Small Molecule API Volumes - Trends From the Last 15 Years of NCEs
Sponsored by: Cambrex
- A P I
- Small Molecule
- C M O
Date: 17 May
Time: 3PM London/10AM New York
Where do CMOs like Cambrex need to invest?
Innovation in the small molecule drug industry is at an all-time high. In 2015, the US FDA approvals for new chemical entities (NCEs) were at their highest level since 1999. There are more chemical molecules in every phase of drug development than ever before when looking back over the last 15 years. With an increased number of new small molecules reaching the market and a growing pipeline in clinical research, the importance of chemical-based therapeutics to the pharmaceutical market has never been more prominent.
During this same time period, small molecules have also shown their great versatility in treating diseases. They have evolved from global blockbusters, treating millions of patients with chronic conditions, to more targeted therapies for oncology or orphan indications - where previously patients were living with debilitating diseases without treatment option.
The broadening landscape of small molecules in new therapeutic indications presents changing requirements from its supply chain - in particular manufacturers of active pharmaceutical ingredients (APIs) and intermediates. Chemical manufacturing assets need to be sufficiently flexible to produce APIs ranging from kilogramme to metric tonne quantities.
In this webinar we present a condensed review of the last 15 years of launched small molecules with regards to market consumption and resulting volumes of API and how CMOs need to be investing in their manufacturing assets to be able to supply pharmaceutical innovators with the required volumes. We finish with two examples of how Cambrex is monitoring the demand and investing the right capacity to satisfy customer needs as small molecules continue to evolve.
Dr. Matthew Moorcroft,
VP of Global Marketing / Cambrex
Matt is the Vice President of Global Marketing and Communications for Cambrex. Prior to joining Cambrex, he worked for Lonza and held a number of roles including Head of Global Marketing, VP Generics and Biosimilars, and Head of Strategy, Pharmaceuticals and Biologics. After gaining experience in the custom development & manufacturing business, he developed models for biosimilars and generic drug products. He has 15 years of commercial and scientific experience in the pharmaceutical, biotechnology and chemical industry covering both innovative and generic medicines. Matt graduated with a Ph.D. in chemistry from the University of Oxford.
Joshua Van Kley,
Sales Operations Manager
Joshua Van Kley is the Sales Operations Manager for Cambrex Charles City, Iowa, USA. Since 2008, he has been working with clients to determine API project needs, defining gaps, and delivering proposals which provide detailed solutions, timings and pricing. Joshua holds an Economics degree, and minor in Chemistry, from the University of Northern Iowa.
Managing Director / Cambrex Karlskoga
Bjarne Sandberg is the Managing Director of Cambrex Karlskoga site and has managed the site since 2013. Prior to his current position, Bjarne has held a number of roles in Cambrex including Vice President Business Improvement and Finance, Business Unit Controller and Finance Director. Bjarne has been instrumental in the improvement and expansion of the Cambrex Karlskoga site over the past 10 years.
He has more than 20 years' experience in the industry including both commercial and operations. Prior to joining Cambrex he worked for Procter & Gamble. Bjarne holds a MsC in Industrial Engineering and Management from the University in Lulea.
Key Learning Objectives
- Learn first-hand how the API volume range for small molecule drugs has changed and the effect this has on the manufacturing footprint and infrastructure for CMOs responsible for supplying APIs to the pharmaceutical industry
- Understand peak volume requirements for APIs and how this has changed over the last 15 years, an essential measure for any CMO responsible for capacity planning
- Monitor how the trend for therapeutic dose (total consumption of medicine required to achieve therapeutic effect) and how tablet unit size has changed over the last 15 years
- Identify the need for CMOs to continue to monitor and adapt their manufacturing footprint to meet market demand.
- Explore how Cambrex continues to make leading investments into small molecule chemistry that make it one of the fastest growing CMOs
- Director Covering API / Intermediates Outsourcing
- Chemical Manufacturing or CMC
- Project Managers
- Supplier Manager
- Contract Manufacturing Managers
- R&D Chemists
- Process Chemists