ending stagnation: how collaboration tools are enabling a … · hepatitis c drugs and was priced...

Ending Stagnation: How Collaboration Tools Are Enabling A New Era of R&D

FierceMarkets Custom Publishing, Sponsored By:May 2015

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The disaggregation of drug research

Sponsored Content: Going Beyond Travel Cost Savings to Achieving Productivity Gains

How Polycom is facilitating remote research

How video is enabling fast, efficient clinical trials

What next? The future of R&D

Ending Stagnation: How Collaboration Tools Are Enabling A New Era of R&D // May 2015

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Biopharma R&D, from drug discovery through to late-phase clinical trials, suffers from two fundamental, near industry-threatening problems: It is too slow and too expensive. And with payers and the public getting increasingly vocal about drug prices, the long-standing tactic of passing on costs to the healthcare system is on shaky ground. Something has to change. Fortunately for the industry, tools and tactics that can shave time and money from drug development already exist.

The need for cost savings is growing more and more clear, as drug development becomes an increasingly expensive process. The Tufts Center for the Study of Drug Development (CSDD) estimates the cost of bringing a drug to market rose by 145% in constant currency between 2003 and 2013. That equates to a compound annual growth rate of 8.5%, pushing the total outlay from $1 billion to $2.6 billion over a decade. Some people have disputed the math, but

with other estimates ranging from $1 billion to $5 billion, almost everyone agrees biopharma R&D is a shockingly expensive endeavor.

Companies have traditionally propped up their expensive R&D operations by charging ever-higher prices for products that win approval. However, governments in Europe and payers in the U.S. have started to push back against high drug prices, particularly as the huge price tags have spread from orphan drugs to products meant for much larger markets. The hepatitis C price war between AbbVie and Gilead is the current poster child for the payer protest, but it’s likely to be just the first of many attempts to curtail costs. Cardiovascular drugs and cancer treatments are among the next targets for cost-conscious payers.

One way to remain profitable in such an environment is to shorten R&D timelines. This saves money














upfront and adds to profits later, particularly in competitive therapeutic fields. Gilead’s Sovaldi, for example, was clearly superior to other available hepatitis C drugs and was priced accordingly. But once competition arrived in the form of AbbVie’s Viekira Pak, the price Gilead could charge for Sovaldi fell rapidly. Sovaldi is forecast to sell for an average discount of 46% this year. In this payer environment, the value of shaving months off R&D timelines for drugs in competitive indications is higher than ever.

Even a four-month cut to the R&D timeline can make a difference, as Sanofi and Regeneron showed recently when they paid BioMarin $67.5 million for a voucher that will shorten the FDA’s review of their PCSK9 cardiovascular drug by that amount of time. The four-month saving is of particular value to Sanofi and Regeneron because it gives them a head start on Amgen in the hotly tipped PCSK9 market. That said, speed has always been important. In 2010, think tank The Manhattan Institute estimated moving Herceptin’s approval date forward by one year would have added $730 million to Genentech’s earnings.

With R&D costs continuing to rise and the diminishing ability to easily recoup outlays from payers, companies can ill-afford to leave such sums on

the table. Every day and dollar count. Much of the current cost of drug development is tied to the high failure rate: Just 10% of drugs that enter Phase I make it to market, according to a paper published in Nature Biotechnology in 2014. That may fall as our understanding of biology grows, but companies can still take immediate steps to cut the time and money it takes to establish whether a drug will succeed or fail.

In the absence of better ways to pick winners based on preclinical data, fast and lean operations that take drugs from one go/no-go decision to the next as efficiently as possible are the best option for companies. Unfortunately, adopting such a model brings up some obstacles.

The disaggregation of drug research In the late 2000s, the triple blow of the recession, the loss of patent protection on key products and faltering R&D pipelines forced both Big Pharma and biotech to rethink their approaches to organizing and financing drug research. With Big Pharma losing patent protection on drugs with annual sales north of $100 billion from 2010 to 2013 and biotechs struggling to raise money over the same period, both ends of the drug research food chain revamped their approaches. Big Pharma tossed out the vertically integrated R&D sites they had dreamed up in the blockbuster era and biotechs adopted capital-efficient, asset-centric models.

The responses made large and small companies alike more reliant upon disaggregated networks of in-

“The cost of bringing a drug to market rose by 145% in constant currency between 2003 and 2013”














house and third-party teams. Big Pharma companies began outsourcing more R&D work to contract research organizations (CROs) in the West and Asia, while also becoming more reliant on biotech and academia for innovative drug discovery. The upshot is that Big Pharma R&D chiefs have gone from managing campuses at which most of their company’s work in a particular therapeutic area takes place, to overseeing global networks of internal and third-party collaborators spanning from San Francisco to Shanghai.

Early-stage biotechs have evolved in parallel. Many companies retooled during the financial crisis to focus on getting their most promising asset to proof-of-concept as quickly and cheaply as possible, and in so doing they de-prioritized the establishment of in-house infrastructure. Investors had no desire to pay to build or buy research centers and Big Pharma had no wish to acquire them as part of deals to add biotech-discovered assets to their pipelines. Once again, the upshot was that more and more biotechs moved toward the virtual model of research, in which a small in-house team managed CROs.

The swing from centralized to disaggregated research was intended to lower fixed costs and give firms access to innovation, wherever it was happening. Big Pharma as a collective has subsequently managed to bring growth in its outlay on R&D under control—the top 10 companies now spend around $70 billion a year—and started to chalk up approvals for some potential blockbusters. Biotech firms, having weathered the financing storm, are now combining

their stripped down research models with larger amounts of money and becoming the darlings of Wall Street in the process.

Such a rosy assessment masks ongoing logistical teething problems, though. Eli Lilly revealed some of the communications issues associated with outsourcing to China when it pulled a portion of its medicinal chemistry work back to the U.S. Albany, N.Y.-based CRO AMRI picked up the slack by overseeing a team working out of an underused Lilly laboratory in Indiana. Talking to investors in 2012, then AMRI CFO Mark Frost said: “One of the major reasons Lilly...pulled [the work] back from China was to improve project management and communication with their own scientists.”

While the problems faced by Lilly are common, its response was more extreme than those of many of its







Sponsored Content

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The RealPresence Platform delivers a highly personalized experience to every user, where staff can click a name on their Lync contact list and instantly connect and collaborate together, face-to-face via Polycom video on their desktop or in a conference room-based system to bring people together in high definition.

Video Bridges the Distance among Global Locations for the Lowest TCO Dispersed over many different business groups and locations, Lonza has seen global collabora-tion increase through the use of high-definition multi-party video conferences, enabling teams to gather information together and collaborate on documents live over video. One of initial driving forces behind Lonza utilising video col-laboration was to reduce its travelling costs, but after a while they discovered another important aspect, it saves time and makes the team more productive. They found that conducting meet-ings over video avoided the time taken to plan for a meeting involving travel. The use of video conferencing bridges the distances between global locations to cross both language and cultural barriers as video collaboration has be-come central to the way Lonza does business

and the travel desk now encourages employees to use video instead of travelling to meetings.

More Efficient and Personalised Collaboration Polycom video solutions are being used by all Lonza employees for a wide variety of meet-ings – from management and board meetings, to facilitating inter-departmental meetings and expediting quality control group meetings Ad-ditionally, HR use the rooms for global training and interviews without the need to travel.

Improved Productivity and Work-life Balance Lonza have seen a major adoption of video conferencing as it empowers staff to commu-nicate and collaborate whilst experiencing the benefits of increased flexibility. Staff now have more time to do their jobs and be more pro-ductive rather than be tired from jetlag due to travelling from Europe to China to the United States. Video collaboration provides Lonza with flexibility and speed, enabling them to meet people within the same week without the need for travel. n

Going Beyond Travel Cost Savings to Achieving Productivity Gains









peers. Others have turned to technology to overcome their communication issues. With video conferencing having passed through its own teething troubles—such as dropped connections and low resolutions—to mature into a reliable, effective medium, geographic proximity is no longer essential to good communication. The era of connecting remote teams through intuitive video conferencing systems has arrived.

How Polycom is facilitating remote research Astellas’ interest in video conferencing predates the existence of the company in its current form. In 1993—12 years before Astellas was created through the merger of Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical—Polycom began providing video conferencing services to a business unit that would ultimately become part of the Japanese drugmaker. The technology that was available in the 1990s—despite being primitive compared to today’s systems—proved useful as a way to connect staff and cut travel costs.

In 2008, with 15 years of real-world evidence on the value of video conferencing in its possession, Astellas decided to step up its use of the technology. Like many drug developers, Astellas was rethinking its approach to development in response to some of the pressures described previously. In the space of 12 months, Astellas struck big-ticket deals with a pair of Californian biotechs. At the same time, Internet speeds were improving. Home broadband adoption in the U.S. topped 50% that year.

With its research operations disaggregating, Astellas doubled down on video conferencing. Polycom retained the contract and applied its network consulting and Elite Service teams to the job, providing proactive assessment and support. The result was a network that expanded beyond the 100 conferencing systems at Astellas’ Japanese offices to include teams in Europe and the U.S. When Astellas used the system to defy the distance between executives and R&D teams, decision-making accelerated. And with billions of dollars resting on these decisions, return on investment in the system soon followed.

Astellas and other users realize returns on their investments in multiple ways, some of which are more obvious and easy to quantify than others. The hard endpoint is often time-to-market—a metric that improved at Astellas—but there are many other factors. Amid the thicket is the intangible issue of trust. Quantifying gains in trust is difficult, but many users say engaging face to face with collaborators at other companies—and even remote outposts of their own business—brings them closer together. From this trust flows speedier decisions and abbreviated development timelines.

Such gains are only achievable if the system is quick and easy to adopt. Simple, intuitive and reliable are the watchwords at Polycom. The system has to work the first time, every time and be immediately useable by teams regardless of whether they are in Basel, Bangalore, Boston or Buenos Aires. Video only truly mimics face-to-face meetings, and the decision














making and relationship building such talks facilitate, when it is so unobtrusive it is invisible. This has been Polycom’s mission for 25 years and the reason it trained Astellas’ staff on best video practices. Morale improved after the training.

While retaining the simple, intuitive and reliable mantra, Polycom has gradually built out the functions of its video system to help companies unleash the power of human collaboration. Each advance is designed to better replicate—and in some cases improve on—what happens when people get together to talk about an issue. Users can now share, analyze and mark-up work processes, images and other documents from room displays or computers. All the annotations and markups can be recorded, as can everything that is said in the meeting.

Users can search the audio of recorded meetings for key words, allowing both attendees and anyone who was unable to be there to quickly find critical discussions and follow the conversations and data that led to the making of a decision. The value of such asynchronous meetings to geographically dispersed biopharma research teams is particularly high given the challenges of meeting across time zones. By lessening this common barrier to fast decision-making in drug research, video collaboration tools can help companies move quickly and thoroughly through preclinical tests and into first-in-human trials.

How video is enabling fast, efficient clinical trials Establishing a research network that provides a flow of new compounds is essential to the future of biopharma companies, but it is the clinical trials downstream of these activities that are the most expensive and time-consuming steps in the R&D process. The closer a drug gets to the market, the bigger the savings available to savvy firms. In 2013, market research group Cutting Edge Information calculated Phase III oncology trials cost $74,800 per patient on average. Some trials top $100,000 per patient. With enrollment numbers for some indications breaking four figures, overall costs are high.

In this environment, small efficiency gains translate into significant savings of both time and money. On the long and oft-discussed lists of areas in which clinical trials can become more efficient, one topic






Find out how >

There are many reasons why the top ten pharmaceutical companies worldwide are Polycom customers.Perhaps most important is that global operations depend on innovation fueled by collaborative decision environments. Polycom helps companies unleash the power of human collaboration.

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is always near the top: Enrolment. Tufts CSDD calculates that while 90% of trials ultimately hit their patient enrolment targets, doing so takes twice as long as expected. Around one in ten sites fail to recruit a single patient and more than one-third fall short of their enrollment target. Estimates of the proportion of patients who enroll in a trial but drop out before it ends hover around 25%.

These figures are testament to the fact that the current clinical trial model is failing patients. Only people who live near to a trial site are able to participate in research. Even then, the inconvenience of traveling to and from the site multiple times during the study can deter people from joining or staying in a trial. However, in the 21st century such yoking of trials to geography should be unnecessary. Online, informed-consent tools and wearable data-collection devices are ending the need for participants to visit sites. Pfizer and Sanofi have taken the idea to its logical conclusion by running fully virtual trials.

Yet while sensors can now track many metrics that previously necessitated on-site tests, there is still a need for face-to-face interactions between participants and study staff. Such communication is important as a way to allay participants’ worries

and gather data in trials covering all indications. Video conferencing meets this need. In doing so, the technology removes a barrier to the running of virtual and semi-virtual trials. In these trials, participants may only need to visit the study site once or twice—or not at all—lessening the geographically imposed bottleneck on recruitment and retention.

The effectiveness of video conferencing as a replacement for physical meetings between participants and study staff is demonstrated by its success in one of the most demanding fields: Central nervous system (CNS) diseases. Clinicians need to see participants in CNS trials to judge disease progression based on visual and auditory cues. Video can replace physical meetings, but only if the connection is reliable and high quality. The risks of unreliable connections are particularly severe in trials of mental disorders, because patients may confuse jittery video streams for hallucinations.

With CNS trials necessitating such high standards, MedAvante knew it needed a near-perfect system that biopharma companies trusted if its plan to offer remote patient assessments was to succeed. In 2005, the company chose Polycom as its technology provider. MedAvante made the decision based on Polycom’s reputation within the biopharma industry for providing video streams of the highest quality and reliability. Since then, the business has taken off, with Polycom supporting more than 1 million minutes of video conferencing between trial participants and clinicians in the first four years.

“Video collaboration tools can help companies move quickly and thoroughly through preclinical tests and into first-in-human trials”














Video conferencing offers some unique benefits to CNS trials, primarily relating to its ability to cut the risk of biased assessments, but many of the gains and the features that make them possible apply to all studies. Severing the tie between geography and trial participation will have a huge impact on the efficiency of clinical research and will only be widely achievable through use of video conferencing. Again, not just any video conferencing will do. The system has to be simple enough for trial sites and participants to set up and use without training. MedAvante found this was the case with Polycom.

What next? The future of R&D The experiences of Astellas, MedAvante and the 415,000 other companies and institutions that rely on Polycom for video collaboration show the workplace of the future is unimpeded by geography. Distances of thousands of miles become irrelevant to the efficient operating of a business. The technology that bridges these gaps will continue to evolve, something Polycom is well placed to both lead and adapt to given its co-development relationships with other vendors and open, standards-based approach to compatibility. But how the technology is used will be as important.

Biopharma and Polycom continue to collaboratively assess the best ways to use today’s technology, notably by learning how to incorporate tools seamlessly into existing workflows. Research units, trial sites and everyone else involved with bringing a drug to market need tools to fit into the way they

work, not the other way round. Biopharma R&D is hard enough as it is without technology getting in the way. The goal at Polycom is to facilitate the small changes—a 30 minute video chat instead of an eight-hour flight—that make R&D faster and cheaper. The future looks like today, only more efficient.

Here is how it might look: A drug discovered in Oxford, U.K. is in-licensed by a biotech based out of Boston, MA. The partners use video conferencing to defy the 3,000 miles between their offices and collaboratively decide on the next steps for the asset. A CRO in Shanghai, China is brought on board to run preclinical tests. All three organizations now keep in touch via video conferencing. The asset then advances into human trials, during which clinicians assess participants remotely on the same technology the biopharma company uses to liaise with in-house teams, study sites and CROs.

In this vision of the future, video conferencing acts as the bridge between remote teams at each step of the process, from drug discovery and clinical trials through to commercial manufacturing, sales and marketing. The Internet has already made the world seem much smaller, but video conferencing is now ready to defy the adage that nothing can replace

“Severing the tie between geography and trial participation will have a huge impact on the efficiency of clinical research”














in-person meetings. Face-to-face meetings via video conferencing accurately simulate the feel and benefits of gathering in person, with the added bonus that the conversations can be recorded and archived in a searchable format for future reference.

By incorporating video conferencing into drug research and clinical trials, biopharma companies can address some of the factors that caused the cost of bringing a product to market to double from 2003 to 2013. Over that period, drug research operations globalized and clinical trials ballooned in size. Both trends put strains on the industry. Now, video

conferencing can lessen those strains by making the distance between research teams irrelevant and increasing the pool of potential clinical trial participants.

Biopharma R&D will continue to strain under the burden of many major challenges, but there is no good reason for geography to be one of them. The experience of Astellas, MedAvante and others shows that video conferencing technology has eliminated that particular problem and set the stage for a new era of R&D. n






ending stagnation: how collaboration tools are enabling a … · hepatitis c drugs and was priced...

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