Roundtable Hemato-Oncology

Quicker access to innovative cancer treatments: Swissmedic, the FDA and Swiss professional associations in dialogue

28.11.2024

The first Roundtable between Swissmedic and leading professional Swiss hemato-oncology associations as well as guests from the US Food and Drug Administration (FDA) took place on 18 November 2024 in Bern. It focused on the question of how to speed up patient access to innovative cancer treatments in Switzerland.

At the first Roundtable Hemato-Oncology, Swissmedic, a delegation from the US Food and Drug Administration (FDA) and experts from Swiss hemato-oncology associations met in Bern. The discussions focused on the challenges in the authorisation of new treatments, speeding up innovative treatment options and the influence of international cooperation on the availability of medicines in Switzerland.

They illustrated the importance of international cooperation: through initiatives such as Project Orbis (see infobox), innovative medicinal products can be authorised for patients in Switzerland an average of seven months earlier.

The Roundtable also offered an opportunity to highlight the different regulatory frameworks and perspectives of the two countries. Challenges and solutions for rapid authorisation of innovative cancer medications in Switzerland were discussed. This requires targeted, efficient cooperation to achieve common objectives and ensure patient safety and supply. The importance of this Roundtable for faster access to innovative cancer treatments for patients in Switzerland was illustrated once again.

Participants at the Roundtable on 18 November 2024

Name

Company/Organisation/Association

Richard Pazdur

U.S. FDA

Angelo de Claro

U.S. FDA

Dianne Spillman

U.S. FDA

Shannon Thor

U.S. FDA

Simona (Ioana) Ulea

U.S. FDA

Roger von Moos

Swiss Society of Medical Oncology (SGMO)

Dominique Froidevaux

Swiss Society of Medical Oncology (SGMO)

Anne Angelillo-Scherrer

Swiss Society of Hematology (SGH)

Katrin Scheinemann

Swiss Paediatric Oncology Group (SPOG)

Claudia Althaus

Swiss Paediatric Oncology Group (SPOG)

Vincent Gruntz Swiss Group for Clinical Cancer Research (SAKK)

Miklos Pless

Swiss Group for Clinical Cancer Research (SAKK)

Sacha Rothschild

Swiss Group for Clinical Cancer Research (SAKK)

Jakob Passweg

Swiss Cancer Research (Krebsforschung CH)

Thomas Cerny

Swiss Cancer Research (Krebsforschung CH)

Solange Peters

Krebsliga

Aline Descloux

Krebsliga

Eveline Trachsel

Swissmedic              

Jörg Schläpfer

Swissmedic

Christine Haenggeli

Swissmedic

Julia Djonova

Swissmedic

Ulrich-Peter Rohr

Swissmedic

Matea Zosso

Swissmedic

Gabriela Zenhäusern

Swissmedic

Eiman Atiek

Swissmedic

Mari Vihertola

Swissmedic

Project Orbis: Quicker access to innovative cancer treatments

In September 2019, the US FDA's Oncology Center of Excellence (OCE) initiated Project Orbis to speed up the global authorisation process for cancer treatments. Pharmaceutical companies can submit their applications for authorisation in parallel to the FDA and other international regulatory authorities. This also enables Swiss cancer patients to benefit from quicker access to innovative treatments.

Swissmedic first participated in the project in 2020 and, following a positive evaluation, has continued its participation on a permanent basis to support its strategic objectives.