Lars Nieba
CEO of Engimmune Therapeutics
Lars Nieba
CEO of Engimmune Therapeutics
Reinach, Basel-Country
Overview
Work Experience
CEO
2023 - Current
Engimmune Therapeutics is developing next-generation T cell receptor (TCR)-based therapies to address unmet patient needs in oncology and immune-mediated diseases We couple high-throughput data generation with machine learning to radically change the way protein engineering is applied to TCR drug development.
Venture Partner
2021 - 2023
Evaluate early-stage companies for potential investments
CEO (until May 2021) & Chief Technology Officer
2019 - 2023
Challenge: Restructuring of the company and implementation of a new strategy. Developing Betalutin (Radioimmunotherapeutic Therapy) in time and in budget. Positioning of Nordic Nanovector as a leader in the field of Radioimmunotherapeutics. Responsibilities: Provide oversight and general management for the company as CEO Oversee a staff of > 60 FTEs in Switzerland, UK, Norway and Denmark a 40 Mio € budget Being directly accountable as CTO for the CMC development, QA, RA and the clinical supply of Betalutin and other pipeline products Overseeing 6 CDMOs Achievements: Developed and implemented a new strategy for the company Successfully managed the turnaround of the company Successfully finalized 3 oversubscribed financing rounds Developed a go-to-marker strategy for Betalutin Developed and implemented a robust production process for Betalutin Initiated the set-up for a commercial supply chain Prepare the company for FDA submission
VP and Strategic Product Lead
2016 - 2019
Challenge: Developing a technical product strategy for Bayer 2nd biggest product (Eylea) and building-up a portfolio management group for Bayer’s Bayer Biotech Portfolio. Responsibilities: Being accountable for 4 biotech product. Overseeing an investment of >150 Mio € (OPEX and CAPEX) for the biotech development, including a pre-filled syringe for Eylea with 2 new production facility projects in Germany and Japan Being accountable for the global commercial supply of Eylea Leading the Eylea leadership team, being accountable for all aspects with respect to production, QA, RA, supply chain and related safety issues Member of several senior management boards Chair of the Eylea Steering Committee Achievements: Developed and successfully launched in time and in budget a pre-filled syringe for Eylea Established a portfolio management group within Bayer Pharma Implemented several continuous improvement projects Established a robust commercial supply chain
Global Head of Functional Excellence in Clinical Operations
2012 - 2016
Challenge: Clinical Operations challenged for ever greater agility, speed and compliance in developing world class output Responsibilities: Provide oversight and general management for System Support, Training, Patient Recruitment, Quality Management, Reporting, Portfolio Management, Process & System Excellence, Resource Management and Biosample & Repository Management. Oversee a staff of > 350 FTEs in Switzerland, USA, China, UK and Canada with a 100 Mio CHF line budget and 40 Mio CHF in project variable costs Member of several senior management boards Chair of the Reporting, Systems and Process Governance board Chair of the Quality Oversight Group Achievements: Developed and successfully implemented a customer-focused strategy Harmonize the processes (Business and IT) in clinical operations globally Implemented several continuous improvement projects (i.e. Clinical Trail Management System, Quality Management System, electronic Trial Master File) and cultural change management projects (i.e. Introduction of Business Process Management)
Global Head of Clinical Supply Planning and Business Excellence
2010 - 2012
Challenge: Volatile external conditions created a continual challenge for agility whilst meeting cost targets and ideal service levels Responsibilities: Provide oversight and general management for Clinical Supply Chain Planning, Business Process Excellence, Resource Management and IT systems. Oversee a staff of 70 in Basel, Kaiseraugst and San Francisco with a 20 Mio CHF line budget. Member of several senior management boards Member of the PT Strategy Council Responsible and accountable for several continuous improvement projects and cultural change management projects Achievements: Developed and implemented a new Clinical Supply Chain Strategy with tighter integration with study management and high-level decision support tools for planned and predictable management Harmonize the processes (Business and IT) in clinical supply planning globally Implementation of the right CMC (Chemistry, Manufacturing, Control) strategy and global packaging initiative Introduced the New Opportunities program for talent development and talent exchange
Head of Biologics Technology Area Strategy Teams
2006 - 2009
Challenge: Expensive production costs as a result of previous poor productivity Responsibilities: Oversaw a group of 24 FTEs and with a budget for external collaboration of 5.5 Mio CHF Led a new platform for antibody process development Accountable for scouting new technologies, initiating deals, negotiating contracts, and closing deals Led negotiation for outsourcing clinical manufacturing for biologics Member of different joint steering committees Alliance manager for 1 big collaboration (Lonza) and 7 additional collaborations Achievements: Established and managed the first integrated biotechnology process development group involving in more than 25 successful deal closures and acquisitions Increased development speed by 30%, increased output productivity by 500%
Head of Technical Business Development Biologics
2003 - 2006
Challenge: Roche wanted to have access to outside molecules Responsibilities: Part of Due Dilligance teams, accountable for the CMC part, including GMP audits Core member of contract negotiation teams Global Technical Leader for Herceptin (new process) Achievements: Involved in more than 10 successful product deal closures Refined the way how Technical Development is collaborating with Pharma Partnering Developed a new process with titer improvement from 0.6 g/L to 2.0 g/l. Calculated savings for PT commercial manufacturing 100 Mio CHF
Senior Project Manager
2000 - 2003
Responsible for a Swiss nanotechnology program, major focus for nanobiotechnology and nanobiology Consultant for Technology (High-Tech) Achievements: Consultancy support for the foundation of a biotechnology unit in a Swiss mid-sized company Developement of a business model for an university group. Strong support in negotiation with potential partners. Evaluation of the best partner. Successful foundation of a new business unit in a major Swiss company. Master thesis of the MBA in Technology triggered contracts with new clients
Head Therapeutic Vaccine Research
1997 - 2000
Building-up and leading a research group of 15 people (I was the third employee at Cytos) Intellectual property evaluation and responsible person for the patent portfolio Core member in negotiation with Venture Capital companies for the first 2 financing rounds Achievements: Establishing Cytos as a leading Swiss Biotech company
Education
Doctor of Philosophy - PhD
1993 - 1997
Executive MBA
2001 - 2003
Master's degree
1987 - 1993