– Overcoming challenges when moving from non-clinical to clinical
Going from non-clinical to clinical is no easy step. That’s why we’ve gathered a few of our key experts from essential product development areas to talk about how to survive and minimize the early risks biotech companies face during the life cycle of product development.
Join us in the live session to discuss common Biotech pitfalls within factors to consider when selecting a manufacturer, the importance of a TPP, the critical path for Regulatory CMC, how not to lose sight of the target, statistical considerations, aligning your data management team and clinical trial safety. This presentation will be packed with insightful information for Biotech, Pharma and MedTech companies. Join the discussion and meet the experts!
Date: Tuesday, May 24th, 2022
Time: 9:00 – 11:15 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
|9:00||Networking, registration, and light breakfast|
David Munis Zepernick, Head of Member Engagement and Communication, Medicon Valley Alliance
|9:35||Factors to consider when selecting a manufacturer: The value of a GMP audit|
Hilde Ringstad, Director Quality Assurance and Compliance
Non-clinical development and the importance of a Target Product Profile (TPP)
The critical path for regulatory CMC – Biologics
Clinical development: don’t lose sight of the target
Biostatisticians early in the design
The importance of proper data handling
Clinical Trial Safety
|Hilde Ringstad, Director, Quality Assurance and Compliance|
Hilde has a background from the pharmaceutical industry and wholesale of medicinal products, where she has held different roles within management and quality assurance, e.g. Qualified Person and Responsible Person. She has also had several positions with the health authorities, last as head of inspection at the Norwegian Medicines Agency. She joined LINK Medical in 2018 and holds a MSc in pharmacy.
|Jenny Lund, Regulatory Manager|
Jenny holds a Ph.D. and M.Sc. Pharm. from the University of Oslo, focusing on research in basal pharmacology, mainly within diseases related to metabolic disturbances, in particular insulin resistance and diabetes mellitus type 2. Furthermore, she has participated in preclinical research and medical writing for pharmaceutical companies. She has also been an external evaluator within pharmacokinetics for the EMA. She joined LINK Medical in 2021 as a Regulatory Manager, specializing in the early phase of drug development, including advising on preclinical study programs, conducting target product profiles and medical writing.
|Lone Dyrby, Regulatory Director (Denmark)|
With over 20 years’ experience within Regulatory CMC, Lone has been working extensively within biologics. She has a MSc in pharmacy and a diploma in leadership (bachelor level). Lone has been part of the LINK Medical team in Denmark since in October 2020. Prior to that, she had various positions in the pharmaceutical industry as Regulatory CMC specialist and Head of Regulatory Affairs and in the Danish Medicines Agency as CMC assessor of biologics. Lone has extensive experience within Regulatory CMC worldwide.
|Rikard Reneland, Medical Expert|
Rikard has 20 years of biopharmaceutical experience focused on clinical development and clinical operations, with experience from small biotech to big pharma companies. After graduating as MD from the University of Uppsala, Rikard completed his Ph.D. in preventive cardiology. In parallel to his research, he was working as an investigator in several clinical trials. Following his PhD he received his license to practice. Shortly thereafter, he started his industry career in a pioneering small biotech company developing pharmacogenetic tests to predict response to drugs. After 6 years as Medical Advisor in early biotech and small pharma Rikard started working as Medical Advisor at the Nordic Baltic Clinical Study Unit at Sanofi, providing first-line medical support in studies of all phases and across disease areas. He also held positions as Country Medical Lead immunology at Roche and Global Safety Physician at Sobi before joining Link Medical in 2022.
|Ingmarie Johanson, Sr, Biostatistician|
Ingmarie Johanson joined LINK Medical on Sept. 2020 as a Senior Biostatistician. She has a master’s degree in Medical Sciences from the University of Lund, Sweden and has combined her education with two years of studies in statistics and worked as a medical biostatistician since 2000. She started first as statisticican at an Oncology center in Gothenburg and has worked at several CROs in Sweden and Denmark. She has also taught at the university in Gothenburg and Lund and has been a coordinator in a large epidemiological project.
|Lise Egholt, Biometrics Project Manager|
Lise joined LINK Medical in 2019 as Biometrics Project Manager and holds a Master of Human Nutrition from the University of Copenhagen. She has a background in clinical research and data management. With hands-on experience in project management, data collection, and statistical analyses, Lise has in-depth knowledge of the requirements to obtain high-quality data.
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