Life Sciences Innovation Forum

The applied life sciences are critical to growth and socioeconomic development because healthy people produce healthy economies—innovations to make patient-focused products and services efficient, effective, and easily available, for example, can improve a population's longevity, wellness, productivity and economic potential. 

Established by APEC Leaders in 2002, the Life Sciences Innovation Forum (LSIF) has since grown to become APEC's leading initiative on health and health sciences innovation.

It is a tripartite forum that engages representatives from the highest levels of government, industry and academia to create the right policy environment for life sciences innovation.

To address the challenges such as infectious and chronic disease and ageing populations, the LSIF brings together scientific, health, trade, economic and financial considerations. It operates under guiding principles of transparency, meaningful dialogue with stakeholders, recognition of due process and acknowledgement that capacity building is critical to successful implementation.

Last page update: Aug 2017

Current Activities

The LSIF held a suite of meetings during this year’s First Senior Officials Meeting in Nha Trang, Viet Nam:

  • LSIF Regulatory Harmonization Steering Committee (19-21 Feb)
  • LSIF Planning Group (22 Feb)
  • LSIF-Health Working Group Joint Session (24 Feb).

Selected Highlights of Current Projects

Global Medical Product Quality and Supply Chain Integrity

APEC economies are among those victimized by the international movement of spurious, substandard, falsified, falsely labelled and counterfeit (SSFFC) medical products.

As the medical products industry becomes more globalized and specialized, APEC economies must increasingly rely on the global marketplace to provide the products needed to keep citizens healthy.

This introduces a need to ensure that the trade in legitimate products is not disrupted. Specific areas are being explored by APEC economies; they 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
  • The establishment of a single point-of-contact (SPOC) within each APEC economy 

This multi-year initiative includes activities such as cracking down on medical product fraud. The ultimate goal is regulatory convergence, to enhance the quality of global medical products and the integrity of supply chains. 

The APEC Multi-Regional Clinical Trial Regulatory Science Center of Excellence 2013 Pilot 

Multi-regional clinical trials (MCRT)—the simultaneous conduct of a clinical trial in multiple geographical regions—play a major role in providing patients with access to innovative new medicines.

The APEC region is becoming an increasingly important destination for MRCTs. A Roadmap to Promote Multi-Regional Clinical Trials is being pushed forward by Japan, and is has entered the implementation phase, which 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.

However, in order to attract the investment of these clinical trials, it is also critical for the APEC region to converge its medical product regulatory approval procedures and its human resource capacities of member economies for regulatory science.

The LSIF, through its Regulatory Harmonization Steering Committee (RHSC) (see section below), has been tasked to achieve regional convergence on regulatory approval procedures for medical products by 2020.

The RHSC met in Jakarta in February 2013, and agreed to explore the establishment of an APEC MRCT Regulatory Science Center of Excellence (CoE) Pilot.

CoEs are a new and sustainable model for advancing regulatory convergence on a global scale. More are expected to be established in 2017.


Workshop on Investment in the Blood and Blood Products Supply Chain to Promote Sustainable APEC Healthcare Systems 

In 2010, the World Health Organization (WHO) called attention to an increased movement across boundaries of blood products and blood safety-related in vitro diagnostics devices—these products are enjoying rapid development and are being introduced into the health-care systems of both developed and developing economies.

There are wide disparities across the APEC region in terms of access to safe blood. In 2014, a two-day workshop on Investment in the Blood and Blood Products Supply Chain was organized to support 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;
  • Examining the role of blood safety in preventing the spread of HIV, hepatitis, other infectious and potentially pandemic diseases
  • Promoting regulatory cooperation and best practices on handling blood and blood products

In 2015, the 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.

Expected outcomes/deliverables for 2017 

  • A study reviewing the innovative financing mechanisms for health (both industry-led and government backed) and the identification of enabling factors for the utilization of the industry-led mechanisms and enablers for the government and financial services sector
  • The statement of the 7th APEC High-Level Meeting on Health & the Economy
  • A report from the Third Senior Officials’ Meeting, LSIF High Level Dialogue on Innovation and Regulatory Convergence
  • The establishment of APEC Regulatory Sciences Centers of Excellence (CoEs) in the following institutions:
    • Northeastern University, United States (for Biotherapeutics)
    • Peking University, China (for MRCT/GCP)
    • Pharmaceuticals and Medical Device Agency, Japan  (for MRCT/GCP and Pharmacovigilance & Medical Device Vigilance)
    • Duke/National University of Singapore (for MRCT/GCP)
    • Regulatory Affairs Professionals Society of Chinese Taipei, in cooperation with Chinese Taipei FDA (for Good Regulatory Management). 
  • A framework that would enable responsible and secure sharing of medical data for secondary analysis to facilitate health and life sciences research
  • Capacity building workshops through the APEC mental health digital hub
  • Recommendations on implementing good manufacturing practices in blood establishments and recommendations on enhancing access to safe therapy for bleeding disorders
  • The establishment of an APEC Tropical Health Workforce Development Hub

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.

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Achievements

Life Sciences innovation Forum

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.