Happy New Year! New year, new actionable insights on how we’re forging a better drug discovery and development process.

We are grateful for all our loyal blog readers. Can you believe that it’s been eight years since we started blogging about our challenges and accomplishments in model-informed drug development, scientific informatics, regulatory science, and market access? Before plunging headfirst into 2023, we wanted to stop, reflect, and share our 2022 highlights with you in this curated collection.

When Should I Select an eCTD Vendor for My Regulatory Submission?

By Evan Richardson

As your company performs project planning for the regulatory submission of a marketing application for an investigational drug to a health authority, there are many things to consider. Among those is whom your key vendors will be. It’s already challenging enough to figure out which vendors you should be engaging with, and it’s even more challenging to know when to engage each of them. One example of this is electronic Common Technical Document (eCTD) publishing.

At first glance, you might think that choosing an eCTD publishing vendor can wait until near the end of your project timeline. After all, you can’t start publishing the submission until all the regulatory content has been generated and finalized, right? Wrong. Don’t wait until it’s too late. Here are three reasons why the earlier you engage an eCTD vendor, the better off you’ll be.

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PBPK Modeling to Support Bioequivalence & Generic Product Approvals

By Nikunjkumar Patel

Bioequivalence studies are needed when creating a generic drug, creating a new formulation, or switching manufacturing sites. Bioequivalence compares the relative bioavailability between two preparations of the same drug. Bioavailability is the extent to which a drug enters its intended biological destination or systemic circulation. Virtual Bioequivalence (VBE) is used to show bioequivalence using modeling and simulation instead of clinical studies.

Physiologically-based pharmacokinetic (PBPK) models can be used to support bioequivalence and to ease generic product approvals. For example, the U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) for a generic diclofenac sodium topical gel, 1% using a VBE assessment leveraging dermal PBPK modeling and simulation supported by a totality of evidence approach. This approval shows that alternative BE methods for product development and regulatory approval are achievable.

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Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development

By Rajesh Krishna

The safety of human participants in clinical trials, the intended patient population, and the labeled indications at the point of introduction into the market is undoubtedly the paramount consideration of any drug-hunting enterprise. Often considered the distant (and unfortunately often forgotten) cousin of its more popular version, “efficacy,” safety often gets relegated to the back seat. In other words, while sponsors push to understand dose/response for efficacy, they rarely worry about safety if there is general or “acceptable” safety.

What does acceptable mean? Well, that’s a nebulous term. In general, if there are no “issues,” safety is often not the center of attraction, not even worth reflecting about. This is where, unfortunately, most mistakes are made. If anything, safety should be given far more attention than efficacy.

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By Julie Bullock

There is mounting evidence that some oncology drug doses are too high, and that cancer patients may not be able to tolerate their treatments because of this. Project Optimus, an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE), is being used to help cancer drug makers evaluate the efficacy of a wider range of doses in development.

The goal is to shift away from using maximum tolerated dose (MTD) approaches to finding starting doses earlier in a drug’s development that will be better tolerated by patients.

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How the Simcyp Discovery Simulator will Accelerate Early Drug Development

By Hannah Jones

Physiologically-based pharmacokinetic (PBPK) modeling is a technique used to predict the absorption, distribution, metabolism, and excretion (ADME) of chemicals in both human and animal populations. The use of PBPK modeling and simulation has increased in all stages of the drug development process and can be used in new drug applications. With the release of the Simcyp Discovery Simulator, scientists can utilize PBPK modeling earlier in the drug discovery and development process. This can help them make better, informed decisions to reduce the risk of drug failure.

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How Pharmaceutical Companies Can Engage Payers Digitally

By Shawn Bates and Pascaline Faivre

When you look at the global pharmaceutical market overall, North America is at the forefront of payer digital engagement, spending $1.3 billion per year with a growth rate of 28%, followed by Japan at $890 million and a growth rate of 43%, and the top five EU countries combined at $92 million with a combined growth rate of 4%.

The rest of the world is still focused predominantly on traditional promotional channels with little digital share and multi-channel sophistication. This is especially true as it pertains to payer engagement and even more so for local payer engagement. This is where engaging digital content can substantially impact the decision-making of local payers, particularly in “white space,” where many local payers find themselves due to pharma or biotech manufacturer resource limitations.

Many payers are open to digital engagement, and pharmaceutical companies can encourage this engagement by selecting digital communication tools at various stages in a product’s lifecycle.

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Mind-blowing applications of QSP in drug development: Part 1

By Piet van der Graaf

Certara’s Simcyp COVID-19 vaccine model, a 2021 R&D 100 Awards winner, was developed within a few months of the pandemic. Certara leveraged its multi-year work with a group of leading pharma companies developing its Immunogenicity Simulator (IG) to address this global health challenge.

By flipping the concept of simulating unwanted biologic drugs’ IG adverse events to amplifying desired vaccine effects, we were able to simulate the impacts of dosing intervals, age, and ethnicity-related dosing and other critical steps to accelerating COVID-19 vaccines using Quantitative Systems Pharmacology (QSP) —virtual patients in virtual trials.

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Major Implications of New European Clinical Trial Regulations

By Emily McShane

Have you heard the buzz around the new European Union Clinical Trial Regulations (EU-CTR) for transparency and disclosure of clinical trial data? The European Medicines Agency (EMA) released these regulations in early 2022, giving pharmaceutical companies a year to pilot programs and prepare for full implementation.

Starting in January 2023, all new clinical trials submitted to the EMA must be compliant with EU-CTR. Just in case you haven’t had time to digest hundreds of pages of regulations, guidances, and updates, here are the three main ways in which EU-CTR will impact Sponsors and require new processes and workflows.

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Takeaways from the FDA Oligo Guidance You Need to Know

By Kathryn Brown and Marie-Cecile Secouard

In June 2022, the FDA published their first oligonucleotide clinical pharmacology-specific guidance. This is a welcome addition and clarifies the agency’s position on key aspects about the development of oligonucleotide therapies. While this new guidance still leaves some open questions, it provides drug developers with a starting point and acknowledges that oligonucleotides present some unique aspects and challenges. Here, we’ll discuss the new guidance, highlight our 3 key takeaways, and share our wish list for the next guidance!

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Tips to Use Phoenix WinNonlin More Efficiently

By Ana Henry

Certara’s Phoenix™ Pharmacokinetic and Pharmacodynamic (PK/PD) Platform is the single, interoperable hub for sharing pre-clinical and clinical knowledge across your organization. With Phoenix, you can create, manage, and use workflows that streamline your PK/PD data management and analysis. Here are some tips to help you utilize Phoenix more efficiently. Let’s start by making sure you can view Phoenix correctly and familiarize yourself with other more less known functions.

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We hope that you found this collection informative as well as enjoyable. If you need help accelerating your drug development program, please contact us!

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