strategic and operational support for biopharmaceutical programs

frese biopharma consulting is your partner for the development, registration and maintenance of biopharmaceuticals in highly regulated markets - covering technical, preclinical and clinical aspects. Our experiences include innovative drugs as well as biosimilars from early development, through global clinical trials, BLA/MAA preparation and beyond.

Dr. Marc-André Frese
principal consultant, co-owner

Marc is a regulatory affairs professional with > 15 years of experience in biologics. He has broad expertise and deep scientific knowledge in technical, preclinical and clinical development of biologics with a track record of > 15 successful health authority meetings with FDA, EMA, local authorities and notified bodies. Marc has been authoring and coordinating numerous briefing books, > 15 new IMPDs/INDs and had major contributions to 3 BLAs/MAAs.

Dr. Katrin Frese
principal consultant, co-owner

Katrin is a project management professional with > 15 years of experience in technical development of biologics, covering all steps from candidate selection to clinical trials, process validation and registration. She has been leading international project teams, CMO interactions, technical transfers and due diligences. Since October 2022, Katrin provides technical project management and CMC expert services as a consultant.

Marc's professional experience

since Sep 2021

principal consultant, co-owner
frese biopharma consulting GbR

Nov 2019 - Aug 2021

Director Regulatory Affairs
Polpharma Biologics S.A., Gdańsk, Poland/remote
building and leading a global Regulatory Affairs/Regulatory CMC department and a large network of external consultants, member of the Polpharma Biologics management team reporting directly to the CEO, responsible for a portfolio of biosimilar products in advanced stages of development, defining regulatory strategies and executing global submissions in the EU, US and RoW

Jun 2016 - Oct 2019

Senior Manager/Manager Regulatory Affairs
bioeq, Holzkirchen, Germany
global regulatory lead for several biosimilar programs

Nov 2011 - Mai 2016

Manager Technical Regulatory Affairs
Roche, Penzberg, Germany
technical regulatory leader for innovative development products

Sep 2009 - Oct 2011

Laboratory Head Protein Characterization
Sandoz Biopharmaceuticals, Kundl, Austria
building and leading an analytical lab, project analyst

May 2009

Dr. rer. nat. (Ph. D.) in biochemistry
University of Bielefeld, Germany

Katrin's professional experience

since Oct 2022

principal consultant, co-owner
frese biopharma consulting GbR

Mar 2021 - Jul 2022

Director, Group Leader Technical Project Management
MorphoSys AG, Germany
building and leading a team of technical project managers in the CMC department, responsible for a portfolio of innovative products in the commercial phase as well as in early and advanced stages of development, moving several monoclonal antibody programs from candidate selection to commercialization

Jan 2020 - Feb 2021

Associate Director, Technical Project Leader
MorphoSys AG, Germany
leading technical projects teams in the development of innovative antibody products, representing all aspects of technical development in global project teams, performing due diligences, executing technical transfers

Apr 2015 - Dec 2019

(Senior) Manager, Technical Project Management
MorphoSys AG, Germany

Nov 2009 - Mar 2015

(Senior) Scientist, Protein Sciences
MorphoSys AG, Germany
development of analytical methods and bioassays for innovative product, transfer of analytical methods, leading comparability studies