EXCITE International Update June 2018

Posted Jun 26th, 2018 in News

EXCITE Announces New Board Members

EXCITE International is pleased to announce the appointment of two new Board members:

Sir Bruce Keogh KBE, FRCS, FRCP, recently appointed Chair of Birmingham Women's and Children's NHS Foundation Trust. Sir Bruce was Medical Director of NHS England from 2007 to 2018, with oversight for clinical policy and strategy including medicine supply chain, policy regarding the pharmaceutical industry, and sponsorship of NICE work programs. He also led a taskforce that increased the number of organ donors by 50%.

Sir Bruce was responsible for implementing recommendations from the 2008 Darzi Review of the NHS and is credited with refocusing the NHS on quality of care, developing the NHS Quality Framework, the Healthcare Quality Improvement Partnership to develop and run national clinical audits, and promoting research and innovation by working with universities and biotechnology companies to form academic science networks. His work on healthcare quality was incorporated into the Health and Social Care Act (2012).

Sir Bruce has an impressive career as a cardiothoracic surgeon. He was appointed Senior Lecturer in cardiothoracic surgery at the Royal Postgraduate Medical School, where he went on to become lead in cardiothoracic surgery in Birmingham, and was appointed Professor of cardiac surgery at University College London and Director of Surgery at The Heart Hospital in 2004.

Dr. Carl Christian Gilhuus-Moe is Chairman of the Board of Norway Health Tech, Norway’s largest health cluster consisting of 225 companies, hospitals, finance, knowledge and research institutions that focus on health innovation. He is a Senior Advisor of NeoMed Management, a Europe-based venture capital fund focused on international healthcare and medical technology, is Chair of the Board of Sonitor Technologies, and is a board member of Respinor AS. Dr. Gilhuus-Moe is an active investor in several health technology companies in Norway, was chairman of the board for SINTEF-Unimed (the Norwegian Institute of Technology) and the European Committee for Clinical Laboratory Standardization (ECCLS). He was the founding President and CEO of Dynal Biotech ASA, now part of Thermo Fisher Inc., VP and head of Hafslund-Nycomed, ASA's diagnostic division (now part of Abbot Inc).

Consolidating International Partnerships

EXCITE International has expanded its collaboration base in the U.S. through our recent association with the Baim Institute. The Institute will become our default clinical trials center for the U.S. Contacts are also currently being explored with the NEST program at MDIC and with the Patient Centered Research Foundation, a part of the PCORI initiative. We are especially pleased with the progress the Payers’ Advisory Committee (PAC) continues to make in consolidating the larger Payer and Health Systems in the U.S. and internationally and the large experience the International Scientific Collaboration (ISC) has drawn on from thought leaders and experts in the U.S. and other jurisdictions.

EXCITE International is strengthening its partnership with MaRS EXCITE in Canada through an MOU we hope to concluded very soon and envisage consolidating our U.K. base with essential existing “moving parts” as soon as possible.

Future communication bulletins will focus on one or two partner countries: in this bulletin we are pleased to profile Norway and the Netherlands


A Memorandum of Understanding was concluded between Norway HealthTech and EXCITE International in March 2018. It is expected that this partnership will evolve to form EXCITE Norway and will expand to include other Nordic Countries.

Norway Health Tech has been at the forefront of encouraging Norwegian companies to access EXCITE International offerings, with recently completed Early Technology Reviews for SoftOx and Mode Sensors. Kathrine Myhre and Carl Gilhuus-Moe (CEO and Board Chair of Norway HealthTech, respectively) have been key to forging the relationship with EXCITE International, a relationship that has grown steadily over the last 2 years. This partnership will provide increasing opportunities for Norway to influence the development of EXCITE International through participation in all its Board Committees. In turn, the partnership will facilitate global reach for Norwegian health technologies and access to Nordic markets for other EXCITE International member countries.

We welcome the recent addition of Nordic Proof clinical trials network as an EXCITE International partner through Norway HealthTech.

We congratulate SoftOx on its recent public offering and appreciate the very positive feedback we have received from their CEO, Geir Almas, on how our Early Technology Review has expedited the company’s development.

The Netherlands

An MOU was concluded in March 2018 between Radboud University Medical Center in Nijmegen and EXCITE International which, as of May 2018. This agreement is currently evolving into a broader Netherlands partnership involving government and additional academic centers and is intended to be in place by January 2019. In May 2018, the Netherlands government announced an €105 million fund to better support smaller innovative parties such as SMEs, start-ups and general hospitals in the final development step towards reimbursement.

Radboudumc has three programs that are key leads for EXCITE International, these being:

MedValue: Under the leadership of Dr. Maroeska Rovers and Dr. Sabine Mulders, this unit has expertise in early health technology assessment (HTA) and decision analytical modeling. This is an important contribution to EXCITE International’s Early Technology Reviews and clinical trial protocol developments.
Radboud Technology Center Clinical Studies Group: A clinical trials network that extends into many parts of Europe, it will become an important focus for EXCITE International clinical trials networks.

REshape is providing leadership in developing a Patients Included initiative to ensure patient input into all EXCITE International offerings. This is headed by Lucien Engelen, an international leader in patient engagement and founder of the internationally acclaimed #patientsincluded which develops charters and expectations for including patients in health systems, publications and research. 

It is expected that the Netherlands will shortly nominate a member to the Board of EXCITE International, and to the Payers Advisory Committee to add to the existing appointment of Dr. Maroeska Rovers, who is a member of EXCITE International’s Scientific Collaboration.

EXCITE International has enjoyed a stimulating and valued relationship with the Radboudumc, now expanding to a broader engagement as mentioned above. We are especially thankful to the Dean, Dr. Paul Smits, Dr. Simon Broecheler, Dr. Maroeska Rovers for her scientific leadership and Dr. Sabine Mulders, CEO of MedValue.

Board Committees and Recent Appointments

EXCITE International has established its first two important Board committees: 1) the Payers’ Advisory Committee (PAC) under the Chair of Dr. Naomi Aronson, Executive Director of Clinical Evaluation, Innovation, and Policy at BCBSA (U.S.); and, 2) the International Scientific Collaboration (ISC) under the Chair of Dr. Bryan Luce, President of Luce Outcomes Research and immediate past CSO PCORI.We are pleased to announce the recent addition to the Scientific Collaboration of Gheorghe Doros, Professor Biostatistics, Boston University U.S., and Rachael Fleurence, Director of the NEST Program, MDIC, U.S.

Two additional Board Committees are currently being struck:

The Industry Advisory Committee, under the Chair of Dr. Richard Kuntz, who is also the Chair of the EXCITE International Board and Senior Vice President, Chief Medical and Scientific Officer at Medtronic. This Committee will advise EXCITE International on engagement with industry and create opportunities to interact with the Payers’ Advisory Committee and International Scientific Collaboration.

The Patients Included Committee, under the Chair of Lucien Engelen, is developing a Patients Included charter (#patientsincluded) for EXCITE International and will form the basis for ensuring meaningful patient participation in the selection and evaluation of new health technologies. Initially focusing on the Netherlands, this initiative will scale up to include all member countries based on existing initiatives in patient engagement.

The EXCITE International Advisory Council

Development of the Advisory Council was put on hold while EXCITE International built its international infrastructure. Now that its four Board subcommittees are in place or nearing activation, the Advisory Council, under the direction of Dr. Anne Kolbe, is being mobilized to provide the Board with overarching advice on how best to implement its strategic direction internationally.

Status of EXCITE International Offerings

Early Technology Review (ETR)

EXCITE International has added this new offering which provides confidential advice to companies from payers, health systems, expert end-users, and patients at the proof-of-concept stage of development. The ETR provides invaluable insights into the ecosystem that the technology can expect to perform in and information on downstream events and costs that may be avoided or incurred. It determines the magnitude of effect needed to be of interest to payers, expectations by payers and health systems – including ideal comparators and target populations – and high-level technical advice regarding prototype development and testing. Companies communicate with Regulators in parallel to the Review process to ensure that their expectations are addressed.

Two ETRs have been completed, a third is underway and interest has been expressed by other companies. We are pleased with the increasing market interest in ETR.

Protocol Development

The International Scientific Collaboration has created a Protocol Development guidance document based on EXCITE International’s unique approach to providing input by Regulators, Payers, Companies, Health Systems, Patients, and Expert End-Users into protocol development. This allows all stakeholder expectations to be addressed in studies that harmonize these multiple perspectives.

The methodological basis for conducting single harmonized studies has been an important focus of the EXCITE International process as is the increasing use of existing patient outcomes datasets. The latter was recently announced by FDA as being of increasing interest to their processes and EXCITE International will work closely with FDA, the NEST Program at MDIC and our Payers’ Advisory Committee to incorporate this approach as appropriate.

Clinical Trials

EXCITE International does not run clinical trials, relying on appointed Global Methodology Resource Centers (GMRCs) and Clinical Research Organizations to conduct trials. These organizations run protocols through their existing international trial networks aligned to their member countries. Companies engaging with EXCITE International reduce their costs and streamline their pathway to adoption through excellence in the execution of clinical trials.

EXCITE International is especially pleased to announce its new partnership with the Baim Institute, a Harvard-based not-for-profit academic research organization which EXCITE International will use for clinical trials focused in the U.S. and internationally. EXCITE International has similar objectives to the Baim Institute: to contain costs and be more efficient. This will be achieved in part through new approaches to clinical trials designs, including the optimal use of existing patient outcomes datasets.

EXCITE International is also pleased to announce the addition of the Nordic Proof clinical trials network as mentioned above.

Recent Presentations

  • Members of EXCITE International’s Scientific Collaboration presented a successful panel session on the organization at the HTAi international annual meeting in Vancouver on June 3rd, 2018.

  • Dr. Les Levin met with the Baim Institute in April 2018 and visited EXCITE International’s partners in the Netherlands (Nijmegen) and Norway (Oslo) in May 2018.

  • Dr. Les Levin, Dr. Naomi Aronson, and Dr. Bryan Luce joined together in Washington in December 2017 for a series of meetings. Time was spent with Rachael Fleurence, Director of the new NEST program, Murray Sheldon Associate Director for Technology and Innovation Center for Devices and Radiologic Health at the FDA, Kathy Hudson, CEO of the Patient Centered Research Foundation, Mark Leahey, CEO of the Medical Device Manufacturers Association and Joe Gatewood, VP, AdvaMed.

Work with us. EXCITE International can assist you in facilitating multi-jurisdictional clinical trials through its partnership with government, clinical experts, methodology centres and health system decision makers.