Drug Development to Commercialization PDT
Welcome to the Drug PDT, an innovative initiative tailored to guide academic and clinical investigators through the complex journey of bringing novel therapeutics and diagnostics from discovery to commercialization. Our program is strategically designed to support projects that address unmet medical needs, offering a comprehensive array of resources and mentorship. Our team of experts with industry experience understands the challenges and opportunities of drug development. We’re here to empower researchers and drive advancements that have a real impact on healthcare.
- Project-Specific Mentorship:
Experienced mentors are assigned to each project, offering personalized guidance and insights. This one-on-one mentorship is tailored to the unique needs of your research, providing invaluable support throughout the development process.
- Multi-disciplinary Product Development Guidance:
Our program offers valuable advice on navigating the multi-disciplinary landscape of product development. We guide you through every step, from intellectual property considerations to regulatory compliance.
- Seed Funding:
We provide essential seed funding to kickstart your research and propel it towards successful development. This financial support is a catalyst for turning promising ideas into tangible projects.
Education and Mentorship Areas
Our program encompasses a broad spectrum of education and mentorship, covering key areas crucial for successful drug and diagnostic development:
- Intellectual Property and Patent Law:
Understand the intricacies of intellectual property and patent law to safeguard your innovations and navigate the legal landscape.
- Assay Development:
Learn best practices for developing robust assays, a critical component in validating and optimizing novel therapeutics and diagnostics.
- Optimization of Therapeutic Chemical Structures:
Explore strategies for optimizing the chemical structures of therapeutic agents, enhancing their efficacy and safety profiles.
- Preclinical Pharmacology and Proof of Concept Studies:
Gain insights into preclinical studies, including pharmacology and proof of concept, to build a strong foundation for clinical development.
- Preclinical Safety and Pharmacokinetics:
Understand the importance of preclinical safety assessments and pharmacokinetics in ensuring the viability and safety of your products.
- Regulatory Science and Agency Expectations:
Navigate the regulatory landscape by staying informed about regulatory science and understanding the expectations of regulatory agencies.
- Clinical Study Design and Conduct:
Learn the principles of designing and conducting successful clinical studies, optimizing your path to regulatory approval.
- Commercialization/Start-up Company Funding and Incorporation:
Explore the strategies and avenues for commercializing your discoveries, including funding options and incorporating a start-up company.
For inquiries and applications, please get in touch with Padma Portonovo, Navigator for the drug PDT, to learn more about how we can support your project’s success.
Andrew Dahlem, PhD, chief of clinical pharmacology and senior research professor of medicine at IU School of Medicine and Richard Taylor, PhD, professor of chemistry and biochemistry at the University of Notre Dame and director of the Molecular Therapeutics Program for the Indiana CTSI, co-lead the Think Tank pharmaceutical program.
Chair: Andy Dahlem, IU School of Medicine
Co-Chair: Rich Taylor, University of Notre Dame
Regulatory Rep: Chris Caldwell, IU School of Medicine
- Timothy Richardson, IU School of Medicine
- Brian Blagg, University of Notre Dame
- Ramaswamy Subramanian, Purdue University
- Zhong Yin-Zhang, Purdue University
- Adrienne Takacs, IU School of Medicine/Eli Lilly
- Mary Mader, IBRI
- Yvonne Lai, Indiana University
- Mark Kelley, IU School of Medicine
- Kim Saxton, IU Kelley School of Business
Navigator: Padma Portonovo, IU School of Medicine
Related Indiana CTSI Programs:
- Concepts to Clinic Project Development Team
- TL1 Postdoctoral Fellowship, Innovation-Entrepreneurship Track
- For applications specific to Alzheimer’s Disease and Cancer:
TREAT-AD Center for Alzheimer’s Disease Drug Discovery
IU Simon Comprehensive Cancer Center (IUSCCC) Cancer Drug Discovery & Development (CDDD) Working Group Platform