Susan Galbraith, PhD, VP and Head of Oncology Innovative Medicines Unit, AstraZeneca
Eliminating cancer as a cause of death is a bold ambition. But it is at the front and centre of our thoughts as we devise new ways of redefining cancer treatment and restoring the lives of patients. These may be big ambitions but I believe that AstraZeneca and MedImmune are uniquely placed to deliver. We have an exciting portfolio of small and large molecules, which offer opportunities to pick the best combinations for the right cancers and initiate pivotal studies.
Delivery of these ambitions is against a backdrop of a rapidly changing global health care environment. Health care is becoming more personalized, treatments are becoming more targeted, and economic pressures mean governments and health care systems are demanding increasingly cost-effective solutions to health care problems.
In order to meet these challenges, we need to create a perfect combination at the very start and I’m not talking about drug combinations. We recognize that a lot of great science and innovation thrives outside of our own laboratories. And that by accessing and combining the best science wherever it may be coming from, we will accelerate the delivery of the next generation of medicines to the patients who need them.
“Open innovation” is a term that I see every day. But what does it mean for my team at AstraZeneca? We are continually looking at ways to make ourselves more “porous” to the external environment: academia, industry and government departments. Earlier this year we launched our dedicated “Open Innovation” website, which is our “shop-front” for collaborations across all stages of drug discovery. The AstraZeneca Open Innovation platform helps us work at the crossroads of different scientific disciplines, where true creativity and innovation occurs and progress can be accelerated.
In oncology, we are attacking cancer using a four-front offensive; we are focused on delivering medicines that target key tumour drivers and mechanisms of resistance, overcoming the barriers to tumour cell killing, developing antibody drug conjugates to deliver chemotherapy in a highly targeted way and harnessing the power of the immune system through the exciting area of immuno-oncology. This work takes place across the globe; both within our own labs and through a variety of collaborations. We are fortunate to have a number of highly effective such partnerships in Asia.
Our work with Hutchison MediPharma of China is part of a global licensing, co-development and commercialization agreement for Volitinib, a novel, targeted approach for the treatment of cancer. Volitinib entered Phase I testing in China in June 2013. The study has two primary objectives: to evaluate safety and tolerability in advanced cancer patients in China and to determine the maximum tolerated dose of the drug candidate. The study will also evaluate Volitinib’s preliminary efficacy against various tumours, including lung and gastric cancer.
Our collaboration with Taiwan’s National Research Program for Biopharmaceuticals connects physicians and scientists with a wide range of high-quality, small molecule compounds and biologics developed by AstraZeneca. Successful research proposals will explore new therapeutic uses, which may lead to the development of novel therapies for patients in oncology and other areas of high interest.
In March 2014, AstraZeneca announced a memorandum of understanding with the Korea Health Industry Development Institute (KHIDI) to establish an oncology research programme. AstraZeneca will provide support for 12 early-stage translational research projects by Korean investigators in the field of oncology, with a focus on early-stage translational research. Successful researchers will also benefit from technological advice, collaboration and networking with AstraZeneca oncology scientists globally.
Around the same time, we also kicked off a collaboration with Korea’s Samsung Medical Center (SMC) for an innovative, multi-drug clinical trial. It offers gastric cancer patients the opportunity to receive a novel targeted therapy based on the molecular profile of their disease, as part of a personalized health care (PHC) approach. Understanding which patients are the right ones to treat with novel medicines based on their genetic changes is a key part of our development strategy. We are therefore excited to be working with SMC in bringing the concept of PHC to cancer patients in Korea.
AstraZeneca and the National Cancer Center (NCC) of Japan have a comprehensive clinical study agreement to promote the joint clinical development of anti-cancer drugs. NCC will promote and participate in joint trials which involve AstraZeneca’s oncology candidates in global, Phase I studies.
In September 2012, the two companies signed a new, five-year master agreement on pre-clinical cancer research. AstraZeneca also partners with Keio University Medical School in Japan across a number of clinical oncology projects.
Our global biologics unit, MedImmune, signed its first oncology research agreement in China with the Shanghai Chest Hospital back in 2011. The goal is to build a database of small and non-small cell lung cancer cases.
AstraZeneca is clearly focused on the benefits of collaborating with Asia’s top cancer research organizations and acknowledges that together, we make a pioneering force that is greater than the sum of its parts.
My vision is to be as inclusive as possible and to make it easy to partner and collaborate with AstraZeneca. One of the ways in which we managed to simplify and expand our external collaborations was through the creation of what we call the “Oncology Toolbox”. Sharing compounds with investigators from academia has been accelerated, thanks to the quick and efficient way in which the Toolbox makes our compounds available for pre-clinical research.
In the past, only AstraZeneca’s contracted partners had access to the Toolbox. Then, in November 2012 we opened the toolbox up to academic institutions with whom we had no established working relationships. Since then, it has proved popular with external research institutions. It has enhanced AstraZeneca’s reputation as a collaborative organization and brought new research opportunities to light.
The Toolbox is bringing benefits to the company and external investigators, who have benefited from fast access to the compounds and the targets they were aimed at. It gives them the chance to carry out high quality research to investigate cancer signaling pathways, evaluate novel combinations, develop novel cancer models, test new indications, discover novel biology and test hypotheses.
AstraZeneca has shared its compounds with academia in the past, but the Toolbox has expedited the process. It used to take an average of 154 days from receiving an application to shipping the material; now it takes an average of 66 days. The timeline has gone down by 57%, giving investigators confidence that they will have rapid access to molecules and making AstraZeneca their first stop for experimental material. The number of applications has gone up by 40% over the last twelve months.
So what’s made the Toolbox so successful? At the heart of it all is a simplified Materials Transfer Agreement (MTA) template. This has fewer restrictions than a standard contract, which enables easier negotiation. Applicants use the template to request material via email. They submit a research proposal stating which compound they want and the hypothesis they want to test to an Oncology External Science Manager, who reviews their request. Lastly, lawyers for both parties negotiate an MTA.
The Toolbox is truly global: 88 proposals have been approved since the start of 2013, from 12 different countries. The approval rate for compound requests to date is over 90%.
In December 2012, during the initial phase of the programme rollout in Asia, we introduced the programme to eight centres in four countries: Singapore, Korea, Japan and China. As of today, we have received requests for 23 compounds. Of these, 17 have already been delivered or approved and one is still under review.
One of the best examples of a Toolbox success came via a request from Professor Byoung Chul Cho at Severance Hospital of Yonsei University in Korea. He requested AZD4547 in order to do biomarker studies on sqCC and SCLC PDX models. This Toolbox collaboration led to a decision by AstraZeneca to fund the proposal and test the hypothesis in the clinic.
I have no doubt that it is only by working together and sharing our scientific expertise that we stand the best chance of one day reaching our bold ambition of eliminating cancer as a cause of death. l