Strategic Alliance Made Official Following Successful mid-December Pharma CMO Summit Event in Berlin
Princeton, NJ – Supply Chain Wizard (SCW) – a leading full-service global consulting firm specializing in serialization and traceability, supply chain strategy and operational transformation programs – has officially partnered with Medicines for Europe, which represents the generic, biosimilar and value-added medicines industries across Europe.
Held December 12 in Berlin, the co-hosted Pharma CMO Summit drew more than 100 pharmaceutical executives from 27 countries. The summit was formed to serve as a resource for European pharmaceutical manufacturers moving to incorporate serialization processes to meet approaching regulatory deadlines – 2017 & 2023 for the United States, 2019 for the European Union – the strategic alliance comes on the heels of a highly successful event of the same topic.
With Optel Vision as the main sponsor, additional pharma manufacturer sponsors such as Abbott, Teva, Mylan and Nordic Group, and leading third-party logistics and solution sponsors, the event was well represented by key players in the serialization space. With serialization and track & trace deadlines looming, all parties were eager to obtain valuable insights into the challenges and intricacies facing companies in both Europe and the United States. Key to the event’s success were the networking events that provided ample opportunity to exchange serialization advice and experiences with peers from around the world.
The event also showcased ways in which serialization can go beyond mere regulation compliance to provide opportunities for enhanced business practices through data analytics produced by such systems. In this fashion, regulations once deemed onerous are actually opening doors to smarter manufacturing and supply chain operations.
As for the new partnership between Supply Chain Wizard and Medicines for Europe, the alliance brings together an industry advocacy group with a leading serialization consultant, helping European manufacturers of generic, biosimilar and value-added medicines connect the dots between learning about pending regulations and actually meeting their requirements.
“Education about serialization and track & trace regulations will always be ongoing but, as deadlines approach, it is time to turn informed plans into actualized, real-world solutions,” said Evren Ozkaya, founder and CEO of Supply Chain Wizard.
“As a leading partner for better healthcare, the organization aims to increase the health and well-being of all Europeans, while also addressing the business needs of European pharmaceutical manufacturers,” said Adrian van den Hoven, Director General of Medicines for Europe. “Partnering with a serialization & supply chain expert as well-regarded as Supply Chain Wizard helps us better serve both of these audiences.”
About Supply Chain Wizard
Supply Chain Wizard, LLC, is a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs. Dedicated to optimizing operations for growth, service and efficiency, Supply Chain Wizard offers strategic innovations in products and services targeting serialization and supply chain transformation initiatives, along with a team of expert consultants providing comprehensive support toward cost-effective compliance with serialization mandates and post-go-live operational support.
Supply Chain Wizard organizes serialization roundtables, summits and training programs throughout Europe, Asia Pacific and the United States, and runs frequent webinars to support clients with their regulatory and compliance challenges. Committed to helping clients maintain significant and sustainable performance improvements, Supply Chain Wizard guides customers to a more secure supply chain via the implementation of high return-on-investment initiatives.
Supply Chain Wizard is headquartered in Princeton, NJ, with additional offices in Germany, Netherlands, Turkey and India. For more information, please visit www.supplychainwizard.com.
Medicines for Europe and Pharmexcil today organised a Workshop on Global Pharmaceutical Operations in New Delhi, gathering key authorities, regulators and senior pharma executives from India and Europe for the first time. During the workshop, the conference participants debated on mutual reliance with regard to the effects of globalisation and the interplay of trust, regulation and business; how to create a universally acceptable quality culture in relation to GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) compliance and how to foster regulatory cooperation between the EU and India.
India and Europe are two major centres for pharmaceutical development, clinical development and manufacturing. There are opportunities to strengthen the global competitiveness of these two centres through cooperation. Close cooperation and trust between regulators and industry in both regions can support a positive environment for business cooperation based on mutual reliance. One of the tools through which this trust can be built is through regulatory collaboration and by partnering with stakeholders in the globalised market to ensure full understanding of the requirements of good practice.
Adrian van den Hoven, Medicines for Europe Director General commented: “The globalisation of the pharmaceutical industry operations has fuelled a debate internationally regarding opportunities, challenges related to regulation across the manufacturing supply chain. Medicines for Europe supports regulatory cooperation with our partners to ensure effective and efficient regulation for better access to high quality medicines for patients in India and in Europe”.
Medicines for Europe assessed the publication of the report ‘Health at a Glance 2016’ launched yesterday prepared by the OECD for the European Commission. The report acknowledges that the development of generic medicines markets increases efficiency in pharmaceutical spending, however it focusses on short term cost-containment rather than taking into account access to medicines and the long-term sustainability of healthcare. Generic cost-containment policies have had no significant impact on overall healthcare budgets as the expenditure for generic medicines is only 2-3%. On the other hand, as underlined by the German Pharma Dialogue, cost-containment measures such as tendering significantly increase the risk of medicines shortages that ultimately undermine patient health. The most extreme examples of medicines shortages in Europe are found in countries with unsustainable pharmaceutical pricing policies such as Romania, where the combination of external reference pricing, price linkage and clawback have led to the withdrawal of 2000 medicines and chronic shortages of inexpensive medicines.
Regrettably, the OECD report does not underline the importance of timely availability of generics and biosimilar medicines in order to facilitate patient access to pharmaceutical therapies and to improve the sustainability of national health systems , which would be in line with the Council conclusions and the ‘Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability’. Aside from financially incentivising prescribers, pharmacists and patients, policies should be put in place to reduce time to market and to educate the population on the quality, safety and efficacy of generic medicines and their equivalence to originator medicines. Furthermore, it is important to emphasise the relevance of putting in place key policy measures to increase the use of biosimilar medicines which play a key role in increasing patient access and in the long-term sustainability of healthcare systems.
Adrian van den Hoven, Medicines for Europe Director General commented: “The State of Health in the EU cycle is an important platform to support health policies in EU countries. We encourage the Commission to focus on generic, biosimilar and value-added medicine policies that increase access to medicines for patients rather than short term and counterproductive cost containment measures. Our medicines are developed and manufactured to serve patient needs not austerity policies”.
The statistics are truly disturbing, with an annual death toll of around 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017.
But industry and regulatory authorities are fighting back with new measures to identify rogue shipments and coordinated action to disrupt the supply lines that criss-cross the globe.
The trend to seek medical aid online has made it easy for bogus medicines – containing anything from paint and antifreeze to brick dust and floor wax – to be mailed around the world. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering from the 30,000 illegal pharmacy websites that have flooded the Internet.
Summit to Provide Insight into Cost-Effective Compliance with Track & Trace Mandates for Pharma Contract Organizations in Europe & U.S.
Princeton, NJ – Supply Chain Wizard – a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs – is co-hosting the Pharma CMO Summit on December 12, 2016 at the Ramada Hotel Alexanderplatz in Berlin. Titled Preparing Pharmaceutical CMOs & CPOs for Cost-Effective Serialization Compliance, the event will bring together manufacturers, CMOs, CPOs, 3PLs and solution providers for a full day of education and networking around the theme of making real progress toward serialization compliance.
The event is co-hosted with Medicines for Europe (formerly European Generics Association), an organization serving as the voice of Europe’s generic, biosimilar and value-added medicines industries. The December 12 gathering is the latest iteration in a series of such summits initiated by Supply Chain Wizard. Pharmaceutical industry professionals can register for the conference by visiting www.pharmacmosummit.com.
The goal of the event is to address the serious challenges presented by upcoming global serialization mandates, especially those in Europe and the United States. The day-long event will feature keynote addresses on major topics in serialization, along with panel discussions, breakout networking and roundtable sessions. Speakers and workshops will provide manufacturers and CMOs with strategies, processes and tools to prepare for serialization compliance and integration.
The event’s esteemed roster of sponsors speaks to the summit’s overall heft: The list includes Abbott, Teva and other leading pharmaceutical manufacturers. Solution providers will share best IT and packaging technologies, processes and tools for streamlining and enhancing serialization implementation. In addition, the conference will present opportunities for hands-on serialization learning activities, and will stress the sharing of content and experience among participants – a concept often seen as challenging in a largely close-to-the-vest pharmaceutical culture.
Another highlight of the event – one in which Supply Chain Wizard is particularly well-versed – is the opportunities for enhanced business practices through data analytics offered by optimized serialization systems. It is, according to the company, an instance where regulations once deemed onerous are opening doors to smarter manufacturing and supply chain operations.
“The exchange of knowledge this event will facilitate is the cornerstone of its success,” said Evren Ozkaya, founder and CEO of Supply Chain Wizard. “By bringing together multiple perspectives, and sharing both successes and struggles, we are confident attendees will leave this conference with a better understanding of what is needed to assure compliance with looming serialization mandates, and to effectively utilize the resulting data these new processes and systems will provide.”
About Supply Chain Wizard
Supply Chain Wizard, LLC, is a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs. Dedicated to optimizing operations for growth, service and efficiency, Supply Chain Wizard offers strategic innovations in products and services targeting serialization and supply chain transformation initiatives, along with a team of expert consultants providing comprehensive support toward cost-effective compliance with serialization mandates and post-go-live operational support.
Supply Chain Wizard organizes serialization roundtables, summits and training programs throughout Europe, Asia Pacific and the United States, and runs frequent webinars to support clients with their regulatory and compliance challenges. Committed to helping clients maintain significant and sustainable performance improvements, Supply Chain Wizard guides customers to a more secure supply chain via the implementation of high return-on-investment initiatives.
Supply Chain Wizard is headquartered in Princeton, NJ, with additional offices in Germany, Turkey and India. For more information, please visit www.supplychainwizard.com.
The Value Added Medicines Group a sector group of Medicines for Europe, participated in the CPhI Pre-connect Conference today to promote greater access to medicines for patients across Europe. During the conference, Pieter Dylst, Senior Manager Market Access & Value Added Medicines at Medicines for Europe presented the new study Value Added Medicines: Rethink, Reinvent & Optimise Medicines: Improving Patient Health and Access. The report by Mondher Toumi, Professor of Public Health at Aix-Marseille University, identified several areas of healthcare inefficiencies in Europe. It highlights new opportunities for innovation, health improvements and budget efficiency but also identifies several barriers to the uptake of value added medicines. To ensure that all stakeholders concerned can access and take advantage of this innovation, we need clear market access pathways that recognise the benefits these medicines provide.
Christoph Stoller, Chair of the Value Added Medicines Group called on companies investing in this important innovation to join Medicines for Europe in improving medicine options for patients “We need to move from responding to sickness towards improving well-being, keeping people healthy, looking ahead and thinking in the widest sense about care that is holistic, efficient and effective. “We need more companies to join us in strengthening the dialogue with policy makers, payers, patients, and healthcare professionals to address the barriers to access so that patients can benefit from value added medicines.”
The Value Added Medicines Group is open to existing members of Medicines for Europe and new Medicines for Europe members (i.e. not already member of any Medicines for Europe sector group) interested in developing this industrial sector. For more information please contact: info@medicinesforeurope.com
Medicines for Europe will engage rapidly with Health Ministers across Europe to implement the Health Council Conclusions on “strengthening the balance in the pharmaceutical system in the EU and its Member States”. The Conclusions underline the importance of the timely availability of generics and biosimilar medicines to improve patient access to therapy and to ensure the sustainability of national health systems. Value added medicines should also be included in this process as they can also contribute significantly to the efficiency of health systems while stimulating more competition between pharmaceutical innovation models.
Adrian van den Hoven, Medicines for Europe Director General, commented on the conclusions: “Member States have now understood the importance of stimulating competition in pharmaceuticals after patent expiry to help rebalance a market heavily impacted by the introduction of new highly priced patent protected medicines. Our members are ready to drive this agenda forward to ensure better access for better health”.
Medicines for Europe strategy to deliver better access for better health can contribute significantly to efficient and sustainable pharmaceutical policies. To strengthen the balance of the pharmaceutical market in Europe, Medicines for Europe calls for:
During the next two days, the key pharmaceutical industry leaders from the generic, biosimilar and value added medicines industries will meet in Dubrovnik to foster international partnership, cooperation and dialogue and discuss the most recent challenges of these industries for the future. With this year’s conference in Croatia, Medicines for Europe and the International Generic and Biosimilar Medicines Association (IGBA) celebrate their first joint event.
Amongst the key topics that will be tackled during the conference are the most important global challenges that the generic, biosimilar and value added medicines industries are facing today, such as the need to stimulate more competition in pharmaceutical markets, the trade and regulatory cooperation for better access, sustainable business models, improving the efficiency of healthcare systems and the stronger representation of the generic, biosimilar and value added industries in global fora regulating the pharmaceutical industry.
Jacek Glinka, Medicines for Europe President commented: “The impact of high cost new medicines on healthcare system sustainability is a concern for many healthcare policy-makers and advocacy groups. However, our industry is committed to delivering solutions that improve patient access to high quality medicines. We see this as an opportunity for our industry to provide leadership in the pharmaceutical market through an accessible innovation policy”.
Vivian Frittelli, IGBA Chair highlighted that “The majority of the world’s medicines in use today are generic medicines, while biosimilar medicines offer opportunities to treat millions more patients with biologic medicines and value added medicines are bringing sustainable innovation to all patients across the world”.
About IGBA
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines. Its membership includes Medicines for Europe (Europe), the CGPA (Canada), the GPhA (USA), the JAPM (Jordan), the NAPM (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos) and Mexico (AMEGI) are Associate Members. The IGBA is at the forefront of stimulating competitiveness and innovation in the pharmaceutical sector by providing high quality pro-competitive medicines to millions of patients around the world. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities (including the European Commission for Europe) as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org
· Value Added Medicines bring innovation throughout a molecule’s lifecycle to address patients’ health, improve the safety and efficiency of the work of healthcare professionals and increase physicians’ treatment options, while preserving the sustainability of the healthcare system.
· The Value Added Medicines Group seeks to work together with policy makers, payers, patients and healthcare professionals to address the barriers to this innovation so that all concerned stakeholders can take advantage of these opportunities.
A new study Value Added Medicines: Rethink, Reinvent & Optimise Medicines: Improving Patient Health and Access was launched today in Brussels by the Value Added Medicines Group, a sector group of Medicines for Europe. The report, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, identified several areas of healthcare inefficiencies in Europe and highlights new opportunities for innovation, health improvements and budget efficiency. Professor Mondher Toumi emphasised that “on average, 50% of patients do not take their medication as prescribed[1], which can have considerable consequences for their health and the healthcare system[2]. Value added medicines represent an opportunity to address a number of healthcare inefficiencies such as the suboptimal use of drugs, but also an opportunity to enhance healthcare system efficiency and contribute to the sustainability of healthcare systems.”
This was acknowledged by Christoph Stoller, Chair of the Value Added Medicines Group: “We need to move from responding to sickness towards improving well-being, keeping people healthy, looking ahead and thinking in the widest sense about care that is holistic, efficient and effective. The Value Added Medicines Group aims to rethink, reinvent and optimise medicines based on known molecules. It brings innovation throughout a molecule’s lifecycle to develop medicines which better understand patient needs and improve care delivery.”
While the majority of existing treatments deliver on their promises to a large number of patients, some may need to be adapted to match specific needs of the healthcare community. Since the discovery of these off-patent medicines more than 20 years ago, new scientific knowledge and new technologies have emerged, opening new research and development opportunities to address specific situations that could not be tackled 20 years ago.
The resulting value added medicines are medicines based on known molecules that address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers. Beyond improving patients’ quality of life and adherence, they can improve the safety and efficiency of the work of healthcare professionals, increase physicians’ treatment options and improve overall budget efficiency. Unfortunately, the current market environment in Europe does not allow the healthcare community to fully capture the benefits of value added medicines as the study has identified several obstacles for their uptake. While all stakeholders should recognise the benefits that value added medicines bring, HTA and pricing and reimbursement authorities should adapt their pathways so that their added value can be shown and rewarded appropriately. In return and with the right pathways, the industry needs to take a proactive approach and engage with authorities to assess how the evidence can be generated to support their claims.
Christoph Stoller added: “Delivering better outcomes will be lost if the healthcare community does not acknowledge and reward incremental innovation in the off-patent segment. Policy makers, payers, patients, healthcare professionals and our sector group need to work together to address the barriers highlighted in the study so that all concerned stakeholders can take advantage of this innovation”.
Supporting documents
[1] Sabaté E. Adherence to long-term therapies. Evidence for action. World Health Organisation (WHO). 2003. [Internet]. Available from: http://apps.who.int/iris/bitstream/10665/42682/1/9241545992.pdf (Cited 2016 May 09)
[2] Kelly M, McCarthy S, Sahm LJ. Knowledge, attitudes and beliefs of patients and carers regarding medication adherence: a review of qualitative literature. IJPP 2015, Supplement 1: 28–49. (Original reference: European Council Policy Makers Debate. An EU response to medication non-adherence. Brussels, 2010)