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SMi is proud to announce the return of their 6th annual Orphan Drugs event to Berlin on the 15th -16th May 2017!
The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019.*
With such growth and innovation witnessed in this field now is the best time to discuss and strategize the best route to market.

Germany is Europe's largest pharma market but is recognised as having one of the toughest pricing policies in Europe.
Smi 6th annual Orphan Drugs conference will discuss the controversial German pricing mechanism as well as bring together leading industry professionals to discuss the latest regulatory developments, explore how to reduce costs and learn from the latest innovations in the orphan drug landscape.

*http://www.businesswire.com/news/home/20160406005885/en/Global-Orphan-Drug-Market-Set-Grow-191
*http://www.pmlive.com/pharma_news/germany_planning_to_table_pricing_reforms_by_the_summer_1007643
 

 

Abeona Therapeutics; Agency for Medicinal Products and Medical Devices of the Republic of Slovenia; AKU Society; Alexion Pharma International Intl; Apex Healthcare Consulting Limited; Boehringer Mannheim GmbH; Cello Health Insight - London; Chiesi Farmaceutici SpA; Debio Pharm S A; Dorphan; Findacure Development; GENETHON; Genetic Alliance; Grifols Deutschland; Grunenthal GmbH; GSK; GW Pharmaceuticals; I.D.E.A. Ltd; ICON Clinical Research; INC Research; Infusion Pharma Consulting LLC; Loulou Foundation ; Merck Serono; NDA Regualtory Science Ltd; Newcastle University; Orphazyme ApS; Otsuka Europe Development and Commercialisation; Otsuka Pharmaceutical Europe Ltd; Pfizer Group; PSR Group B.V.; PSR Orphan Experts; Raglan Capital; Rare Disease UK; Roche; Roche Products; Russian Respiratory Society; Shire Pharmaceuticals Limited; Society for Mucopolysaccharide Diseases; Swedish Orphan Biovitrum (SOBI) AB; Taylor & Francis Group; The Birmingham Childrens Hospital; The Medical Research Network; The Ultra Rare Diseases Disorder & Disabilities Foundation; Thomson Reuters; Tikomed; University College London; Zogenix Inc
 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Goran Medic

Goran Medic, Market Access Manager Europe, Horizon Pharma, Inc.

9:10 First time ever a patients story: Living with Ataxia

  • An introduction to the challenge of the ataxias, a set of rare degenerative neurological condition and the role of patient group, Ataxia UK.
  • Patient experience of being a patient living with ataxia, her strategies for living with the condition, and her engagement as a patient with the NHS.
  • An overview of the challenges for Ataxia UK, as a patient group working with a set of rare conditions with no treatments or cures. 
  • Their  research strategy, partnerships with pharmaceutical companies and others, and the progress which has been made to date
  • Carol  McCudden

    Carol McCudden, Patient Ambassador, Ataxia UK

    Julie Vallortigara

    Julie Vallortigara, Research Officer, Ataxia UK

    9:50 Host nation address: AMNOG and Orphan pricing & reimbursement in Germany

    Bertram Haussler

    Bertram Haussler, Chairman of the Board of Management, IGES Institut

    - Current situation and implications of the regulation update in 2017 (AMVSG)
    - Key issues in early benefit assessments of Orphan Drugs
    - Outlook  to the future
     

    10:30 Morning Coffee

    11:00 Case study on the regulatory hurdles and opportunities for development of a gene therapy for a rare inherited retinal disorder

    Leigh Shaw

    Leigh Shaw, Head of Regulatory Affairs/Quality Assurance, NightstarX

     • Experience with the regulatory opportunities in terms of what we gained from obtaining EU and US Orphan Drug Designation, and our interactions through regulatory meetings.
    • Hurdles; Lack of information on the natural history of the disease, issues because of limited availability of patients, using state of the art manufacturing and surgical techniques.
    • Differences in approach to gene therapies in different countries.
     

    11:40 Setting reimbursement strategies: How to establish a foundation for reimbursement

    Nigel Nicholls

    Nigel Nicholls, Director and Country Manager UK/Ireland, BioMarin Europe Ltd

    • Analysing how payers are considering reimbursing drugs that are coming on the market for orphan drugs and rare diseases
    • Can workable changes be made to improve current reimbursement strategies?
    • Creating a collaborative reimbursement strategy that satisfies and benefits all parties involved
    • Taking a look at regulatory frameworks and how they influence the reimbursement process

    12:20 Networking Lunch

    13:20 Panel discussion: The sustainability of orphan drugs

  • Economic tools that improve access to orphan drugs
  • Sustainability of orphan drug reimbursement. How can we ensure the ongoing sustainability of orphan drugs
  • Is there a correlation between sustainability and the cost-effectiveness of orphan drugs? Is there a relationship between cost-effectiveness and affordability?
     
  • Robert Karl

    Robert Karl, Partner, RBV Capital

    Massimo Bertelli

    Massimo Bertelli, Country Manager - Italy, Aegerion Pharmaceuticals

    14:00 Pricing and evaluating orphan drugs – past, present and future

    Goran Medic

    Goran Medic, Market Access Manager Europe, Horizon Pharma, Inc.

    • Prices of orphan drugs vs. rarity of disease – is there a link?
    • Are orphan drug prices increasing or decreasing since the launch date?
    • Landscape overview of orphan drug availability in several European countries

    14:40 Afternoon Tea

    15:10 Case study from an early stage project on achondroplasia and its associated complications

    Richard Porter

    Richard Porter, Chief Operating Officer, Therachon AG

    15:50 Uncertainty in early drug development: What are the factors and steps to be taken to ensure success of the drug development?

    James Mcarthur

    James Mcarthur, Chief Scientific Officer, Cydan


    • What are the challenges in target identification and target validation for a particular rare disease?
    • What are some of the payer issues that should be addressed early on?
    • How does market and financing landscape factor into early drug development?
    • Is there a major role for repurposing of old drugs for new uses in orphan and rare disease space?
     

    16:30 Case study Facio Therapies: Breaking Through to an FSHD Therapy

    David Dasberg

    David Dasberg, Managing Director, Facio Therapies

    • Why we are established
    • Lessons learned translating science into early stage drug discovery
    • How to align with the community you serve
     

    17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Alastair Kent

    Alastair Kent, Director, Genetic Alliance

    9:10 Orphan Drugs: Criteria, comparison and case studies for US and Europe regulatory landscapes

    Cecile De Coster

    Cecile De Coster, Associate Director, Regulatory Affairs, Alexion Pharma International Sàrl

  • What are the criteria for orphan drugs in EU and US?
  • What are the incentives available to companies developing orphan drugs?
  • What are the differences in the regulatory landscape for orphan drugs in EU and US?
  • 9:50 Identifying the market in an orphan indication – challenges and opportunities

    Peter  Ramge

    Peter Ramge, Senior Global Product Manager, .

  • Campaign development for small target groups
  • Market access and pricing challenges
  • Reaching the prescriber and patient engagement opportunities
  • 10:30 Morning Coffee

    11:00 Handling emergencies in the middle of crisis: Orphan drugs in Greece

    Elly Gabriel

    Elly Gabriel, Market Research Manager, Institute of Pharmaceutical Research & Technology (IFET SA)

  • Orphan drugs marketed in Greece
  • Reimbursement procedure
  • Regulatory framework
  • Early access for orphans and HST in general
  • Aggregation of demand: possibilities and opportunities
  • 11:40 Is Italy attractive for a first wave country orphan drug start up?

    Massimo Bertelli

    Massimo Bertelli, Country Manager - Italy, Aegerion Pharmaceuticals

  • Italy macroeconomic data and pharma/biotech industry overview
  • Helthcare system with focus to rare diseases and orphan drug
  • Clinical trials role in Italy
  • Laws for EAP like 648, 326 and CU
  • Role of top KOL and Real world data
  • Authorized Orphan drugs
  • Outlook for future
  • 12:20 Networking Lunch

    13:20 Orphan drugs in developing (Emerging) Markets

    Robert Karl

    Robert Karl, Partner, RBV Capital

  • A significant early potential in emerging markets
  • Overview of markets and potential
  • Key players and landscape
  • Fast track access routes
  • Critical success factors
  • 14:00 Experience on various aspects related EU based companies and MENA market

    Tony Zbeidy

    Tony Zbeidy, General Manager MENA, Orphan Europe

  • Early Market Access, Market Structure, Current Market Situation
  • Current and Future perspectives
  • Optimal business models, what works and what does not?
  • 14:40 Afternoon Tea

    15:10 Development and commercialisation of advanced therapy medicinal products: The Holoclar case

    Giorgio Iotti

    Giorgio Iotti, Medical Scientific Manager - Rare Diseases Unit, Chiesi S.p.A.

  • Translating stem cell therapy from academic research to industrial production
  • Peculiarities of the regulatory process of Holoclar, the first stem cell based product approved
  • Commercialisation of ATMPs and the challenge of hospital exemption in European countries
     
  • 15:50 What can be done to actively improve diagnosis of orphan diseases and increase number of patients in care?

    Jama  Nateqi

    Jama Nateqi, Co-Founder, SYMPTOMA

  • Why most patients with orphan diseases go undiagnosed and others take 10 years from symptom to diagnosis.
  • What new ways can be utilised for physicians to diagnose orphan diseases?
  • How to empower patients and physicians to actively uncover their underlying orphan disease.
  • Why orphan drugs need new techniques of marketing & patient finding.
  • 16:30 Rare is not so rare if everyone is in one place: patients and the internet.

    Jana Rautenberg

    Jana Rautenberg, Co-founder, Decodeon B.V.

  •  Bringing people together by being patient focused in order to help people with a rare disease.
  • Can online services make an actual impact on a patients life?
  • Bridging the gab between patients and research with the goal to advance clinical trials and knowledge.
  • What are the opportunities for leaders in research and industry?

     

  • 17:10 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Cecile De Coster

    Cecile De Coster

    Associate Director, Regulatory Affairs, Alexion Pharma International Sàrl
    Goran Medic

    Goran Medic

    Market Access Manager Europe, Horizon Pharma, Inc.
    Tony Zbeidy

    Tony Zbeidy

    General Manager MENA, Orphan Europe

    Alastair Kent

    Director, Genetic Alliance
    Alastair Kent

    Bertram Haussler

    Chairman of the Board of Management, IGES Institut
    Bertram Haussler

    Carol McCudden

    Patient Ambassador, Ataxia UK
    Carol  McCudden

    Cecile De Coster

    Associate Director, Regulatory Affairs, Alexion Pharma International Sàrl
    Cecile De Coster

    David Dasberg

    Managing Director, Facio Therapies
    David Dasberg

    Elly Gabriel

    Market Research Manager, Institute of Pharmaceutical Research & Technology (IFET SA)
    Elly Gabriel

    Giorgio Iotti

    Medical Scientific Manager - Rare Diseases Unit, Chiesi S.p.A.
    Giorgio Iotti

    Goran Medic

    Market Access Manager Europe, Horizon Pharma, Inc.
    Goran Medic

    Heiko Packeiser

    Co-founder & Director, Decodeon B.V.
    Heiko Packeiser

    Jama Nateqi

    Co-Founder, SYMPTOMA
    Jama  Nateqi

    James Mcarthur

    Chief Scientific Officer, Cydan
    James Mcarthur

    Jana Rautenberg

    Co-founder, Decodeon B.V.
    Jana Rautenberg

    Julie Vallortigara

    Research Officer, Ataxia UK
    Julie Vallortigara

    Leigh Shaw

    Head of Regulatory Affairs/Quality Assurance, NightstarX
    Leigh Shaw

    Massimo Bertelli

    Country Manager - Italy, Aegerion Pharmaceuticals
    Massimo Bertelli

    Nigel Nicholls

    Director and Country Manager UK/Ireland, BioMarin Europe Ltd
    Nigel Nicholls

    Peter Ramge

    Senior Global Product Manager, .
    Peter  Ramge

    Richard Porter

    Chief Operating Officer, Therachon AG
    Richard Porter

    Robert Karl

    Partner, RBV Capital
    Robert Karl

    Tony Zbeidy

    General Manager MENA, Orphan Europe
    Tony Zbeidy

    Official Publication

    Supporters

    Workshops

    The impact of Brexit on the orphan drug market
    Workshop

    The impact of Brexit on the orphan drug market

    Crowne Plaza Berlin - Potsdamer Platz
    17th May 2017
    Berlin, Germany

    Is the party over for orphans?
    Workshop

    Is the party over for orphans?

    Crowne Plaza Berlin - Potsdamer Platz
    17th May 2017
    Berlin, Germany

    VENUE

    Crowne Plaza Berlin - Potsdamer Platz

    Hallesche Str. 10, Berlin, Germany

    The Crowne Plaza Berlin - Potsdamer Platz offers Berlin Zeitgeist and a big city feeling. The listed building of the former Postpalais exudes the high-class elegance reminiscent of the Bohemian circles of the 1930s. Broad corridors with natural stone floors, high ceilings, wood panelling and an open fire in the lobby convey glamorous Berlin city life. Art Déco elements and a well thought out design ensure freshness and modernity. Generous rooms and suites, an elegant restaurant with a show kitchen and the stylish THE POST Bar take the Berlin hotel scene to a new level.

    HOTEL BOOKING FORM

    Interview with Giorgio Iotti, Medical Scientific Manager, Rare Diseases Unit Chiesi Farmaceutici

    Download

    Interview with Alastair Kent, Director, Genetic Alliance UK

    Download

    Orphan Drugs and Rare Diseases 2016 - Past Attendees List

    Download

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    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    Copybook - Pharmaceutical

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    http://www.copybook.com/pharmaceutical

    Copybook is a global business network with many pharmaceutical events, exhibitions and seminars. We encourage business-to-business transactions and work tirelessly to gain our customers new business contracts worldwide. You can add events, companies and associations for free. When you are a member, you can add your company to the events listed in order to encourage other visitors to arrange meetings and appointments at those events to facilitate new business contracts. Want to see how we can increase your business network and transactions? SIGN UP FOR FREE today! Copybook – Your Global Business Network


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.


    Absave

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    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    AntibodyChain

    Supporters
    http://www.antibodychain.com

    The complete and transparent marketplace for your research antibodies, kits, proteins and small molecules. The sophisticated search engine, with more than 800.000 products, transparency in suppliers, easy comparison, the one stop shop for your research antibodies in combination with interesting news and events plus a CMO exchange makes us a full service partner for you.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    One Nucleus

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    http://www.onenucleus.com

    Established in May 2010, One Nucleus is the result of the merger of ERBI and London Biotechnology Network. One Nucleus is a not-for-profit membership organisation for international life science and healthcare companies and the largest of its kind in Europe. The company is based in Cambridge UK and London, at the heart of Europe's largest cluster. The 470 members include pharmaceutical, biotech, medical device and diagnostic companies and associated technical and commercial Service Providers.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.

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    Crowne Plaza Berlin - Potsdamer Platz

    Hallesche Str. 10
    Berlin 10963
    Germany

    Crowne Plaza Berlin - Potsdamer Platz

    The Crowne Plaza Berlin - Potsdamer Platz offers Berlin Zeitgeist and a big city feeling. The listed building of the former Postpalais exudes the high-class elegance reminiscent of the Bohemian circles of the 1930s. Broad corridors with natural stone floors, high ceilings, wood panelling and an open fire in the lobby convey glamorous Berlin city life. Art Déco elements and a well thought out design ensure freshness and modernity. Generous rooms and suites, an elegant restaurant with a show kitchen and the stylish THE POST Bar take the Berlin hotel scene to a new level.

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    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, SMI 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@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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