Gabriele Dallmann

Dr. Gabriele Dallmann

Founding Partner

Dr. Gabriele Dallmann is an internationally renowned expert with more than 25 years of experience in regulatory affairs and drug development of medicinal products with focus on biopharmaceuticals. 
 

Dr. Dallmann is an ex-regulator who has worked at Committees of the European Medicines Agency (EMA) and at the Paul-Ehrlich-Institut, the Germany's federal agency for Vaccines and Biomedicines. Dr. Dallmann was in charge of the approval of antibody-containing products at the Paul-Ehrlich-Institut and has been involved in the assessment of other product classes of biopharmaceuticals including ATMPs. 

In her function, she has been in charge of the review of all kind of life cycle applications of medicinal products and all parts of the applications, i.e. CMC, pre-clinical and clinical part, she has reviewed applications, has lead the decision on the benefit-risk ratio and had to decide on regulatory, legal and administrative issues related to applications. She has been involved in the authorisation process of medicinal products in committees and working parties at the European Medicines Agency in London for many years. She was deputy member of the CHMP, a member of the Scientific Advice Working Party of the EMA and a member of other scientific working parties. Dr. Dallmann was rapporteur or co-rapporteur of a large majority of biopharmaceuticals including products with current blockbuster status. She has represented the opinion of the German Authority on various product classes to the EMA committees such as on monoclonal antibodies, other recombinant proteins, vaccines, biosimilars, plasma-derived products, ATMPs. In addition, she has experience in laboratory analysis of biopharmaceuticals, has established an accredited control laboratory for the conduct of potency and functional assays and has conducted inspections at manufacturing and testing sites of pharmaceutical companies.

Dr. Dallmann has detailed knowledge of the global administrative processes required by agencies such as the EMA and FDA to get approval of new medicines, of the regulatory and legal requirements applicable to medicines, of the drug development process including experimental testing of medicines, of the relevant quality management systems, of interests and practises utilised for in-licensing and outsourcing of product candidates and technologies and services. She has been involved in the elaboration of regulatory guidelines as rapporteur or as an invited expert of the relevant drafting group. She has extensive Agency, industry, academic and consultancy contacts.

As a consultant, she is working as an innovative partner with local and global life science companies of all size to support their drug development planning, their regulatory strategy and market positioning. She helps in partnering and outsourcing activities. She provides her input based on her long-term experience and know-how in efficient drug development and regulatory strategy. She provides solutions which include the view and thinking of Dr. Dallmann as ex-regulator and the expertise of her drug development consultancy. The services include mission-critical advice on science, strategy and processes of drug development, trouble shooting, support and coaching for scientific advice processes and agency meetings, marketing authorisation application procedures, due diligence and partnering processes. An expanded expert team supports in the preclinical area, statistics, medical writing etc.

She has published various articles, gives invited talks and conference presentations on aspects of development, testing and regulatory affairs of biological medicinal products.

In 2013, together with Dr. Diane Seimetz she founded Biopharma Excellence.

She founded EUCRAF which offered a seminar programme on “Regulatory affairs for biopharmaceuticals”. 

Dr. Gabriele Dallmann is biologist by training with a PhD in immunology from Berlin University (Charité).