Risk Management Colloquium 2010

The 5th Pope Woodhead Risk Management Colloquium was held at King's College, Cambridge from 30th June to 1st July 2010. Senior clinical development, safety, risk and regulatory staff were invited to attend this private round table event, along with senior representation from the European Medicines Agency (EMEA). Topics discussed included personalised risk of medicines, benefit risk communication, and the regulatory agencies' perspective. There were also updates on the US risk evaluation and mitigation strategies (REMS) and the evaluation of risk minimisation plans.

We intend to arrange the 6th Pope Woodhead Risk Management Colloquium for the summer of 2011, and requests for information should be addressed to either:
Dr Swapu Banerjee, Board Member and Head of Development Consulting, or to
Marianne Cassidy, Commercial Development Manager.

Risk Sharing Masterclass 2010
A 1-day masterclass on risk sharing/patient access schemes
Date: 29 June 2010 Location: The Office of Health Economics, London

Pope Woodhead’s Risk Sharing Masterclass, in partnership with the Office of Health Economics, was held on the 29th June 2010 and was well-attended by people from 24 companies. Key insights were provided into the background and future context for payer risk sharing as well as the process for evaluation, development and implementation of patient access schemes (PAS) in the UK.

A combination of theory and interactive breakout sessions, gave clients the opportunity to network, learn from each other and engage directly with our expert facilitators, while case studies of existing schemes illustrated important principles and success factors. Our approach appeared to work well, with 85% of attendees saying they would recommend the course to their colleagues.

Other client comments highlighting the value of our Risk Sharing Masterclass:

“A good step by step process - high level but also very practical”,
“Provided a logical process to develop a successful PAS”,
“It was useful sharing experiences”,
“Great comprehensive overview”.

Using our extensive experience in risk sharing, Pope Woodhead has led the development of two PAS schemes approved and implemented during 2009/10. We continue to work actively with clients in this area on a number of schemes due to launch over the coming months.

Risk Share poll

There is still time to participate in our Risk Share poll. Click here to begin.

Market Access Summit - 19th March 2010

On 19th March Pope Woodhead hosted its annual Market Access Summit at Downing College, Cambridge. The Summit is now in its third year and provides a recognized high level forum for senior industry leaders to discuss key issues, trends and proposals relating to market access. This year’s presentations focused on organizational structure for optimal market access, methodologies to discuss value with payers (beyond cost effectiveness), the role of real-world data in market access strategy, and the current proposals for centralizing relative efficacy/effectiveness evaluation in Europe. Summit participants expressed diverse views on many of these topics, and often the solutions proposed required a fresh approach by the industry. This is certainly reflected in Pope Woodhead’s own experience as we continue to work with several clients in each of these areas.

Click here to register your interest in future Pope Woodhead events.

Pope Woodhead welcomes
Cambridge University Masters students
16th March 2010

Over the past four years Pope Woodhead & Associates has built a strong relationship with the Masters in Bioscience Enterprise (MBE) programme, the University of Cambridge’s postgraduate life science business course. This course is based at the Institute of Biotechnology, and has a close affiliation with the Judge Business School. Read more.....

Risk Sharing & Value-Based Pricing & Reimbursement Models
Bratislava 15th-16th April 2010

On 14th April we will host and run a half-day pre-conference workshop on Innovative pricing agreements and risk sharing schemes, and on 16th we will present a UK case study about designing and implementing a successful and efficient patient access scheme. Click here for more details.

NICE approves Yondelis^® patient access scheme
22nd December 2009

Yesterday NICE approved the use of PharmaMar’s Yondelis (trabectedin) for the treatment of soft tissue sarcoma. The approval is conditional on the implementation of a patient access scheme (Yondelis PAS) through which the first five treatment cycles are funded by the NHS and additional treatment is funded by PharmaMar. Pope Woodhead is proud to have collaborated with PharmaMar in the development and implementation of the scheme.

ISPOR 12th Annual European Congress

Dr François Lucas, Head of Insights and Strategy at Pope Woodhead, will present a poster entitled 'The usefulness and challenges of patient access (risk sharing) schemes in the UK'. This poster presents the results from primary research with stakeholders from the UK NHS and pharma companies, highlighting the issues they face when assessing and implementing these schemes, and suggesting evaluation criteria. You are warmly invited to meet François at POSTER SESSION I on Sunday, 25th of October, 12:00-18:30. Click here to visit the ISPOR website.

Please come and see us or e-mail francois.lucas@popewoodhead.com to set up a meeting

International Society of Pharmacovigilance (ISoP)

International Society of Pharmacovigilance (ISoP) conference 'From pharmacovigilance to risk management' on 7-9 October in Reims, France. Dr Steve Mayall, senior consultant in the Development Consulting practice, will be presenting a poster entitled 'Significant challenges remain for the optimum implementation of EU Risk Management Plans'. This poster highlights the key challenges facing pharmaceutical/biotech companies and regulatory authorities concerning creating, reviewing and implementing EU-RMPs. Visit the ISoP website.

Please come and see us!

Pharmacovigilance and risk management

Pharmacovigilance and risk management conference in Prague on 24 and 25 November. This event will focus on overcoming current controversies in pharmacovigilance and risk management to develop successful RMPs. Dr Swapu Banerjee, Pope Woodhead's Head of Development Consulting, will be speaking about novel methods of monitoring the risk management plan, including:
• user testing of tools
• post-marketing tool evaluation
• how to keep health authorities satisfied
• evaluation of the RMP as a whole
• section 8.4 of the PSUR and predicting evaluation metrics.
Click here for more information on the conference.

Risk-sharing and value-based pricing
& reimbursement models

Risk-sharing and value-based pricing & reimbursement models conference in Boston, Massachusetts on 6 and 7 October. This conference will cover the need for more innovative pricing and reimbursement agreements to help balance the conflicting objectives of pharmaceutical and medical technology manufacturers, payers, health technology assessors, physicians and patients. Andrew Hobbs, Pope Woodhead's Managing Director, will be speaking at the conference, covering the potential synergies between risk sharing and risk management when dealing with uncertainities in real world effectiveness and real world safety.
Click here for more information on the conference.

HOT OFF THE PRESS!!!

In 2007 PW introduced our house journal Axiom, which aims to provide an informative and useful introduction to some of the key issues facing the Pharma, Biotech and Medtech industry, and illustrates our thinking and experience on these topics. Axiom Digest includes a selection of articles from previous editions of Axiom. Our back catalogue of Axiom is available below to read online or download. You can also register your interest in receiving future editions of Axiom, in hard copy or electronic format by following the link.

To register for future editions of Axiom click here.

PW and Cambridge Business School

Pope Woodhead has a long-standing relationship with the Institute of Biotechnology at the University of Cambridge. For the 3rd year running, students from the Masters in Bioscience Enterprise joined PW to work on their research projects. This year, Mike Hayoun looked into the professional development of physicians working within the pharmaceutical industry; Grant Jackson investigated the impact of ‘real-life’ data on the assessment of medicines; and Carol Walton assessed the impact of the European RMP. Findings from each intern’s dissertation will appear in the next issue of Axiom.

NICE approve patient access scheme

NICE recently announced their intention to approve a patient access scheme for Celgene’s Revlimid in multiple myeloma (final decision in April 2009) – a move considered to be a win-win for all stakeholders. Pope Woodhead are pleased to have worked alongside Celgene to achieve this.

Risk Management Colloquium 2009

The Pope Woodhead 3rd annual Risk Management Colloquium was held on 2nd July 2009 at Downing College, Cambridge University. This popular event was was attended by 15 participants from pharmaceutical companies, and started with dinner the previous evening. A concise report of the day’s discussion is to be distributed to attendees at a later date.

Topics covered included:
•	REMS in practice (Risk Evaluation & Mitigation Strategies)
•	Frameworks for implementation and evaluation of RMPs (Risk Management Plans)
•	How stakeholder decision making may be improved/evaluated
•	Harmonisation of global risk management
•	The relationship between corporate and developmental risk.

Click here to register your interest in future Pope Woodhead events.

Axiom 3rd edition NOW AVAILABLE!

The 3rd edition of Axiom, our house journal, is now available.
Topics include:
- The ‘who, what, when and how’ of local EU payer engagement
- Registries: Real-world knowledge for competitive advantage
- Has clinical trial disclosure helped the average patient? An industry perspective
- Focus on commercial innovation and risk sharing.

Click here for the Spring 2009 edition of Axiom.

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