NEXT Annual Report 2017

Transcription

1 NEXT Annual Report 2017 June 2018 Final version

2 NEXT Annual Report 2017 Executive Summary The number of early clinical trials carried out in the centers exceeded the number anticipated in the original applications to the Innovation Fund Denmark. For 2017, the planned number of initiated early clinical trials in NEXT was 17, while the actual number was 29. A good year for NEXT. The majority of the initiated clinical trials were in oncology (14 trials), sponsored by a broad range of pharma companies (NEXT parners and non-next partners). Four trials were initiated in respiratory medicine, four trials in infectious diseases and six trials in dermatology. In 2017, the private NEXT partners invested a total amount of DKK 37 million in clinical trials a combination of direct payments to the hospital departments as well as in-kind expenses of the clinical trials. In 2017, NEXT participated in working groups in the Danish Regions and in the Ministry of Industry, Business and Financial Affairs to agree on the future national organization of clinical trials. The working groups involved NEXT staff, Clinical Trials Office Denmark, Lif, Medicoindustrien, the Regions, and the Ministry of Health. The effort to ensure the continuity of NEXT was adopted by the Growth Team for Life Science, appointed by the Government. NEXT was represented in the Growth Team by NEXT Chairman Thomas Kongstad Petersen. On the 2nd March, 2018, the Government announced the Growth Plan for Life Science, in which NEXT has a future governmental investment, ensuring a national organization of clinical trials in Denmark. This organization is a merger of the existing NEXT and Clinical Trials Office Denmark. The future organization will contain infrastructure for clinical trials with medicine and medical devices covering all clinical trial phases. More centers will be established. By 2021, the plan is to have in total eight centers covering relevant disease areas with clinical trial expertise, where companies anticipate to be able to place clinical trials. NEXT was represented in the governmental Growth Team for Life Science , and the recommendation from the team was very clear: Establish NEXT 2.0 one national organization for clinical trials including all diseases, all phases of clinical trials, and tests of farmaceuticals as well as medical devices. NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 2

3 NEXT (National Experimental Therapy Partnership) is a public-private innovation partnership with the aim of making Denmark a preferred country for early clinical trials of new drugs for patients. NEXT is comprised of four clinical research centers, one research center in bioinformatics, and the NEXT secretariat. NEXT has four national clinical research centers focused on: Oncology & Hematology, Dermatology, Respiratory Medicine and Infectious Diseases. All centers consist of five to six hospital departments, which include the infrastructure for early phase clinical trials and serve as part of a national network with one point of entry for early phase trials. The NEXT center for Bioinformatics consists of four hospital departments in a research-based collaboration supporting the precision medicine aspects of patient allocation to clinical trials. NEXT Bioinformatics works to establish national standards for genomic profiling, making it possible in the future to establish a national database of genomic profiles. The NEXT secretariat has a neutral role and facilitates the cooperation between the pharmaceutical industry and the hospital departments, as well as the national collaboration within each center. This includes streamlining processes, facilitating national collaborations, optimizing site readiness, and overseeing clinical trial conduct. NEXT was formed by an initial investment of DKK 50 million (in 2014) and an additional DKK 30 million (in 2015) over five years from Innovation Fund Denmark plus DKK 12 million from the regions. The in-kind investment from the pharmaceutical industry amounts to DKK 168 million., and in the regions it amounts to DKK 85 million. The founding partners of NEXT are the Regions, the universities, Bioneer and the private companies LEO Pharma, MSD, Novo Nordisk, Novartis, and Roche. In April 2016, the following private partners joined the partnership: AstraZeneca, Boehringer Ingelheim, Pcovery, RSPR Pharma, Serendex Pharma, Statens Serum Institut, and Symphogen. NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 3

4 Successful collaboration attracts additional trials and provides access to new medicine for patients. The clinical trial unit at Odense University Hospital was established in 2015 and initiated the first trial in 2016 in collaboration with Biocryst Pharmaceuticals. Subsequently, the site has been offered to participate in three other trials in the development program of Biocryst Pharmaceuticals. Furthermore, the clinical trial unit has been contacted by another company also developing drugs for Hereditary Angioedema. This is an illustration of how successful research collaboration on clinical research provide early access to medicine for patients suffering from rare diseases. Departments at Bispebjerg and Hvidovre Hospital were included as sites in 2017 for a phase II asthma trial at a very late stage due to recruitment difficulties in the originally selected countries. Within two months from site initiation, the Danish sites, in a remarkable effort, managed to recruit the required patients. Such rescue recruitment promoted the commitment and resources of hospital departments in a highly competitive global context. NEXT activities Partners and stakeholders In 2017, six companies joined NEXT as associated partners: AbbVie, Bristol-Myers Squibb, Celgene, InCyte, Pfizer and Sanofi. Additionally, NEXT arranged six pipeline meetings at congresses where relevant physicians met with company representatives to discuss company trial pipeline. The congresses with such meetings were the European Hematology Association Congress (EHA), the European Congress of Oncology (ESMO) and the European Respiratory Congress (ERS) in Milano. In October 2017, NEXT promoted the Center of Dermatology at a Roundtable meeting at the Danish Consulate in New York. Consul General of Denmark in New York, Anne Dorte Riggelsen, hosted a roundtable discussion with the companies AbbVie, Bristol-Myers Squibb, Celgene, Cipher Pharmaceuticals, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Pfizer, Regeneron Pharmaceuticals, and Strata Skin Sciences, where the industry could explore the opportunities of running clinical trials in Denmark within dermatology. NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 4

5 The value of clinical trials in Denmark A Report by Copenhagen Economics Clinical trials add value to the society and the participants, according to a report published by NEXT, The Danish Association of the Pharmaceutical Industry (Lif), and Invest in Denmark. The report quantifies the value generated by clinical trials in Denmark, and the main conclusions are that clinical trials by pharmaceutical companies deliver value to the Danish society. On average, a clinical trial improves GDP by DKK 0.9 million and the public budget by DKK 1.2 million. In total, pharmaceutical companies spent DKK 248 million on improving the Danish public health sector in conjunction with clinical trials in Patients in clinical trials in Denmark have more consultations (7 vs 2.3 visits per year), and each one is longer (56 vs 24 minutes). The positive economic effects arise from trials conducted in Denmark through several drivers: More and better healthcare, highly productive jobs, and new research in Life Sciences. The report can be found on the NEXT webpage. New NEXT Centers In 2017, NEXT explored new therapy areas for NEXT, and it was decided to establish two disease specific networks within dementia and metabolic diseases, due to demand from companies. The network of dementia, NEXT-link Dementia, is formed and ready to receive inquiries in a coordinated national manner and the second network will follow in 2018/19. NEXT Regulatory Dialogue Forum NEXT has taken the initiative to create a forum with representatives from the Danish Medicines Agency, Lif, the secretariat for the Danish National Committee on Health Research Ethics, and NEXT. Two meetings are held yearly. The forum is a strong platform for dialogue among the participants, and NEXT has been an active contributor in the discussion on how the fees for the Danish Medicines Agency could be lowered and how companies get in dialogue with the secretariat for the national committee on health research ethics concerning genome research. NEXT CRO Network NEXT established the NEXT CRO Network consisting of representative CRO companies. The CRO network has quarterly meetings with different themes around mutual interests and opportunities for collaboration in relation to performance of clinical trials in Denmark. NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 5

6 NEXT Project Nurse Seminar A shared initiative between hematological department at Aarhus University Hospital and NEXT will create a platform for learning and sharing among Danish project nurses across the country. Preparations for the two planned seminars were carried out in 2017, and they will be held in We look forward to report learnings from the seminars in Center Activities Number of Trials The number of early clinical trials carried out in the centers exceeded the number anticipated in the original applications to the Innovation Fund Denmark. In 2017, the planned number of initiated early clinical trials in NEXT was 17 while the actual number was 28. The majority of the initiated clinical trials were in oncology (14 trials), sponsored by a broad range of pharma companies (NEXT partners and non-next partners). Four trials were initiated in respiratory medicine, four trials in infectious diseases, and six trials in dermatology. Center for Oncology & Hematology In 2017, the Center for Oncology and Hematology expanded with the Department of Oncology at Little Belt Hospital Vejle and the Department of Hematology at Odense University Hospital. Center for Oncology and Hematology Number of feasibilities received Number of trials Number of open trials in year Number of patients enrolled in trials Further, the center included the Department of Pediatric Oncology at Rigshospitalet meaning NEXT now has the possibility of offering a site capable of running early phase pediatric clinical trials. The Medical Lead position was in February handed over from Professor Ulrik Lassen to Chief Physician Morten Mau-Sørensen at Rigshospitalet. Center for Dermatology In 2017, the Center for Dermatology initiated a total of six commercial clinical trials involving one or more of the clinical trial units. Additionaly, three trials are already planned for initiation in NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 6

7 Overall, seven clinical trials were ongoing in 2017, as one trial initiated in 2016 was still open in the first half of Furthermore, the departments were involved in more than 20 late phase clinical trials and therefore several departments have increased capacity. Center for Dermatology Number of feasibilities received Number of trials Number of open trials in year Number of patients enrolled in trials Center for Respiratory Medicine In 2017, 16 feasibilities were received and four clinical trials were allocated to Denmark, within the following indications: Two asthma trials and two Idiopathic pulmonary fibrosis trials. Center for Respiratory Medicine Number of feasibilities received 9 16 Number of trials 5 4 Number of open trials in year no data 8 Number of patients enrolled in trials Center for Infectious Diseases In 2017, the Center for Infectious Diseases received a total of 13 feasibilities for company-sponsored clinical trials. Feasibilities were shared amongst the five departments in the center. The number of feasibilities received in 2017 reflected a broad disease spectrum e.g. HIV, HCV, cystic fibrosis and influenza. Center for Infectious Diseases Number of feasibilities received Number of trials 2 3 Number of open trials in year 2 3 Number of patients enrolled in trials no data no data The major activities in 2017 have been database updates for patient recruitment, preparation for clinical trials, and development of internal procedures. NEXT Bioinformatics In 2015, a network of clinical bioinformaticians was established across the different regions of Denmark with participation from Rigshospitalet, Odense University Hospi- NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 7

8 tal, Aarhus University Hospital, and Aalborg University Hospital, and with coordination from Aalborg. Each bioinformatics unit supports the local university hospital s department within oncology and hematology in aspects of implementing personalized medicine therapy of patients based on genomic profiles. During 2017, Herlev Hospital joined NEXT and the bioinformatics network. In 2017, NEXT Bioinformatics has been involved in various working groups advising the National Genome Center on the implementation of the National Strategy for Personalized Medicine NEXT Secretariat In 2017, NEXT has invested resources in the center coordination of the Center for Oncology & Hematology. Since March 2017, a Senior Network Manager has worked on the formation of new NEXT networks in addition to working as the national center coordinator of Center for Dermatology. The partnership managers associated with the Center for Infectious Diseases and the Center for Respiratory Medicine have ensured the national process of feasibility inquiries in the centers one point of entry, and a national handling of sponsor inquiries. Furthermore, a continuous dialogue with the center departments and relevant companies has taken place. A closer and more formal collaboration between NEXT and Clinical Trials Office Denmark has taken place in Efforts to ensure the future model of NEXT as the merger of NEXT and Clinical Trials Office to a national organization of clinical trials in medicine and medical devices covering all clinical development phases have taken place in Throughout the year, NEXT was mentioned several times in the Danish media as a result of proactive PR initiatives. In total, the proactive PR activities have generated media coverage for NEXT 10 times (3x Medwatch, Erhvervsbladet CSR, 2x Ugeskrift for Læger, Biopeople.dk, 3x Pharma). Annual Accounts In 2017, the private NEXT partners invested a total amount of DKK 37 million in clinical trials in the NEXT centers a combination of direct payments to the hospital departments as well as in-kind expenses of the clinical trials. NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 8

9 Focus in 2018 Our main focus areas in 2018 are attracting trials to Denmark and successfully merging NEXT with Clinical Trials Office Denmark to a national organization in accordance with the Growth Plan for Life Science. Thus, we will continue the effort to make Denmark a leading life science nation in Europe. An additional key focus in 2018 is to strengthen the true national collaboration in all NEXT centers in order to optimize clinical trial performance and ensure that companies experience NEXT as a single point of contact to the Danish clinical research community. NEXT will work to support the execution of early phase commercial clinical trials in Denmark and to optimize start-up times, recruitment goals, and national collaboration. Further, NEXT will work to increase awareness of clinical trial participation among patients through collaboration with relevant patient organizations. Focuses in each center in 2018 The Center for Oncology & Hematology will expand with hematological departments at Herlev Hospital, Righospitalet, Little Belt Hospital Vejle, and Zealand University Hospital. A key focus in the Center for Dermatology will be recruitment of patients to the NEXT derma patient database the goal is to double the number of patients added in the database. The Center for Respiratory Medicine will further improve the collaboration within the center by strengthening personal relationships between NEXT and the individual partners, industry as well as the clinical departments. For the Center for Infectious Diseases, the particular efforts of 2018 will be external marketing activities reflecting the center s capabilities directed towards relevant industry segments. This includes planning of a Roundtable meeting in New York, in collaboration with Invest in Denmark. NEXT NATIONAL EXPERIMENTAL THERAPY PARTNERSHIP 9