An open symposium on ‘Regulatory Support of Innovation in the Pharmaceutical Industry' on 21st June 2017 as part of the first Annual PEARRLS of Wisdom Week in Cork, Ireland http://www.pearrl.eu/rss2017.html. PEARRL is a European Training Network (ETN) that brings together partners from European pharmaceutical industry, academia and regulatory agencies as a multi-sectorial team to deliver collaborative research and training network focused on accelerating the development and approval of breakthrough therapy drugs.
The focus of the symposium was to outline the various approaches that Regulatory agencies across Europe have adopted with a view to supporting innovation in the development and manufacturing of medicines. Regulatory authorities are increasingly acknowledging the need to make “breakthrough therapy” (FDA 2012) medicines available to patients as quickly as possible. Initiatives such as “Earlier Access to Medicines” (MHRA, 2014) and “Adaptive Licensing” (EMA, 2014) highlight the recent intensification of regulatory efforts in this area.
The symposium, in which four of the most influential regulatory authorities in Europe (EMA, MHRA, BfARM and HPRA) discussed the various instruments that they are developing to help get better, safer drugs to market more quickly, was attended by over 80 pharmaceutical scientists from all over Europe. In addition to some of the top researchers in drug formulation development from both academia and industry, nearly 30 scientists from outside the PEARRL network were in attendance, mostly representing pharmaceutical companies in Ireland, including Eli Lilly, Novartis, Eirgen, Eirgen, Alkermes, Biomarin, Cuspor, Ipsen, Sigma Pharm, Sothic Bioscience, Pfizer, Recordati Ireland Ltd and Janssen.
The PEARRL Project Coordinator, Brendan Griffin, initiated proceedings and welcomed the attendees to the first Regulatory Science symposium of its kind in Ireland. Dr. Griffin outlined how the Symposium was organised around four distinct themes. The first session was focused on Regulatory Pathways adapting to Innovation and was introduced by Evangelos Kotzagiorgis, Scientific Administrator in the Human Medicines Evaluation Division at the European Medicine Agency (EMA). Mr. Kotzagiorgis presented an overview of the EMA ‘Early access tools’ including Conditional Marketing Authorisation, Adaptive pathways and PRIME – PRIority MEdicines initiatives. Subsequent, a joint speaker session with Peter Kiely (HPRA) and Sean Jones (MHRA) presented an overview of how regulatory agencies at a national level are supporting innovation through Scientific Advice. A common and central message from both Peter and Sean was to emphasize that early and open dialogue with the national regulatory authorities on scientific matters increases the likelihood of faster and more streamlined approval.
Session 2 focused specifically on HPRA’s approaches to supporting Innovation. In her presentation entitled ‘Innovation – Benefits and Risks’, Dr. Una Moore, Pharmaceutical Assessment Manager at the HPRA, outlined how the HPRA is supporting innovation in the biological medicinal product space. She also highlighted that the HPRA is planning to extend assessment activities into Advanced therapies TMP (e.g. gene, cell and regenerative therapies). Laurence O’Dwyer, Scientific Affairs Manager then provided an overview of some of the HPRA activities to support innovation, and in particular the role of the HPRA’s Innovation office. The final speaker in Session 2 was Tom Melvin, who focused on how HPRA is supporting innovation in Medical Devices.
After a “meet and greet” luncheon, the third session on ‘Innovation and Clinical Trials’ was chaired by Dr. Jayne Crowe, Director of Human Products Authorisation and Registration at the HRPA. Martin O’Kane, Head, Clinical Trials Unit, MHRA presented an interesting oversight of the Clinical Trials Unit at the MPRA. He outlined the key considerations for assessment of a clinical trial and key risks to consider in the design in First in Human (FIH) trails. He indicated that the MHRA CTU assesses up to 80 FIH trials in the UK per year and emphasised that mitigation of risk is key to successful outcomes. He also was keen to stress that CTU has a range of opportunities for innovators to seek advice directly from the MHRA. Subsequently, Prof. Geraldine Boylan from the Irish Centre for Fetal & Neonatal Translational Research at UCC gave a presentation in which she outlined her first-hand experience in designing Clinical Trials in special populations within the INFANT centre UCC INFANT centre UCC.
The final session of the day was built around Innovation in pharmaceutical manufacturing. Dr. Jobst Limberg, Scientific Director in the department for European and International affairs at BfArM, Germany, compared the ‘Conventional approach’ to the ‘Quality by Design’ approach for supporting regulatory filings and submissions. Interestingly, he described how QbD has been applied for scenarios to augment conventional submissions, and to support real time release (RtR) strategies. Interestingly, he also commented that it was rare for a complete RtR strategy to be applied on all quality attributes; based on his experience, a combination of RtR (e.g. identity, uniformity of single dosage unit and/or assay) and conventional quality testing (e.g. impurity testing) is more often applied. The last speaker of the day was Dr. Nick Lee, Pharmaceutical Assessor at the HPRA on Process Analytical Technology (PAT) and Continuous Manufacturing (CM). He outlined how PAT can be used to enable real-time monitoring and process control. He explored the “PAT toolbox” with applications for pharmaceutical manufacturing. He then outlined the potential for CM to produce a true ‘paradigm shift’ away from conventional batch pharmaceutical manufacturing
To summarize, the Symposium provided the attendees with an open, up-to-date and unembellished appraisal of the various regulatory approaches to support innovation in the pharmaceutical industry, showing clearly how new approaches in regulatory science streamline access to market for innovative, emerging medicines.
The symposium, in which four of the most influential regulatory authorities in Europe (EMA, MHRA, BfARM and HPRA) discussed the various instruments that they are developing to help get better, safer drugs to market more quickly, was attended by over 80 pharmaceutical scientists from all over Europe. In addition to some of the top researchers in drug formulation development from both academia and industry, nearly 30 scientists from outside the PEARRL network were in attendance, mostly representing pharmaceutical companies in Ireland, including Eli Lilly, Novartis, Eirgen, Eirgen, Alkermes, Biomarin, Cuspor, Ipsen, Sigma Pharm, Sothic Bioscience, Pfizer, Recordati Ireland Ltd and Janssen.
The PEARRL Project Coordinator, Brendan Griffin, initiated proceedings and welcomed the attendees to the first Regulatory Science symposium of its kind in Ireland. Dr. Griffin outlined how the Symposium was organised around four distinct themes. The first session was focused on Regulatory Pathways adapting to Innovation and was introduced by Evangelos Kotzagiorgis, Scientific Administrator in the Human Medicines Evaluation Division at the European Medicine Agency (EMA). Mr. Kotzagiorgis presented an overview of the EMA ‘Early access tools’ including Conditional Marketing Authorisation, Adaptive pathways and PRIME – PRIority MEdicines initiatives. Subsequent, a joint speaker session with Peter Kiely (HPRA) and Sean Jones (MHRA) presented an overview of how regulatory agencies at a national level are supporting innovation through Scientific Advice. A common and central message from both Peter and Sean was to emphasize that early and open dialogue with the national regulatory authorities on scientific matters increases the likelihood of faster and more streamlined approval.
Session 2 focused specifically on HPRA’s approaches to supporting Innovation. In her presentation entitled ‘Innovation – Benefits and Risks’, Dr. Una Moore, Pharmaceutical Assessment Manager at the HPRA, outlined how the HPRA is supporting innovation in the biological medicinal product space. She also highlighted that the HPRA is planning to extend assessment activities into Advanced therapies TMP (e.g. gene, cell and regenerative therapies). Laurence O’Dwyer, Scientific Affairs Manager then provided an overview of some of the HPRA activities to support innovation, and in particular the role of the HPRA’s Innovation office. The final speaker in Session 2 was Tom Melvin, who focused on how HPRA is supporting innovation in Medical Devices.
After a “meet and greet” luncheon, the third session on ‘Innovation and Clinical Trials’ was chaired by Dr. Jayne Crowe, Director of Human Products Authorisation and Registration at the HRPA. Martin O’Kane, Head, Clinical Trials Unit, MHRA presented an interesting oversight of the Clinical Trials Unit at the MPRA. He outlined the key considerations for assessment of a clinical trial and key risks to consider in the design in First in Human (FIH) trails. He indicated that the MHRA CTU assesses up to 80 FIH trials in the UK per year and emphasised that mitigation of risk is key to successful outcomes. He also was keen to stress that CTU has a range of opportunities for innovators to seek advice directly from the MHRA. Subsequently, Prof. Geraldine Boylan from the Irish Centre for Fetal & Neonatal Translational Research at UCC gave a presentation in which she outlined her first-hand experience in designing Clinical Trials in special populations within the INFANT centre UCC INFANT centre UCC.
The final session of the day was built around Innovation in pharmaceutical manufacturing. Dr. Jobst Limberg, Scientific Director in the department for European and International affairs at BfArM, Germany, compared the ‘Conventional approach’ to the ‘Quality by Design’ approach for supporting regulatory filings and submissions. Interestingly, he described how QbD has been applied for scenarios to augment conventional submissions, and to support real time release (RtR) strategies. Interestingly, he also commented that it was rare for a complete RtR strategy to be applied on all quality attributes; based on his experience, a combination of RtR (e.g. identity, uniformity of single dosage unit and/or assay) and conventional quality testing (e.g. impurity testing) is more often applied. The last speaker of the day was Dr. Nick Lee, Pharmaceutical Assessor at the HPRA on Process Analytical Technology (PAT) and Continuous Manufacturing (CM). He outlined how PAT can be used to enable real-time monitoring and process control. He explored the “PAT toolbox” with applications for pharmaceutical manufacturing. He then outlined the potential for CM to produce a true ‘paradigm shift’ away from conventional batch pharmaceutical manufacturing
To summarize, the Symposium provided the attendees with an open, up-to-date and unembellished appraisal of the various regulatory approaches to support innovation in the pharmaceutical industry, showing clearly how new approaches in regulatory science streamline access to market for innovative, emerging medicines.
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