FPM Conversation: In Vitro Diagnostics – Companions or Not?

Date – Wednesday 14 July 2021
Platform – Webinar hosted on Zoom

This meeting discussed and debated the rapidly evolving IVDs landscape.

There is increasing adoption of biomarkers and diagnostics/companion-diagnostics in clinical trials and clinical practice, leading to an ever-rising collaboration within and between pharmaceutical companies and in vitro diagnostic medical device manufacturers.

It is important that pharmaceutical physicians and scientists, across a variety of different roles, have an understanding of how the IVD regulatory landscape is continuing to rapidly change and, critically, how Pharmaceutical Companies are adapting by developing new strategies to ensure effective collaborations in the IVDs arena.

This FPM Conversation aimed to enhance attendees’ awareness of the major elements of relevant IVD regulation(s) and provide expert perspective on important strategic and practical aspects of developing and implementing IVDs in support of patients.

Enabling a Greater Diversity of People in Clinical Trials

Date – Thursday 18 March 2021
Platform – Webinar hosted on Zoom

This online meeting discussed and debated scientific and social issues surrounding enabling a greater diversity of people in clinical trial programs, and the implications for Pharmaceutical Medicine professionals who design study protocols/programs.

Bringing together an expert panel with extensive experience in pharmaceutical medicine clinical trial program strategy and design, this conversation aimed to further explore areas such as genetic PK-PD heterogeneity, appropriate inclusion of ethnically diverse populations and less commonly studied patients & diseases.

Pharmaceutical Medicine Liability – “Do I Need a Get Out of Jail Free Card”?

Date – Thursday 17 September 2020
Platform – Webinar hosted on Zoom

Continuing the popular FPM Conversation Series, this videoconference meeting discussed and debated some of the common pitfalls and legal liabilities (civil and criminal) potentially facing physician/scientist professionals working in Pharmaceutical Medicine and how attendees could avoid them!

Bringing together an expert panel with extensive hands-on experience in pharmaceutical medicine personal and professional legal risk minimisation, this FPM Conversation explored questions such as:

• Is there anything I should be especially concerned about legally regarding products developed or marketed to treat COVID-19?
• Have I been writing emails/slides “appropriately”?
• Am I at legal risk as a supervisor/manager?
• Does the UK QP have new liabilities post-Brexit?
• Oh Gosh – I’ve been deposed! – what does this mean for me?

Panellists

Event chair
Dr Craig Hartford

Biotechs/Startups – a Pharmaceutical Medicine Perspective

Date – Wednesday 8 July 2020
Platform – Webinar hosted on Zoom

Moving the popular FPM Conversation Series into the virtual environment, this well-attended videoconference meeting debated the issues and opportunities, and looked at practical solutions, surrounding the challenges of working in a Biotech/Start-Up.

Bringing together a panel of medical and non-medical leaders from start-up/biotech companies and venture capital organisations, the conversation encompassed the following topics:

• What are the main differences between working in big pharma and a start-up/biotech?
• How can you overcome challenges of working in a small company?
• How does a start-up/biotech convince investors to invest?
• What are some of the regulatory, scientific, legal, compliance and logistical challenges?
• How can you best handle acquisitions?
• How should you support and get the most out of academics?

Panellists

Dr Emma Harvey FFPM
Global Head of Medical Affairs at F2G Ltd

Dr Shahzad Malik
Founding General Partner at Advent Life Sciences

Dr Duncan McHale
Clinical geneticist and early drug development expert

Dr Eliot Foster
Chief Executive Officer at F-star Therapeutics Ltd

Event chair
Dr Craig Hartford
Independent pharmaceutical physician and committee member of the FPM Policy and Communications Group

The Commercial and Medical Partnership

A Marriage Made in Heaven, or Fraternising with the Enemy?

Date – Tuesday 11 February 2020
Venue – Voysey Room, Mary Ward House Conference and Exhibition Centre, 5 – 7 Tavistock Place London, WC1H 9SN

Event description

The role of Medical Affairs has evolved considerably in the last two decades, but one thing has not changed: Medical and Commercial often fail to engage fully and Medical Affairs can play a “husband/wife of…” role rather than being an equal partner in this “marriage”.

A recent survey of Senior Medical and Commercial leaders shows that a lack of mutual trust, failure to understand each others’ roles, inability to work as complementary partners and lack of good communication underpin the key challenges in this relationship.

And yet there may be a better way – just as in any marriage getting the basics right can help; there is an opportunity to step up the Medical contribution from one of “Support Function” to a true “Strategic Partner”.

Bringing together a panel of senior Commercial and Medical Leaders this FPM conversation covered the following topics:

• Developing shared strategy with commercial partners
• Executing against the strategy
• Execution and measuring added value
• The leadership mind-set and language necessary to be a strategic partner.

Panellists

Dr Bobby Mulrooney
General Manager UK & Ireland, Portola Pharmaceuticals

Dr Rav Seeruthun
Medical Director, Roche UK

Event photos

Trust and transparency in the pharmaceutical industry: How far have we come?

Date – Tuesday 10 September 2019
Venue – Dickens Library, Mary Ward House Conference and Exhibition Centre, 5 – 7 Tavistock Place London, WC1H 9SN

Event description

It is 2019 and the pharmaceutical industry still struggles to be trusted. Reports of falsifying data, bribery and corruption, price hikes and manipulative patent litigation have steadily soured the public’s view of the pharmaceutical industry. Yet, the drugs that pharmaceutical companies produce save millions of lives a year and improve the lives of millions more. So, what is going wrong?

Pharmaceutical companies have made only modest progress in improving trust over the last few years. The Edelman ‘Trust Barometer’ shows that, globally, public trust in the industry has edged up marginally from 55% in 2015 to 57% in 2019. In the UK the figure is 50% in 2019. Why is it not higher for an industry whose business is saving lives?

• How can the industry restore its credibility in the eyes of patients, policymakers and the rest of the taxpaying public?
• Are prices too high? What can we do about it?
• Is moving from clinical medicine to a job in industry still thought of as moving to the ‘dark side’? Why?
• ‘Patient-centricity’ and ‘patient engagement’ How can it make a real difference? Can familiarity breed trust?
• Do companies adequately and accurately warn patients and clinicians about the risks as well as the benefits of taking medicines?

These are key questions that the pharmaceutical industry continues to grapple with, as trust and transparency holds more weight among the public than ever before. We, as doctors working in all aspects of the industry – companies, regulators, academia – must do more, in the interests of patients and wider society. We must strive for greater engagement and understanding, and further development of appropriate regulations and guidelines.

In this FPM ‘conversation’ event we brought together a panel of leaders in this field to discuss issues around public trust and transparency:

Mike Thompson, Chief Executive, ABPI
Alastair Benbow, Chief Development and Medical Officer, Norgine
Fiona Fox, CEO, Science Media Centre