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Managing Collaborative Science for Improved Patient Care

Collaborative science may involve working across groups or companies on the other side of town or across the ocean. They may be branches of your own company, contract research organizations or even competitors! In the race to improve patient care, however, the current thought is to involve those best positioned to make great progress and work together toward improved patient care.

 

"Today there are over seven million researchers around the world, drawing on a combined international R&D spend of over US$1,000 billion (a 45 percent increase since 2002), and reading and publishing in around 25,000 separate scientific journals per year. These researchers collaborate with each other, motivated by wishing to work with the very best people and facilities in the world, and by curiosity, seeking new knowledge to advance their field or to tackle specific problems." – 2011 report, The Royal Society

Why Collaborate?

As further stated in The Royal Society report: "Collaboration enhances the quality of scientific research, improves the efficiency and effectiveness of that research, and is increasingly necessary, as the scale of both budgets and research challenges grow. However, the primary driver of most collaboration is the scientists themselves. In developing their research and finding answers, scientists are seeking to work with the best people, institutions and equipment which complement their research, wherever they may be."

The presentations organized for the Spring 2013 SLAS Webinar Series, Effectively Managing Collaborative Science, mirror these thoughts and can help participants learn to formulate strategy, employ best practices and establish successful long-term collaborations. The webinar series comprises three one-hour webinars, free to SLAS dues-paying members both live and afterward, on demand, at SLAS.org. Each webinar independently addresses different topics and issues relating to successful collaborations.

R&D Partnership in Asia and Emerging Markets
March 20, 8:00 p.m. CDT (convert time)
Ajay Gautam, Ph.D.
Executive Director and Head of Emerging Markets Collaborations
AstraZeneca, Shanghai, China
Free to members and non-members

Lessons Learned in Pharma - CRO Collaboration in Discovery Research
April 17, 10:30 a.m. CDT (convert time)
Jonathan H. Connick, Ph.D.
Executive Director and Chair In Vitro Pharmacology Council Merck & Co., MSD
Shanghai, China
Free to members

Challenges and Strategies for Successful Transfer of Cell-Based Potency Assays
May 15, 10:30 a.m. CDT (convert time)
Liming Shi, M.A, M.Sc., ADMET Certificate
Senior Research Scientist, Bioassay Development
Eli Lilly, Indianapolis, IN
Free to members

Tap Emerging Markets to Discover Talent

"Global innovation is the name of the game," says Ajay Gautam. With undergraduate degrees in biotechnology and bioengineering from Indian Institute of Technology (IIT), India, a Ph.D. in biomedical sciences and research experience at Baylor College of Medicine and MD Anderson Cancer Center, Gautam understands science…and business. He also earned an M.B.A. in finance, started companies and navigated collaborations in the United States, and across emerging markets such as India, Brazil, China, Mexico, Russia, the Middle East and Northern Africa. Having lived and worked in the U.S. and various emerging markets in Asia, Latin America and Middle East/Africa, Gautam has a broad understanding of how to navigate cultures, bring people together and establish highly functional relationships. Together, his scientific and business experience and skill establish an important foundation for his current position with AstraZeneca where he is tasked with building successful partnerships across emerging markets.

"You could say the world is vastly inter-connected and flatter these days," says Gautam. "At AstraZeneca, we look to see wherever the best minds are, wherever the best innovation is happening, and then we reach out to start working with them. We are really interested in bringing the best medicine to patients."

Gautam and his AstraZeneca colleagues cast a wide net in their efforts to bring the best medicines to patients.

"Over the last 10 to 15 years, countries like China, India, Korea, Brazil and Russia, amongst other emerging economies, have been building innovation ecosystems at their universities and academic institutions, attracting key talent and bringing capital from government and from the venture side," he explains. "Key scientists and executives are coming back to these countries, bringing back their wealth of experiences and education from the U.S. and Europe, to help kick start R&D, so you are seeing more and more research coming out of academia, out of biotech and out of the labs in these countries, more publications, more start-up companies. It becomes clear to everyone that we have to start building networks of collaborations in these countries if we are truly to capture the innovation going on globally."

With energetic innovation driving great science, Gautam's webinar presentation focuses on how to build an effective partnership – from exploring strategies and detailing business plans to seeking and securing the best partners and creating win-win situations for all. He believes AstraZeneca is a leader in building partnerships in the emerging markets and shares recent success stories to illustrate his points.

For example, in December 2011, AstraZeneca entered into partnership with Hutchison Medi Pharma for the biotech's continued development of Volitinib, a phase 1 selective c-Met oral small molecule inhibitor with potential to inhibit the growth of tumors, especially in gastric and non-small cell lung cancer. AstraZeneca's role is to lead the development, registration and commercialization of Volitinib for the rest of the world. This partnership earned AstraZeneca and Hutchison Medi Pharma the 2012 Alliance of the Year Award from Elsevier Business Intelligence and the BayHelix Group.

"This is the first partnership between biotech and pharma for a novel molecule that was developed in China laboratories with potential for global development," Gautam says. "Historically, this has never happened."

According to the AstraZeneca website, the Volitinib program began in February 2012 with a Phase I clinical trial study in patients with advanced cancer. The companies are "developing Volitinib as a single agent treatment as well as a combination therapy. Strong translational research is examining a combination of Volitinib with an epidermal growth factor receptor (EGFR) inhibitor for treating non-small cell lung cancer that has both EGFR sensitive mutations and c-Met overexpression."

Another recent success story Gautam shares in the webinar is AstraZeneca's research collaboration that launched February 2013 with the N.N. Petrov Institute of Oncology, one of Russia's leading cancer research institutions, to identify genetic mutations in cancer patients.

Gautam says that, in combination, Petrov Institute scientists and AstraZeneca's Oncology Innovative Medicines group global teams have created a perfect collaboration by combining Petrov's research infrastructure and scientific expertise in St. Petersburg with AstraZeneca's proven track record in global research and discovery in oncology. This collaboration is one of the first of its kind in Russia between a pharmaceutical company and a research institution.

In a company blog, Gautam notes, "The collaboration will focus on various genes and other biomarkers that may be common within the Russian population. Establishing these mutations and the role they play in the growth and spread of cancers may lead to the development of better therapies, improvements in disease management and innovative approaches to personalized healthcare for patients in Russia and worldwide.

Use Contract Research Organizations Successfully

In the second webinar of the Spring 2013 SLAS Webinar Series, Jonathan Connick zeros in on how to effectively work with contract research organizations (CRO), those organizations that exist to provide support to the pharma, biotech and medical devices industries. These types of collaborations, while in existence for decades, have taken on higher levels of prominence as companies search for the best ways to move discovery from the bench to the bedside.

Connick, who began his pharmacology career in the United Kingdom over 25 years ago, has seen many positives to this growth.

"Collaborations in general, and working with CROs specifically, have grown from a piecemeal, transactional way of doing business to a more strategic method," he says. "The way we do partnerships today is with long-term plans and partners. Engaging much more actively with CROs, we work together to solve problems."

While a CRO is a different company, in many ways working with CROs is the same as working within the company, Connick says. This includes the need to establish the basis for scientific trust, earn the respect of one another, understand expectations and share common goals.

"A partnership, whether external or internal, will always grow and evolve," Connick offers, "but the basic chemistry has to be there. You need to look at the leadership of the partner company and be sure they are looking at your partnership in the same strategic way."

He adds that there is always temptation to look at partnerships in terms of money alone. "If you take a long-term business point of view, you need to acknowledge and accept that all aspects of the partnership may not work in a revenue setting. Agree on the vision, and it will be a much more productive partnership and a win-win for both sides."

Once the partners agree on long-term goals and strategies, the hard work of making it happen begins. Connick will share his experience and advice in his webinar presentation.

"Wherever possible, initial contact between partners should be face-to-face and you need to get the right people talking to each other at the right level," he instructs. "If you have A tell B who tells C who tells D, you're going to lose something in the translation. Try to keep scientists talking to scientists and allow them to concentrate on the scientific aspect and keep business discussions separate."

This is just one of several communications issues raised by Connick as potential challenges. Another is detailing processes and procedures.

"Take communicating procedures for example," Connick says. "For conducting many of our routine assays, we document procedures that go into detail even including where we buy specific components. Then we go through a process with our partners to check understanding of those procedures. This is a best practice and continues throughout the partnership."

Establishing and checking that proper protocols are followed also exists within internal situations, Connick notes, but its importance is magnified when operations are happening across great geographical distances. "Compliance differs in different cultural situations, so this needs continual attention," he says. "Cultures and countries may have different standards, but you must apply the same principles and high ethical standards that you would in the original environment."

He acknowledges that there are numerous books and theories about working effectively with people of different cultural backgrounds, but that in his experience, it is not that complicated.

"You need to respect different cultures," Connick says. "Different cultures may have an emphasis on different values and you need to understand that. In a work situation, however, basic principles exist wherever you work in the world. Make sure both parties understand expectations and what success looks like. Make absolutely clear what needs to be done, where the fine lines are and what issues may arise."

One mistake he made early in his career was avoiding negative feedback, especially in external collaborative situations. He said he needed to learn to give constructive feedback to CRO partners so that performance could be improved.

"Provide constructive feedback to collaborative partners and time it appropriately, just as you would with a member of your internal team," he advises.

He finds the benefits of working with CROs to be many, but flexibility and potential cost savings top the list.

He does wish, however, that pharma could come to a joint understanding about many of the procedures and protocols used and standardize how things are done to make working with CROs more seamless.

"Much like the development of microplate standards streamlined the way assays are conducted across companies, we could sit down and agree upon how to define workflow, analyze data and transfer data across the globe," he adds. "We should come to an understanding across pharma on some of these principles. We could find a way to manage the IP concerns."

Transfer Bioassays Seamlessly

As SLAS's third presenter in the Spring 2013 SLAS Webinar Series, Liming Shi takes a deep dive into one specific aspect of working effectively in partnerships – how to successfully transfer biological assays between the sponsor and contract research organization (CRO). Bioassays, especially cell-based potency assays, are considered to be the closest and most relevant measure of a biological mechanism of action, he says, and they differ from physical/chemical assays in a number of ways.

"They are more variable, and the readout reflects biological activity at multiple levels," Shi explains. "Because of the inherent variability, it is critical to employ statistical methods to design experiments and analyze data. The current trend in the biopharmaceutical industry is to include bioassays at earlier stages of product development. Bioassays are used for lot release, and are often the early indicators of problems with product stability, impurities and decreased potency."

Because of this, Shi adds, bioassays are required by regulatory agencies for biologic product submissions.

"When transferring internationally, some overlook the challenges that can be presented by the customs process for example," Shi explains. "The planning focus may be on scientific steps, and this logistical step of transferring biological materials like live microorganisms or cells can be overlooked. All countries have different laws and you may find out materials may be held two to six months before clearing customs. You must build this into the timeline and procedures."

Since his first industry job at Genentech working on testing qPCR through today's responsibilities at Eli Lilly, Shi has grown in his understanding of development, transfer and validation of bioassays. His work at Genentech resulted in three of the first qPCR manuscripts: "A real time quantitative PCR-based method for the detection and quantification of Simian Virus 40," Biologicals, 1999; "Real time quantitative PCR as a method to evaluate Simian Virus 40 removal during chromatography procedures for pharmaceutical protein purification," Biologicals, 1999; and "Real-time quantitative PCR as a method to evaluate xenotropic murine leukemia virus removal during pharmaceutical protein purification," Biotechnology and Bioengineering, 2004.

During this webinar, Shi first will provide the big picture of the biological assay transfer – the who, what, where, when and why – to illustrate the process and procedures. This includes defining strategy, scope, timeline, product management, documentation, sample plan and how to manage and monitor performance to be sure everything is scientifically rock solid. He also will share examples of lessons learned, using real data to show how to make plans for transfer, test success and get to the root cause of any issues.

"Transferring biological between locations, especially international, is anything but simple," he says, "and must be considered early in the planning process, especially when materials will be transferred across borders.

"I had a situation early in my career where the results we were seeing in our home location were a bit off from those in the transfer location," Shi explains. "We researched the steps taken and found that they were using a different type of reagent and that alone was causing the differences."

Documentation going forward, he says, was always prepared to include the necessary details to avoid issues like this.

"We now make sure to address all parameters, from reagent type to culture bath prep to serial dilutions and even the differences in weather," Shi says. "It is important these be addressed early and all together."

During the webinar, he also will spend some time on the importance of partner training for optimal performance.

Biological assay transfer is a complex project, which needs not only scientific expertise and statistical knowledge but also project management, supply chain consideration, communication and people skills.

"Setting up the appropriate expectations and getting the aligned scope at beginning are very important," Shi says. "The webinar will include real examples to demonstrate the tricky parts and loopholes during the transfer business. I would like every attendee of the webinar to understand that bioassay transfer is a complicated process with multiple steps that require thorough technical expertise and acute management skills. However, with rock solid scientific knowledge, complete training and project management expertise, it can be done effectively."

Shi serves as chair of the SLAS Technology Transfer and CRO/CMO Project Management SIG, which maintains a year-round forum on SLAS LinkedIn. Read more about this SIG in a previous SLAS Electronic Laboratory Neighborhood e-zine feature article. He is a frequent conference speaker and will keynote at the Biological Assay portion of the International BioAnalytical Congress in Berlin, Germany, September 2013.

The Future is Bright

Webinar leaders Gautam, Connick and Shi agree that collaborative science is here to stay. They want to arm webinar participants with strategic understanding and practical techniques to effectively manage science across groups and geographies to ultimately benefit patients.

"All involved in medical research and drug development have come to realize that while individual companies have some really smart, very intelligent people doing some really great science, we are just not capable of doing everything ourselves," Gautam says. "To get access to the best minds and the best science, you go out and partner with companies, with academia, with peers so that you can make sure you are developing the medicines that patients need and progressing things as fast as you can so the patients can benefit earlier. Taking discoveries from the bench and labs to the clinic and then to the market takes a long time and costs an enormous amount of money with high risks of failure. With cost constraints faced globally, everyone is more and more realistic that managing these risks and costs more judiciously by partnering is a very intelligent and realistic way of moving things forward."

April 1, 2013