Biologics Drug Delivery & Beyond Event Agenda

Agenda at a Glance

Morning Workshop | Afternoon Workshop | Conference Day One | Conference Day Two

Conference Workshop Day • Wednesday, September 23rd, 2009

AM Pre-Conference Symposium: Technical & Scientific Strategies for Developing Biosimilars

8:30 Registration and Morning Coffee

9:00 Part I: Therapeutic Equivalence of Proteins and Peptides : Viewpoint from the Innovative Industry

Biosimilar manufacturers and regulatory authorities now acknowledge that the data requirements accepted for generic small molecules are not appropriate or sufficient to support the registration of “follow-on” biologics. Reaching scientific and regulatory agreement, however, on exactly what the data requirements should be to support the registration of “follow-on” biologics in the US has not yet been achieved. This session will outline an approach that provides a conceptual framework for generating key data sets to support registration dossiers for a “biosimilar” biologic. This comparative data would allow for scientists and regulatory authorities to arrive at a conclusion that will assure patient safety and allow the introduction of new therapeutic options to the marketplace. This session focuses on scientific issues that bear on safety considerations for “biosimilar” or “follow-on” biologics.

James D. Green, Ph.D., DABT, Senior Vice President - Preclinical and Clinical Development Sciences, Biogen Idec, Inc

9:45 Part II: Case Study: Overview of Delivery Technologies for GLP-1 Analogues

In 2006, the first incretin mimetic exenatide was approved for use in type II diabetic patients and represented the most significant innovation in diabetes treatment in the last 20 years.

This session explores the landscape of delivery technologies under evaluation for GLP-1 analogues.

Gain an understanding of GLP-1 and its actions
Explore GLP-1 analogues in research and development
Grasp technical strategies for GLP-1 delivery including injectable sustained release formulations and bio-conjugates
Tap into the third generation of GLP-1 product opportunities with non-injectable delivery systems

Christopher A. Rhodes, PhD, Executive Director, Pharmaceutical Sciences, Amylin Pharmaceutical, Inc.

10:30 30 Minute Networking & Refreshment Break

11:00 Part III: Clinical & Manufacturing Opportunities & Challenges in Biosimilar Development

Discuss challenges that need to be overcome to be successful in scale up and clinical trials
Determine what clinical studies need to be done to prove Biosimilar effectiveness
Explore the different long-acting GLP-1 analog molecules currently in clinical development and others in advanced preclinical stages

To join the symposium speaking faculty, contact Sarah Scarry, SScarry@iirusa.com, 646 895-7472.

12:00 Symposium Concludes; Luncheon for AM Symposium attendees only

PM Workshop: Biologics Formulation & Delivery 101

Developing Successful Delivery Systems for Biologics: Formulation Basics through Commercial Manufacturing Success
The development of successful, commercially viable delivery systems for biologics requires a detailed understanding of variables unique to both the target therapeutic molecule and the selected delivery system. The complex properties of biologics present additional technical challenges beyond those presented by traditional small molecule drugs in terms of formulation development, delivery, manufacturing and integration into drug delivery systems. This workshop presents the challenges unique to the formulation of biologics, and discusses how this knowledge can be applied to the development and manufacturing of a wide range of novel delivery systems.

Workshop Goals:

Learn formulation fundamentals unique to biologics and the application of this knowledge in delivery system development
Explore state of the art delivery technologies and the challenges associated with each system
Apply fundamental knowledge to manufacturing issues unique to a variety of delivery systems for biologics
Examples of products that are using unique delivery systems and their success and failure

Workshop Leaders:
Bret Shirley, PhD, Sr. Director, Pharmaceutical Sciences, Stryker Biotech
Warren Jaworowicz, Associate Director, Formulation Development, Stryker Biotech

12:30	Workshop Registration	2:30	30 Minute Networking & Refreshment Break
1:00	Workshop Begins	4:00	Workshop Concludes

Main Conference, Day One • Thursday, September 24th, 2009
8:00	Main Conference Registration & Morning Coffee
8:30	Chairperson’s Welcome & Opening Remarks
8:30	Peter Hoffman, PhD, Vice President, New Technology Development, Genzyme Pharmaceuticals
8:45	The Magic Bullets of the Shots Heard Round the World: Targeted Macromolcule Delivery
8:45	Peter Hoffman, PhD, VP, New Technology Development, Genzyme Pharmaceutical
9:30	Challenges to Delivering High Protein Drug Content in Small Volume Dose
9:30	Tapan K. Das, PhD, Senior Principal Scientist, Pfizer Global Biologics
10:15	30 Minute Networking & Refreshment Break
10:45	Local and Systemic Lung Delivery of Peptides, Oligos and Proteins using Solution Inhalers
10:45	David Cipolla, Senior Director, Pharmaceutical Sciences, Aradigm Corp.
11:15	Injecting Biological Drugs and Vaccines in a Solid Dosage Form
11:15	Charles Potter, PhD, Chief Executive Officer, Glide Pharma
11:45	Altea Therapeutics PassPort® Transdermal System: Biologicals Delivered Painlessly from a Convenient and Cost-effective Skin Patch
11:45	Eric Tomlinson, PhD, DSc, President and Chief Executive Officer, Altea Therapeutics Corporation
12:15	Luncheon
1:30	PEG-Like Protein Sequences for Half-Life Extension of Protein Therapeutics
1:30	Volker Schellenberger, PhD, Vice President, Drug Discovery, Amunix, Inc.
2:00	Mimicking Endogenous Peptide Secretion with Inhaled Dry Powder Formulations
2:00	Andrea Leone-Bay, PhD, Vice President, Pharmaceutical Development, MannKind Corporation
2:45	Challenges & Progress In the Rnai Therapeutic Arena
2:45	Marion Jurk, PhD, Director, Discover and Development, Coley Pharmaceuticals GmbH – A Pfizer Company
3:15	30-Minute Networking & Refreshment Break
3:45	Development of Oligonucleotide Therapeutics – Challenges in Immune Modulation and Delivery
3:45	Amina Benahmed, PhD, Coley Pharmaceuticals GmbH – A Pfizer Company
4:15	Development of Novel RNAi Therapeutic Compounds and in vivo Delivery Approaches
4:15	Dmitry Samarsky, PhD, Vice President, Technology Development, RXi Pharmaceuticals
4:45	Day One Concludes

Main Conference, Day Two • Friday, September 25th, 2009
8:00	Morning Coffee
8:30	Conference Chairperson’s Recap of Day Two
8:30	Peter Hoffman, PhD, Vice President, New Technology Development, Genzyme
8:45	Enhancing the Potency of Nucleic Acid-Based Drugs with Electroporation
8:45	Claire Evans, PhD, Director, Therapeutic Programs, Ichor Medical Systems
9:15	Creating Novel Therapeutics with Superior Potency, Duration of Action and Unique Delivery Potential by Harnessing Second Generation Dicer Substrate RNAs (DsiRNAs)
9:15	Sujit K. Basu, PhD, Senior Director, Formulation, Dicerna Pharmaceuticals, Inc
9:45	Preclinical Pharmacology of Stable Nucleic Acid Lipid Particles (SNALP)
9:45	Ian MacLachlan, PhD, Executive Vice President & Chief Scientific Officer, Tekmimira Pharmaceuticals Corp.
10:30	30 Minute Networking & Refreshment Break
11:00	Small Group Strategy Sessions
11:45	Develop Novel Methods for Combined Imaging and Delivery of siRNA to Disease-Relevant Targets
11:45	Zdravka O. Medarova, PhD, Instructor in Radiology, MGH/MIT/ HMS Athinoula A. Martinos, Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital
12:15	A Novel DNAi Being Developed for the Treatment of Cancer
12:15	Wendi Rodriquez, Pronai Robert Forgery, President and Chief Operating Officer, Pronai
12:45	Scale up and Manufacturing of siRNA-Based Drugs
12:45	Peter Lutwyche, PhD, VP of Pharmaceutical Development, Tekmimira
1:15	Delivery of Biologics & Beyond concludes; See you next year!

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Agenda at a Glance

Agenda at a Glance