The side-effects of bad data in API development and manufacture

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Innovation is key to delivering new drugs faster and cheaper while tailoring them to patient needs. Data drives this, but how do you know it’s the right data? From solubility and delivery to bioavailability and stability, the application of intelligent analytics is crucial to the success of your candidate formulation. The fundamental question every pharmaceutical scientist must ask himself is: “Considering the intended route of delivery, what do I need to know about this formulation?”. 

Using real-life examples, our experts explain how the best – and worst – decisions in pharmaceutical development and manufacture are made, and offer their tips for success.


David Fengas, Director of CMC Services, Concept Life Sciences

David joined CRO (contract research organization) Concept Life Sciences in 2010 following seven years at Pfizer as a Team Leader supporting various therapeutic areas, including allergy & respiratory and pain. During his time at CLS, David has successfully managed numerous teams and projects for global pharmaceutical and biotechnology companies across a wide range of therapeutic areas. He gained his first degree from the University College London and was awarded his PhD in 2001 from the University of Manchester, working on total synthesis. David’s interests center on Chemical Biology and Antibody Drug Conjugates.

Paul Kippax, Pharmaceutical Sector Director, Malvern Panalytical 

Following a degree in chemistry and a Ph.D. in colloid science, Paul joined Malvern Panalytical (formerly Malvern Instruments) in 1997 as a technical support scientist.  He has spent the past 23 years developing an in-depth understanding of material characterization techniques and their application in solving pharmaceutical industry challenges. A keen believer in the power of collaboration in enabling innovation, Paul works closely with customers on applying analytics to enable innovative product development.

Natalia Dadivanyan, Field Application Specialist, X-ray Products, Malvern Panalytical 

Natalia is a polymer chemist by education, and studied chemistry in Moscow State University (Russia). After completing her Master’s thesis on polymer liquid crystals Natalia moved to University of Freiburg (Germany) to obtain her PhD degree working on liquid crystalline elastomers. This was followed by a post-doc position in the Eindhoven University of Technology (The Netherlands), where Natalia did research on organic semiconductors. In 2012 Natalia joined PANalytical, now Malvern Panalytical as an Application Specialist in X-Ray Diffraction in Almelo (The Netherlands). In the past five years Natalia was primarily supporting the customers from the pharmaceutical industry with a focus on work in regulated environment. Nowadays Natalia is dedicated to application and business development of X-ray products in Pharmaceutical industry.


What will I learn?

  • Understand the complementary of physicochemical analytical tools
  • Examine the full workflow for assessing the microstructure of pharmaceutical formulations
  • Learn how to robustly assess the developability of a new drug product