The Life Sciences Innovation Forum Planning Group (“LSIF PG”) Meeting was held on February 26, 2016 in Lima, Peru as part of the First Senior Officials Meetings (“SOM1”) for 2016 where discussions covered Peru’s theme in 2016 “Quality Growth and Human Development”, including its four themes: (1) advancing regional economic integration and quality growth; (2) enhancing the regional food market; (3) towards the modernization of micro, small, and medium-sized enterprises (“MSMEs”) in the Asia-Pacific region; and (d) developing human capital. Subthemes have been identified beneath each theme. The representative from the host economy encouraged LSIF PG attendees to identify how the LSIF could contribute to these themes.
Selected Highlights of Current Projects
Global Medical Product Quality and Supply Chain Integrity
APEC economies are adversely impacted by the international movement of spurious, substandard, falsified, falsely-labelled and counterfeit (SSFFC) medical products. As the medical products industry has become more globalized and specialized, APEC economies must increasingly rely on the global marketplace to provide the medical products needed to keep citizens healthy and ensure trade in legitimate products is not disrupted. Specific areas being explored include good distribution practices, controls on components used as part of good manufacturing practices and quality management systems, import and export practices, dispensing practices via the internet, detection technologies, and establishment of a single-point-of-contact (SPOC) within each APEC economy. This APEC multi-year project includes activities focused on developing and implementing processes and procedures directed at regulatory convergence to efficiently enhance global medical product quality and supply chain integrity. For more information:http://www.apec.org/Press/News-Releases/2014/0512_medical.aspx
APEC Multi-Regional Clinical Trial (MRCT) Regulatory Science Center of Excellence - 2013 Pilot
The APEC LSIF Regulatory Harmonization Steering Committee (RHSC) is tasked to achieve regional convergence on regulatory approval procedures for medical products by 2020. Multi-regional clinical trials (MCRT) is the simultaneous conduct of a clinical trial in multiple geographical regions. These clinical trials play a major role in providing patients with access to innovative new medicines. The APEC region is an increasingly important destination for multi-regional clinical trials (MRCTs) as drug development and testing are globalized. However, in order to attract the investment of these clinical trials, it is critical for the APEC region to achieve regulatory convergence on medical product regulatory approval procedures and regulatory science human resource capacity. The Roadmap to Promote Multi-Regional Clinical Trials (MRCT), led by Japan, is highly advanced and has entered the implementation phase. This phase requires focused training in regulatory sciences. The Roadmap’s goal is to facilitate multi-regional clinical trials (MRCT) and the acceptance of these clinical trial results for review by regulatory authorities. The LSIF Regulatory Harmonization Steering Committee (MRCT) met in Jakarta in February 2013 and agreed to explore the establishment of an APEC MRCT Regulatory Science Center of Excellence Pilot. This project further develops and tests the concept, regulatory science training methods and financial support for such a pilot center.
Workshop on Investment in the Blood and Blood Products Supply Chain to Promote Sustainable APEC Healthcare Systems
In 2010, the World Health Organization (WHO) noted the increased movement across boundaries of blood products and blood safety-related in vitro diagnostics devices, together with their rapid development and introduction into health-care systems of both developed and developing economies. Across the APEC region, wide disparities in the level of access to safe blood exist. This 2-day workshop supports APEC economies’ efforts to close remaining gaps in promoting sustainable healthcare systems by improving their capacity to collect, test, and distribute safe blood and blood products. The project’s key objectives include: building the capacity of APEC economies in their blood services, infrastructure, and governance and promoting more harmonized standards for blood and blood products; and examining the role of blood safety in preventing the spread of HIV, Hepatitis, other infectious and potentially pandemic diseases as well as promoting regulatory cooperation and best practices on blood and blood products.
In 2015, LSIF endorsed the APEC Blood Supply Chain 2020 Roadmap and the establishment of the APEC Blood Supply Chain Partnership Training Network (PTN) to support the Roadmap’s implementation.
An APEC Life Sciences Strategic Plan was approved by APEC Ministers in 2004 and it includes recommendations for collective action and an implementation schedule. The Strategic Plan also provides recommendations for strengthening the innovative life sciences sector in the APEC region, placing particular emphasis on boosting region-wide levels of investment in research and development for health innovation.
In 2007, the LSIF was tasked to undertake a multidisciplinary study on the role of investment in health innovations that address health and related economic and fiscal challenges facing the region, and the return on investment for economies. It was also mandated to establish frameworks for public-private sector partnerships to better utilize resources to meet health needs.
The LSIF has developed an Enablers of Investment Checklist, a voluntary guidance tool for policy makers in each APEC economy to assess their investment environment for life sciences innovation. Singapore volunteered to fill out the implementation of the Checklist in 2009.
The LSIF has developed an Anti-counterfeit Medical Product Action Plan. The objective is to share best practices in the detection and prevention of counterfeits with both regulatory authorities and industry professionals and to build capacity at the economy level to combat the threat. A workshop on anti-counterfeit medicines was held in Beijing, China from September 27-28, 2011. Since 2008, a series of regional seminars for government regulators on the issue of harmonization of medical device regulation were organized by the Regulatory Harmonization Steering Committee (RHSC). The objective was to help regulators of medical devices in APEC economies develop robust regulatory systems. The seminars highlighted the benefits to patients, regulators, and industry and to global and regional trade when economies implement a medical device regulatory system based on harmonized standards and procedures. Industry representatives were invited to participate. The training programs were closely coordinated with the medical devices Global Harmonisation Task Force and two regional working parties: The Asian Harmonisation Working Party and the Latin American Harmonisation Working Party.
RHSC continues to break new ground in developing innovative approaches to address regulatory priorities and to serve as a global catalyst for change. Significant progress has been made toward promoting regulatory convergence in the medical products sector by 2020, in partnership with key international bodies and initiatives, and according to the strategic framework and roadmap.
The RHSC’s Priority Work Areas (PWAs) are: Multi-Regional Clinical Trails (Japan) and Good Clinical Practices Inspections (Thailand); Pharmacovigilance & Medical Device Vigilance (Korea) ; Biotechnological Products (Korea); Cellular Therapies (Singapore); Good Registration Management (Chinese Taipei, Japan); and Global Supply Chain Integrity (US).
The 2016 SOM1 RHSC meeting accomplishments included: securing agreement on a Center of Excellence (CoE) Memorandum of Understanding (MOU) Template between the LSIF and Host Institutions; the contents of the Steps to Formalize a CoE draft document was endorsed by the RHSC; and the Annual Performance Report template was endorsed as a mechanism to assess/evaluate CoEs. The RHSC also endorsed the following institutions to serve as CoE host institutions on a pilot basis: Seoul National University (Biotherapeutics), Northeastern University (Biotherapeutics), Peking University (MRCT/GCP), Duke/NUS Singapore (MRCT/GCP), PMDA (MRCT/GCP), RAPS (GRM), KIDS (Pharmacovigilance & Medical Device Vigilance), PMDA (Pharmacovigilance & Medical Device Vigilance), and the University of Tennessee HSC (Supply Chain).
The APEC Harmonization Center (AHC) was launched in Seoul, Korea in June 2009. The AHC is an important step towards harmonizing regional regulatory priorities. An LSIF Regulatory Harmonization Steering Committee (RHSC) has also been created to advance the harmonization agenda. The AHC has since organized a series of events, including an "APEC Harmonization Center Biosimilar Workshop" in 2009. The workshop was focused on the opportunities and challenges of biological medicines, regulatory issues for biosimilars and the regulatory landscape for biosimilars. - In 2016, the AHC serves as the coordinator of Centers of Excellence (CoEs). AHC closely cooperates with the RHSC and PWA Champion Economies. The AHC is establishing a separate CoE page on its website, which will provide information for CoEs and open source training materials, annual training schedules of CoEs, and available content for each topic. It also conducts accreditation assessments in collaboration with the RHSC and champion economies.
Maureen Goodenow (Ms)
Senior Science Advisor and Jefferson Science Fellow
Department of State, United States
Professor and Stephany W. Holloway Endowed Chair for HIV/AIDS Research
College of Medicine, University of Florida
David Wu (Mr)