How will US pharma manufacturing be reshaped by the Trump administration?

“We seek long-term partnerships where our technologies can bring genuine value-add that sustains growth. It’s not about geography – it’s about matching specialties and capabilities with companies who share our vision for innovation,” says Rocco Paracchini, Director of CDMO Business Unit Morpho at Alfasigma.Rocco Paracchini brings a blend of a biology background and extensive pharmaceutical manufacturing experience to his role as Director of Morpho at Alfasigma. After transitioning from biotech to CDMO operations in 2011 in different CDMOs across Europe, he joined Alfasigma in June 2024 to drive its Contract Development Manufacturing transformation and growth.In the latest episode of the PharmaSource podcast, Rocco shares insights into how Alfasigma, a global pharmaceutical company founded over 75 years ago in Italy with 4,000 people across four continents, is evolving its CDMO strategy to meet growing market demands, with particular focus on customer-centric manufacturing solutions and technological innovation.Read the full article onPharmaSource

A perfect Storm for US Drug Manufacturing as FDA Changes, Trade Wars and M&A Surge Collide "There's optimism… but the challenges aren't day to day - it can be minute to minute," warns Gil Roth, President of the Pharma and Biopharma Outsourcing Association (PBOA), describing a pharmaceutical manufacturing sector facing unprecedented change in 2025. Gil Roth brings deep expertise in pharmaceutical policy and manufacturing legislation, having launched PBOA in 2014 as an essential bridge between contract manufacturers and government stakeholders. In the latest PharmaSource podcast episode, Gil shares detailed insights into how the new administration's trade policies and leadership changes will likely create both challenges and opportunities for US pharmaceutical manufacturing. Read the full article Join Gil Roth and other industry experts at CDMO Live 2025

“The automotive industry was once in a similar setup to big pharma players, but they evolved through closer supplier collaboration and continuous improvement practices,” says Fabrice Le Garrec, drawing parallels between today’s pharmaceutical manufacturing challenges and the automotive industry’s transformation. “Toyota’s model of developing suppliers as an extension of your company is something pharma isn’t doing enough of.” Fabrice Le Garrec brings extensive pharmaceutical operations experience as former VP of Global Operations at Teva and GSK, and ex-McKinsey consultant. Through OSCIS Network, he now leads a network of over 100 pharmaceutical professionals providing performance transformation services across North America and Europe. In the latest episode of the PharmaSource podcast, Fabrice shares crucial insights about how pharmaceutical manufacturers can transform their operations by adopting Toyota’s proven approaches to supplier integration, continuous improvement, and operational excellence, including lessons learned during the COVID-19 vaccine manufacturing ramp-up. Don’t miss Fabrice’s talk at CDMO Live 2025: 10 things I’d do differently if leading new fast-track pandemic drug launch again. Download the agenda here

Kolon Biotech's Jungjong Cho believes that the future of cell and gene therapy lies in automation, which offers unprecedented precision and cost efficiencies. "Traditional manufacturing is prone to human error and variability among operators, affecting the quality of the product," JJ explains. "To overcome these disadvantages, our robotic manipulator significantly reduces these errors and ensures batch-to-batch consistency." Kolon Biotech is pioneering the use of two innovative technologies that are reshaping manufacturing capabilities: The 2D Automated Closed Platform represents a quantum leap in manufacturing precision. The use of 3D Bioreactors further demonstrates the power of scale-up technologies. Read the full interview

“The Americans put a man on the moon in less time than it takes us to transfer a product between countries – this has to change,” says Luiz Barberini, who leads External Manufacturing for Bayer Consumer Health across Latin America. Luiz Barberini combines over three decades of pharmaceutical supply chain expertise from roles at Pfizer, Merck and now Bayer with academic positions at Brazil’s leading business schools. His unique perspective spans both practical implementation and theoretical frameworks for supply chain excellence. In this exclusive interview with PharmaSource, Luiz shares why pharmaceutical companies must fundamentally transform their approach to supply chain management, offering practical insights on breaking down organisational silos, accelerating time-to-market, and building collaborative supplier relationships in an increasingly complex global landscape. Read the full article here

The Netherlands has emerged as one of Europe's most vibrant and interconnected biotech ecosystems, home to over 1,797 life science companies, world-class pharmaceutical manufacturers, and the European Medicines Agency. With its strategic location, exceptional infrastructure, and collaborative spirit, the country has become known as 'what industry leaders call 'Europe's connected life sciences & health metropolis'. Ahead of CDMO Live 2025, which takes place in Rotterdam's historic World Trade Center this May, we gathered insights from three leaders at the heart of the Netherlands' biotechnology sector. Wieteke Wouters, Program Director at hollandbio, which represents over 260 biotech companies; Esther Peters, Director of Leiden Bio Science Park, the country's largest life sciences hub; and Ellen Smit, Managing Director of Rotterdam Square, the organisation behind the emerging health tech campus in Rotterdam, shared their perspectives on what makes the Dutch biotech ecosystem uniquely successful. Read the full article

“The market for lipid nanoparticles really exploded during COVID-19,” says Alexander Aust, LNP manufacturing expert. Alexander Aust, a consultant specialising in lipid nanoparticle (LNP) manufacturing, brings years of experience from companies like Sigma-Tau Pharmaceuticals and Exelead. His expertise spans from commercial liposomal drug products to cutting-edge mRNA and gene editing technologies. In the latest PharmaSource podcast episode, Alexander explains why LNPs have become crucial in drug delivery, particularly for mRNA vaccines, and shares insights on manufacturing challenges, regulatory considerations, and future applications of this technology. Read the full article

The COVID-19 pandemic didn't just disrupt pharmaceutical manufacturing—it catalysed a fundamental shift in how we approach CDMO partnerships. Johnson & Johnson's Paolo Giudici reveals how their four-year digital transformation journey is reshaping the future of external manufacturing. Key transformations reshaping sponsor-CDMO relationships: Real-time manufacturing floor visibility enabling proactive process control Seamless ERP integration across the partner ecosystem Standardised quality data exchange and monitoring Compressed timelines from years to months The critical challenge? Standardisation. Unlike mature industries, pharma lacks unified frameworks for digital CDMO collaboration. "Currently, if a sponsor attempts to establish digital collaboration with a CMO, they essentially start from scratch," notes Giudici. Strategic implementation insights: Secure explicit partnership agreements before technical integration Focus on value creation, not job displacement Establish clear cost-sharing frameworks upfront Leverage industry collaboration networks Read the article here Paolo will be speaking about Digital Transformation of Pharma Manufacturing at CDMO Live 2025. Tickets available now

Leadership insights from our latest Women in BioPharma meetup. "I fully expect that the industry will have multiple female CEOs in the years to come," predicts Elizabeth Hickman, Chief Executive Officer of Austin Pharmaceuticals. However, the current state of the pharma industry is that while gender mix starts fairly even, by the time you get to the C-suite, the top table is still overwhelmingly male. In our most recent Women in BioPharma meetup Elizabeth Hickman was joined by Nikki Whitfield, CEO of Upperton; and Hennie Zijlstra, Chief Commercial Officer at Adragos to share their perspective. Their combined experience spans research and development, commercial operations, and executive leadership, offering a comprehensive view of how women can succeed in this traditionally male-dominated industry. Join our next meetup: 20th March 2025 Join us for an enlightening conversation with a pioneering female health startup founder, Valentina Milanova, Founder and CEO/CPO of Daye. Valentina will explain her own personal journey in creating an innovative period care and gynae health startup and discuss the systemic issues which are harming women’s health. She will reveal the hidden gender biases she has encountered that are ingrained in the pharmaceutical industry, from research and testing, to investment, manufacturing and marketing. Join the conversation by signing up here

Gene editing and cell therapy, they’re going to be entrenched modalities, much like small molecules and antibodies are today, that will fundamentally reshape healthcare.” says Devyn Smith. Devyn Smith, CEO of Arbor Biotechnologies and Chairman of the Alliance for Regenerative Medicine, brings a wealth of experience to the cell and gene therapy ecosystem. With a PhD in developmental biology and eight years in strategy consulting, Devyn’s journey led him to Pfizer, where he served as COO of their cell therapy group in Cambridge, UK, before a series of board roles at various biotechs. In the latest PharmaSource podcast episode, he shares insights on the promise of cell and gene therapy to transform lives and the operational challenges the industry must overcome to realise this potential. Here's the full article