Taren Grom, Editor
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Trends From the Top
From the ACA to a value-based system, executives representing all aspects of the life-sciences industry name the top trends they believe will impact near- and long-term success. Phil Birch Senior VP, Global Strategic Marketing Aptiv Solutions 1. Value-Based System. The evolving transformation of the U.S. healthcare market into a value-based system will amplify realities already emerging in advanced healthcare markets worldwide. The pressures of the value-based system will shape how sponsor companies acquire evidence to support value-based payment structures, forcing an evolution of current practices. 2. Adaptive Trial Designs. A continuance of regulatory support for adaptive trial designs, both at conferences and through agency-issued guidances, will accelerate adoption and break through the barriers identified by the Tufts Center for the Study of Drug Development and others. Portfolio-wide adoption of adaptive design will address fundamental factors that suppress the success rate of drug development. 3. High-Value Medicines. Also achievable through adaptive design is the successful marketing of high value medicines that work in specific subpopulations of patients, where the health economic arguments become stronger. The adoption of enrichment designs will drive the development of highly successful targeted therapies, and in the process save a number of new medicines that either wouldn’t make it through a pivotal trial or would fail to achieve success at the pricing and reimbursement step. • • • Nick Colucci CEO Publicis Healthcare Communications Group 1. Data Transparency. Pharmaceutical organizations worldwide pledged to provide in-depth drug data to outside researchers. This intended transparency has a direct effect on how we communicate. We must understand how drugs impact different patient groups and integrate information into our client campaigns so consumers have compelling reasons to believe in brands and trust them on their health journey. This data transparency has the potential to position brands as a trusted ally and partner. 2. Simplifying the Journey. Disease is complex and decision making must be simplified. From less invasive technology to treat chronic diseases, such as an adhesive insulin dispenser system and monitoring device instead of insulin injections, to the wealth of health content online, the industry is changing the way health decisions are made. Marketers too need to simplify communication for patients and health professionals. Aligning brand assets, creating easy-to-understand information, and working with the people on the care journey are critical milestones. Brands with voice are solutions to patient needs and help them more easily navigate their healthcare journeys. 3. Personalization. In the era of digital, approaches are shifting from mass marketing to more personalized and targeted communications. In the past, we sliced and diced demographics — today that is not enough. Consumers seek to personalize and tailor what they read, see, and experience. We have seen audiences targeted based on their gender, age, or overall personal profile. Pharma leaders must remain ahead of the curve by personalizing brand messages and targeting specific patient populations with relevant and engaging content. • • • Richie Etwaru Group VP, Clouding and Digital Innovation Cegedim 1. Protect Value with Shared Services. As organizations orient around value, the first stage will be to protect the value in existing investments. Protecting value requires the installment of a shared services mindset built on a horizontal organization design and driven on efficiency, cost reduction, and agility. Here we will see the final stages of cloud technologies, “everything-as-a-service,” and consolidation of vendor contracts, reducing redundancy, resulting in homogenous functional organizations built on services — shared services. 2. Capture More Value with Collaboration. Once shared services are in place to protect the value of existing investments, organizations will need to capture more value from existing business processes. Collaboration enables organizations to squeeze more from existing business processes by sharing knowledge, practices and insight. Here we will see BYOD get fully implemented, enterprise social get adopted, and the human resources of organizations empowered to contribute more into knowledge capture and use — and innovation and transformation. 3. Create New Value with Co-creation. Finally, once value of existing investments are protected, and remaining value captured, organizations will be forced to create new value in the areas of products, services, and processes. Creating new value will require organizations to think about co-creating new products, services, and processes with unusual partners. These partners may be known competitors, or unknown startups. In this area, the CFOs of organizations and heads of innovation must be thinking of digital reviews, over analog revenues. • • • Patrick Flochel Global Pharmaceutical Leader EY 1. New Business Model. The transition to value-based healthcare, requiring pharma companies to innovate new business models to serve the needs of increasingly empowered payers and patients. 2. Portfolio Management. The need to enhance returns and rekindle growth through more effective portfolio management. In recent years, investors have rewarded companies that demonstrated revenue growth and efficient capital allocation. R&D efforts have yielded more approved drugs but even if they’re as successful as planned, organic growth alone will not be sufficient to meet the market’s expectations. 3. R&D Efficiency. The need to significantly improve R&D efficiency through combining the power of big data with relevant analytics. • • • Mary Anne Greenberg Regional President for North America Ashfield Commercial 1. More Patients. Increasing number of patients covered by government funded healthcare. 2. Transfer of Care. Moving more healthcare from institutions to homes. 3. Technology. Using technology to improve care and reduce costs. In the past, patients’ primary health relationships were with their physician. In the face of a changing healthcare landscape and the movement toward value-based delivery and reimbursement, it will be important for life-sciences and health insurance companies to develop sustained relationships with patients in the form of disease education, incentives for compliance and for improvements in lifestyle (eating, exercise, etc). Outsourcing providers who can provide the tools and resources to manage these relationship will benefit in the new healthcare environment. Patients’ preferences for interactions, as well as patient segmentation based on their likelihood to comply, will need to be taken into account in any design of a wellness program along with the ability to measure health outcomes. • • • Patrick Homer Principal Industry Consultant, Global Practice, Health and Life Sciences SAS 1. Using Big Data to Drive Productivity. By combining physician prescription, patient level, and CRM data, we have the foundations for big data in life sciences. This needs to be mined for insight, for example which physicians may be high value and responsive to promotion. The big data agenda requires transformation to the way that information is currently managed and what types of analytics should be used. 2. Transparency. The growing requirements to make information available due to legislation such as the Sunshine Act and the trend toward clinical data transparency will require the modernization of information management infrastructure. 3. Better Insight into Patient Needs Through Social Media. The e-patient is here and makes public all of their needs and wants through social media channels. Capabilities are required to capture and analyze these conversations through analytics. • • • Rick keefer President and CEO Publicis Touchpoint Solutions Inc. 1. Operational Efficiencies. Life-sciences companies must continue to do more with less and become even more agile, scalable, and flexible. 2. Focus on Health Outcomes. The shift toward health outcomes requires a similar change in the operational mindset to align with this approach. 3. Changing Talent Base. The skill set for talent that will thrive in the new healthcare marketplace requires dramatically new approaches to recruiting, training, and development. • • • Lawson Macartney, Ph.D. CEO Ambrx 1. Bioconjugates. Continued interest in developing novel bioconjugates such as ADCs and bispecifics. 2. Sophisticated Moieties. An evolution away from simple targeting and payload moieties toward more sophisticated approaches. 3. Funding Shift. Increased formation of capital efficient, risk-and-reward sharing, and strategic relationships to develop innovative molecules in not only western markets but also emerging markets. • • • Jamie Macdonald CEO INC Research 1. Delivering Technology. Technology is evolving at a greater rate than it has previously, providing significant opportunities for improving delivery. 2. Big Data. The use of big data, made possible by new technologies, will help make better, faster decisions as to what to advance in the pipeline and how to deliver it. 3. Growth on the Genomics Side. Protocols are becoming much more specific in terms of patient eligibility, so an advancement in patient identification also is necessary. • • • Martin McGlynn President and CEO StemCells Inc. 1. Stem Cells. The maturation of the stem cell space will draw increased attention to the potential of the technology. 2. Clinical Trials. Success in well-controlled Phase II and III clinical trials. 3. New Capital. Access to affordable capital needed to fund a rapidly growing number of clinical trials. • • • Rick Morrison Founder Comprehend Systems 1. Risk-Based Monitoring and Centralized Analysis. 2. Data Warehouses. Realizing that data warehouses don’t provide the promised value. 3. Cost-Efficient Technologies. Adopting new technologies that can drastically change the cost structure of bringing new treatments to market. • • • Shankar Narayanan VP Strategy, Life Sciences Cognizant 1. Empowered Patients. The advent of the empowered patient will drive differentiated business operations model. Life-sciences companies will have to implement the pill-plus-service model. 2. Evolution of Outcomes-Based Models. With the advent of outcomes based models, life-sciences organizations will have to articulate product value from an outcomes perspective. 3. Externalization. Through alliances/partners with academia in early state research, through JV/consortia with peers in precompetitive operations, and through strategic vendors in operations/IT outsourcing. • • • David Rear Founder and President Advanced Clinical Concepts 1. The Sunshine Act. Many of us are awaiting the response when physicians’ names are posted with dollars attached to them as a result of the Sunshine Act. What will be their reaction? Given all the activity that has occurred up to this point, will anyone care? Will this information set off another wave of activity? How will the various stakeholders react? While we’ve been forewarned about the Sunshine Act, we still don’t know how this will actually impact our industry. 2. New Communication Channels. The pressure to deliver content through new communication channels may encourage pharma companies to explore different approaches to medical education. That’s fine, if the decision to explore new channels is supportive of the core strategic plan. Digital is not a strategy, however, and following the herd without a vision is a sure way to get lost in the crowd. Regardless of the channel, it’s important that companies amortize the brand story along the promotional continuum to ensure consistency of communication. 3. Agency Models. Holding companies continue to court pharma, emphasizing that their model of multiple agencies under one brand delivers cost efficiencies. On the surface, the idea sounds good. Some in the industry like it. The procurement groups like it. And some brand managers may like the bigger names. Independent agencies and medical communications companies, however, are not worried. • • • Sheila Rocchio VP of Marketing and Product Management PHT?Corp. 1. Patient Centricity. Patient centricity will drive greater adoption of mobile platforms to communicate with patients and disseminate information. 2. Beyond Gold Standards. It’s not enough to offer new drugs that treat disease. We have to treat them better and more cost effectively than existing gold standards. 3. Big Data. Big data analytics of social media platforms will provide new insights and opportunities in drug development. • • • David Shoemaker Senior VP R&D Rho CRO 1. Industry Evolution. Continued evolution of large pharma companies into sales and marketing companies. 2. Outsourcing. Continued increase in outsourcing of research to smaller pharma and biotechnology companies, academia, and governmental agencies and development to smaller companies and contract research organizations is necessary to enable products to reach the market in approximately the same historical rates. 3. The ACA. Implementation of the Affordable Care Act and the impact of growing awareness of cost-effectiveness on the cost of pharmaceuticals and the subsequent effects on reimbursement allowances. • • • Al Topin President Topin &?Associates 1. The Emergence of IT. The information technology (IT) department will become a significant player in commercialization and marketing. IT has the potential to aggregate and analyze customer data from far-flung sources to deliver new marketing insights. On the other hand, as more and more marketing goes digital, the IT department can become a barrier when it comes to streamlining processes, linking silos, or even getting the latest technology in the hands of the sales force. The IT team should be brought into the commercialization and marketing process earlier, where it can play a leadership role in uniting global contributors, analyzing customer audiences, and linking sales information to brand performance. Matt Wallach President and Co-founder Veeva Systems 1. Paperless Revolution. We live in an electronic world today. We shop online, video-chat instead of writing letters, and work in the cloud from anywhere and everywhere. As consumers, we have adjusted to these changes and reaped the rewards — increasing our efficiency, becoming more productive, and maintaining closer relationships with distant relatives. However, as professionals, we haven’t adapted as smoothly, especially in life sciences, where many organizations still think on paper. Some companies have created hybrid systems that currently serve as band-aids, but won’t work long-term. As easy-to-implement and access cloud technologies continue to evolve, the industry will start making the full switch to paperless operations across the organization — from commercial to clinical. The overall benefits in terms of agility, regulatory control, and even creativity are simply too monumental for companies to miss. And as early adopters make the full switch, they will leapfrog their competitors forcing more companies to join the paperless revolution or risk being left too far behind. 2. Industry Collaboration. The commonly referenced paradigm shifts in the life-sciences industry over the last few years — increased competition, globalization, the patent cliff, and so on — are forcing life-sciences companies of all sizes to find ways to collaborate with each other and with third parties more than ever. This is true in every aspect of the industry, from drug discovery and clinical trials to manufacturing and sales. This will transform the industry, which has been notoriously isolated for decades, changing the life-sciences landscape and how businesses operate within it. We are already seeing examples of this industrywide collaboration in clinical with the nonprofit organization TransCelerate BioPharma Inc. and its attempts at developing shared industry solutions to simplify and accelerate drug development. Many more examples will follow and the industry will benefit as a result. 3. Multichannel Strategies. Will 2014 finally be the year of multichannel? Sure, we’ve been talking about the move to multichannel for a decade and all the data supports this move. But life-sciences companies are still not executing truly integrated multichannel sales and marketing strategies. Luckily, the technology now exists to enable it. With modern cloud computing platforms, sales and marketing teams are able to collaborate across channels to dramatically improve their relationships with customers. This will drive major changes in how a life sciences company commercializes its products and 2014 looks like it will be the real start.