Development

  • Development and approval of a first in class monoclonal antibody
  • Recombinant protein: review of programme to characterise the drug substance and final product
  • Establishment of the key preclinical investigations for a recombinant protein
  • Determination of key elements and review of comparability programmes: recombinant protein used in development program vs. commercial product


Regulatory strategy

  • Analysis of the regulatory pathway and regulatory strategy for biotech products with the EU as the target market
  • Target product profile and SmPC / product information development for monoclonal antibodies
  • Switch of a nationally registered medicinal product to a medical device allowing enhanced commercialization
  • Orphan drug and PIP strategies for monoclonal antibodies
  • Design and conduct of a regulatory roadshow in preparation of a centralized procedure


Centralised procedure

  • Preparation and successful conduct of a centralized procedure for a monoclonal antibody
  • Review of the clinical Module 2 CTD section for monoclonal antibody submissions of TOP 20 pharma
  • Review of the Module 2 for recombinant protein submissions of TOP 20 pharma
  • Preparation, conduct and debrief of pre-submission meetings with EMA
  • Liaison with the EMA for preparation of centralised submissions for monoclonal antibodies
  • Interpretation of the CHMP list of questions and preparation of response documents for various recombinant proteins
  • Support in appeal processes at CHMP level
  • Preparation, rehearsal and debrief of oral hearings incl. SAG meetings for recombinant proteins and monoclonal antibodies
  • Adaptation of a US CTD for EU-submission of a Marketing Authorisation Application for two recombinant proteins


Agency interactions

  • Briefing packages for Scientific Advice at national EU authorities
  • Strategic outline and review of the briefing package for a pre-IND meeting at the FDA including presentation of specific topics at the meeting on behalf of the client
  • Drafting questions and company's positions for Scientific Advice meeting with the German authority, PEI, including review of briefing book
  • Liaison with the EMA for preparation of numerous scientific advice submissions incl. pre-submission activities
  • Communication with the German agency PEI for national scientific advice


Rescue projects

  • Turn negative CHMP opinions into positive opinions for a monoclonal antibodies
  • Turn a negative CHMP opinion into a conditional approval for a monoclonal antibody
  • CMC trouble-shooting regarding changes introduced in the manufacturing of a marketed biotech product
  • Use of invalid equipment caused by supplier error in purification of recombinant proteins – evaluation, presentation, decision-making on use of the material, interaction with agencies


Due diligence for

  • Tissue-engineered products
  • Portfolio of monoclonal antibodies
  • Merger / acquisition of a biopharmaceutical company


Clinical trial applications

  • Gap analysis of the preclinical programme to support the first-in-human clinical trial of a monoclonal antibody
  • Review of the protocol for a first-in-human trial with regard to regulatory requirements


Paediatric investigational plan (PIP)

  •  Paediatric investigational plan for monoclonal antibodies: review of application and analysis of PDCO feedback


Board and advisory board activities

  • Member of the scientific and regulatory evaluation boards of three TOP-10 Pharma and several mid-size biotech companies
  • Preparation and conduct of scientific board meetings of TOP20 pharma and start-up biotech companies