PharmaSource Podcast

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

“The biggest challenge for scientists to understand that it’s not just your expertise that people are buying, it’s your ability to connect with their problem.” Dr. Jeff Kiplinger, a former scientific leader at Pfizer, founded, scaled and sold Averica Discovery Services, a Boston-based CRO specializing in early-stage contract research and analytical development. Now best-selling of author “Expert to Entrepreneur” and consultant, his company Selling Science advises contract service providers on how to improve their science selling techniques. Ahead of his lighting talk at CDMO Live, we sat down with Jeff to discuss how CROs and CMOs can position themselves for success in today’s crowded marketplace, and advice for outsourcing leaders in selecting the right partner for their business.

Pfizer CentreOne is an “altogether different kind of CDMO”. Unlike a pure play contract development and manufacturing partner, they don’t own their own plants and pharmaceutical development centres. Instead their customers can leverage the wealth of expertise and state-of-the-art facilities Pfizer possesses. Ahead of CDMO Live 2024 we sat down with Tom Wilson, VP of Global Contract Manufacturing at Pfizer CentreOne, to discuss how their integrated business model sets them apart from other contract manufacturing partners. Pfizer CentreOne offers a comprehensive range of services including small molecule API, solid oral dose, sterile injectables, biologics, and cell & gene therapies. “Pfizer spends over a billion dollars every year to maintain our global network of 38 plants.” says Tom. “When we bring a client partner on board, they get access to the same manufacturing work centres, scientists, and analysts that Pfizer uses for its products. We have robust ways of controlling intellectual property, ensuring we’re protecting our clients and our own IP.” “Pfizer’s main mission statement is ‘time is life’. We bring that patient centricity to our CDMO practice. Clients are usually surprised that we’re not talking immediately about our technology, but instead about their patient’s journey, then how can we help make a difference.” Read the full article

“Good quality supplier data is the backbone of procurement,” says Lana Radosevic, Global Supplier Lead in Procurement Excellence at Astellas In her role in Procurement Excellence, Lana Radosevic’s primary focus is on improving supplier data quality across all SaaS systems used by Global Procurement and integrating supplier data. In the latest episode of the PharmaSource podcast she explains the importance of accurate supplier data and shares her experience in driving improvements. Read the full article on PharmaSource

Terumo is a mid to large size-global medical device company based in Japan, with offices in over 160 countries around the world and over 50,000 products and services. The Terumo Pharmaceutical Solutions Division, also known as ‘PSD’, is a leading manufacturer of injectable solutions – including primary container, infusion therapy devices, general drug delivery devices – and contract development manufacturing (CDMO) services for parenteral drugs. “2024 so far has been very good for us.” says Marco Chiadò Piat, President of Terumo Pharmaceutical Solutions Division. “We’re seeing continuous growth this year, as we did in 2023 and 2022. Continuous growth in capabilities, the solutions we provide to our pharmaceutical customers, and hence a continued increase of the positive impact that we have on patients worldwide.” Ahead of CDMO Live, we sat down with Marco and Anil Busimi, Vice President Strategy & Marketing at Terumo Pharmaceutical Solutions Division, to discuss the integrated CDMO services that Terumo offer to their growing, international customer base Read the full article

Grand River Aseptic Manufacturing (GRAM), as the name suggests, is a leading sterile injectable drug manufacturer based in Grand Rapids, Michigan. Following significant investments in state-of-the-art facilities and equipment, GRAM has capacity for fill-finish biologics, small molecules, and vaccines. Ahead of CDMO Live, we had the opportunity to sit down with David Powell, Vice President of Business Development at GRAM. “We strive to have the latest manufacturing technology. All our equipment is always cutting-edge. But at the same time, as a good old Mid-west company, customer focus, authenticity, and transparency are the hallmarks of who we are.” say David During the COVID-19 pandemic, GRAM helped manufacture the vaccine. “We pivoted and quickly invested in more capacity. Now, post-COVID, we have a significant amount of capacity available to our customers, with a total of three fill lines and a fourth on the way,” David explained. With newer capabilities and facilities, GRAM has pivoted to specialize in biologics fill-finish. “That is where our sweet spot is. We’re not into drug substance, we’re not in oral solids, we are really just focused on fill-finish and helping our customers, large or small, take their products through and get it to market.” GRAM have announced plans for a third manufacturing facility focused on syringe and cartridge filling to complement existing capabilities. “We’re leaving plenty of space to also get into more downstream auto injector and other device manufacturers assembly for our syringe and cartridge customers. We realize we need to continue to expand in there to match the market demand.” PharmaSource

Bayer Consumer Health heavily relies on contract development and manufacturing, maintaining a network of nearly 200 contract manufacturers that account for approximately half of their global sales. This is set to change with the Project Martini initiative, which aims to significantly “shake up” and consolidate their network of contract manufacturers. Speaking ahead of CDMO Live, David Buhmann, Vice President of Procurement Finished Goods, explains the new strategy and its critical importance to Bayer. “Contract Manufacturers are an integral part of our overall supply chain. We require top-tier partners to ensure that we fulfil our mission of helping over 1 billion people lead healthier lives with the most trusted selfcare solutions in the market. This includes every link in the supply chain, including the CMO network.” Over the years, Bayer’s contract manufacturing network has grown organically, resulting in a situation where the company now collaborates with nearly 200 CMO sites, accounting for roughly half of the company’s revenue. “Our priorities shifted rapidly during the COVID-19 pandemic,” says David. “Initially, our focus was on securing materials and supplies at any cost. However, more recently, we’ve shifted our attention to cost management and cash flow, right-sizing the inventories that accumulated during the pandemic.” Read the full article on PharmaSource

Onyx Scientific is a Contract Development and Manufacturing Organization (CDMO) that specializes in process R&D, non-GMP scale-up, and GMP manufacture for clinical trials and commercial applications. With facilities in the UK and US, their dedicated teams in chemistry, solid-state and analytical chemistry guide small molecule Active Pharmaceutical Ingredient (API) products through development and manufacturing. In anticipation of CDMO Live, we had a conversation with Chris Atherton, the Commercial Manager of Onyx Scientific, who shed light on their business operations. "Onyx was one of the first chemistry CDMOs to invest in solid-state, and we plan to continue investing in this area in the future." says Chris. Established in 2000, Onyx Scientific has garnered 24 years of successful experience within the preclinical development space, completing thousands of development projects. Their pragmatic ‘fit for purpose’ approach is centred on intelligent rapid process development with an eye towards future GMP campaigns. Connect with Onyx Scientific at CDMO Live

“Contract negotiations are often perceived as a POWER GAME but in reality, it has to be a collaboration.” says Dr Roxana Timmermans In the latest episode of the PharmaSource podcast, Dr. Timmermans explains why contract negotiations are of critical importance in pharma outsourcing and shares her framework for success. “Proper negotiation, is the foundation of a strong partnership. In the highly regulated world of pharma contract manufacturing, precise terms are essential." "Negotiation skills are not just desirable; they are paramount, says Roxana. “If you not trained you will put the company in a very damaging position.” Read the interview The Art of Contract Negotiations

While pharmaceutical companies have proven the return on investing in digital at early stages of drug discovery, manufacturing has been slower to embrace digital transformation. To understand how pharma R&D and manufacturing can unlock more business value through adopting digital tools and technologies, we speak to Digital CMC consultant Mark Buswell. Mark is a chemical engineer by training, with over 20 years in R&D and Manufacturing at GSK, before joining NGT BioPharma consultants to head up Digital CMC services to help pharmaceutical companies navigate digital transformation of their CMC function. Read the full article on Digital CMC Maturity on PharmaSource

In 2024 the world of Contract Development & Manufacturing has been going through a period of major upheaval. Since the start of the year, every day have been significant acquisitions or investments in the CDMO space. In the United States there are highly significant legislative changes working their way through Congress which will re-define the industry. Ahead of his talk at CDMO Live, we spoke Gil Roth, President and founder of the PBOA (Pharma & Biopharma Outsourcing Association) to give us his take on all the challenges and opportunities faced by this dynamic sector. For more insights into the changing contract manufacturing landscape in the United States, don’t miss Gil’s expert talk at CDMO Live in June, where he will be sharing his insights on How the upcoming US Election and Legislative Changes could Impact CDMOs. Register here for your free ticket

Alcami, a contract development and manufacturing organization headquartered in North Carolina, is in a period of high growth. With more than 50 years of experience advancing products through every stage of the development lifecycle, Alcami serves pharmaceutical and biotech companies of all sizes for small molecules and biologics – primarily in the United States. Ahead of CDMO Live, we sat down with Kerrie Powell, Senior Vice President of Sales at Alcami Corporation, to understand more about the services that the company offers to clients, and how they help clients to navigate the the fast-changing contract manufacturing landscape in 2024. Register today for your free ticket

Supplier Relationship Management is a ‘systematic approach to evaluating vendors that supply goods, materials, and services to an organization. It involves determining each supplier’s contribution to success and developing strategies to improve their performance’. Anirban Mukherjee, Head of Procurement at Immunovant, argues that while Supplier Relationship Management (SRM) is crucial for achieving high performance in complex industries such as pharma and biotech, it often receives insufficient attention. In the latest episode of the PharmaSource podcast, Anirban explains the steps to take when implementing a successful SRM programme, drawing on his experience at Ford, Becton Dickinson, and Gilead, where he served as the Global Head of Development for outsourced vendor management. Anirban is passionate about SRM in driving business outcomes: “Over the course of your career, you realize what you deeply believe in” he says. Read the full article here

On International Women's Day 2024, the PharmaSource community hosted an important debate, asking "how can the biopharma industry do better at supporting and elevating women into leadership roles?" The panel included Elke Geysen, SVP Head of Global Procurement and External Supply at Grünenthal Group, Roxana Timmermans PhD, Supply Chain Procurement & Global Alliances Leader and was chaired by Alicia Ryan, Principal Consultant at Proxima. Read the full Women in Pharma article on PharmaSource

In today’s episode we talk about real-world applications of AI and Pharma 4.0 and how it can make a difference to Pharma Manufacturing. Our guest is Daniel O’Mahoney a Digital Transformation consultant in the Life Sciences, working for Körber Pharma, and Part-time Lecturer in Pharma 4.0 Bio-Industry 4.0 NIBRT National Institute for Bioprocessing Research and Training In this interview, we talk about how to get started with Pharma 4.0, a concept that applies the principles of Industry 4.0 to the pharma sector, and some of the ways that technology can be used to improve the productivity of pharmaceutical manufacturing. Read the full interview on PharmaSource

“Honesty is between sponsor and contract manufacturer is essential,” says Philip Coetzee, Director CMO Management for Daiichi Sankyo Europe. “Be honest. I find it very difficult to work with someone who tells me ‘half-truths and whole lies’. I’d rather someone say – ‘someone messed up’ than try to hide it. It’s human. Things happen.” In the latest episode of PharmaSource podcast Philip talks about his experience on both sides of the table - from his experience working at Catalent and now leading contract manufacturing outsourcing Daiichi Sankyo Europe Successful partnerships thrive on trust, transparency, and genuine connections. Here are some key takeaways from Philip’s insights on optimising relationships with Contract Manufacturing Organizations: Read https://pharmasource.global/content/dos-and-donts-of-managing-contract-manufacturers-interview-with-philip-coetzee-daiichi-sankyo/https://pharmasource.global/content/dos-and-donts-of-managing-contract-manufacturers-interview-with-philip-coetzee-daiichi-sankyo/ DON’T MISS! Philip will be hosting a roundtable at #CDMOLive on the topic of how to run better RFP/RFQs. To join the session, sign up here

Bernardo Estupiñán has a career spanning chemistry and business development, and now working as a consultant to guide companies developing new biopharmaceuticals through contract manufacturing In this interview we talk about his advice for how biotechs can successfully navigate the contract manufacturing landscape in order to bring new products into the clinic on budget. “The biggest challenge? Money. “ says Bernardo. Key considerations for Biotech contract manufacturing 1. Manufacturing Location Matters 2. Standardise processes to reduce costs 3. Find the right size and cultural fit 4. Document everything for a Smooth Tech Transfer Read the full article How to navigate contract manufacturing in biotech