A New Path Ahead

According to a recent Quintiles New Health report, a lack of capital and the increased reluctance of payers to reimburse for new medications are serious concerns among biopharma companies.

Everyone is in agreement that the current level of healthcare spending is unsustainable, and one of the chief culprits is the industry’s current business model, says Colin Hill, CEO, president, chairman, and co-founder of GNS Healthcare.

“Inevitably, the system has to evolve so that we are paying for value, not for volume," Mr. Hill says. “In this new environment, it is going to be critical to demonstrate a company is delivering value to patients in the real world, not just in the clinic. And that means looking at real-world outcomes. The key for pharma is to plan for this new reality early in the drug development cycle and to develop strategies for generating that real-world evidence. Our belief is that some of the answers pharma companies seek is in the data, waiting to be found."

Nagaraja Srivatsan, senior VP and head of life sciences, North America, at Cognizant, says life-sciences companies should be migrating from being just pure drug manufacturers to being companies that provide the drug and services around their products. This is a fundamental shift in the go-to-market model.

“Life-sciences companies are slowly migrating from giving a pill to the market to a pill plus service model," he says. “This model will help payers with what they need. This means not just providing a drug, but also providing a program that ensures compliance with the drug regimen to ensure that the right outcomes are delivered."

According to Rob Bazemore, president of Janssen Biotech, the economic and cost pressures put on the industry will continue to force companies to streamline ways of developing and commercializing their products and improving the value provided to the overall healthcare system while enhancing operating efficiencies.

“The need to innovate and improve pipeline success rates will force companies to rethink their approach to traditional drug discovery and development," Mr. Bazemore says. “Finally, the shift to quality, outcomes, and patient satisfaction will require companies to rethink the kinds of data they generate, the endpoints they design into clinical trials, and the services they provide to support the appropriate use of their products."

Laurent Schockmel, president, Latin America, and chief strategy officer, of Cegedim Relationship Management, says it has been said that a good hockey player skates to where the puck is and a great one skates to where it will be.

“While salesforces may be more nimble in the future, we are already seeing a trend toward broader healthcare teams, introducing additional providers and system models that overshadow the solo practitioner," he says. “The most important characteristic required in the near future to be an effective healthcare leader is the ability to think strategically, which means planning for how healthcare will be delivered and understanding the needs of the different stakeholders who will play an integrated role in its delivery. Fostering stakeholder connectivity and ensuring internal agility will be the keys to success."

Innovation: The Way Forward

At Janssen, Mr. Bazemore says the goal is to create the best new treatment options, and that is causing Janssen to focus on true scientific innovation in the development process to establish new efficacy and safety standards for the diseases the company is treating.

“This approach goes beyond the discovery and clinical development process, and extends to formulations, drug delivery, and services to support our brands commercially as well," he says. “Ultimately, we use the patient’s needs on his or her treatment journey as the lens through which we assess everything, and our focus has to be on the overall patient experience and the outcomes we’re delivering."

Nick Colucci, president and CEO of Publicis Healthcare Communications Group, says innovation will fuel new discoveries, but not just in the laboratory.

“Innovative new ways to partner with others, who may have expertise in manufacturing, distribution or complementary technology, will help to keep biotech sustainable," he says.

New Partnerships

Strategic partners can support the needs of pharma companies from early product development, through commercialization and well into a product’s life cycle.

According to Chuck Stevens, VP and general manager, commercialization strategy, at Parexel, when selecting the right strategic partner, a gap analysis needs to be done first.

“Pharma companies should assess the following: the partner’s global reach; experience in therapeutic categories; whether it has a formalized process for operationalizing a strategic partnership; the number of subject matter experts with relevant experiences; established expertise in all phases of product development, including clinical trial design and execution, regulatory, commercialization; and comfort with key members of the strategic partnership team. Considering these factors will aide in selecting the right strategic partners."

On the sponsor side, partnerships take many forms.

“We have fostered strategic alliances with many industry partners that share our passion for innovation and transforming treatment paradigms for populations where unmet medical needs continue to exist," Mr. Bazemore says. “At Janssen Biotech, an aligned partnership means getting the best patient outcome from a therapeutic standpoint — putting the right patient on the right product at the right dose at the right site of care and helping the patient stay on the product as long as it is appropriate. It is important to select strategic partners that share these goals and are willing to work through the organizational differences to arrive at decisions that ultimately optimize the benefit of products to patients."

Mr. Bazemore’s colleague, Marian Nakada, Ph.D., VP, strategy and operations and external innovation, at Biotechnology Center of Excellence, Janssen Research & Development, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, says the company is complementing its internal research and discovery with external innovation and capabilities that are unique and promising, so that together with partner organizations, they can efficiently and effectively explore a broad range of new biologic therapies that provide benefits not addressed by current medicines.

“We look at the world as our laboratory and we find the best organizations to partner with, whether academia, biotech, or pharmaceutical companies based on the particular goal at hand," Dr. Nakada says. “Our internal strengths often provide important enabling capabilities to our external partners’ technologies and drug candidates, making their speed to market and probability of success greater to achieve our ultimate goal of bringing new treatments to patients around the world where unmet need exists."

Becky Holloway, product marketing manager at Revitas, believes for pharmaceutical companies to be successful in these types of partnerships, they need to have systems and procedures in place to quickly implement these new types of agreements, including outcomes-based agreements.

“They need a vehicle to support the management of new and different types of data to support these agreements, and they need to be more creative through incentive programs without sacrificing compliance, productivity, or profitability," she says.

Melissa Hammond, managing director of Snowfish, says a number of leading industry players are developing incubator type programs throughout the world with leading hospitals and research institutions around specific disease state areas.

“The goal is to identify promising new product concepts at an early stage that can be commercialized," she says.

Sheila Rocchio, VP of marketing and product management at PHT, believes because outsourcing will continue to be a huge trend, sponsors will want to create a smaller set of truly invested companies that focus on specific therapeutic areas.

“Sponsors are partnering with a smaller set of service providers to create more of a partnership strategy instead of a vendor-of-the-week tactical approach," she says.

On the commercialization front, Jay Bolling, CEO of Roska Healthcare Advertising, says the industry has grown up in a world of silos — marketing and sales, professional and consumer, digital and non-digital, PR and media — but the world no longer works this way.

“Today’s professionals and consumers are, for the most part, skeptical of advertising and promotion," he says. “They don’t believe what we’re saying. They’re not interested in what we want them to do. Tried-and-true pharmaceutical marketing and sales practices are only minimally effective at best, and it’s time to adopt a new model if we hope to be successful in the future."

Mr. Bolling believes unique, new partnerships and relationships are at the core of this future success model.

“Agencies are partnering with other agencies to truly integrate best-in-class services for the brand’s benefit — not solely their own; clients are partnering with agencies to look beyond marketing to commercial opportunities and true life cycle management; relationships between agencies and marketing/media partners aim to deliver messaging that’s iterative, relevant, and noninvasive," Mr. Bolling says. “If we’re going to truly deliver on the promise of better health and wellness as our raison d’etre, we better start partnering with each other and our audiences to create relationships that are mutually-beneficial and in everyone’s best interests."

Payers: Staking a Claim

One of the questions being posed is whether pharmaceutical companies are providing payers with what they need to make the right strategic decisions. Parexel’s Mr. Stevens says the short answer, according to payers, is no.

“Some private payers have publicly questioned the validity and relevance of clinical trial data when products are used in the real-world setting," he says. “The problem facing pharma is that the postapproval payment market is changing rapidly, implementing new types of payment methodologies, focusing on outcomes, and requiring patient consumers to pay more for products, while regulatory approval processes and clinical trial methodologies have not. This results in pharma companies delivering product data that meets regulatory approval standards, but falls short of meeting the new data demands of payers."

Mr. Stevens adds that pharma companies must understand what data will be required by payers to provide optimal coverage, payment, and patient access to newly approved products.

“This means that early research — before Phase II — should be conducted to outline what data must be demonstrated during development to meet payer needs," he says. “The results of this research must then be incorporated into clinical trial designs in a way that does not jeopardize regulatory approval, but provides the market with secondary endpoints and other data that help to clearly demonstrate product value to patients, payers, and providers."

Mr. Srivatsan agrees that the new model will require organizations to prove that their medication is better than what exists in the market.

“I do not agree that new medications per se face higher challenges for reimbursement," Mr. Srivatsan says. “The need is for better articulation of the value of new medicines. Most payers are looking to deliver better patient outcomes and will look for multiple new medications that can comparatively keep people healther than existing medications."

He believes me-too drugs in crowded segments of the marketplace will definitely face increased challenges from payers.

According to Terry Nugent, executive VP sales and marketing, Medical Marketing Service (MMS), public payers are seriously challenged financially so the pressure on price will continue to increase.

“The industry must find ways to maintain profitability," he says. “More efficient marketing and R&D are the best strategies."

Claire Gillis, CEO of WG Consulting, says pharma must create and communicate a clear and compelling value story.

“Companies will need to provide strong evidence that their brands offer the highest effectiveness and the lowest cost, placing particular emphasis on reducing relapse rates," she says. “They also face a growing reimbursement challenge. A changing customer base, dominated by payers, will mean higher hurdles to overcome in seeking reimbursement."

A recent survey WG completed with Penn Schoen Berland reveals that pharma is already predicting the ACA will make reimbursement more difficult.

“The shifting political landscape will mean significant changes to our healthcare environment," Ms. Gillis adds. “With the ACA about to take hold, changes to Medicare and other government programs being debated, pharma must anticipate and prepare for a range of new scenarios and learn from successful EU strategies. Certainly, we will be dealing with tighter regulations, a greater focus on outcomes, and stronger pressures for cost containment."

She believes payers will be looking for the greatest value at the lowest price to meet the demands of the ACA and other potential regulatory and political changes.

“In addition, we will see the market moving from a fee-for-service to a fee-for-value model," Ms. Gillis predicts. “As a result, biopharma companies will need not just to tell a powerful clinical story but an equally effective economic story. This will be particularly true for more expensive therapies, such as biologics, which can carry a hefty price tag."

Faraz Ali, VP, program management and commercial development, at bluebird bio, points out that customers in every industry expect the products they buy to perform well, especially those with high prices and high margins.

“Drugs are no different," he says. “It should not come as surprise to the biopharma industry that insurers are looking to reduce costs and to maximize the value of their spend just like everyone else."

bluebird bio is developing potentially one-time transformative therapies for severe diseases with high unmet medical needs.

“We believe this type of product profile has a unique opportunity to create real value for payers, for example, by arresting the course of devastating acute or chronic diseases that would otherwise cost the healthcare system dearly," Mr. Ali says. “But the burden is on us — and on the rest of the biopharmaceutical industry — to demonstrate the value of our products in every way possible, whether by using clinical data, patient-reported quality of life instruments, long-term outcomes databases, health economic analysis, etc.

“It may also be necessary to proactively envision innovative pricing and reimbursement models in collaboration with payers during development," he continues. “Risk-sharing agreements might be necessary for high-priced, one-time therapies. While pay-for-performance models may have proved difficult to implement in practice, the idea is here to stay, and we need to plan and to be prepared to adjust to that reality."

Shifting from a fee-for-service model to payment systems that reward for health outcomes gives incentives to providers to work toward driving adherence.

“Better, more informed conversations between healthcare providers, such as physicians and pharmacists, and their patients will increase the likelihood of patient adherence," says Derek Rago, VP, strategy and marketing, at McKesson Patient Relationship Solutions. “With these changes, providers will be seeking resources to help achieve these healthier outcomes. Pharma manufacturers can help physicians navigate this new terrain by providing them resources to maximize patient adherence."

Mr. Rago says while non-adherence is physicians’ biggest complaint about their patients, many physicians acknowledge they do not have sufficient time for adequate adherence counseling.

For pharma, development and commercialization initiatives will now need to include an understanding of how to keep patients adherent to their medications by developing a product and personalized support program that promotes long-term adherence," he says. “A comprehensive patient support structure that incorporates healthcare providers, leverages technologies, and engages patients will be imperative in moving the needle on patient outcomes."

Mr. Colucci says there are opportunities for closer collaboration between pharma and payers, particularly in the early development stages by better understanding the data that payers need to make reimbursement decisions, and by working together to establish what those reimbursement criteria are in the first place.

To prepare for the new market, Mr. Colucci says pharma companies need to embrace and leverage their power as mass educators.

“They have the unparalleled bandwidth to reach a huge number of stakeholders through multiple channels, from packaging inserts and clinical trial design," he says. “Pharma companies can prove their value beyond merely producing medicines by elevating education efforts that can facilitate better doctor-patient dialogue, help ensure patients understand how to take their medicines properly, and provide clinicians with access to the most complete product and outcomes data."

Risky Business

According to Mr. Srivatsan, life-sciences companies should take on more risks by going after unmet needs in disease states that have lower numbers of patients.

“Companies have two approaches: a red ocean strategy that goes after disease states with many competitors and a blue ocean strategy that goes after unmet needs in disease states with a lesser market, but that can have more impact/penetration," he says. “To limit risks one needs to identify the strategy for the product and make sure that there is enough of a market differentiation to ensure that companies are not creating me-too drugs."

Risk is inherent in the life-sciences industry, but Ms. Hammond says the challenge is to identify successful ways to mitigate risk.

“There are a number of ways risk can be mitigated," she says. “The development of partnerships is the most obvious and has changed dramatically over the past decade. By keeping research and development outside the funding company it is possible to participate in the upside and limit the downside. Another tool for mitigating risk is to identify all the known pitfalls up front. For example, by performing a clinical data gap analysis that involves a comprehensive analysis of hundreds, and in certain cases thousands, of clinical trials to identify potential points of failure companies can reduce the risk."

Mr. Nugent believes that the major pharmaceutical companies may end up being distributors, buying promising products in Phase II and laying R&D risk on entrepreneurs.

“But if they follow this model they will have to allow their R&D staffs to leave and become entrepreneurial," he says. “In other words, they can’t carry the overhead while essentially outsourcing R&D."

“The future is changing," Cognizant’s Mr. Srivatsan says. “We are going from a fee-for-service model to a fee-for-outcome model. To obtain better market share, organizations will have to share the risks with the payers to ensure that their products deliver better outcomes. The approach to risk sharing is to look at disease states and episodal outcomes and for life-sciences companies to quantitatively come up with information on how they can deliver them better."

Mr. Colucci says appealing, risk-sharing agreements with payers may be hard to implement, whether due to design or administrative costs on both sides.

“They can, however, be beneficial for all parties," he says. “Successful RSAs must include explicit objectives, produce measurable data, and have a clear exit strategy defined. RSAs should be used for products and situations that will truly benefit — not just because it’s the hot trend."

He adds that it may be a cliché, but it’s true: no risk, no reward.

“And with catastrophic health risks like Alzheimer’s disease growing in scope and impact, bold research is needed now more than ever," Mr. Colucci says. “Collaboration is the ultimate risk mitigation tool — when government, academic, and industry interests align, we can share both knowledge and risk."

Ms. Gillis believes many risk-sharing agreements in the European Union could be applied in the United States.

“In fact, they may have to implement ACA’s fee-for-outcome model with pharma paying up front until benefits are realized," she says.

mHealth

mHealth is an important opportunity for the industry, especially pharma and health plans, to have meaningful relationships with patients and members to better manage health.

“Today, enabled by the spread of information on the Internet and mobile access via smartphones and tablets, patients are far more engaged and proactive with their health," says Chris Mahoney, director of healthcare strategy, at Cynergy.

Mr. Mahoney says 80% of doctors use smartphones and medical apps, and more than two-thirds of the 91 million smartphone users in the United States have used their mobile phone for some kind of health-related task.

“As mobile devices continue to become part of the health management toolkit, pharma and health plans will need to find and develop new and innovative ways to connect with patients, especially ways that can motivate healthy behaviors," he says. “For example, insurance companies, such as Aetna, Humana, United, and the Blues, are responding by investing in and developing a better digital presence, such as mobile applications that connect their members to services beyond traditional insurance products, such as tools and support for patients to better manage their diseases.

“Patients are interested in using their mobile device to help them make better health decisions and to manage their diseases," Mr. Mahoney continues. “Apps that focus on keeping patients healthy and providing tools to personalize and manage treatments will be well-received and will also more effectively address the pressure on controlling healthcare costs for both patients and providers. With the right goals and solutions, mHealth and supporting technologies are poised to fundamentally change how patients manage their conditions and will provide new avenues for the entire healthcare system, from pharma to caregivers, to help patients on their path to better health."

Mr. Srivatsan says the proliferation of mobile devices will drive a continued adoption of mHealth in the next five years.

“mHealth will be used in all aspects of the industry, including telemedicine, better diagnostics, device, remote monitoring of patients, and for helping with medication compliance," he says. “In addition, mHealth will be used to drive better patient-centric wellness models."

Both developed and developing markets are increasingly relying on mobile technologies to transfer healthcare information, according to Parexel’s Mr. Stevens.

“This includes the sharing of patient information among healthcare professionals, payers, and other stakeholders," he says. “In many developed markets, mHealth closely aligns with electronic medical record initiatives and systems. The industry will be pressured to develop programming to support mHealth, but will be constrained by legal requirements to protect patient health information. The industry will be best served to invest in technology platforms that will ensure the secure transfer of information as part of any mHealth program."

Tom Jones, senior VP, health practice, Makovsky, believes mHealth is poised to create huge advances in patient care, particularly in the area of patient adherence.

“But mHealth won’t generate its own content," he says. “It’s up to the pharmaceutical industry to create the easy-to-understand information patients need to best care for their own health. mHealth will reinforce the push for improved health literacy efforts within pharma companies."

Extensive use of iPads will continue to grow, experts predict.

“Recent research shows the majority of reps are already using iPads to increase the effectiveness of details," Ms. Gillis says. “In addition, findings also reveal that providers use smartphones more than any other communication tool. In fact, the vast majority of physicians today use their phones to access the Web — often during patient visits. Companies will need to alter the way they deliver their information to fit this new model."

Patients also search for health data online and use their iPads and smartphones to find health-related information.

“In the United States, 80% of Internet users search for health information online," Ms. Gillis says. “Simple mobile sites that explain clinical and health economics metrics of treatments in easy-to-understand language will be critical tools moving forward, as will quick locators that provide insights into the reimbursement process, billing codes, and other key information to help patients get on therapies faster. Certainly, mobile health apps are exploding. Research2guide reveals that the mobile health market has increased seven-fold in the last year, counting apps, as well as the devices, marketing, and transaction feed around them."

“We look at the world as our laboratory and we find the best organizations to partner with, whether academia, biotech, or pharmaceutical companies based on the particular goal at hand."

Dr. Marian Nakada / Janssen Research & Development “Life-sciences companies are slowly ­migrating from giving a pill to the market to a pill-plus-service model. This model will help payers with what they need."
Nagaraja Srivatsan / Cognizant

“While salesforces may be more nimble in the future, we are already seeing a trend toward broader healthcare teams, introducing additional providers and system models that overshadow the solo practitioner."
Laurent Schockmel / Cegedim Relationship Management

“Companies will need to provide strong ­evidence that their brands offer the highest ­effectiveness and the lowest cost, placing ­particular emphasis on value drivers such as ­reducing relapse rates."
Claire Gillis / WG Consulting

“The need to innovate and improve pipeline success rates will force companies to rethink their approach to traditional drug discovery and development."
Rob Bazemore / Janssen Biotech

Trending Now

Keith Dionne, Ph.D.
President and CEO
Constellation Pharmaceuticals

1. Early-stage companies and novel platforms will re-emerge as attractive investments.
2. Greater appetite from pharmaceutical companies and VCs to support novel discovery platforms.
3. Creative deal structures (like Constellation-Genentech alliance) create win-win scenarios.

Yuichi Iwaki, M.D., P.h.D
President, CEO, and Founder
MediciNova Inc.

1. Increasing collaboration among pharma, government, and NGOs.
2. Improving efficiencies in clinical development.
3. Strategic focus on cost-avoidance strategies.

Nancy Lurker
CEO
PDI Inc.

1. How we tap into the power technology brings to defining our markets and communicating with them will define our growth and profitability.
2. Healthcare reform. The impact current or modified legislation will have on our industry is significant, from how we are reimbursed to how we are able to develop new biopharmaceuticals.
3. Genomics and personalized medicine/diagnostics. This emerging science will have an enormous impact on our business model and the way we develop new products and bring them to market.

Rick Morrison
Founder and CEO
Comprehend Systems

1. Using analytics and modern technology will enable all players in the industry to understand what is actually happening. It will enable sponsors to expect more from their CROs, and it will force all companies to modernize.
2. What has always worked in the past will not necessarily work in the future (in fact, it most certainly will not).
3. We’re entering a new era of accountability for all companies in the pharma ecosystem, and those that aren’t creating value will cease to exist.

Jon Smith
Director, Industry Development
Revitas

1. Risk sharing.
2. Maximizing profits in the face of rapidly closing patent windows.
3. Adapting to increasing regulatory pressure, while still driving profitability

“There are a number of ways risk can be mitigated. The development of ­partnerships is the most obvious, and this has changed ­dramatically over the past decade."
Melissa Hammond / Snowfish

“Pharma companies need to have ­systems and procedures in place to quickly implement new types of agreements, ­including outcomes-based agreements."
Becky Holloway / Revitas

“The industry must find ways to ­maintain profitability. More efficient ­marketing and R&D are the best strategies."
Terry Nugent / MMS

“It is going to be critical to ­demonstrate a company is delivering value to patients in the real world, not just in the clinic. And that means looking at real-world outcomes. "
Colin Hill / GNS Healthcare

Hot Button Issues in Biotechnology

According to a recent E&Y report, the global biotechnology industry showed a second straight year of increasingly stable financial ­performance in 2011, with established biotech markets registering more than 10% revenue growth for the first time since the start of the global financial crisis. But longer-term ­sustainability remains challenging, with the ­traditional funding-and-innovation model for precommercial biotech firms under ­unprecedented strain.

According to Rob Bazemore, president of Janssen Biotech, one of the biggest issues ­gaining the most attention is the regulatory ­approval of biosimilars.

“These are defined as biologic products that are similar — not identical — to biologic ­medicines, and the FDA issued draft guidance earlier this year related to biosimilar product ­development to ensure safety and efficacy," he says. “To that end, Janssen Biotech has long ­supported a defined pathway for biosimilars that puts patient safety at the center while seeking to expand access to important medicines. We’ll ­continue to closely monitor this issue."

Ryan McGuire, research team leader at ­Cutting Edge Information, says as biologics ­enter the market, ­generics ­companies will need to ­expand their ­manufacturing capabilities to offer low-priced biosimilars.

“In fact, some generics companies may begin to expand into clinical development in order to have biosimilars approved in different parts of the globe," he says.

Rodeina Challand, executive director, ­biosimilars development, at PRA, says ­biotherapeutics have had a successful record in treating many life-threatening and chronic ­diseases, but their cost has limited patient access.

“The expiration of patents and/or data protection for the originator’s biotherapeutic has ushered in an era of products that are ­designed to be similar to a licensed originator product — biosimilar products," she says. “As ­regulatory ­agencies clarify the pathways to ­approval of biosimilars, many organizations are seizing the ­opportunity to produce biosimilar drugs."

But, she adds, manufacturing of biosimilars ­requires specialized capabilities and significant ­financial investment.

“Current technology does not allow complete characterization of biologic products due to their complex structure and therefore chemical ­comparability," Ms. Challand continues. “Additional clinical trials are necessary for approval, which add not only to the overall R&D cost, but to ­competition for sites and patients."

Large pharma as well as generics companies are moving into the biosimilar space, and with strongly integrated R&D, refined global planning, rigorous clinical trials, and post-marketing safety studies, Ms. Challand says companies can tap into this space and access the benefits offered.

“In emerging markets, early-market entry, state funding, and low development costs make biosimilars an attractive opportunity," she adds. “Bioclusters are rapidly emerging in the major Asian emerging markets and will fuel growth of the biopharmaceutical sector in this area. Biosimilars are here to stay."

Nick Colucci, president and CEO of Publicis Healthcare Communications Group, says some of the hottest issues in biotechnology today are not strictly related to healthcare.

“The role of algae in new biofuels and the controversial call to label foods with biotech contents are examples," he says. “But a key issue impacting all sectors of biotechnology is the role of intellectual property rights, which recent studies suggest can impact innovation in a positive and sustained way."

The Generic Fallout

Mr. Colucci says generic companies will play a larger role in providing medicines for the U.S. and global marketplaces, but even they will face pressures as fewer and fewer products go off-patent because of the gap in innovation.

“To make up for this gap, we already see some of these companies increasing focus on diversifying their businesses and product lines, becoming more of a blend between generic and brand players," he says. “Generic companies are also beginning to position themselves within the still-forming biosimilars space, which will force these players to operate as a ­quasi-generic/brand functional blend as well."

Mr. McGuire says consolidation of the generics industry has been a major trend over the past five years, but there isn’t much more opportunity for that to continue.

“At least not at the same rate," he says. “There just aren’t enough independent ­generics companies out there for consolidation at such a high rate."

Rodeina Challand
PRA
The expiration of patents and/or data protection for the originator’s biotherapeutic has ushered in an era of products that are designed to be similar to a licensed originator product — biosimilar products.

Nick Colucci
Publicis Healthcare Communications Group
A key issue impacting all sectors of ­biotechnology is the role of intellectual property rights, which recent studies suggest can impact innovation in a positive and ­sustained way.

Outcomes: The New Reality Outcomes:

Nagaraja Srivatsan, senior VP and head of life sciences, North America, at Cognizant, says patient outcomes is one of the most significant transformational agents for life-sciences companies.

“This is impacting all aspects of the life-sciences value chain, starting from discovery to identify if the drug is going to deliver better outcomes to the development process to ensure that the trials collect not just data from the treatment regimen but information about the ­benefits of the regimen over others," he says. “This effort should drive better comparative effectiveness results to commercialization efforts where patient outcomes will be used to position drugs against their competitors for better pricing and placement with the payers."

Chuck Stevens, VP and general manager, ­commercialization strategies, at Parexel, says successful pharma companies will change the alignment of their ­internal organizations to ensure that the right ­development decisions are made well before ­commercialization.

“An integrated product development team ­consisting of clinical, regulatory, and commercial experts will identify if potential patient outcomes will be ­meaningful enough to the payer market to warrant ­continued investment," he says. “Analysis of payer data needs can impact trial designs and identify what ­information should be collected during ­development to support the demonstration of product value. This will better position a product to ­receive ­favorable payer coverage and give the pharma company a better opportunity to meet commercial ­objectives."

In this environment, according to Claire Gillis, CEO, WG Consulting, companies will need to conduct more ­efficient clinical trials that ensure patient adherence and minimize or control for outside influences on outcomes.

“For example, we will not only need trials that quantify standard clinical outcomes but also less common ones, such as patient’s lifestyle and food intake, as well as health economic utilities," she says. “Spending money to ensure clinical trials include these variables will allow them to succeed or fail sooner, saving millions of dollars on ­wasteful exercises that yield poor data. Improving trials not only cuts costs, it shortens timing, results in more ­accurate data, and supports more effective messaging around safety and efficacy. Companies will have better data they can deliver to the FDA sooner, potentially ­reducing the time it takes to bring new drugs to market and allowing patients to get faster access. Patients will benefit both from lower-cost products and faster access to new therapies."

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