Lennard Hachmann

About Lennard Hachmann

Leader of global CMC teams, with demonstrated success in strategic and tactical analysis and implementation spanning pre-clinical to commercialization in the inhaled drug / device combination products space. Organized, analytical, and efficient leader with a proven track record of managerial and regulatory success. Program manager shepherding product in late-stage clinical development, interfacing with CMC, Clinical, and Regulatory functions to drive progress.

Experience

1. Senior Director Project, Program, and Portfolio Management

   Kodiak Sciences

   Sep 2018 — Present · CA

   Leading cross-functional team during late-phase clinical development, including initiation and completion of six world-wide Phase 3 clinical trials for a biologic anti-VEGF drug that is intravitreally administered. Coordinated activities between Clinical, Regulatory, Quality, CMC, and senior management- Led device-design and packaging-design efforts for a new-in-class pre-filled syringe that matches functionality for the physician with the enhanced value proposition of the development product, including defining user requirements and design inputs, performing contextual inquiry, design development and verification- Managed relationship with IRT vendor, including writing user specifications, leading and conducting user acceptance testing- Led development of serialization and aggregation strategy- Reviewed and negotiated contracts with external clinical, CMC, and compliance suppliers - Modeled program-level drug-product demand as a function of time, site enrollment, and highly-complex treatment regimens to project required timing and quantity for drug re-supply - Modeled and determined re-supply parameters for automated inventory management at clinical sites- Led the development and approval of the lead product’s non-proprietary name- Participated in design of bespoke drug-product manufacturing facility, combining equipment requirements with process flow- Led GDPR-readiness efforts for company to achieve compliance

Education

• Massachusetts Institute of Technology

  Master's degree, Chemical Engineering

  1998 — 1999

• Brown University

  Bachelor of Science (BS), Chemical Engineering

  1994 — 1998