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Yahoo
19-05-2025
- Business
- Yahoo
Power of collaboration more pertinent than ever says pharma experts
As the pharma industry navigates uncertainty caused by successive moves by the US administration, including international tariffs and drug pricing changes, experts at a recent conference stressed the importance of collaboration. Swiss Biotech Day, which was held in Basel, Switzerland, on 5-6 May, brought together pharmaceutical industry leaders from across the world. One key theme for the event was 'the power of international alliances,' with many discussions focusing on international collaborations. Swiss Biotech Association CEO Michael Altorfer said: 'International cooperation is in the heart of our city because our city lies in daily life in three countries….In these times, it's important to be stable and predictable, to continue our policies as we always did, and will do in future—policies to support science, that leave it the independence it needs.' One of the main findings of a report released by the Swiss Biotech Association was how investment in the Swiss R&D space had increased in 2024 compared to 2023. The report also highlighted partnerships forged by Swiss biotechs in 2024, such as AC Immune and Takeda Pharmaceutical's Alzheimer's immunotherapy deal; Epalinges, Switzerland-based Haya Therapeutics' long non-coding RNA therapy deal with Eli Lilly; and a partnership between Switzerland-based Basilea Pharmaceutica and Innoviva to commercialise the former's antibiotic. Sanofi R&D head Houman Ashrafian spoke about the importance of collaboration in running the right trial for a therapy. He added that Sanofi has funding and guidance schemes available to help biotechs that may be struggling to fully fund a study, and stressed the importance of being thoughtful about clinical study designs. "Don't mess up the clinical trial. It's critically important... Doing the wrong trial with your asset will kill it very quickly," he said. Tracy Laabs, PhD, head of innovation and strategic partnerships at Wyss Center for Bio and Neuroengineering, spoke about how the FDA is assisting with computing and neural interfacing and how companies are collaborating with regulators to make it easier to develop technology in this space without constant regulatory hurdles. Laabs said it is important to initiate dialogue with the regulators early: "You have to be your own advocate, find the regulatory authorities and say, 'Let's build together a way that you can understand how my product might change over time so that you don't have to go to the regulatory authorities every single week,' essentially because it is just a software update." She was optimistic about the potential for the future of AI-driven diagnostics and therapeutics being developed in collaboration with regulatory authorities who are ready and willing to trust the technology. Another way in which regulators are working more closely with industry leaders is through multi-agency approval pathways designed to assist companies in gaining wider global market approval more quickly. Three specific pathways were discussed: Project Orbis, the Access Consortium, and the Marketing Authorisation for Global Health Products (MAGHP), and how these can help accelerate drug approvals worldwide. Generally, approval timelines in Switzerland are longer than in other regions, admitted Eveline Trachsel, head of medicinal product authorisation and vigilance at Swissmedic, the Swiss Agency for Therapeutic Products. She said: '[The] reason for this is the so-called 'submission gap'. This means that it takes longer for dossiers to get submitted to Swissmedic compared to other agencies.' As per Trachsel, Swissmedic generally receives a dossier almost one year after it is received by the FDA, which lines up with drug approval dates in Switzerland being one year later than in the US. As a result, Swissmedic is asking companies to use multi-agency approval pathways that include the Swiss agency, where possible, to get earlier approval. While this is an attractive approval pathway for small and medium-sized biotechs, these schemes are also being utilised by the big players, including AstraZeneca and Roche. Roche's regulatory affairs head Corrine Wenger said that, as a Swiss company, such pathways that speed up approval in the home nation are attractive. As the US Government encourages a more country-centric approach, with tariffs and a push to onshore manufacturing, there are concerns about how this will impact the European pharma sector. Some impact from the Trump administration is already being felt globally, for example, with cuts to global funding for research grants and projects such as the US Agency for International Development (USAID). Despite this, the US remains a crucial country in the pharmaceutical industry, so companies need to find solutions to these incoming changes. Branden Berns, partner at Gibson, Dunn & Crutcher LLP, commented on the recent missed Prescription Drug User Fee Action (PDUFA) date for Needham, Massachusetts-based Stealth Therapeutics' drug, which scared some biotech company executives who believed it was related to recent staffing cuts. In March 2025, the Department of Health and Human Services (HHS) announced the layoffs of 10,000 employees, which included 3,500 jobs cut from the FDA. On 29 April, Stealth announced that the FDA said it would not be given an approval decision for the drug elamipretide, for the treatment of the ultra-rare disorder Barth syndrome, before the assigned PDUFA date. Apart from the Covid-19 pandemic period, there are only two to four times that the FDA misses PDUFA targets. "A lot of the FDA funding is based on meeting these targets at a 90% level," Berns said. 'I think for now, we can breathe a sigh of relief that the FDA hasn't broken the system that everyone has come to rely on.' Nonetheless, FDA commissioner Martin Makary said the agency still intends to meet these targets. With the push for international collaborations comes an appreciation for local customs. Experts at the conference emphasised the importance of Europeans understanding the US culture and how US investors respond to companies seeking funding. While Europe has a much more science-based approach with funding pitches, US investors like to know the story behind a company. Additionally, it is also important to connect and speak with investors, said Matthias Bodenstedt, CFO of Swiss biopharma MoonLake Immunotherapeutics, who added that he travels to the US up to 15 times per year to maintain a good relationship with investors. "Power of collaboration more pertinent than ever says pharma experts" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-05-2025
- Business
- Yahoo
Swiss biotech sector's R&D investment grew in 2024 despite global trends
Research and development (R&D) investment in the Swiss biotech sector grew in 2024, despite ongoing global funding struggles. While many countries have seen a decline in investment in recent years, according to the Swiss Biotech Report 2025, investment into R&D in Switzerland reached SFr2.6bn ($3.16bn) in 2024, with private company investment accounting for SFr1.4bn of that. Apart from R&D investment, companies in Switzerland raised SFr2.5bn in funds in 2024, a 22% increase on 2023. Revenues in the biotech sector were SFr7.2bn in 2024, slightly lower than SFr7.3bn in 2023. Most pharma and biotech companies in Switzerland (95%) are private and in earlier stages of the development pipeline. The remaining 5%, including big pharma such as Roche and Novartis, are public. While the private fundraising market did relatively well in 2024, there were challenges in public markets, with no initial public offerings (IPOs) taking place by Swiss biotechs last year. The only capital market transaction in Switzerland in 2024 was a reverse merger transaction of Curatis. The Swiss Biotech Report 2025, authored by the Swiss Biotech Association, EY and eight other partner organisations, was launched at the Swiss Biotech Day on 5-6 May in Basel. The theme of the Swiss Biotech Report 2025, 'The Power of International Alliances', is pertinent given recent global political shifts favouring domestic operations. Last year, Swiss biotechs forged several partnerships with large pharma companies such as AC Immune and Takeda's Alzheimer's immunotherapy deal, Haya's long non-coding RNA therapy deal with Eli Lilly, and a partnership between Basilea and Innoviva to commercialise the former's antibiotic. While the Basel-Landschaft-based Idorsia also signed a deal with Viatris centred on two Phase III assets in early 2024, the former did not later pay the required development costs due to low cash reserves, and consequently, agreed to accept a reduced future milestone payment. Swiss Biotech Association CEO Michael Altorfer said: 'In an era when isolationist policies and 'me-first' approaches have gained traction, Switzerland's collaborative model offers a compelling counterproposal. None of the Swiss biotech innovators develops a new product or technology for the Swiss market alone.' The report's theme also ties in with two key Swiss sector developments. Firstly, the Swiss innovation agency Innosuisse has assumed the chair of the Eureka innovation initiative - a network of 47 countries plus the European Commission (EC) - to expand non-dilutive global research grants. Secondly, Swissmedic, Switzerland's regulatory agency, will play a role in the Access Consortium, facilitating joint approvals across Australia, Canada, Switzerland, Singapore and the UK.
