Collaboration is the Key

Presented by: Dr. Ronan Mac Loughlin

Developing core technologies –Collaboration is the Key

Aerogen Intro

Aim and Scope

Aerogen’s History

Introduction

Copyright © 2013 Aerogen. All rights reserved.

The core technology

Top- Aperture Plate

High quality aerosol

High Speed Microscopic Photo of Uniform Aerosol

Droplets Generated from a Single Aperture


The end user

The end user

Aerogen’s business strategy

Blue Ocean Strategy

Uncontested markets

Making the competition irrelevant

Customer Value Proposition = Healthcare economics

Requires innovation NOT invention



HomecareHomecare

ICU

Ward /Non-invasive

Emergency room/A&E

Specialty Drug Device

Combination Products

€50m

€200m

€125m

€3-500M per

product

€350m

Leveraging Aerogen’s ICU market leadership to createthe Aerosol Delivery Continuum of Care

Homecare Ventilation

Continuum of Care

Execution of the business strategy

Aerogen

Core technology

Patient Intervention

Value adding

IAC - Where does it sit within the business strategy?


Core technology: understanding and optimising

AIM:

• Characterisation of wafer elements with

a view to increasing reliability and

achieving COGS reductions



human hair ~ 70 µm in diameter

aperture exit diameter ~ 4 µm



Wafer Performance related to;

• Surface features

• Microstructure

• Grain

• Size

• Shape

• Orientation

• Direction

• Behaviour during processing





Outcomes

Several patents that extend coverage for nearly 20 more years

Zero fractures

Scalable production – 7million/yr/line

Greater understanding of vibrational modes of mesh

Unparalleled knowledge of electro-deposition process for mesh

manufacture


Value Added #1: Basic technology characterisation

AIM #1:

• Characterisation of physicochemical

characteristics and capabilities of technology

in nebulising novel formulations.

AIM #2:

• Characterisation of compatibility of

technology with next generation therapeutics,

e.g. Proteins/Peptides/siRNA.


Value Added #1: Basic technology characterisation

OUTCOMES:

• Characterisation of nebuliser

performance with several next gen

therapeutics (e.g. proteins).

• Demonstrated compatibility with

labile actives.

• Funded HRB grant investigating

novel treatments for TB.

OUTCOMES:

• Characterisation of nebuliser

performance with <150 excipients.

• Developed an in silico means of

predicting nebuliser performance

based on various physicochemical

characteristics.

• Several publications in draft/in

review.


VALUE ADDED #2: Development of Theranostic Nanoparticles

AIM:

• Overcome formulation issues for highly insoluble APIs.

• Develop drug loaded NPs suitable for aerosol-mediated drug delivery.

• Build a performance database specifically around the performance of

Aerogen’s aerosol generator technology and next generation therapeutics.


VALUE ADDED #2: Development of Theranostic Nanoparticles

OUTCOMES:

• Development of x2 candidate NPs (gold and iron)

• Preclinical studies demonstrating safety & efficacy of highly insoluble anticancer

drug

• Performance data on unique and “representative” NP drug/device combinations

In vivo analysis

+

In vitro analysis


Value added: Outcomes

Outcomes

Increased knowledge around pharmaceutical agents and

formulation.

Understanding of effect of physicochemical characteristics of

nebuliser performance.

Development of x2 nanoparticle vector systems.

Several peer reviewed publications.


Advantages/Pitfalls

Advantages:

• Access to key expertise at a lower risk & cost than commercial

consulting rates.• Access to equipment

• Access to fresh ways of thinking

• Access to next generation therapeutics and those that developed them

• Access to people interested in performing both “basic” and

“advanced” science around your technology.• Academic drive for peer reviewed publications

• Networking

Pitfalls:

• Timelines: All researchers may appreciate the expectations of

industrial collaborators around timely reports and progress.• IP/Confidentiality must be carefully controlled. Not the same rigour as in industry.

• Researchers must be bought into the project. If it is not a priority project for them, no amount of

pressure will prevail.

• Inappropriate levels of funding will lead to researcher apathy and

risks investment being wasted in it’s entirety.


Applying the learnings

KEY TO SUCCESS

ALIGN GOALS OF INDUSTRY-ACADEMIA COLLABORATIVE

RESEARCH WITH COMPANY STRAGEGY


No part of this publication may be reproduced, stored in a retrieval

system or transmitted in any form or by any means (electronic,

mechanical, photocopying, recording or otherwise) without the

permission of the author.

This document provides an outline of a presentation and is incomplete

without the accompanying oral commentary and discussion.

Aerogen Limited

Galway Business Park, Dangan, Galway, Ireland

Email

Phone

Dr. Ronan Mac LoughlinSenior Scientist

Adjunct Assistant Professor, Trinity College, Dublin

[email protected]

+353 91 540400

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Collaboration is the Key