Abstracts for Round Table (RT) Session 4: Biologics/Long Acting Injectables
Moderators: Dimple Modi and Veeran Kadajji
Presentation 1
Drug Product Design and Manufacturability Considerations for Long Acting Suspension Products
Chandan Bhugra, PhD, Director, Drug Product Development, GSK
Abstract:
Bio:
Chandan is a drug product leader with over 18 years of experience in leading oral and parenteral drug product development from early stage through commercialization. He is currently a team director at GSK leading a team of highly skilled scientists to meet portfolio demands, including formulation and process development, externalization and deviceability assessments for complex long-acting injectables. Chandan has maintained a strong external presence with 49 peer-reviewed publications, podium and poster presentations and has collaborated with academia to mentor PhD and post-doctoral students. Chandan has a PhD in Pharmaceutical Sciences from University of Connecticut.
Presentation 2
Route Agnostic Vehicles for Non-invasive Delivery of Large Molecule Therapeutics
Vivek Gupta, PhD, Associate Professor, St. John's University
Abstract:
Non-invasive routes of administration, including oral and inhaled routes, have always been the mainstay of developing patient-compliant and physiological delivery systems, specifically for chronic ailments. Each delivery route presents unique challenges regarding physiological barriers and formulation parameters. These challenges become more cumbersome for delivering large molecules and biologics, traditionally delivered by injection. This work will divulge our efforts in developing novel platform nano-formulations capable of delivering large molecules by oral and inhaled routes of administration with minimal modulation, using insulin as a model molecule.
Bio:
Dr. Vivek Gupta currently serves as the Associate Dean of Graduate Education & Research; and Associate Professor of Pharmaceutical Sciences at St. John’s University College of Pharmacy & Health Sciences. Dr Gupta is an experienced pharmaceutical researcher with an interest in developing novel therapies for respiratory disorders. His expertise lies in the areas of non-invasive delivery of small and macromolecules via oral, nasal, and inhalation routes. He also has significant research interest in the fields of pharmaceutical scalability, and nano-repurposing. Dr Gupta completed PhD in Pharmaceutical Sciences from Texas Tech University HSC, followed by postdoctoral research at the University of California Santa Barbara (UCSB). Dr. Gupta’s research group has published >100 high-impact publications in peer-reviewed journals; with >6,000 citations. Multiple technologies and therapies developed by Dr. Gupta’s group have been patented and are at various stages of preclinical/clinical development.
Presentation 3
AI-driven automation for LAI discovery and scale-up – A Case Study
Karthik Raman, PhD, CEO, Persist AI
Abstract:
Quickly determining the right process and material attributes for LAIs remains an ongoing challenge along with predictable scale-up of the process. In this talk we will demonstrate:
· Using robotics and AI predictive tools, it is possible to rapidly screen LAI formulations to meet a QTPP at the small scale
· By utilizing microfluidics, even the scale-up process can speed up. We utilize an in- line flow measurement process and vary parameters until we meet the results of the high throughput screening platform
Bio:
Karthik is the CEO of Persist AI. A company that’s using AI x Robotics to accelerate drug formulation development. He previously received his PhD from the University of Utah, where his research focused on sustained drug delivery to the brain. Most recently he held an automation role at Zymergen, where he helped develop a modular and reconfigurable automation lab for synthetic biology. Persist AI is a venture backed company supported by YCombinator, Spero Ventures, 2048, Innospark.
Moderators: Dimple Modi and Veeran Kadajji
Presentation 1
Drug Product Design and Manufacturability Considerations for Long Acting Suspension Products
Chandan Bhugra, PhD, Director, Drug Product Development, GSK
Abstract:
Bio:
Chandan is a drug product leader with over 18 years of experience in leading oral and parenteral drug product development from early stage through commercialization. He is currently a team director at GSK leading a team of highly skilled scientists to meet portfolio demands, including formulation and process development, externalization and deviceability assessments for complex long-acting injectables. Chandan has maintained a strong external presence with 49 peer-reviewed publications, podium and poster presentations and has collaborated with academia to mentor PhD and post-doctoral students. Chandan has a PhD in Pharmaceutical Sciences from University of Connecticut.
Presentation 2
Route Agnostic Vehicles for Non-invasive Delivery of Large Molecule Therapeutics
Vivek Gupta, PhD, Associate Professor, St. John's University
Abstract:
Non-invasive routes of administration, including oral and inhaled routes, have always been the mainstay of developing patient-compliant and physiological delivery systems, specifically for chronic ailments. Each delivery route presents unique challenges regarding physiological barriers and formulation parameters. These challenges become more cumbersome for delivering large molecules and biologics, traditionally delivered by injection. This work will divulge our efforts in developing novel platform nano-formulations capable of delivering large molecules by oral and inhaled routes of administration with minimal modulation, using insulin as a model molecule.
Bio:
Dr. Vivek Gupta currently serves as the Associate Dean of Graduate Education & Research; and Associate Professor of Pharmaceutical Sciences at St. John’s University College of Pharmacy & Health Sciences. Dr Gupta is an experienced pharmaceutical researcher with an interest in developing novel therapies for respiratory disorders. His expertise lies in the areas of non-invasive delivery of small and macromolecules via oral, nasal, and inhalation routes. He also has significant research interest in the fields of pharmaceutical scalability, and nano-repurposing. Dr Gupta completed PhD in Pharmaceutical Sciences from Texas Tech University HSC, followed by postdoctoral research at the University of California Santa Barbara (UCSB). Dr. Gupta’s research group has published >100 high-impact publications in peer-reviewed journals; with >6,000 citations. Multiple technologies and therapies developed by Dr. Gupta’s group have been patented and are at various stages of preclinical/clinical development.
Presentation 3
AI-driven automation for LAI discovery and scale-up – A Case Study
Karthik Raman, PhD, CEO, Persist AI
Abstract:
Quickly determining the right process and material attributes for LAIs remains an ongoing challenge along with predictable scale-up of the process. In this talk we will demonstrate:
· Using robotics and AI predictive tools, it is possible to rapidly screen LAI formulations to meet a QTPP at the small scale
· By utilizing microfluidics, even the scale-up process can speed up. We utilize an in- line flow measurement process and vary parameters until we meet the results of the high throughput screening platform
Bio:
Karthik is the CEO of Persist AI. A company that’s using AI x Robotics to accelerate drug formulation development. He previously received his PhD from the University of Utah, where his research focused on sustained drug delivery to the brain. Most recently he held an automation role at Zymergen, where he helped develop a modular and reconfigurable automation lab for synthetic biology. Persist AI is a venture backed company supported by YCombinator, Spero Ventures, 2048, Innospark.
