QUESTIONSConference on 4th Annual Pharmaceutical PLM (Pharmaceutical)
Venue: BSG Conference Centre
Location: London, United Kingdom
| Event Date/Time: Mar 03, 2010 | End Date/Time: Mar 04, 2010 |
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Key Speakers
• Jonathan Deutsch, Director Pharma Development Safety, Licensing and Early Development, Hoffmann-La Roche
• Maciej Gil, Medical & Regulatory Director & CIS, Eli Lilly Russia
• Mario Maio, Head of Formulation & Process Development , Merck Serono
• James Down, Vice President, Product Lifecycle Management, Beckton Dickinson
• Ralph C. Schimmer, Global Head Drug Safety Sciences - Metabolism and Cardiovascular, Hoffmann-La Roche
• Vishal K. Gupta, Director Pharmaceutical R&D, Covidien
• Alok Aggarwal, Co-Founder and Chairman, Evalueserve
• Alexandra C. Gruber, Director Business Development & Marketing, BIOCRATES Life Sciences
• Mike Rea, Chief Executive Officer, IdeaPharma
• Peter G Nielsen, Executive Vice President of Pharmaceutical Development and Chemistry Manufacturing & Control, Lifecycle Pharma
• Nigel Stoate, Partner, Taylor Wessing
• Paul FitzGerald, Owner, Syntropy Medica
Pharmaceutical and biopharmaceutical companies are under severe pressure to improve product pipelines, accelerate time to market, and improve margins on existing products, while maintaining strict adherence to quality principles and regulatory requirements. It is imperative that pharmaceutical and biotech companies address these business challenges to stay competitive, increase revenue, enhance profit, and reduce the risk of noncompliance.
4th Annual Pharmaceutical PLM Conference will feature keynote addresses, presentations, case studies and interactive discussions from development to commercialisation, quality control, supplier issues, regulation and inspection. Please be sure to register your participation amongst the industry's elite for this intensive two-day of learning, networking and exploiting business opportunities.
By attending this conference, you will:
• Hear from R&D, design, engineering and technical professionals and executives
• Recognise the potential benefit of PLM in drug development process
• Learn how to achieve target quality profiles and comply with regulatory requirements
• Find out how partnerships with technology vendors can maximise value through an efficient PLM implementation
• Eliminate inconsistent branding, improve brand communication and enable brand growth
• Gain knowledge of how to manage PLM in a patent environment
Who should attend:
Vice/Presidents, Directors, Heads of:-
• Lifecycle Management
• Portfolio Management Research & Development
• Strategic Planning Partnering
• Licensing & Alliance
• Process Chemists, Pre-Formulation
• Formulation Clinical Scientists
• Clinical Investigators
• Brand Management
• Patent
• Regulatory Affairs
Target audience - industry
Pharmaceutical companies, biopharmaceutical
companies, software vendors, PLM vendors, Analysts, Consultants
Day 1
Day 1, Wednesday 3rd March 2010
09:00 Registration and refreshments
09:30 Chair’s opening remarks
09:40 Evaluating the potential benefit of PLM in drug development process
• Accelerating new drug development, introduction, and commercialisation
• Prioritising new product development and introduction
• Managing collaboration with external supply and service networks
Mario Maio
Head of Formulation & Process Development
Merck Serono
10:20 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
IdeaPharma
11:00 Morning refreshment & networking session
11:20 Developing differentiation, innovation, and long-term growth strategies with lifecycle technologies
• Brief introduction on fundamentals of oral controlled release
• Product innovation through mechanistic changes in product design
• Examining drug delivery technologies as growth driver
• Big pharma and generic company perspective
• Looming patent losses for big pharma
• Examining how emerging markets drive growth
Vishal K. Gupta
Director, Pharmaceutical R&D
Covidien
12:00 Maximising ROI through patent protection strategies
• Understanding how to effectively reassess, develop and exploit patent protection strategies
• Enhancing market exclusivity and revenue returns over the lifecycles of new drugs
• Successful case scenarios on strategy application
Nigel Stoate
Partner
Taylor Wessing
12:40 Lunch
13:40 Enhancing life cycle management through effective pharmaceutical licensing strategies
• Examining the licensing process in pharmaceutical industry
• Developing effective strategies while managing costs effectively
Jonathan Deutsch
Director Pharma Development Safety, Licensing and Early Development
Hoffmann-La Roche
14:20 Effective brand optimisation
• Development of intangible value
• Planning for PLM - when is early? And when is too late?
• Best practice methodologies
• Yo-yo marketing – the customer IS king
• Putting the ‘life’ in lifecycle
Paul FitzGerald
Owner
Syntropy Medica
15:00 Afternoon refreshments & networking session
15:20 Panel discussion: Why new developments are important in injectable delivery today?
Panelists will identify and understand the growing importance of injectable drug delivery on self-administration, drug formulations, drug-device development, and therapeutic treatment protocols. If you want to submit a question, please email it to info@bharatbook.com
16:00 Reformulation using new technologies as a strategy to lifecycle management
• Examples on how new technology and patent protection can maximise the value of a product.
• How the clinical benefit needs to be balanced to the clinical and regulatory requirements.
• The importance of a timely lifecycle management strategy
Peter G Nielsen
Executive Vice President of Pharmaceutical Development and Chemistry Manufacturing & Control
Lifecycle Pharma
16:40 Chair’s closing remarks
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 2
Day 2, Thursday 4th March 2010
09:00 Registration and refreshments
09:30 Chair’s opening remarks
09:40 Mergers and acquisitions: The need for PLM tools
• How does it affect the longer term delivery by the vendors to the customers?
• Harmonising the product portfolio and enhancing visibility across the value chain
• Managing portfolio of drug candidates – from research to development and beyond
Alok Aggarwal
Co-Founder and Chairman
Evalueserve
10:20 Optimising life cycle management through efficiency measurements
• Explaining why is there a need to measure
• Identifying appropriate efficiency measurement tools
• Defining the challenges
• Exploring some best practice examples
Alexandra C. Gruber
Director Business Development & Marketing
BIOCRATES Life Sciences
11:00 Morning refreshment & networking session
11:20 Panel Discussion: - The role of partnership in implementing PLM software
Panelists will identify and understand how partnerships with technology vendors can maximise value through an efficient PLM implementation. If you want to submit a question, please email it to info@bharatbook.com
12:00 Managing brands across the four phases of product lifecycle
Ihab Dimian
Regional Marketing Director
Abbott Laboratories*
12:40 Lunch
13:40 Evaluating technical and integration issues in PLM
• Understanding the implementation process of PLM solutions
• Customisation and configuration issues within the pharmaceutical environment
• Configurable packages versus customised PLM projects
• Discuss successful PLM strategies
James Down
Vice President, Product Lifecycle Management
Beckton Dickinson
14:20 Presentation to be announced
Marc Dawkins
Partner
Simmons & Simmons
15:00 Afternoon refreshments & networking session
15:20 Case study - How the integration of Product Life-cycle Management and manufacturing execution systems (MES) closes the loop between manufacturing and design, enabling rapid innovation cycles while at the same time managing the risk, increasing product quality, maximising production yields and decreasing costs.
Zadeo Cimarosti
Manager, Chemical Development
GlaxoSmithKline Italy*
16:00 Managing drug safety throughout product lifecycle management
• Understanding the benefit-risk decision making by prescribers and patients
• Adaptative design for RMP/REMS based on their outcome
• Best practices for developing transparency with safety governance committees
Ralph C. Schimmer
Global Head Drug Safety Sciences - Metabolism and Cardiovascular
F.Hoffmann-La Roche
16:40 Complying with regulatory requirements in Pharmaceutical life cycle management
• Analysing the increasing pressure by regulatory bodies to ensure drug safety
• How FDA requirements and EMEA requirements differ?
• Identifying and reducing risks of non-compliance through PLM
Maciej Gil
Medical & Regulatory Director & CIS
Eli Lilly Russia
16:50 Chair’s closing remarks
17:00 End of conference
• Jonathan Deutsch, Director Pharma Development Safety, Licensing and Early Development, Hoffmann-La Roche
• Maciej Gil, Medical & Regulatory Director & CIS, Eli Lilly Russia
• Mario Maio, Head of Formulation & Process Development , Merck Serono
• James Down, Vice President, Product Lifecycle Management, Beckton Dickinson
• Ralph C. Schimmer, Global Head Drug Safety Sciences - Metabolism and Cardiovascular, Hoffmann-La Roche
• Vishal K. Gupta, Director Pharmaceutical R&D, Covidien
• Alok Aggarwal, Co-Founder and Chairman, Evalueserve
• Alexandra C. Gruber, Director Business Development & Marketing, BIOCRATES Life Sciences
• Mike Rea, Chief Executive Officer, IdeaPharma
• Peter G Nielsen, Executive Vice President of Pharmaceutical Development and Chemistry Manufacturing & Control, Lifecycle Pharma
• Nigel Stoate, Partner, Taylor Wessing
• Paul FitzGerald, Owner, Syntropy Medica
Pharmaceutical and biopharmaceutical companies are under severe pressure to improve product pipelines, accelerate time to market, and improve margins on existing products, while maintaining strict adherence to quality principles and regulatory requirements. It is imperative that pharmaceutical and biotech companies address these business challenges to stay competitive, increase revenue, enhance profit, and reduce the risk of noncompliance.
4th Annual Pharmaceutical PLM Conference will feature keynote addresses, presentations, case studies and interactive discussions from development to commercialisation, quality control, supplier issues, regulation and inspection. Please be sure to register your participation amongst the industry's elite for this intensive two-day of learning, networking and exploiting business opportunities.
By attending this conference, you will:
• Hear from R&D, design, engineering and technical professionals and executives
• Recognise the potential benefit of PLM in drug development process
• Learn how to achieve target quality profiles and comply with regulatory requirements
• Find out how partnerships with technology vendors can maximise value through an efficient PLM implementation
• Eliminate inconsistent branding, improve brand communication and enable brand growth
• Gain knowledge of how to manage PLM in a patent environment
Who should attend:
Vice/Presidents, Directors, Heads of:-
• Lifecycle Management
• Portfolio Management Research & Development
• Strategic Planning Partnering
• Licensing & Alliance
• Process Chemists, Pre-Formulation
• Formulation Clinical Scientists
• Clinical Investigators
• Brand Management
• Patent
• Regulatory Affairs
Target audience - industry
Pharmaceutical companies, biopharmaceutical
companies, software vendors, PLM vendors, Analysts, Consultants
Day 1
Day 1, Wednesday 3rd March 2010
09:00 Registration and refreshments
09:30 Chair’s opening remarks
09:40 Evaluating the potential benefit of PLM in drug development process
• Accelerating new drug development, introduction, and commercialisation
• Prioritising new product development and introduction
• Managing collaboration with external supply and service networks
Mario Maio
Head of Formulation & Process Development
Merck Serono
10:20 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
IdeaPharma
11:00 Morning refreshment & networking session
11:20 Developing differentiation, innovation, and long-term growth strategies with lifecycle technologies
• Brief introduction on fundamentals of oral controlled release
• Product innovation through mechanistic changes in product design
• Examining drug delivery technologies as growth driver
• Big pharma and generic company perspective
• Looming patent losses for big pharma
• Examining how emerging markets drive growth
Vishal K. Gupta
Director, Pharmaceutical R&D
Covidien
12:00 Maximising ROI through patent protection strategies
• Understanding how to effectively reassess, develop and exploit patent protection strategies
• Enhancing market exclusivity and revenue returns over the lifecycles of new drugs
• Successful case scenarios on strategy application
Nigel Stoate
Partner
Taylor Wessing
12:40 Lunch
13:40 Enhancing life cycle management through effective pharmaceutical licensing strategies
• Examining the licensing process in pharmaceutical industry
• Developing effective strategies while managing costs effectively
Jonathan Deutsch
Director Pharma Development Safety, Licensing and Early Development
Hoffmann-La Roche
14:20 Effective brand optimisation
• Development of intangible value
• Planning for PLM - when is early? And when is too late?
• Best practice methodologies
• Yo-yo marketing – the customer IS king
• Putting the ‘life’ in lifecycle
Paul FitzGerald
Owner
Syntropy Medica
15:00 Afternoon refreshments & networking session
15:20 Panel discussion: Why new developments are important in injectable delivery today?
Panelists will identify and understand the growing importance of injectable drug delivery on self-administration, drug formulations, drug-device development, and therapeutic treatment protocols. If you want to submit a question, please email it to info@bharatbook.com
16:00 Reformulation using new technologies as a strategy to lifecycle management
• Examples on how new technology and patent protection can maximise the value of a product.
• How the clinical benefit needs to be balanced to the clinical and regulatory requirements.
• The importance of a timely lifecycle management strategy
Peter G Nielsen
Executive Vice President of Pharmaceutical Development and Chemistry Manufacturing & Control
Lifecycle Pharma
16:40 Chair’s closing remarks
16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting
Day 2
Day 2, Thursday 4th March 2010
09:00 Registration and refreshments
09:30 Chair’s opening remarks
09:40 Mergers and acquisitions: The need for PLM tools
• How does it affect the longer term delivery by the vendors to the customers?
• Harmonising the product portfolio and enhancing visibility across the value chain
• Managing portfolio of drug candidates – from research to development and beyond
Alok Aggarwal
Co-Founder and Chairman
Evalueserve
10:20 Optimising life cycle management through efficiency measurements
• Explaining why is there a need to measure
• Identifying appropriate efficiency measurement tools
• Defining the challenges
• Exploring some best practice examples
Alexandra C. Gruber
Director Business Development & Marketing
BIOCRATES Life Sciences
11:00 Morning refreshment & networking session
11:20 Panel Discussion: - The role of partnership in implementing PLM software
Panelists will identify and understand how partnerships with technology vendors can maximise value through an efficient PLM implementation. If you want to submit a question, please email it to info@bharatbook.com
12:00 Managing brands across the four phases of product lifecycle
Ihab Dimian
Regional Marketing Director
Abbott Laboratories*
12:40 Lunch
13:40 Evaluating technical and integration issues in PLM
• Understanding the implementation process of PLM solutions
• Customisation and configuration issues within the pharmaceutical environment
• Configurable packages versus customised PLM projects
• Discuss successful PLM strategies
James Down
Vice President, Product Lifecycle Management
Beckton Dickinson
14:20 Presentation to be announced
Marc Dawkins
Partner
Simmons & Simmons
15:00 Afternoon refreshments & networking session
15:20 Case study - How the integration of Product Life-cycle Management and manufacturing execution systems (MES) closes the loop between manufacturing and design, enabling rapid innovation cycles while at the same time managing the risk, increasing product quality, maximising production yields and decreasing costs.
Zadeo Cimarosti
Manager, Chemical Development
GlaxoSmithKline Italy*
16:00 Managing drug safety throughout product lifecycle management
• Understanding the benefit-risk decision making by prescribers and patients
• Adaptative design for RMP/REMS based on their outcome
• Best practices for developing transparency with safety governance committees
Ralph C. Schimmer
Global Head Drug Safety Sciences - Metabolism and Cardiovascular
F.Hoffmann-La Roche
16:40 Complying with regulatory requirements in Pharmaceutical life cycle management
• Analysing the increasing pressure by regulatory bodies to ensure drug safety
• How FDA requirements and EMEA requirements differ?
• Identifying and reducing risks of non-compliance through PLM
Maciej Gil
Medical & Regulatory Director & CIS
Eli Lilly Russia
16:50 Chair’s closing remarks
17:00 End of conference
Venue
BSG Conference Centre, London, UK
MORE INFO ON THIS VENUE Restrictions
Invitation Only
