Manuel Leal, business development director, Idifarma, reveals what he believes have been the best opportunities, the biggest changes and most influential trends of the year.
2017
1. What has been the biggest opportunity of 2017 for your company/organisation?
Expanding our GMP manufacturing offering with the installation of new automatic capsule filling capabilities. The investment bolsters our manufacturing capabilities and strengthens our position as a specialised contract partner for the development and manufacture of oral solid dosage forms, with a particular focus on high potent compounds and niche pharmaceutical products requiring small batches.
2. Which factors have driven the biggest changes to the industry in 2017?
The US Food and Drug Administration’s recent decision to recognise eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements is a very relevant change for the industry.
Under the ‘Mutual Recognition Agreement’*, U.S. and EU regulators will be able to utilise each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.
This is a positive move and will bring greater efficiency across the industry.
3. What market trends have been influential for 2017?
The industry has seen increasing demand for highly potent niche drug development and manufacturing.
Currently, approximately 25 percent of drugs in development worldwide are classified as highly potent. This number continues to rise, driven in particular by growth in the oncology market and cancer-related drugs, which account for approximately 60% of all highly potent APIs.
In turn this is driving the need for agile CDMOs like Idifarma that have the experience, expertise and quality facilities to handle complex, low volume projects involving highly potent drugs.
Also, increasing regulatory, safety and environmental requirements are also driving the need for specialist providers of high potency capabilities in the pharmaceutical industry.
References*
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583057.htm