Serving the pharmaceutical and biotechnology industry in designing, planning and execution of international clinical development and medical affairs.
“I had the pleasure of leading a consulting team in a partnership with a Global Medical Affairs organization led by Hartwig Gajek. Dr. Gajek brought us on board to support his efforts in transforming a traditional Medical Affairs organization into a truly strategic organization at the global...» more
Clinical development planning (medical need assessment, clinical development plans, study design, evaluation of clinical data)
Implementation whilst overseeing clinical programs
Assessment on suitability of clinical trials/programs for regulatory licensing
Clinical safety and benefit/risk assessment
Creation and implementation of life-cycle management activities (publication/communication plans, third-party-sponsored research programs, advisory/focus groups, platforms development for scientific collaborations)
Evaluation of business opportunities
Process design and implementation for clinical operations and medical affairs
Hartwig Gajek M.D., Managing Director of Hesyra-Medical has practiced clinical medicine over 10 years, and looks back at an industry career of approximately 30 years.
Hartwig has held various positions in the global pharmaceutical and biologics/biotechnology industry with both, world-wide and regional responsibility for all phases of clinical development, or medical affairs.
In particular, he gained experience in the field of rare or orphan diseases, with special focus on benign haematology i.e. haemostasis and thrombosis, immunology and auto-immunity. Scope included:
Design and implementation of development plans through all pre-clinical and clinical phases, including negotiations with national and international regulatory authorities.
Selection of external service providers, overseeing clinical operations activities
Contribution to regulatory licensing activities (e.g. clinical dossiers, labelling).
Safety management (e.g. assessment of individual and aggregated events, PSUR/DSUR, ongoing benefit/risk assessment in clinical trials and in the post-marketing period).
Life-cycle management pre- and post-launch (e.g. Expanded Access, late-phase research studies, publication and communication plan, liaison with the medical-scientific community, support of third-party-sponsored research, medical advisory boards and working groups, advocacy creation, value dossiers).
More recently, Hesyra-Medical GmbH has been retained by a mid-size Italian bio-pharmaceutical company, to re-shape global Clinical Development and Medical Affairs, to fit their needs in globalization. Deliverables included:
Gap analysis and development of a roadmap for implementation.
Design, implementation and training on industry-standard clinical SOPs, and comprehensive Medical Affairs process guidance.
Rescue activities for clinical projects on a critical path.
Revision of the operational model for clinical development projects to increase operational efficiency, stringency and compliance.
For further information on the professional background, please refer to the LinkedIn profile
“In my interactions with Dr. Gajek I found an experienced and innovative colleague who was able to create clinical development and trial designs that considered both opportunity and risk without compromise for patient safety. His regulatory and operational acumen frequently identified potential problems to be avoided as well as novel approaches based on the most recent information."
Mike Fournel, Chief R&D Officer, Kedrion S.p.A.
Castelvecchio Pascoli – Barga (Italy)
at Pharmaceutical Industry Conferences
Building Long-Term Sustainability of Clinical Research Networks and Registries
Orphan Drugs & Rare Diseases Global Congress 2015 Europe
29.06. - 01.07.2015, London/UK
Running efficient patient registries
2nd Annual Optimising Orphan Drug Development
19.01. - 20.01.2012, Lyon/France
Working with stakeholders to build patient registries
World Orphan Drug Summit
31.05. – 01.06.2011, Frankfurt/Germany
Continued clinical development and risk management in the post-approval phase
SMI Paediatric Clinical Trials Conference
25.01. - 26.01.2010, London/UK
Challenges in Clinical Trials on Rare Congenital Disorders
SMI’s 3rd Annual Conference on Paediatric Clinical Trials
19.01. – 20.01.2009, London/UK
Case study: Conducting Trials for Orphan Indications
Jacob Fleming Conferences: 4th Annual Patient Recruitment and Retention in Clinical Trials,
13.10. - 15.10.2008, Amsterdam/The Netherlands
1.: Stein M, Nemet A, Kumar S, Lumry W, Gajek H, Macchia R, Zamfirova V, Bergman G, McNeil D, Hooper J, Moy J, Pesek R, Upton J, Shapiro R, Sussman G, Roifman CR
Efficacy, Safety and Tolerability of Kedrion 10% IVIG in Primary Immunodeficiency
LymphoSign J 2016; 3: 99-109
2.: Planitzer CB, Säemann MD, Gajek H, Farcet MR, Kreil TR
Cytomegalovirus neutralization by hyperimmune and standard intravenous immunoglobulin preparations
Transplantation 2011; 92(3): 267-70
3.: Oldenburg J, Goudemand J, Valentino L, Richards M, Luu H, Kriukov A, Gajek H, Spotts G, Ewenstein B
Postauthorization safety surveillance of ADVATE (antihaemophilic factor (recombinant), plasma/albumin-free method) demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice
Haemophilia 2010, 1-12, DOI: 10.1111/j.1365-2516.2010.02332.x