End to end drug development expert.

You need to know what you don’t know.

You need to feel confident everything is on schedule.

You need to feel confident your risks are identified and mitigated.

That’s what I can do, either broadly or focused on a particular issue.

I do it all with grace, dignity, and shared success.

Now Accepting New Clients

Balto Consulting

Mischa A. Hepner

Contact me: info@baltoconsulting.com

With over 20 years of experience in both research and development, I can be your asset and company’s advocate on your development teams. By solving specific challenging problems, being a single point of truth in the organization, establishing development plans, I provide Biotech / Pharma Project Management Services from Pre-IND through Commercialization.

  • Services offered:

    • A second set of eyes to review the project, work with the team, pull everything together, ensure important risks have been identified, mitigated, and communicated appropriately - I can provide you an accurate assessment and give you the information you need to make important decisions.

    • Work with your team to create a governance structure that meets the needs of your organization

    • Develop custom project management tools

    • Lead team in creating or updating robust drug development plans from pre-IND through commercialization and anywhere in between, as well as thought out and vetted timelines to guide in team execution and inform internal and external stakeholders

    • Operational Project Management - ensure an overall project timeline is in place, up to date, and accurate

    • Coordinate Regulatory Submissions

    • Coaching and Mentorship

  • Have you recently acquired an asset and need to transfer asset files into your company? Do you need good communication between the two organizations, working to create a strong working relationship? I can assist you with this.

    You may have scientific experts on board but no one to manage the vendors they're overseeing to ensure a successful project - I can support your organization.

  • In addition, I also offer Clinical Trial Support

    • Phase 1 PK strategy - how to fast track your phase 2 program. From first in human, ADME, human PK, TQT, DDI, hepatic and renal impairment, among others, let's ensure you have a plan to deliver this data in time.

    • Study Synopsis and Protocol Development

    • Vendor management

Services