Interacting with Industry Dr Kamlesh Sheth, PharmacoMedics Shared - PowerPoint PPT Presentation

Interacting with Industry Dr Kamlesh Sheth, PharmacoMedics

Shared Objectives  One of the objectives for the patient groups is to ensure that there is a safe and effective treatment for condition/s of their interest and such treatment is accessible to all those who need it  One of the objectives of the pharmaceutical industry is to develop safe and effective treatments and ensure there is uptake of the products they develop  This common objective of helping patients is the basis of collaboration between patients groups and the Industry

What else do pharma companies care about?  Shareholder return  Corporate social responsibility  Company reputation and image

Some differences  Patients group: not-for profit organisations, largely run by volunteers to look after patients interest  Industry: legal and ethical obligations to look after share-holders interests (reasonable financial returns on their investment) and run by paid employees  Cultural and organisational differences (more bureaucracy in industry, may not be passionate about your cause)

Some hurdles in collaboration  Lack of understanding of each other (strengths, weaknesses, culture and operational aspects)  Lack of trust (due to lack of understanding)  Regulations (actually are protective) and media

Practical tips Find a suitable partner / company to help your cause   Transparency is key  Find a person who will champion your cause within the pharmaceutical company (limited resources within company and every one is fighting for the resources for their department)  Create a win – win proposal (need to show how the collaboration helps both the organisations)  Each bringing something to the table

Patient groups have  Knowledge of the disease  Knowledge of the impact of the disease on patients and families  Network of patients  Influence with policy makers

Patient groups can help pharma companies  Marketed products and near-market products  Research and development

Patient groups can help with  Identifying unmet medical needs (which condition)  Natural history of disease- registry (observational studies)  Interventional studies (clinical trials) Help with speedy recruitment of subjects for clinical trials Retention of subjects in the clinical trials (reduce drop outs)

Patient groups can help with Identifying the treatment outcomes and experiences most relevant to them (design of the trial)  Regulatory end point in a trial  Clinical endpoint  Surrogate end point

Patient groups can also help with Disease awareness campaign   Motivating physicians (to enroll patients in trials) Motivating academic institutions (to do basic research)   Influencing government policies on research  Influencing regulatory agencies policies and processes (e.g. explaining patient attitude to risk to the agencies)  Influencing HTA agencies (NICE / SMC / CCGs)  Sourcing funding for research

Industry has  Regulatory knowledge  Clinical trial expertise  Project management expertise  Commercialisation expertise

Industry can help with  Designing and conducting clinical trials  Regulatory and ethical approval of clinical trials  Publicising trial results  Regulatory approval of products  Manufacturing/distributing products  Reimbursement processes

Industry can also help with  Funding  Training of patient organisation – e.g. media training

 Rules governing interaction between patient advocacy groups and industry  EFPIA and ABPI CoP

ABPI

EFPIA

Summary  Shared objectives  Both parties bring something to the table and can create a win-win situation  It is possible to work collaboratively and help find new treatment for rare diseases

Thank You Any Questions?