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 Wulf 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

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.
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.
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.
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 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.
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.

DRUG
DEVELOPMENT
COUNSELLING