pharma

CONFERENCE

...see all

4th Annual Pharmaceutical PLM

Maximising return on investment through product life cycle management

14th - 15th September 2010, Thistle Marble Arch, London, UK

Download brochure Book now

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

Associate Sponsors

Media Partners

Background Info

Key Speakers
• Jonathan Deutsch, Director Pharma Development Safety, Licensing and Early Development, Hoffmann-La Roche
• Mark Hyde, Business Consultant, Oracle
• Ralph C. Schimmer, Global Head Drug Safety Sciences - Metabolism and Cardiovascular, Hoffmann-La Roche
• 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
• Martin Hawkins, Executive Director, SBT
• Matej Janovjak, CEO, InSysteA
• Jason Berning, Professional Services Consultant, Lorenz Life Sciences Group
• Dr. Barbara Domayne-Hayman, Chief Executive Officer, Stabilitech
• Vinod Balakrishnan, Senior Engagement Manager, Infosys

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.

Visiongain's 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

Venue:

Thistle Marble Arch
Bryanston Street
London
W1H 7EH
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_marble_arch/index.html

Day 1

Day 1, Tuesday 14th September 2010

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Senior Representative
Infosys

09:40 Towards an integrated PLM solution for pharmaceutical industry – A perspective
• PLM maturity model and pharma challenges
• Solution ideation, As Is landscape and business goals
• Case study and Infosys credentials

Vinod Balakrishnan
Senior Engagement Manager
Infosys

Ashish Goel
Practice lead, Healthcare practice
Infosys

10:00 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

10:40 Morning refreshment & networking session

11:00 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

11:40 Patent and data exclusivity developments for lifecycle management
• Recent UK patent decisions concerning enantiomer products
• Focus on data exclusivity and escitalopram
• SPC development in relation to combination products
• Data exclusivity issues concerning combination products
• How does this impact product lifecycle management?

Gareth Morgan
Partner
DLA Piper

12:20 Taking the pain out of the launch process
• Ensuring consistency of label/graphics design
• Examining best of breed approaches to product launches
• Removing complexity of PLM

Martin Hawkins
Executive Director
SBT

12:40 Lunch

13:40 The benefits of early phase drug safety management
• Drug safety withdrawals
• The cost of drug failures
• Exploring why pharmaceuticals fail
• The early drug safety strategy approach

Jonathan Deutsch
Director Pharma Development Safety, Licensing and Early Development
Hoffmann-La Roche

14:20 Improved stability for biologics as next generation life cycle management tool
• Stabilitech’s broadly applicable stabilisation technology removes need for refrigeration
• Differentiation tool for mature products
• Examples of application to vaccines and biopharmaceuticals

Dr Barbara Domayne-Hayman
Chief Executive Officer
Stabilitech

14:40 An integrated approach for better product decision making
• Consistency, Transparency and Ownership > Increase speed & profitability
• Are you reinventing the wheel or learning by building “Corporate Memory”?
• Connecting the silos – seamless flow of information between Portfolio Management, BD&L, Alliance Management, R&D project management and LCM
• Examples from companies that make better decisions with a structured process

Mark Hyde
Business Consultant
Oracle

15:20 Afternoon refreshments & networking session

15:40 The limits of patent strategy
• Validity challenges - attitudes at the EPO, US and EU national courts
• The European Commission's 2009 pharma industry review and follow-up investigations
• To SPC or not to SPC?
• Branding - legal and regulatory issues

Lorna Brazell
Partner
Bird & Bird

16:20 Chair’s closing remarks

16:30 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2

Day 2, Wednesday 15th September 2010

09:00 Registration and refreshments

09:30 Chair’s opening remarks

Mark Hyde
Business Consultant
Oracle

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 Strategic product portfolio life cycle management
• Complexity and performance of the Product life cycle process
• Key objectives of Product portfolio Life Cycle Management PLCM
• Model based PLCM
- Conceptual design and structure
- Operational concept, Managers user interface und demonstration of case studies
• Benefits

Matej Janovjak
CEO
InSysteA

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 pranita.nangia@visiongain.com

Panelists: Mark Hyde, Business Consultant, Oracle
Amit Sharma, Head, PLM Europe, Infosys Product Lifecycle Engineering Services, Infosys
Mike Rea, Chief Executive Officer, IdeaPharma
Vinod Balakrishnan, Senior Engagement Manager, Infosys

12:00 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

12:40 Lunch

13:40 eSubmission Management Challenges
• History of electronic submission formats
• Breaking down the eCTD complexity & current status
• Understanding the technology: Document Management vs Submission Management

Jason Berning
Professional Services Consultant
Lorenz Life Sciences Group

14:00 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

14:40 Afternoon refreshments & networking session

15:00 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

15:40 Chair’s closing remarks

15:50 End of conference

Partners

Associate Sponsors:

SBT
SBT is the market leading specialist in Brand Lifecycle Management (BLM) and Product Lifecycle Management (PLM) solutions that optimise speed of product to market and deliver real business savings.
Our sophisticated ODIN solution is a platform for recording all New Product Development activities within a business, complimented by an end user interface encompassing intuitive Project Management and Artwork Approval tools. The ODIN application runs via a web browser making it easily accessible from anywhere in the world. The product has been developed and managed by industry experts, highly skilled system architects and experienced developers, but above all was built by end users for end users. For further information, please visit www.sbrandtech.com

Infosys
Infosys (NASDAQ: INFY) defines, designs and delivers IT-enabled business solutions that help Global 2000 companies win in a Flat World. These solutions focus on providing strategic differentiation and operational superiority to clients. With Infosys, clients are assured of a transparent business partner, world-class processes, speed of execution and the power to stretch their IT budget by leveraging the Global Delivery Model that Infosys pioneered. Infosys has over 105,000 employees in over 50 offices worldwide. Infosys is part of the NASDAQ-100 Index and The Global Dow. PLM, a part of Global Engineering has been a major focus for Infosys, in which it partnered with many leading pharmaceutical majors in realizing full potential of their PLM initiatives.
For more information, visit www.infosys.com

Lorenz Life Sciences
LORENZ is the most established provider of e-regulatory software and services in the world, focused on submission management, labelling and tracking. LORENZ docuBridge® was designed specifi cally to address the challenges facing submission managers in creating, quality control and publishing authorization dossiers (IND, NDA, eCTD, CTD, NeeS) in electronic and / or paper form. LORENZ' solutions foster independence, empowering customers to develop their own processes and maintain control of their own intellectual property. Media Partners: 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 more information please visit www.lorenz.cc/userBridge

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

Pharma Connections Worldwide
Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. For further information please visit www.pharmaconnections.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 4th Annual Pharmaceutical PLM Conference 2010, please contact:
Christopher Clegg, +44 (0)20 7549 9943
christopher.clegg@visiongainglobal.com
Emma Thomas, +44 (0)20 7549 9943
emma.thomas@visiongainglobal.com

Past Papers

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

Buy Now

Venue Info

Thistle Marble Arch
Bryanston Street
London
W1H 7EH
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_marble_arch/index.html

Please note: The information contained herein is intended for guidance purposes only. The responsibility to ensure accuracy of the details before visiting remains that of the individual. Visiongain can not be held responsible for any losses resulting from actions taken on the above information.

Speakers

Speaker bios:

Gareth Morgan

Partner

DLA Piper

Gareth Morgan is a Partner in the London office of DLA Piper's intellectual property department. Gareth has experience in all areas of contentious and non-contentious intellectual property law with a particular focus in the life sciences and healthcare sector.
Gareth is a qualified solicitor and higher court advocate in England and Wales and is an Associate of the Charted Institute of Patent Attorneys (CIPA). He has a degree in Biochemistry and a DPhil in molecular biology, both from Oxford University.
Martin Hawkins

Executive Director

SBT

As Executive Director retains accountability for all Sun Branding Solutions and SBT Client Service personnel and is a key interface for numerous blue chip clients tasked with the strategic development and roadmap of the ODIN application on a global basis.