DRUG DEVELOPMENT COUNSELLING

CLINICAL
TRIAL SUPPLY
SOLUTIONS

Business solution

KLIFO Drug Development Counselling provides experience, competence and strategic leadership to maximise the value of drug and device development projects.

We build and execute optimal plans based on a thorough understanding of the projects.

Hanne Wulff 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
Drug device combinations

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

Kim Krogsgaard

Senior Medical Advisor

Kim, MD, DMSc has more than 40 years of broad clinical development experience. Kim joined KLIFO in 2014 and works with strategic drug development and development programmes from pre-clinical to early and later clinical stages in collaboration with non-clinical and regulatory experts as well as PK specialists and biostatisticians. Kim’s experience spans multiple therapeutic fields and drug classes including small molecules, peptides, biologics, oligonucleotides, vaccines and stem cells and includes multiple interactions with FDA, EMA and national European regulators. Kim has served in positions as chief medical officer, medical director, medical lead, senior medical advisor, sponsor’s medical expert and sponsor’s medical monitor.
Thomas Matthiesen

Senior Director, DDC

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.
Klas Råberg

Senior Strategic Advisor

Klas holds a Master of Science degree and a PhD within Gastroenterology and joined KLIFO in March 2017. He has 16 years of experience from the clinical trial field where he has worked as project manager and clinical research director at big and mid-sized pharma companies as well as CROs. During these years, Klas has been actively involved in the delivery of more than 35 clinical trials/projects.

Direct/mobile: +45 44 222 935
Email: moc.ofilk@grebdaaR.salK
Alejandra Mørk

Strategic Development Advisor

Alejandra Mørk, PhD and MSc Pharm, has more than 30 years of experience in drug development and life cycle management. In 2008, Alejandra acquired KLIFO to build an international end to end drug development consultancy. From 2008 to 2023 she was CEO of the company. Prior to acquiring KLIFO, Alejandra spent 18 years at Nycomed Pharma in various leadership positions in Project Management, Clinical Development and Regulatory Affairs and was overall responsible for Drug Development.

Member of the Board of Directors at the Danish industry association Danish Bio and at Scandion Oncology.