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

Finn Møllgaard

Senior Regulatory Affairs Advisor

Finn holds an MSc Pharm degree from the Royal Danish School of Pharmacy, University of Copenhagen, Denmark. Finn has more than 30 years’ experience working in the pharmaceutical industry, including senior positions such as Corporate Vice President, Regulatory Affairs Insulins at Novo Nordisk. Over the years, Finn has been responsible for developing and implementing regulatory strategies for all phases of drug development from idea through development to approval and throughout life cycle management and have followed several new drug candidates through to global approval. He has attended multiple agency meetings and negotiated with regulatory authorities globally, including Oral Explanations in EU and Advisory Committee meetings in the US.
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.
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.
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.
Roman Föll

Senior Non-clinical Advisor

Roman holds a doctorate from Ludwig-Maximilian-Universität in Munich. For 20 years, he has worked within the non-clinical area primarily in pharmaceutical companies. Roman is a European Registered Toxicologist and has been working as a consultant within toxicology since 2006.
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.

DRUG
DEVELOPMENT
COUNCELLING