Provide FDA regulatory affairs support to scientists/teams developing novel cancer treatments.

Experienced consultant providing expertise for R&D and Regulatory strategies for biopharmaceuticals, including small and biomolecules, and gene / cell therapies.

Beyond Monumental (http://www.beyondmonumental.org/) is the parent organization for the Indianapolis Monumental Marathon. Heading into its 12th year the Indianapolis Monumental Marathon is Indiana's largest and fastest marathon and among the 100 largest marathons in the world. Starting and finishing in downtown Indianapolis, this flat and fast course highlights landmarks and historical neighborhoods throughout Indianapolis. No matter your hometown, the Monumental is the ideal fall marathon, offering more than 20 hotels within walking distance of the Start, Finish and Health & Fitness Expo at the Indiana Convention Center. In addition to the Boston Qualifying Monumental Marathon, there is a half marathon, 5k and Kids' Fun Run. Since its inception ,this not-for-profit marathon has donated over $800,000 to support fitness, health, and leading healthy lifestyles for students in IPS school.

Douglas Balogh, Ph.D., recently retired as a Director in Guidehouse Consulting's Life Sciences Regulatory practice, focusing on FDA Regulatory matters.Over the past 13 years, first with Anson Group later Navigant Consulting (Anson Group was acquired by Navigant in 2013) and finally with Guidehouse (Guidehouse acquired Navigant in 2019) I have been assisting clients with CMC projects and development and management of Regulatory strategies. My areas of expertise are listed below, and over the past 13+ years, I have assisted clients in almost all these areas. CMC: * CMC project planning and development timeline * API route selection* Formulation selection* Problem solving and recovery from technical set backs* Specifications* Stability study design* Vendor selectionRegulatory Affiars:* Development of Regulatory Strategy* Regulatory submissions: . - Meeting requests. - INDs. - Orphan drug applications. - ANDA / NDA / 505(b)(2). - Annual updates* Prepare clients for meetings with the FDA* Risk Assessment* cGMP Quality AuditLitigation and Disputes:* Assisted law firms in understanding FDA regulations as they might pertain to particular legal cases* Participated as expert witnesses in legal disputes involving pharmaceutical development and manufacturing.Prior to my consulting experience, I retired after twenty seven years in drug development from Eli Lilly and Company, where I had significant experience leading teams in developing CMC plans, API processes, clinical trial & commercial formulations, analytical methodology. My teams also developed regulatory strategies and prepared regulatory submissions, and transferred technology to 3rd party and/or commercial manufacturing sites. As a team leader, I had vast project management experience with development of timelines, budgets, risk management. Integration of CMC activities with the Preclinical, Clinical, and Marketing objectives was critical.

Douglas Balogh, LLC, as an independent consultant has been put into "idle" mode, as I have taken a regular position as Navigant Conculting.My specialty is as a consultant for the pharmaceutical industry, specializing in CMC, Regulatory Affiars, and Project Management. For the last 5 years, I have been assisting clients with their CMC and Regulatory development strategies. I understand how important cost is to my clients, and work to fully understand each project to find the most cost effective way to meet valid project requirements.In 2008, I retired after twenty seven years in drug development from Eli Lilly and Company, where I had significant experience leading process development teams for drug candidates in various stages of clinical development. These teams prepare development plans, develop/optimize API processes, develop CT and commercial formulations, supporting analytical methodology, prepare and respond to regulatory submissions, and transfer technology to 3rd party and commercial manufacturing sites. I am intimately familiar with: developing and managing to timelines, integration of project components, budgets, risk mitigation strategies, and team leadership.

Team Leader/Project Manager for drug candidates in late phase clinical trials. Teams developed commercial processes and formulations, established specifications, transferred technologies, supplied clinical materials, and submitted regulatory documents.