🔎 Understanding Investigator Initiated Studies: A Deep Dive with Dr. Kamlesh Thakker

As the landscape of clinical research evolves, Investigator Initiated Studies (IIS) have become increasingly important in driving innovation and expanding medical knowledge. To help professionals navigate this complex area, the Academy of Global Medicines Development Professionals is proud to present a new webinar in our Certification in Medicines Development (CMD) program:

Investigator Initiated and Sponsored Studies, Trials, and Research
with Dr. Kamlesh Thakker

Why Investigator Initiated Studies Matter

Investigator Initiated Studies, also known as Investigator Initiated Protocols or Trials, are research projects conceived and led by individual investigators or institutions rather than industry sponsors. These studies often fill critical gaps in knowledge by exploring questions that may not be addressed through traditional industry-driven trials. Understanding how IIS are funded, designed, and regulated is crucial for anyone involved in clinical research, regulatory affairs, or medical affairs.

What You Will Learn

This webinar offers a comprehensive overview of Investigator Initiated Studies, covering:

  • ✅ What are Investigator Initiated Studies (also called Investigator Initiated Protocols/Trials/Research)
  • ✅ Who sponsors and funds them
  • ✅ The general process for applying for IIS proposals
  • ✅ 3–4 case studies highlighting commonly encountered IIS proposals
  • ✅ Regulatory compliance considerations by country and region

The goal is to provide attendees with practical knowledge that can be directly applied in their work, whether in pharma, biotech, academia, or regulatory bodies.

Webinar Details

Choose the session that fits your schedule:

🗓️ May 27, 8:00 AM EST – Register here
🗓️ May 29, 12:00 PM EST – Register here

This webinar is part of the CMD program’s Module 4 series and is ideal for clinical researchers, regulatory professionals, and medical affairs teams looking to deepen their understanding of Investigator Initiated Studies and their impact on medicines development.

Why Attend?

Investigator Initiated Studies can open new avenues for clinical research and innovation, but they come with unique challenges in funding, design, and compliance. This webinar will equip you with the knowledge and real-world examples needed to confidently engage with IIS proposals and collaborations.

About Dr. Kamlesh Thakker

Dr. Kamlesh Thakker PhD, MBA is the Founder/Managing Partner of Notting Hill Consulting LLC, which provides consulting services for pharmaceutical, biotechnology, and financial services companies in the areas of Clinical Development and Medical Affairs, Phase I-IV Clinical Pharmacology, PK-PD, Bioequivalence, and Biopharmaceutics.

At Abbvie/Abbott, Kamlesh led/managed US/global teams responsible for Medical Affairs strategy and tactics from clinical development to launch/on-market support, across several indications/products/development candidates in the Dyslipidemia, Renal, and Immunology Therapeutic Areas (TAs), including Trilipix, Niaspan, Simcor, Zemplar, Humira, Upadacitinib (now Rinvoq), and bardoxolone and other early candidates. Prior to Abbvie/Abbott, Kamlesh briefly worked as Medical Affairs and Clinical Development consultant for Sanofi for their Insulin franchise (Lantus/Apidra) in the US Diabetes Business Unit. Dr. Thakker also has on-market, pre-launch, and launch experience in Cardiovascular Medical Affairs and Clinical Development from his time at Pfizer with the Hypertension and Lipids on-market franchise products, specifically Norvasc and Caduet (Norvasc + Lipitor Fixed Combination). While at Pfizer and Abbvie, Kamlesh also worked in a Pipeline Medical Affairs role for development and licensed candidates across different TAs within the New Product/Pipeline Development Group.

Dr. Thakker also has experience working in Phase I-IV Clinical Pharmacology/Early Development/PK-PD/Biopharmaceutics with Pfizer, Ciba-Geigy (now Novartis) and at Softgel company Banner Gelatin Products. Kamlesh’s Clinical Pharmacology achievements while at these companies include leading/co-leading successful prosecutions of NDAs and sNDAs for several products across different TAs, like Zyrtec, Zithromax, Tegretol Oros, Habitrol, Zantac GelDose capsules and others, and FIH studies for many CNS Neuroscience pipeline development candidates (at Pfizer).

In addition to his extensive Industry experience, Kamlesh also has academic and teaching experience from working as an Assistant/Adjunct Professor at the Colleges of Pharmacy of the University of Florida and the University of Southern California, respectively. Kamlesh has presented and published extensively during his career and has received numerous citations and awards over the years while working with Pfizer, Abbvie/Abbott, Ciba-Geigy, and Banner Gelatin.

Don’t miss this opportunity to learn from one of the industry’s leading experts. Register today and take the next step in your professional development.

Presented by the Academy of Global Medicines Development Professionals
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