Related Experiment Video
Updated: May 8, 2026
09:30
Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
The PCAST report: impact and implications for the pharmaceutical industry
S A Morris1, M Rosenblatt, J J Orloff
1Johnson & Johnson, New Brunswick, New Jersey, USA. JWaldstr@its.jnj.com
Clinical Pharmacology and Therapeutics
|August 22, 2013
Summary
The President's Council of Advisors on Science and Technology (PCAST) aims to double innovative medicine output in 10-15 years. Achieving this requires strong leadership and collaboration for societal benefit.
Area of Science:
- Biomedical innovation
- Pharmaceutical development
- Drug discovery and safety
Background:
- The President's Council of Advisors on Science and Technology (PCAST) has identified a critical need to accelerate medical progress.
- Current drug development timelines and success rates present significant challenges to innovation.
Purpose of the Study:
- To outline an ambitious goal for increasing the output of novel medicines.
- To emphasize the importance of enhanced efficacy and safety in new therapeutic agents.
Main Methods:
- Analysis of current pharmaceutical innovation landscape.
- Policy recommendations for accelerating drug development.
Main Results:
- A strategic objective to double the production of innovative medicines.
- Identification of key drivers for achieving this goal, including leadership and collaboration.
Conclusions:
- The PCAST report presents a transformative vision for medicine.
- Realizing the goal necessitates a concerted, collaborative effort across the scientific and healthcare communities.
Related Concept Videos
01:19Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
01:26Pharmaceutical Poisoning: Potential Scenarios
Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:26FDA Approved Drugs: Changes to Approved Drugs
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...