Although the industry has seen an increase in overall R&D spending the number of novel compounds making it to market has decreased. Drug innovators are faced with wading through thousands of compounds in order to get one to market, spending an average of 10 years in drug development. By speeding a potential compound into man, drug developers can make critical portfolio decisions, potentially saving millions of dollars and years in development. Also, technological advances such as high throughput screening (HTS) have offered drug developers a seemingly endless number of candidates to investigate. However, HTS favors higher molecular weight compounds which tend to be larger, less soluble and less bioavailable, increasing the challenges faced in getting a drug to market.

Aptuit INDiGO® accelerates early drug candidates, even those that are poorly bioavailable, into the clinic by reducing time from API to regulatory submission (IND/CTA) in as little as 26 weeks under certain circumstances. Accelerated development is achieved by tightly integrating traditional silos - API manufacturing, toxicology metabolism/pharmacokinetics and clinical supplies - into a single project. Aptuit INDiGO® projects are managed by a veteran, dedicated project manager and staffed by professionals with experience spanning the entire drug development process. This service may be used for small molecules, peptides, proteins, cell-based therapies and combination products in all therapeutic areas and can be customized to accommodate varied client needs.

Our program utilizes state-of-the-art development science and formulation approaches, such as amorphous dispersions, to accelerate initiation of Phase I programs. Aptuit’s accelerated approach can also be applied to molecules with acceptable solubility. We provide all the Aptuit INDiGO® elements in-house, ensuring expert-to-expert handoff and tight project management within our world class, global facilities. Our ability to integrate these early development components is unprecedented and still unmatched in the industry. We combine our capabilities to deliver superior timelines that will help accelerate your drug development program maximizing your investments and patent portfolio.

Why choose Aptuit INDiGO®?

• Get drug candidates, including poorly bioavailable drugs, into human trials quicker
• Customize your program to meet your needs, with or without API supply
• Leverage integrated in-house capabilities, including world-class preclinical toxicology, clinical supplies, regulatory consulting and compliance services and regulatory documentation and IND/CTA preparation support services
• Achieve reduced timelines and accelerated time to submission
• Benefit from streamlined scientist-to-scientist communication
• Apply quality-by-design principles
• Ensure the best possible approaches for poorly soluble drugs including amorphous dispersion in capsule
• Leverage first class solid state chemistry expertise
• Take advantage of intellectual property support capabilities.