Welcome to the inauguration of ASCRO

Transkript

1 Welcome to the inauguration of ASCRO Stockholm, May 29 th 2012 The ASsociation for CRO s active in Sweden

2 Öka medvetenheten om vad ett CRO faktiskt är inom läkemedels/biotech/ medtech; myndigheter och akademi..(peter) Feasibility- träsket Utan CRO stannar Sverige! Vi möjliggör att kliniska prövningar genomförs i Sverige faktiskt hela Sverige!! (Helena) Med läkemedelsindustrins nya ansikte är CRO den enskilt största aktören inom kliniska prövningar i Sverige.. (Christina) Vi är neutrala vs. terapi och produkt med fokus på att bygga processer, nätverk och expertis inom kliniska prövningar!! (Sverre)

3 Guest Speakers Katarina Thor, Medical Products Agency Arvid Söderhäll, IVA Dr. Stefano Marini, EUCROF

4 Agenda Welcome and Introduction ti ASCRO Board MPA and ASCRO- a dialogue on clinical trials in Sweden? Interfaces, opportunities and challenges ahead Katarina Thor, Pharmaceutical Inspector, The Swedish Medical Products Agency. The Life Science value chain clinical trials a means for good evidence based and cost effective health care in Sweden ASCRO mutual representation of CROs active in Sweden an opportunity for collaboration and action? Arvid Söderhäll Fil dr, Projektledare Kungl. Ingenjörsvetenskapsakademien (IVA) EUCROF Background and key accomplishments the need for regional alignment of national initiatives Dr. Stefano Marini, Italy President EUCROF ASCRO - Vision, mission and guiding principles, CRO s active in Sweden today an overview and round table discussions on key talking points. Summary and closing remarks ASCRO Board and all. Mingling session - refreshments

5 Building the Foundation - Process Q Formation of a Working Party Draft mission statment and identifikation of key questions Q Soliciting iti input from key stakeholders Q Discussions with potential members Q Constitution of ASCRO Formation of Board Q Inauguration and first member meeting 29 th May 2012 LIF SKL IVA Läkemedelsverket Utbildningsdepartementet QUALITY ETHICS STANDARDS

6 Katarina Thor Arvid Söderhäll Stefano Marini

7 Responding to change A lasting opportunity and an increasing use of CRO s Big pharma going through big changes creating new innovation networks increasing amount of external research (Thomas Hedner, 2012) Swedish research groups stay strong -conditions for the pharma industry are not worse in Sweden than elsewhere (Anders Ekblom, AZ) CRO s engaged in ~60% of clinical trials; a 20% increase in four years (Source LIF, 2012) Number of patients per clinical trial have declined 39 patients engaged per clinical trial in 2011 (peak in 2005; 69) (Source LIF, 2012) ASCRO

8 Staying competitive Sweden Patient poulation that is loyal, stable and adhering Investigators well educated, experienced, honest and organized Strong academic tradition Several leading examples of effective collaboartion in the Nordics e.g. the 4S Trial, UCR - clinical trials, hosting registries Cost efficient (data per invested 1000 ) Health care systems under pressure(!) ASCRO strives to make clinical trials in Sweden more competitive, ii with ihthe highest h levels l of quality, ethics and standards at their heart.

9 A conference on collaboration* Sweden well represented Industry players - Differences are small and can be overcome - Boehringer Ingelheim Regional academic Government - networks - Nordic Trial Securing growth Alliance - regional networks in efficient collaboration Danish Regions clinical research Health Care Single point of initiatives - Ease of contact - Cross functional access to patients Finn Trials, Gothia Forum foras academia, health care and Industry * 3rd Nordic Conference on Clinical Trials, Arlanda April 2012 QUALITY ETHICS STANDARDS

10 Poor recruiters, are we? (MSD case study) If so, we have an opportunity to impact 25-60% of trials conducted in Sweden Gettng the planning right Feasibility Outreach Patients being better informed Study conduct less of an issue Quality in Sweden well above average across Europe CRO s fit for the challenge Managing customer needs and behaviours? Demand from regulators? CRA s of tomorrow? Are we actively driving change and improvement? ASCRO

11 Our response ASCRO strives to make clinical trials in Sweden more competitive, with the highest levels of quality, ethics and standards at their heart. Vision, mission and guiding principles ASCRO

12 Building the Foundation - Process Q Formation of a Working Party Draft mission statment and identifikation of key questions Q Soliciting iti input from key stakeholders Q Discussions with potential members Q Constitution of ASCRO Formation of Board Q Inauguration and first member meeting 29 th May 2012 LIF SKL IVA Läkemedelsverket Utbildningsdepartementet QUALITY ETHICS STANDARDS

13 Stakeholder comments LIF-Karin Eriksson, 27 Maj 2011 Gemensamt intresse i kunskapsspridning, tänk på en code of conduct, gemensamma nämnare mellan olika typer av CROer, delta i arbetsgrupper, samarbeta kring tillämpad klinisk forskning, välkommen entitet för att bjuda in till- och engagera i debatt, arbeta för att höja statusen på CRA-jobbet... IVA-Arvid Söderhäll, Workshop om Kliniska Prövningar 14 November 2011 Projekt om det minskade antalet kliniska prövningar som görs i Sverige för närvarande. Det finns många initiativ för att öka den kliniska forskningen i Sverige, men "inget händer". Behövs nya samarbetsformer för att vända trenden? SKL-Göran Stiernstedt/Gunilla Thörnwall Bergendahl, 25 Oktober 2011 antalet kliniska prövningar minskar i Sverige - hur man kan vända trenden.? Ett gemensamt intresse mellan SKL och ASCRO. Utbildningsdepartementet-Maria Wästfelt/Viktoria Mattson, 11 April 2012 En betydande del av kommande forskningsproppen kommer att beröra LifeScience-området, inklusive industrisponsrade klinisk forskning. Nationellt samordnande organ under diskussion. CRO s en väsentlig spelare välkomnar fortsatt dialog Läkemedelsverket- Gunilla Andrew-Nielsen/Lena Björk,7 Maj 2012 Positiva till att ASCRO bildas, enskilda företag kan bara få svar på individuella frågor, med ASCRO kan vi ta bredare diskussioner eftersom vi driver branschfrågor QUALITY ETHICS STANDARDS

14 se Mission Partnership Improve the conditions Standards d for partnering with CRO s Recruitment of investigators and patients/subjects Advocacy on policy issues Improve business conditions Minimum required standard for the provision of CRO services Provides essential support for its members

15 se Vision ASCRO members are recognized stakeholders and contributors towards the effective management of clinical research/clinical trials in Sweden ASCRO has raised the profile of consultancy in clinical research ASCRO members are associated with a minimum required level of quality of its services, and for employing market leading business ethics

16 se How? Be an active part in the provision of information, in lobbying to influence political, public, industry and other decision makers in matters of importance for its members and those serving the mission of ASCRO Represent and promote the common interests of its members towards sponsors, governmental agencies/bodies, research organizations and similar entities Serve as a facilitator, organize meetings and conferences as means for dialogue between its members and with the Industry Promote training, education and mentoring for CRO consultants Drive the development of tools, techniques and technologies for state of the art recruitment of investigators and patients into clinical trials QUALITY ETHICS STANDARDS

17 Talking Points Interfacing with MPA, SKL and LIF Best practices to achieve quality, cost effective studies and the delivery of final data on time and within budget Best practices for contract processes Best practices that ensure minimal Changes in Scope Best practices for patient recruitment and retention Best practices for proactive study management, as well as the importance of quality of investigators, project managers and monitors

18 Workshop - Christina Forselius Director Clinical Management PPD Scandinavia AB

19 Discussion topics Vilka ska ASCRO vara? Who/What do you want ASCRO to be? Vad vill du att ASCRO ska prioritera? What do you want ASCRO prioritize? Var i vilka sammanhang ska ASCRO finnas representerade? Where in which h fora should ASCRO be represented? Vill du arbeta aktivt t med ASCRO? Isåfall med vad? Do you want to work actively with ASCRO? If so, with what?

20 Thank you for your contribution ti and we look forward to working with you within ASCRO

21 Membership Membership a legal entity providing consultancy services to academia, the pharmaceutical, biotech and medical technology industry; have a quality management system in place (i.e. working instructions, SOPs) be stable and able to contribute to the overall means for ASCRO follow ASCRO s lead words: Quality, Ethics, Standards all members are subsequently reviewed and accepted for membership by the ASCRO Board of Directors Membership is granted for the duration of two calendar years Each Member should nominate one named individual to act as its representative in the association. The membership year will run from 1 July 30 June Membership fees 1-15 employees in Sweden: SEK 5, employees in Sweden: SEK 10, > 50 employees in Sweden: SEK 15,000 In addition there will be an increased fee for the first year of membership for all companies, an entrance fee of SEK 10,000. ASCRO