5th Annual Symposium
Applications of Quality by Design in Drug Development &
Manufacturing
Speakers and Topics
Dean Indra Reddy, Ph.D. (Keynote) – Developing
Pharmaceutical Leaders for Tomorrow: A Framework for Leadership
Mansoor Khan, R.Ph. ’92Ph.D. – Quality by Design: Scientific and
Regulatory Aspects
Christopher Balducci, R.Ph. ’98P, ’00MBA – Implementation of
Quality by Design
in the Pharmaceutical Development and Full Scale Manufacturing
Gintaras (Rex) Reklaitis, Ph.D. – FDA/NIPTE Quality by Design
Case Study for an Oral Dosage Product: Lessons Learned
Apiromraj (Pito) Roslansky – The Quality by Design Paradigm and
the Generics Industry
Douglas Becker ’75P, ’78GP, ’82Ph.D. – The Application of
Tunable Diode Laser Absorption Spectroscopy (TDLAS) for Monitoring
Spray Coating
4th Annual
Symposium
Development of Modified-Release Dosage Forms for Optimal Drug
Development
Speakers and Topics
Waseem Malick, Ph.D. (Keynote) – Controlled and Targeted Drug
Delivery: Past, Present and Future
Avinash Thombre, Ph.D. – Recent Advances in Modified Release
Oral Drug Delivery
Hapreet Sandhu, Ph.D. – Multi-Particulate Delivery for Oral
Controlled Release: Design Considerations
Sailesh Singh, Ph.D. – Application of Quality by Design (QbD) in
the Development of Modified Release Oral Delivery Systems: A Case
Study
Anand Baichwal, Ph.D. ’81GP – Modified Release Dosage Forms:
Some Regulatory Aspects and Considerations
Vishal Saxena ’05Ph.D. – Going From Good to Great: Taking
Commercial Modified - Release Oral Technologies to the Next
Level
3rd Annual
Symposium
Recent Advances in Pharmaceutical Processing
Speakers and Topics
Salah Ahmed ’85GP, ’90Ph.D. (Keynote) – Drug Development and
Manufacturing in the 21st Century
David Ellis, B.S. – Critical Parameters in High Shear and Fluid
Bed Granulations
Colleen Ruegger, Ph.D. – Trends and Recent Advances in
Compression and Tabletting Sciences
Ashlesh Sheth ’86GP, ’91Ph.D. – Hot Melt Extrusion Theory and
Pharmaceutical Application
Abu Serajuddin ’82Ph.D. – Recent Applications of Melt
Granulation Technology: Development of High-Dose Tablets and
Continuous Processing
Mansoor Khan, R.Ph. ’92Ph.D. – Quality by Design: Recent
Progress in FDA GRADA Initiatives
2nd Annual
Symposium
Challenges in the Development of Poorly Water-Soluble Drugs:
Formulations and Technological Approaches
Speakers and Topics
Navnit Shah ’73P, ’81Ph.D. (Keynote) - Challenges in Drug
Product Development in the 21st Century
Emilio Squillante, Ph.D. – Application of Supercritical Fluid
Technology in Developing Nanoparticle, Cyclodextrin Complex and
Solid Dispersion Formulations
Joseph Famulare ’76C – Advances in Quality Systems in the New
Paradigm of Drug Regulation
Sanjeev Gupta, R.Ph. ’87GP, ’92Ph.D. – Development of
Lipid-based Delivery Systems for Poorly Water-Soluble Drugs:
Challenges and Opportunities
Madhav Vasanthavada, Ph.D. – Development of High-Energy Solids
by Melt Extrusion: Case Studies
Mansoor Khan, R.Ph. ’92Ph.D. – Scientific and Regulatory Aspects
of Developing Poorly Water-Soluble Drugs
1st Annual
Symposium
FDA Perspectives on Pharmaceutical Product Development in the 21st
Century: Opportunities and Challenges
Speaker
Mansoor Khan, R.Ph.’92Ph.D.