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CONFERENCE

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5th Pharmaceutical Product Lifecycle Management

An integrated advance towards pharmaceutical product lifecycle management optimisation

24th - 25th January 2012, Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, UK

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Background Info
Day 1
Day 2
Partners
Past Papers
Venue Info
Speakers

Media Partners

Background Info

Key Speakers
• Dr Enrica Alteri, Head Risk Management & Epidemiology, Merck Serono
• Dr Miri Halperin, Global Head of Business Affairs, Actelion Pharmaceuticals
• Hans Hoogkamer, Global Business Affairs, Actelion Pharmaceuticals
• Dr. Jasna Rakic-Connors, Senior Safety Physician, AstraZeneca
• Garreth Duncan, Partner, D Young & Co
• Professor Johanna Gibson, Intellectual Property Law, Queen Mary, University of London
• Professor Howard Stevens, Professor of Exploratory Drug Delivery, University of Strathclyde
• John Bennett, Consultant, Harpum Consulting
• Paul Fitzgerald, Director, Syntropy Medica

• Remco Munnik, RPN Regulatory, Pharma Net
• John Ansell, Owner and Founder, John Ansell Consultancy
• Vishal Gupta, Chief Scientific Officer, CorePharma
• Praful Mehta, Senior Healthcare Analyst, IHS
• Cyrus Choudhury, Practice Leader, Global Market Access, Insight Strategy Advisors
• Mike Rea, CEO, IDEA Pharma
• Elisabeth Berthet-Maillols, Lawyer at the Paris Bar, Armengaud-Guerlain

Research shows that pharmaceutical companies spend approximately 19% of their total revenue on activities that fall under the heading of pharmaceutical lifecycle management (PLM)¹. With many blockbuster drugs drawing closer to the end of their patents, R&D new chemical entity output declining and the current economic climate; the utilisation of product lifecycle management is set to increase as pharmaceutical companies look for ways to optimise revenue.

Join us at Visiongain’s 5th Pharmaceutical Product Lifecycle Management Conference where you will obtain up-to-date practical knowledge on PLM encompassing an array of issues ranging from drug portfolio management, patent protection, regulation, submission and drug safety. In a period when PLM is increasing in popularity and importance, we aim to provide applicable case studies as well as a focus on topical PLM strategies such as Reformulation and Brand Optimisation.

Do not miss this exciting opportunity to further your knowledge in an interactive learning environment while networking with diverse leaders in the PLM sector!

Reasons to register today:

• Gain integrated insight of the entire process of PLM.
• Learn about patent protection strategies.
• Investigate improving the selection of drug candidates
• Analyse challenges involved with increasingly complex regulation and submissions
• Evaluate drug safety throughout PLM
• Optimise introduction, growth and maturity phases in PLM.
• Focus on brand optimising as a PLM strategy
• Analyse the reformulation strategy of PLM
• Network with key leaders in the industry and take advantage of the learning platform

Who should attend?

Presidents, CEOs, Vice-Presidents, CSOs, Directors, Senior Business Developers, Researchers, Consultants and Professors in:
• Product Lifecycle Management
• Portfolio Management
• Research & development
• Business Development
• Strategic Planning
• Licensing
• Mergers & Acquisitions
• Process Chemistry
• Formulation
• Brand Management
• Clinical Research
• Patent Law
• Patent Counsel
• Regulatory Affairs
• Drug Development

Venue:

Thistle City Barbican
Central Street, Clerkenwell
London, EC1V 8DS
Phone: 0871 376 9004 / +44 845 305 8304
Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html

Day 1

Day 1, Tuesday 24th January 2012

09:00 Registration and refreshments

09:30 Opening address from the Chair

Hans Hoogkamer, Global Business Affairs, Actelion Pharmaceuticals

09:40 Portfolio optimisation for the emerging markets: brand birth or brand revitalisation?
Who is paying for medicines in the emerging markets, and how much are they spending?
Which therapies are being financed by government payers and which criteria are used to select them (orphan, oncology, high-mortality, lifestyle, etc.)?
What is the willingness to adopt new treatment modalities in the emerging markets?
What are your key considerations for portfolio design in the emerging markets?

Cyrus Choudhury
Practice Leader, Global Market Access
Insight Strategy Advisors

10:20 Benefit-risk evaluation throughout a drug’s lifecycle: a paradigm shift
• Impact of the new pharma legislation: is the industry ready?
• The technical challenges: an overview of methodologies
• Highlights of the PROTECT project
• How proactively managing safety during a product’s life cycle could be a competitive advantage

Dr Enrica Alteri
Head Risk Management & Epidemiology
Merck Serono

11:00 Morning refreshments

11:20 Strategies for maximising IP protection
• Secondary patent strategies
• Patent term extension strategies
• Data exclusivity and other regulatory protection

Garreth Duncan
Partner
D Young & Co

12:00 Supplementary Protection Certificates
• European Judicial Decision-Making
• "Commercial" Quality
• Research Innovation and Strategy

Professor Johanna Gibson
Professor of Intellectual Property Law
Queen Mary, University of London

12:40 Networking lunch

13.40 Fixed combination products
• Today’s best selling blockbusters
• Where fixed combinations are branching out therapeutically
• Overall trends

John Ansell
Owner and Founder
John Ansell Consultancy

14:20 Managing drug safety throughout product pipeline and lifecycle
• Integrating signal detection using totality of information
• Implementing proactive safety risk management
• Understanding benefit-risk assessment and decision making
• Best practices for developing transparency with safety governance committees

Dr. Jasna Rakic-Connors
Senior Safety Physician
AstraZeneca

15:00 Afternoon refreshments

15:20 Increasing importance and impact of drug safety programs on a product's LCM

Chair: Hans Hoogkamer, Global Business and Science Affairs, Actelion Pharmaceuticals
Panelists: Jasna Rakic-Connors, AstraZeneca
Paul Fitzgerald, Syntropy Medica
Enrica Alteri, Merck Serono

16:00 Innovative lifecycle and portfolio management strategies: create value for patients and pharma
• Lifecycle and portfolio management: how do they really create value?
• Why science is an important driver of corporate strategy
• How can innovation in science and corporate strategy be linked?
• Efficient portfolio planning in a resource constrained environment

Dr Miri Halperin Wernli & Hans Hoogkamer
Global Business and Science Affairs
Actelion Pharmaceuticals

16:40 Closing remarks from the Chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day 2, Wednesday 25th January 2012

09:00 Registration and refreshments

09:30 Opening address from the Chair

Remco Munnik, Regulatory Information Director, Asphalion

09:40 Leveraging Novel Drug Delivery Technologies to Drive Innovation and Differentiation
• Controlled Release (CR) History, Market, and Economics
• Health of Pharmaceutical Industry and Economic Indicators
• Product Innovation Through Design and Mechanistic Changes
– Fundamentals and Design of Oral CR Products
– Life-Cycle Management
– Mini Case Study
• Looming Patent Losses and Life Cycle Management
• Generic Pharma Perspective and Opportunities

Vishal Gupta
Chief Scientific Officer
CorePharma

10:20 Portfolio Management: crucial areas
• The varying requirements for industry
• Drug discovery and development phases
• Market access and commercial route of new drugs
• Effective resource optimisation.

John Bennett
Consultant
Harpum consulting

11:00 Morning refreshments

11:20 Lifecycle management begins at phase II
• Evaluating commercial probability of success in early-stage portfolios
• Evaluating strategic options in phase II
• Roadmapping product launch options
• What ‘great’ looks like: case studies of brands that managed early

Mike Rea
Chief Executive Officer
IDEA Pharma

12:00 Biosimilars: patent protection issues
• Why biotech patents are difficult to enforce?
• Could biotech patents be easier circumvented compared to chemical product patents?
• Biotech product and SPC : how to define a "biotech product" and how to apply the "one SPC per product" rule?
• What about the USA legislation on follow-on biologics ("FOBs")?

Elisabeth Berthet-Maillols
Lawyer at the Paris Bar
Armengaud-Guerlain

12:40 Networking lunch

13:40 Electronic submissions: regulatory perpspective
• Update on electronic submissions
• Use of eCTD
• Case study

Remco Munnik
Regulatory Information Director
Asphalion

14:20 Understanding barriers towards effective lifecycle management (LCM)
• Overview of current pharmaceutical environment
• Key Challenges in the LCM landscape
• How to navigate those challenges
• Conclusions and Summary

Praful Mehta
Senior Healthcare Analyst
IHS

15:00 Afternoon refreshments

15:20 Brand leverage methodologies
• Overview
• Preparing the product
• Defining the brand
• Resources
• Examples

Paul Fitzgerald
Director
Syntropy Medica

16:00 Chair’s closing remarks

16:10 End of Conference

Partners

Media Partners:

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 5th Annual Pharmaceutical Product Lifecycle Management Conference, please contact:
Piyush Patel, +44 (0)20 7549 9961
piyush.patel@visiongainglobal.com

Past Papers

Speaker presentations are free to paying delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase.

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Venue Info

Click here for Google maps.

Transport links:

London Underground
You can access this venue via the Northern Line (black), Metropolitan (purple), Circle (Yellow) and Hammersmith & City (Pink) line.

From Old Street Tube station (10 mins walk)
Take exit 8 out of Old Street station and walk up city road until you reach Moorfields Eye Hospital. Turn left after the hospital down Cayton Street and cross over Bath Street into Lever Street opposite. The Thistle City Barbican is 350 yards up this road on the right hand side.

From Barbican Tube station (10 mins walk)
Turn left out of Barbican station down Goswell Road. Turn right on to Old Street and take the first left up Central Street. Walk up this road and you will see The Thistle City Barbican to your right.

Heathrow Airport to the Thistle Barbican
Take the Heathrow express to Paddington national rail Station. Walk to Paddington underground station and take the Circle line (yellow) or Hammersmith & City line (pink) towards Kings cross St Pancras or Baker Street. Alight at Barbican and follow the above directions.

Gatwick Airport to the Thistle Barbican
Take the First Capital connect service towards Bedford Rail Station. Alight at London Bridge, walk to London Bridge underground station and take the northern line (black) towards Edgware or High Barnet. Alight at Old Street and follow the above directions.

Accommodation:

The Thistle City Barbican
Central Street
Clerkenwell
London
EC1V 8DS
Phone: 0871 376 9004 / +44 845 305 8304
Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/location/index.html

How to book:
Guests to make their own reservations, by calling:
UK Telephone Number: 0871 977 0218
International Telephone Number: +44845 073 7154
E-mailing: groupsadmin.citybarbican@thistle.co.uk
Reference Number: VISY240112
Guests should quote the booking reference when making their booking in order to guarantee they receive the group rate.
Guests to provide credit card details on booking in order to guarantee their accommodation
The above sleeping rooms will be held until Tuesday 17th January 2012. After this date reservations will only be taken on a space and rate availability basis.

Travelodge - London City Road Hotel
7-12 City Road
London
EC1Y 1AE
Tel: 0871 984 6333
Fax: 0207 628 2503
http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340

Jury's Inn Islington
60 Pentonville Road
Islington
London
N1 9LA
Tel: +44 (0) 207 282 5500
http://londonhotels.jurysinns.com/jurysinn_islington

London City Holiday Inn Express
275 Old Street
London
EC1V 9LN
Tel: +44 (0) 207 300 4300
http://www.hiexpress.com/hotels/gb/en/london/lonct/hoteldetail

For further information contact details:

Sarah Nicoise
Conference Co-ordinator
Tel: +44 (0) 20 7549 9988
Fax: +44 (0) 20 7549 9930
Email: sarah.nicoise@visiongainglobal.com

Carrie Lancaster
Conference Manager
Tel: +44 (0)20 7549 9978
Fax: +44 (0) 20 7549 9930
Email: Carrie.Lancaster@visiongainglobal.com

Sara Peerun
Commercial Director
Tel: +44 (0) 207 336 6100
Fax: +44 (0) 207 549 9930
Email: sara.peerun@visiongainglobal.com

Speakers

Enrica Alteri

Head Risk Management & Epidemiology

Merck Serono

Dr. Enrica Alteri received her Medical Doctorate from the University La Sapienza in Rome, Italy. Dr. Alteri completed a post-doctoral Fellowship in the Department of Immunopathology of the National Cancer Institute (USA). A Diploma in Pharmaceutical Medicine completed Enrica’s academic education.
Enrica gained extensive Pharmacovigilance experience in Ciba and Novartis, as Safety Medical Expert responsible for products in various therapeutic areas. Among them is worth mentioning Coartem/Riamet, the current WHO first-line treatment against malaria, the safety profile of which was established by Enrica’s Team.
Enrica has been Head of the Risk Management & Epidemiology Department in Merck-Serono since 2010.
Dr. Alteri has been a member of the European Course of Pharmaceutical Medicine faculty (ECPM in Basel) and of the CIOMS Working Group on Pharmacovigilance in Resource-poor Countries.
Garreth Duncan

Partner

D Young & Co

Garreth Duncan is a patent attorney and partner based at D Young & Co's Southampton office, and a member of the firm's Biotechnology, Chemistry & Pharmaceuticals team.
Garreth's 14 years in the patent profession, both in private practice and as an in-house attorney in Pfizer's European Patent Department, have focused strongly on pharmaceutical patents, including new chemical entities, formulations, further medical uses, combinations and processes. Garreth has drafted and prosecuted pharmaceutical patent applications worldwide, conducted opposition proceedings before the European Patent Office, provided validity and freedom-to-operate opinions on pharmaceutical and other chemical products, and advised on a wide range of other intellectual property matters. He also has particular experience in obtaining Supplementary Protection Certificates and other forms of patent term extension.
Hans Hoogkamer

Global Business Affairs

Actelion Pharmaceuticals

Hans started his career in 1982 working for the Dutch Forensic Institute in The Hague.
After obtaining his university degree in Bio-Pharmaceutical Sciences from the University of Leiden in 1988, he joined Roche working in Global Clinical Research.
Since then, he as held various positions in international pharmaceutical industry, including Johnson & Johnson until joining Actelion in 2000.
In his current role, he has strategic responsibilities for all aspects of a drug's life cycle including development and commericalization. Hans is a member of Actelion’s portfolio planning group.
John Ansell

Owner and Founder

John Ansell Consultancy

John Ansell has been a pharmaceutical industry consultant since 1989, following 20 years in the industry in international marketing and business development. He has advised over 140 clients and is the author of 50 pharma publications, including several articles on combination products. He has previously presented on combination products in Japan, the UK and the US, where he has also chaired two conferences on the topic.
Remco Munnik

Regulatory Information Director

Asphalion Spain

Remco Munnik has a Bachelor degree in a study of Management, Economics & Law.
He has over ten years experience in European submission procedures and electronic submission and regulatory data management.
In 2011 Remco moved from the Netherlands to Barcelona and is currently chairperson of the EGA working group for eCTD.
He is member of the TIGes (Telematics Implementation Group for electronic submission and ICH Implementation) and several sub-groups to discuss the development and harmonisation processes for eCTD in the EU, as well as the electronic requirements for the implementation of the pharmacovigilance legislation.