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Optimizing for Success: How Sponsors Can Overcome the Challenges in Early-Phase Drug Development
The Challenges With Outsourcing Drug Development
In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.
Collaborating for Success Tips for Improving Partnerships Between QA and Clinical Operations at Your Site
Disrupting the CRO Model: Altasciences Participates in Documentary Series for 2024 Global Health Summit
Altasciences is leading the conversation on change in the drug development industry as part of a new documentary series for the 2024 Global Health Summit, hosted alongside the WHO’s 77th World Health Assembly in Geneva in May. The mini documentary explores transformation in the slow-to-change drug development industry.
The Year in Review 2023
Top 10 Life Science Resources - October 2023
There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!
ISSUE NO. 34 — Toxicokinetics, Pharmacokinetics, and Pharmacodynamics
Understanding a new drug’s absorption, distribution, metabolism, and excretion (ADME) is critical to ensure its safety for human use. That understanding is achieved through the collection and analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data, which together account for approximately 25% of the contents of a drug package insert or label.
The characterization of PK/PD effects starts with nonclinical toxicokinetic (TK) studies in animals. The purpose of TK studies is to define the chemical properties of the drug, including pharmacology and toxicology, and to assist in the development of downstream clinical protocols. The necessary nonclinical studies are conducted before submission of Investigational New Drug (IND) applications to the FDA or other global regulatory agencies, and deliver critical data used to set the parameters for future clinical trials.
In Issue 34 of The Altascientist, we discuss how the understanding of a novel drug’s PK and PD properties begins with nonclinical studies and evolves through early-phase clinical trials, including:
- IND requirements and translation to clinical PK/PD;
- Translating nonclinical knowledge of PK/PD analyses to clinical study;
- How PK/PD scientists add value to drug development processes; and
- A scenario case study from Altasciences.
HOW DO PHARMACOKINETIC/PHARMACODYNAMIC SCIENTISTS ADD VALUE TO THE DRUG DEVELOPMENT PROCESS?
A PK/PD scientist will perform a myriad of tasks for your studies, some of these tasks may include:
Top 5 Ways Integrated Drug Development Solutions Save You Time and Money
Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion, without, for the most part, shorter development time
Bioanalysis—Three Decades in the Making
Improving Your Quality Toolbox with Quality Metrics
ISSUE NO. 29 — Building Your Early Phase Clinical Data, from Protocol to Regulatory Submission
Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.
In this journal, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.
In Issue 29 of The Altascientist we explore:
- Protocol development
- Data management
- Statistical support
- Analysis and reporting