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In this episode of the Drug Solutions podcast, Grant Playter, Associate Editor, speaks with Siegfried Schmitt, vice president, Technical at Parexel, discusses the state of biopharma investment in 2023. Topics of discussion include key areas of investment, where investment is occurring and why, and how the industry is adjusting to post-COVID regulatory and supply chain changes.

Dr. Siegfried Schmitt is a Fellow of the Royal Society of Chemistry, Chartered Chemist and Chartered Scientist. He started his career with F.Hoffmann-La Roche in Basel, Switzerland, where he worked as Senior Production Chemist in Active Pharmaceutical Ingredients and Vitamin production. Following a move to the UK, he worked for several years as consultant and validation manager for Raytheon E&C, followed by two years with ABB Eutech as Senior Lead Consultant. In 2002 Dr Schmitt joined Amersham Health (now GE Healthcare) as global Quality Assurance Director in Information Management. In July 2007 he joined PAREXEL Consulting in the UK as Principal Consultant. Dr Schmitt regularly publishes articles on scientific and business subjects, and has written several books. He speaks on a variety of topics at international conferences and industry meetings.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode, Siegfried Schmitt, vice president, Technical at Parexel, discusses the state of biopharma investment in 2023.

Drug Solutions Podcast: Examining the State of Biopharma Investment

Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.

AstraZeneca and Alteogen Sign License Agreement for Developing Subcutaneous Formulations of Oncology Assets

The partnership aims to develop and commercialize a novel checkpoint inhibitor for immuno-oncology applications.

Shilpa Biologicals and mAbTree Biologics to Collaborate on Novel Immuno-Oncology Asset

The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days. 

Trenchant BioSystems Partners with Autolomous to Form Integrated Automated CGT Manufacturing Platform

Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

Cytiva Collaborates with Cellular Origins to Deliver Automated Manufacturing for CGTs

Production is set to take place at Samsung Biologics’ Songdo, South Korea, site, and the agreement will run through December 2030, subject to change.

Samsung Biologics Scores Major Manufacturing Deal Worth Over $1.4 Billion with European Pharma Company

In an interview with Pharmaceutical Technology Roger Viney from ICE Pharma highlights the importance of sustainability for the bio/pharma industry and some important future considerations for companies.

Creating a Sustainable Approach

Sustainability in the pharmaceutical industry has increased in the past few years as a significant initiative for regulators and many pharmaceutical companies. Sustainability practices may include investment in renewables, zero emission buildings, and greener manufacturing practices (1). ICE Pharma has adopted a sustainability strategy that includes fighting illness through product innovation, caring for people, accelerating sustainable operations, and building strong relationships (2).To gain more perspective on sustainability in pharma, 

spoke withRoger Viney from ICE Pharma about what pharmaceutical companies should consider when developing a sustainability strategy.

Viney stresses that the healthcare industry, which is responsible for approximately 5% of global emissions, must be aware of the impact the industry has on the environment. “I think it's important to recognize that what we manufacture is biologically active,” says Viney. “So, in that case, it has a bigger environmental impact than some other products. I think in terms of the regulations that we have to comply with, you know, or the quality compliance regulations, I think the pharma industry is relatively slow to change, and we're slow to introduce new manufacturing technologies. We have difficulty adapting to new technologies which would lower our environmental impact. So, I think we've been slower than we would have liked. It's the nature of our industry. But I think, of course, there's a very big expectation from our customers, whether it be governments, businesses, or patients, that we do make progress in this area.”

Sustainability in the Pharmaceutical Industry

 (accessed Dec. 16, 2024). 
2. Lavery, P. 

ICE Pharma Touts Fully Recyclable Booth at Its CPHI Milan Exhibit

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

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In part of the session "Continuous Manufacturing and Publication of ICH Q13" at the PDA/FDA Joint Regulatory Conference, Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

 Manufacturing technologies such as continuous manufacturing, offer a number of benefits. Advantages of continuous manufacturing compared to other manufacturing include increased venture productivity, decreased capital cost, smaller cadence size and footprint and decreased cycle times or the ability to make product faster. You can also streamline your process flows with continuous manufacturing. There are several options if you'd like to increase your manufacturing output, you don't necessarily have to increase [imminent size]. Instead, you could run for a longer time. Or you could run at a higher mass flow rate. You also have the option to duplicate equipment not to scale out. Pharmaceutical quality assures the availability, safety and efficacy of every dose. This powerful yet simple statement, we hear a lot about safety and efficacy and rightly so. However, advanced manufacturing technologies such as continuous manufacturing, also have the potential to modernize pharmaceutical manufacturing and avoid or reduce drug shortages. I think drugs are of no use to patients if they're not available.

 The words in the [bracket] are an assumption of what is being said, as we have not gotten confirmation yet from the speaker about what exactly is being said.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

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The Impact of Advanced Manufacturing Technology (PDA/FDA Joint Regulatory Conference 2023)

Deals, Development and Manufacturing

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