Category: Preclinical Research (CRO)

This is an unprecedented time for innovation in life sciences — from advancements in precision medicine to artificial intelligence to advanced diagnostics, and so much more. In order to keep up with the quick pace of this evolution, WuXi AppTec’s Laboratory Testing Division (LTD) has expanded its footprint to create even more opportunities for its global partners to address unmet medical needs through the development of novel medicines.

LTD recently doubled the size of its US facility in Cranbury, New Jersey to over 115,000 square feet, expanding its open-access technology platform and integrated services and positioning the company to collaborate and innovate with partners to create disruptive technologies. Combined, LTD’s Plainsboro and new Cranbury operations will represent one of the largest laboratories in the US for preclinical and clinical drug development testing. The expansion of the capabilities in New Jersey is the latest example of LTD’s commitment to accelerate drug development around the world, and will allow its team to deliver high quality service with faster turnaround times, better leverage the resources and expertise of the local pharmaceutical and biotechnology community, and develop a stronger connection with customers.

“WIND” The WuXi IND

In combination with this comprehensive strategy, WuXi’s Laboratory Testing Division provides end-to-end customer support for regulatory filings. Many startups, midsize companies, and even large pharma firms are not fully equipped to handle the entire filing process. To help address this gap, LTD, in 2016, created the WIND (WuXi Investigational New Drug) program — to support clients in the preparation of investigational new drug applications.

What’s unique about WuXi’s preclinical testing platform is that it combines world-class CRO services with cross-functional program management and global regulatory expertise to support Investigational New Drug (IND) applications. With capabilities in toxicology, DMPK, pharmacology, CMC and analytical services all under one roof, the Laboratory Testing Division can support the full scope of its partners’ drug development programs, from IND-enabling studies to document preparation and submission. While LTD works with both large and smaller companies, the WIND program is ideal for smaller biotechs who want a one-stop shop with an experienced CRO. After all, small biotechs have become the growth engine for the pharmaceutical industry, supplying the majority of the drug candidates to the big pharma companies.

Through the WIND program, LTD is also striving to help bridge the Pacific gap to accelerate preclinical drug development.  For example, in the last few years, China has seen a major boom in innovative drug development, while the pharmaceutical industry in China has been rapidly transitioning from a generic drug-focused industry to an innovative drug development industry. The new policies of the CFDA have made global pharmaceutical companies more welcome in China, both for market access and patient access. Now global companies can bring their ex-China trial data to regulatory filing with CFDA, saving years of time for marketing approval in China.

While the industry and regulatory agencies work to bridge the Pacific gap to accelerate preclinical drug development, LTD continues to foster growth across its entire platform, enabling its scientists to transform ideas into the best healthcare products, and ultimately improve human life. The WIND program is a good example of how the Laboratory Testing Division continually innovates even within its existing portfolio to provide ongoing service enhancements for clients.

Overall, WuXi works with more than 3,000 leading pharmaceutical, biotech and medical device companies worldwide, with many big pharmaceutical clients in New Jersey.

Accelerating Development through Integration

In the last four-and-a-half years, the Laboratory Testing Division has evolved into a fully integrated testing platform supporting customers across the full scope of drug discovery and development and reflecting the company’s “Platform to Patient” philosophy.

LTD provides testing services that cover the clinical testing continuum – drug development, medical devices and clinical diagnostics. The most recent addition to the continuum, clinical diagnostics, is part of a recent joint venture with the renowned Mayo Clinic. The purpose of the partnership is to accelerate development of novel esoteric tests that will be offered in both company’s respective markets, benefiting patients in China and around the world. Together, the three service sectors create a platform that enables WuXi’s partners and clients to achieve more rapid and targeted innovation.

As a global open access technology platform, LTD strives to change how new drugs are developed and manufactured and to facilitate the creation of innovative medical device technologies with the ultimate goal of benefiting patients worldwide. The company is infusing its business with technology to identify innovative new approaches to drug development and to meet the vision of WuXi founder Dr. Ge Li that “Every drug can be made and every disease can be treated.”

Propelling Forward

The pharmaceutical industry is experiencing promising and accelerated growth that is being driven by a number of factors. The global economy is expanding at a healthy rate and the world population is increasing rapidly. At the same time, the global population is aging, leading to greater demand for medications to treat chronic diseases. As emerging economies mature, and the middle-class expands, more people can afford, and expect, access to advanced therapies. In addition, the blurring of the lines between technology and healthcare, including advances in science and the emergence of artificial intelligence, big data, and blockchain, are facilitating the discovery and development of next-generation treatments.

The effort it takes to develop new drugs is increasing – in part because the obvious targets have already been addressed. New drugs under development today are themselves more complex. As a result, more innovation is required. At the same time, overall acceleration of the business lifecycle is creating both pressure and its own form of disruption.¹

NJ Site

Expansion Ceremony, Ribbon cutting

To achieve success today, WuXI’s pharmaceutical clients must do things faster, cheaper and better. WuXi’s Laboratory Testing Division must provide customers with better service, better quality and better customer experiences. The path forward involves innovative, complex, technical, collaborative and transparent partnerships; collaboration and the global enterprise are key to innovation.

Given this combination of growth drivers and challenges, it is no surprise that WuXi is experiencing continually increasing demand for integrated services from across the global pharmaceutical industry. WuXi’s global partnerships are driven by the need to innovate and identify more efficient and effective ways of working.

While WuXi’s headquarters are in Shanghai, the company has 28 operations around the world and a relentless commitment to further focus on its mission to accelerate growth of its enabling platform. In 2017, 36 of the 46 drugs approved by FDA came from the WuXi customers.

As WuXi continues to help push transformative solutions to humankind, the company will strive to refine its world- class, open access platform to enable the continued success of its customers and to accelerate the creation of better treatments for patients.

References

1. “Insights & Implications from the J.P. Morgan Healthcare Conference.” J.P. Morgan. 2018. Web.

Originally published on PharmasAlmanac.com on May 25, 2018.

The pharma landscape is constantly changing, especially as many players in the industry move toward slimmed-down in-house R&D. This includes embracing the “growth pharma” model in which drug discovery programs are obtained via acquisitions. Many big pharma executives have left their posts to spearhead lean, high-risk, high-reward biotech firms, start-ups and virtual companies, which lack wet labs and other means of obtaining experimental results.

A Changing Industry

Recent examples of plunging stock prices at several big firms portray an industry too reliant on blockbuster drugs to sustain growth. But clinical failures are only part of the story. Branded drugs have faced pricing pushbacks from consumers, and in several key areas are confronted with competition from generics and biosimilars.¹ On November 23 of this past year, the NYSE Arca Pharmaceutical Index was down 13% and the Nasdaq Bio- technology Index was 17% lower, all while broader market indexes remained up.² What this tells us about the industry as a whole is that investors are anticipating a tide change. Perhaps the best indicator of this is the numerous stories of big pharma executives changing careers and joining smaller biotech startups.³

But one can argue that the recent upsurge in smaller biotech firms came before the industry was adequately equipped to handle the substantial outsourcing these firms rely on.

These lean companies often lack rudimentary wet labs or any internal facilities capable of producing novel experimental results, and therefore face logistical challenges in which services of one drug discovery program are splintered into multiple organizations. To add to this, finding the best CRO can lead the search into different time zones, geographies and company cultures.⁴

To cope with difficulties these small firms face in terms of integrating different aspects of a drug screening program, other biotech startups have arisen to allow experiments to be designed in-house and carried out in robotic facilities elsewhere. Although these ‘cloud laboratories’ will certainly find a demand within an increasingly fractured industry, for companies looking for guidance alongside experimental results, they offer little.⁵

The Rise of Growth Pharma

The shift in the industry was made clear when then-Actavis — now Allergan — CEO Brent Saunders coined the term ‘growth pharma’ as a differentiator to separate Actavis from a big pharma industry that was, and still is, having difficulties meeting investors’ expectations. The growth pharma paradigm differs from the aging big pharma business model that does not rely on internal R&D but fosters innovations through acquisitions. Ultimately this has been a successful model, at least for Allergan, which saw a 4.5% revenue increase in the third quarter of 2016 when compared to the same quarter in 2015.⁶

What came of this was that 2015 saw a 20-year high in venture capitalist investment in biotech firms.³ A market filled with high-risk, high-reward companies allows for an agile industry that quickly pivots to shirk selloffs that happen when potential blockbuster drugs fail in the clinical setting. To be sure, 2016 in particular saw a flurry of acquisitions, and the nix of the merger between Pfizer and Allergan has again solidified the growth pharma paradigm philosophically as well as economically (both Pfizer and Allergan have committed to more than $20b in acquisition since they went their separate ways).⁷

Icagen has been anticipating the industry’s arrival of growth pharma over the aged big pharma model, and has uniquely positioned itself to be the industry’s incubator: a one-stop shop with a completely integrated drug discovery program, one that moves beyond the fractured outsourced model of specialized CROs and into a true partnership for biotech firms looking to innovate and grow within the pharmaceutical industry.

A Truly Integrated Drug Discovery Program

Icagen’s acquisition of Sanofi’s Tucson facility in mid-2016 changed the face of the company. This move transformed Icagen from a highly specialized CRO into North America’s first truly integrated drug discovery contract research organization. This was achieved by introducing the broad scope of the Tucson facility’s drug discovery program to the rigor of a highly specialized North Carolina site that has spent nearly a quarter of a century, with essentially the same core team, trying to unravel one of the more difficult drug discovery targets: ion channels and transporters.

The acquisition of the Tucson facility added chemistry, structural biology and in silico approaches for early drug discovery to the North Carolina site’s top-of-the-industry biology. Adding Icagen’s meticulous knowledge of ion channels and transporters to the Tucson facility’s integrated approaches is already starting to transform the way the company pursues a wide range of targets. For example, Icagen’s deep knowledge in ion channel biology is now married to an expertise in Tucson for patient-stem-cell–derived skeletal and cardiac muscle models.

The Advantages of Real-Time Research Optimization

In the current fractured model of outsourcing, a company must rely on different CROs to put together a drug discovery program. For example, a pharma company may contract one organization for early drug discovery via in silico approaches, and several others for medicinal chemistry and biology wet labs. At Icagen, all of these services are provided in a fully integrated drug discovery program that is capable of adaptive learning, as Icagen’s lattice of biology, chemistry, structural biology and in silico modeling interface with each other continuously throughout the program.

Real-time research optimization not only increases efficiency, ultimately it enables Icagen to be a better partner — especially because of the crosstalk that happens between the sciences. Biologists thinking about chemistry, and chemists thinking about the implications for biology, create a unique form of translational science that cultivates novel approaches to drug discovery, one where in silico simulations turn into promising compounds. At Icagen, a partner will find everything they need under one roof, in addition to a different kind of scientist. Scientists at Icagen not only have strong expertise in their field but offer a unique translational knowledge of all fields, demonstrating that true integration leads to the discovery of strong drug candidates. In the fractured model, a company must wait on results from one CRO before moving to the next — at best creating ‘white space’ in programs, at worst missing key insights between disciplines. At Icagen, drug discovery occurs in a web of biology, chemistry, structural biology and in silico modeling, in which reevaluations and readjustments happen seamlessly and in real time.

Biotech’s New Incubator

In a changing industry model that increasingly embraces ‘growth pharma,’ guidance and expertise are needed more than ever. In many ways, Icagen sees itself as this new industry’s incubator. Not only is Icagen a fully integrated drug discovery CRO, Icagen is a think tank that houses industry leaders in every realm of drug discovery. This means better results in less time, especially when the real-time research optimization of the integrated drug discovery program at Icagen is compared to linear and other fractured models of CRO outsourcing. Furthermore, Icagen’s two facilities — in Tucson and North Carolina — mean that it is not necessary for potential partners to maneuver time zones, language barriers and corporate cultures that can create costly disruptions in getting drug candidates to IND.   

References

1. Grant, “The Problem With Lilly Is the Problem With Pharma.” The Wall Street Journal. Dow Jones & Company, 23 Nov. 2016. Web.
2. Loftus, “Eli Lilly Alzheimer’s Drug Fails Trial.” The Wall Street Journal. Dow Jones & Company, 23 Nov. 2016. Web.
3. Alsever, Jennifer. “Big Pharma Innovation in Small ” Fortune, 12 May 2016. Web.
4. Whalen, Jeanne. “Virtual Biotechs: No Lab Space, Few ” The Wall Street Journal. Dow Jones & Company, 04 June 2014. Web.
5. Hayden, Erika “The Automated Lab.” Nature. 516 (2014): 131-132. Web.
6. Herper, Matthew. “This Giant Drug Firm Won’t Invent Investors Are Cheering.” Forbes Magazine, 9 Feb. 2015. Web.
7. Grant, “Big Pharma’s Big Checkbooks Drive Biotech Resurgence.” The Wall Street Journal. Dow Jones & Company, 21 Sep. 2016. Web.

Originally published on PharmasAlmanac.com on March 8, 2017.

Taking a drug from compound to candidate is the most crucial test of any discovery contract research organization. At IRBM, we have a proven track record advancing our partners’ programs from target ID to clinical candidate, having made pivotal contributions to the discovery of four approved drugs.

From Compound to Candidate and Into the Clinic

IRBM was founded in 1990 as a joint venture between Sigma Tau and Merck. In 2000, Merck obtained sole ownership of the site. During this time, researchers at IRBM invented and identified three drugs that were then further developed by Merck and other partners and ultimately brought to market (Isentress^®, Zepatier^® and Zejula^®) and collaborated on the discovery of Zolinza^®. Merck divested the facility in 2009, and IRBM was reopened in 2010 as the current facility.

IRBM has grown extensively over the last nine years and achieved a number of milestones: bringing the first non-proprietary small molecule into the clinic in 2014 and our first non-proprietary peptide to the clinic in 2019. This rapid progress has been facilitated by our impressive in-house capacity. All programs are carried out under one roof, allowing for rapid cycle times and swift decision making.

As a fully integrated discovery organization with highly experienced and tenured medicinal chemists, IRBM has more than 25 candidates in preclinical or clinical trials, with more than 800 publications and over 100 patents attributed to our staff. Our scientific team averages two decades of drug discovery experience, and over three-quarters of our staff possess M.Sc. or Ph.D. degrees. All customers that partner with IRBM are given access to a dedicated team that works specifically on their project with a large pharma approach to ensure the highest quality from beginning to end.

The IRBM Difference

Taking drugs to market not only requires a high level of experience, knowledge and drive, but it also demands acutely developed capabilities. The advanced range of services IRBM offers represents the IRBM difference: HTS, biomarker assay development, translational biology, phage display technology and peptide therapeutics. All phases of the discovery pathway are covered, including target ID and validation, hit ID, lead optimization, and candidate nomination. Exceptionally strong medicinal chemistry expertise underpins all integrated programs, and the chemistry team is led by two ACS Heroes of Chemistry. We also work across all modalities — small molecules, peptides and biologics — particularly in in vivo and in vitro studies and DMPK profiling.

IRBM has over 320,000 compounds available for HTS, and our library is more than 98% free of PAINS or undesirable compounds. We also offer fully automated, acoustic compound transfer and assay miniaturization. Our biomarker assays include ultrasensitive neurofilament (NFL) detection in plasma, a neurodegenerative biomarker for clinical trials and bioanalytical validation in human plasma. Our proprietary M13 phage display libraries for biologics programs feature linear dodecamers, loop-constrained dodecamers and CDR3-based dodecamers. In addition, we offer antibody, abdurin, and custom-built phage display libraries.

We are continuously looking to expand our drug discovery toolkit. A recent innovation at IRBM is the use of human stem cells to generate a blood–brain barrier (BBB) assay.

We are partnered with several of the top ten global big pharma companies to develop drugs to address a comprehensive range of therapeutic areas, including oncology, obesity, rare diseases, metabolism, neurodegeneration, antivirals, malaria, and tropical and cardiovascular diseases.

The advanced range of services IRBM offers represents the IRBM difference: HTS, biomarker assay development, translational biology, phage display technology and peptide therapeutics.

The IRBM Network

Our collaborative approach to drug discovery has helped us establish partnerships with pharmaceutical, governmental and academic institutions. We leverage a larger network that includes both public and private organizations and have ongoing collaborations with some of the top universities in Italy. Through our sister company Advent, IRBM can offer a cGMP CMO facility that produces adenoviral vectors for investigational vaccines, including the Chad–Zaire3 Ebola vaccine. Additionally, we have partnered with the largest research hospital in Italy— the San Raffeale in Milan —which gives us access to clinical opinion leaders, researchers and clinical samples.

IRBM is pledged to continued innovation in discovery chemistry and biology. Our expansive internal network reinforces our position as a leading contract research organization positioned to take on and successfully advance any project, from anywhere in the world.

Gene therapy developers face numerous analytical challenges, from discerning what product qualities are critical attributes to the need for fit-for-purpose analytical methods for viral vectors that offer a combination of speed, sensitivity, and resolution. Leveraging a contract research organization (CRO) partner with specialized expertise and awareness of evolving technological and regulatory development that functions as part of their customers’ internal analytical teams can lead to accelerated timelines and a higher probability of program success.

Short List of High-Level Challenges for Viral Vector–Based Therapies

Gene therapy based on viral vector delivery is still in its infancy, and like all other emerging technologies faces several high-level analytical challenges. One of the biggest is gaining the necessary depth of understanding of these novel materials. What is the best approach for analytically identifying viral vectors, and how does that approach scale so that it continues to provide valuable information? Making the right choices is central to the development of these products.

The in vivo outcomes of gene therapy drug products are becoming increasingly important in establishing the longevity and persistence of these treatments from the payer perspective. Gaining a platform understanding through detailed molecular characterization and interfacing that knowledge with clinical outcomes (safety and efficacy) is, therefore, essential, but can be difficult to achieve.

More specifically, what features of the molecules dictate both positive and negative aspects of the infectivity, productive transcription, and persistence of the therapeutic product in the body must be understood. Liquid chromatography (LC) and mass spectrometry (MS) are increasingly important because applying different methods to establish in vivo outcomes is critical.

Particular to viral vectors is the issue of full versus partial versus empty capsids. Production platforms that maximize full at the expense of partial and empty capsids are needed, as are methods for efficiently and effectively separating the desired full capsids from the undesirables.

Fortunately, because the application of analytics is really dictated by the product itself, there is a great deal of flexibility from a regulatory perspective. The key is to go back to the fundamentals of controlling quality for the purpose of known safety and efficacy, and safety is, ultimately, the priority for these products.

Analytics of Process Changes

Analytics are essential for understanding the impact of process changes on product quality attributes and safety and efficacy. Analytical tools (notably including potency assays) selected at the front end are important to enable full understanding of process changes and to correlate them with the outcomes of those assays for a limited number of batches.

With the necessity of making decisions on the basis of analysis of only a handful of samples, it is necessary to gather as much detail and establish as many correlations as possible to better control the process and outcomes. Platform methods are ideal because they enable the amalgamation of data from different batches and apply that amassed understanding in addition to the data from the actual runs under evaluation. 

Evolution of Understanding

Gene therapy is not only an emerging field, but a rapidly evolving one, including from the point of view of analytics. There are some standard methods, but many methods are still evolving, and some are just being developed. In some cases, the current gold standard is not practical or appropriate, so alternatives are highly sought after, but analytical method development typically requires large sample sizes and is both time-consuming and costly. With viral vectors based on adeno-associated virus (AAV), for which more than a dozen serotypes are currently being leveraged in developmental programs, there is also the need to address serotype-specific issues.

The goal is to identify faster platform methods with sufficient resolution and sensitivity. LC- and capillary electrophoresis (CE)-based MS methods are emerging that require much smaller sample quantities and that offer much higher throughput. Work has also been conducted using ion exchange (IEX) chromatography for these purposes.

Improvements in capsid separation using these new techniques, however, are creating new questions that must be answered. Both IEX and CE-based methods reveal multiple peaks believed to represent partial capsids that have not previously been resolved. These results reflect the evolution of what is possible to monitor and what will become expected over time as understanding increases.

Wide Range of Expertise Required

While much of the initial analytical work on gene therapies was developed from a biology-focused perspective, analytical and protein chemists now have significant influence on current development and clinical thinking. In fact, the interface between this broad array of experts is critical, given the complexity of gene therapies and our current limited understanding.

For instance, while fluorescence and antibody detection are common tools for biologists, there are inherent biases in those methods for quantitation and consistency, because the xenogeneic reagent must be remade periodically. In contrast, with a chemical approach, such as MS, the right controls and approaches remain consistent for the lifetime of the product. Researchers are beginning to appreciate the advantages and disadvantages of these different approaches and how they can be used together to establish the optimum analytical package and understanding to drive gene therapy candidates forward. 

As importantly, gains on the research side are translated into clinical understanding that then feeds back into the research end, enabling the design of more efficacious and practical platform solutions. Indeed, given the complexity of these products and the need to understand clinical parameters, it is essential to have more people at the table that can contribute different perspectives to the development of effective analytical solutions and strategies.

Material Limitations and Orthogonal Analyses

Adapting techniques used for monoclonal antibodies (mAbs) poses challenges for viral vectors, because access to large sample volumes is not an issue with most mAbs. With viral vectors, there is limited material available, which limits the ability to conduct orthogonal analyses for every characteristic or molecular feature.

The right approach for a given viral vector is often determined by the product yield. Analytical ultracentrifugation (AUC) could be appropriate for a high-yield vector, but not for a vector with a poor yield that is early in the development process. The key is to consider the current point in the project and what will be needed in the future to select the most appropriate method(s) at any given development stage. 

In general, there is some consensus forming around the numbers of samples and key assay types that go with them. A full/empty analysis must be included, and one that is based on AUC and orthogonal LC methods will be highly advantageous. Where AUC is not possible, size-exclusion chromatography (SEC)–multiple-angle light scatterings (MALS) is often applied. Aggregation is often evaluated today using differential scanning fluorimetry, due to its high throughout and sensitivity.

On the molecular characterization side, peptide maps generated using MS have become typical for viral vector identification. For AAV vectors, there are three viral proteins, and there may also be variants of each (e.g., sliced, truncated) that must be identified, and MS is the preferred method. If product-related variants are present, they can initially be detected using a simple SDS-PAGE gel electrophoresis analysis and quantified using reverse-phase chromatography. Subsequently, intact MS is leveraged to orthogonally confirm those results.

Moving Regulatory Expectations

While regulatory requirements for viral vectors are probably less rigorous than those for mAbs, the level of rigor is increasing rapidly. Regulators’ expectations are moving as analytical capabilities improve and as they better understand the need for more effective analytical monitoring and characterization to ensure product consistency.

For instance, analysis of posttranslational modifications (PTMs) on viral proteins was not required even a few years ago, but regulatory agencies require this information in later application packages and are increasingly expecting it in the initial data package. They do not occur as frequently as for mAbs, but end-terminal modifications (e.g., phosphorylation, oxidation, deamidation, glycosylation) and their quantification are important.

In addition, there is an evolution away from a biology-centric mentality about gene therapy development to one with an emphasis on clinical outcomes, which requires much greater detail with respect to product characterization. Regulators want to understand what clinical outcomes are being driven by different aspects of the manufacturing process and are consequently steadily raising expectations. They continue to be driven by the goal of ensuring product quality and safety by mandating manufacturing consistency.

Rapid Evolution of Gene Editing

Viral vectors are not the only vehicles for delivering gene therapies. Much work is being done to develop non-viral approaches, including gene editing using CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and CRISPR-associated (Cas) proteins.

As with viral vector solutions, there has been significant evolution in CRISPR-Cas approaches and the associated analytics. Protein-based work has led to the development of many different proprietary Cas enzymes, and, similar to AAV, the proprietary nature of Cas is a dependency for most companies. Differences in the Cas protein at the molecular level influence product safety and efficacy and thus must be thoroughly characterized. Critical material and product analyses must be performed and correlated to outcomes for both ex vivo and in vivo product application.

Mass spectrometry is once again becoming a critical analytical tool. In some cases, a single base change could lead to a single amino acid change indicating a successful gene edit. MS has the sensitivity and resolution needed to analyze that level of change.

Meaningful Tech Advances

With the high level of complexity associated with gene therapy, the ability to integrate disparate pieces of information and understand the many aspects involved is crucial. Even seemingly small advances, such as an LC separation method that provides desired information on full versus empty capsids while also affording insights into the presence of other product-related impurities can be really powerful for understanding the potential clinical impact. Being able to apply these newer analytics on the clinical front to identify these correlations will drive the field forward.

In addition, these small advances and the growing diversity of analytical tools are making it possible to generate the volume of data really needed to help the field of gene therapy evolve and advance to the next stage. The bioinformatics approach will allow us to be much more systematic and predictive, as has occurred with mAbs. The sector is just at the beginning, but it is on a similar trajectory.

Support from an External Internal Analytical Development Group

Many of the companies advancing novel gene therapies are small companies operating with little information, internal infrastructure, or resources. They often have experts in biology, generally with mAb experience, but lack analytical knowledge and capacity specific to viral vectors. They consequently turn to external service providers for assistance.

Because AAV and other viral vector–based gene therapies are not standardized products, the typical CRO model isn’t sufficient; a different level of effort is required. Established polymerase chain reaction (PCR) analyses aren’t sufficient. Small biotechs need a trusted partner that can work closely with their internal teams to rapidly solve problems and accelerate product development.  

BioAnalytix (now ProtaGene) takes a thoughtful, interactive, and iterative approach and acts as an internal analytical development group. We interact with our customers as if we were part of their team and treat each project as a collaborative exercise. We begin with a philosophical discussion, spending significant time upfront building trust in our capabilities before customers ever commit to a project. We then provide more specifics, homing in on what analytics are needed.

It is a methodic and precise practice followed by implementation. These interactions with the whole customer team continue as the gene therapy candidate progresses through development and include not only analytics issues, such as method development, but additional advice on the full scope of work and information needed to keep the project moving forward.

For many customers, their first project is confirmation that the trust we build is indeed deserved, which then leads to more projects. In fact, every client that BioAnalytix has ever worked with has continued to work with us, including individuals that move from one company to another, because that type of trust and effective, collaborative relationships are so important in this field.

The strategy at BioAnalytix is to offer an integrated protein and gene therapy collaborative testing service. With the recent merger of Protagen Protein Services with GeneWerk, we now offer the most advanced integrated set of analytical services capabilities in biologic development, especially in gene and cell therapy–related testing, from early development through drug approval and onto commercialization. 

Integrating the analytic platforms and expertise of BioAnalytix, Protagen Protein Services, and GeneWerk makes it possible to design, generate, and deliver integrated, best-in-class analytical data packages and provide strategic support along the full development spectrum from developability, lead optimization, clone selection, and process development to vector safety, gene editing targets, sequence analysis, and gene expression.

Plans are also underway to significantly expand BioAnalytix’s laboratory capabilities to include GeneWerk’s technology platforms and analytical solutions, including the determination of fusion sequences adjacent to known DNA or RNA fragments in minimal tissue samples down to the single-cell level.

Originally published on PharmasAlmanac.com on March 20, 2022.

To be competitive today, drug companies must get their novel medicines to market as quickly and cost-effectively as possible. Since its founding, Celerion has been focused on leveraging innovative technologies to help small and virtual biopharma companies accelerate the transition from discovery to early-phase clinical trials.

Speed, Efficiency, and Personalization

Today, there is a tremendous need to condense speed to the clinic and market, increase efficiency, and reduce overall costs. Beyond these fundamental challenges, the transitions from blockbuster drugs to personalized medicines and from centralized clinical trials to virtual/dispersed studies is driving a departure from traditional development approaches and creating greater need for innovative technologies.

Celerion (from the Latin celeritas, meaning swiftness and speed) was founded in 2010 as a full-service, early clinical CRO to address the need for faster drug development, and today is the leader in accelerating development for phase I–IIb. Our strategy is to be an early adopter of technologies that provide agility to respond to our clients’ needs. For example, our bioanalytical labs employ automated, high-throughput laboratory solutions and electronic data collection systems, which align with our expertise in evaluating biomarkers that enable deeper, earlier insight into drug effects during clinical drug development.

Avoiding Delays

Leveraging smarter strategies that pre-identify potential issues, Celerion significantly reduces development timelines by avoiding delays. Celerion helps clients define what a successful clinical proof-of-concept study should entail and strategizes with the endpoint in mind to determine which phase I/II study design will provide appropriate assessment of safety and pharmacokinetics, which in turn will impact how and what toxicity studies should be conducted.

Thus, the keys to our approach include prospective thinking, a decision-gate structure, interactive communication with regulatory authorities, and operational input from investors and study managers during trial design. This is rational drug development, not reactive drug development.

The COVID-19 pandemic is contributing to the accelerated adoption of some new technologies by everyone in the pharmaceutical industry.

Accelerating the Translation of Science to Medicine

Everything we do at Celerion is focused on accelerating the translation of scientific ideas into potential medicines. We provide full study services designed to optimize outcomes, reduce risks, and optimize development timelines, even for the most complex phase I trials. With facilities across North America, Europe, and Asia, in 30 countries worldwide, we conduct trials with the right patients, in the right places, to get the data each client needs.

Our unique combination of medical expertise, clinical operations experience, and scientific excellence enables clients to make timely decisions with expert advice and high-quality data. Our ongoing investment in new technologies enables us to continuously enrich data collection and analysis and expedite data delivery. From data acquisition strategies to advanced facilities, we are leaders in leveraging new technology to provide faster, more accurate data, at less cost. In addition, by applying Celerion’s experience managing more than 6,000 clinical research studies, we offer valuable insights from protocol development through study conduct and analysis.

Our areas of specialized expertise include respiratory and inhaled drug products; metabolic disease testing methods and hands-on operational experience that support early proof of concept in the development of diabetes, obesity, NAFLD/NASH, and cardio-metabolic interventions; clinical trials with certain drugs used in oncology settings, including pharmacokinetic and safety studies in healthy subjects when scientifically and medically justified; biomarker assays to assess effects on tumors, inflammation, and immune response; traditional clinical project management and clinical monitoring; vaccines; and biologics/biosimilars.

Achieving clinical proof of concept is a critical milestone for drug candidates. When a sponsor demonstrates that a drug works in humans in the manner that preclinical study results suggested, that drug for the first time acquires real value. Good results often attract investors and create a range of business opportunities. Celerion has therefore established a global clinical group dedicated to accelerating project movement from first-in-human to early patient studies that provide early patient readout data.

Relationship-Based Service

One consequence of the shift to targeted therapies and personalized medicine has been the emergence of small biopharma companies as the engine of innovation in the pharma industry. Celerion has enjoyed success in supporting these small and virtual new product generators by providing highly personalized attention and establishing long-term relationships. We work with more than 10 companies in a closer, preferred-provider or partnering model where Celerion is much more engaged in program development and planning. This approach provides significant benefits for all parties, including operational efficiencies, the more effective use of collective knowledge, increased mutual respect and trust, and ultimately the shared satisfaction of contributing to new medicines that impact people’s lives.

Our technology platform enables these partners to review data in real time and adjust studies on the fly in response to emerging results — flexibility that is highly valued during early clinical research, when the fate of new drug candidates is being judged on information built from data gathered from the first people to receive the drug.

We also have the capability to compound drugs in the research setting within our qualified pharmacies. In 2019, Celerion’s pharmacies were updated to meet new USP requirements for the compounding of unapproved drugs, which are now considered to be hazardous. This differentiates us among phase I CROs.

Early Adopter of Innovative Technologies

Indeed, Celerion is constantly investing in our capabilities across the board, using technology in innovative ways that provide real value. We seek technologies that can impact our business significantly with respect to providing more useful, higher-quality data faster and at lower cost. We were at the forefront of highly automated electrocardiogram overread, which provides more accurate results and alerts the reviewing cardiologist to abnormal or more difficult-to-interpret data.

Celerion was also the first laboratory to move completely to electronic lab notebooks. Lab technicians now spend just 15% of their time on data documentation for the GLP environment — rather than 50% — providing a tremendous boost in productivity. The accuracy and quality of study execution is also improved, as the electronic system keeps track of expiration of solutions and reagents, instrument service and maintenance, sample storage environments, inventory, and chain of custody.

We have also been a leader in leveraging the use of apps on tablets and smartphones for patients to provide data on an ongoing basis once they leave the clinic. Not only are the data provided electronically, the resulting volume of data is greater, which can add statistical power to the eventual analysis. In addition, the data do not need to be transcribed, so errors are reduced and significant time is saved.

Developer of Innovative Solutions

Our science-driven approach and commitment to applying innovation have led to the development of several proprietary solutions geared toward accelerating early clinical research. Developed to address the most challenging aspects of data collection, data management, and clinical operations, ClinQuick^® is Celerion’s industry-leading eSource solution that electronically captures data in real time.

A CFR Part 11–compliant barcoded system that automates all aspects of clinical operations, ClinQuick ensures that we can provide faster delivery of high-quality data, benchmark level study execution times, and consistently execute clinical trials across Celerion’s global facilities. By combining our processes with Omnicomm’s TrialMaster^® electronic data capture system (EDC), we are able to design, build, and deploy databases quickly, which is crucial for studies in early development.

Because ClinQuick is integrated not only with TrialMaster and our clinical and laboratory equipment but also our proprietary client data portal, Celexus®, clients see clinical study results in real time online, allowing for faster, data-driven decision making. In addition, all critical study documentation and reports are maintained in a centralized location. In addition, all electronic trial master files (eTMFs) are DIA TMF formatted and accessible to clients and trial monitors through a secure portal managed by experienced eTMF personnel.

Celerion’s ECG Core Lab provides quality data in a fast, cost-efficient manner while also allowing cardiologists, clinical pharmacologists, biometrics specialists, statisticians, and data management experts to actively collaborate with clients as the study progresses. Our bioanalytical electronic laboratory notebook system, Labnotes, allows us to document observations, control procedures, exchange information with other software solutions, and easily find and collaborate on scientific results while operating more efficiently in a compliant manner.

Ongoing Developments

While we believe these innovative solutions set Celerion apart as a leading early-phase CRO, we realize that ongoing advances are required to maintain that leadership position. We will therefore be expanding our Celexus client portal to allow more real-time access to data for sponsors, including our laboratories, which will be valuable for SAD/MAD dose-escalation studies and aspects of real-time monitoring. We are also employing FibroScan^® (Echosens, Paris) as a noninvasive procedure for detecting early signals of efficacy for drugs targeting nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

Cell-based therapies and 3D-printed tissues/organs are just two examples of future modalities for curing diseases rather than treating symptoms. More current are advances being made in drug delivery, such as antibody–drug conjugates, patches, and implantable wafers. Such next-generation medicines and devices present both clinical and analytical challenges. We believe that Celerion has an important role to play in mapping out the impacts of these therapies using our expertise in biomarkers and clinical study design and conduct.

Going forward, we also anticipate leveraging artificial intelligence/machine learning to more quickly and effectively analyze data to advise protocols and provide other crucial insights. The use of augmented reality tools to virtually engage with potential trial participants, educate them about a study, and gain their consent is also being explored to facilitate virtual/siteless/direct-to-patient trials and other evolving clinical trial models.

Leveraging smarter strategies that pre-identify potential issues, Celerion significantly reduces development timelines by avoiding delays.

COVID-19 Pandemic Accelerating Technology Adoption

The COVID-19 pandemic is contributing to the accelerated adoption of some new technologies by everyone in the pharmaceutical industry. Companies that would normally be hesitant to adopt remote monitoring solutions and accept patient-reported data, for instance, have found that, driven by necessity, these technologies present effective solutions.

Celerion was already positioned to implement many remote technologies before the emergence of the novel coronavirus, including remote auditing, virtual site tours, and remote viewing of dose preparations. We believe our clients will continue to use many of these systems going forward, because they are effective and can boost productivity and efficiency while reducing cost.

We also expect that there will continue to be changes in the way clinical research is performed. Flexibility and an open mind on new approaches while still maintaining the high quality standards required of our business will be key to successfully managing the many impacts of the pandemic.

In addition to the use of personal protective equipment, Celerion has implemented novel working procedures and facility changes to accommodate COVID-19 concerns and federal, state, and local working requirements around social distancing. Creating more bed and lab space and ensuring controlled entry and exit are other challenges Celerion is addressing.

We also have our own highly sensitive assay to detect very low levels of the SARS-CoV-2 virus, which is necessary to establish that an asymptomatic individual does not have the virus. Diagnostic tests to show that someone with symptoms has COVID-19 or another infection are not sufficiently sensitive for screening of asymptomatic people. Our test provides results in six hours, and we are using it to test both trial participants and staff at our clinics. We expect testing in both society at large and in the research environment will be necessary for the foreseeable future.

Science-Driven, Disruptive CRO

In March 2020, Celerion celebrated 10 years of industry leadership providing early clinical research services to the biopharmaceutical industry’s most innovative companies. Unlike very large CROs that are too big to allow flexible, direct, and personal interactions, Celerion has adopted a disruptive service model focused on building close, long-term relationships that enable direct connections among the right people.

We are, in fact, like Goldilocks: not too big and not too small, but just the right size for the clients we serve with our relationship-driven, science-based approach to accelerating projects from preclinical to proof-of-concept studies. Our management team is led by Dr. Susan Thorton, who leverages her experience as a scientist CEO to understand key industry trends and evolving client needs. As a result, they consistently make the right decisions about investments in technologies that will have a measurable impact on our ability to reduce time to market while ensuring the highest-quality data.

In 2019, regulatory bodies approved 48 new drugs; Celerion conducted 32 studies with 11 of those drugs. This impressive track record demonstrates our overriding goal of advancing new drugs to market to help those in need of innovative drug therapies. 

Celerion’s second decade of growth will continue from locations spanning North America, Europe, and Asia and expand on the global recognition we have achieved as the premier provider of early stage clinical research. Driven by our strong scientific foundation and demonstrated capabilities in the drug-development process, we will continue to focus resources on early clinical development to proof of concept. We will also continue to build strong collaborative relationships with our customers and invest in the knowledge, talent, and technologies necessary to help them make rapid, informed decisions and rapidly bring new medicines to the patients that need them.

Originally published on PharmasAlmanac.com on July 1, 2020.

Collecting, sharing, and visualizing the huge volumes of data created during the early stages of drug discovery and development have long represented bottlenecks to accessibility and efficiency in need of smart digital solutions. Charles River Laboratories is an established leader in providing essential products and services to help accelerate preclinical research and drug development, and is well positioned to understand the pain points in data sharing during safety assessment and toxicology studies and their impacts on workflows and efficiency and to develop frictionless, real-time, and customer-centric tools to improve the efficiency of customer interactions and the development process overall. In this Q&A, Charles River’s Corporate Senior Vice President, Sales and Client Services, Kristen Eisenhauer and Corporate Senior Vice President and Chief Information Officer Mark Mintz discuss the company’s development and recent launch of Apollo^TM, a secure, cloud-based platform for real-time toxicology study data, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.

David Alvaro (DA): To begin, can you share a bit of background on Charles River and introduce the idea behind Apollo and its origins at Charles River?

Kristen Eisenhauer (KE):  Charles River helps support drug research and product research. The company originally focused on supporting animal studies, but we expanded over time to provide early-stage drug discovery services, middle-stage services used to gain approval from the FDA and other appropriate regulatory agencies, and post-market services, where we test both small and large molecule products for impurities. We are a comprehensive preclinical or nonclinical CRO; we perform sample analysis on clinical trials but otherwise focus on all of our customers’ research needs before they reach clinical phases.

Mark Mintz (MM): Our mission at Charles River is to help accelerate drug development processes to, wherever possible, reduce the time required for those processes. The idea for Apollo came from a larger push at Charles River to update how we work in a more automated fashion.  Obviously, the work that we do to support our customers generates massive volumes of information and data, but before Apollo, all of that information was accessed and shared manually: a customer would send an email asking for information or data or a document, and then somebody at Charles River had to manually send that back –– sometimes requiring multiple steps and multiple people. We had a simple portal in place, but it wasn’t really interactive, and data were manually uploaded and not in real time. We saw a critical opportunity here to digitize, automate, and streamline the way that these data travel from our labs to our customers and back. The underlying goal is to make data sharing as quick, easy, and automated as possible to allow us to focus less on these manual processes and more on the science itself.

DA: Can you expand on the types of data your customers need during these studies and the limitations of not having easier, real-time access to the data? 

KE: Before we developed Apollo, accessing, monitoring, and utilizing data was completely manual. Typically, the client would have to email the study director, who would then need to get access to that data if they didn’t have it at their fingertips. Then, they would have to respond either with an email containing spreadsheets of data or manually put them into the portal, where files could be accessed by the customer. No matter how responsive our people were, this inevitably took time. Additionally, it was virtually impossible for a customer to access these data during off-hours because there needed to be a person working on the other end of the line to support those requests. In many cases, there really was an important unmet need to share data –– things like body weights and observation and pathology findings –– more rapidly than was possible.

Additionally, many customers expressed ongoing and increasing concerns about the limitations of how those data could be shared or transferred. Manual processes unavoidably create opportunities for data to be sent to the wrong person, and in this day and age there are more secure options than using email to share data.

DA: Will giving your customers increased and real-time access to these data create new opportunities and transform how these studies are conducted and what is possible? 

KE:  We believe so. At a very simple level, this allows employees at our customer and client organizations to have more immediate meetings with their management to evaluate data that has already been visualized for them, rather than them needing to take the time to input the data into their database or system to do so. They are able to make decisions very rapidly about the next dose or the next study that otherwise might have taken weeks of back and forth between the study director and the client around the major milestones of the study. We can definitely envision taking that and growing it beyond just an individual study in a programmatic way and seeing timelines continue to shrink as these decisions can be made faster and faster. 

With the self-quoting or ballpark quoting tool we have added to Apollo, people can not only assess what study to run next on the basis of those real-time data but even what budget is likely to be required for that next study. Rather than taking a month to make those determinations, customers can now prepare their next step internally and act much more quickly. As we know, everything these days requires approval, and budgets are incredibly tight –– the faster people can access that type of budget information rather than waiting on our end for a quote, the quicker they can act.

MM: By building this platform to make these data accessible and secure –– and through ongoing dialogues with our customers around how they work with us and how they would like to work with us –– we’re constantly exploring new and different ways to bring additional data together to make it easier to develop new and more meaningful insights and to enable them to make decisions more quickly and optimize how they work.

KE: We are always thinking about the future and what else we can enable. Today, we’re identifying trends very early on with regards to a specific study with a specific drug for a specific customer. Going forward, as we look to free the rest of our data and put it all together as the Western world’s largest nonclinical CRO, the amount of information and data we have access to on a very high-level perspective will absolutely transform the decisions made in the future. Our next step will be to go from an individual client and an individual biologic or small molecule to examining, for example, all of the monoclonal antibody studies we’ve run, and assessing the collective impacts to different tissues. We think that we could ultimately leverage that huge data set on a very holistic basis to help clients make better decisions and/or to better predict outcomes, which help transform the speed and accuracy of drug development.

Apollo™ is an innovative platform that empowers users with real-time access to study data, milestones, documents and program planning tools.

DA: Was developing something like Apollo inevitable given the bottlenecks you mentioned, or was there a particular inflection point that got things moving?

KE: The real impetus came through feedback from our customers. While a large portion of the Charles River preclinical business comes from large, global pharma companies that have large staffs and lots of resources to conduct research, the majority of our customer base is smaller biotechs that lack these resources. Our initial focus was on providing real-time data in a way that could support these companies that most need help to make these quick decisions. The more we looked into developing solutions, the more we found that data visualization tools were practically nonexistent in the preclinical CRO space, and as a result companies were having to spend money either building teams to do it or outsourcing those activities separately. We had a bit of a eureka moment where we realized that, since we are producing the data, it would add significant value to present it in a way that is both visually pleasing and more easy to grasp, along with a self-help tool that allows people to access it any time that they want.

MM: Like a lot of the digital transformations across the industry, the push for Apollo really came in 2020, during the lockdown phase at the peak of the COVID-19 pandemic, which really emphasized the need for digital experiences, technology enablement, and moving more efficiently with less manual work. That drove the company into a real commitment to a digital journey and digital transformation, and Apollo represents the first big piece. Ultimately, we want to expand this offering, not only help to our safety assessment customers but to create end-to-end access across the portfolio of products and services that Charles River provides so that all of our customers can benefit from these types of experiences and reduce timelines to get results out efficiently and as effectively as possible. Additionally, we want to enable our own employees to spend maximal amounts of time on the science and helping our customers, versus having to do manual things that can be addressed through analytics and automation. 

We developed our minimum viable product (MVP) in 2021, which we then released internally with just a few customers and just a few data sets and features. We then spent the last year-and-a-half growing the MVP exponentially to the point where every preclinical Safety Assessment customer working with Charles River is on Apollo and has access to their data, their study milestones, etc. We launched Apollo publicly this March, which was a big milestone for us. We first wanted to make sure that we felt confident that we could stand behind everything and fully put out there in the marketplace, and we did.

DA: Has the response from both customers and your own teams aligned with your expectations?  

MM:  Absolutely. Apollo truly transforms these workflows in a positive way: people can spend far less time on routine tasks like pulling things together, creating spreadsheets, and sending emails back and more time actually examining the data, discussing them with the customer, or coming up with new insights. There is a change-management component built into Apollo to ensure that everybody understands how to use the new tools, which also creates opportunities to improve workflows and interactions with customers and with internal colleagues. 

The customer feedback we have received has been very positive. Apollo eliminates steps from their workflows by creating these visualizations that ensure they are looking at the data in the way we intend. They don’t have to worry about doing those things; they can just log in and get the data, develop insights, and make decisions without having to do that manual work, which not only saves them time but also makes their processes more effective.

DA: I’d like to circle back around on the point you made about Apollo being the first big step in the digital journey Charles River is embarking on. Can you share anything about that larger vision? 

MM: As I mentioned, in 2020, Charles River embraced the idea that a digital transformation was critical to furthering our mission of accelerating drug development timelines while also creating unique and delightful experiences and industry-shaping opportunities. We set out to bring people, processes, and technology together to reimagine how we work both internally and with our customers toward that goal of meaningfully reducing drug development timelines. 

We will achieve this by implementing best-in-class technologies that are instrumental in optimizing internal processes into more digitally native ones, which enables us to help our clients get their drugs and therapies to patients in less time. The core pillars for our digital transformation and journey are customer-centric design thinking, agile test-and-learn processes, and technology-led innovation. With a strong emphasis on the customer and employee experiences, we’re working to reimagine important processes that could ultimately improve patient care, cost effectiveness, drug discovery, and development and create new and better ways of working. 

From a technology perspective, what we’re doing is tightly aligned with the most important and high-impact customer needs and business opportunities. We assess our customers’ biggest needs and where can we help them to drive their drug development processes as effectively as possible and determine how we can best use technologies like the cloud, artificial intelligence and machine learning, connected devices, digitization, and automation to create these experiences and help get their products and therapies to patients as quickly as possible.

Apollo™ provides access to study data that empowers users with insights and digital features to enhance decision-making abilities.

DA:  Sometimes, when an interaction shifts from being handled by people into a digital portal, there can be a perception that something gets lost without that human contact. Do you think that’s an issue at all with Apollo, or does it simply free people up and allow them to focus on more meaningful interactions?

KE:  Apollo allows us to spend our time communicating about important things –– like the real science underlying drug discovery and development–– rather than the logistics of running studies, milestones or budget quotes. Everyone’s time is limited, but now, rather than spending 30 minutes of an hour on the logistics of how to share data, we can spend the whole hour discussing the drug itself. The interaction isn’t lost, but the quality is significantly increased.

DA: You mentioned the quoting tool within Apollo and the budget confidence that it adds. Can you expand on how that works and whether it really adds something to the picture that just wasn’t possible previously?

KE: This was an important piece of our evolving ability to respond to the voice of the customer. When we were developing the MVP for Apollo and determining what features to work on first versus what would be deprioritized, we conducted customer interviews, and this kept coming to the top in terms of unmet needs. I manage the group that creates these quotes, and even I was surprised by how important this was to customers. We already had this on our radar for later versions of Apollo, but customer interactions convinced us that it should be a top priority from the beginning.

The feedback on this tool has been tremendous. Customers understand that it provides a ballpark budget rather than a precise quote, but that is what they are looking for at those early stages. However, it is absolutely our goal to continue to refine the tool and eventually get to a place where people can develop their own study online and create a quote document that they can digitally sign right then and there. It was definitely a learning experience for us in terms of what’s important to the customers, and we ended up with a really important and useful tool that we didn’t anticipate.

MM: I think that this is a reflection of things people have become accustomed to doing in their personal lives: you can go online and find the price of something, whether you are making a purchase or just considering budgets; you can buy cars and even houses online now. People expect similar things from their business environments –– to be able to see what things would cost and how might they configure things. Allowing them to do that digitally and enabling them to either complete it on their own or talk to somebody to help do that extends our ability to meet our customers where they are and provide them the tools and capabilities to work in the ways they want to work to enable the most efficient process. I like to use the word “frictionless” a lot: make it as simple as possible for them to engage with us in any way they need to so that we can serve their needs as best as possible. 

DA:  Did any other unanticipated features emerge along the way that have either already been integrated into Apollo or are in the wings for future updates?

KE: One surprising benefit has been how Apollo has increased our understanding of the complexity of our customers’ organizations and how they are structured and organized. While that may not have yet led to a new feature in Apollo, it’s helped us to better identify what will be helpful for them in the future to avoid other speed bumps, like determining the different stakeholders at the customer company that ought to have access to the features for a given project. It been a very good learning moment for us to better understand how they work internally, which has in turn helped our salespeople interact with them in a more productive way to ask the right questions and reach the right people faster. 

Additionally, it’s helped us better understand our customers who are smaller, one-drug biotechs for whom everything really hangs on the development of that drug, which gives them a competitive advantage that they need to maintain. Apollo has helped further solidify to us how important these individual drugs and the corresponding data are to these companies’ lifelines. 

MM: At a very high level, what always fascinates me when we work on projects like this that are strongly driven by conversations with customers is that we often end up somewhere quite different from what we imagined at the onset. Those conversations don’t only happen early on; we also share different mockups and prototypes and have them walk through them and inevitably iterate that many times. 

That direct connection is invaluable. By the time we properly launch the product, we can feel confident that it meets those customer needs, because we have had the conversation multiple times during development. The iterative process is critical, because you keep being able to refine your original concept and understand which elements were spot on and which need to change. It requires being open to ending up in a different place than where you thought you would, but that usually means discovering a lot of great new ideas.

Currently designed to support safety assessment and toxicology studies, Apollo™ offers complete program oversight to help create efficiencies in the drug development process.

DA: I realize you only just launched Apollo, but I’m curious about what may come next. Are you more focused on further refining the existing features, adding new ones, or extending the portal across the other work that Charles River does? 

MM: It’s really all of the above. We are continuously expanding the scope of Apollo’s features for our safety assessment customers –– including expanding to different study types, as well as different data sets and insights on those data sets –– and continuing to increase the breadth and depth of what’s there. We also plan to do this beyond our safety assessment business and across our entire portfolio of products and services. 

Ultimately, we aspire to create industry-leading digital experiences that more seamlessly enable the drug discovery and development process. We are working to do this across all of our businesses and products; in different ways depending on what different customers need. We aim to delight our users and colleagues with intuitive, easy-to-use experiences that take meaningful time off the drug development cycle and ultimately help our customers create healthier lives. 

DA:  Looking beyond the immediate term, is there a vision for more significant shifts that Apollo and the rest of this digital transformation may enable in the future?

KE: We have a longer-term vision for Apollo to not only support the work that customers do with Charles River but to integrate all of their drug development activities, whether those are services outside of the scope of what we do or simply things for which the client has chosen another provider. We see real value for customers to have a single hub for all of their drug development data; on the other hand, we see value for Charles River in better understanding work outside of our purview, which can help our M&A and digital strategy. 

MM:  Charles River is known for vast scientific expertise, and the work we do for our customers and the trust we have built is second to none. From my perspective, science and technology go hand in hand. Further evolving our technical capabilities to align with our science capabilities and growing as a leader in both the science and the technology enabling that science is not only a great aspiration for us internally –– it’s exciting and motivating and allows everyone to focus on super high-value work. It’s also good for our customers and the industry overall to create these frictionless, high-speed processes that help get these therapies out there more quickly, which is great for patients and the health of society. Becoming a true technology-backed science leader is a real aspiration for us.

Originally published on PharmasAlmanac.com on May 5, 2023