PhRMA 2013 Research & Hope Awards: Dr Sophie Biernaux and team

Rebecca Aris interviews Dr Sophie Biernaux of GlaxoSmithKline Vaccines, whose team was recently awarded a 2013 Research and Hope Award for vaccines.

This week, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the recipients of the 2013 Research & Hope Awards, which honors outstanding achievements in vaccines research and immunization by individuals and research teams in the biopharmaceutical sector, academic / public research and health care provider communities.

"Over the last century, vaccines have transformed the public health landscape in the United States and around the world, preventing disease and improving the quality of life for multiple generations," said PhRMA President and CEO John J. Castellani. "PhRMA is proud to honor the recipients of this year's Research & Hope Awards. These inspiring collaborators within the biopharmaceutical ecosystem have helped drive the latest advances in vaccines and immunization to the benefit of patients everywhere."

pharmaphorum is pleased to interview here Dr Sophie Biernaux who serves as head of the Malaria Vaccine Franchise for GlaxoSmithKline Vaccines, where she leads the company's research and development efforts on malaria vaccines. The GlaxoSmithKline Malaria Vaccine Team is the recipient of the The PhRMA Research & Hope Award for Biopharmaceutical Industry Research in Vaccine Development.

Award recipient: The GlaxoSmithKline Malaria Vaccine Team, led by Dr Sophie Biernaux

Company: GlaxoSmithKline Vaccines

Award: The PhRMA Research & Hope Award for Biopharmaceutical Industry Research in Vaccine Development

Reason for winning the award: The GlaxoSmithKline Malaria Vaccine Team is receiving the 2013 PhRMA Research & Hope Award for Biopharmaceutical Industry Research for its ongoing development of a vaccine against malaria targeted to children in Sub-Saharan Africa. The vaccine, RTS,S is now in the final stages of a large, multi-center Phase III clinical trial.

Interview summary

RA: Thank you for agreeing to take part in the interview. Could you please tell us about your work that led you to being awarded the 2013 Research and Hope Award for Biopharmaceutical Research?

SB: Malaria is a disease that affects more than 3.3 billion people, and so scientists around the world have searched for a vaccine to combat malaria through other interventions for the past 40 years. GSK Scientists have been working on this challenge for almost 30 years and so far we have invested more than $350 million to get to the point where we are now.

Hundreds of staff at GSK have been really dedicated and committed to working on the RTS,S vaccine. Developing a vaccine against malaria has been a very scientifically challenging task, because the parasite is extremely complex. To illustrate this, this will be the first vaccine against malaria, and even the first vaccine against a parasite. So our vaccine, RTS,S for which we have received the prize in the names of the malaria team is the most advanced candidate because we are already in the late phase development, what we call phase III clinical development.

30 years of development for a vaccine is extremely long. One of the challenges that we faced was maintaining the required support of the project for such a long period of time, which is why we entered into a partnership with the PATH Malaria Vaccine Initiative (MVI) with the support of the Bill and Melinda Gates Foundation (B&MGF) in 2001 to share the risk and cost of developing this vaccine.

If everything goes well a malaria vaccine recommendation could be available in 2015. So there is big hope for children and families in Africa.

"GSK Scientists have been working on this challenge for almost 30 years"

RA: Why does malaria still present such a great risk to African children?

SB: There are more than 250 million cases of malaria globally, and there are still 650,000 people dying of malaria every year, mostly children under five, and living in sub-Saharan Africa.

After HIV, malaria is the leading cause of death in Africa. One child dies of malaria every minute, and many more suffer long-term brain damage or other very severe illness as a result of malaria. So it's a very huge burden, not only on the health but also on the economic growth of Africa. It is estimated that $12 billion are spent on the health system to try to fight the disease.

RA: What work is GSK doing to tackle the problem of malaria outside of vaccine development?

SB: We have a global approach which is activated around three different arms to tackle the disease. Firstly, we conduct R&D for a new malaria vaccine and treatment.

We also have a community investment activity through the African Malaria Partnership, in addition to a preferential pricing for malaria in the least developed countries, and more specifically in sub-Saharan Africa. For example the African Malaria Partnership was established back in 2001, and it's really for educating communities about the disease and how to prevent it, such as sleeping under bed nets, and also seeking immediate treatment for children showing signs of fever.

RA: What are the biggest improvements that the African partnership has made?

SB: The whole development of the RTS,S vaccine that we started 30 years ago was about partnership. We started a partnership with the Walter Reed Army Institute of Research in the US for the early development, and the phase I and the first phase II studies. We entered into a partnership with PATH MVI, and we have also extended the partnership in 2001 to the Clinical Trial Partnership Committee, which is a collaboration between leading African clinicians and scientists involved in the phase III study older African research institution for academics, also the northern partner, and together with B&MGF and GSK.

I really think that this collaboration with African scientists was key to the success of RTS,S development in Africa. Because going to a phase III study in 11 sites, seven African countries, 15,000 children involved, you should do it with extremely highly skilled African scientists and clinicians.

"If everything goes well a malaria vaccine recommendation could be available in 2015."

RA: What is so special about RTS,S?

SB: Well so many things:-

• 30 years is a very long time to develop a vaccine against malaria, a vaccine against the parasite and has required the dedication of hundreds of scientists at GSK and in Africa.

• It's the most advanced malaria vaccine candidate.

• The partnership between public and private organisations really shows the power of the new business model to share risk and cost of such development.

• The partnership with African scientists to drive the clinical development in sub-Saharan African countries.

• The hope for families and children in malaria in each region that this brings, because if the vaccine is approved we expect the vaccine will have a very important impact in Africa.

RA: Within what timeframe do you think it's feasible to predict that you could eradicate malaria?

SB: Eradication is really a great goal that is extremely ambitious. But before that, the first step is we need to control the disease.

We hope that we will have very soon the new tool to fight malaria, which is the prophylactic vaccination in Africa.

"One child dies of malaria every minute..."

RA: Finally what does winning this award mean to you and the team?

SB: It means a lot. First the story of the development of malaria vaccine provides hope for families and children. But if everything goes as planned we hope that we will be able to introduce the vaccine in 2015.

It demonstrates the power of partnership between two completely different organisations – MVI and GSK Vaccines, and our partnership with African scientists and institutions.

Importantly, it also shows that innovation is not just the science behind finding new vaccines or new medicines for developing countries, it's also about developing new business models that allow us to tackle diseases that have a huge impact on society and on public health.

I'm very proud because the malaria vaccine team is really a model of individuals extremely dedicated and committed to the RTS,S vaccine development.

I am extremely proud to be part of this group, and I feel personally very honoured for the malaria team to receive this Research and Hope award, and also to work at GSK where science comes from the commitment of hundreds of people.

We are proud to see the vaccine where it is today, so close to introduction.

RA: Wonderful Sophie, thank you very much for your time.

SB: Really my pleasure.

About the interviewee:

Dr. Sophie Biernaux serves as Head of the Malaria Franchise for GlaxoSmithKline Vaccines where she leads the company's research and development efforts on malaria vaccines. Dr. Biernaux currently directs all aspects of GSK's work in advancing the RTS,S malaria vaccine candidate, including the management of the Phase IIIs trial across Africa in conjunction with the company's Global R&D Department. She also ensures an effective partnership with PATH's Malaria Vaccine Initiative, GSK's partner in the study, and a transparent collaboration with European regulatory authorities, the World Health Organization and African governments to accelerate the eventual registration of an effective malaria vaccine.

Dr. Biernaux holds a PhD in cellular biology and immunology and after a couple of years of research at the International Institute of Cellular Pathology in Brussels, she joined SmithKline Beecham in 1986. Over more than 10 years, she has led numerous projects and teams, gaining broad experience in all aspects of vaccine development.

Her management competencies have led her to take on the global leadership of all pediatric vaccine development at GSK, in particular the combined pediatric vaccines and the Neisseria meningititis vaccines. Her deep commitment for the poorest was translated in her heavy involvement in the development of vaccines for the meningitis belt and other vaccines for Africa.

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.

By when do you think we will have eradicated malaria?