A Delicate Balancing Act

A new stem cell therapy developed by scientists in Melbourne gives hope to more than 5000 Australian women who lose their breasts to cancer each year.

The technology and company behind the breakthrough is called Neopec. It is a revolutionary technique that helps women regrow their breasts by using their own fat cells.

Neopec CEO and international stem cell pioneer, Dr Peter Mountford is charged with developing this world first technology.

“Neopec has the potential to be life changing for so many people.

“You don’t realise how many people are affected by breast cancer – mothers, fathers, husbands, daughters, friends – the flow on effects don’t discriminate.

“By helping women rebuild their breast with natural tissue, Neopec offers a long list of physical and importantly, emotional benefits to victims of breast cancer,” he said.

Pioneered by the O’Brien Institute, one of the world’s leading research centres for tissue engineering and microsurgery, the Neopec breast would look and feel natural, and would only require one operation.

With incidence of breast cancer worldwide on the increase and an estimated 1.5 million people diagnosed with breast cancer each year, it is little wonder there is so much excitement surrounding the possibilities.

In Australia alone, more than 13,000 women are diagnosed with breast cancer each year, and of those approximately 5,000 need to have a mastectomy.

Following the success of animal trials, a human trial is scheduled to start in November 2010. The trial is the first of its kind anywhere in the world.

Peter said that using the stem cells of our own fat to regenerate body parts is a huge step forward on current techniques – many of which just mask damage.

“The Neopec breast reconstruction could be the tip of the iceberg. If we are successful, the possibilities – from congenital deformities to traumas, breast augmentation and cosmetic procedures – are endless.

The technology could be widely available to breast cancer patients after a three year trial, while the cosmetic surgery industry will need to wait up to a decade.

“It’s time for this industry to become innovative in business, not just in discovery.” – Dr Peter Mountford

Peter joined Neopec earlier this year, returning to Australia from the UK where he was President and Chief Executive Officer of Stem Cell Sciences, a dual listed multi-national company developing stem cell technology for the pharmaceutical industry.

In addition to helping thousands of patients worldwide, he believes Neopec can develop and deliver a much needed business model to ensure local stakeholders reap greater benefits in the global marketplace.

“We have many partners contributing to this project in different ways – financial, surgical, engineering and biological. We’re keen to see everyone involved (including the local community) realise the benefits of this technology.”

Sadly, this isn’t always the case.

“Too often, great Australian medical and scientific discoveries and developments are sold prematurely to the international market.”

Peter said that Australians are renowned for being leaders in innovation but fall short in realising the full commercial and economic benefits. “It’s time for this industry to become innovative in business, not just in discovery”, he said.

There are so many risk factors for small organisations like Neopec – developing the technology is only the first hurdle.

Peter knows his organisation needs to be strong in science and business in order for it to be successful.

“For Australia to compete with big international players, you need to take a more holistic view of the innovation cycle.

“You can’t just focus on development. You need to collaborate across business and industry to ensure the gains of the full innovation cycle are realised on home soil.

The irony is that by selling out too early, Australian consumers end up buying back products that were pioneered in this country – but at a retail price. Not only is part of the financial benefit lost, but also manufacturing, jobs and other associated benefits,” he said.

For Peter having the right business structure and model means that he can help Neopec keep the royalties at home and deliver a product to the market quickly and in a way that maximises patient safety.

“At the end of the day, this technology has the potential to change lives.

“Being more savvy in business doesn’t change that – it just means that we can help more people,” he said.

HOW IT WORKS

Neopec is a combination of a device and a surgical procedure that utilises a woman’s own regenerative capacity to grow a living fat tissue substitute for breast reconstruction.

The process, NeopecTM, involves implanting a biodegradable synthetic chamber. Surgeons then redirect blood vessels and a small fat pad from the woman’s underarm into the chamber.

If results seen in preclinical testing hold true, over the next four to six months the fat grows in the shape of the chamber, which dissolves after the new breast is formed. The Neopec chamber, made from a clinically-approved biodegradable material, can be customised to have the size, shape, strength and degradation properties to allow the growth of fat to fill the space permanently and precisely.

This will provide women with a unique surgical solution to breast reconstruction, giving them a natural breast which aesthetically matches the healthy one.

THE BENEFITS

Breast cancer survivors can experience a range of difficulties, ranging from physical limitations to psycho-social problems.

Self esteem derived from feeling better about their bodies through breast reconstruction has been shown to be an important factor in their recovery.

Several methods of reconstructive surgery are currently used following mastectomy, each with its own associated risks.

Autologous flap reconstructions involve transferring sections of a woman’s fat tissue from the abdomen to the breast area. Another method is implant reconstruction, which involves placing a silicone-gel or saline filled implant behind or in front of the chest muscle.

With Neopec, women would have the benefit of a natural looking and feeling breast in only one operation - with no further surgery or corrective procedures required to repair scarring or implant damage. With this comes a shorter hospital stay, shorter recuperation time and no abdominal or back scarring as with tissue transfer surgery.

Surgeons will also benefit from a less complex procedure. Neopec will require less anaesthesia and will reduce the theatre costs often associated with tissue transfer procedures. The procedure may also potentially lower the levels of corrective surgeries that often come with implant reconstruction.

COMMERCIALISATION – GETTING IT RIGHT FROM THE START

Corrs partner and commercialisation expert, David Smith knows how vital it is to get the commercial and legal framework right from the start of a project.

“When you have contributions from a number of stakeholders, it is important to establish the ground rules for negotiating collaboration agreements.

“Multi-party negotiations can easily become protracted, particularly when lengthy draft agreements are sent back and forth over weeks or months,” he said.

David suggests ways to avoid this occurring include asking each stakeholder to articulate, in plain English, what they propose to bring to and take out of the collaboration and project.

“This helps reduce future difficulties that might arise where a stakeholders’ interests are not aligned, or not understood by the other parties,” he said.

David also encourages collaborating parties to document their roles and responsibilities – both at the R&D stage and the commercialisation stage – settling issues such as which party will market the technology, who will make decisions about which patents to lodge and how any commercialisation proceeds will be divided up.

“By establishing the right governance and communications structure up front, a project is more likely to be successful - delivering the right outcomes quickly and cost effectively so everyone benefits,” he said.

ABOUT NEOPEC PTY LTD

Neopec Pty Ltd brings together the skills and expertise of a consortium of collaborating organisations including the Australian Tissue Engineering Centre, the O’Brien Institute, St Vincent’s Hospital, the University of Melbourne and commercial partners Anatomics and Cogentum.

Neopec's breast reconstruction project is supported by the Victorian State Government via a $2.95 million grant under Victoria's Science Agenda (VSA) Investment Fund. The $41 million VSA Investment Fund is supporting market driven collaborative projects that develop science and technology-based solutions.

Corrs lawyers David Smith and Frances Wheelahan worked with the O’Brien Institute to establish Neopec and to draft and negotiate documents for the development and commercialsation of Neopec’s technology.