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: michael.engsig@klifo.com

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

Thomas Matthiesen

Project Director

Thomas holds a Master of Science in Chemistry and Cell Biology degree. He joined KLIFO in October 2015 with more than 15 years of experience with managing development projects within the pharmaceutical area.

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.

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.

Charlotte Videbæk

Drug Development Consultant

Charlotte holds a Doctor of Medicine degree and is a board certified Neurologist. She has worked internationally with drug development both as line manager in large pharma companies and as CEO for small entrepreneurial biotechs.

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.

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.

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.

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.

Anke Domdey

Senior Pre-clinical advisor

Anke holds an MSc in Pharmacy and a PhD in Science and has extensive international experience in management and leadership of early development projects as well late stage drug and vaccine discovery. She has 25 years of experience with R&D and marketing in the global biotech and pharma industries. Anke is an expert in product development covering a broad range of therapeutic areas, among others oncology, autoimmune diseases, CNS, infectious diseases, dermatology and cardiovascular diseases.

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.

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.

Lars Kjerrumgaard

Drug Development Consultant

Lars holds an MSc in Chemistry and European Patent Attorney. He is specialised in providing IP, in particular, patent consulting to pharmaceutical and biotech companies, including for medical devices.

Peter Bergqvist

Drug Development Consultant

Peter holds a Ph.D. in Clinical Pharmacology (1997) and has 20 years of experience within drug development including clinical trial management, medical writing, and management of medical writers. He has substantial experience in authoring clinical trial outlines and protocols, clinical trial reports, summaries and overviews, paediatric investigation plans, orphan drug applications, briefing documents, bridging reports, investigators brochures, abstracts, and manuscripts within the fields of uro-oncology, urology, endocrinology, hemophilia, and gastroenterology.

Tina Kjøller

Drug Development Consultant

Tina holds an M.Sc. in Pharmacy and for more than 30 years she has worked in the pharmaceutical industry especially within regulatory affairs and quality assurance of both drugs and medical devices. Her key competences within regulatory affairs are drugs, medical devices, drug-device-combination products, orphan drugs, and within QA she specialises in GMP/GDP audits, deviation handling, and CAPAs.

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.

Anders Nyberg

Drug Development Consultant

Anders Nyberg joined KLIFO in December 2018. He is an experienced and well-known capacity in the clinical QA field and has a long track record in audits and inspections within GCP, vendors, phase 1 units, and subsidiaries.

DRUG DEVELOPMENT COUNSELLING