SAE Media Group is proud to announce the return of their 6th annual Orphan Drugs Europe 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.
SAE Media Group 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.



"Nice disease/compound specific talks"

“Good schedule, good variety of speakers”

“Very good speakers”

“An intensive and useful conference"


  • First time ever Patient Story An introduction to the challenge of the ataxias, a set of rare degenerative neurological conditions – joint with Ataxia UK who are aiming for a cure for one or more of the ataxias by 2020
  • Host nation address from IGES institute will discuss the German federal government introduced a new bill to regulate pricing & reduce reimbursement prices in October 2016. It is likely to take some six months before coming into force.
  • Novel case studies on rare inherited retinal disorders, Achondroplasia; the most common form of short limbed dwarfism, FSHD therapy
  • Hear Alexion discuss criteria, comparison and case studies for US and Europe regulatory landscapes
  • Listen to global orphan drug market case studies including Italy, Middle East, Greece & UK and other emerging markets


CEOs, Chiefs, VPs, Directors, Heads, Principals working in the area of orphan drug development and rare disease research


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 agenda



Registration & Coffee



Chairman's Opening Remarks

Mark Connolly, Department of Pharmacy, Unit of Pharmacoeconomics, University Of Groningen



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, Patient Ambassador, Ataxia UK

    Julie Vallortigara, Research Officer, Ataxia UK



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

    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



    Morning Coffee



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

    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.



    Setting reimbursement strategies: How to establish a foundation for reimbursement

    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



    Networking Lunch



    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, Partner, RBV Capital

    Mark Connolly, Department of Pharmacy, Unit of Pharmacoeconomics, University Of Groningen

    Carina Schey, Researcher, University Of Groningen



    Value Assessment of Orphan Drugs and Treatments for Rare Diseases - a U.S. Perspective

    Cate Lockhart

    Cate Lockhart, Health Economics and Outcomes Research, Omeros Corporation

    • 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



    Afternoon Tea



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

    Richard Porter

    Richard Porter, Chief Operating Officer, Therachon AG



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

    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?



    VAL001 for Treatment of Diffuse Large B-cell lymphoma - Recently Granted Orphan Drug Designation in EU and US

    Johan Drott

    Johan Drott, CEO, Respiratorius AB

  • Company considerations pursuing an orphan drug designation
  • Commercial, medical and regulatory strategic thoughts to be considered
  • How might the Orphan Drug Designation affect development plans
  • clock


    Chairman’s Closing Remarks and Close of Day One



    Registration & Coffee



    Chairman's Opening Remarks

    Carina Schey, Researcher, University Of Groningen



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

    Nadia Assenova, Senior Director Regulatory Affairs, EMEA, Alexion Pharma GmbH

  • 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?
  • clock


    Identifying the market in an orphan indication – challenges and opportunities

    Peter Ramge, Senior Global Pharma Lead & Orphan Drug Expert. Advocacy Specialist, Freelance

  • Campaign development for small target groups
  • Market access and pricing challenges
  • Reaching the prescriber and patient engagement opportunities
  • clock


    Morning Coffee



    Case study Facio Therapies: Breaking Through to an FSHD Therapy

    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



    Opportunities and challenges for biotech companies developing orphan drugs

    Anders Waas, Chief Executive Officer, Tikomed

  • Evolution of the orphan/rare disease market
  • Steps in Orphan drug development – From idea to new treatment of patients
  • Unmet need, science hand in hand
  • clock


    Networking Lunch



    Orphan drugs in developing (Emerging) Markets

    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
  • clock


    Experience on various aspects related EU based companies and MENA market

    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?
  • clock


    Afternoon Tea



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

    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
  • clock


    What can be done to actively improve diagnosis of orphan diseases and increase number of patients in care?

    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.
  • clock


    Chairman’s Closing Remarks and Close of Day Two

    Chief Executive Officer
    Chairman of the Board of Management
    IGES Institut
    University Of Groningen
    Patient Ambassador
    Ataxia UK
    Health Economics and Outcomes Research
    Omeros Corporation
    Managing Director
    Facio Therapies
    Member of the Brussels and Paris Bar, Partner
    mayer brown llp
    Medical Scientific Manager - Rare Diseases Unit
    Chiesi S.p.A.
    Market Access Manager Europe
    Horizon Pharma, Inc.
    Chief Scientific Officer
    Decodeon B.V.
    Respiratorius AB
    Research Officer
    Ataxia UK
    Head of Regulatory Affairs/Quality Assurance
    Department of Pharmacy, Unit of Pharmacoeconomics
    University Of Groningen
    Senior Director Regulatory Affairs, EMEA
    Alexion Pharma GmbH
    Director and Country Manager UK/Ireland
    BioMarin Europe Ltd
    Senior Global Pharma Lead & Orphan Drug Expert. Advocacy Specialist
    Chief Operating Officer
    Therachon AG
    RBV Capital
    General Manager MENA
    Orphan Europe

    Official Publication



    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.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.

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


    Orphan Drugs UK 2016: Anthony Hall, Therapeutic Area Head Orphan Drugs, Mero BioPharma Presentation


    Orphan Drugs UK 2016: Tim Guilliams, Founder & CEO, Healx Presentation


    Orphan Drugs UK 2016: Timothy J. Miller, Ph.D.President & CEO, AbeonaTherapeutics Inc Presntation


    Orphan Drugs UK 2016: Sheela Upadhyaya, Associate Director, NICE Presentation


    Interview with Julie Vallortigara, Research Officer, Ataxia UK


    Orphan Drugs and Rare Diseases 2016 - Past Attendees List


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    Ataxia UK is the national charity for people affected by ataxia, a group of rare, neurological conditions, for which there is currently no cures. Ataxia UK works in partnership to facilitate, promote and fund research to develop much needed treatments for this neglected group of conditions. The charity also provides support services to the ataxia community



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    Crowne Plaza Berlin - Potsdamer Platz

    Hallesche Str. 10
    Berlin 10963

    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.



    speaker image






    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.


    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.


    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.


    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

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    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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