October 10, 2023 Dr. Christian Schetter on Real-World Data and Success Factors of CDMOs
How do we leverage real-world data as a global leading CDMO? Our Chief Scientific Officer Dr. Christian Schetter recently joined industry experts in Pharma´s Almanac roundtable and discussed the importance of this topic. Moreover, he shared his opinion on conventional industry wisdom in the biopharma industry, and if this holds true on a daily basis, as well as the real key success factors for us as a leading global CDMO.
Creating value for our clients with reliable data
For the market launch of drugs, it is beneficial to complement the data derived from clinical studies with Real-World data and evidence (RWD/RWE). Real-World data is not collected in randomized controlled clinical trials, but rather in everyday medical care. Examples include information from disease registries or patient records. In turn, RWE is clinical evidence about the use and potential benefits or risks of a medical product or drug derived from analysis of RWD. RWE is gathered outside the context of RCTs.
“We at Rentschler Biopharma do not see data only as a by-product of bioprocess development and manufacturing processes, but also a strategic asset that can help us create value for our clients and ultimately for patients affected by serious and rare diseases. As a leading global CDMO in the biopharmaceutical industry, we are always looking for ways to enhance our services and capabilities to meet the expectations of our clients”, shared Dr. Christian Schetter.
“One of the areas that we are focusing on is data evaluation and analysis, which we believe is essential to extract value from our manufacturing processes and to deliver high-quality therapeutics. RWD/RWE can provide valuable information on the safety, effectiveness, and value of biopharmaceutical products in real-world settings, as well as support the development and approval of new indications, formulations, and delivery methods. We could well imagine offering RWD/RWE services to our clients as soon as these evaluations are routinely outsourced to CDMOs”, Dr. Christian Schetter explained.
Key success factors for CDMOs
We all encounter conventional industry wisdom on a daily basis that can be misguided, outdated or incorrect. The systematic use of data can be helpful in dealing with these truths and replacing them with facts. “From the perspective of a CDMO with almost 50 years of experience in biotechnology, we at Rentschler Biopharma know that volume is not the only factor that determines our success. We also need to consider the diversity and complexity of the products we manufacture and the necessity to establish robust processes for also difficult to make products, as well as the needs of our clients and their projects”, commented Dr. Christian Schetter.
“For example, while some products, like blockbuster drugs, may require large-scale production of 10,000 L or more, many others may only need smaller volumes, such as ATMPs and protein-based therapeutics for rare diseases”, clarified Dr. Christian Schetter. He continued: “Bioprocess development and optimization are crucial to project success. We recognize that biopharmaceuticals are not trivial commodities that can be easily manufactured. Each therapeutic has its own unique characteristics and challenges, depending on the type of molecule, expression system, purification method, formulation, and delivery.” This is why Rentschler Biopharma brings the development and implementation of exceptional processes into focus that can handle the complexity and variability of biopharmaceuticals, and that can meet the highest standards of quality and regulatory compliance.
“Moreover, we believe that competition is not a zero-sum game in our industry. We are all in the same boat, and we all want to see the industry grow and thrive. That is why we at Rentschler Biopharma adopt a coopetition mindset, where we support and cooperate with other players in the industry on issues such as supply chain management and technology innovation. We also form strategic alliances with companies that share the same values and client centricity, to leverage our complementary strengths and capabilities, and to ultimately create value sustainably for our clients and their patients”, Dr. Christian Schetter elaborated.
Rentschler Biopharma SE
Dr. Latika Bhonsle-Deeng
Senior Director Corporate Communication