PharmaSource Podcast

“The best CDMO is the one you haven’t worked with.” says Audrey Greenberg.”That’s really unfortunate.. it’s not that hard to be a good service provider.” Audrey is the Founder of Centre for Breakthrough Medicines, the innovative, Pennsylvania-based Cell & Gene therapy Contract Development and Manufacturing Organization (CDMO). Audrey launched and then sold the company to SK Pharmteco, where she is currently is Chief Business Officer for their wider CDMO business that operates facilities in United States, Ireland, France, and South Korea. In the latest episode of PharmaSource podcast Audrey discusses her journey in launching a CDMO that put digital at the centre of operations right from the start. “Digital infrastructure is an important piece that people underestimate.” say Audrey. Read the full interview

“CDMO environments can often be very tough and chaotic, requiring leaders who can navigate uncertainty" says Neil Kelly, CEO and founder of Vector, a company specializing in talent solutions for the biopharma industry.  "To succeed in this sector, you need to be able to thrive in 'grey' areas. Not all leaders can handle this kind of environment." At CDMO Live 2024, a poll of attendees indicated that leadership skills was the most significant talent-related issue that was holding their company back from achieving growth. “Strong leadership is critical in any organization, but it's especially vital in the fast-paced and complex world of CDMOs." says Neil, speaking on the PharmaSource podcast. Read the full interview

Kurt Nielsen, Ph.D. shares his strategies for sponsors to extract maximum value from contract service providers, the overlooked benefits of AI, and the shifting dynamics of the global supply chain. Kurt has an extensive background in contract development and manufacturing, having previously held senior leadership roles such as CEO at Pharmaceuticals International, Inc. (PII), President of Lupin, VP at Sandoz, SVP at Catalent, and EVP at Teva. His consultancy, Longview Leader, assists life sciences clients with continuous improvement and asset management. “The work we do every day truly makes a difference in people’s lives,” says Kurt. “Putting aside the politics and profit debates, at its heart, the pharmaceutical industry’s mission is to improve health, cure diseases, and enhance quality of life makes it an amazing place to work.” Read the full interview

UK Biocentre is a respected leader in sample management, high-capacity bioprocessing & analysis, and automated storage. With the capacity to store 35 million individual sample, it is the main processor for many of the UK’s government genetics projects, including the ambitious Our Future Health project which aims to collect and analyse the genetic samples of 5 million residents. We sat down with Dr Tony Cox OBE a molecular biologist and CEO of UK Biocentre to discuss the centre’s pivotal role during the COVID-19 pandemic, and how they have returned to supporting ambitious biopharmaceutical projects. “I’ve always been fascinated by DNA and the concept of information moving between generations. It blows my mind that something as simple but as complex could have arisen,” says Dr Cox. “We have a vibrant life science sector in the UK. It’s a fantastic place to be doing genetics." Read the full article

“The healthcare industry is responsible for 5% of global emissions, which is more than aviation,” says Robert Williams Director of Sustainable Procurement at AstraZeneca. As Vice Chair of the Pharmaceutical Supply Chain Initiative (PSCI), he regularly engages with a wide cross-section of stakeholders from across the industry. The PSCI is the leading association for pharmaceutical and healthcare companies, focused on driving an agenda for safety, environmental, and social outcomes across the global value chain. The 81 members of the association, and the 1,000 registered suppliers, have a combined turnover of $1.3 trillion USD, representing approximately 80% of the global pharmaceutical industry (which is estimated to be $1.6 trillion USD). Speaking to the PharmaSource podcast ahead of CDMO Live, Rob explains that working with suppliers is critical if the pharma industry is to realise its ESG and Net Zero ambitions. “As more than 80% of PSCI member companies’ emissions are in the supply chain (97% in the case of AstraZeneca), the focus has to be on working closely with suppliers to achieve decarbonisation goals.” “It’s clear that there is more that needs to be done globally, as we go beyond tier one and two suppliers, right back to the raw materials that we use,” he says. Read the full article

Founded in June 2020, INCOG has secured FDA-approval and now establishes itself as a new force in contract manufacturing with a focus on sterile injectables.  As we gear up for CDMO Live, we had the opportunity to speak with Corey Lewis, CEO, President, and Founder of INCOG Biopharma Services, about their dedicated approach to serving customers in the high-growth sterile injectable market. Despite the company only being four years old, INCOG’s leadership team brings decades of industry experience. Cory says he has brought the ‘band back together’ by reuniting seasoned professionals to create a tier-one contract manufacturing organisation (CDMO). “Our goal is to compete at the highest level, and that requires a seasoned executive team with a robust investment strategy.” INCOG’s investments in vial, syringe, and cartridge filling capabilities are “just the beginning” says Lewis. “We’re also expanding into quality control, lab stability services, and eventually, auto-injector device assembly and final packaging. Our long-term site master plan outlines our ambition to not only enhance  filling capacity, but also integrate additional business units to support commercial packaging and device assembly.” Read the full interview

UniD Manufacturing are the first global Contract Development and Manufacturing Organization (CDMO) fully dedicated to micro-implants based on sustained release and polymeric formulations. 2024 is an important year for UniD Manufacturing, their first as a CDMO open to external customers, with new projects expected to be launched by the year’s end. Ahead of CDMO Live 2024, Chief Operational Officer Pascal Bertholet shares the company’s innovative strides in micro-implant technology and their vision for a sustainable future. “2024 marks a significant year for us as we undergo a substantial shift in our business approach.” says Pascal. The company was originally established to develop ocular implants for sister company, EyeD Pharma, but has recently expanded to offer small implants in other therapeutic areas. “What sets us apart is our expertise in developing both the formulation and the manufacturing process for micro-implants that release active ingredients according to a specific dissolution profile. This can range from a few hours to several years. Our formulations include biodegradable, non-biodegradable, and resorbable polymers,” explains Pascal. Read the full article on PharmaSource

Prasfarma is a company full of experts in the manufacturing of cytostatic and highly potent products (HPAPI), with a focus on oncology.    Ahead of CDMO Live we spoke to Diana Alarcón, Business Development Manager at Prasfarma to understand more about the services they offer by the Barcelona-based Contract Development & Manufacturing organisation, and how they have become Annex-1 ready .  “Prasfarma has made significant investments adapting their facilities and machinery to Annex 1 requirements for the manufacturing of sterile projects. We have expanded our facilities and increased both production and analytical departments.” Prasfarma has a reputation for working under an agile strategy. We consider our clients as our partners. “One of our main value is our flexibility. We work on tailor-made projects and we adapted to our customer’s needs” says Diana.  Read about their upcoming roundtable on Annex 1 here

Vitema is a fast-growing Contract Development and Manufacturing Organization (CDMO) based in Sibiu, Romania. With one of the largest GMP-certified pharmaceutical manufacturing facilities in Europe, new management team and assets worth over €100 million, they have ambitious goals. Ahead of CDMO Live we spoke to Diana Serban, the Head of Commercial and Business Development at Vitema. Diana describes the company as “More than just a CDMO: we are a robust ecosystem that supports the entire pharmaceutical development lifecycle.” This includes everything from the research and development of medicines and food supplements to full-scale production. Vitema also boasts specialised capabilities for oncology products and clinical trials. Vitema has more than 20 years experience in the pharmaceuticals market, and prides itself on its ability to assist pharmaceutical, biotech, and healthcare companies in delivering high-quality medicines and food supplements to their customers. They offer integrated services, full transparency throughout the entire manufacturing process, and highly competitive pricing data. Read the full article

Aizon is on a mission to integrate modern computing into the complex arena of GMP manufacturing processes in life sciences. In the latest episode of the PharmaSource podcast we sat down with Claus Abildgren, Chief Revenue Officer at Aizon, and David O’Gara, Strategic Advisor to Aizon to understand how artificial intelligence can make an impact on manufacturing in the highly-regulated industry. “Our goal is to evolve the industry by taking pragmatic steps towards enhancing manufacturing performance through practical applications.” says Claus. “We aim to optimize the current capacity of manufacturers and utilize artificial intelligence to anticipate and mitigate the risk of adverse events with predictive capabilities.” When producing drug products under stringent GMP conditions, “ensuring quality is fundamental. This includes securing data integrity and maintaining comprehensive audit trails—key aspects of deploying technology in a highly regulated environment.” Leveraging the data generated at a plant leads to identifying opportunities for yield improvements, thereby ensuring high-quality production, delivered on time and at reasonable costs. says David. “Automated quality reports can significantly reduce the workload for quality organizations and production plant chemists.” Deploying this technology, especially at CDMOs and for their sponsors, can yield substantial returns, particularly with high-value molecules where even a 1% improvement can have a remarkable impact on return on investment. Read the full article