Main Conference Agenda

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1 Sponsored by: (Co-located with Bioequivalence: Intersection between Science & Regulatory Conference) Main Conference Agenda Day One Wednesday, November 5 th, :30 Registration Opens & Continental Breakfast for Attendees 8:50 Chair s Day One Welcome and Opening Remarks Riccardo Panicucci, PhD, Global Head, Chemical and Pharmaceutical Profiling, Novartis 9:00 OPENING KEYNOTE: Breakthrough Innovations in the Next Generation of Drug Products: A New Thinking for Formulation Design Riccardo Panicucci, PhD, Global Head, Chemical and Pharmaceutical

2 Profiling, Novartis 9:40 PANEL DISCUSSION: Creating Next Generation Products: Evaluating Innovations in Oral Drug Formulation and Delivery Technologies Participants: Stefan Proniuk, PhD, Vice President, Product Development, Arno Therapeutics Riccardo Panicucci, PhD, Global Head, Chemical and Pharmaceutical Profiling, Novartis Mark Wilson, PhD, Director, Collaboration Management, Europe, Platform Technology and Science, GlaxoSmithKline Praveen Hiremath, PhD, Manager, Formulation Development & Pilot Plant, Bayer Healthcare Adam Feiler, PhD, Chief Technical Officer, Nanologica; Professor Applied Nanotechnology, Royal Insititue of Technology, Sweden 10:30 Morning Networking & Refreshment Break in Exhibit Hall 11:00 PANEL DISCUSSION: Beyond the Pill: Addressing Future Patient Needs Through the Importance of Pharmaceutical Profiling Participants: Vijay Gupte, PhD, Associate Director, Formulation Development, Takeda Kurt Van Scoik, PhD, Research Fellow, Eli Lilly and Company Weiguo Dai, PhD, Scientific Director, Drug Product Development, Janssen Research & Development, Johnson and Johnson 11:45 Impact on Solubility and Dissolution Rate upon Nanosizing Poorly Soluble Pharmaceuticals Sharad Murdande, PhD, Principal Scientist, Pharmaceutical Development, Lifecycle Management, Pfizer, Inc. 12:30 Networking Lunch 1:30 Design of Oral Bioavailability Enhancing Formulations using Absorption Modeling and Simulation Akash Jain, PhD, Senior Scientist I, Discovery Pharmaceutics, Cubist Pharmaceuticals

3 2:10 Enhancing Oral Formulation and Process Development Timelines: Integrated Computational Materials Science Approach in Drug Product Development Ilgaz Akseli, PhD, MBA, Senior Principal Scientist, Boehringer Ingelheim 2:50 An Integrated In Silico-In Vitro Nested Modeling Platform for Assessing Oral Bioavailability - Enabling Formulations Daniel Hines, PhD, Senior Research Scientist, Takeda Pharmaceuticals 3.30 Afternoon Networking and Refreshment Break 4:00 Towards Integrated Drug Product Design via Particle Engineering Terry Kougolous, PhD, Head, Process Development, Novan Therapeutics 4:40 Understanding the Impact of Excipients Selection on Oral Drug Product Performance Minli Xie, PhD, Associate Director, Senior Scientist, Pharmaceutical Sciences, Genentech (A Member of the Roche Group) 5:20 Chair s Closing Remarks & Networking Drinks Reception in Exhibit Hall Day Two Thursday, November 6 th, :00 Registration Opens & Continental Breakfast for Attendees 8:50 Chair s Welcome and Opening Remarks Eric Munson, PhD, Patrick DeLuca Endowed Professor of Pharmaceutical Technology, University of Kentucky 9:00 Effectively Understanding the QbD/Risk Management Process for Developing a Bioequivalent Product

4 Adnan Sabir, M.S., RPh., QA-CMC Manager, Kowa Pharmaceuticals America, Inc. 9:40 Innovations within Characterization of Amorphous Materials to Advance Product Development Eric Munson, PhD, Patrick DeLuca Endowed Professor of Pharmaceutical Technology, University of Kentucky 10:20 Morning Networking & Refreshment Break in Exhibit Hall 10:50 Combining In-Vivo Animal Models with Physiologically Based Pharmacokinetics (PBPK) Modeling to Optimize Oral Formulation Dosage Forms Handan He, PhD, Director, Head, Pharmacokinetics and Pharmacodynamics (PK/PD), Novartis 11:30 Nanoporous silica: A platform for enhanced solubility and a tool for formulating hard to handle molecules. Adam Feiler, PhD, Chief Technical Officer, Nanologica; Professor Applied Nanotechnology, Royal Insititue of Technology, Sweden 12:10 Networking Lunch 1:10 Drug Delivery Technologies for Improved PK Variation and Food Effect Reduction Jim Huang, PhD, Co-Founder & CEO, Ascendia Pharmaceuticals 1:50 A New Approach for Sustaining Supersaturation of High Energy Forms of Poorly Soluble Compounds Shirlynn Chen, PhD, Senior Research Fellow, Pharmaceutics, Boehringer Ingelheim 2:30 Afternoon Networking and Refreshment Break 2:50 Examining Innovative Strategies for Maximizing Exposure for New Compounds in Early Formulation Development

5 John Morrison, PhD, Senior Research Investigator, Discovery Pharmaceutics, Bristol-Myers Squibb 3:30 Gastro-Retentive Controlled Release Technology to Enable Once-Daily (QD) Dosing Pranav Gupta, PhD, Principal Scientist, Pharmaceutical Sciences, Merck Research Labs (MRL), Merck and Co. 4:10 Chair s Closing Remarks and End of Conference Registration Pricing Discounted (Register before Friday, September 12, 2014) Conference Only $1995 Standard (Register after Friday, September 12, 2014) Conference Only $2195 Group Discounts Available: Save 25% per person when registering four people from your company. For every three simultaneous registrations, you will receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person. (Please note that registration enables participant access to both the Oral Drug Formulation Innovations Summit and the Bioequivalence: Intersection between Science & Regulatory Conference).

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