CPHI Worldwide experts advocate single reference product for generics and printed personalised formulations

Big data forecast to revolutionise pharma’s operations, everything from outsourcing thorough to drug discovery.

The overall findings reveal pharma may now be on the cusp of a new age of high tech applications, as new technologies begin to imbed in pharma and the industry re-imagines the art of the possible – with potential new drugs targets identified using far large data sets and computational analysis. In terms of manufacturing, drugs could be individually 3D printed to a patient’s requirements (dose, release profile and combinations). In generics, overall growth is predicted to continue to expand rapidly, but with the caveat that faster approvals are need to improve time-to-market and patient benefit.

Alan Sheppard, Principal, Global Generics at IMS Health, states that we will now see fewer generic opportunities in the short term (2016-2020) due to a lower number of significant small molecules losing exclusivity. The US will understandably remain as the single largest profit generator (particularly in terms of margin); China, however, is set to become the second largest market by 2020. Japan is likely to achieve its 80% generics usage goal ahead of its 2021 target, with Europe remaining the most competitive and leading in the use of biosimilars.

Dilip Shah, CEO at Vision Consulting, however, warns of potential drag factors on the rapid utilisation of generics, imploring the industry to look towards the use of a single reference product for generics (as is the case for approval of patented drugs) – rather than using data from each market, which slows down approvals and increases costs.

Ultimately, Shah advocates that the industry and regulators need to work more closely together, not just in terms of meeting diktats (regulatory standards), but also in terms of training and implementation, and believes that ‘capability building’ and regulatory convergence will begin to occur during the next 3 years.

In the longer term, Emil Ciurczak of Doramaxx Consulting foresees revolutionary changes in how the industry manufacturers final dosage forms for the patient. He predicts that the natural evolution of emerging technologies, such as continuous processing, is the application of 3D printing. Using 3D printing, the industry will be able to individualise dosage forms – printing on demand for orphan drugs – combining two or more active ingredients in a single tablet, and using complex layers to alter the release profile.

In the more immediate future, 3D printing should be used to standardise the United States Pharmacopoeia tester tablets. He added: “3D printing will expand due to the growth of personalized medicines and medical devices. A synergy between 3D and CM is also a potential, where formulations are developed on CM units and produced on 3D units, as needed.”

Finally, Bikash Chatterjee, president and CSO at Pharmatech Associates, envisages some equally transformational applications the emerging field of big data will bring to pharma: "Big data will become the underlying foundation behind all electronic control and governance strategy, from product development and supply change management to business continuity.” In the more immediate future, he sees e-clinical trial applications continuing to expand through 2020 and big data analytics playing an increasing role in the search for the next blockbuster. He concluded: “The next decade of therapeutic drug development will be based upon new and more effective means of data mining and data analytics.”

Chris Kilbee, Group Director Pharma at CPHI Worldwide, said: “In the last few years there has been a notable shift in the industry and increasingly pharma customers, both generic and patented manufactures, are looking for new technologies and approaches – be that regulatory, digital or manufacturing. At CPHI Worldwide we have mirrored this change and each year deliver the latest news and trends through the CPHI Annual Report and our onsite content sessions. As the industry’s annual meeting point, the event is a central node in helping speed up new partnerships to bring these products and technologies to market faster. The discussions had this week will be vital in furthering pharma development and implementing more advanced manufacturing and drug development.”