What we offer
IMV is a premier strategic advisor to the life sciences industry with focus on industrial applications and offers consulting in the following areas:
● New platform technologies for vaccine delivery: Advances in vaccine technologies have evolved significantly in the last decade, profoundly changing the future of prohylactic and therapeutical vaccine development. Next-generation vaccines with improved safety profiles, enhanced efficacy, and targeted utility. Which technology matches your vaccine candidate most suitable? ● Selected bacterial vaccines: Classical bacterial vaccines contain killed or attenuated bacteria that activate the immune system. However, the development of multidrug-resistant (MDR) bacteria are rapidly increasing. There is an emerging unmet medical need for the development of the next generation of bacterial vaccines based of innovative delivery systems. ● Therapeutic vaccines: Cancer (tumor associated antigens and neoepitopes) Chronic infectious diseases Autoimmune diseases Allergies Analysis of undesired outcomes or unsatisfying efficacy in preclinical/ clinical trial and re-programing of R&D strategy. Successful therapeutic regimes are based of a combination of various tools to maximise immune efficacy and minimise immune exhaustion. ● Adjuvant and immune profiling All licensed adjuvants for human vaccines are based on aluminum salts or oil in water emulsions. Their mechanisms of action is only partially understood. Novel adjuvants targeting specific innate immune receptors have been tested in human clinical trials. Systems biology is applied to immune profiling and vaccine responses.
1. Vaccine Consulting
A discrepancy is observed in many diseases treated with vaccines that the measured clinical immune response does not correlate with the vaccine-induced protection. There is a lack of correlates of protection. With molecular tools the traces of a vaccination can be followed up in real-time and checked for molecular signatures on cell, protein, DNA and RNA level. Assessment of companion diagnostics for therapeutic (cancer) vaccines as referred to EMA/FDA guidance for industry. Today, approximately 50% of new cancer drugs in development are projected to have a companion biomarker. Biomarkers are essential for Precision Medicine.
2. Diagnostics & Biomarker Consulting
Bridging the gap between academic research, small to mid-size pharma and leading companies by project partnerships. Support of licensing and acquisition decisions based on in-depth analysis and research. Translating new technologies to trials. Regulatory enviroment of therapeutical vaccines: regulations, guidelines for new biologic entities (NBE) to meet FDA/EMA requirements. Currently there are over 1,400 trials with cancer vaccines registered on Clincaltrials.gov.
3. Pharma & Biotech Consulting
● Matrix leadership of cross-functional project/ portfolio teams ● Experience in managing complex issues on a global level ● Management of portfolio budget, resources and timelines ● Strong analytical and conceptual thinking as well as target- orientation ● Risk analysis and scope change processes (CAPA) ● Experienced team player in a multi-cultural, cross-functional environment ● Effective oral and written communication skills, Project Progress Reports (PPR) ● 25+ years PM experience within pharmaceutical industry across several fields
4. Project-Portfolio-Program Management (IPMA-B certified)
Institute for Molecular Vaccines - Consulting / PPP Management
● Experience in managing complex projects (portfolio, program) on a global level ● Risk analysis and scope change processes (CAPA) ● 25+ years project management experience within pharmaceutical industry across several fields ● CMC management and advisory. Support for traditional and accelerated approval.
● Global Senior Project Leader for Animal By-Products (ABP) projects ● Coordination of global activities with ABPs according to EU rules and guidelines ● Implementation and standardization of import and export processes ● Establishing SOPs for safe and efficient operations of ABPs ● Global technical support for ABPs (Quality assurance) ● Analysis and evaluation of the complete product portfolio ● Teaching of ABPs and German Animal Welfare Act for R&D ● Expert on ABP-imports for national and international authorities
Fraunhofer Institute for Cell Therapy and Immunology / FhG: CRO No.1 in Europe
● Head of Vaccine Development & Diagnostics ● Global account management ● Evaluation and prioritization of new projects for drug development ● Operational portfolio leadership: therapeutical molecules and processes ● Discovery biology (new targets); functional bio-assays, diagnostic systems ● GMP-Manufacturing of microorganisms, eukaryotic cells, proteins, DNA ● Quality control and assurance (QA/QC) ● Project leader gene technology/ bio safety: § 15 Abs.4 GenTV ● Sterile working in BSL-1/-2/-3 laboratories
University of Leipzig/ Institute for Virology
● Habilitation: Venia Legendi for Virology (major PhD) ● Expert on therapeutical vaccines (cancer, infection, metabolic diseases) ● Large animal models (swine, horse, cattle) ● Teaching, publications, presentations, talks
● Head of Special Projects Animal Health (Ingelheim ) ● Project governance and portfolio management ● Drive of feasibility projects to commercialization ● Responsibility for global R&D portfolio ● Operational portfolio leader (EU-wide, preclinic to PhI) ● Experience with in-licensing projects ● Lead of the global bio strategic group ● Reports to the Board of Managing Directors ● Head of Therapeutical Cancer Vaccines program (Vienna) ● GMP-Manufacturing of cancer cells and vector viruses (whole cell vaccine) ● Expert on genetically engineered viral vector systems ● Expert on recombinant cancer vaccines ● Clinical trial management phase I/ II (GCP)
Battelle-Institute Frankfurt a.M./ Germany
● Head of Tumor Biology and Virology ● Diagnostic systems for various cancer diseases ● In vitro and in vivo tests for anti-cancer drugs ● Management of cancer cell banks ● Experience in small animal models (rats, mice) ● Contract manufacturing of viruses