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Viral Diseases

Viral diseases include everything from the common cold and the flu to human immunodeficiency virus (HIV) and Ebola. Because of the vast diversity of viral diseases and of the potential therapies designed to treat them, drug development in this area can be uniquely challenging.

Among the biggest challenges to creating antiviral therapies is the tendency for viruses to rapidly evolve their genomes and the ability of some viruses to “hide” their genetic material within the host genome. These viral strategies change the way viruses present themselves, making it more difficult to design targeted therapies.

Some viral diseases, by their very nature, make a standard clinical program impossible. For example, Ebola is an uncommon disease and its clinical manifestation is both severe and of rapid onset. As a result, enrolling Ebola patients into a typical clinical trial is not feasible. To address this issue, the FDA has established what is known as the Animal Rule, which allows development of drugs for diseases like Ebola in a way that uses animal models of disease rather than requiring human efficacy studies.

While pathogen-related factors are important to developing antiviral drugs, having an accurate understanding of host (i.e., human) factors is equally critical. Variabilities within the target patient population, such as demographics (e.g., age, race, renal function) or concomitant medication use, can have significant impacts on drug exposure and efficacy. Modeling and simulation can be used to relate a wide variety of intrinsic and extrinsic factors to patient response and can help inform dosage adjustment recommendations.

Antiviral formulations can present their own challenges. For example, a number of antiviral therapies now consist of combinations of two, three, or more drugs that target various aspects of the viral structure or life cycle. While these therapies can dramatically increase efficacy, they can also increase the possibility of drug-drug interactions and make pharmacokinetic (PK) assessments more challenging.

Despite the many complexities associated with developing antiviral drugs, having a team of clinical pharmacology experts with broad experience in viral diseases, combination therapies, and the unique regulatory challenges associated antiviral drug development can dramatically increase the probability of getting your drug to market.

Nuventra’s Viral Disease Experience

Nuventra can perform any of our wide range of services for drugs to treat Viral Disease indications. Some of our recent project experience in this area includes:

  • Addressing Clinical Holds
  • Advisory Committee
  • Animal Rule Development
  • Clinical Development Plan
  • CSR Preparation
  • Data Management
  • Due Diligence
  • Early Project Lead
  • EOP1 and EOP2
  • IND Preparation
  • Manuscript Preparation
  • NDA Preparation
  • Pediatric Study Plan (PSP)
  • Population PK Modeling
  • Pre-IND
  • Protocol 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.

Viral Disease Indications

Nuventra has experience with a number of Viral Disease indications, including:

  • Adenovirus
  • Cytomegalovirus
  • Ebola Virus
  • Hepatitis B
  • Hepatitis C
  • HIV
  • Influenza
  • Smallpox
  • Zika Virus

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