Indo US Organization for Rare Diseases (IndoUSrare)的动态

Transcript

Hello, my name is Geetika Savasta. I'm I'm a hematologist, medical oncologist at a medical officer in the Division of Oncology at the US FDA. I'm also the lead for Project Asha that I'll be talking about today. Thank you for the invitation. I'm honored to be speaking today. In June of 2023, when Prime Minister Modi visited United States and met with President Biden, there was announcement of the US India Cancer Dialogue to advance prevention, early detection and treatment of cancer in India. The goal of this collaboration is to identify short and long term opportunities for bilateral cooperation that will drive greater care and improved outcomes for cancer patients. One of the key priority areas identified as part of the US India Cancer Dialogue is clinical trials and research training. This includes identifying collaborative opportunities that promote more inclusive and equitable participation of India in international cancer clinical research and trial programs. As well as training of early career clinical researchers and pragmatic patient centered clinical trials focused on key questions in low resource setting enabled by Indian pharmaceutical companies. In January of 2024, the Oncology Center of Excellence at the USFDA launch project Asha to increase cancer clinical trial access in India. The project is aimed at assisting development of a robust clinical trial ecosystem in India. Das Enebling in der Debian. Equitable partner in multi regional cancer clinical trials. This should also provide a platform for Indian pharmaceuticals and cancer drug development in India to grow to international standards. Project NASHA aims to hold a series of discussions and dialogue with the key stakeholders to understand the current availability of oncology clinical trials as well as the regulatory landscape of the clinical trial in India. The goal is to work closely with Indian regulatory authorities as well as the Indian government to identify opportunities to increase access to cancer trials. And share regulatory insights and guidance with regulators as well as researchers to strengthen the clinical trial ecosystem. Briefly, on the current landscape of clinical trials and regulatory framework in India. We know that India is now the most populous country in the world, approximately 20% of the world population. However, it has less than 1.5% participation in global clinical trials. In terms of regulatory landscape, the period from 2005 to 2013 witnessed the rapid expansion of clinical research in India, which was due to favorable regulatory changes, removal of phase lag, decrease review time and tax incentives. However, in 2012 there were several court cases filed claiming subject exploitation, inadequate compensation, poorly documented informed consent processes under reporting of adverse events, as well as some cases of data falsification. This resulted in the Supreme Court of India intervening to halt all ongoing and planned clinical trials unless the system for protection of clinical trials subject was strengthened. This led to various amendments in the regulatory framework. While the intention of these was to bring clarity and transparency in clinical trial operations and to restore public trust in clinical trials, the practical implementation of these measures was challenging for research based pharmaceutical companies and there was a significant decline in clinical trials. Recognizing that the stringent regulatory environment in India was stifling research and the need to improve the trust in the regulatory framework, the new drugs and clinical trial rules were implemented in 2019 by the Indian government. This led to a paradigm shift and is making Indian equal Indian trial ecosystem more aligned with global practices. For Project Asher to dive in, we really wanted to 1st understand the current landscape of trials as well as regulatory framework for for oncology clinical trials and thus be able to identify opportunities. Since its launch in January of 2024, we first organized a roundtable with key stakeholders in India. This included patients in India with cancer, Indian oncologists, sponsors and Indian regulatory authorities. We've had multiple closed door sessions with the Central Drugs Standard Control Organization, CSIO and have identified future knowledge sharing opportunities. At the annual American Society of Clinical Oncology, also known as ASCO, meeting in June of 2024. The US India Cancer Dialogue and Project Asher was discussed with the ASCO leadership. CSIO was invited by the FDA to attend the international regulator session, where the official had a chance to interact with other international regulators, leveraging common regulatory practices and sharing initiatives and guidance for overcoming barriers to clinical trial access. Also at this meeting, our team published the analysis of the FDA database on enrollment from India and cancer clinical trials, which led to an FDA approval of oncology products in the last 12 years. I've seen in the table below, enrollment from India was less than 0.7% in all trials and for some pertinent cancer such as head and neck cancer and cervical cancer, the numbers were actually 0, highlighting some key areas of opportunity for India. Project Asha participated in the 1st US India Cancer Dialogue meeting which was held in New Delhi in August of 24. This was attended by leadership from both countries including Nobel Laureates as as well as lead political appointees. The project has also been included in the Cord Moon Shot Cancer initiative announced in September 2024. Word, which comprises of the United States, Australia, India and Japan announced the Moon Shot Initiative as a groundbreaking effort to help end Cancer as we know it in the Indo Pacific region. Starting with cervical cancer and laying the groundwork to address other forms of cancer as well. As mentioned, the goal of the project is to share regulatory insights and guidance with researchers as well as regulatory authorities. Our team along with FDA India participated in the Indian Council of Medical Research, ICMR and PGI Chandigarh LED phase one clinical trial regulatory workshop from N6 to November 9th last week in Chandigarh. The program included didactic lectures and regulatory science by the FDA staff, as well as interactive panel discussions and sessions to provide regulatory insights. This was followed by visit to New Delhi and included in person visits with other key stakeholders such as academic research institutions as well as Indian regulatory body and outlining of some strategic future engagements. Project Ashe is also engaging with the strong Indian American oncology community in the US who are leaders in the field of global cancer clinical trials and have special interest in cancer care in India. We organized an internal mini symposium in October of 2024 titled Bridging Borders. We have been invited and provide support to other external initiatives that align with the goals of the project. These include regulatory insights and form of didactics and lectures or panel discussions. In summary, since the launch of the initiative, we have established engagement with key stakeholders, developed a better understanding of the cancer clinical trial framework as well as the regulatory landscape in India. The product is sharing regulatory insights and knowledge with early career researchers and regulators. The project continues to have open dialogue to identify future opportunities for strengthening the Indian cancer clinical trial ecosystem. This will not only enable India to be an equitable partner in global cancer clinical trials but also lay the framework for Indian pharmaceuticals for developing innovative cancer drugs. I would like to acknowledge the leadership and team at FDA who are contributing to the project. Thank you.