Day One – Wednesday, September 6th, 2017

7:30am - 8:30am

7:30am - 8:30am

Registration Opens & Continental Breakfast for Attendees

8:30am - 8:40am

8:30am - 8:40am

Chairperson’s Day One Welcome and Opening Remarks

GENERAL SESSION PLENARIES

8:40am - 9:20am

8:40am - 9:20am

KEYNOTE: Precision Medicine & Healthcare Delivery: Making Precision Medicine a Reality via Novel Technology Advancements

Keynote to be confirmed shortly

9:20am - 10:00am

9:20am - 10:00am

Commercializing Extended Release Delivery of Drugs in Oral Liquid Dosage Form
Ketan Mehta PhD

Ketan Mehta PhD

President & CEO, Tris Pharma

10:00am - 10:40am

10:00am - 10:40am

Breakthrough Advances & Commercial Strategies for Orphan Drug Development
Linda Lohr, PhD.

Linda Lohr, PhD.

Senior Director, Portfolio Strategy, Pfizer, Inc.

10:40am - 11:10am

10:40am - 11:10am

Morning Networking & Refreshment Break in Exhibit Hall

11:10am - 11:50am

11:10am - 11:50am

Merck’s Approach to 3D Printing & Continuous Manufacturing for Biopharmaceuticals: Next-Generation Commercial and Industrial Scale-Up Opportunities
Adam Procopio, PhD.

Adam Procopio, PhD.

Senior Principal Scientist, Drug Product Additive Manufacturing (3D Printing) Lead, Merck & Co.

11:50am - 12:30pm

11:50am - 12:30pm

PANEL SESSION: Exploring Innovative Collaboration Models to Accelerate Next Generation Product Development

Panelists to be confirmed shortly

12:30pm - 1:30pm

12:30pm - 1:30pm

Networking Lunch

4th Annual Controlled & Modified Drug Release
3rd Drug Delivery Strategy: Advanced Mechanisms & Product Design
2nd Peptide Drug Design & Delivery Summit

NEXT GENERATION DELIVERY OPPORTUNITIES

NOVEL DRUG DELIVERY PARTNERING STRATEGIES

DESIGN IMPLICATIONS FOR NOVEL PEPTIDE-BASED PRODUCTS

1:30pm - 2:00pm

1:30pm - 2:00pm

Breakthrough Innovations in the Next Generation of Controlled Delivery Systems

Esmaiel Jabbari, PhD.

Esmaiel Jabbari, PhD.

Professor of Chemical Engineering University of South Carolina

Optimizing your Drug Device Strategy via Effective Risk Management: Foundations for Successful Product Development

Bonnie Fendrock, MBA

Bonnie Fendrock, MBA

CEO and Co-Founder, Cyta Therapeutics, Inc.

Overcoming Drug Delivery Barriers for Peptide-Based Drug Products: Approaches and Strategies

Christopher A. Rhodes, PhD.

Christopher A. Rhodes, PhD.

President & CEO, Drug Delivery Experts

2:00pm - 2:30pm

2:00pm - 2:30pm

Utilizing Emerging Sustained Delivery Technologies to Enhance Product Performance

Liz Proos, PhD.

Liz Proos, PhD.

Director, Formulation Development, Microchips Biotech, Inc.

The Importance of Identifying and Serving User Needs and About Risk-Based Development of Drug Delivery Devices

Molly Story, PhD.

Molly Story, PhD.

Head, Global Usability Engineering and Risk Management, Medical Device Development Unit, Sanofi

PANEL SESSION: Examining Futuristic Platforms for the Discovery of New Peptide Therapeutics

Amit Joshi, PhD.

Amit Joshi, PhD.

Senior Manager, Advanced Sourcing & Innovation, Johnson & Johnson

2:30pm - 3:00pm

2:30pm - 3:00pm

Panel Session: Evolving Controlled Release Technologies to Support the Next Generation of Drug Delivery

Rakesh Dixit, PhD.

Rakesh Dixit, PhD.

Vice President, Research & Development, ‎MedImmune (AstraZeneca Biologics)

Long-Acting Implants: A Novel Therapeutic Modality that can Assist Adherence and Compliance

Alex Schwarz, PhD

Alex Schwarz, PhD

Vice President, Early Development, Braeburn Pharmaceuticals, Inc

Advances in Solubilization, Protection, and Delivery of Oral Peptides with SEDDS

Vincent Jannin, PhD.

Vincent Jannin, PhD.

Research Director, Pharmaceuticals, Gattefossé

3:00pm - 3:30pm

3:00pm - 3:30pm

Afternoon Networking & Refreshment Break in Exhibit Hall

TARGETED & LOCALIZED DELIVERY

COMMERCIAL OPPORTUNITIES IN NANODELIVERY

ADVANCES IN PEPTIDE THERAPEUTICS

3:30pm - 4:00pm

3:30pm - 4:00pm

Combination Products: Examining how Quality by Design (QbD) can Aid Formulation of Targeted Delivery

Abizer Harianawala, PhD

Abizer Harianawala, PhD

Senior Director - Product Development and Technical Operations, TARIS Biomedical

Evolution of Nanoparticle Delivery: Targeted Approaches in Oncology Drug Development

Shaker Mousa, PhD

Shaker Mousa, PhD

Chairman & Executive Vice President, The Pharmaceutical Research Institute

Commercial Advances and Opportunities in Antimicrobial Peptides in Immunotherapy

Laszlo Otvos, PhD.

Laszlo Otvos, PhD.

Adjunct Professor, Semmelweis Medical School

4:00pm - 4:30pm

4:00pm - 4:30pm

Successful Delivery of Small & Large Molecules using Polymers in Localized / Sustained Release Manner

Tian Wu, PhD.

Tian Wu, PhD.

Senior Scientist, Drug Product Technology, Amgen

Next Generation Non-Invasive Delivery: Targeted Delivery of Nanoparticles to the Brain

Susan Rosenbaum, JD.

Susan Rosenbaum, JD.

Founder, Chairman & Chief Executive Officer, Lauren Sciences LLC

Novel, High-Loading Encapsulation of Peptides and Biologics into Nanoparticle and Microparticle Forms

Robert Prud'homme, PhD.

Robert Prud'homme, PhD.

Professor, Department of Chemical & Biological Engineering, Princeton University

4:30pm - 5:00pm

4:30pm - 5:00pm

Innovative Approaches for Ligand-Targeted Drug Design

Anthony Tuesca, PhD

Anthony Tuesca, PhD

Scientist II, Formulation Sciences, MedImmune

Delivering Therapy to Target: Improving the odds for Successful Drug Development

Raghu Raghavan, PhD

Raghu Raghavan, PhD

President and Co-Founder, Therataxis, LLC

Matrix-Binding Peptides for Targeted Delivery to Tissues

John Paderi, PhD.

John Paderi, PhD.

Founder, Director Research & Development, Symic Bio

5:00pm - 5:30pm

5:00pm - 5:30pm

Ocular Delivery: Sustained and Targeted Drug Delivery Systems

Viral Kansara, PhD.

Viral Kansara, PhD.

Investigator and Head of Ocular Pharmacology and Drug Delivery Laboratory, Novartis

Enhanced Bioavailability of Drugs for Malaria, TB and Neglected Diseases using Cost Effective, Continuous Processes

Robert Prud'homme, PhD.

Robert Prud'homme, PhD.

Professor, Department of Chemical & Biological Engineering, Princeton University

Novel Approaches for Improving Peptide Stability

Sonia Bedi, PhD

Sonia Bedi, PhD

Principal Scientist, Biopharm Product Sciences, Biopharm R&D, GlaxoSmithKline

5:30pm - 5:40pm

5:30pm - 5:40pm

Chair’s Closing Remarks and Wrap-Up of Day One

5:40pm

5:40pm

Cocktail Reception in Exhibit Hall

Day Two – Thursday, September 7th, 2017

8:00am - 8:50am

8:00am - 8:50am

Registration Opens & Continental Breakfast for Attendees

4th Annual Controlled & Modified Drug Release
3rd Drug Delivery Strategy: Advanced Mechanisms & Product Design
2nd Peptide Drug Design & Delivery Summit

8:50am - 9:00am

8:50am - 9:00am

Chairperson’s Day Two Welcome and Opening Remarks

DEVELOPING SUSTAINED RELEASE FORMULATIONS

NOVEL INJECTABLE FORMULATION APPROACHES

METABOLIC & CARDIOVASCULAR PEPTIDE THERAPEUTICS

9:00am - 9:30am

9:00am - 9:30am

Optimal Parenteral Sustained Release Drug Delivery

Joseph Della Rocca

Joseph Della Rocca

Senior Scientist, Merck & Co.

What’s Next for Parenteral Product Development? Effective Strategies for Customizing Existing Delivery Platforms for New Products

Jaymin Shah, PhD.

Jaymin Shah, PhD.

Senior Research Fellow and Team Leader, Pharmaceutical Sciences, Pfizer, Inc. (Pending Confirmation)

Identification of Breakthrough Therapies for the Treatment of Diabetes and Obesity: Challenges and Opportunities

Michael Wagner, PhD.

Michael Wagner, PhD.

Head of Insulins & Peptides, Diabetes Division, Sanofi

9:30am - 10:00am

9:30am - 10:00am

An Integrated Biopharmaceutics Approach for Effective Drug Development for Clinical Trials

Rob Harris, PhD.

Rob Harris, PhD.

Chief Technical Officer, Juniper Pharma Services

Formulation and Commercial Scale-Up Advances in Orphan Drug Development/Pediatric Dosage Development

Anthony Qu, PhD

Anthony Qu, PhD

Vice President, Drug Product Development, Halo Pharmaceuticals

Overcoming Drug Delivery Barriers for Peptide-Based Drug Products: Once a Year or Half Yearly Dosing of GLP-1 Agonist

Scott Peterson, PhD.

Scott Peterson, PhD.

Executive Director, Corporate Development, Intarcia Therapeutics

10:00am - 10:30am

10:00am - 10:30am

Developing Sustained Release Formulations for Oral Delivery

Jay Lakshman, PhD

Jay Lakshman, PhD

Project Leader and Technology Platform Leader, Novartis

Nanoparticle Fabrication in Pharmaceutical Formulation Development

Ghazal Hariri, PhD

Ghazal Hariri, PhD

Senior Scientist, Drug Delivery Systems, Pfizer, Inc.

Development of Sustained Release Orally Stable Peptide-Based Products

Zhen Yang, PhD.

Zhen Yang, PhD.

Associate Principal Scientist, Biopharmaceutics & Specialty Dosage Form, Merck & Co.

10:30am - 11:00am

10:30am - 11:00am

Morning Networking & Refreshment Break in Exhibit Hall

TECHNOLOGY UTILIZATION FOR ORAL MODIFIED RELEASE PRODUCTS

TOPICAL / TRANSDERMAL & OCULAR DELIVERY SYSTEMS

ADVANCES IN PEPTIDE ENGINEERING & SYNTHESIS

11:00am - 11:30am

11:00am - 11:30am

Utilizing Novel Modified Release Technologies for the Future of Patient-Centered Drug Delivery

Liz Proos, PhD.

Liz Proos, PhD.

Director, Formulation Development, Microchips Biotech, Inc.

Recent Advances in the Commercialization of Ocular Drug Delivery Systems

Grégoire Schwach, PhD.

Grégoire Schwach, PhD.

Head of Drug Delivery, F. Hoffmann-La Roche

Design and Discovery of Permeable Macrocycles using Massively Parallel Combinatorial Synthesis

Brad Garcia, PhD.

Brad Garcia, PhD.

Strategic Technology Commercialization Leader, Roche Sequencing

11:30am - 12:00pm

11:30am - 12:00pm

Oral Modified Release - Novel Formulations, Technologies and Development Strategies

Stephen Tindal, BSc.

Stephen Tindal, BSc.

Director, Science & Technology, Catalent Pharma Solutions

Advances in Topical and Transdermal Product Development for Biologics

Gaurav Tolia, PhD.

Gaurav Tolia, PhD.

Senior Research Scientist, Mylan Inc.

TECHNOLOGY SESSION (Open for sponsorship opportunities) Commercial Scale-Up Manufacturing of Complex Peptide Drug Products: Novel Strategy and Sourcing Approaches

Speaker to be confirmed shortly

12:00pm - 12:30pm

12:00pm - 12:30pm

Improving Adherence with Patient-Centric Modified Release Formulations: Transforming Oral Delivery Challenges into Proprietary Product Solutions

Rubi Burlage, PhD

Rubi Burlage, PhD

Director, Formulation Sciences, Merck & Co.

TECHNOLOGY SESSION (Open for sponsorship opportunities) Uncovering Opportunities to Evaluate Compound / Early Strategies for Topical and Transdermal Product Design

Speaker to be confirmed shortly

Overcoming Drug Development Barriers for Peptide Products: Analytical, Physical and Formulation Aspects

Tian Wu, PhD.

Tian Wu, PhD.

Senior Scientist, Drug Product Technology, Amgen

12:30pm - 1:30pm

12:30pm - 1:30pm

Networking Lunch

MODELING & SIMULATION APPROACHES

ADVANCES IN LARGE MOLECULE DELIVERY

PEPTIDE DRUG DEVELOPMENT: FORMULATION & DELIVERY

1:30pm - 2:00pm

1:30pm - 2:00pm

Rapid and Efficient Reformulation of an Immediate Release Formulation with TID Regimen to CR Formulations with BID Regimen via Adaptive Clinical Design

Irina Kadiyala, PhD.

Irina Kadiyala, PhD.

Senior Scientist, Delivery Systems, Vertex Pharmaceuticals

Drug Delivery Strategies for CNS Administration of Diverse Molecular Modalities

John Morrison, PhD.

John Morrison, PhD.

Senior Research Investigator, Bristol-Myers Squibb (Invited)

Next Generation Injectable Peptide Drug Products: Formulation Challenges and Strategies

Marian Gindy, PhD.

Marian Gindy, PhD.

Director and Head of Sterile Products Development, Merck & Co.

2:00pm - 2:30pm

2:00pm - 2:30pm

Formulation Selection and In-Silico Design for Extended Release Products

Alfred Berchielli, PhD.

Alfred Berchielli, PhD.

Senior Principal Scientist, Drug Product Design, Pfizer, Inc.

Enhancing Patient Outcomes by Optimizing Biologic Drug Delivery Systems

David Schaffer, PhD.

David Schaffer, PhD.

Professor, Chemical and Biomolecular Engineering, University of California, Berkeley

Accurate Computational Design of Hyper-Stable Constrained Peptides

Gaurav Bhardwaj, PhD.

Gaurav Bhardwaj, PhD.

Head of the Institute for Protein Design, Professor of Biochemistry, University of Washington

2:30pm - 3:00pm

2:30pm - 3:00pm

Modified Release Multi-Particulate Drug Delivery Systems: Formulation & Process Considerations

Sree Nadkarni, PhD.

Sree Nadkarni, PhD.

Senior Director, Pharmaceutical Dev. (CMC) Biotie Therapies, Inc. (Acorda Therapeutics)

New Generation Development and Techniques to Expedite Product Time-to-Market

Mehuli Kulkarni, PhD

Mehuli Kulkarni, PhD

Consultant Chemist, Eli Lilly

TECHNOLOGY SESSION (Open for sponsorship opportunities) Novel Approaches for Improving Peptide Stability, Bioavailability & Half-Life Extension

Speaker to be confirmed shortly

3:00pm - 3:30pm

3:00pm - 3:30pm

Afternoon Networking & Refreshment Break in Exhibit Hall

DEVELOPING CONTROLLED RELEASE COMBINATION PRODUCTS

ADVANCES IN PERSONALIZED DELIVERY SYSTEMS

ADVANCES IN ANTIBODY THERAPEUTICS

3:30pm - 4:00pm

3:30pm - 4:00pm

Supporting Innovation in Controlled Release and Combination Products

Personalized Medicine and Future Delivery Systems

Ocular and Targeted Brain Delivery and PKPD of Antibody Therapeutics

4:00pm - 4:30pm

4:00pm - 4:30pm

Combination Products: Examining how Quality by Design (QbD) can Aid Formulation of and Controlled Delivery

Expediting Product Development for Precision Medicine

Development of Immunotherapy mABs and Bispecific Antibodies with Clinical Pharmacology and Dose/Regimen Considerations

4:30pm

4:30pm

Chair’s Closing Remarks and Close of Conference

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