2023 Agenda
Washington, D.C., 23 - 25 May 2023
Schedule
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May 2313:00
Conference pass
Expanding the possibilities of one-time treatments
Next Gen Therapies Seminar
Albert Seymour, President & Chief Executive Officer, Homology Medicines
May 2313:00
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Payer Panel: How do we get to more Value-Based Purchasing in the market? Exploring how the three major payors are approaching VBP
Pricing & Reimbursement
Payers to be announced: Commercial, Medicare, Managed Care Organization
Moderator: Matt Salo, Former, Executive Director,, National Association Of Medicaid Directors
May 2313:00
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Session title to be announced
Patient Data Seminar
Reserved for NORD
May 2313:00
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Workshop Sponsored by Volv Global
Workshops
Christopher Rudolf, Chief Executive Officer and Founder, volv global
May 2313:20
Conference pass
Session title to be announced
Patient Data Seminar
Sponsored by TREND
May 2313:40
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Harnessing the power of small molecules to modulate macrophages for the prevention and treatment of rare diseases
Next Gen Therapies Seminar
Suchismita Acharya, Founder & CEO, AyuVis Research
May 2313:40
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Panel: Data Collection, ownership and use and sharing with external partners
Patient Data Seminar
Michelle Davis, Executive Director, International Fibrodysplasia Ossificans Progressiva Association
Sharon Hesterlee, Chief Research Officer, MDA
May 2314:00
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ROUNDTABLE - Endpoint development: Discussion on PDUFA provisions relevant for rare diseases including pilot program and Accelerating Rare Disease Cures Program
Roundtables
Moderator: Imein Bousnina, Program Director, US Regulatory Policy, Product Development Regulatory, Genentech
May 2314:00
Conference pass
Session title to be announced
Next Gen Therapies Seminar
Carole Cramer, CEO & Co-Founder, Biostrategies
May 2315:00
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Panel: Data federation for newborn sequencing
Patient Data Seminar
Speakers to be announced
May 2315:00
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Workshop Sponsored by P2P Syncro
Workshops
Moderators to be announced
May 2315:40
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Panel: Intersection of data providers and rare disease patient groups - How can providers and advocacy groups work more effectively together to benefit rare disease patients
Patient Data Seminar
Tricha Shivas, Chief Strategy Officer, Foundation for Sarcoidosis Research
Connie Lee, President And Chief Executive Officer, Alliance to Cure Cavernous Malformations
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May 248:40
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Opening Chair Remarks
Keynotes
Al Freedman, Counseling Psychologist, Freedman Counseling Associates
May 248:50
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Keynote Address from FDA
Keynotes
Reserved for FDA Commissioner
May 249:10
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Keynote: Better care for rare - better diagnosis, treatment, innovation and engagement
Keynotes
Alaa Hamed, Global Head of Medical Affairs Rare Diseases, Sanofi
May 249:40
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Keynote panel: Expediting drug development for rare diseases
Keynotes
Peter Marks, Director, Center For Biologics Evaluation And Research (CBER), U.S. Food and Drug Administration
Maria Mccaffrey, VP Regulatory Affairs, Quality, Alexion – AstraZeneca Rare Disease
Kinnari Patel, Chief Medical Officer, Rocket Pharma
Adora Ndu, Chief Regulatory and interim Legal Officer, BridgeBio Gene Therapy
Annie Kennedy, Chief of Policy, Advocacy, & Patient Engagement,, EveryLife Foundation for Rare Diseases
May 2411:10
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Commercialising innovations: Level up your launch sequence
Pricing & Reimbursement
Lavni Varyani, Founding Partner, Pharma BP DMCC
May 2411:10
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Considerations for preclinical evaluation of cell and gene therapies for rare diseases
Advanced Therapies Clinical Development
Sandhya Sanduja, Leader-Pharmacology/Toxicology, FDA
May 2411:10
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Considerations for preclinical evaluation of cell and gene therapies for rare diseases
Advanced Therapies Clinical Development
Sandhya Sanduja, Leader-Pharmacology/Toxicology, FDA
May 2411:10
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Equity considerations for digital health and AI in rare diseases
AI & Digital Health
Melissa Penn, Director Patient Engagement Research & Development, Bayer
May 2411:10
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Equity considerations for digital health and AI in rare diseases
AI & Digital Health
Melissa Penn, Director Patient Engagement Research & Development, Bayer
May 2411:10
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Presentation from Rare Diseases International
Rare Disease Advocacy World
Mary Wang, Programme Director, Rare Diseases International
May 2411:10
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Presentation on rare oncology - description to be announced
Rare Oncology
Mark Manfredi, President and CEO, Ikena Oncology
May 2411:10
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Presentation on rare oncology: description to be announced
AI & Digital Health
Mark Manfredi, President and CEO, Ikena Oncology
May 2411:10
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Session title to be announced
Commercial
Paula Ragan, President and Chief Executive Officer, X4 Pharmaceuticals
May 2411:10
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Starting rare disease studies off right: Meeting the challenges of site identification
Clinical Development & Regulatory
FDA speaker to be announced
Afshawn Chakamian, Director of Therapeutic Expert, ICON
May 2411:10
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Venture Capital Panel: Evaluating opportunities, trends and challenges for rare diseases and orphan products
Pitch and Partner
Moderator: Ken Kengatharan, Managing General Partner, Atheneos Ventures
Geeta Vemuri, Managing Partner, Agent Capital
Walter Kowtoniuk, Venture Partner, Third Rock Ventures, LLC
May 2411:30
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Early access to cell and gene therapies as part of the clinical development strategy
Advanced Therapies Clinical Development
Tom Smith, Strategic Initiatives Director, Durbin
May 2411:30
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Early access to cell and gene therapies as part of the clinical development strategy
Advanced Therapies Clinical Development
Tom Smith, Strategic Initiatives Director, Durbin
May 2411:30
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Fireside Chat on Real-World Evidence
Commercial
Simon Andrews, SVP, Head of Analytics, EVERSANA
May 2411:30
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Fireside Chat: Discussion and Audience Q&A
AI & Digital Health
Christopher Rudolf, Chief Executive Officer and Founder, volv global
May 2411:30
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How are payers responding? New challenges and approaches for reimbursing orphan drugs in the US
Pricing & Reimbursement
Payer to be announced
Moderator: Mark Trusheim, Strategic Director, MIT NEWDIGS
Lisa Feng, Senior Director, Health Policy, Alexion – AstraZeneca Rare Disease
May 2411:30
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In-house drug development for patient advocacy groups - tackling ultra rare through de-risking regulatory pathways
Rare Disease Advocacy World
Sharon Hesterlee, Chief Research Officer, MDA
May 2411:30
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Presentation on clinical development: description to be announced
Clinical Development & Regulatory
Sponsored by PAREXEL
May 2411:30
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Presentation on clinical development: Sponsored by PAREXEL
Clinical Development & Regulatory
PAREXEL speaker to be announced
May 2411:30
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RNA therapeutics in rare oncology
Rare Oncology
Michael Dudley, Chief Executive Officer and Co-founder, TransCode Therapeutics
May 2411:50
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Bigger isn’t necessarily better - examining the creativity and flexibility smaller companies have in the rare disease space
Commercial
Denise Scots Knight, CEO, Mereo Biopharma
May 2411:50
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Creative Synergy: The Role of Patient and Caregiver in Innovative Trial Design
Clinical Development & Regulatory
Erin Griner, Assistant Director of Clinical, Worldwide Clinical Trials
May 2411:50
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Pitch: Pathway for orphan products in bone disease
Pitch and Partner
Lisa Padilla, Chief Executive Officer, Beryl Therapeutics Inc
May 2411:50
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Reserved for NORD
Rare Disease Advocacy World
Speaker to be announced
May 2411:50
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Session title to be announced
Advanced Therapies Clinical Development
Paolo Martini, Chief Scientific Officer Rare Diseases, Hematology and External R&D, Moderna, Inc.
May 2412:00
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Pitch: Exploiting oxidative stress vulnerabilities in cancer
Pitch and Partner
George Naumov, Chief Operating Officer & Hea, RS Oncology
May 2412:10
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Panel on clinical development
Clinical Development & Regulatory
Sponsored by Allucent
May 2412:10
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Panel: How are payers responding? New challenges and approaches for reimbursing orphan drugs in the US
Pricing & Reimbursement
Moderator: Mark Trusheim, Strategic Director, MIT NEWDIGS
Kollet Koulianos, Vice President Payer Relations, The National Hemophilia Foundation
May 2412:10
Conference pass
Pitch: Description to be announced
Pitch and Partner
Bryan Kobel, Chief Executive Officer, TC Biopharm
May 2412:10
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Reserved for EURORDIS
Rare Disease Advocacy World
Speaker to be announced
May 2412:10
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The need for novel endpoints: A case for using multimedia, audio and video to capture novel digital endpoints
AI & Digital Health
Scott Bergeron, Partner, Clinical Research, iTakeControl, a Red Nucleus Company
May 2412:20
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Pitch: Characteristic Opsins - A new wave of optogenetic therapeutics for vision restoration
Pitch and Partner
Sulagna Bhattacharya, Executive Officer & Co-Founder, NanoScope Technologies
May 2412:40
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Pitch: Description to be announced
Pitch and Partner
Carole Cramer, CEO & Co-Founder, Biostrategies
May 2413:00
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Lunch Keynote: Disrupting the digital transformation for rare diseases - What is working and what needs to change?
Keynotes
Moderator: Scott Snyder, Chief Digital Officer, EVERSANA
Maria Kirsch, GM of Patient Services, EVERSANA
May 2414:00
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ROUNDTABLE - PAG to Pharma - transitioning from the rare disease patient community to an advocacy role within industry
Roundtables
Wendy Borsari, Senior Manager of Patient Advocacy, Tenaya Therapeutics
May 2414:00
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ROUNDTABLE - Patient care - Improving treatment guidelines for sickle cell disease
Roundtables
Augusta Elizabeth Koroma, Chief Executive Officer, Sickle cell Intervention U.K
May 2414:00
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ROUNDTABLE - Patient Services - How industry can better collaborate internally and externally to best educate HCP, patients, and families
Roundtables
Marie Brace, Patient Access Liaison, Catalyst Pharmaceutical Partners
Amy Grover, Director of Patient Advocacy, Catalyst Pharmaceutical Partners
May 2414:00
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ROUNDTABLE - Sponsored by Sanofi
Roundtables
Moderator to be announced
May 2414:00
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ROUNDTABLE - Sponsored by TREND
Roundtables
Moderator to be announced
May 2414:00
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ROUNDTABLE: Case Study - How to enable a Patient Focused EAP? Working with the ALS community as a partner to ensure positive patient engagement from design to delivery of an EAP
Roundtables
Moderator: Naomi Litchfield, Global Patient Advocacy Lead, Bionical Emas
Moderator: Rachel Harrison, Associate Director, EAP, Apellis Pharmaceuticals, Inc
Moderator: Cath Lawrence, VP, Rare Disease, Bionical Emas
May 2414:00
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ROUNDTABLE: Sponsored by Blueprint Orphan
Roundtables
Moderator to be announced
May 2414:00
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ROUNDTABLE: Sponsored by Blueprint Orphan
Roundtables
Moderators to be announced
May 2415:00
Conference pass
A path to acceleration: In silico designs in rare disease drug development
Clinical Development & Regulatory
Sponsored by Premier Research
May 2415:00
Conference pass
Advancing rare disease Studies: fulfilling the promise of gene therapy
Advanced Therapies Clinical Development
Jonathan Schwartz, CMO, Rocket Pharma
May 2415:00
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Case study: Launch strategy in the North America - patient education, HTP education, building advocacy relationships
Commercial
Mona Moonis, NA Brand Lead, Rare Disease, Kyowa Kirin
May 2415:00
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Panel: Working together nicely in the same sandbox - how patient groups within the same disease state can work together and not against each other
Rare Disease Advocacy World
Moderator: Kim Stephens, President, Project Alive
Terri Klein, President And Chief Executive Officer, National M.P.S. Society
May 2415:00
Conference pass
Pitch: Description to be announced
Pitch and Partner
Molly Harper, Chief Business Officer, Synlogic
May 2415:00
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Updates on Real World Evidence for use of reimbursement strategies for rare disease products in Europe
Pricing & Reimbursement
Speaker to be announced
May 2415:10
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Pitch: Clinical-stage development of novel GCS inhibitors to treat lysosomal storage diseases
Pitch and Partner
Jerry Shen, Co-Founder, AceLink Therapeutics, Inc
May 2415:20
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Panel: A holistic approach to patient-centered rare disease clinical trials
Clinical Development & Regulatory
Moderator: Timothy Miller, VP and Therapeutic Area Head,, PPD, Part of Thermo Fisher Scientific
Galina Nesterova, Executive Medical Director, Ra, PPD, part of Thermo Fisher Scientific
Richie Pfeiffer, Senior Director, PPD, part of Thermo Fisher Scientific
Susan Mccune, Neonatologist, Thermo Fisher Scientific
May 2415:20
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Pioneering mutation-agnostic gene therapy for retinal disorders
Advanced Therapies Clinical Development
Samarendra Mohanty, Founder-President, Chief Scientific Officer, nanoscope therapeutics
May 2415:20
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Recent trends in managed access and impact to rare disease
Commercial
Lauren Heiser, Director-Business Development, Clinigen Group
May 2415:30
Conference pass
Navigating the patient and caregiver experience in Sickle Cell Disease
Rare Disease Advocacy World
Speaker to be announced
May 2415:30
Conference pass
Pitch: Description to be announced
Pitch and Partner
Michele Gerber, Chief Medical Officer, Myeloid Therapeutics
May 2415:40
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Examining hurdles of commercial models for platform technologies - bridging the science and business models to make platform approach more economically attractive
Advanced Therapies Clinical Development
Moderator: PJ Brooks, Health Scientist Administrator, NIH/NCATS
May 2415:40
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Panel: Cell and gene therapies in Europe – Examining decision making process for pricing & reimbursement and regulatory policy that allow for speedy access to therapies
Pricing & Reimbursement
Moderator: Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)
May 2415:40
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Pitch: Pioneering a novel platform technology for prophylactic treatment of a rare pediatric disease, bronchopulmonary dysplasia
Pitch and Partner
Rusty Bromley, Director of Operations, AyuVis Research, Inc.
May 2415:40
Conference pass
Session title to be announced
Commercial
Sponsored by IPM.ai
May 2415:50
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A novel CD127 antibody for treating patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL)
Pitch and Partner
Atul Varadhachary, President & CEO, Fannin Innovation Studio
May 2416:00
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Fireside Chat: Patient Voice and partnership throughout clinical development
Clinical Development & Regulatory
Patient representative to be announced
Stephanie Duffy, Global Patient Advocacy and En, The Janssen Pharmaceutical Company of Johnson and Johnson
May 2416:00
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Panel: Commercializing orphan products for rare diseases
Commercial
Mona Moonis, NA Brand Lead, Rare Disease, Kyowa Kirin
Tsveta Milanova, CCO, Agios
Ashley Cox, Senior Principal, Head of EUR, EVERSANA
Grant Castor, SVP Commercial Strategy & Operations, Sentynl Therapeutics
May 2416:00
Conference pass
Panel: Industry's role in providing support beyond treatments to patients and families affected by rare disease: A case study
Rare Disease Advocacy World
Moderator: Al Freedman, Counseling Psychologist, Freedman Counseling Associates
Kenneth Hobby, President, Cure SMA
May 2416:00
Conference pass
Pitch: Restoring Brain Function with Novel, First-in-Class Regenerative Therapeutics for ALS and other Neurodegenerative Diseases
Pitch and Partner
Ryan Witt, Chief Business Officer, Spinogenix
May 2416:50
Conference pass
Keynote Fireside Chat
Keynotes
Nitin Choudhary, Executive VP, IPM.ai
May 2417:10
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Keynote Panel on standardizing care for rare diseases: benefits in trials and commercialization
Keynotes
Moderator: Lynn Bush, Bioethicist-Developmental Research Scientist, Division of Genetics and Genomics, Pediatrics and Center for Bioethics, Harvard Medical School and Boston Children’s Hospital
Marshall Summar, Director, Rare Disease Institute, Children's National Medical Center
John F. Crowley, Chairman and Chief Executive Officer, Amicus Therapeutics Inc
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May 259:00
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Keynote Fireside chat: Value of advanced therapies - what it means for patients and health systems
Keynotes
Speakers to be announced
May 259:40
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Keynote panel on policy and access: A changing world - how can we increase access for rare disease patients in the US and beyond?
Keynotes
Moderator: Jayson Slotnik, Partner, Health Policy Strategies, LLC
Christoph Glaetzer, Chief Global Value and Access, The Janssen Pharmaceutical Companies of Johnson & Johnson
May 2511:10
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Commercialization cell and gene therapies for rare diseases
Advanced Therapies Commercial
Lisa Deschamps, Chief Executive Officer, AviadoBio
May 2511:10
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Fireside chat: Policy developments in Europe
Policy
Moderator: Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)
Robert-Jan Van Son, GM, BeNeLux and Nordic, Orphalan
May 2511:10
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Informed Consent - how do we need to evolve informed consent to address the DEI gap?
Clinical Development & Regulatory
Speaker to be announced
May 2511:10
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Nof1: Meeting the diverse needs of nano-rare patients: industrializing an individual approach to disease
Advanced Therapies Clinical Development
Sarah Glass, Chief Operating Officer, n-Lorem Foundation
May 2511:10
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Post approval commitments - considerations for data collection
Global Market Access
Speaker to be announced
May 2511:10
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Session title to be announced
Commercial
Sponsored P2PSyncro
May 2511:10
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Session title to be announced
Diagnosis
Sponsored by Invitae
May 2511:30
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Accelerated Approvals & Payers - How can regulators and payers better align?
Global Market Access
Speaker to be announced
May 2511:30
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Global harmonization on a path forward for Newborn Sequencing
Diagnosis
Speakers to be announced
May 2511:30
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How Patient Advocacy within a CRO can better support drug development programs - How to build a bridge over the drug development valley of death
Clinical Development & Regulatory
Christine McSherry, Executive Director, The Emmes Company, LLC
May 2511:50
Conference pass
Current best practices for diversity in clinical trials - taking a holistic look at inclusivity, outreach and engagement
Clinical Development & Regulatory
Moderator: Kim Stephens, President, Project Alive
Hearn Jay Cho, Chief Medical Officer, Multiple Myeloma Research Foundation
Priscilla Rodriguez, Diversity Inclusion Manager, EveryLife Foundation for Rare Diseases
May 2511:50
Conference pass
Examining Accelerated Approvals in the US and beyond
Global Market Access
Silas Martin, Senior Director, Johnson & Johnson
May 2511:50
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Panel: Entering the EU orphan drug market: peculiarities and strategic considerations
Advanced Therapies Clinical Development
Henrik Krook, VP Commercial Commercial Ops, Egetis Therapeutics AB
Leonardo Calzetti, Co-Founding Director, BlueDil International
Sylvain Forget, CEO, BlueDil International
Charlotte Damiano, Global Regulatory Partner, Hogan Lovells
Henric Bjarke, COO, Inozyme
May 2511:50
Conference pass
Panel: Inflation Reduction Act (IRA) and what does it mean for rare disease patients?
Policy
Moderator: Del Lebel, Head US Gov Affairs & Policy, Alexion – AstraZeneca Rare Disease
Jamie Sullivan, Senior Director Of Public Poli, EveryLife Foundation for Rare Diseases
May 2511:50
Conference pass
Panel: Making quality Nof1 treatments a reality for all – regulatory, access and equity considerations
Advanced Therapies Clinical Development
FDA speaker and patient organization to be annouced
Moderator: Sarah Glass, Chief Operating Officer, n-Lorem Foundation
Irina Antonijevic, Chief Medical Officer, EveryONE Medicines
May 2511:50
Conference pass
Pitch: Developing treatments for rare diseases on a shoestring
Pitch and Partner
Sean Ekins, Chief Executive Officer, Collaborations Pharmaceuticals
May 2512:00
Conference pass
Access to Newborn Sequencing – how can we ensure there is diversity, equity, and inclusion?
Diagnosis
Speakers to be announced
May 2512:00
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Pitch: Universal gene therapy for Hemophilia A or B with or without Inhibitors
Pitch and Partner
Damon Race, CEO, GeneVentiv Therapeutics, Inc
May 2512:10
Conference pass
Pitch: Description to be announced
Pitch and Partner
Judith Kelleher-Andersson, President and CEO, NeuroNascent Inc
May 2512:20
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Pitch: To treat a unique disease, engineer a novel biologic - CT-001
Pitch and Partner
Terry Hermiston, CEO and Founder, Coagulant Therapeutics
May 2512:30
Conference pass
Pitch: Description to be announced
Pitch and Partner
Pallavi Sharma, QC Lead, Adverum Biotechnologies
May 2512:40
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Biotech and pharma partnerships for successful (and fast) pathways to treatment of patients diagnosed
Diagnosis
Speakers to be announced
May 2512:40
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Pitch: Description to be announced
Pitch and Partner
David Young, Chief Executive Officer, Processa Pharmaceuticals, Inc.
May 2512:50
Conference pass
Pitch: Revolutionizing the future of cancer treatment through application of the TransCode TTX platform to deliver on the promise of RNA in oncology
Pitch and Partner
Michael Dudley, Chief Executive Officer and Co-founder, TransCode Therapeutics
May 2514:00
Conference pass
ROUNDTABLE - Legislation & advocacy - discussion on how parents can impact state legislation
Roundtables
Annette Muaghan, Co-Founder And Chief Executive Officer, KBG Foundation
May 2514:00
Conference pass
ROUNDTABLE - Sponsored by ICON
Roundtables
Moderator to be announced
May 2514:00
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ROUNDTABLE - Sponsored by Worldwide Clinical Trials
Roundtables
Moderator to be announced
May 2514:00
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ROUNDTABLE: 50% effective or less - how can we increase regulatory flexibility to value effectiveness based on rare disease population needs
Roundtables
Moderator: Julie Breneiser, Executive Director, Gorlin Syndrome Alliance
May 2514:00
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ROUNDTABLE: Education & collaboration - discussion on how advocacy and industry can both educate and learn from each other to advance meaningful clinical trials
Roundtables
Cara Mayfield, VP, Patient Advocacy and Corporate Communications, Homology Medicines
May 2514:00
Conference pass
ROUNDTABLE: Rare preterm births - Addressing the gap in care and treatment of rare preterm births - Successes and lessons learned in rare disease clinical trials
Roundtables
Moderator: Susan Mccune, Neonatologist, Thermo Fisher Scientific
Moderator: Norman Barton, Chair of the Clinical Science, Oak Hill Bio
Victoria Niklas, CMO, Oak Hill Bio
May 2515:00
Conference pass
Innovative & sustainable ways to increase access to treatments & care for rare disease patients in LMICs
Global Market Access
Daniel Wainstock, Researcher and Rare Disease Advocate, PUC-Rio
Andrew Auruku, Chief Executive Officer, Rare Diseases Uganda-RDU
May 2515:00
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Panel and interactive Q&A: Expanded Access (Compassionate Use, Early Access Programs) - Regulatory frameworks, data collection, and global disparities
Expanded/Early Access
Moderator: Holly Fernandez Lynch, Department of Medical Ethics & Health Policy, University of Pennsylvania
Paul Aliu, Head Global Governance Office, Novartis Chief Medical Office (CMO), Novartis
Larissa Lapteva, Associate Director, FDA
last published: 29/Mar/23 03:45 GMT
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