Advanceutics Inc.
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Overall Experience:
- About 20 years in industry; 13 years in management functions for CMC, Pharmaceutical Development & Manufacturing.
- About 4 years in consulting for broad spectrum (pre IND to post approval) for pharmaceutical, technology, and process development, process validation, LCM, regulatory CMC (IND and NDA and post approval changes), CMO selection and management. Consulted with about 20 companies (San Francisco bay area and EU based).
- More than 6 years experience as Sr. Director / Ex. Director in leading integrated CMC functions (API, drug product, analytical development, packaging, scale-up, validation, launch manufacturing, LCM, and BD support).
- More than 8 years experience in identifying and managing external CDMOs.
- Architect for pharmaceutical development and Manufacturing facilities (Discovery Pharmaceutics, API Development, Product Development, Analytical Development, Clinical Packaging, Process Engineering).
- Successfully hired Directors; led reorganizations; developed CMC teams and hired CMC team leaders.
CMC Leadership and Project Management:
- Led more than 10 products to commerce from different stages of development.
- Project manager for several CMC programs in transitioning from Phase 2 to Phase 3 and eventual registration. Proactively managed fiscal, staffing, and external resources to meet project goals.
- Successfully led programs in early stage (pre candidate nomination, pre IND dev, Phase I), late stage (Phase 3, ICH stability, scale-up, process validation, launch manufacturing, etc), and LCM.
- CMC team leader for several NCE programs (oral and iv) with approval in US and EU.
- Small molecule - oral (IR and MR) and injectable - US & EU.
- Developed and implemented CMC regulatory strategies for EOP2 CMC, background packages, drafting NDA / MAA, responses to FDA review and Day 120 / day 180 from EMEA.
- Management responsibility and oversight for logistics and supply chain to provide supplies for clinical trials; supported five phase 3 trials in one year.
- Lead for CMC Due Diligence to support BD initiatives (In/Out Licensing) on 3 programs.
- Implemented key elements of QbD (DOE, Cpk) in Mid 1990s, ahead of current FDA guidelines.
Contract Management:
- Led CMO selection (US and EU), led more than 10 development agreements, negotiated 1 commercial supply agreement (MSA), and co-led negotiations for Quality & Technical Agreements.
- Co led more than 5 successful PAIs; co-led external quality at CMOs, prepared CMOs and in house manufacturing plants for successful PAIs.
Patents / Publications / Presentations:
- Co-inventor of 6 patents (issued or under review).
- Co-author for book chapter on "Process Development and Scale-Up of Oral Fast-Dissolving Tablets".
- Co-author for 2 review articles in drug delivery.
- Delivered more than 25 lectures at meetings & universities.
- Led and organized numerous panel discussions and workshops at national and local meetings.