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

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.
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.
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.
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.
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

END-TO-END SPECIALISED EXPERTISE

MAXIMUM FLEXIBILITY
AND ADAPTABILITY

EXPERT STRATEGIC
INPUT AND PROJECT
MANAGEMENT