Patient Empowerment – Part One

Patient Empowerment; Why involving patients from early drug development through to launch is a no-brainer!

This month we have a special 2-part series focused on Patient Empowerment, with special guests Laurence Woollard, On the Pulse, Neil Bertelsen, Independent Consultant & Sophie Schmitz, Managing Partner at P4A. This podcast is a MUST to listen too if you are a company looking to successfully develop and commercialize an orphan drug or ATMP

The first part will focus on how do we ensure there is genuine patient involvement at all stages of drug development? What are the challenges and barriers for patients living with a rare disease vs drug developers within the rare/ultra-rare sphere?

The second part will solely focus on the WHY! Why should drug manufacturers, payors, regulators and HTA bodies involve and listen to the patients? What do they bring to the table? We will also dive into the implications of not including the patient voice and use examples of companies that have successfully managed toto do this and the benefits of doing so.

Host: Georgie Rack & Owen Bryant

Guests: Laurence Woollard, On the Pulse, Neil Bertelsen, Independent Consultant, Sophie Schmitz, Managing Partner at P4A

Links:

“Moving beyond box-ticking and lip-service – why patient involvement matters in a new era of ATMPs for rare diseases”

“Setting priorities for bleeding disorders – Final report”

“More than a Top 10: How James Lind Alliance Priority Setting Partnerships transform research, people and organisations”

Laurence Woollard, Owner On The Pulse

Laurence Woollard is founder and director of On The Pulse – an independent, strategic consultancy providing specialist insight to global healthcare providers and multi-agencies on the development and rollout of patient activation campaigns in haemophilia and rare disease. Laurence has extensive patient advocacy experience, having advised on and implemented a broad scope of community awareness, research and educational initiatives for commercial partners and third-sector organisations. He has published numerous thought-leadership articles on the theory and practice of patient empowerment and engagement across leading industry and advocacy platforms as well as peer-reviewed journal manuscripts related to patient education priorities and informed consent for haemophilia gene therapy. Laurence is a member of the Patient Engagement Committee for Beacon (formally Findacure), a UK based charity supporting capacity building of rare and ultra-rare patient groups to drive research and develop treatments. He is also a Patient Voice Partner on the Advanced Therapy Medicinal Product (ATMP) Patient and Public Involvement and Engagement (PPIE) Group by the Gene and Cell Therapy Catapult (supported by Genetic Alliance UK). Laurence is highly driven by his own journey and challenges of living with severe haemophilia and the impact on the family dynamic, to campaign for and effect real change in improvements to quality of life and care for his peers.

Neil Bertelsen, Independent Consultant

Neil Bertelsen is an independent consultant and patient advocate with over 25 years of experience bringing the patient voice to health care decision makers and communicating the science of health care to patients in a way that truly informs their own personal health choices. Neil is passionate about bringing the patient experience and perspectives to decision-makers including industry and health technology assessment (HTA) bodies. Neil is the past chair of HTAi (the global scientific society of HTA) Patient and Citizen Involvement Interest Group. This is an international multi-stakeholder group whose remit is to work alongside HTA organizations and patient organizations to bring patient involvement processes and patient insights and experiences into access decision making processes. Neil is currently on the steering committee of this group. Neil is also a board member of PFMD (Patient Focused Medicines Development), an international consortium of stakeholders working towards more integrated inclusion of the patient voice across the medicine lifecycle. Neil also recently authored the PARADIGM toolkit for patient involvement in Early Dialogues with HTA bodies. During this work, Neil partnered with eleven HTA bodies to develop a range of tools to assist in the involvement of patients during early discussions between HTA bodies and medicine developers. Neil works directly with the patient advocacy community, the industry, and authorities such as HTA agencies to facilitate collaborations and co-creation of approaches to improve access to healthcare and better provision of care. As a facilitator of meetings and advisory boards, Neil has global experience working with multiple stakeholders on demanding issues that require a coordinated response. Neil has worked within the industry, as a member of the Global Market Access team at Bayer Pharmaceuticals, where he worked on bringing the patient voice into access strategies for pipeline products as well as working with regulatory and R&D colleagues on ensuring that evidence generation plans would capture meaningful benefits. Further background Neil was the managing director of several specialist health care consultancies where he developed integrated strategy, education, communication, and engagement programs that considered the patients as an equal partner in the health care landscape. Neil served for six years on the board of trustees of Terrence Higgins Trust, Europe’s largest HIV and sexual health advocacy group. In the 1990s Neil was the editor of Positive Times, the UK’s first national magazine for people with HIV. This pioneering magazine tackled the relevant issues of the day in a time that spanned the era before the advent of combination therapy, through to its successful introduction. Neil has also been editor and deputy editor of several peer review journals in the field of physics and mathematics. He was also a successful television director and producer making science documentaries that brought new science to life for the public and patients. This included producing and directing ‘Horizon’ for the BBC, where he was part of the team awarded a BAFTA (British Academy of Film and Television Awards) for best factual series

Sophie Schmitz, Managing Partner P4A

Sophie is Managing Partner at Partners4Access (P4A), a global consultancy 100% focused on orphan drug access. P4A support the biotechnology and pharmaceutical industry along their launch journey to help secure successful price, reimbursement, and access for orphan drugs. The company has solid partnerships with clients supporting their strategy and operations to effectively ensure launch success. Sophie has worked in a range of disease therapy areas and has industry experience in both medical device and pharmaceutical industries, as such she has developed a solid appreciation of strategic challenges and opportunities facing companies. Through her time in industry, she worked on several key product launches in both strategic planning and implementation. She has worked in global, regional, and local teams which gives her a strong appreciation of real-life challenges in modern day healthcare organizations. Sophie’s has enjoyed a successful 20-year commercial career within consultancy and industry. Prior to setting up Partners4Access, she worked at Alliance, PriceSpective, BMS, ConvaTec, SSL International and Smith & Nephew. In this time, Sophie has been involved in several product launches, organizational changes, and acquisitions.