“How to reach more patients faster: the promise of international collaboration and shared regulatory approval pathways” – panel discussion at Swiss Biotech Day 2025

At Swiss Biotech Day 2025, high-ranking panellists discussed how international regulatory cooperation is accelerating patient access to innovative therapies. The panel discussion, organised and moderated by Swissmedic, featured insights from representatives of the pharmaceutical industry on collaborative pathways such as the Access Consortium, Project Orbis, and MAGHP, highlighting both the benefits and practical challenges of global collaborative assessment procedures.

With "The Power of International Collaboration" as its focal topic, Swiss Biotech Day 2025 in Basel brought together key stakeholders from across the global life sciences community. The event underscored how cross-border cooperation fuels innovation, accelerates therapeutic development, and shapes the future of biotechnology. Focusing mainly on shared regulatory frameworks, joint research efforts, and common public health objectives, the panel demonstrated the pivotal role of multinational partnerships in tackling global health issues and advancing treatment solutions.

On the opening day, Eveline Trachsel, Head of the Marketing Authorisation & Vigilance Sector at Swissmedic, moderated the panel discussion on "How to reach more patients faster: the promise of international collaboration and shared regulatory approval pathways." The discussion focused on three key initiatives: the Access Consortium, Project Orbis, and Marketing Authorisation for Global Health Products (MAGHP).

Panellists: Sabine Ledderhose, Astra Zeneca; Corinne Wenger, Roche; Sergio Cantoreggi, Sintetica
Moderation: Eveline Trachsel, Swissmedic

Ensuring that patients in Switzerland gain timely access to safe, effective, and high-quality medicines is a core objective. In an increasingly interconnected regulatory landscape, collaboration between health authorities has become instrumental in facilitating this access. As Switzerland's national regulatory agency, Swissmedic actively participates in several multilateral efforts designed to streamline approval processes while maintaining stringent safety and efficacy standards. Swissmedic retains its independent decision-making power in all these initiatives, ensuring that it maintains its high standards of safety, quality, and efficacy when assessing applications. These initiatives not only benefit Swiss patients, but also contribute to global access to critical therapies.

To all: Why did you decide to use international pathways, what is the benefit for you as a company? What challenges and pitfalls do you wish you had known upfront?

Corinne Wenger

The Access pathway for new molecular entities was first presented at the 2018 DIA congress, where it immediately struck us as a way to conserve global teams’ resources with its consolidated list of questions and unified, predictable timetable across multiple countries. Subsequently, our Canadian, Australian, and Swiss affiliates selected a suitable candidate from the pipeline and persuaded the global team to pilot this approach. The anticipated benefits materialised, resulting in significantly faster approval times compared to the local standard processes in all the regions involved. Challenges included increased coordination between affiliates as regards communication and simultaneous submissions, as well as the demanding short response windows following questions and preliminary decisions, particularly in Switzerland owing to German labelling requirements. Maintaining harmonisation of Modules 2-5 across all jurisdictions, unclear question categorisation (minor/major), and managing country-specific demands or off-cycle requests also presented complexities. Overall, the Access Consortium offers a promising pathway for faster, more harmonised drug approvals, though continued refinement is needed to fully realise its potential.

Sabine Ledderhose

AstraZeneca's decision to use international pathways like Project Orbis is driven by the desire to improve efficiency and expedite review and approval. Participating in these pathways offers several benefits, including accelerated review timelines compared to standard national procedures, enhanced collaboration between regulatory agencies and progress towards a globally harmonised regulatory framework. These advantages allow AstraZeneca to facilitate faster patient access to innovative therapies worldwide. However, engaging in international pathways also presents several challenges and pitfalls. The process demands substantial resource commitments, both within AstraZeneca and across the collaborating agencies, and these can be difficult to anticipate and manage. Coordination is another hurdle, given the need to synchronise submission timelines globally and deal with the complexities associated with large dossiers. Challenges arise from Information Requests issued by multiple agencies, which require extensive resources to address. Understanding these challenges upfront is helpful in managing international regulatory pathways effectively. Further complexity arises when such international pathways are combined with national accelerated procedures. Project Orbis represents a significant step towards more unified and efficient global drug approvals, with clear benefits for companies and patients alike – provided the operational demands can be effectively managed.

Sergio Cantoreggi

For a small player like Sintetica, any opportunity to optimise the use of resources and get to key markets faster is very welcome. In the specific context of the MAGHP programme, our South African commercial partner suggested we consider it. Admittedly, we were initially a bit hesitant as we had no experience with the procedure and were worried about the possible additional workload and unknown issues. In reality though, the process turned out to be straightforward thanks in part to the support of Swissmedic, which helped us understand the procedure at the pre-submission meeting and coordinated behind the scenes with SAHPRA throughout. The primary review work done by Swissmedic resulted in a “light” LoQ from SAHPRA which was certainly an advantage. Possible pitfalls may stem from the inclusion of additional low- to mid-income countries in a MAGHP submission and also starting earlier with a Scientific Advice meeting, which in our case was not needed. SAHPRA's approval was expected within 90 days of Swissmedic’s approval, approximately one month ahead of Sintetica's track record for regulatory reviews in South Africa. The process was described as smooth and collaborative, and Sintetica recommended it to other companies.

To C. Wenger: If you could improve just one thing about the Access Pathway – and you can only name one – what would it be?

To increase the attractiveness of the Access procedure, consider incorporating conditional approvals, new formulations and other variations, and establishing timelines that are shorter than those of national procedures. If Access could be extended to include conditional approvals, this could broaden the pool of eligible candidates for the newly established accelerated Access Promise procedure.

To S. Ledderhose: What are your main considerations when choosing Orbis for an application? If both Orbis and Access were possible for an oncology product, which would you prefer and why? How do you decide which countries to include?

When choosing Project Orbis for an application, AstraZeneca considers several key factors. These include the scale of the clinical benefit, the complexity of the application, such as endpoints and the number of studies, vendor readiness and resource availability at the sponsor, country and partner levels. Differences in regional requirements and procedures are also crucial. Additionally, the interest and readiness of the Project Orbis Participants (POPs), the type of Orbis review and the availability of other review pathways are important considerations. Submission readiness of the dossier is another critical factor in ensuring successful participation in Project Orbis.

When both Orbis and Access are possible pathways, AstraZeneca is currently opting for Orbis, as we have more experience with it and the pathway is faster, especially for applications for new indications.

When deciding which countries to include in a Project Orbis application, factors such as local CMC (Chemistry, Manufacturing, and Controls) and device requirements play a critical role. The availability of internal regulatory publishing resources and capacity is also considered. There is a need for thorough discussions and alignment both at the global team level and within the specific country teams of the participating regions. The potential for a faster review and approval process through synchronised timing with the FDA submission and review is important. Support for overlapping submissions and responses across regions must be ensured, considering the feasibility of participation for each region outside of Project Orbis, particularly when a Type C Orbis pathway is recommended.

To S. Cantoreggi: Are initiatives like the ones we discussed today just the beginning? Are we moving towards a model of global regulatory convergence?

As a scientist, I personally believe that science and medicine are largely superimposable at a global level and I don’t see why regulatory agencies need to review independently the same (or very similar) data over and over unless there are specific local or regional reasons. Today we discussed the Orbis, Access and MAGHP programmes. These were introduced fairly recently and, as you have seen, they are already being used quite extensively. However, if we go back just a few decades, you may recall that the first ICH conference took place in 1990 and EMA was created in 1995, two major initiatives that we take for granted nowadays, but which really paved the way for what Dr Trachsel calls “regulatory convergence”.

I don’t know what the future has in store for us and there will always be procedural, legal, and political constraints, yet I personally would like these international programmes to further develop so they can facilitate the work of pharmaceutical companies and regulatory agencies alike for the benefit of the patients we all serve.

^{Biographical notes on the panel members}

^{Dr Sergio Cantoreggi has been working in the life sciences industry for over 30 years. He is currently Chief Scientific Officer (CSO) at Sintetica, overseeing a team of professionals across preclinical and clinical R&D, regulatory affairs, drug safety, pharmaceutical development, CMC, medical affairs, IP and project management. Before joining Sintetica he was CSO and Global Head of R&D at Helsinn for 10 years, where he held similar responsibilities. He had initially joined the company in 2000 as a scientist working on preclinical and clinical studies. From 1996 to 2000 Dr Cantoreggi worked as Study Director and Project Manager of toxicology and animal PK studies at Sandoz/Novartis in Basel. Before that, he was a postdoctoral fellow at DuPont in Newark, Delaware. He holds an MSc in chemistry and a PhD in natural sciences from the Swiss Federal Institute of Technology (ETH) in Zurich, where he also did his first postdoctoral fellowship. Dr Cantoreggi is the author or co-author of 16 peer-reviewed publications and holds four patents.}

^{In terms of collaborative international regulatory approval pathways, he has experience with Project Orbis and MAGHP.}

^{Dr Sabine Ledderhose has been working in the pharmaceutical industries for over 25 years. She currently serves as Head of Regulatory Affairs at AstraZeneca AG's Swiss marketing company in Baar, where she leads a team responsible for overseeing all AstraZeneca's medicinal product authorisations in Switzerland. Prior to her tenure at AstraZeneca, Dr Ledderhose held various positions in regulatory affairs, medical affairs, quality assurance, and compliance across different organisations. She holds an MSc in chemistry and a PhD in organic chemistry from the Georg-August-Universität in Göttingen, Germany.}

^{In terms of collaborative international regulatory approval pathways, she has experience with Project Orbis procedures.}

^{Dr Eveline Trachsel is the Head of Medicinal Product Authorisation and Vigilance at Swissmedic, the Swiss Agency for Therapeutic Products. Dr Trachsel is a pharmacist with a PhD from the Swiss Federal Institute of Technology in Zurich. In 2023 she completed an executive MBA, majoring in digital transformation, at the University of Zurich. Dr Trachsel started her career as a project manager in the biotech industry, then moved to the USA, where she was the Clinical Research Manager of the Early Drug Development Center at the Dana-Farber Cancer Institute in Boston. After returning to Switzerland, she worked in various Medical Affairs roles at Bristol-Myers Squibb, including as Medical Director for Switzerland and Austria. She has been in her current role at Swissmedic since January 2024.}

^{Corinne Wenger has been working in the life sciences industry for over 22 years. She is currently Head of Regulatory Affairs at the Swiss affiliate of Roche in Basel, responsible for all Roche drug authorisations in Switzerland. Ms Wenger joined Regulatory Affairs 17 years ago and has worked in different roles in Switzerland, Germany and the global function. Before that she gained experience working in clinical research and as a community pharmacist in Switzerland. Ms Wenger holds an MSc in Pharmacy from the University of Basel and a specialist title in pharmaceutical medicine (Swiss Medical Association equivalent). In 2024 she completed an eMBA at the School of Business and Technology in Washington US.}

^{In terms of collaborative international regulatory approval pathways, she brings experience from several Access and ORBIS procedures.}