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
- Medical devices:
- Leading both medical device only and drug-device combination development projects
- Strategic project management from ideation to pilot production to registrations
- Medical device development strategy
- Due diligence of device projects
- Medical support to device development
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
-
Jesper KjerulffDirector, Senior Project Leader
Jesper holds a master in chemical engineering, a PhD in mammalian cell culture, and a bachelor in business administration. Jesper joined KLIFO in 2020 after two decades as global project leader at Lundbeck for numerous early and late stage development projects and LCM programs across small molecules and biologics within CNS. In his current role, Jesper is working as project leader with various biotech companies providing strategic guidance and leadership to management.
-
Inge TarnowDirector, Senior Project Leader
Inge holds a degree in Veterinary Medicine and a PhD in pathophysiology (hemostasis, immunology and animal models). Inge joined KLIFO in 2022 after several different positions in biotech and pharma, where she has been leading global development projects and nonclinical development with special focus on orphan diseases. Inge also has hands-on experience from clinical development and medical affairs. In her current role, Inge is working as cross-functional project lead developing and executing strategies and plans for biotech companies.
Senior advisors
- Carsten Roepstorff (DK)
- Charlotte Videbæk (DK)
- Christine Felding (DK)
- Cordula Wolf (DE)
- Gabor Liposits (DK)
- Inger Christine Munch (DK)
- Jan Harry Petersen (DK)
- Klaus Stöhr (DE)
- Lars Jelstrup Petersen (DK)
- Maria Bech (SE)
- Mikael Thomsen (DK)
- Peter Nissen Bjerring (DK)
- Stig Waldorff (DK)
- Ulrik Mouritzen (DK)
- Achim Orzechowski (SE)
- Andrew Makin (DK)
- Annsofi Nihlen (SE)
- Geertje Lewin (DE)
- Ingrid Bøgh (DK)
- Line Hartvig (DK)
- Martin Munk (DK)
- Roman Föll (DE)
- Christina Mørk (DK)
- Hanne Jensen (DK)
- Henrik Tønsberg (DK)
- Mette Theilade (DK)
- Gertrud Schuster (AT)
- Hanne Bendixen (DK)
- Peter Bergqvist (SE)
- Anders Vagnø Pedersen (DK)
- Babak Jamali (DK)
- Jens Bukrinski (DK)
- Jørgen Lang Pedersen (DK)
- Julia E. Diederichs (DE)
- Kaare Gyberg Rasmussen (DK)
- Kaare Lund (DK)
- Karen Rørbæk (DK)
- Karin Liltorp (DK)
- Lars Foldager (DK)
- Lars Gyldenvang (DK)
- Marianne Svärd (SE)
- Mats Reslow (SE)
- Timo Schmidt (CH)
- Anders Nyberg, GCP (SE)
- Siglinde Duerr, GMP (DE)
- Tine Jørgensen (DK)
- Thomas Bengtsson (SE)
- Lars Bo Kjerrumgaard (DK)
- Hans Mosberg (DE)