FAIR in CMC: Addressing Data Silos in Chemistry, Manufacturing, and Control

 We are having September BAGIM in-person event with Zifo. We welcome presenter Tamerlan Adamovich Saidov where he will discuss Digital Transformation and FAIR in CMC: Addressing Data Silos in Chemistry, Manufacturing, and Control

Date: September 11, 2024 @ 5:45 PM
Location: CIC Cambridge, 1 Broadway, Cambridge, MA 02142
Havana Room, Floor 3

5:45 PM - Sign-in
6:00 PM - 7:00 PM - Presentation & Q&A
7:00 PM - 9:00 PM - Reception / Social Gathering with Food & Drink

Please arrive early and promptly to get signed in and to join us for the presentation with a reception afterwards.

You can register Here - FAIR in CMC: Addressing Data Silos in Chemistry, Manufacturing, and Control, Wed, Sep 11, 2024, 5:45 PM | Meetup

Host: BAGIM & Zifo
Speaker: Tamerlan Adamovich Saidov
Title: Digital Transformation and FAIR in CMC: Addressing Data Silos in Chemistry, Manufacturing, and Control
Abstract:

Digital transformation plays a crucial role in optimizing Chemistry, Manufacturing, and Control (CMC) processes in the pharmaceutical and biotech industry. The use of a FAIR (Findable, Accessible, Interoperable, Reusable) data standards approach is instrumental in this transformation. It is vital to have a deep scientific and strategic understanding of pharmaceutical and biotech development to enable effective digital transformation, solve the data silo issues and avoid the creation of so-called digital-induced silos. Our discussion will focus on how the integration of scientific knowledge and digital principles can enhance data governance and analytics within CMC-specific environments. Our approach involves evaluating data not solely as isolated units, but also in the context of the type of development and the associated unit operations, as well as the settings in which studies are conducted – be it internally or at CROs and CDMOs. This comprehensive perspective leads to a new FAIR vision, encompassing data-specific and CMC-specific scientific nuances in data.

At Zifo, our approach to digital transformation involves adopting this holistic, multilayered view. Real-world examples will illustrate how digital tools and FAIR data frameworks can streamline data integration and enhance decision-making. Witness how these innovations drive compliance, efficiency, and agility, thereby paving the way for a more responsive and competitive pharmaceutical industry.

Speaker Bio

Tamerlan Adamovich Saidov, Ph.D, has 15 years of experience driving innovation in medical physics and the pharmaceutical industry. He has led numerous projects in drug product development, digital toxicology, digital transformation, and data strategy. Tamerlan is currently a CMC and Data Strategy Consultant at Zifo RnD Solutions, where he leads global digital transformation, advanced CMC-specific data strategy transitions, and data governance initiatives for top pharma companies. Tamerlan is passionate about applying a deep scientific approach, AI, and data-driven decision-making to enhance business processes and drug development in the complex CMC space.