The world’s largest life sciences manufacturers and global industry regulators came together last month in Budapest, Hungary for The Global Generic, Biosimilar and Value Added Medicines Conference to support the advancement of better access to better healthcare across the world. The conference provided a forum for the exchange of global perspectives on the challenges and opportunities to advance generics, biosimilars and valued added medicines (VAM) to patient populations around the world. Discussions about cutting edge science to develop biosimilars and VAMs to regulatory challenges faced by all manufactures in the European Union and United States were some of the highlights of the conference.
How to Make Medicine More Available
Chip Davis, president and chief executive officer of the Association of Accessible Medicines in Washington, D.C., set the stage for the important work that needs to be accomplished to enable manufacturers around the world to develop, market and distribute generics, biosimilars, and VAMs. A focus on the unserved populations, as well as the global aging population, were defined as drivers to important political and industry regulators. Communication and collaboration will be keys to unlocking the opportunity to make medicine accessible to all people to improve quality of life.
The keynote speech by Mihály Varga, minister of National Economy in Hungary, provided insight into growth potential of Hungary and the investment the government is making to improve healthcare and access to medicine. From infrastructure developments to a commitment to collaborate with life science manufacturers and industry regulators, the minister’s enthusiasm was felt by everyone in the audience.
Key highlights from the meeting included the panel discussion on “New challenges impacting the availability of medicine” led by Adrian van den Hoven, director general of Medicines for Europe.
The panel was well-rounded with experts Adele Paterson, CEO and head of corporate partnerships at International Health Partners, Christoph Stoller, general manager of Cluster Germany & Austria for Teva-ratiopharm, Alexandra Moulson, head of GCO (Global Commercial Operations) Strategy at Sandoz, Deborah M. Autor, head of Strategic Global Quality & Regulatory Policy at Mylan and Greg Perry, assistant director general for Global Health, Innovation, and Regulatory Affairs at IFPMA lead by van den Hoven, director general of Medicines for Europe, on day one. The director general led a panel of experts including Stoller, Moulson, and. Autor.
A key theme for the two-day meeting emerged. All manufacturers face challenges:
- Dealing with regulatory, environmental, and distribution channels.
- Securing he local and global approval and distribution of medicines.
The panel emphasized the need for generics and biosimilars manufacturers to come together to address issues and market conditions that impact the industry’s core mission to improve access to medicines for patients around the world.
How to Make the Most of Big Data
“Dealing with Data: How to keep up in providing data, recognizing its value and making the best use of it” was a panel discussion moderated by Jim Keon, president of the Canadian Generic Pharmaceutical Association.
The panel included Alison Cave, principal scientific administrator of European Medicines Agency, Michaeline Daboul, president and CEO of MediSpend, Anna van Nieuwenhuizen, director in the Global Strategy Function at Sandoz, John Peter Mary Wubbe, Secretary General of DHE / EPPOSI II / EuDiPPA / ICPEU and Frederik van Remoortel, lawyer at Crowell & Moring.
During the discussion, van Nieuwenhuizen set the stage by sharing the best practices that Sandoz follows to gather internal data for analysis of market conditions based on data generated from business operations. Wubbe and Cave both discussed the importance of data aggregation and analysis to support the movement to harmonize data across countries to enable governments to better address patient populations who would benefit from wide distribution and access to generics, biosimilars and VAMs. Lawyer van Remoortel presented the GDPR regulations and Daboul followed by sharing how cloud-first technology solutions enable companies to aggregate enterprise data into a commercially available data warehouse. Another topic on the table was new commercial off-the-shelf (COTS) solutions making it easy for business stakeholders to better manage operations using data analytics and COTS dashboards used for compliance monitoring.