Taren Grom, Editor
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Getting Down to Business: What’s Ahead in 2013
Thought leaders from all sectors of the industry identify what they believe are the most important business objectives for the life-sciences industry and their companies for 2013 and beyond. They also provide their insights on the strategies/approaches that need to be implemented to achieve these objectives.
Our core strategic objectives and priorities for 2012 will be carried through 2013 via the “4 Big Bets,” which create a focus within the organization on strengthening our business, organization, market position, and people as we work toward better health outcomes for our patients.
The pharmaceutical industry and our company must continue to strive to find solutions that make healthcare more efficient, more sustainable, and deliver better outcomes. At Janssen Biotech, we remain committed to finding ways to enhance the value we deliver, where our investments are being focused on those things that directly improve the patient experience.
Chief Operating Officer
As large CROs continue to focus on forging strategic partnerships with big pharma, there is an opportunity for midsized CROs to continue to expand to meet the steady, growing demand for outsourcing services among emerging and specialty biopharmaceutical companies. Whether a CRO and sponsor are engaged in a multi-million dollar alliance or working on one project together, the challenge is to improve the efficiency of clinical trials while driving higher quality to allow the sponsor to get to decision points faster. Whatever the size of the companies involved, this requires a high priority commitment to collaborate and align expectations, and CROs have the opportunity, and more importantly, the obligation to make this happen. To that end, CROs can better leverage technology to increase efficiency in the clinical trial process. There is a need for new tools and methodologies to streamline data collection, review, analysis, and reporting. These would take advantage of the data available from various sources, such as medical records, centrally collected data such as clinical labs or patient reported outcomes, site monitoring reports, and other trial metadata.
Making this data more readily accessible and usable would allow sponsors to make better decisions faster. Data access and integration through better use of technology is an opportunity to help save time and costs and enhance the efficiency of drug development while ensuring quality.
Our industry today is challenged by the need to change the way we do business to remain sustainable. At the same time, this presents opportunity, as increased value is placed on a new breed of clinical development professionals who develop the skills, processes, and tools to deliver further innovation and productivity through transformational change. At the end of the day, by achieving innovation and productivity goals, we carry out our mission of delivering a better future to patients.
Senior VP, Director of Strategy Services
In 2013, more blockbuster brands will lose patent exclusivity. The industry will continue to make its way through the years of the patent cliff, and the objectives will reflect the times: to reduce staff to a number that drives the business in the future, to invest the substantial resources of the industry into the right R&D assets, and to speed commercialization of every asset in a company’s portfolio.
Irrespective of previous business models, leaders need to evaluate the organization for what it needs versus what it has, and address inefficiencies quickly. They need to focus acquisition and R&D efforts on assets that will show a strong return on investment for an organization, and invest quickly. The price of promising Phase I and Phase II compounds is continuing to rise, but that doesn’t mean that companies should refrain from investing. It means they must decide and act quickly, before competitors that are slower to move. And once companies have a portfolio, they need to get it to market as quickly as they can, while accounting for the new needs of the marketplace.
Neil de Crescenzo
Senior VP and General Manager
Oracle Health Sciences
The industry will continue to seek improvements in return on investment, leveraging stringent cost controls to maximize the chances of meeting these objectives. At the same time, companies will continue to invest in innovation that uses insights and ideas from outside the walls of their company, leading to increased collaboration. The industry also will continue to increase its investment in personalized medicine technologies and processes, as the benefits of these approaches become increasingly accepted.
Companies will collaborate more among themselves in what is often referred to as precompetitive activities. In addition, biopharma companies will further establish long-term, collaborative relationships with academic, governmental, and regulatory groups to optimize processes and develop a more productive approach to executing clinical trials.
Glen de Vries
Given the continued proliferation of modern technologies in clinical trials infrastructure, 2013 will see a shift from implementing technology for its own sake to an environment where technologies will be expected to drive human outcomes.
By replacing paper processes with Internet-backed systems and leveraging the growing data assets available to sponsors and CROs, the most innovative and successful life-sciences leaders will start up clinical trials that are more attractive to investigators and patients, and moreover, will ultimately expose fewer subject volunteers to ineffective and harmful doses of investigational drugs.
Although some of these effects will come from past efforts to streamline development operations, an awareness of the intersection of the financial and ethical benefits of better study design and management will further galvanize our industry for change.
Eve Dryer Healthcare Consulting
Improving consumer health and patient outcomes by providing a roadmap and efficient information to support informed and shared medical decisions is at the leading edge of true health reform.
As the healthcare system grows more complex, and more people need help finding their way through the maze, there is a relatively new industry growing in response to this need. One of the fastest-growing companies in this space is a southeast Pennsylvania company — Accolade — which has contracted with major employers such as Comcast to provide their employees with “personal health assistants,” who provide help on everything from benefits coverage, to locating an in-network doctor, to coordinating a second opinion, to providing insights on a symptom, to championing them on a health plan appeal.
It is widely believed that more and more patients will likely turn to patient navigation services for help choosing doctors, treatments, medications, and even dealing with billing. In fact, the state insurance exchange infrastructure has a built-in patient navigator function.
There is also a growing and necessary trend in shared decision making, which helps patients be better informed about their treatment choices and make better decisions, which might in fact be the most promising trend in terms of improving care and reducing spending. Shared decision-making ensures that patients are fully informed, and then use that information to get the treatment they want, and I predict that 2013 will see a significant growth in its utilization.
Another trend is that employers and health plans are putting teeth into health management programs with incentives. The past 12 months saw a two-fold increase in incentive designs that pinpoint specific outcomes for weight control or cholesterol levels, and according to a December 2011 Towers Watson survey, “an astonishing 87% of large employers (planned) to add or strengthen programs or policies in 2012 to encourage more health-conscious behavior.”
In a most recent example, Humana and Wal-Mart announced in September a program to offer a segment of Humana members who shop at Wal-Mart a 5% rebate on products under Wal-Mart’s Great For You icon, including fresh fruits, vegetables, and low-fat dairy.
A final trend I hope not to see continuing into 2013 is the negative impact that Senator Grassley and the tightening noose of governmental regulation has had on many patient advocacy organizations during the past year. Despite the positive intentions that have influenced most corporate funding of third-party partnerships, as companies ramp up their regulatory guidelines governing corporate giving and advocacy partnerships, the resultant impact has been a loss of funding for many nonprofits’ long-time patient education and resource programs.
2012 even saw several patient organizations closing their doors, including the long-functioning Y-Me, the only organization offering a 24/7 telephone support line for women diagnosed with breast cancer.
Global Pharmaceutical Leader
Ernst & Young
Over the next year, companies will face the pressures of positioning for growth and organizing their resources to meet the demands of an increasingly complex market. Market access, defined in the broadest sense, will be the most critical issue.
Companies will be challenged to demonstrate the value of their products to payers for the purposes of pricing and reimbursement, and they need to position themselves to deal with the complexity of health system requirements in the various markets they serve, including important, less mature growth markets.
They will need to focus on the diverse and often challenging regulatory requirements of these various markets, and the unique demands of customers will shape their ability to deliver their products in new, often nontraditional ways.
In addition to aligning their organizations to have a global response and strategy for market access, companies also can leverage value from collaborations with nontraditional partners and public-private partnerships to deliver health outcomes to healthcare systems in a manner that benefits most stakeholders. This will require a unique way of aligning incentives and initiatives across the wider health system.
It is an exciting time in the life-sciences industry for several reasons that will have an impact on our business. The convergence of technology that can treat diseases at the genetic level is occurring at a time when we are understanding more about the biology of disease and the genes that are implicated in the origin of many diseases. Additionally, regulators are recognizing that these factors will mean a different approach to evaluating drugs for approval that are tailored to diseases that are rare and have a low prevalence.
This is occurring at a time when patient advocates are voicing their views about how the risk-benefit ratio is different in progressive, life-threatening diseases where no options exist, and they are having increasing influence and a seat at the table in determining how we should consider drug approvals in this new era.
Sarepta is directly impacted by these factors as we have an RNA-based technology that can treat rare diseases at the genetic level. Our lead program is in Duchenne muscular dystrophy (DMD), and the DMD patient advocacy community is playing a direct role in how we and the FDA should consider their views in determining the feasibility of accelerating approval of drugs based on early signals of safety and efficacy in small patient populations.
The combination of genetic-based drug technologies and many of the ultra-orphan diseases that they are designed to treat will require a forward-looking and flexible approach by the FDA. Our technology has the potential to treat 85% of the DMD patients around the world, but it will require more than 20 versions of our drug to personalize the technology to treat every genetic subtype of the disease. Most of these subtypes are so rare that it is infeasible to conduct clinical safety and efficacy trials that can be easily enrolled and/or impossible to power for an efficacy claim. I believe the FDA and other regulators understand the need to anticipate technologies that can easily be modified to treat many more patients without altering the drug-like characteristics that have been proven in specific genotypes.
Director, Life Science and Pharmaceutica
One of the really exciting developments in 2013 will happen at the pointy end of personalized medicine, and that is autologous therapies. Here the therapy is specifically developed for an individual patient. The cost of these highly tailored therapies has previously been extremely expensive due to the industry being locked in to using capital-intensive technology such as building more and more clean rooms to support the scale up of the manufacturing.
We are finally seeing enabling technologies, such as closed and automated processing, that provide a commercially viable option. I think we will shortly see cell therapies advance through clinical trials on automated systems that will avoid the unnecessary pain associated with having to change the production process mid-stream to enable scale-up. The benefits to the patient will be substantial and the challenges will lie in selecting the diseases where the cell therapies offer the greatest benefit.
By 2025, virtually no significant revenue will be generated by today’s approved branded pharmaceutical products. Thus, innovation is paramount. This may occur as the result of old-fashioned blood, sweat, and tears, however most likely strategic partner development will come into play. This does not only refer to commercial acquisitions but academic alliances. While the research being performed in academia is early stage, we are starting to see a handful of forward-thinking companies taking a systematic approach to optimizing upon these opportunities. In 2013, I predict that we will be seeing more of this.
New strategies and approaches need to be developed for careful identification and development of new products. First and foremost, companies need methods to determine ideal partners or product acquisitions. Much time can be wasted on poor potentials with key opportunities missed. Once a partner is identified, life-sciences companies need to be well aware of the benefits and risks for undertaking development for a particular product. For example, drugs that have failed in the past due to trials that included a diverse genetic pool have the potential to be successful in a far smaller pool. It is critical to avoid potential development pitfalls and ensure that the focus is on more optimal candidates. This may be accomplished through in-depth clinical data evaluation; we term this clinical data gap analysis.
VP of Marketing, Healthcare
The assault on pharma’s current commercial model has been nothing short of epic. We’ve seen volumes written about the declining impact of the salesforce and how the locus of control is shifting to the marketing function, which is finding itself pressed to quickly move up the marketing maturity curve. But there’s an equally pressing trend within the industry, one that has received much less attention: the transformation of commercial operations from its traditional role of salesforce enablement to a focus on capabilities that must power a new model of data-driven marketing.
For the past 20 years, the sales and finance functions have received the lion’s share of capital investment for technology capabilities. That tide has turned, although arguably much later than it should have. This will have profound implications for commercial operations. Commercial operations will be challenged to develop an end-to-end commercial infrastructure with marketing at the center rather than at the periphery. Their role will take on greater strategic importance, and at the same time they will find themselves facing a new level of complexity — integrating many disparate data sources, enabling customized multi-channel campaigns, and providing real-time insights that optimize campaign performance and maximize ROI.
Fortunately, technological innovations in the market will help ease this transition. Rather than having to build large, IT systems that are slow to evolve and expensive to maintain, commercial operations leaders are leveraging nimble cloud-based capabilities that can significantly shorten the time-frame for deployment and value-realization. They are also leveraging a new breed of partners to quickly bring in the skills and processes needed to succeed in this new world.
In reality, pharma companies will spend the next three to five years building marketing capabilities other industries have built over the last 20. There is great opportunity for significant market advantage for those that aggressively move in this direction — and great risk to those that lag. About 30% of the pharma companies we’ve talked to are well down this path; another 30% are talking about big changes coming next year.
Dr. Anand Iyer
President and Chief Operating Officer
Today, much of the life-sciences industry continues to focus on business as usual: drug innovation and the practices and policies that support the marketing, sales, and support of drugs in regulated environments. However, very few focus on the “last tactical mile” — that is, understanding and optimizing how patients and providers consume or interact with their drug therapy. The enormity of the opportunity for the pharma industry to help optimize clinical decisions and improve medication adherence is comparable with the size and impact the Internet had on the global communications industry in the 1990s. However, pharma must shift focus as the communications industry did, toward not just “selling the widget” but delivering the value, solutions, and support around and even beyond the widget, in their case, the “pill.” To unlock this hidden value, pharma must adopt a wider ecosystem — inclusive of mHealth software, communication services, and informatics.
Senior VP, Health Practice
Stakeholder alignment and engaging patient advocates are two trends in 2013 to watch. Ensuring that expectations — across industry, policymakers, patients, payers, and physicians — are understood and closely aligned throughout the life cycle of a medical technology is critical to its success. Communication is at the heart of this idea. Life-sciences companies should not be intimidated by educating patient advocates, regulatory agencies, or payers about the challenges they face. The best way to rally others around a common goal is transparent, engaging communication.
Identifying and acknowledging players across the space from very early on is critical — particularly patient advocates and professional groups. Engaging in dialogue early in the process, seeking to answer questions, and establishing a relationship of respect can lay tremendous groundwork for future communications efforts. The days of transactional advocacy support are gone. Today, it is about identifying a common mission and leveraging each side’s strengths to move toward a solution for patients.
Dr. Jay Licther
The most important business objective for Avalon Ventures and our portfolio companies is to develop better relationships with big pharma to create a long-term financial strategy that is win-win-win for pharma, biotech, and VCs. This is absolutely critical or our industry will disappear.
We are doing this by making more contacts, reaching out earlier in the development process, keeping an open dialogue, and trying to better understand the needs of each of the parties involved.
Over the past decade our industry has been buffeted by market, regulatory, and economic forces leading to a restructuring effort that is far from finished. The biopharmaceutical commercial model remains problematic. One of the key priorities needs to be the improvement of this model by effectively harnessing technology to more efficiently inform and service healthcare providers and bring needed products to market. Other industries are far ahead of us on the technology implementation curve. There are enormous advances in technology especially in communicating with HCPs. These technological advances need to become part of the way the industry goes to market.
Preparing for the long-term implications of the Patient Protection and Affordable Care Act is also critical. We need to identify how and where altered reimbursements will affect biopharmaceutical products, where the accountable health organizations will put additional demands on formulary acceptance and the consequent impact on products.
We have been struggling with the changes necessary to our commercialization model. Too many companies continue to operate with a mindset that is costly and inflexible. Many still send sales representatives on details during office hours, failing to address rising healthcare practitioner pushback. Today’s HCPs have made it painfully clear that they need to specify what information they need, when they need it and within what venue. The industry has to get aggressive again. We need to pursue alternative ways to reach our customers, more extensively tapping nontraditional channels such as nonpersonal promotion and using different sales rep profiles to meet the needs of the brand. Faced with the economic restructuring that will be part of our response to the Patient Protection and Affordable Care Act, many will find investing in dedicated sales teams or nonpersonal promotion infrastructure will be too costly and inefficient, increasing the need for outsourcing.
Chief Operating Officer
For the life-sciences industry, a key objective for 2013 and beyond is ensuring that more physicians are willing and prepared to participate in clinical research. With more targeted therapies becoming available in areas such as oncology, it will be important to know where potential patients exist. That means making more of an effort to encourage the physicians who treat them to participate in research for the benefit of their patients and for drug development as a whole.
One of the drivers for INC Research in 2013 will be to align our systems and processes so that we’re better able to offer innovative tools and technologies that deliver efficiencies in the trial process and accelerate the accessibility of data to help make informed decisions more quickly.
To encourage increased participation in clinical research, there needs to be greater effort in ensuring more positive experiences by making sure physicians are well-trained and confident in managing trial patients and protocols. As a therapeutically focused CRO, we rely heavily on physicians to identify protocol-eligible patients and make it a point to build a balanced network of sponsors, academic organizations, and patient advocacy groups to support the clinical trial effort. By investing in external databases, we’ve extended this network to bring more physicians new to clinical research into the mix as well.
Identifying a drug that is safe, effective, and provides real value to patients is the overarching business objective for the life-sciences industry. However, this goal has become increasingly difficult to attain with the skyrocketing cost of R&D, increasing development timelines, and declining new molecular entity (NME) approvals. The single biggest lever we have to address these challenges is reducing late-stage clinical failures, which pose an extremely high cost to companies, patients, and our healthcare system. We as an industry have to focus on achieving greater clinical predictive power during discovery and preclinical stages. One of the most important objectives for the life-sciences industry, and the major mission of Organovo, is to develop new technologies, tools, and processes that provide better insights into clinical outcomes earlier in the drug discovery process.
More than ever before, drug developers are revisiting the commonly accepted assumptions and processes used in discovery and preclinical stages. The earliest and very successful discovery paradigms were rooted in physiology, but as low-hanging fruit was picked, the industry moved to target-based approaches to achieve high throughput and better understand mechanisms of actions (MOA). However, determining MOA in non-physiologically relevant systems such as biochemical and cell culture assays can often mislead drug development programs and extend timelines. The –omics (genomics, proteomics, metabolomics, etc.) have provided a new window into MOA, but one that may be difficult to interpret since each “omic” only tells part of the story, and the animal models and cell cultures upon which the “omic” assays are used are themselves not always clinically predictive. With advancements such as 3D tissue technologies and bioprinting, early candidates can be tested on more clinically predictive, physiologically relevant systems than ever before.
Executive VP, Sales and Marketing
Medical Marketing Service (MMS)
The industry will in all likelihood have to take advantage of the opportunities posed by implementation of the Affordable Care Act (ACA), as well as the continuing patent cliff. The regulatory environment will, to some extent, be a function of the makeup of the new administration and Congress.
Pharma will have to learn to market efficiently and effectively more like other business verticals. R&D will have to be shaken up to enrich the pipeline. As the ACA plays out, marketers will have to learn how to navigate the changes in purchasing and prescribing power. The industry will have to learn how to sell programs that are aligned with ACA incentives, packages of products and services that maximize health rather than treating illness, which involve cost-effective patient behavior modification. It won’t be enough to just sell the molecule.
The need to do more with less will be the theme in 2013. Even in the midst of budget pressure, brand teams still need to meet and exceed their sales goals. Marketing tactics that can’t demonstrate ROI above an aggressive hurdle rate are at risk, and agencies that have long dodged outcomes measures will no longer enjoy fat year-over-year budgets. Senior product managers will look for agency account teams that understand and care about the financials of a brand’s performance.
There will be a continuation of focus and specialization around therapeutic areas, patient types, and geographical markets. Most large pharma companies have managed to muddle through the patent cliff through a combination of strategies, including M&A, deep cost-cutting, and simply managing Wall Street expectations. Now that we have largely refactored and resized for this new world of fewer blockbusters, there is a race to own specialty markets. Business development and strategic alliance offices have grown headcount, and executives are piling up global frequent flier miles looking for new products and companies. The challenge is that many of the leading global markets are getting more sophisticated in their own right, with regulatory restrictions and pricing limits altering the balance of power between manufacturers and markets.
As companies attempt to become more nimble and decisive, they will need timely access to relevant data, insight, and recommendations. Brands can no longer wait months for campaign activity reports or ROI analysis. Product managers feel the pressure to make mid-game go/no-go decisions and reallocate marketing budgets even before a campaign is complete. This urgency requires a level of agency transparency and collaboration that is still uncommon in this industry.
Life-science companies need to rethink the rules of engagement with their neighbors in the healthcare ecosystem. Virtually every relationship is strained, whether with providers, consumers, payers, disease management companies, advocacy groups, regulators, or the government. Pharma represents innovation and a path to increased quality of life for millions, but it must earn that respect every day at those moments of truth when its products are prescribed and administered and refilled and reimbursed.
There has been a growing acknowledgement of the need to reduce costs, but since the industry has never been known for its cost-management expertise, cost cutting is not always done in a strategic manner. Sales representative headcount has been reduced over the past few years, but that represents only a fraction of total headcount. Look for more judicious outsourcing of key activities to established partners in the areas of R&D, market research, and sales and marketing. But this time, partners will be held on a short accountability leash, with the need for better data integration, real-time reporting, and in some cases, even shared risk.
To accomplish more with less, the business relationship between pharma and its agencies will begin to look like the risk-sharing partnerships that pharma has developed with CROs. Agencies will need to rethink their revenue model away from the traditional fee-for-service vendor relationship to outcomes-based compensation — sound familiar?
Therapeutic specialization has the potential to liberate the profit engine in many companies. From R&D focus and strategic alliance leverage to staff expertise to targeted marketing, specialization offers a level of productivity and efficiency not available to large, unfocused companies with a Chinese menu of products. But it requires fierce adherence to the positioning and an allergic aversion to opportunism.
The attention that big data has been getting is warranted, but to date, most of the large datasets still reside in their respective marketing silos. 2013 will begin to see integration of marketing and response data across agencies, data partners, and internal IT to offer analysts a real-time insight sandbox.
A new reporting framework will increase transparency and accountability both internally and externally and give managers the ability to make smarter and more timely investment decisions. For most medium-size and large pharma companies, the global health ecosystem is broader and more complex than ever before.
Partnerships across the aisle with payers and providers mean that pharma must move from a self-image of product manufacturer to solution partner. Physicians are accountable for managing patient care, but pharma can play a larger role quarterbacking a range of therapy options, from Rx to OTC to diagnostic and device suppliers. Pharma’s global footprint, capital muscle, and therapeutic expertise give it a unique platform for leadership, and it’s ready to play that role.
If you’re not in the workflow, you’re out. It’s essential to build value within the clinician’s workflow with marketing solutions relevant to HCPs’ needs within electronic health record and e-prescribing (EHR/eRX) systems and to provide an easily accessible, seamless experience.
That calls for implementing an integrated digital strategy, and revising the sales and marketing model to consider new content and functionality needs across industry channels, including the customer experience of the HCP and the patient.
This may mean working with an altered reimbursement system, the development of sleeker mHealth apps, increased compliance goals, and more.
VP, Product Management and Innovation
Cegedim Relationship Management
Today’s life-sciences industry does not engage in a meaningful, open, clear, and mutually beneficial conversation with its customers — namely, consumers or patients. This can be attributed to various reasons, such as restrictions imposed by regulations, fear of liability, or the lack of need to do so in the past.
Some might argue that this is not the case, and cite advertisements by pharmaceutical companies on television and in print media. I would like us to take a moment to pause and think if this interaction is truly meaningful, open, and mutually beneficial. If we put ourselves in the role of a patient or a consumer, when did we last read or seek out such a communication?
A two-page advertisement in a popular magazine generally includes a great deal of technical and statutory information, which a consumer cannot possibly understand.
However, the pharmaceutical companies are not to be blamed for this because they are simply complying with regulations, which are complicating the interaction.
I think that in 2013 we may possibly see a change for the better. Driven by the economic necessity that we see all around us, all associated players in the healthcare ecosystem will be forced to innovate, define, and engage in truly meaningful, timely, and mutually beneficial conversations to co-create something sustainable.
Social media will probably be an important communication channel to enable this change.
True Health & Wellness
As the buying decision dynamic between physicians, patients, and payers evolves, the life-sciences industry must learn how to connect relevantly with all customers on an individual level. Brands that value meaningful customer relationships are positioned for the growth customer-centric models have proven.
This organizational evolution is under way in many life-sciences companies. Now it is time for brand marketers to embrace relevance at an individual customer level as the model for driving business growth.
Making a brand ready for individual customer engagement starts in the brand development process.
In this new social era, a brand must build a relationship with its customers. It must listen to them, have an interactive dialogue, and put the customer’s needs first. Building this rapport ends with a lasting business relationship. Of course, this must be implemented by taking into account efficiencies, another factor among today’s marketing challenges.