Home
Generics, Super-Generics and Patent Strategies
10 May - 11 May 2010
Generics, Super-Generics and Patent Strategies

The worldwide generics industry has seen strong growth in recent times as the demand for affordable treatment has increased worldwide. In addition to this, numerous branded-drug patent expirations, the prospect of generic biotechnology drugs and a favourable regulatory environment is providing a huge opportunity for the sector to expand further.

Join us for SAE Media Group's 13th annual Generics, Super-Generics and Patent Strategies and discover the future of the generics market. Hear experts in the field discuss the latest patent strategies, regulatory updates and growth strategies that will be key to the future of the industry.

For speaker opportunities, contact SAE Media Groupproduction@SAE Media Group-online.co.uk

For sponsorship and exhibitioning opportunities, contact  sponsorshipdept@SAE Media Group-online.co.uk


  • Examine the legal framework and litigation mechanics in both the EU and US 
  • Latest legislative and regulatory updates in generics and biosimilars
  • Identify key growth areas and methods to take advantage of these
  • M&A activities and their implications
  • New business models
  • Emerging markets
  • R&D in generics

Bill Haddad
Chairman & CEO 
Biogenerics

John Beighton
Generics Industry Consultant
 

See the full lineup...

 


 

From generics manufacturers:

  • Business Development leaders
  • Presidents and CEOs
  • Commercial Directors
  • Operations Directors
  • Directors of R&D
  • Managing Directors

From pharmaceutical innovators:

  • Patent, Directors and Managers
  • Directors of Intellectual Property
  • Brand Directors and Managers
  • Product Directors and Managers
  • Directors of Business Development

Industry stakeholders:

  • Patent attorneys
  • Intellectual Property experts
  • Branding specialists

 

 


  

Crowne Plaza St James Hotel

45-51 Buckingham Gate
London
SW1E 6AF
 
 Tel: +44 (0) 207 834 6655
Fax: +44 (0) 207 6307
www.london.crowneplaza.com
 Crowne Plaza St James Hotel

Crowne Plaza St James London is a traditional deluxe hotel right in the heart of the city, perfectly situated for all your business and leisure needs. In the

Conference agenda

clock

8:30

Registration & Coffee

clock

9:00

Welcome and Introductions

clock

9:10

Generic portfolio's & sourcing products

clock

9:45

Portfolio planning tools and techniques

clock

10:30

Morning Coffee

clock

11:00

Case studies

clock

11:45

Discussion Session

clock

12:30

Close of Workshop

clock

13:30

Registration & Coffee

clock

14:00

Welcome and Introduction

  • Commercial overview
  • The market for generic antivirals and anti-infectives
  • Upcoming patent expiries
  • clock

    14:10

    Case studies - valacyclovir & ribavirin

  • valacyclovir
  • Dosage regime claims
  • Crystalline forms
  • ribavirin
  • Data exclusivity issues
  • Ribavirin and Pegylated interferon alpha: Copegus®
     
  • clock

    14:50

    Focus on Supplementary Protection Certificates

  • Overview of SPCs
  • Enantiomers:  lessons from the levofloxacin case
  • Two SPCs - one product - how?
  • clofarabine
  • clock

    15:30

    Afternoon Coffee

    clock

    15:50

    Neuraminidase Inhibitors - Lessons from the Public Record

  • zanamivir (Relenza®)
  • oseltamivir (Tamiflu®)
  • clock

    16:30

    Discussion and Questions

    clock

    17:00

    Close of Workshop

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Bill Haddad

    Bill Haddad, Chariman & Chief Executive Officer, Biogenerics

    clock

    9:10

    The Acquisition of Generic Companies by Big Pharma

  • Why there is so much activity
  • Attractiveness of emerging markets
  • Innovation Model versus Diversified Strategy
  • Where does IP come into it?
  • Brian Tempest

    Brian Tempest, Chairman, Hale & Tempest

    Brian Tempest

    Brian Tempest, Chairman, Hale & Tempest

    clock

    9:50

    Pharmaceutical Products Protection and Patenting Strategies in China

    Qinghong Xu

    Qinghong Xu, Partner, Lung Tin International Patent & Trademark Agent

  • Protecting products via obtaining strong patents
  • Protecting products via regulatory exclusivities
  • Invalidating patents via invalidation activities
  • Enforcing patents via administrative procedures and judicial actions
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Developments in US Law and its Effects on Litigation under the Hatch-Waxman Act

    Joseph  Reisman

    Joseph Reisman, Partner, Knobbe, Martens, Olson & Bear LLP

  • New legislations and regulations
  • Case law developments
  • Effect on patent challenges
  • Permissible settlement structures
  • clock

    11:40

    EU Intellectual Property Agenda

    Duncan Curley

    Duncan Curley, Director, Innovate Legal

  • Growth in the EU
  • Patents and SPCs: Legal Update
  • Review of major cases: escitalopram, olanzapine
  • EU Patent Strategies
  • clock

    12:20

    Networking Lunch

    clock

    13:20

    An Update on Data Protection and Recent Patent Developments

    Elisabeth Berthet-Maillols

    Elisabeth Berthet-Maillols, Lawyer, Armengaud-Guerlain Law Firm

  • How data protection and patents are used to block generics?
  • Which strategies are set up in the both sides?
  • Relevant case law updates
  • clock

    14:00

    Pharmaceutical Patent Intelligence

    Martin Paltnoi

    Martin Paltnoi, CEO, MPA Business Services Ltd

  • Significance of upcoming expiries
  • Regulatory considerations and limitations
  • Paediatric extensions: taking into account US vs. EU
  • Illustrative case studies
  • clock

    14:40

    Market Access Issues

    Brian Lovatt

    Brian Lovatt, Managing Director & Chief Executive, Vision Healthcare Consultancy Ltd

  • The augmented value proposition
  • Biosimilar prices down or ?
  • Price - Volume - Value - Profit
  • clock

    15:20

    Afternoon Tea

    clock

    15:50

    Pharmacovigilance for Generics

    Nawab Qizilbash

    Nawab Qizilbash, Director, OXON Epidemiology

  • Challenges
  • Unique aspects applicable to generics
  • Operational considerations: responsibilities and options available
  • Case study: post-approval safety studies (PASS) and generics
  • Case study: commercial strategies in entering the Spanish market
  • clock

    16:40

    The Future of Biosimilars

    Bill Haddad

    Bill Haddad, Chariman & Chief Executive Officer, Biogenerics

  • Post Eshoo / Waxman update - the status of biosimilars
  • Current and European concerns
  • Opportunities
  • Developing markets
  • clock

    17:20

    Chairman’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

    clock

    9:10

    Biosimilar Development Costs & the Future Global Biosimilars Market

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

  • Why biosimilar profits are difficult in EU
  • Differing guidelines and laws
  • Where the profits are
  • Specifics on how to make a profit
  • Impact on the future global biosimilars market
  • clock

    9:50

    Pharmaceutical Gateway Concept

    Peter Hartnack

    Peter Hartnack, General Manager, Bactimm | Farmalyse

  • Background
  • Benefits in efficiency, efficacy & traceability
  • Cost comparisons
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Engineering Controlled-Release Formulations for Supergeneric Products

    Celal Albayrak

    Celal Albayrak, CEO and Founder, Alrise Biosystems GMBH

  • Application of encapsulation technology for both hydrophilic and hydrophobic drugs independent of the molecule size
  • Rationale for controlled-release depot formulations
  • Advantages of ImSus® technology
  • Field of application
  • clock

    11:40

    Supergenerics - Threat or Opportunity?

    Malcolm Ross

    Malcolm Ross, CEO, Generapharm

  • What constitutes a supergeneric
  • Supergeneric possibilities
  • Combination products
  • New dosage forms
  • The barriers to developing supergenerics
  • Commercial considerations for generic companies
  • Case study: Zolpidem
  • clock

    12:20

    Networking Lunch

    clock

    13:20

    Strategies for Success

    Peter Wittner

    Peter Wittner, Senior Consultant, Interpharm Consultancy

  • Which markets?
  • Generic biologics situation
  • Mergers, acquisitions and the options for smaller companies
  • EU Sectoral Inquiry & US FTC review
  • clock

    14:00

    Entering the Emerging Markets

    Hordur Thorallsson

    Hordur Thorallsson, Executive Vice President of Emerging Markets, Actavis

  • Entry strategies
  • Pitfalls and barrier
  • Opportunities and growth prospects
  • clock

    14:40

    Commercial Strategies in Today's Financial Climate

  • Already stretched healthcare provision hit even harder as a result of financial crisis
  • How are payers addressing current constraints?
  • Are traditional models of pricing and reimbursement under threat?
  • Are current models of generics sales and marketing still appropriate?
  • Commercial dilemmas that generics companies are currently facing will become more acute
  • How can generics companies adapt to, respond to or even lead this evolving process?
  • John Beighton

    John Beighton, Consultant, Generics Industry

    clock

    15:20

    Chairman’s Closing Remarks and Afternoon Tea

    Workshops

    Strategic Portfolio Planning for Generic Drugs

    Strategic Portfolio Planning for Generic Drugs

    Crowne Plaza Hotel - St James
    12 May 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.