Medical Director Early Clinical Development

  • Medical Doctor and PhD at University of Copenhagen
  • License to practice independent medicine
  • Specialist in medical oncology and radiotherapy

16 years of Clinical experience, 6 years of basic research and 14 years of drug development.

Key areas of interest include

  • Early clinical development phase I trials
  • Proof of concept trials - randomized phase II trial
  • Development of strategic plans, target product profile, interactions with health authorities

Experience and publications

Lars Damstrup MD, PhD

Specialist in medical oncology and radiotherapy

I qualified as a medical doctor from University of Copenhagen (Denmark) and have license to practice medicine as a specialist in medical and radiation oncology including a certification to treat patients with radioligands. After 4 years in general medicine and oncology, I entered a PhD program which resulted in a PhD from University of Copenhagen, this led to a post-doctoral fellowship at Vanderbilt university medical center, Nashville, Tennessee. I have more than 30 peer-reviewed publications and some submitted for review.
I am a physician-scientist (MD and PhD) by background and have academic expertise in all solid tumors both in terms of medical oncology, radiotherapy as well as radio-ligand treatment.

I have 16 years (since 2005) of expertise as senior medical director, medical director, and medical advisor in several pharmaceutical companies - Novartis Denmark, Genmab Denmark, Topotarget Denmark, Merck KGaA, Germany and Debiopharm Lausanne, Switzerland.
During these years I have been medical lead of several oncology drugs e.g. SOM203, and sandostatin, zalutumumab (a human monoclonal antibody targeting the EGF receptor), Belinostat (HDAC inhibitor - has been approved by FDA) pimasertib (a MEK1/2 inhibitor), Peposertib (a DNA damage and repair inhibitor), Debio 0123 (a Wee1 inhibitor) and 1143 (xevinapant – an IAP inhibitor).

Medical-Scientific expertise in Global Clinical Development Phases I - III, such as:

  • Expertise in global early clinical trials mainly phase I and II.

  • Collaborate with non-clinical scientist to understand the mode of action of early clinical and pre-clinical assets and adapt clinical development plans based on this including biomarker programs.

  • Clinical development of an asset; providing strategic advice in the disease selection, planning, execution and reporting of trials.

  • Strategic planning of a clinical development programme: Implementing the medical, clinical and translational (predictive biomarkers) work if a biomarker development would be needed.

  • Assessing the viability of a product, considering unmet medical need, risk / benefit /, biomarkers & feasibilities
    Evaluate development candidates in preclinical and early clinical development.

  • Medical and scientific support for the realization of clinical development plans (e.g. medical representation tasks; study design, -conduct and -reporting).
  • Medical support SAE and SUSAR reporting as well as required narrative and pharmacovigilance.

  • Building a network of key external experts and opinion leaders.

  • Preparation of relevant documentation for submission to Regulatory Agencies (e.g., briefing books, IB).

  • Medical support for communication with regulatory bodies (e.g. FDA, EMA, PMDA).

  • Supporting the team in the development of PIP and PSP or waivers for pediatric study plan(s).

  • Participated in EMA meeting(s).

  • Publication planning in publication steering committees.

  • Medical training of company staff.

As a person I am concrete, realistic, and practical, I also thrive on the experimental aspects of drug development with a logical and reasonable approach. I am also questioning data and like to bridge the gap between non-clinical research and clinical study protocols. When confronted with problems I have been told that I can appear quiet, but this is my way of contextualizing, visualizing, and solving problems or issues. I have over the years been involved in numerous early clinical assets and have led clinical development from the non-clinical phase through phase I and II and often we feedback into non-clinical setting (from bench to bed and back). In these situations, I have been commended that with my high level of clinical expertise and non-clinical expertise, it has been of value to the company to design smart studies. Over the years I have also developed a big key opinion leader network in several malignant diseases.