Welcome to Medicon Valley Alliance Good Morning Meeting on “Cancer immunotherapies – Preparing for a successful clinical program” with KLIFO.
Recent advances in immuno-oncology have shown great promise for effective and safer treatments.
Best examples are the check point inhibitors which are moving towards first line treatment in various cancer types. Currently, numerous drug modalities within immuno-oncology are pursued resulting in a vast clinical activity. To ensure rapid market entry and benefit for larger patient segments, new complex clinical trial designs (covering e.g. ‘umbrella’ and ‘basket’ designs) have emerged concomitantly. For biotech companies entering immuno-oncology, it is important to be able to navigate safely within this evolving field to secure timely progress optimizing investor value.
This MVA oncology seminar will address the importance of engaging in early drug development strategies, hereunder the clinical development plan encompassing regulatory and trial design considerations.
Date: Thursday September 19th 2019
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Danmark – Ground floor
8:30 – 9:00
Registration & Coffee
9:00 – 9:05
9:05 – 9:20
The importance of early focus on drug development strategies
9:20 – 9:50
Clinical design options in cancer immunotherapy
9:50 – 10:10
Vignettes from late approvals in cancer immunotherapy
10:10 – 10:30
Clinical learnings from the T-cell based cancer therapy ALECSAT
10:30 – 10:40
10:40 – 11:00
Alejandra Mørk has since January 2008 been the CEO and main shareholder of the drug development consultancy, KLIFO. Previously, she worked for Nycomed Pharma for 18 years, in various management positions in drug development and lifecycle management. Alejandra has worked as a part of drug development counselling for numerous biotech and pharma companies paving the strategic and operational paths over the past decade. Furthermore, Alejandra is member of the board of Danish Biotech and member of the Danish Academy of Technical Sciences.
Lars Jelstrup Petersen
Lars Jelstrup Petersen has nearly 20 years of drug development experience; Lars has served as Medical Director at Genmab and Abbott and has since 2005 been a clinical development consultant at ljpmedical and KLIFO Drug Development Council. He has assisted numerous clients around the world with drug development, primarily advanced biologics and targeted therapies in oncology, immunology, and rare disease projects. He is Clinical Professor in Nuclear Medicine (functional imaging) at Aalborg University Hospital. He obtained his MD and later Doctor of Medical Science (DMSc/dr.med.) degree in immuno-pharmacology from the University of Copenhagen, and his Certificate in Business Administration (CBA) from AVT Business School, Copenhagen, Denmark. He has published more than 150 peer-reviewed publications.
Birgitte holds a Master of Pharmacy degree and a Master of Public Administration degree. She joined KLIFO in June 2015 and has more than 30 years of experience in regulatory affairs both from industry and regulatory authorities. For 12 years, Birgitte was VP in Global Regulatory Affairs at ALK-Abelló. Prior to this, Birgitte was for 10 years head of the Secretariat for Marketing Authorisations / the EU Secretariat at the Danish Medicines Agency and participated in the interactions between EMA, the EU Commission and the European national authorities.
Karen Tornøe holds a MD and Ph.D. degree from the University of Copenhagen. In addition to a broad clinical experience as MD, she has a long experience within clinical drug development and regulatory strategies. Karen Tornøe was working 4 years as Senior Medical Officer at the Danish Medicine Agency and as Danish alternate of the Paediatric Committee at EMA before she joined Novo Nordisk as International Medical Director in 2011. In this position, she has been involved in clinical trials planning, execution and reporting, product safety and successful regulatory outcomes for Victoza and Saxenda. In 2017 Karen Tornøe was appointed to Senior Director, Regulatory Affairs and in 2018 to Scientific Medical Director, Global Medical Affairs, also in Novo Nordisk. As of 2019, Karen joined the clinical-stage biopharmaceutical company, Cytovac, as the CMO, focusing on novel immunotherapies.
In collaboration with: