Indian American Association for Professionals in Cell and Gene Therapy (IAAP-CGT)

Eli Lilly to Expand Research Center in India, Says CEO David Ricks Eli Lilly plans to expand its research center in India, highlighting the country's growing status as an economic superpower. CEO David Ricks emphasized India’s importance in global research and development, particularly in pharmaceutical innovation. The expansion will focus on leveraging India's talent and scientific expertise to bolster Eli Lilly’s R&D efforts, contributing to drug discovery and development on a global scale. This move aligns with the company’s strategic vision to enhance its innovation capabilities through India's vast potential. Telangana Lifesciences Dave Ricks Sridhar Babu Duddilla #BiopharmaExpansion #IndianTalentPool #LifeSciencesinIndia #ResearchHub #PharmaCollaboration #ScientificAdvancements #GlobalR&DNetwork #InnovationinIndia #EmergingMarkets #EconomicSuperpower #EliLilly #IndiaResearch #PharmaInnovation #DavidRicks #R&DExpansion #DrugDiscovery #GlobalPharma #IndiaEconomicGrowth #Biopharma #PharmaIndustry #EmergingMarkets #ScientificAdvancements #LifeSciencesIndia

The Department of Health Research (Government of India) is set to initiate a program to develop 12 indigenous drugs for the following 8 rare diseases to make life saving therapies accessible and affordable to patients. 1.     Familial Duchenne Muscular Dystrophy: a genetic disorder that leads to progressive muscle weakness and degeneration. 2.     Familial Hypercholesterolemia: a disorder that causes LDL (bad) cholesterol level to be very high. The condition begins at birth and can cause heart attacks at an early age. 3.     Spinal Muscular Atrophy: a genetic disorder that causes progressive muscle weakness and atrophy.  4.     Gaucher disease: causes bone pain, anaemia, enlarged organs, a swollen, painful belly, and bruising and bleeding. 5.     Pompe Disease: a metabolic disorder that causes a build-up of glycogen in the body's cells, damaging cells and impairing the function of organs and tissues, especially muscles. 6.     Fabry Disease: a rare X-linked lysosomal disorder that results in excessive deposition of lipids in the tissues. 7.     Niemann Pick Disease: a group of inherited disorders that cause lipids to build up in the cells of the brain, liver, and spleen. 8.     Alkaptonuria or black urine disease: a very rare inherited disorder that prevents the body fully breaking down two protein building blocks (amino acids) called tyrosine and phenylalanine. Currently, the National Policy for Rare Diseases, 2021 lists 63 rare diseases categorized into 3 groups: Group 1: Disorders amenable to one-time curative treatment. Group 2: Diseases requiring long term/lifelong treatment with relatively lower cost of treatment. Group 3: Diseases for which definitive treatment is available but challenges are to make optimal patient selection for benefit, very high cost and lifelong therapy. Financial support is provided of up to Rs 50 lakh per patient during the course of the treatment at Centres of Excellence for rare diseases. Twelve Centres of Excellence have been identified at premier Government tertiary hospitals with facilities for diagnosis, prevention and treatment of rare diseases. The Ministry of Finance has also exempted Goods & Services Tax (GST) and Customs Duty on drugs imported for Rare Diseases for individual use and through Centres of Excellence. Indian Council of Medical Research (ICMR) Rajeev Raghuvanshi Indian Organisation For Rare Diseases (IORD)

Proud Moment for Telangana's Lifesciences Sector! I am thrilled to welcome Amgen, one of the world’s largest biotech firms, to Hyderabad, as they join an illustrious list of global companies in our city. Amgen's decision, following an extensive assessment of various cities across India, reaffirms Telangana's position on the global stage as a mature and thriving life sciences ecosystem. My interactions with David Reese, Peter Griffith, Derek Miller and Som Chattopadhyay over the last several months have been incredibly inspiring. Their commitment to leveraging Hyderabad's exceptional talent and infrastructure to accelerate their innovation efforts is greatly encouraging. This Hyderabad center, first-in-India, will play a crucial role in advancing Amgen's global mission to deliver life-changing therapies to patients worldwide. As the CEO of Telangana Lifesciences, I am particularly proud of our team's relentless efforts over the past several months to make this a reality. The proactive approach, seamless support, and unwavering commitment shown by our government were instrumental in this decision. This is not just a monumental milestone in Telangana’s lifesciences growth story but also a testament to our vision for the future of innovation in healthcare. We are committed to ensuring that Amgen’s journey in Telangana is seamless and rewarding. We look forward to working closely with them as they begin operations later this year in their new 3,000-seater office in this vibrant city. Sridhar Babu Duddilla, Jayesh Ranjan, Thanmay Krishna, Jeff Chism, Colby Allen, Michael Strapazon, Saptarsi Haldar, David Lucas

"India Waives Local Clinical Trials for Drugs Approved in Select Countries to Enhance Market Access and Affordability" 1. Government Decision: The Indian government has decided to waive the requirement for clinical trials in India for drugs approved in specific countries including the U.S., U.K., Japan, Australia, Canada, and the European Union. 2. Objective: The aim is to make drugs manufactured outside India more accessible and affordable in the local market by expediting the approval process. 3. Categories for Exemption: Five categories of new drugs will be considered for the Indian market, including: - Drugs for rare diseases. - Gene and cellular therapy products. - Drugs used in pandemic situations. - Drugs for special defense purposes. - Drugs with significant therapeutic advances over current standards. 4. Regulatory Change: The order was issued by India’s drug regulatory agency, the Central Drugs Standard Control Organisation (CDSCO), under Rule 101 of the New Drugs and Clinical Trial Rules, 2019. 5. Industry Support: The Organisation of Pharmaceutical Producers of India (OPPI) welcomed the move, noting it could significantly benefit domestic and foreign drug manufacturers by facilitating faster access to essential medications in India. 6. Healthcare Impact: The inclusion of specific drug categories in this exemption is expected to address critical and unmet medical needs, particularly in the areas of rare diseases and advanced therapies. 7. Further Consideration: The government may consider adding more therapeutic areas where similar waivers could benefit patient access to innovative treatments. 🔗 Link-https://lnkd.in/gu6Q_sHh #clinicalresearch #trialresults #healthcareinnovation #medicalresearch #patientcare #researchstudies #evidencebasedmedicine #healthtech #drugdevelopment #researchcommunity