Unlocking India for rare disease clinical trials
Sponsored by: Orphan Reach Ltd
- Clinical Trials
- Rare Disease
Date: 30 June
Days to go: 17
Time: 2PM London / 3PM CET
Outlining the key benefits and considerations of utilising India as a contributing country when recruiting patients for rare disease trials
India has close to 70 million people affected by rare diseases in a population above 1.3 billion people. This corresponds to about one fifth of all rare disease cases globally. As the globally operating biopharmaceutical industry often struggles to find enough patients for their clinical trials and rare diseases don’t stop at borders, India represents an attractive location to accelerate patient recruitment and to collect a sufficient amount of data for analysis.
This webinar will explore why India represents as an attractive country to conduct rare disease trials, by delivering a thought-provoking session including a case study to highlight how India can fit into the global picture of international trials. Orphan Reach has had an established presence in India since 2012. With a robust infrastructure in place across the country, the company has gained important experience allowing them to find patients in many rare disease areas and to reliably conduct clinical trials.
We will explore details regarding obtaining central and local approvals, to support sites and how to monitor these trials locally given the challenges around rare disease complexities. We will also cover how to manage vendors (locally) and centralised data liaison activities for trial success in India.
The patient experience and perspective are of utmost importance to all clinical trials and therefore we will also hear from the Organisation for Rare Diseases India, who will focus on how ORDIndia is enabling rare disease diagnostic and therapeutic program deployment in India. In addition to an overview of current rare disease regulations, with a focus on the impact of the latest guidelines outlined by the Indian Government in 2019 and what this means for clinical research in the country.
If you’re considering site and patient recruitment in India, register for this webinar to utilize Orphan Reach’s experience to assist you getting started.
Project Director – Orphan Reach
Eve has a varied background within clinical research, starting her career as a Pharmacy Technician at Guys & St. Thomas’s Hospital London where she developed a passion for clinical research. Whilst working in pharmacy and studying towards a MSc in Clinical Research, Eve started her CRA career in a non-commercial environment. Over the years Eve has moved across to work within a commercial CRO with various clients before specialising in Rare Diseases with Orphan Reach over the last 5 years.
Eve’s current role as a Project Director allows her to provide guidance and support for clients with programs of studies, mentoring junior staff and managing her own studies.
Director of Data Operations & GPM – Orphan Reach
Gajendra is the Director of Data Operations and Global Partnering Management at Orphan Reach. Before he joined Orphan Reach in 2016 to set up global data operations within the company, he spent more than 12 years in various roles within the CRO industry, including roles as a Data Manager, QA Auditor, Project Manager, BD Manager and Strategist.
Gajendra plays an important role in Orphan Reach’s centralised project management and oversees the planning of project resources as well as the tracking and management of contracts and budgets. He is also responsible for managing relationships with partners and vendors, including identification, approval, and ongoing oversight
Dr. Sudheendra Rao,
Scientific Advisor – Organisation for Rare Diseases India
Sudheendra Rao is a medical scientist, with clinical and preclinical research experience, in addition to industry R&D, product development and regulatory experience.
As a Scientific Advisor at ORDI, Dr Sudheendra Rao, provides technical and scientific observations to ORDIndia on rare disease policies, such as the national policy on the treatment of rare diseases, new drugs, and clinical trial rules alongside the compassionate use of orphan drugs. Dr Sudheendra Rao also provides scientific inputs to ORDIndia’s affiliated patient advocacy groups with regards to diagnostics, therapeutics, and policy issues.
Key Learning Objectives
- Learn why India is an attractive country for conducting rare disease clinical trials
- How to obtain central and local approvals, to support sites in India
- How to monitor these trials locally given the complexities of rare disease trials
- How to ensure a positive patient experience
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