WHITE PAPERS & CASE STUDIES

• Advancing A Cell Therapy Drug To The Clinic: Safety Tox Package

  Cytopeutics, a provider of mesenchymal stem cells (MSC) for clinical trials and treatment, needed to conduct safety and tumorigenicity studies in appropriate animal models for its hMSC product.

• Streamlining Study Start-Up For Accelerated Drug Development

  Discover how we accelerated a Phase 1 study’s start-up time by 70%! This case study shares insights on streamlining communication, strategic planning, and more.

• Expediting Early-Phase Development Of Small Molecules: An Integrated Approach

  Small molecule APIs and drug products are more complex and potent than ever. Explore key strategies for efficiently advancing small molecules from API to pre-clinical data and clinical supply.

• FDA Recommendations For Gene Therapy For Primary Mitochondrial Diseases

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• Formulation Development Strategy For Early Phase Human Studies

  Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

• Nonrodent Models: Minipig Specialty Capabilities

  The minipig's similarity to humans, availability, known disease status, and feasibility of genetic manipulation offer advantages over traditional species, impacting ethical considerations and cost of animals in biomedical research.

• Development And Regulation Of Veterinary Monoclonals

  Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

• Women-Centric Approach To Clinical Trials

  Women are demanding more power, information, and control when it comes to their health. Learn how women now have a stronger voice when it comes to clinical research for treatments that impact their care.

• Safety First: Occupational Exposure In Oncology Drug Development

  This report provides a roadmap for assessing toxicological and potency risks of small molecule oncology compounds while consistently ensuring worker and patient safety.

• Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma

  Treatments for glioblastoma multiforme (GBM) are in high demand. Learn more about the new possibilities for increased dosing and diffusion capabilities offered by nanoformed APIs.

• Nasal Vaccine Development, Manufacturing, And Device Selection

  When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.