Hot topics at CPhI

October 07, 2016 / by Paul Moran

jglcphi.jpgThe CPhI conference in Barcelona did not fail to deliver on hot industry topics and trends in global pharma. After meetings with clients, new contacts and industry thought leaders the Broughton team were well placed to gather commercial and technical opinions shaping the future direction, technologies, opportunities and threats in pharma.

Biopharmaceuticals accelerated growth. The global Biologic drug market is predicted to top $390bn by 2020. The fastest growth segment in pharma is undoubtedly Biosimilars with the market estimated at $1.7bn in 2015 and predicted to grow 20 fold to $33bn by 2020. It is also predicted that 350 Biosimilar launches will be made by 2020 with patent expiration being a key driver. The ability of Biologics to target specific proteins makes them an attractive treatment. The next generation of Biosimilar products will provide affordable access to complex Biologics with the promise to enhance the quality of patients’ lives. Governments in major markets such as the EU have recognised the potential financial benefits of Biosimilars and are driving their uptake.

Quality and Regulatory matters – resource constraints within regulatory bodies (MHRA, FDA) is forcing pharma companies to develop quality metrics to support risk based inspections. Adherence to the requirements of Data integrity, still the hot pharma industry topic, is a major driver in this trend. With the FDA, MHRA and PIC/S all issuing their latest guidance there is no sign that this focus will diminish anytime soon.

Insourcing vs Outsourcing. With so many service providers present at CPhI many discussions surrounded the positives and negatives of outsourcing. Despite the pending UK exit from the EU, confidence in committing to UK service from across the world remains strong. With a number of new molecules and generic versions of existing molecules being launched, an increased demand in stability storage and testing was detected. Many license holders/manufacturers have been able to reduce costs and increase internal QC testing capacity by outsourcing finished product stability studies.

Technology and data is defining pharma and the landscape is evolving at great pace. There is a clear shift towards a scientific, data driven definition for quality which is being adopted by companies to survive and be competitive in the future market. The ability to acquire, verify and leverage the power of data is a key success factor for all involved. Investment in technology and automation is providing tangible benefits by streamlining processes.

What a great location Barcelona was for this prestigious event! With 36,000 visitors, 2,500 exhibitors from all four corners of the world the event was once again a great success. Thanks to all our customers and those we met for the first time. See you all next year in Frankfurt!

data integrity - 2017 deadline

Topics: LIMS, Data Management, News, Data Integrity, MHRA Guidance, FDA, MHRA

Paul Moran

Written by Paul Moran

Dr. Paul Moran is the founder of Broughton Laboratories Ltd and Broughton Software Ltd who serves as their Chief Executive. As a chemistry graduate with a PhD in Biotechnology, Paul began his career at the US pharmaceutical manufacturer Johnson and Johnson. In his role as QC Laboratories Manager, Paul obtained Six Sigma Black Belt certification. Paul entered the world of contract QC testing in 2003 supporting the successful growth of a contract laboratory leading to its merger in 2005. Paul started his first venture in 2006, establishing Broughton Laboratories as one of the leading UK MHRA and US FDA GMP licensed contract laboratories with its own dedicated stability storage facility which opened in 2011. The spin-off company, Broughton Software, was established in 2012 to provide a LIMS solution for regulated QC Laboratories. LabHQ LIMS launched its 4th release in September 2015.