case
case
An efficient regulatory environment and authorities willing to engage in a dialogue made the difference for a San Francisco based biotech company as they were looking for sites for their clinical trial in Europe.
When
San Francisco ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs and cells implicated in disease, enabling improved efficacy and potency.
Recode Tx has a pipeline of rare disease therapeutics and is planning to initiate their first clinical trials in the EU in 2024. In particular, Recode Tx are exploring EU sites for the conduct of a Phase 1 study to evaluate their mRNA-based LNP therapy for patients with Primary Ciliary Dyskinesia caused by mutations in the DNAI1 gene. With Denmark being home to one of the leading researchers in the field, Professor Kim G. Nielsen from Copenhagen University hospital (Rigshospitalet), it made sense for ReCode Tx to partner closely with Dr. Nielsen to design a trial for PCD patients with mutations in the DNAI1 mutation that could begin Europe.
As the company were preparing the study protocol, they were looking at an opportunity to consult with the Clinical Trials Unit at the Danish Medicines Agency (DKMA).
“We had some very specific regulatory questions and much to our surprise, we were able to have an informal conversation with the Danish Medicines Authority within a very short time frame. This interaction was extremely helpful in that all of our questions were answered and we were able to move forward without delay.”John Matthews
Senior Vice President of Clinical Development at ReCode Tx
The Danish Medicines Agency aims to ensure timely reviews with high standards while at the same time developing guidelines that support the conduct of tomorrow’s clinical trials. The agency is open for dialogue with partners and stakeholders, as they recognize that collaboration and dialogue is the best way to improve options for patients.
“Together with the other players in the Danish clinical trial ecosystem, we strive to put the patient at the core of research by involving their perspectives so that together we can position Denmark firmly in Europe when it comes to future methods and innovation within clinical research, such as decentralized clinical trials.”Frederik Grell Nørgaard
Head of Unit, Clinical Trials, Danish Medicines Agency
Accelerating clinical trials is important to swiftly providing new treatments, especially for life-threatening conditions. Speedier trials save lives, reduce costs, offer a competitive edge, and contribute to scientific progress. Regulatory support and ethical considerations also favor expeditious development, but it's crucial to balance speed with rigorous research to ensure safety and reliability.
“Denmark offers a robust system for conducting clinical trials and we are excited to be assisting companies like ReCode Therapeutics to get started. At Invest in Denmark, our experts in Denmark and around the world are ready to assist similar companies connect with investigators and navigate the process of starting a clinical trial.”Tine Hartmann
Team leader for the Life Science Team at Invest in Denmark
Invest in Denmark is part of the Ministry of Foreign Affairs and has experts located around the world ready to provide free and confidential advice to companies looking to accelerate their business through activities in Denmark – including clinical research.
Click to learn more about how to get in touch with our life science experts at this years events
We provide free-of-charge confidential and tailor-made solutions for foreign companies looking to set up a clinical trial in Denmark. Please contact one of our experts here:
Title: Director
Area: Copenhagen
Email: [email protected]
Phone: +4533921195
Title: Deputy Director
Area: Copenhagen
Email: [email protected]
Phone: +4521836195
Title: Director for Europe
Area: Copenhagen
Email: [email protected]
Phone: +45 6197 9220
Title: Team Leader - Life Sciences & Food
Area: Copenhagen
Email: [email protected]
Phone: +45 3392 1350
Title: Team Leader - Cleantech
Area: Copenhagen
Email: [email protected]
Phone: +4533920836
Title: Team Leader, Tech
Area: Copenhagen
Email: [email protected]
Phone: +4533921736
Title: Team Leader - Analysis & Partnership
Area: Copenhagen
Email: [email protected]
Phone: +4533921093
Title: Special Advisor - Life Sciences
Area: Copenhagen
Email: [email protected]
Phone: +4521247056
Title: Special Advisor – Maritime and transport – Analysis & Partnerships
Area: Copenhagen
Email: [email protected]
Phone: +4533920423
Title: Special Advisor - Cleantech
Area: Copenhagen
Email: [email protected]
Phone: +4533920810
Title: Special Advisor - Quantum Tech & Venture Capital
Area: Copenhagen
Email: [email protected]
Phone: +45 2938 9943
Title: Special Advisor – Dual-use tech
Area: Copenhagen
Email: [email protected]
Phone: +45 2133 8147
Title: Special Advisor - Analysis & Partnerships
Area: Copenhagen
Email: [email protected]
Phone: +4533921639
Title: Digital Marketing Specialist
Area: Copenhagen
Email: [email protected]
Title: Special Advisor - Quantum Tech
Area: Copenhagen
Email: [email protected]
Phone: +4533920783
Title: Special Advisor - Life Sciences & Biosolutions
Area: Copenhagen
Email: [email protected]
Phone: +45 40 25 69 08
Title: Project Assistant – Analysis & Partnerships
Area: Copenhagen
Email: [email protected]
Phone: +4533920535
Title: Project Assistant - Tech
Email: [email protected]
Phone: +4533921916
Title: Life Science Production Coordinator
Area: Berlin
Email: [email protected]
Phone: +49 3050502140
Title: Special Advisor - Logistics, Distribution & Production
Area: Kolding
Email: [email protected]
Phone: +45 5144 8613
Title: Special Advisor - Cleantech
Area: Silkeborg
Email: [email protected]
Phone: +45 2170 5851
Title: Special Advisor - Food
Area: Aarhus
Email: [email protected]
Phone: +45 2383 4608
Title: Special Advisor - Tech
Area: Aarhus
Email: [email protected]
Phone: +45 2051 7594
Title: Special Advisor - Life Sciences
Area: Aarhus
Email: [email protected]
Phone: +45 2856 8540
Title: Special Advisor – Cleantech & ICT
Area: Aalborg
Email: [email protected]
Phone: +45 6010 6101
Title: Special Advisor - ICT & Cleantech
Area: Aalborg
Email: [email protected]
Phone: +45 4115 3125
Title: Investment Manager
Area: Oslo
Email: [email protected]
Phone: +47 9132 2010
Title: Investment manager – Tech & Quantum
Area: London
Email: [email protected]
Phone: +44 (0) 78 1083 7296
Title: Senior Investment Manager - Cleantech & Life Sciences
Area: London
Email: [email protected]
Phone: +44 (0) 20 7333 0218
Title: Investment Manager – Life Sciences & Food
Area: London
Email: [email protected]
Phone: +44 7511 877225
Title: Investment Manager – Life Sciences & Food
Area: Paris
Email: [email protected]
Phone: +33 (0) 6 72 32 40 82
Title: Investment Manager - Cleantech
Area: Paris
Email: [email protected]
Phone: +33632637658
Title: Investment Manager - Tech
Area: Munich
Email: [email protected]
Phone: +498954585425
Title: Investment Manager – Tech
Area: New York
Email: [email protected]
Phone: +1 (929) 726-9167
Title: Investment manager - Cleantech
Area: New York
Email: [email protected]
Title: Investment Manager - Life Sciences
Area: New York
Email: [email protected]
Phone: +1 (212) 7054946
Title: Director for North America
Area: New York
Email: [email protected]
Phone: +1 (212) 705 4972
Title: Deputy Director, North America & Senior Investment Manager - Life Sciences & Location Denmark
Area: New York
Email: [email protected]
Phone: +1 (917) 497 1300
Title: Investment Manager - Food & Location Denmark
Area: New York
Email: [email protected]
Phone: +1 (212) 705 4928
Title: Life Science Production Coordinator – Life Sciences
Area: New York
Email: [email protected]
Phone: +1 (212) 705-4974
Title: Investment Manager – CleanTech, Life Science & Food
Area: Canada
Email: [email protected]
Phone: +1 647 295 5704
Title: Investment Manager - Tech
Area: Toronto
Email: [email protected]
Phone: +1 (416) 565-0248
Title: Investment Manager - Life Science & Digital Health
Area: Silicon Valley
Email: [email protected]
Phone: +1 (650) 272-9510
Title: Investment Manager - Cleantech
Area: Silicon Valley
Email: [email protected]
Title: Investment Manager - Quantum Technology
Area: Tokyo
Email: [email protected]
Phone: +818040006915
Title: Investment Manager – Life Science & Food
Area: Tokyo
Email: [email protected]
Phone: +81 3 3496 3001
Title: Investment Manager
Area: Tokyo
Email: [email protected]
Phone: +81337808745
Title: Investment Manager - Cleantech & ICT
Area: Bangalore
Email: [email protected]
Phone: +91 963 234 2021
Title: Investment Manager – Tech
Area: Bangalore
Email: [email protected]
Phone: +91 91088 19810
Title: Investment Manager - Tech, Life Sciences & Cleantech
Area: Taipei
Email: [email protected]
Phone: +886 968 309 526
Title: Head of Marketing & Communication, Asia
Area: Shanghai
Email: [email protected]
Phone: +86 21 8025 0642
Title: Investment Manager - Cleantech & Maritime
Area: Shanghai
Email: [email protected]
Phone: +86 158 0058 0725
Title: Senior Investment Manager - Location Denmark & Life Sciences
Area: Shanghai
Email: [email protected]
Phone: +86 21 8025 0636
Title: Director for Asia
Area: Singapore
Email: [email protected]
Phone: +6565060277
Title: Investment Manager in Cleantech, Tech, Life Science, Food & Maritime
Area: Singapore
Email: [email protected]
Phone: +65 8028 3668
