CPhI Worldwide Experts Advocate Single Reference Product For Generics And "3D Printed Personalised Formulations"
Big data forecast to revolutionise pharma’s operations, everything from outsourcing thorough to drug discovery
SUMMARY of part iii:
Dilip Shah, CEO at Vision Consulting Group:
• A big need for better cost containment in regulatory approvals for generics, including using a single reference product (not re-approval for a generic in each market). Need for the convergence of standards not harmonisation
• Regulators need to change from merely being an auditor to that of being a facilitator
• To prevent drug shortages we need a faster remedial process for breaches. Similarly risk based inspections will help reduce burden
Emil W. Ciurczak, Doramaxx Consulting
• Predicts personalized 3D printed oral tablets: even using complex layers, and a combination of drugs to treat multiple ailments at once or each layer dispensing APIs at a different rate
• Near term use of 3DP for
o controlled or high potent drugs to increase safety
o tester tablets could be printed in smaller batches not every couple of years (increasing reproducibility)
o cost of orphan drugs will be lowered quickly with “on demand” production using 3DP
• A synergy between 3D and CM is also a potential, where formulations are developed on CM units and produced on 3D units, as needed.
Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates
• Big data to drive discovery of new more complex drug molecules
• Big data will become the underlying foundation behind all electronic control and governance strategy, from product development and supply change management to business continuity.
• Clinical data transparency is here to stay and establishing a structured framework, infrastructure, policies and practices will be central to being compliant and avoiding controversy or even litigation in the future
Alan Sheppard, Principal, Global Generics at IMS Health
• USA market which in 2016 is forecasted to reach $472.9 billion in sales. Growth is forecast at a CAGR of 7.6% for the next 5 years with new product launches fuelling the growth. Interestingly small molecule patent expiries will have a larger impact in 2016-2020 than in the prior five years
• China will be second largest generic market by 2020
• European generics market to be dominated by biosimilars and Japan may achieve 80% generic use ahead of its 2020 target
• The highest volume consumption is in the Asia/Australasia region, but this is also where the lowest revenue per unit is achieved
Amsterdam, 04 October 2016:CPhI Worldwide, (#cphiww) organised by UBM EMEA, today announces the findings of part iii of the 2016 CPhI Annual Report, which focuses on growth opportunities over the next 5-years – specifically generics consumption and approval process, the use of big data in pharma and the potential of 3D printed formulations. Four experts – Alan Sheppard, Bikash Chatterjee, Emil Ciurczak and Dilip Shah – examine the implications on clinical trial design, generic drug time to market and even the ‘holy grail’ of individualised patient dosage forms.
The overall findings reveal pharma may now be on cusp of new age of high tech applications, as new technologies begin to imbed in pharma and the industry reimagines 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) d ue 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), however China is set to become the second largest market by 2020. Interestingly, 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 (like is the case for approval of patented drugs) – rather than using data from each market, as this slows down approvals and increases costs.
Ultimately, Shah advocates that the industry and regulator 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 over 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. His prediction is that the natural evolution of emerging technologies like 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 together 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. Stating that “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 increasingly role in the search for the next big 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: “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.”
Dilip Shah, CEO at Vision Consulting Group:
• A big need for better cost containment in regulatory approvals for generics, including using a single reference product (not re-approval for a generic in each market). Need for the convergence of standards not harmonisation
• Regulators need to change from merely being an auditor to that of being a facilitator
• To prevent drug shortages we need a faster remedial process for breaches. Similarly risk based inspections will help reduce burden
Emil W. Ciurczak, Doramaxx Consulting
• Predicts personalized 3D printed oral tablets: even using complex layers, and a combination of drugs to treat multiple ailments at once or each layer dispensing APIs at a different rate
• Near term use of 3DP for
o controlled or high potent drugs to increase safety
o tester tablets could be printed in smaller batches not every couple of years (increasing reproducibility)
o cost of orphan drugs will be lowered quickly with “on demand” production using 3DP
• A synergy between 3D and CM is also a potential, where formulations are developed on CM units and produced on 3D units, as needed.
Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates
• Big data to drive discovery of new more complex drug molecules
• Big data will become the underlying foundation behind all electronic control and governance strategy, from product development and supply change management to business continuity.
• Clinical data transparency is here to stay and establishing a structured framework, infrastructure, policies and practices will be central to being compliant and avoiding controversy or even litigation in the future
Alan Sheppard, Principal, Global Generics at IMS Health
• USA market which in 2016 is forecasted to reach $472.9 billion in sales. Growth is forecast at a CAGR of 7.6% for the next 5 years with new product launches fuelling the growth. Interestingly small molecule patent expiries will have a larger impact in 2016-2020 than in the prior five years
• China will be second largest generic market by 2020
• European generics market to be dominated by biosimilars and Japan may achieve 80% generic use ahead of its 2020 target
• The highest volume consumption is in the Asia/Australasia region, but this is also where the lowest revenue per unit is achieved
Amsterdam, 04 October 2016:CPhI Worldwide, (#cphiww) organised by UBM EMEA, today announces the findings of part iii of the 2016 CPhI Annual Report, which focuses on growth opportunities over the next 5-years – specifically generics consumption and approval process, the use of big data in pharma and the potential of 3D printed formulations. Four experts – Alan Sheppard, Bikash Chatterjee, Emil Ciurczak and Dilip Shah – examine the implications on clinical trial design, generic drug time to market and even the ‘holy grail’ of individualised patient dosage forms.
The overall findings reveal pharma may now be on cusp of new age of high tech applications, as new technologies begin to imbed in pharma and the industry reimagines 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) d ue 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), however China is set to become the second largest market by 2020. Interestingly, 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 (like is the case for approval of patented drugs) – rather than using data from each market, as this slows down approvals and increases costs.
Ultimately, Shah advocates that the industry and regulator 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 over 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. His prediction is that the natural evolution of emerging technologies like 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 together 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. Stating that “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 increasingly role in the search for the next big 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: “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.”