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PharmTech.com Bio/Pharma Outsourcing Innovation eBook 2023 Pharmaceutical Technology ® 11 Industry OutlOOk I n t he com i ng yea r, qu a l it y w i l l h ave new e x- pectations that include enabling proactive quality management and risk-based approaches. To sustain such changes, companies will need to establish an end-to-end quality technology landscape that deliv- ers data-driven metrics and insights while executing connected processes and workf lows. This can ele- vate qua lit y beyond compliance to provide much- needed time and cost savings. Increasing externalization will bolster quality partnerships As companies began collaborating more closely with contract partners, a pioneering few invited their CDMO partners into their quality networks. Others, too con- cerned about security and data access, shied away from this approach. This, however, will change. Encouraged by software innovations that permit seamless access and granular control over informa- tion, more biopharma companies and CDMOs will in- vite suppliers to participate in key processes within their QMS. CDMOs will also increasingly bring their customers directly into their QMS, quality documen- tation, and training systems for better visibility and real-time information sharing. This approach will make it easier for smaller in- novators to accept products, sign off and approve batches, review quality events, and share quality data. Over time, companies will develop distinct informa- tion-sharing strategies, training programs, and new processes tailored to each partner. Rising mergers and acquisitions will fuel new technology decisions The current macroeconomic conditions forecast a friendly climate for mergers, acquisitions, and di- vestitures in the year ahead. PricewaterhouseCoo- pers released a report stating that it expects a f lurry of biotech deals in the $5 billion to $15 billion range in 2023 as organizations look to solidif y their prod- uct portfolios in the near and long term (3). The growth in activity will create opportunities for modernization and harmonization as companies look to bring together their people, processes, and systems. With the existing f ragmentation across mid-sized companies, unif ying on one system will be a tall task for quality and IT teams. Using appli- cations on a single cloud platform will significantly simplif y the consolidation of data and documents t y pica l ly required in a merger or acquisit ion, en- abl i ng speed a nd ag i l it y a s t hese orga n i z at ion s adapt to new business environments. Biopharmas will invest in agile drug development Before the pandemic, typical vaccine development could take upwards of five to 10 years to ensure that assets are safe, ef fective, and have gone t hrough the appropriate regulator y, qualit y, and manufac- t uring processes (4). That abr upt ly changed wit h the COVID-19 pandemic, which f ueled reg ulator y cha nges t hat a l lowed mu lt iple vacci nes to reach patients in less than a year without compromising safety or scientific integrity. Leading companies will use this blueprint to drive agility into the drug development value chain. Dis- ruptors in the industry will create different ways of working or reallocate resources to revolutionize pro- cesses and decision-making. In certain areas, com- panies will experiment with smaller, agile teams that work in parallel to drive speed and innovation. T h i s process w i l l a l so res u lt i n i nc rea sed col- laboration wit h externa l par tners where t here is strong alignment, driving exclusive partnerships in cer ta in a reas. Creat iv it y a nd compet it iveness will continue to fuel innovation in this space for the benefit of patients. The path to modernization A s more ph a r m a compa n ies adopt I ndu st r y 4.0 and continuous manufacturing approaches, they w i l l need ways to ha nd le good prac t ice content and data in a single source. When paired with the grow t h in emerging CDMOs t hat a re look ing for innovative solutions to scale fast and show differen- tiation in a competitive market, it becomes readily apparent that quality transformation will continue to take center stage. With the advancements made so far, life sciences companies have a solid foundation to build off. Ef- forts to transform end-to-end quality management will gain momentum for automated, digital processes across the value chain. By simplifying and unifying operations, companies will accelerate developing, manufacturing, and delivering critical medicines to people who need them. References 1. Grand View Research. Quality Management Software Market Size, Share & Trends Analysis Report By Solution, By Deployment, By Enterprise Size, By End-use, By Re- gion, And Segment Forecasts, 2023 – 2030; 1st Edition; Grand View Research. December 2022. 2. Veeva Systems. The Center for Breakthrough Med- icines Adopts Veeva Vault Quality Suite to Help Advance Cell and Gene Therapy Contract Services. Press Release. Nov. 16, 2021. 3. Lewin, K. PwC Predicts 'Flurry' of $5B to $15B Biotech Deals in 2023. endpoints.com, Jan. 17, 2023. 4. John Hopkins University & Medicine. Vaccine Re- search & Development: How Can COVID Vaccine De- velopment Be Done Quickly and Safely? coronavirus. jhu.edu/vaccines/timeline (accessed Feb. 2, 2023) ■