Why Timing and CRO Expertise are Critical to the Success of Your Bioanalytical Program

In recent years, pharmaceutical outsourcing of bioanalysis has grown tremendously. Simultaneously, bioanalytical programs have become more complex due to increasing regulatory demands. While a comprehensive understanding of the regulatory guidelines is required to develop a winning bioanalytical strategy, several other challenges, such as strategic timing, are common with outsourcing. Additionally, the regulatory environment of bioanalysis is constantly evolving, and being in compliance and on time remains a big challenge for many Biotech and Pharma professionals.

What’s the best way for companies to accelerate their drug development programs, while not compromising quality?

Be on time for our breakfast talk to learn why timing and CRO expertise can be the difference between success and failure in your bioanalytical strategy. In this event, we will explore the benefit of a local partner with a focus on key recommendations for streamlining bioanalytical programs, beginning with a regulatory perspective (Dr. Marianne Scheel Fjord), followed up by a CRO perspective from Svar Life Science, (Anne Thjømøe, CEO Svar Life Science, Filiz Ibraimi, PhD, Chief Operations Officer, Sabrina Bodevin, PhD Principal Scientist and Malin Molander, Bioanalytical Manager). Along with the planned presentations, attendees will be able to network with representatives from Svar Life Science and other pharma professionals including key opinion leaders.

Key learning objectives:

• Why a local partner could be beneficial
• The benefits of working with a CRO Specialist
• Learn how to overcome challenges of timing in bioanalytical outsourcing
• Learn how to secure the right level of quality
• Learn the benefits of working with a CRO Specialist
  

Date: Tuesday, 30th of May, 2023
Time: 8:30 – 11:00 CET
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium

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Program

Speakers​​

	Anne Thjømøe, Chief Executive Officer at Svar Life Science  Anne Thjømøe became CEO of the Svar Group in September 2022. Before then she was the CEO of Svar subsidiary Calpro AS since 2014. Anne has extensive management experience and has been heading functions such as Finance, HR, IT, Commercial services and Sales and Marketing. She holds a Master of Business and Economics from BI Norwegian Business School and has experience from various industries, such as manufacturing, finance, insurance and enterprise federations. She has also held various board positions.
	Marianne Scheel Fjording, PhD, CEO and Founder of Biolyzr and Consultant for Svar Life Science Marianne Scheel Fjording, MSc, PhD, is CEO and founder of Biolyzr, a consultant company specialized in bioanalysis excellence. The consultancy covers all aspects of bioanalytical activities, including strategy, project scoping and management, audits, compliance as well as CRO selection and monitoring. Prior to founding Biolyzr, Marianne was Scientific Director at Novo Nordisk, Denmark and Scientific Officer and Executive Director at a global CRO, where she worked with regulated bioanalytical assay validation. Her experience is within Large Molecules. Marianne was member of the EWG for the newly implemented ICH M10 guideline as a representative for PhRMA.Marianne has a Master of Science degree in biochemistry from Copenhagen University, and a PhD in intracellular signalling and more than 25 years of experience within pharmaceutical companies.
	Filiz Ibraimi, PhD, Chief Operations Officer at Svar Life Science Filiz Ibraimi is the COO at Svar Life Science and responsible for overseeing daily operations, managing resources, and developing strategic plans to support business growth. She has over 20 years of experience within the Life Science industry, in various management positions including COO, Head of R&D and Head of Manufacturing. She has extensive experience of working in different departments and across all phases, from immunoassay development, regulatory compliance, production processes, supply chain/logistics handling, to commercial activities. Filiz holds a Master of Science degree in Chemical Engineering and a PhD in Pure and Applied Biochemistry from Lund University.
	Sabrina Bodevin, PhD, Principal Scientist at Bioanalytical Services Sabrina Bodevin, PhD, is a principal scientist, project manager and study responsible in regulated bioanalytical studies at Svar Life Science. Sabrina is involved in assay design, assay troubleshooting, non-clinical/clinical studies implementation, and regulatory submission activities. Sabrina has worked within regulated bioanalysis (PK/Biomarkers) for the past 10 years.
	Malin Molander Manager at Bioanalytical Services Malin Molander is Manager of the Scientists in the Bioanalytical Service department at SVAR Life Science. She has more than 20 years of immunoassay experience and a strong background in regulatory bioanalytical compliance. Malin has previously worked within regulated large-molecule bioanalysis at pharma companies with responsibilities within the bioanalytical program and assay design, troubleshooting, strategy and implementation for non-clinical/clinical regulatory interaction.

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