COMSTECH Distinguished Scholar Webinar on “Regulatory Innovation in Clinical Trials: Bridging Gaps in Pakistan’s Regulatory Ecosystem”
Date: Monday, August 4, 2025. 3:30 PM (Pakistan Standard Time)
By:
Dr. Shamsher Ali
Clinical/Regulatory Affairs Specialist at the University of Massachusetts Chan Medical School, USA.
Flyer: Click Here
Introduction:
In recent years, the importance of robust clinical trial frameworks has grown significantly, particularly as global health crises and rapid advancements in medicine demand faster yet safer drug development. Pakistan, with its large and diverse patient population, holds untapped potential for clinical research. However, the regulatory environment governing clinical trials in the country remains a significant bottleneck. The approval processes managed by the Drug Regulatory Authority of Pakistan (DRAP) are often slow, which discourages both local and international research sponsors.
Despite attempts to align with international standards, Pakistan’s clinical trial regulations remain loosely harmonized with global benchmarks such as those set by the FDA, EMA, and ICH. Ethical oversight mechanisms, particularly Institutional Review Boards (IRBs), are inconsistently developed across institutions, often lacking the training and resources required to conduct timely and rigorous reviews. This adds further delays and raises concerns about compliance with Good Clinical Practice (GCP).
In addition, regulatory bodies face challenges in terms of staffing, expertise, and technological infrastructure. The absence of digital submission systems, real-time monitoring tools, and centralized databases hinders the efficiency and transparency of trial management. Legal ambiguities around participant rights, data protection, and injury compensation further complicate the regulatory landscape, contributing to an environment of uncertainty for sponsors and investigators alike.
This talk will examine the primary regulatory challenges confronting clinical trials in Pakistan today, evaluates their impact on research and innovation, and outlines actionable steps to align the country’s clinical trial framework with global best practices.
Speaker Profile:
Dr. Shamsher Ali is a highly experienced clinical and regulatory affairs professional with more than 15 years of multidisciplinary expertise spanning clinical research, regulatory strategy, scientific innovation, and trial operations. With a robust academic foundation and advanced training in biomedical research, Dr. Ali has successfully transitioned into leading global Phase I–III clinical trials in diverse therapeutic areas, including oncology (CAR-T, plasma-derived therapies), cardiology, dermatology, diabetes, autoimmune, and rare diseases.
Currently serving as a Clinical/Regulatory Affairs Specialist at the University of Massachusetts Chan Medical School, Dr. Ali oversees end-to-end regulatory operations for over 100 active clinical studies. He is responsible for regulatory submissions (INDs, CTAs, ICFs, CSRs), AE/SAE reporting, TMF and CTMS oversight, vendor management, and regulatory correspondence with the FDA, EMA, and major IRBs (WCG, Advarra, NCI CIRB). His expertise in tools such as OnCore, Advarra eReg, REDCap, Medidata, and Shared Investigator Platform (SIP) enhances trial efficiency, documentation integrity, and inspection readiness.
Dr. Ali’s industry and academic career includes leadership roles at Alliance Foundation Trials, Beth Israel Deaconess Medical Center, Dräger Medical Systems, and American International Chemical. Across these positions, he led regulatory and quality operations, vendor compliance programs, global clinical submissions, and cross-functional collaboration to meet both scientific and regulatory milestones.
Prior to transitioning into regulatory leadership, Dr. Ali conducted extensive postdoctoral research in biomedical sciences. At Harvard T.H. Chan School of Public Health, he led projects on airway remodeling and stem cell behavior using advanced biophysical and imaging techniques. At MIT/Harvard (Brigham and Women’s Hospital), he co-developed microgel-based bioengineered tissue platforms and pioneered cell-patterning technologies for regenerative medicine. At Northeastern University, he specialized in the chemical modification and structural characterization of bioactive oligosaccharides, contributing to drug development for inflammatory diseases.
Dr. Ali holds a PhD in Chemistry and a Master of Science in Regulatory Affairs from Northeastern University. His unique blend of translational science, clinical operations, and regulatory strategy positions him as a leader at the intersection of innovation, compliance, and patient-focused research. Dr. Ali has published his research in peer-reviewed journals like PNAS and Lab on a Chip
Who can attend?
Potential participants for the webinar include clinical researchers, regulatory professionals, pharmaceutical companies, healthcare policymakers, academic researchers and educators, and international research sponsors.
How to register
For registration, please fill the following form: Click Here
Zoom Link will be shared with the participants 1-2 days before the webinar.
Webinar Coordinator:
Muhammad Haseeb Ahmad
Program Officer
Haseeb.ahmad@comstech.org