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 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

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

Peter Bergqvist

Senior Medical Writer

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.
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.
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.
Roman Föll

Senior Pre-clinical Advisor

Roman holds a doctorate from Ludwig-Maximilian-Universität in Munich. He is a European Registered Toxicologist since 2008 and has worked for more than 20 years within the non-clinical area, primarily in pharmaceutical companies, as an employee or an external consultant. Since 2016 he is partner and general manager of Föll, Mecklenburg & Partner GmbH.
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.
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.

DRUG DEVELOPMENT COUNSELLING

END-TO-END SPECIALISED EXPERTISE

MAXIMUM FLEXIBILITY
AND ADAPTABILITY

EXPERT STRATEGIC
INPUT AND PROJECT
MANAGEMENT