Oncology includes a spectrum of diseases that involve abnormal cell growth that can affect any part of the body. According to a report from the World Health Organization, cancer was the second leading cause of death worldwide in 2015, accounting for nearly 1 in 6 deaths.
Current pharmacotherapeutic options for cancer include not only traditional small molecule drugs, but also a number of innovative biologics such as oncolytic viruses, antibodies, tissue-agnostic therapies and CAR-T cell therapies. These novel therapeutics are welcome advances in the field, but they can also present unique challenges from both a drug development and a regulatory standpoint.
From a mechanistic perspective, it would be ideal for cancer drugs to exhibit selective toxicity towards cancerous cells while sparing healthy cells. In practice this has been no easy task. Establishing appropriate dosing regimens to maximize safety and efficacy requires expert analysis of a drug’s pharmacokinetics (PK) and pharmacodynamics (PD).
Clinical trial design can be challenging and cumbersome for oncology drugs. In an effort to increase efficiency, many oncology drug development programs have adopted adaptive clinical trial designs. These types of trials are more flexible, require fewer study participants, and shorten the time to completion compared to traditional study designs. However, managing adaptive clinical trials and analyzing their results, can be more challenging than for traditional trials. Nuventra understands that having competent and experienced scientists to guide the process can mean the difference between a successful, efficient, and maximally informative trial and one that is not a success.
Nuventra’s Oncology Experience
In-depth design and analysis of PK/PD studies can significantly enhance rational development of novel anticancer therapies. Nuventra’s team has contributed to a large number of oncology programs across all phases of drug development.
Nuventra can perform any of our wide range of services for drugs to treat Oncology indications. Some of our recent project experience in this area includes:
- Clinical Study Design
- Data Management
- Modeling and Simulation
- PK Analyses and Reporting
- Program Oversight and Project Planning
- Regulatory Writing and Submissions
- Safety Monitoring Committee
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Nuventra has experience with a number of Oncology indications, including the following cancers: