Veeda engages with life sciences startups for Phase 1 trial solutions

New Delhi: Veeda Group in collaboration with Atal Incubation Centre – Centre for Cellular and Molecular Biology (AIC – CCMB) organized a half-day symposium on Phase 1 trial solutions for emerging life sciences start-up companies, at Hyderabad.

The symposium, titled “Integrated Phase I Trial Solutions for Emerging Biopharmaceuticals: Addressing Development Challenges and Accelerating Timelines” aimed to address the challenges and optimize the processes related to the development of New Chemical Entities (NCEs) and Large Molecules.

Covering various aspects within this domain, the symposium featured an illustrious panel of experts from the pharma and biopharma industry, researchers, scientists, and esteemed regulatory experts. The phase 1 symposium featured expert-led presentations, encompassing a range of topics from regulatory considerations to advanced analytical methods, imparting knowledge and understanding that is shaping the future of pharmaceutical and biopharmaceutical industries.

The registered participants at the Phase 1 symposium featured life sciences start-up companies from healthcare, biopharma, industrial biotech, agriculture, and med-tech fields.

Dr. A. Ramkishan, Deputy Drugs Controller (India) at the Ministry of Health and Family Welfare, Government of India was the chief guest at the symposium. Welcoming the Chief Guest of Phase 1 symposium, Dr. Ramjee Pallela, COO at AIC – CCMB highlighted the importance of new-age research and emphasized on the use of technology to build connects between Industry, Research Institutes and Regulators.

In his opening remarks at the Phase 1 symposium, Dr. Madhusudhan Rao, CEO at AIC – CCMB, addressing the life science start up companies, reiterated the role of AIC – CCMB and said, “At AIC-CCMB, we endeavor to build an ecosystem for enabling biotechnology innovation. As Indian researchers and innovators begin to expand the boundaries of science, pursuing novel therapies, diagnostics, medical devices and industrial solutions, we ensure that their technologies are translated into sustainable business solutions that reach the citizens.”

Dr. A. Ramkishan delivered the talk and presentation on “Regulatory Guidelines for Drug Discovery & Development”. Dr. Ramkishan emphasized the importance of various laws and regulations pertaining to the life science sector. He offered comprehensive understanding of the regulatory landscape governing novel drug development and shared his advice on how start-up companies in the life science and healthcare space can collaborate with the office of Directorate General of Health Services (DGHS).

Diving into the significance of “Biomarkers in Drug Development,” Dr. Jagannath Kota, Director, Translational Medicine at Novartis Institute of Biomedical Research delivered an insightful presentation on Biomarkers and explained how these advanced indicators are revolutionizing the way the pharma companies assess and develop new treatments. He shared a case study related to Oncology research and explained how the findings in Biomarkers were translated in the clinical trials phase.

Followed by this, was a talk and presentation from Dr. Suchita Markan, Scientist and Mission In-Charge of India’s Medical Device and Diagnostics Mission Secretariat (MDMS) under the Indian Council of Medical Research (ICMR). Dr. Suchita delivered a focused talk on ICMR initiatives for strengthening the Medtech ecosystem and the way forward. Dr. Sunita extended invitation to life science start-up companies to collaborate and engage with ICMR and leverage the opportunity to build connects with research and academic institutes.

Highlighting the importance of preclinical aspects of NCEs, Mr. Ravi Kumar C, Head – Toxicology at Bioneeds India Pvt. Ltd., shared intriguing and insightful details about preclinical studies, which provides information on safety, efficacy and helps to determine a starting, safe dose for FIM, (FIRST-IN-MAN).

Advanced Analytical Techniques:

Sharing details of “Analytical Methods for Assessing Higher Order Structure in Biosimilars”, Dr. Rajiv Bhardwaj from Veeda Clinical Research (Biopharma division) delved into innovative methodologies that are driving the development of biosimilar drugs. Highlighting the Higher Order Structure capabilities and expertise at Veeda, Dr. Rajiv presented different biopharma solutions for the start-up companies and invited them to collaborate with Veeda for their specific needs and requirements for biopharma solutions.

The closing session of phase 1 symposium witnessed the most awaited talk and presentation on Subject Safety in phase 1 trials of NCEs by Dr. Kiran Marthak. Beginning his talk by explaining the regulatory pathway for first-in-human (FIH) trials, Dr. Marthak shared case study related to Theralizumab – Mab and explained the entire process starting from enrollment and dosing of patients, designing of trials, right through conducting SAD and MAD studies until the safety considerations for enrolled patients. Highlighting the challenges in phase 1 studies, Dr. Marthak cited Veeda’s expertise in conducting complex phase 1 studies for reputed clients.

AIC – CCMB offered great support and extended hospitality to representatives of life science startup companies, which included Aasya Healthcare, PathnSitu Biotechnologies, Consytel Lifesciences, Pulse Pharma, AET Labs, Vcult Lifesciences, Abiogenesis Clinpharm, PopVax Private Limited, Cohance Lifesciences and member companies of IKP Knowledge Park.

The phase 1 symposium, organized jointly by Veeda Group and Atal Incubation Centre – Centre for Cellular and Molecular Biology (AIC – CCMB), was a great success. The engagement and conversations between eminent experts and participants, during QnA sessions, generated a lot of interest in many attendees as the symposium offered a great opportunity to life sciences start-up companies with knowledge and understanding of regulatory pathway.