Infectious diseases include a diverse array of disorders caused by viruses, bacteria, fungi, or parasites. The need to develop new drugs targeting infectious diseases has never been greater due to the rise of microbial and bacterial resistance and deadly viral diseases such as COVID-19.
In 2019, the Centers for Disease Control and Prevention (CDC) estimated that each year in the US more than 2.8 million people are infected with antibiotic-resistant bacterial infections, resulting in over 35,000 deaths. Given this, significant efforts in the healthcare field have focused on improvements in antibiotic-resistant bacterial prevention. However, there is clearly still a significant need for new therapies to combat these infections, and researchers continue to investigate new possibilities for these drugs.
Viral diseases include everything from the common cold and the flu to HIV and Ebola. Because of the vast diversity of viruses, antiviral drug development can be uniquely challenging. In 2020, infections with the novel SARS-CoV-2 virus, which causes COVID-19, rapidly grew into a global pandemic involving millions of people and continues to be a serious health threat around the world. Drug developers are working towards developing a vaccine to combat the virus in the hope of stopping its spread and sparing the lives of thousands if not millions of people. Nuventra is honored to currently be working closely with the Sponsors of five COVID-19 programs.
Beyond SARS-CoV-2, viruses present some unique drug development challenges. For example, some viruses (especially RNA-based viruses) are able to rapidly evolve as they spread through a population, rendering therapies targeting the mutated structures less effective and often necessitating the development of new therapies. In addition, certain viruses can effectively “hide” within host cells in a state called latency, either by integrating into the host genome directly (e.g., HIV) or by otherwise maintaining viral genetic material in the cell (e.g., herpesvirus episomes).
Some infectious diseases, by their very nature, make a standard clinical program impossible. For example, enrolling Ebola patients into a typical clinical trial is not feasible. To address this and similar issues, the FDA has established what is known as the Animal Rule, which allows the use of animal models of disease rather than requiring human efficacy studies. While the Animal Rule provides a pathway to approval for these critical therapies, it is important to recognize that Sponsors must still establish safety and an appropriate dose in human subjects prior to approval.
Overall experience in the infectious disease field highlights the critical nature of clinical trial design and the role that pharmacokinetics can play in guiding appropriate clinical dosing. Modeling and simulation are also often essential for developing optimal dosing strategies.
Nuventra’s vast experience with infectious disease has enabled our clients to make well-informed decisions about their development programs. Despite the many complexities associated with developing drugs to treat infectious diseases, having a team of broadly experienced clinical pharmacology experts can dramatically increase the probability of getting your drug to market.
Nuventra’s Infectious Disease Experience
Nuventra can perform any of our wide range of services for drugs to treat Infectious Disease indications. Some of our recent project experience in this area includes:
- Animal Rule Development
- Clinical Development Plan
- Data Management
- Due Diligence
- EOP1 and EOP2
- IND, Pre-IND, & NDA Preparation
- Pediatric Study Plan (PSP)
- Population PK Modeling
- Scientific Writing
- Regulatory Strategy
- Type C Meeting
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.
Infectious Diseases Indications
Nuventra has experience with a number of Infectious Diseases indications, including:
- Candida Species
- Coronavirus (e.g., SARS-Cov-2, which causes COVID-19)
- Dermatophytic Fungi
- Ebola Virus
- Hepatitis B and C
- Lyme Disease
- Marburg Virus
- Zika Virus