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Charlie Campion Technology Development Manager, Biosurgery R&D, Baxter

Healthcare Corp.

ApaTech as an example of how “academia / industry partnerships” can

overcome barriers to commercialization of regenerative medicine products

TERMIS 2012 Vienna, 7th September 2012

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Since the acquisition in 2010, ApaTech products have formed part of the Biosurgery portfolio at Baxter

ACTIFUSE ABX ACTIFUSE MISACTIFUSE SHAPE

ApaTech specializes in developing and manufacturing synthetic bone repair products for the global orthobiologics market

ACTIFUSE GRANULES/ MICROGRANULES

ACTIFUSE EZ-PREP

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Barriers to Market Entry

There are many challenges which new companies face when entering the healthcare market

Development Funding

Sales & Distribution

Regulatory Complexity

Surgeon Advocacy

Time to Product Launch

Manufacturing Capacity

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Rapid growth

Although not the only success factor, academic partnerships have been fundamental to growth at ApaTech

Award-winning sales growth180% yr/yr 2006-2009

Publications

Capacity expansion1L : 1600L

upscaling factor in 7 yrs

Process experts

Portfolio development

5 new products in 5 years

Research data

Investor confidence£32.5M of

funding in 7yrs (3 rounds)

Prestige

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Materials Processing

Ageing

Surface Science

Humanities Biomedical Materials

Earth, Planetary, Space and Astronomy

Nanotechnology

ApaTech has academic roots: ApaTech was founded in 2001 as a spin-out from the IRC, Queen Mary, UoL

In the 1990’s the UK government funded specialised centres of research to promote the growth of UK research and manufacturing

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Formed in 1991

Professor Bill Bonfield

£10 million funding

Multi-centre approach:

Institute of Orthopaedics at UCL

IRC Biomedical Materials

There was an established pedigree for bone research within the centre which ApaTech were able to leverage in the early days of commercialisation

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University of London – IRC in Biomedical Materials Bone functions as a mineral reservoir for the body Porous bone graft substitutes comprised of thermally

transformed Bovine and Coralline Hydroxyapatite were already in clinical use for bone grafting

Research Questions: Do low-level ionic substitutions play a role in the biology of

bone repair? What is the role of a bone graft substitute’s structure in the

biology of bone repair?

A multi-disciplinary approach was applied to the common research goal of the IRC : how can we develop superior synthetic bone grafts?

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Professor Iain Gibson BSc (Hons), PhD

− Ionic substitutions− Metabolic role of

minerals in bone− Further increase

in cellular response

Do low-level ionic substitutions play a role in the biology of bone repair?

Professor Gibson now has a chair at University of Aberdeen where his research is based on guiding cell behaviour during tissue repair and wound healing, using

physico-chemical guidance cues

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Dr Karin Hing CEng, PhD, BSc, MIMMM, FRMS

− Foaming ceramics− Porous HA− Increased cellular

response

What is the role of a bone graft substitute’s structure in the biology of bone repair?

Dr Hings’s research group at QM is now engaged in physico-chemical and hierarchical 3-D structural characterisation of bone grafts, the study of protein

interactions, cell response and chemotaxis

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ApaTech continued to expand it’s network of academic partners throughout the UK & across the Globe

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ApaTech used a variety of mechanisms to partner with academic research centres

Academic Research

Centre

PhD Studentships

Consultancy Contracts

Contract Services

Student Award Sponsorship

MSC student Funding

Undergraduate Project

Mentoring

Symposia Sponsorship

IP Purchase agreements

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ApaTech continue to leverage subject matter expertise in Academia to get products to market

33%

67%

Proportion of regulatory non-clinical studies *

Contract Research OrganisationAcademic Research Centre

Portfolio development

5 new products in 5 yearsReg. Data

* Data for the period between 1st round funding up to Baxter Healthcare acquisition (2001 – 2010)

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ApaTech continue to leverage subject matter expertise in Academia to develop product pipeline

67%

33%

Proportion of patents granted or pending by ori-

gin *

ApaTech Academic Research Centre

Portfolio development

5 new products in 5 yearsReg. Data

* Data for the period between 1st round funding up to Baxter Healthcare acquisition (2001 – 2010)

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ApaTech continue to use their academic pedigree to provide robust mechanistic data to support sales

3%

97%

Proportion of supporting publications (1st author) *

ApaTech EmployeeAcademia Based Researcher

Award-winning sales growth200% yr/yr 2007-2009

Publications

* Data for the period between 1st round funding up to Baxter Healthcare acquisition (2001 – 2010)

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Summary

ApaTech was founded in Academia and was able to leverage its pedigree to keep investors on-board. ApaTech

continued to partner with Global academic centres to reduce time-to-market whilst building a robust scientific

story around the commercialised technology.

The way forward:

ApaTech have demonstrated there are a number of mechanisms by which Industry can interact with Academia

in order to minimise the impact of barriers to market, whilst developing the next generation of scientific

advocates for the commercialised technology.

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Acknowledgements

− Professor Heinz Redl for my invitation

− The co-founders of ApaTech and the investors who believed in them

− All Academic research centres ApaTech have collaborated with since commercialisation began in 1999