and requirements for toxicology studies in drug development, both for a regular timescale and an accelerated one?

 The vast majority, if not all, toxicology studies used for regulatory submissions are run under good laboratory practice (GLP) regulations. These are a series of regulations required by countries that dictate how studies must be conducted to ensure that the studies were conducted with the highest scientific quality. Additionally, these regulations have documentation expectations so that regulatory agencies reviewing the toxicology study package can know how the studies were conducted and that they can accurately recreate the study from what was documented.

Regardless of whether the new drug was conducted under a standard or accelerated timeline, countries have the expectation that the studies were conducted under the auspices of the GLPs. Where there is some potential flexibility for the toxicology program, is what individual studies are needed and the duration of those studies that are required to move the drug to the next development milestone. There are examples for rare and orphan disease therapies, where regulatory agencies have been open to alternative toxicology study designs and customized toxicology packages so that these drugs can get to patients that need them faster.

 Could you run through some of the issues surrounding animal models for toxicology studies and what possible solutions there may be in the pipeline or already being used that could benefit industry for wider adoption?

 Some of the common reasons cited as to why whole animal toxicology models are not appropriate to use in drug development are that animal models do not reliably predict human outcomes, drugs that appear to work well in animal models fail to work when given to humans, and having to use animal models and run animal studies delays the drug development process. Numerous articles exploring the limitations of these models have been published (2–4).

Alternatives to the use of animal models are also continually being discussed and developed. We have seen advances made using 

 models (1D, 2D, 3D cell cultures, tissue slices, organs-on-a chip). As an example, for many years chemical irritancy was tested by administering compounds to the eyes of rabbits (Draize eye irritation assay). However, that assay has been replaced by the 

 Bovine Corneal Opacity and Permeability (BCOP) assay that only uses animal corneas that normally would have been discarded.

Also, researchers continue to look at alternative models for testing the toxicity of compounds. Khabib 

 outline the advantages and disadvantages of using alternative models such as brine shrimp, zebrafish, daphnia, copepods, molluscs, and so on (4). These 

, and alternative animal models are useful for identifying if a compound is toxic, can be used as screens to rank order compounds from more to less toxic, and can be used to determine if a compound impacts a specific cell type or a specific cellular pathway. However, they currently do not capture the complex interactions with organ pathways (i.e., communication pathways between cells and organ systems) that are linked together in a whole animal model.

While the predictiveness of animal toxicology models may not be as predictive of human outcomes as researchers would like, history has shown that the testing performed using these whole animal toxicology models has and continues to protect humans/patients from harmful drugs. In addition, the more that is learned about cellular and biochemical mechanisms, and how organ systems operate and communicate, the predictiveness of our models will also improve. Also, as researchers continue to learn about how to better care for and manage research animals, the reproducibility of results will also improve. Even as the predictability and reproducibility of whole animal models improves, researchers will continue to look for assays/methods to replace animal toxicology models in an effort to reduce animal usage (3Rs), bring drugs to ‘in need’ patients faster, and to appreciate the value that these alternate methods bring to drug development.

 Might the use of computer simulations (or other disruptive technology) become the industry standard for toxicology studies in the near future?

 As new data are obtained about cellular pathways, organ systems, and cellular communication networks, and are combined with information about the new drug (structure data, similarity to previously tested drugs, absorption, distribution, metabolism, and excretion data, 

 data, etc.), it is conceivable to envision a time when it will be possible to employ artificial intelligence and machine learning algorithms to characterize new drugs completely 

. There are numerous examples in the literature, where 

 methods have been used as accepted replacement/substitutes for whole animal models or for examining specific biomarkers. However, as 

 models are developed as replacements/substitutes for whole animal toxicology models, they will need to be thoroughly evaluated before they are accepted and implemented, and the associated whole animal toxicology model discontinued.

One of the main challenges facing the use and implementation of these alternate assays/methods is the validation/predictiveness of these alternate assays/methods. Acceptance of the assays/methods as a substitute by regulatory agencies and by the public will be based on researchers being able to demonstrate that the alternative assays/methods are equivalent or better at predicting human toxicity then the current whole animal toxicity models and that the outcomes of these assays/methods can be used to make drug development decisions that will protect patients and not jeopardize human health and safety.

Additionally, with the concerns about rising drug costs and cost of developing new therapies, researchers will need to be aware of the costs of implementing these alternate assays/methods. Current estimates to develop a drug range from $944 million to as high as $4.54 billion (5). If the cost of these alternative assays/methods substantially increases the cost of a drug’s development, companies will need to acknowledge these costs and still be supportive of these alternative assays/methods.

In the end, the development, implementation, and use of these alternative assays/methods will be a balance of how these assays/methods will decrease drug development timelines, how much faster can needed medicines get to patients, how much better they are at predicting human safety, and the value that these investments/costs bring to the drug development process.

, 31 (1) 19.1.1–19.1.35 (2007).
2. G.A. Van Norman, 

J. Am. Coll. Cardiol. Basic Trans. Science

, 4 (7) 845–854 (2019).
3. G.A. Van Norman, 

, 5 (4) 387–397 (2020).
4. M.N.H. Khabib et al., 

, 465, 153053 (2022).
5. M. Schlander et al., 

Toxicology studies are an important and required aspect of drug development that are performed to ensure that drugs are deemed safe prior to patient administration and use in clinical trials.

Predicting Toxicity in Drug Development

According to market research, the size of the outsourcing sector serving the pharmaceutical and biotechnology industries is expected to expand, reaching $99.4 billion by 2028 (1). Demand for outsourced services is being driven by several factors, such as high demand for biologics and small molecules, a lack of in-house expertise, and rising costs associated with in-house development capabilities.

To find out more about how demands have changed for outsourcing partners providing method development services and the trends affecting this sector, 

 spoke with Jerry “Jr.” Mizell, senior director, Analytical Services, Metrics Contract Services.

 Could you provide a brief overview of how the demands have changed over the years for outsourcing partners in terms of method development services?

 Nowadays, there is an increased demand for sound methods to be developed early in the product life cycle. More customers want rugged and robust methods in place as early in the development process as possible, and they want methods that require minimal changes as their programs advance to commercial phases.

Shifting demands from industry innovators is leading to an increased need for flexible and agile outsourcing partners offering broad and integrated models. In 

, Xiaoyong Fu, PhD, chief technology officer and head of API Business, WuXi STA, discusses how process development demands have changed.

Based on the experience of Metrics Contract Services, customers also want to develop quality control (QC)-friendly methods that help maximize laboratory efficiency in the commercial phase. Across various methods developed in recent years, dissolution, in particular, has been in the spotlight. A comprehensive approach to dissolution should produce a discriminating method that can demonstrate that an adequate drug product has been manufactured. Current customer expectations also demand a detailed dissolution method development report describing how the dissolution procedure was derived. This is especially important for new drug applications (NDAs).

 How has demand of outsourced services for method development been impacted by the COVID‑19 pandemic?

 While we haven’t experienced a direct uptick in development services requested because of the COVID-19 pandemic, we have experienced supply chain challenges as a result of it. The delays and disruptions to key supplies have made it imperative to execute method development in the most effective means possible to align with clinical timelines.

Choosing a method development partner with vast experience and a proven track record becomes invaluable to customers who need to deliver treatments to patients at speed, while also ensuring that key project deliverables are met.

Have there been changes in expectations as to what an outsourcing partner should be able to provide or accomplish with method development services?

 The outsourcing partner, or contract development and manufacturing organization (CDMO), should have a vast array of development experience in solid oral dosage formulations. This experience will allow for expedited development services, especially when challenging formulations are being developed. These challenging formulations may include API loaded on resin or beads and molecules that do not contain chromophores, requiring alternative modes of detections.

CDMOs with experience in charged aerosol detection, evaporative light scattering detection, and refractive index detection for challenging molecules can be the deciding factor in awarding a project. Outsourcing partners with mass spectrometry (MS) capabilities are also at an advantage when impurity issues arise and identification is needed. Cost can be a primary focus for some programs; however, quality assurance and the ability to meet deliverable timelines are also very important qualities, which can often outweigh price differences.

 What other trends have impacted outsourced method development in recent years?

 Over the past few years, there has been an increase in the development of poorly soluble small-molecule drug products, which can be extremely challenging when developing a dissolution method. This type of program is challenging because introducing two APIs into the same formulation and combining products, with significantly differing physical and chemical characteristics, means that method development can take on a new level of difficulty.

From a safety perspective, highly potent APIs (HPAPIs) introduce additional challenges, as developers want user-friendly methodologies in place without jeopardizing laboratory staff safety.

 In your expert opinion, what trends might we expect to see in the future and why? Also, how might outsourcing partners be best prepared for future demands/industry trends?

 There should be more and more Biopharmaceutical Classification System Class II and IV molecules being discovered for evaluation.

Customers should seek outsourcing partners with extensive experience in dissolution development and alternative mode of detection in the event that a molecule does not contain a chromophore. Instrumentation must remain compliant with current industry standards to ensure method expectations are met.

There is also an expectation that future demands will call for methodology development for nitrosamine assessments, and the ability to meet FDA (and other regulatory bodies’) requirements for NDA filings and current commercial products on the market. This methodology requires MS, which if not currently available at a CDMO, may become a worthwhile investment to offer to customers. As with elemental impurities, this requirement will not go away and will only face increased scrutiny as time passes.

Biotechnology and Pharmaceutical Services Outsourcing Market Size, Share, and Trends Analysis Report by Service, by End Use, and Segment Forecasts, 2021–2028


Supplement: Biopharma Outsourcing Innovation 2022
February 2022
Pages: s12–s13

When referring to this article, please cite it as F. Thomas, “Method Development in Demand,” Biopharma Outsourcing Innovation 2022 (February 2022).

Experience is an invaluable asset for outsourcing partners, particularly as more challenging method development services are in demand.

Method Development in Demand

By the year 2026, the global outsourcing market for formulation development is expected to reach a value worth $12.65 billion, growing at a 7.2% compound annual rate (1). Factors driving this market growth include the rising demand for innovation of novel drugs due to the increasing number of patent expirations for major drugs and the fact that many pharmaceutical and biotechnological companies are trending toward outsourced services for formulation development (1).

To learn more about outsourced formulation development services, including various industry trends impacting the sector, challenges for outsourcing partners, and key benefits for outsourcing formulation development, 

 spoke with Lynn Allen, vice-president of Business Development at MedPharm.

 Could you provide insights into industry trends that have affected the formulation development outsourcing market?

 The pharmaceutical industry continues to adapt to new business conditions. Life cycle management continues to drive the need for outsourced formulations, often in developing products for alternate routes of delivery.

Companies that are looking to improve patient compliance or reduce systemic side effects can look at new formulations for local delivery through topical dosing. Based on MedPharm’s experiences, there have been increases in the demand for formulation services of ophthalmic preparations and respiratory delivery, primarily intranasally. An increase in the number of biologics with targeted topical delivery routes has also been a trend. As a contract development and manufacturing organization (CDMO) that specializes in dermatological, nail, eye, airway, mucosal membrane, and otic product development, MedPharm continues to support topical formulation development services for local delivery market needs.

Additionally, proprietary nonclinical models that test formulations for effectiveness at early stages continue to be an asset to the company’s client base. For example, MedPharm’s reconstructed human nasal epithelia model is a living representation of the nasal membrane, and allows formulations that are targeted for the different regions of the nose (local, systemic, or brain) be tested to evaluate formulation parameters such as delivery, irritancy, mucoadhesion, and effectiveness.

 What type of formulation work is more commonly outsourced currently?

 There is continued growth in product development by specialty and virtual pharmaceutical companies. As large pharma looks for investments in late-stage assets, start-up companies that effectively deliver well-developed products with effective clinical data are highly sought out for licensing and acquisition deals.

Consequently, start-up companies require formulation expertise at the earliest stages of development and often do not have extensive research labs to perform critical assessments such as screening multiple APIs. Outsourcing of these early research activities continues to grow, and MedPharm continues to invest in these services to support both early start-up and specialty pharma companies.

 What are the biggest challenges for outsourcing partners when working on a formulation project?

 In the fast-paced environment of drug development, it can be challenging to ensure that all stakeholder needs are being articulated at the start of formulation activities and continue through the development process. When sponsors have not conveyed all needs or if they are not prepared to make decisions on formulation priorities when challenges arise during development, it can often mean repeating activities or delaying timelines.

 How do outsourcing partners overcome these challenges?

 One key aspect that must be stressed at the start of any program is the necessity of a well-defined target product profile. The key attributes of what the formulation should achieve and, particularly in the topical space, how it should feel when applied or how it should be packaged and used by the patient are critical considerations of development. Internal expertise is also critical which includes program management, development, or regulatory resources.

 What are the key benefits of outsourcing formulation development?

 When formulation development is not an internal strength or if the delivery route is outside of in-house formulation expertise, the broad experience of a service provider dedicated to these services can save time, money, and avoid the pitfalls of an ineffective, poorly developed formulation. CROs [contract research organizations] and contract development and manufacturing organizations, particularly those focused on niche markets like MedPharm, have broad experience and can pull from decades of experience and current real-time learnings to guide development activities in the constantly changing regulatory environment. Service providers can also offer more dedicated resources when companies need to prioritize critical programs.

Formulation Development Outsourcing Market—Growth, Trends, COVID-19 Impact, and Forecasts (2021–2026)


Supplement: Biopharma Outsourcing Innovation 2022
February 2022
Pages: s14–s15

When referring to this article, please cite it as F. Thomas, “Gaining Formulation Expertise through Partnerships,” Biopharma Outsourcing Innovation 2022 (February 2022).

A key benefit for companies when outsourcing formulation development is the broad experience they can gain from a dedicated service provider, particularly for niche markets.