DRUG DEVELOPMENT COUNSELLING

CLINICAL
TRIAL SUPPLY
SOLUTIONS

Business solution

KLIFO Drug Development Counselling increases the value of development projects and operational strategies by bringing together a wide range of expertise across all key R&D functions to support our clients’ decision making. Based on thorough, data-driven assessments we help you to build robust drug development strategies.

Hanne Wulff Nielsen

VP

Hanne holds a Ph.D. in biopharmaceutics and has more than 25 years of pharma industry experience within pharmaceutical product development, business development, project and vendor management, marketing and medical affairs. She joined KLIFO in January 2019 and prior to this she has held specialist and leadership positions in large pharmaceutical companies and in biotech.

Direct/mobile: + 45 44 222 903
Email: moc.ofilk@neslein.ennah

Expertise &
therapy areas

Expertise

Product development strategies and plans (overall, clinical, preclinical, CMC, regulatory)
Documents for regulatory purposes (efficacy, safety, quality)
Documents for planning and decision-making (project plans, TPPs, risk assessments, gap analyses, second opinions)
Scientific advice/pre-IND (LoQ, briefing documents, facilitate meetings with authorities)
Due diligence of projects and portfolios
Interim experts (medical, clinical, preclinical, CMC, QA, biostatistics and regulatory)
Interim project management, alliance management and R&D management.
GCP Audits – site and CRO/Vendor audits. Support to optimizing your GCP Quality Management System.
Medical writing
Biostat
Clinical CRO qualification, negotiation and oversight

At KLIFO Drug Development Counselling, we offer our services across a wide range of therapy areas including:

Oncology
Immunology
Neurology
Psychiatry
Cardiology
Diabetes
Gastroenterology
Respiratory Pain
Infectious diseases
Haematology

Our expert staff

Michael Gerstenberg

Project Director

Michael holds a Ph.D. in Physics and a Master of Science in Engineering degree. He joined KLIFO in 2017 after 15 years in device and drug research and development at Novo Nordisk, most recently as scientific director and research project director. Michael has primarily worked within diabetes and obesity, but his focus now is on advanced therapeutic medicinal products, especially within immuno-oncology.
Hanne Jensen

Senior Advisor

Hanne holds a PhD in analytical chemistry from the Technical University in Denmark. She has worked 20 years for Novo Nordisk, 3 years in biotech and 3 years at the Danish Medical Devices Certification (DGM). Hanne’s key competences are regulation for medical devices and quality management with emphasis on audits and risk management.
Vilhelm Tetens

Senior Medical Advisor

Vilhelm holds a Ph.D. in Science and has extensive experience in life sciences and clinical development. he has 15 years of experience with basic research and more than 20 years of clinical research experience within the pharma industry. Vilhelm has demonstrated ability to develop global clinical strategy plans to explore and support product opportunities and experience with collaboration with partners in the US, Japan and Europe.
Lars Jelstrup Petersen

Senior Medical Advisor

Lars holds a doctorate of Medical Science from University of Copenhagen as well as an executive certificate in business administration from AVT Business School. Lars has been working in the pharmaceutical business for more than 10 years within medical research and clinical science. He key competences is early drug development in oncology and haematology, including the use of biomarkers and imaging. Lars also works as Clinical Professor at Aalborg University.
Peter Damsbo

Senior Medical Advisor

Peter has a medical degree from Copenhagen University and has more than 25 years of experience from the life science industry and scientific research with an emphasis on clinical development of drugs and devices. He has carried projects from the preclinical phase through to worldwide registration from a clinical perspective. Peter’s medical expertise spans several therapeutic areas, including diabetes, obesity, metabolic diseases and medical devices.
Kim Krogsgaard

Senior Medical Advisor

Kim is a Medical doctor, specialist in infectious diseases and internal medicine. He has comprehensive experience in clinical research, clinical trials and clinical drug development as an investigator and as sponsor representative. Holds specialist recognition with Infectious Diseases and Internal Medicine and is the author of more than 100 scientific papers.

DRUG DEVELOPMENT COUNSELLING

END-TO-END SPECIALISED EXPERTISE

MAXIMUM FLEXIBILITY
AND ADAPTABILITY

EXPERT STRATEGIC
INPUT AND PROJECT
MANAGEMENT