CHDR has more than 25 years of experience using biologicals and biosimilars. Even in the earliest stages of clinical development, we can demonstrate the pharmacological effects of biologicals and/or biosimilars in healthy subjects, thereby providing sponsors with key information for rational decision-making.

Highlights

  • Using specifically targeted biomarkers, CHDR can demonstrate the pharmacological effects of biopharmaceuticals early in clinical drug development, even in healthy subjects.
  • The outcome of first-in-human studies provides a stronger basis for establishing dosage and safety profiles in future studies involving patients.
  • CHDR has extensive experience addressing species specificity, immunogenicity, and unpredicted side effects, as well as establishing the starting dose, thereby optimising safety.

Experience with a wide range of products

Biotherapeutics include a highly diverse array of biologically active compounds. Some of these compounds are produced in animals, bacteria, or cultured cells, whereas others (for example, nucleotides) are synthesised chemically. CHDR has a long history of studying biologicals, including antibodies, lipoproteins, RNA, and DNA, and many of these compounds were first administered to human subjects at CHDR. 

For example, CHDR performed the first-in-human studies of a promising new drug for ApoA-1 Milano, a biologically produced apolipoprotein used to treat atherosclerosis. These studies helped establish a safe dose for use in human subjects. CHDR then studied ApoA-1 Milano in patients with stable coronary artery disease.

Practical answers to important research questions

  • What happens to our compound after it’s administered?

    Because most biotherapeutics are relatively large molecules, predicting their behaviour in the body can be challenging. At CHDR, we use pharmacokinetics and pharmacodynamics (PK/PD) modelling to provide sponsors with the information they need to plan the next steps in clinical research.

  • Are the compound’s unintentional side effects due to impurities, or are they inherent to the compound’s mechanism of action?

    CHDR uses both in vitro and ex vivo approaches to determine whether a biological compound is likely to exert an undesired effect in vivo, and – if so – whether this effect is due to impurities or the compound’s pharmacological activity.

  • Is our biosimilar equivalent to – or even better than – the original patented drug?

    Confirming bioequivalence (i.e. comparable pharmacological activity) is an important step when developing a product designed to replace an existing biotherapeutic. CHDR has developed methods to test bioequivalence early in the drug development process, thereby providing important information to help guide development.

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