API development & manufacture: do you have data clarity or confusion?
Despite rumor to the contrary, small molecule pharmaceutical development is alive and kicking! However, as always, there are multiple hurdles on the route to market. Common challenges that contribute to the high failure rates of new drugs include issues with solubility, delivery, bioavailability and stability. The correct application of intelligent, tailored analytics is key to ensuring your drug product makes it to the finish line.
So, how do you make that ‘giant leap’ from those precious first batches into process scale-up with confidence?
The fundamental question every pharmaceutical scientist should ask themselves is: “Considering the intended route of delivery, what do I need to know about this formulation?” The techniques that provide the detail required must be applied rigorously and repeatedly throughout future development activities.
This is the question we will ask (and hopefully answer!) in our upcoming webinar ‘The side-effects of bad data in small molecule drug development and manufacture’. Hosted by our friends at The Medicine Maker on 28 January, I’ll be joined by experts from specialties, including GMP and technology development. Together we will explore the complementarity of physicochemical analysis techniques and consider how best to ensure the right analytics are applied each and every time.
Our panel will present a number of real-life case studies that illustrate how the best – and worst – decisions in small molecule development and manufacture are made, and offer their tips on how to ensure success.
About the panel
David Fengas Ph.D. Director of CMC Services, Concept Life Sciences
David joined Concept Life Sciences following seven years at Pfizer as a Team Leader supporting various therapeutic areas, including allergy & respiratory and pain. He was awarded his Ph.D. in 2001 from the University of Manchester (UK), working on total synthesis.
Natalia Dadivanyan, Field Application Specialist, X-ray Products, Malvern Panalytical Natalia is a polymer chemist by education. After obtaining her Ph.D. working on liquid crystalline elastomers at the University of Freiburg (Germany), she researched organic semiconductors at the Eindhoven University of Technology (The Netherlands). Nowadays, Natalia is dedicated to supporting X-ray products in the pharmaceutical industry.
Paul Kippax, Pharmaceutical Sector Director, Malvern Panalytical
And then, of course, there’s me! I joined Malvern Panalytical in 1997, following a degree in chemistry and a Ph.D. in colloid science. Over the last 23 years I’ve worked closely with our pharmaceutical customers to understand their material characterization requirements and how our technologies solve their challenges.