BioPharma Ambition 2016 Review

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The inaugural BioPharma Ambition Convention 2016 saw an illustrious set of industry, academic and regulatory representatives converge on Dublin, Ireland for two productive days of dynamic high-level dialogue.

“Ireland is competing – and winning. We make no apologies for competing aggressively”

Mary Mitchell O’Connor, Minister of Jobs, Enterprise and Innovation

Framed as an all-island multi-platform event, it was presented by the Irish Pharmaceutical Healthcare Association (IPHA), the innovators’ organization; BioPharmaChem Ireland (BPCI), representing biopharma manufacturers; the National Institute for BioProcessing Research and Training (NIBRT); and the Massachusetts Institute of Technology Hacking Medicine program, which co-hosted its first health hackathon in Ireland.

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The life sciences industry represents a strategic pillar of both Irish economies: in the Republic of Ireland (ROI), the sector is an unrivalled heavyweight, contributing to annual exports of over EUR 50 billion, while in Northern Ireland, the pharma sector is expected to double its size by 2020. This was reflected by the ministerial presence, with Minister of Jobs, Enterprise and Innovation Mary Mitchell O’Connor TD and Minister of Health Simon Harris TD from ROI, as well as Northern Ireland’s Minister for the Economy Simon Hamilton MLA, in attendance. Minister Harris seized the opportunity to announce that the Irish government is officially preparing its bid to host the European Medicines Agency (EMA), highlighting the fact that Ireland is now the largest net exporter of medicines within the EU, while Minister O’Connor struck an exultant note, pointing out amidst fierce intense international jostling for biopharma investment, “Ireland is competing – and winning. We make no apologies for competing aggressively.”

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Instrumental to the conference’s success was the diversity and quality of the speakers and participants alike. The regulators were represented most notably by Sir Andrew Dillon, chief executive of the UK National Institute of Health Care and Excellence (NICE), Dr. Michael Kopcha, Director of Office of Pharmaceutical Quality at the US Food and Drug Administration (FDA), and Ireland’s own Health Products Regulatory Authority (HPRA) Dr. Lorraine Nolan. Sir Dillon in particular delivered a weighty message: not only does the pharma industry need to craft their value proposition within “the range of possible acceptance” of the relevant healthcare systems, healthcare systems need to be clear on their own priorities and limitations in order to foster productive collaboration between the two sides.

Of particular note was the industry panel on “Addressing the cost of biopharma manufacturing”, which discussed the interplay between biomanufacturing innovation and regulatory oversight, very topical considering Ireland’s own critical position as a global supply chain and manufacturing hub for MNCs. Eddie Reilly, VP Head of Regulatory CMC and Devices at Sanofi, raised the interesting point that markets that had previously accepted EMA and FDA inspections were now beginning to conduct their own inspections. As a result, while the installation of global hubs has capitalized on large-scale cost efficiencies, increasing regulatory complexity presents a barrier to the development of process improvements and supply chain management. Despite harmonization attempts like the International Council of Harmonization, he added, there can still be a difference of two to four years for approval between Europe, the US and the rest of the world. HPRA’s Dr. Nolan provided a counterpoint by pointing out that the European system had significantly increased mutual recognition, with significant progress also being made in the ongoing FDA and EMA negotiations. Audience participation also brought up the separate point that hence or otherwise, the industry is also exploring a return to localized manufacturing, which might become more attractive as the pharma industry shifts away from the ‘blockbuster’ model to the ‘niche-buster’ model. This is being facilitated by innovations like GE Healthcare’s first global BioPark initiative, essentially a ready-to-run biomanufacturing campus, incidentally to be located in Cork, Ireland.

Mary Mitchell O’Connor, Minister of Jobs, Enterprise and Innovation (centre), with Focus Reports’ Valerie Baia (left) and Karen Xi (right)

With academic collaboration being an important driver of industry success, the conference did not fail to showcase the best of Irish science. Professor Luke O’Neill, one of Ireland’s most celebrated scientists, delivered a multifaceted presentation on the diversity in inflammatory responses, informing the audience that the immune system is now the third-largest attractor of venture capital investment. A founder of two promising start-ups himself, he also emphasized the need to commercialize academic research. The next generation of talent was not neglected either, with the winners of the first MIT co-hosted health hackathon in Ireland, 3R Creatives Minds, who developed a user-friendly post-stroke recovery and rehabilitation app, feted at the drinks and dinner reception on the first night. Held at the Mansion House, the official residence of the Lord Mayor of Dublin since 1715, it was an intimate and lively event testament to the collegiate nature of the pharma industry in Ireland.

Running across the two days was the constant refrain of Ireland’s emergence as the global hub of biopharma investment and innovation, succinctly evoked by BioPharma Ambition 2016’s tagline: ‘inspire, connect, influence, innovate.’ No longer content to be a manufacturing base for international companies, Ireland is looking to become “a center of international excellence”, in the words of IPHA CEO Oliver O’Connor. Minister O’Connor summed it up: “a new era is beginning … put your faith and funding in Ireland.”

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