Aptuit Launches Program to Accelerate Early Stage Drug Development
News Oct 06, 2008
Aptuit Inc. has announced the launch of a new program to accelerate early stage drug development. Aptuit INDiGO™ is a fully customizable program that offers an accelerated track from preclinical candidate selection to regulatory submission (IND, CTA) to support Phase 1 Clinical Trials.
Aptuit’s approach streamlines the pre-Phase 1 process by reducing the typical hand-off delays and development obstacles that slow a molecule’s progress in the traditional drug development model.
“The drug industry has witnessed a precipitous decline in the number of drugs reaching the market due in part to the difficulty in translating promising laboratory candidates into products suitable for Phase I studies,” said Tim Tyson, Executive Chairman and CEO, Aptuit.
“As such we have launched Aptuit INDiGO, which we view to be an important and forward-looking program to address the challenges our clients face, and overcome obstacles in the traditional drug development model that are curbing the progression of new medicines,” Tyson added.
While many drug development programs are conducted sequentially and siloed, Aptuit INDiGO is executed across several parallel and integrated tracks – API manufacturing, toxicology, metabolism/pharmacokinetics, clinical supplies and a successful regulatory application.
The program centers around seamless scheduling between development phases; enhanced information and data-sharing between development groups; concurrent work during certain phases of development to expedite the overall process; and increased focus on patent issues and life cycle management early in the drug development process.
All aspects of the approach are designed and implemented to meet the requirements for successful submission of a regulatory application, which is prepared in parallel where possible. The program can be applied to small molecules, peptides, proteins, cell-based therapies and combination products in all therapeutic indications, and is offered with a fixed timeline and price. Aptuit INDiGO can be tailored to span from API manufacture through first-in-human or proof-of-concept Phase 2 studies.
With a significant percentage of molecules under development showing poor solubility, Aptuit INDiGO offers solutions for accelerating the development of poorly soluble molecules. Because solubility and bioavailability can pose significant barriers to successful drug development, the program utilizes drug development science and formulation approaches, such as solid amorphous dispersions, to accelerate initiation of Phase 1 programs.
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