Development

Alita

Development Strategy & Capabilities

Alita embraces a long-term strategy and its experienced management team understands all elements of the commitment required for successful product development and commercialization. As an example, Alita integrates commercial strategy into all development initiatives from an early stage to lay the foundation not only for regulatory approval, but also for successful product launch. In addition, even though the company intends to focus on the United States for its own commercialization efforts, all development planning is conducted with a global perspective. Through this approach of combining a long-term perspective, a highly experienced management team, and a focus on clinical proof of concept and significant unmet medical needs, Alita is able to operate with an extremely clear focus, manage resources effectively, and increase its development programs' probability of success.

Alita has selected the urology/female healthcare therapeutic categories based upon such factors as the unmet medical need for innovative therapies, limited competitive development initiatives within the category, and the ability to effectively and efficiently target a concentrated physician base upon product approval without an excessive investment in sales and marketing.

Alita's management team, with its broad experience in drug development is soundly positioned to work closely with FDA to ensure timely approval and is committed to building strong relationships with partners and contractors to ensure an effective supply chain and cost-competitive pricing.

Alita has built a strong in-house clinical and regulatory structure with the following capabilities:

PRE-CLINICAL
  • Study Design
  • Bioanalytic support
  • Toxicology
  • Pharmacokinetics
  • Pharmacodynamics
CLINICAL
  • Phase I-III development
  • Study design & implementation
  • Biostatistics
REGULATORY
  • Strategy development & positioning
  • Document generation
  • Filing & Operations
  • FDA interaction
  • Compliance with GxPs