MVA Good Morning Meeting – Surviving early biotech pitfalls

Non-clinical development and the importance of a Target Product Profile (TPP)
Jenny Lund, Regulatory Manager

The critical path for regulatory CMC – Biologics
Lone Dyrby, Regulatory Director

Clinical development: don’t lose sight of the target
Rikard Reneland, Medical Expert

Biostatisticians early in the design
Ingmarie Johanson, Sr. Biostatistician

The importance of proper data handling
Lise Egholt, Biometrics Project Manager

Clinical Trial Safety
Anne Krammer, Director, Safety Operations

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 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.

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 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 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 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.