Clinical Pharmacology Insights that Accelerate Drug Development
This blog discusses the clinical pharmacology strategy, dose selection, and safety considerations for cell therapy development programs.
In this blog, we will review and reflect on the scientific and strategic parts of the FDA guidance. We will also reflect on this guidance from a European Union (EU) perspective.
The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public consultation phase. This guideline has several objectives. While aiming to harmonize methodologies and approaches for pediatric extrapolation in drug development, it balances access to pediatric indications and reduction of children’s exposure to experimental medications where warranted. The ICH E11A webpage outlines these considerations.
Model-informed drug development (MIDD) is a network of closely integrated ecosystems that can seamlessly position a new drug candidate while minimizing uncertainty in technical and regulatory success.
The new Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC), Guidance for Industry, was issued by the US Food and Drug Administration (FDA) in February 2022. ADCs are targeted therapies that are designed to deliver cytotoxic payloads to cancer cells.
New therapeutics development in rare diseases presents both opportunities and complexities.
Because of the small patient pool available in these indications, there are challenges in designing and conducting clinical trials and the data interpretation that follows, and the ultimate path to registration.
Bioequivalence enables bridging safety and effectiveness of oral pharmaceutical dosage forms using pharmacokinetics.
Immunotherapy presents interesting and proximally viable therapeutic options in the growing…
Pandemics by nature are excellent fodders for disruptive innovation. They force you to think out of the box. The whole health care apparatus is on the COVID-19 frontlines with some more directly involved than others.
It is gratifying to see the continued uptake and adoption of tools for model-informed drug discovery and development since the early 2000s.
The National Institute of Diabetes and Digestive and Kidney Diseases considers nonalcoholic fatty liver disease (NAFLD) as a condition wherein the liver stores excess fat and nonalcoholic steatohepatitis (NASH) as one type of NAFLD.
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations.
The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc. received FDA approval of voretigene neparvovec-rzyl (Luxturna™), a recombinant adeno-associated virus serotype 2 (AAV2) vector expressing the gene for human retinal pigment epithelium 65 kDa 5 protein (hRPE65), for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
Alzheimer’s disease (AD) is one of the most common forms of neurodegenerative dementia in the United States. In fact, the Alzheimer’s Association predicts that by the year 2050, the number of people age 65 and older with Alzheimer’s dementia is expected to double to comprise 12.4 million patients.
by Rajesh Krishna and Abhijeeth Chandrasekaran
Written by Rajesh Krishna and James Bolognese
Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike a biotechnology or pharmaceutical enterprise, where the assets one typically works on are within that ecosystem, consulting offers the possibility of working on many different innovation pipelines.
Global trials of therapeutic biologics have been historically absent from clinical
Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with its biological target. On the other hand, a targeted covalent inhibitor (TCI) drug is designed to form a covalent bond between an electrophile on the ligand and a nucleophilic center in the target protein (Figure 1).
New therapeutics discovery and development for ocular diseases have been traditionally associated with a low probability of technical and regulatory success.
One fundamental tenant of pharmacology is understanding how a drug works.
The safety of human participants in clinical trials, the intended patient population, and for the labeled indications at the point of introduction into the market is undoubtedly the paramount consideration of any drug hunting enterprise.