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

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.
Bjarne Bodin

Senior Biostatistical Advisor

Bjarne holds a Master of Science in Statistics degree from the University of Copenhagen. He has worked as biostatistician with data management and statistics in CROs, biotech and pharmaceutical companies for more than 25 years. Bjarne is CEO and founder of BioStata, executive member of International Society of Clinical Biostatistics and founder of Danish Association of Data 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.
Martin Munk

Senior Non-clinical Advisor

Martin graduated in medicine at the University of Rio de Janeiro, received his MSc at São Paulo Medical University and earned a MD in Immunology from the University of Ulm, as well as a DMSc (Habilitation) from the Humboldt University Berlin. Munk has served in various academic research positions revolving around immunology and infectious diseases. He has been working in the pharmaceutical industry within the preclinical and early clinical areas of immunology, infectious diseases, inflammation, cancer and diabetes. For the past 7 years, Martin has been working as consultant in different drug development programs.
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.
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