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Surviving early biotech pitfalls – Overcoming challenges when moving from non-clinical to clinical

Join our breakfast meeting together with Medicon Village Alliance (MVA) in Copenhagen and meet our experts!

When: May 24

Time: 9 to 11:15

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. From factors to consider when selecting a manufacturer, Pipeline strategies, to the importance of aligning your data management team and safety in early clinical studies. This presentation will be packed with insightful information for biotech, Pharma, and MedTech companies.

 

Agenda:

9:00 Networking, registration, and light breakfast

9:30 Welcome
David Munis Zepernick, Head of Member Engagement and Communication, Medicon Valley Alliance

9:35-10:35

  • Factors to consider when selecting a manufacturer: The value of a GMP audit by Hilde Ringstad, Director of Quality Assurance and Compliance
  • Non-clinical development and the importance of a Target Product Profile (TPP) by Jenny Lund, Regulatory Manger
  • The critical path for regulatory CMC – Biologics by Lone Dyrby, Regulatory Director
  • Clinical development: don’t lose sight of the target by Rikard Reneland, Medical Expert
  • Biostatisticians early in the design by Ingmari Johanson, Sr. Biostatistician
  • The importance of proper data handling by Lise Egholt, Biometrics Project Manager
  • Clinical Trial Safety by Anne Krammer, Director, Safety Operations

10:35 – Q&A

10:45 – Networking

11:15
– End

 

About the speakers

   

Hilde Ringstad,

Director Quality Assurance and Compliance
Hilde.Ringstad[@]linkmedical.eu

Hilde has a background in 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 an MSc in pharmacy.

 

Jenny Lund,

Regulatory Manager
Jenny.Lund[@]linkmedical.eu

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 
Lone.Dyrby[@]linkmedical.eu

With over 20 years’ experience within Regulatory CMC, Lone has been working extensively within biologics. She has an MSc in pharmacy and a diploma in leadership (bachelor level). Lone has been part of the LINK Medical team in Denmark since October 2020. Prior to that, she had various positions in the pharmaceutical industry as a Regulatory CMC specialist and Head of Regulatory Affairs and in the Danish Medicines Agency as a CMC assessor of biologics. Lone has extensive experience within Regulatory CMC worldwide.

 

Rikard Reneland,

Medical Expert
Rikard.Reneland[@]linkmedical.eu

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 an 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 Ph.D., 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.

 

Ingmari Johanson,

Sr. Biostatistician
Ingmari.Johanson[@]linkmedical.eu

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 a statistician at an Oncology center in Gothenburg and has worked at several CROs in Sweden and Denmark. She has also taught at the university Gothenburg and Lund and has been a coordinator in a large epidemiological project.

 

Lise Egholt,

Biometrics Project Manager
Lise.Egholt[@]linkmedical.eu

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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