Electrocardiography (ECG) is an integral part of the new drug regulatory environment. Mandated by regulatory bodies the world over, the thorough and precise evaluation of a new drug’s cardiac effects is a critical element of new chemical entity (NCE) development. Sponsors must submit all NCEs with systemic exposure to a dedicated thorough QT (TQT) study to understand the drug’s impact on ECG parameters and determine whether the compound prolongs the QTc interval.

A positive finding of QT prolongation usually has a significant negative impact on a drug's development pathway, necessitating extensive additional ECG assessments, and potentially resulting in approval delays or even discontinuation of the program.

In Issue 9 of The Altascientist, we review:

• Electrocardiography
• Global regulations
• QT/QTc study design
• Timing of QT assessments
• A case study about a first-in-human clinical trial involving a QT assessment

Intrinsic factors such as age, biological sex, comorbidities, or genetics can potentially alter drug exposure, as can extrinsic factors such as concomitant drugs, supplements, the environment, and food and beverages. One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occur when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levels—ultimately causing side effects. 

In some cases, these side effects could be life-threatening, such as drops in blood pressure, irregular heartbeats, or organ damage.

In Issue 7 of The Altascientist, we delve into these factors, the importance of drug interaction studies, and how to limit adverse effects and maximize treatment response. Listen to the audiobook or download the PDF below, to learn more about:

• key factors to consider in drug development (age, biological sex, genetics, DDIs);
• examples of common DDI involving the cytochrome P450 enzyme system; and
• drug interactions and guidance for marketed drugs.

Metabolic disorders are conditions that disrupt normal metabolism and the process of converting food to energy at the cellular level. They affect the ability of the cell to perform critical biochemical reactions that involve the processing or transport of proteins (amino acids), carbohydrates (sugars and starches), or lipids (fatty acids). Metabolic disorders can take many forms, with obesity and diabetes being the most common.

The worldwide prevalence of obesity has nearly tripled between 1975 and 2022. Once considered a high-income country problem, obesity is  on the rise even in low- and middle-income countries.

In Issue 5 of The Altascientist, we investigate the challenges of metabolic disorders, with insights from Altasciences’ clinical and preclinical experts, as well as:

• Frequently asked questions about clinical trials for metabolic disorders
• An Altasciences case study
• A hidden threat: nonalcoholic fatty liver disease (NAFLD)
• Altasciences’ end-to-end patient recruitment process and patient access for NASH studies

Biologics have become the fastest-growing class of therapeutic compounds, with seven of the top-10 selling drugs in 2023 being biologics, each exceeding sales of $10 billion USD.  In 2022, biosimilars accounted for 13.7% of all spending on biologics, compared with the 8.9% in 2021.

Biologics have provided treatment options for people who suffer from some of the most serious medical conditions, such as cancer and genetic disorders.

A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine. It enters the market subsequent to the patent expiration of a previously authorized version of a biologic. A biosimilar is approved only after showing that it is “highly similar” to an approved biological product, known as the reference product, in terms of structure, purity, potency, safety, pharmacokinetics, and in many cases, efficacy, with allowable minor differences.

In Issue 4 of The Altascientist, learn about the growing interest of biosimilars, and key considerations in pharmacokinetic (PK) studies, as well as:

• The rise of the biosimilar market
• The regulatory landscape
• How Altasciences puts biosimilars to the test
• Altasciences’ expertise in bioanalysis  
• Key considerations for biosimilar clinical pharmacology studies
• Ensuring the continued success of biosimilar programs