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.

Michael Engsig

EVP

Michael Engsig is a broadly anchored pharmaceutical professional with more than 19 years of experience and successful track record in R&D and commercial functions. When joining KLIFO in January 2017 he came from a position in PPD as Head of Central and Eastern Europe Clinical Management.

Direct/mobile: +45 44 222 913

Email: moc.ofilk@gisgne.leahcim

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 Regulatory 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.
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.
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.
Ira Hartling

Senior Regulatory and QA Advisor

Ira holds an MSc in Pharmacy and has significant experience with most areas of Regulatory Affairs and Quality Assurance from the pharma and biotech industry.
Ingrid Bøgh

Senior Non-clinical Advisor

Ingrid holds a PhD in Veterinary Reproduction from University of Melbourne and is a Doctor of Veterinary Science (DVSc) from University of Copenhagen, and was recently entitled European Registered Toxicologist. For 9 years, Ingrid has been responsible for strategic development and scientific operation of Toxicology and Safety Pharmacology in Novo Nordisk. She has substantial preclinical safety experience of small molecule and biologics drug candidates (including peptides, mAbs, DART, RIT) and within a multitude of indications including metabolic diseases, oncology, haemophilia, growth disorder, cardiovascular diseases, calcification, protein misfolding diseases.

DRUG
DEVELOPMENT
COUNSELLING