Aptuit Launches Program to Accelerate Early Stage Drug Development
Aptuit Inc. announced today the launch of a new program to accelerate early stage drug development. Aptuit INDiGO TM 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."
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 unique solutions for accelerating the development of poorly soluble molecules. Because solubility and bioavailability can pose significant barriers to successful drug development, the program utilizes state–of–the–art drug development science and formulation approaches, such as solid amorphous dispersions, to accelerate initiation of Phase 1 programs.
William Kerns DVM, MS, DACVP, President, Aptuit Consulting, noted, "Given the high failure rates in Phase 1 and Phase 2, it is essential to define the most economical and best path forward to Phase 1 Clinical Trials with acceptable safety and prototype formulations to increase the odds of success. Our Drug Development Experts have broad experience and expertise in early stage development across all therapeutic areas and they are available to assist in the planning and execution of new programs. Aptuit INDiGO provides our clients with a new and unique model to deliver new therapies through the regulatory process into Phase 1 on a fixed timeline at a fixed cost."
For more information on the program, please visit www.aptuitindigo.com
About Aptuit
Aptuit, Inc. is a global company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators. The company was founded by a group of industry experts with extensive market experience who have a track record of building a similar, highly successful company through acquisitions and investment. Aptuit provides a comprehensive suite of product development services and competencies to more than 800 biotechnology and large, fully integrated pharmaceutical innovators worldwide. Aptuit´s mission is to engineer a better drug development process, and is partnered with Welsh, Carson, Anderson & Stowe, one of the world´s largest private equity investors. For more information about Aptuit, please visit www.aptuit.com.