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

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.
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.
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.
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.
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.

DRUG
DEVELOPMENT
COUNSELLING