Insights

We attended the QbD CMC Summit on 10/31, and here are the top 5 key takeaways that resonate with the needs and challenges we hear from our clients and partners in the Biopharma industries.

1. A successful path to any digital journey starts with a plan.
   Digital transformation is not a single occurrence, but rather a multi-stage journey that requires a strategic plan, aligning the organization’s digital vision with targeted operational outcomes. A strong plan will minimize disruption to the organization while still driving the business forward. We define success in the Biopharma Digital Journey through Accelerated Drug Development, Manufacturing, and Time to market. However, each organization will have to develop their own objectives/drivers to define success in their market and within their organization.
2. The call for change is to educate and align with stakeholders at all levels.
   A holistic approach is key in the landscape of technological evolution. Organizations must educate and align the stakeholders at all levels; strong cross-functional collaboration and adaptability are vital and can be achieved by effective communication, both top-down and bottom-up, ensuring a shared understanding of the purpose and benefits of digital transformation. The key to digital transformation is the integration of data-centric technologies and preventing technological regression by arming day-to-day users with knowledge to drive adoption. Training becomes the hub, bridging potential with proficiency, making sure every team member is trained as technology evolves. As organizations navigate this road to achieve sustainable digital transformation, by optimizing product development and tech transfer and strengthening flexibility to tackle continual change.
3. The future of drug development revolves around strong collaboration…interconnecting people and knowledge.
   The future of drug development revolves around robust collaboration and interconnectedness across the different stages in the value chain, facilitated by data initiatives across the team in accelerating product development. Real-time data access and contextualization help knowledge flow across the value chains and make swift decisions to save time and cost. Also, seamless data handoffs between stages are crucial in maintaining data flow continuity. Strong support from the leadership and training is necessary for adopting digital tools. Biopharma digital evolution relies on the right people having the right data at the right time, and adopting a collective effort across the organizations helps to accelerate the product to the market.
4. Technology is a part of the digital journey…but people and process come first.
   Strategic integration of technology requires a people-centric approach to ensure it aligns with organizational vision and adopts successful change management. Recognizing technology as an enabler rather than a standalone driver and defining a clear vision are top priorities for how technology can support the organization’s long-term goals. Cross-functional teams should assess the current challenges and identify the areas where improvement is needed before looking into new technologies. A robust internal Collaboration, Training, and Phase-wise implementation of technology, along with efficient change management plans, is essential to move companies steadily to achieve their digital transformation goals. This helps the cross-functional team to address concerns and showcase the benefits of adopting new technology.
5. Govern the data or the data will govern you.
   The mere generation and accumulation of data is meaningless unless it’s accompanied by the crucial element of context that will transform primary data into knowledge by elevating the basic/raw data to actionable knowledge/insights, which hinges upon the foundational pillars of master data management and data governance. Master data management ensures that the data generated across the organization is unified, accurate, and accessed at any time by the stakeholders. Robust data governance guides orchestrating policies, roles, and processes to safeguard data quality and security and falls under compliance. The efficiency of data governance is contingent on data integrity, starting from data generators (Scientists in R&D) to executives. Educating stakeholders teaches a collective responsibility, and active participation in governance will help understand the data generated into an asset fueling innovation and critical decision-making.

At ZAETHER, we support you at any stage, whether your organization is novice or in the middle of your digital journey.

ZAETHER understands a streamlined tech transfer process optimizes efficiency and helps your company reach its potential. For more information download our Digital Tech Transfer White Paper.