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SMi's 8th Annual Conference
Orphan Drugs and Rare Diseases
17 - 18 October, 2018 | London, UK
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This year’s SMi Orphan Drugs and Rare Diseases Conference will bring together regulatory agencies, pharmaceutical companies, non-profit organisations and orphan drugs developers to construct an agenda that addresses the driving economic factors, policies and issues that will affect the development of orphan drugs globally including commercialisation, policies, reimbursement, and pricing.

Presentations and case-studies from representatives of:
Genetic Alliance, University Of Groningen, Genethon, Healx, AKU Society, BioMarin Europe, Shire, Vifor Pharma, AstraZeneca, Minoryx, MHRA + many others!

PLUS! Interactive Workshop (16 October) on 'Working together for HTA in rare diseases - a step too far or the way forward?'
View detailed information on Associated Events page

View List of Speakers and Conference Agenda on the Download Centre

EXCLUSIVE CONTENT - Interviews with

  • Nicolas Sireau, AKU Society
  • Toni Mathieson, Niemann-Pick UK

Read full transcript on the Download Centre

Follow #smiorphandrugs for Orphan Drugs and Rare Diseases event and industry news

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Register by 31 August to save £200

Orphan Drugs and Rare Diseases conference this year is set to inspire the international rare diseases community by exploring synergies between regulators, health and technology assessors

  • Discuss strategic win-win collaborations to help accelerate rare disease clinical drug development, and improve relationships between drug developers and patients to consider both parties’ interests
  • Hear more about how patient engagement by integrating the patient perspective into the drug development process through patient advocacy, patient-centric research and patient groups
  • Learn about how the regulatory landscape for drug approvals is different between countries, and why it is important to keep informed about the regulations and guidelines of each region
  • Gain knowledge of different rare diseases and their unique challenges, as well as how treatment methods can be transferred to other rare diseases
  • Learn how gene therapy methods can improve the treatment of rare diseases and why it is becoming more commercially successful

View Full Conference agenda on the Download Centre

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Register by 31 August to save £200

Previous attendees include:

Action Duchenne; ADB Medical ; Alexion Pharma GmbH; Apex Healthcare Consulting Limited; Applied Pharma Research Sa; Ataxia UK; Birmingham Children's Hospital; C2AM; Cambridge Rare Disease Network (CRDN); Chiesi Farmaceutici S. p. A.; Chiesi Farmaceutici S.p.A.; Chiesi Ltd; Costello Medical Consulting; Deutsches Krebsforschungszentrum; Findacure; FORTRESS BIOTECH; Healx; High Force Research; Idorsia Pharmaceuticals Ltd; LifeArc; MEDExpansion; Mereo BioPharma Group Limited; myTomorrows; National Institute for Health and Care Excellence; Personalize My Medicine; Philip Chapper; Sanofi; Santhera Pharmaceuticals; Santhera Pharmaceuticals Ltd; Sciad Communications Ltd; Selecta Biosciences; Summit Therapeutics ; TCR Solutions; The London Bioscience Innovation Centre; The Medical Research Network; TranScrip Partners LLP; UCL; University College London; University Of Groningen; University Of Sheffield; Vertex Pharmaceuticals; Voisin Consulting Life Sciences.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Carina  Schey

Carina Schey, Researcher, University Of Groningen
View Bio

9:10 Small data for small diseases – the importance of clinical and patient outcomes data for all stakeholders

Peter Rutherford

Peter Rutherford, Global Medical Lead, Vifor Pharma
View Bio

• Examine the challenges in rare disease in gathering robust clinical outcomes data when patients are rare and when definition of endpoints is required
• Show how real world data can be gathered and used to support discussions with relevant stakeholders
• Demonstrate the importance of gathering patient reported outcomes and experience in rare diseases to demonstrate unmet need and assist in product development
 

9:50 The Rare Disease Nurse Network: formation, development and our future

Neil Dugdale

Neil Dugdale, Vice-President and General Manager, UK and RoI, Sobi

• Rare Disease Nurse Network: Our Vision and Mission
• Our progress so far; how did we form, who are we and what have we achieved?
• The future for those affected by rare disease is getting brighter but how can RDNN make a major contribution by 2025?
 

10:30 Morning Coffee

11:00 Primary data collection on the weighting preferences of a wide range of people for criteria used in multi-criteria decision analysis (MCDA)

Carina  Schey

Carina Schey, Researcher, University Of Groningen
View Bio

• Health technology assessments appraise the value of drugs based on cost-effectiveness (CE)
• Orphan drugs are mostly not cost-effective, and using CE studies doesn’t inform much
• An alternative method, multi-criteria decision analysis has been proposed for orphan drugs
• While MCDA is robust, there is no consensus on the weighting of the different criteria
• This primary data collection, using an interactive tool, seeks to establish the weighting preferences – results to be presented.
 

11:40 Spotlight: Benefit-risk assessment in rare diseases

Yolanda Barbachano

Yolanda Barbachano, Senior Statistical Assesor, MHRA
View Bio

• The role of regulators
• Challenges in rare diseases
• Possible study designs – their advantages and limitations from the regulator’s perspective
• Examples of innovative designs discussed at scientific advice meetings
 

12:20 A manufacturer's perspective of the HST process and NICE-lessons from two case studies

Nigel Nicholls

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

• NICE works with the DHSC to develop a scope. The scope defines the disease, the patients and the technology covered by the evaluation and the questions it aims to answer.
• The manufacturer or sponsor of the technology is invited to provide an evidence submission.
• NICE commissions an independent academic centre to technically review the evidence submission and prepare an ERG report.
• Evaluation consultation document (ECD) and final evaluation determination from the evaluation committee.
 

13:00 Networking Lunch

14:00 The potential of gene therapy and gene editing strategies for efficient treatment of genetic disorders

14:40 Rare diseases – what’s new from the regulatory standpoint?

Solange Corriol-Rohou

Solange Corriol-Rohou, Senior Director Regulatory Affairs and Policy, EU, AstraZeneca

• In 2016, the EU Commission issued a Notice which could have some noticeable impact on orphan designation.
        - Some examples will be presented and discussed further
• Agnostic-tumor indication in oncology and orphan designation – challenge or opportunity?
 

15:20 Afternoon Tea

15:50 Patient Access to orphan drugs: A Global health network model for patient-centered care

Rizwan Arshad Khan

Rizwan Arshad Khan, CEO, Health Services (Pakistan Public Health Association)
View Bio

• How global health networking can reduce challenges for rare diseases patients.
• Patient-centered Care Model for Orphan Drugs.
• Three major  indicators of a Patient-centered model, Accessibility within time frame, Patient Affordability and Quality for best outcomes.
• Pivotal, Transparent and legal channel between developed and under-developing country for orphan drug delivery system .
• Real world patient data and case histories of rare diseases patients and their families.
• Patient unmet needs solutions and interventions through global collaborations and alliances.
• Patient advocacy and strategies to access orphan drugs.
 

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

Carina  Schey

Carina Schey, Researcher, University Of Groningen
View Bio

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Carina  Schey

Carina Schey, Researcher, University Of Groningen
View Bio

9:10 PRIME and Adaptive Pathways in rare diseases drug development

Anthony Hall

Anthony Hall, Therapeutic Area Head Orphan Drugs, Mereo BioPharma

• What are PRIME and Adaptive Pathways?
• When is it appropriate to apply for PRIME and / or Adaptive Pathways?
• How can PRIME and Adaptive Pathways streamline your development programme?
• Case study
 

9:50 A case study on targeting a peroxisomal disorder: X-linked adrenoleukodystrophy (X-ALD)

Xavier Ortega

Xavier Ortega, Project Manager, Rare Diseases, Minoryx
View Bio

• X-linked adrenoleukodystrophy (X-ALD) is the most common peroxisomal disorder and affects adrenal glands
• MIN-102 as the first pharmacological therapy to treat X-ALD
• Current status of the ADVANCE Clinical Study for AMN (Pivotal Phase II/III trial)
 

10:30 Morning Coffee

11:00 Spotlight interactive session - From idea to routine prescribing: best practice in patient involvement

Alastair Kent

Alastair Kent, CEO, Genetic Alliance

This session will bring together a panel of patients with insights and expertise across the spectrum of therapy development to explore how patient input can impact on all stages of this process effectively.

It will address the issues and challenges along the various stages involved in the production of treatments to manage rare diseases – from the discovery of therapeutics targets to patient access arrangements. This session is interactive and will present case studies, practical tools and that can be applied in overcoming the challenges along a drug development to reimbursement pathway.

1. Research into Rare Diseases and Orphan Drugs
2. Clinical development of treatments for Rare Diseases
3. Licensing and Marketing
4. HTA applications - where the patient involvement team at NICE and SMA Trust describe preparation for HTA submission at NICE
5. Reimbursement and Commissioning (service delivery, tech and infrastructure challenges in commissioning)
 

12:20 Networking Lunch

13:20 Keynote: Patient involvement in orphan drug clinical development: the experience of the AKU Society

Nicolas Sireau

Nicolas Sireau, CEO and Board Chair, AKU Society
View Bio

• Setting up an orphan drug clinical trial with a rare disease patient group
• Recruiting patients for a phase 2 and phase 3 clinical trials
• Working in a large consortium
• Tips for success
 

14:00 The impact and challenge of research in a small, rare patient population: the experience of NPUK

Toni Mathieson

Toni Mathieson, Chief Executive, Niemann-Pick UK

• Why research is important to our community, our key objectives in this area and the activities we undertake to facilitate progress
• The challenges we have faced securing interest and funding for research, and in bringing research projects to fruition
• The impact of multiple trials on a small patient population and the subsequent effect on NPUK’s capacity and resources
• Our experience in communicating with the pharmaceutical industry and in lobbying for equity of access to expert care and treatment for rare diseases
 

14:40 Afternoon Tea

15:10 Accelerating drug discovery for rare diseases using AI: the Healx model

Michale Bouskila-Chubb

Michale Bouskila-Chubb, Head of Business Development , Healx
View Bio

• Fragile X case study: the case for AI-driven drug repurposing vs conventional drug repurposing
• Setting up an online tool to share data : how can patient groups accelerate data access and data quality for their rare diseases?
• Translating repurposed drugs to pharma: how can we build viable commercial cases for the pharmaceutical industry ?
 

15:50 Market access in rare diseases: challenges and future strategies

Patrick Mollon

Patrick Mollon, Founder and Owner, Mollon Healh-Economics

• Overview of the current situation and challenges
• US and EU specificities
• Solutions and strategies to improve future access
 

16:30 Chairman’s Closing Remarks and Close of Day Two

Carina  Schey

Carina Schey, Researcher, University Of Groningen
View Bio

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FEATURED SPEAKERS

Carina  Schey

Carina Schey

Researcher, University Of Groningen
Nicolas Sireau

Nicolas Sireau

CEO and Board Chair, AKU Society
Peter Rutherford

Peter Rutherford

Global Medical Lead, Vifor Pharma
Xavier Ortega

Xavier Ortega

Project Manager, Rare Diseases, Minoryx
Yolanda Barbachano

Yolanda Barbachano

Senior Statistical Assesor, MHRA

Alastair Kent

CEO, Genetic Alliance
Alastair Kent

Anthony Hall

Therapeutic Area Head Orphan Drugs, Mereo BioPharma
Anthony Hall

Carina Schey

Researcher, University Of Groningen
Carina  Schey

Carina Schey has many years of both pharmaceutical industry and clinical pharmacy experience. She is a consultant health economist based in Switzerland, also currently pursuing research through the University of Groningen, PharmacoEconomics and PharmacoEpidemiology Unit in the Netherlands. The primary focus of her research is developing ways of demonstrating the true value of orphan drugs, as alternative options to standard cost-effectiveness studies.
Carina was a clinical pharmacist with a special interest in rare diseases, having worked at several leading London hospitals. Between 2002 and 2008, Carina designed and implemented patient-focused homecare services on behalf of the UK NHS to patients with rare diseases.
Carina has published several peer-reviewed articles and abstracts. Notable speaking engagements include the European Parliament “Patients’ Rights Day” and “The Chronic Diseases” conference, both in 2015, and several other rare Diseases conferences.
Carina sits on the expert judges’ panel for the MassChallenge and on the scientific advisory panels for several charities, and as non-executive director for healthcare organisations.
 

Michale Bouskila-Chubb

Head of Business Development , Healx
Michale Bouskila-Chubb

Prior to joining Healx in 2017, Michale held various commercial positions in management consultancy, sales, technology transfer and pharmaceutical business development. Michale has a strong background in all aspects of IP exploitation from University technologies as well as commercial strategy. After a research career in the field of physiology and human metabolism in both academia and industry, Michale completed an MBA specialising in Life Sciences from the Open University Business School. Michale also holds a Pharmacy doctorate and a Toxicology Master’s degree from Paris V University as well as a PhD from the University of Dundee.

Neil Dugdale

Vice-President and General Manager, UK and RoI, Sobi
Neil Dugdale

Nicolas Sireau

CEO and Board Chair, AKU Society
Nicolas Sireau

Dr Nicolas Sireau is the CEO and Chair of Trustees at the AKU Society, a patient group that helps people with AKU (short for alkaptonuria), a rare genetic disease affecting both his children. He is also co-founder and Chair of Findacure, an organisation that helps rare disease patient groups. Previously, Nick was the CEO of SolarAid, an NGO working in Africa. He is a fellow of the Ashoka Fellowship of Social Entrepreneurs and has a PhD in the social psychology of social movements. He is the editor of ‘Rare Diseases: Challenges and Opportunities for Social Entrepreneurs’ (Greenleaf 2013) and of the 'Patient Group Handbook: A Practical Guide for Research and Drug Development' (Findacure 2016).

Nigel Nicholls

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

Nigel Nicholls currently serves as the Director and Country Manager UK/Ireland for BioMarin Europe Ltd. He has held senior positions in clinical research, international marketing and country management for Pharmacia, Rhone Poulec Rorer, Schering AG, Orphan Europe, Jerini AG and BioMarin Europe Ltd.

He completed his MSc (Surrey) and MBA (Bath) postgraduate degrees with a focus on the ethics and economics of orphan drugs. He was formerly a trustee but is now a patron of Contact a Family.
 

Patrick Mollon

Founder and Owner, Mollon Healh-Economics
Patrick Mollon

Peter Rutherford

Global Medical Lead, Vifor Pharma
Peter Rutherford

Peter Rutherford qualified in Medicine from Newcastle University, UK and then completed nephrology training in the UK at the Yale School of Medicine, USA, obtaining a PhD in 1994. For 11 years he was Senior Lecturer in Nephrology, Consultant Physician in the UK NHS and chaired the Guidelines Review Group at NICE. He moved to Pharma in 2007 initially at Baxter Healthcare and then Quintiles and is now Global Medical Lead for Rare Renal Diseases at Vifor Pharma. He has a particular research interest in patient education and decision making.

Rizwan Arshad Khan

CEO, Health Services (Pakistan Public Health Association)
Rizwan Arshad Khan

Dr.Rizwan Arshad Khan is founder and key person of Health Services Pakistan, positioned as CEO.
At this position he is responsible to develop strategic plan, controlling finance and assure full accountability to board for all operations. He is also an executive board member of Pakistan Public health Association and by profession he is Public health speaker and Health consultant who brings innovative and solution oriented projects for better health care. He is also a visiting faculty of Marglla University Pakistan and Ripha institute of sciences Islamabad. He is member of advisory committee of Patient Public health alliance in Pakistan.

 

Sheela Upadhyaya

Associate Director - Highly Specialised Technologies , National Institute for Health and Care Excellence
Sheela Upadhyaya

Sigrid Welte

Founder and General Manager, Pharma Innovation Consultancy GmbH
Sigrid Welte

Solange Corriol-Rohou

Senior Director Regulatory Affairs and Policy, EU, AstraZeneca
Solange Corriol-Rohou

Toni Mathieson

Chief Executive, Niemann-Pick UK
Toni Mathieson

Xavier Ortega

Project Manager, Rare Diseases, Minoryx
Xavier Ortega

Xavier obtained a PhD in Biomedicine, a MSc in Neuroscience and Postgraduate Certificate in Project Management. He has proven record of 7+ years developing and managing R&D projects with a special focus on pharmacological therapies for neurodegenerative diseases. During those years he also participated in Neurotec Pharma to implement a Phase IIa trial for MS patients. He then worked at BioSystems S.A. managing and with direct lead on the development of IVD products that were successfully launched on the market. Xavier joined Minoryx in 2017 to align the projects with the business-driven strategy of the company.

Yolanda Barbachano

Senior Statistical Assesor, MHRA
Yolanda Barbachano

Yolanda is a senior statistical assessor at the MHRA where she has been working for the last 6 years. Her work consists of assessing clinical trial data from marketing authorisation applications and advising pharmaceutical companies on the study design and statistical aspects of their clinical trials, whilst bearing in mind the whole development programme. Before joining MHRA she worked for the Royal Marsden NHS Foundation Trust planning and analysing clinical trials in oncology. Yolanda has a BSc in mathematics and a PhD in statistics both from the University of Sussex.

Supporting Media Partners

Workshops

Working together for HTA in rare diseases - a step too far or the way forward?
Workshop

Working together for HTA in rare diseases - a step too far or the way forward?

Holiday Inn Kensington Forum
16th October 2018
London, United Kingdom

VENUE

Holiday Inn Kensington Forum

97 Cromwell Road , London, United Kingdom

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

HOTEL BOOKING FORM

[Interview] - Toni Mathieson, Niemann-Pick UK

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[Interview] - Nicolas Sireau, AKU Society

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Application of PBPK to Drug Development in Rare Diseases

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[Main Conference Programme]

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[Speaker Line-up]

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[Workshop Programme]

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[Presentations] - snippets of OD&RD 2017 presentations

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[Attendee list] - Orphan Drugs and Rare Diseases 2017

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Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

HOTEL BOOKING FORM

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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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