Latest news with #Europe2025
Yahoo
02-05-2025
- Business
- Yahoo
OCT Europe: Small and mid-sized sponsors demand smart and reliable partnerships
One of the key challenges in clinical trial operations today is maintaining a trustworthy and reliable relationship with partners, vendors, and sites, says Sarah Bischof, Head of Clinical Developments at invIOs, a private biotech company developing next-generation cancer therapies. At a closing panel discussion on the first day of the Outsourcing in Clinical Trials (OCT) Europe 2025 meeting, Dr. Claudia Hesselmann, Founder and CEO of ARENSIA, an early phase clinical trial partner, reproached the current inefficiencies in clinical trials. She stated that 'efficiency in clinical research could be improved at least by 80%' if only counterparts demonstrated greater initiative and accountability, actively questioning existing limitations rather than accepting established practices. In her opinion, one of the best regulatory environments to conduct clinical trials is Moldova, which has a ten day fast-track review timeline for clinical trials of all phases. As the Clinical Trials Information System (CTIS) portal was implemented in the European Union, the authorities in Moldova wanted to attract more clinical trials and drive innovation in the country and become as competitive as other countries such as Australia, said Hesselmann. Moldova's regulatory bodies are an example of how proactive agencies are essential to implement changes that can drive efficiencies, she said. While discussing their experience with CTIS, Bischof shared that when submitting trial protocols for immunotherapies and autologous cell therapy trials through the new EU Clinical Trials Regulation (CTR) with their contract research organisation (CRO), her team was faced with new administration and documentation burdens with new workflows, portals, and registration processes. With the new CTR implementation, Bischof observed lesser flexibility in terms of responding for trial sites and manufacturing because of the tight deadlines, such as twelve calendar days to provide the request for information. Data protection for confidential documentation with the new directive created a need to re-adapt trial strategies to redact and protect their data. Early preparation for CTIS submission is crucial because delays may lead to compliance issues, and the a cross-functional coordination of all teams from regulatory to legal is needed to meet these tight deadlines, Bischof shared. However challenging this was, Bischof stated that she would not go back to the old CTR directive because the timelines are more defined in this new directive, leading to improved trial planning. Still, companies without centralised clinical operations are finding it harder to adapt, and success depends on changes to internal processes, retraining teams, and updating document templates, she noted. Hesselmann highlighted that in her experience from the site's perspective, she has observed a dramatic difference in whether the sponsor has an operational team. 'The sponsor has a different approach to timelines because they own the compound, whereas the CRO does not,' said Hesselmann. In small to mid-sized biopharma companies, resources are limited; however, according to Hesselmann, even a single clinical trials operation leader from the sponsor side can make a meaningful difference in the smooth clinical trial execution. Diving into the topic of limited resources of small and mid-sized companies, both speakers acknowledged the high turnover rate amongst key project managers, scientists, and regulatory staff in the industry, which results in project disruption, uncertainty and disengagement. Hesselmann said that sites see a very high turnover rate, especially on the CRO side, with 'even three to four manager changes in one project,' which negatively affects the project continuity. 'Staff retention in the industry is a huge problem, not only on the programme manager level but even on the monitoring level', she added. In some cases, the dedication of the site staff and principal investigator (PI) hinge on the project leader's commitment. Bischof agreed that when faced with staff turnover as a small and mid-sized company, there is a need to redesign roles to encourage multi-skilling and cross-functional collaborations. Further, she noted that it is important to empower trans-functional market scaling strategies to the remaining team as well as to be agile and adapt fast in terms of structure and processes. The biggest operational challenge of small and mid-sized companies lies in the selection and management of CROs and other vendors as well as the implementation of patient-centric approaches. Hesselmann pointed out that 'the site should not be put in the unfortunate position of inviting patients for screening, only to send them home due to randomisation system failures or other technical or decisional issues caused by the sponsor, CRO, or vendors.' To conclude the panel, Bischof noted that external partnerships can temporarily ease the load with long-term headcount gaps and a transparent empathetic leadership can retain trust during transition periods, while Hesselmann stressed the importance of possessing a problem-solving mentality when faced with limited resources. The 15th Annual Outsourcing in Clinical Trials Europe took place in Barcelona, Spain from 29-30 April. "OCT Europe: Small and mid-sized sponsors demand smart and reliable partnerships" was originally created and published by Clinical Trials Arena, 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. Sign in to access your portfolio
Al Arabiya
27-03-2025
- Business
- Al Arabiya
Germany's Baerbock: European defense union no longer a question of if but how fast
A European defense union is no longer a question of if, but of how fast, German Foreign Minister Annalena Baerbock said on Thursday. 'The European defense industry is still national in character and therefore highly inefficient,' Baerbock said at the Europe 2025 conference on European sovereignty. 'If we continue to use 150 different weapon systems in Europe and they are not compatible with each other, then we can spend all of the world's money on them - we will not be able to be effective enough, which is why I believe that the European defense union is no longer a question of whether, but how quickly we get it off the ground,' she said.
Yahoo
04-03-2025
- Business
- Yahoo
IHTF Europe 2025 finalists announced
The International Hotel Technology Forum (IHTF) Europe 2025 is set to take place from 18th to 20th March at the stunning Tivoli Marina Vilamoura Algarve Resort in Portugal. Now in its 20th year, this premier event brings together hoteliers, technology experts, and innovators to explore the latest industry trends, challenges, and breakthrough solutions. As part of the forum, the prestigious International Hotel Technology Awards Europe 2025 will celebrate the most groundbreaking achievements in hotel technology. The winners will be announced during an exclusive awards ceremony and gala dinner on 19th March 2025 at the Tivoli Marina Vilamoura Algarve Resort. The evening will feature a drinks reception, a three-course dinner, and unparalleled networking opportunities with industry leaders. The shortlist of finalists across key categories has now been revealed, recognising organisations and individuals who are pushing the boundaries of innovation in the hospitality sector. AI Adoption of the Year Canary Technologies Aquaworld Resort Budapest & Everguest Hey Lou Hotels & GauVendi PortoBay Hotels & Resorts Radisson Hotel Group Strawberry Hotels CTO/CIO of the Year Kai Wolffram Kari Anna Fiskvik ESG Initiative of the Year Blue & Green Hotels & Resorts Valamar Riviera d.d. Hotel App of the Year Everguest RIU & Joyned The Largo & OKKAMI Radisson Hotel Group Staymaster Strawberry Hotels In-Room Guest Tech of the Year Alexa Smart Properties X NH Collection Hotels Esferize Comunicaciones London Marriott County Hall Hotel X IRIS Minor Hotels Europe & Americas Orbital Systems Nordic Choice Hotels & Philips AMANO & SuitePad Boscolo Lyon Hotel & SuitePad Yuvod Clarion Hotel Post & Zaplox Integrated Staff Operations Tech of the Year CitizenM & Aphy RPA BV Belmond Wyndham Hotels & Canary Technologies Dharma EISI SOFT The View Oasis Hotel & Sweeply Whitbread Dorint Hotel Alzey/Worms & hotelkit Resort Tech Innovation of the Year Belmond Everguest Valamar Riviera d.d. With a stellar lineup of finalists, this year's awards promise to be a celebration of cutting-edge solutions shaping the future of hotel technology. The IHTF Europe 2025 is not just about recognising excellence—it's a hub for collaboration, learning, and innovation. Attendees will gain exclusive insights from high-level speakers, participate in industry-led case studies, and engage in one-to-one business meetings. Stay ahead of the curve and be part of the conversation shaping the future of hospitality technology. For more information, visit: IHTF Europe 2025 "IHTF Europe 2025 finalists announced" was originally created and published by Hotel Management Network, 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.
