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THE LAUNCH: Lessons from Experts’ Experience at Shire, J&J, Sunovion and More

ROUNDTABLE

Our panel talks about how to launch a brand successfully.

Our panel of experts:

DAVID BAKER

President

DB BioPharma Consulting

PAUL MURASKO

Senior Director, Multi-Channel

Marketing

Sunovion

HARRIS KAPLAN

Managing Partner, Red Team

Associates

SHALINI SHARAD

Partner, Commercial Launch

Excellence & Patient Centricity

Wipro

Doing the research. Finding the funding. Recruiting patients for the trials. Conducting the trials. Filing the applications. The negotiation. The strategies. The competition. The hopes and dreams.

There is no more stressful—and potentially fulfilling— activity in our industry than launching a product. Here we speak to a panel of people who have been intrinsic to numerous launches, from many angles. If you’re involved somewhere in the process right now, maybe this wisdom can help you sort out your own challenges.

What are the major hurdles in launching a product in your sector today?

DAVID BAKER: What has changed over time is that managed care has increasingly more influence on the success of new product launches. Several novel products have been approved and launched in the past several years and seen their uptake stunted by poor formulary access and reimbursement. Payers seem increasingly willing to just say no and not reimburse new products for six months or more unless they see clear clinical advantages or receive substantial discounts that put the net price of these new products in line with the current standard of care treatments.

We are seeing early signs of value-based contracting with payers for specialty products where the payer gets money back for patients who don’t respond well to the medication. However, it is still early days for such agreements and it will take some time to see how those arrangements work for both the pharma companies and the payers.

I also believe that the highly publicized pricing levels and increases of a few outlier products, and frankly, “bad apples,” has further tarnished the pharma industry’s reputation and put everyone on watch regarding their pricing approach with their new product.

HARRIS KAPLAN: I agree with David’s point. As someone who has worked with a number of clients on launches, I think the major challenge faced by most companies is achieving a desired level of managed markets access to enable prescribing. That problem is exacerbated by the fact that over half of physicians are now employees, which means they will follow or adhere to protocols established by a hospital or plan vs. being able to decide freely what drug to use to treat a particular patient.

PAUL MURASKO: I believe the major challenge is the ever-changing healthcare landscape. We cannot launch products the same way we launched a product five or even two years ago. I am sure that is not news to anyone, however change is tough and sometimes pharma and medical devices are slow to change from what has worked in the past. A great example of this change is the ever-growing importance of EHRs. In the past it was enough to get you new product on formulary and sell your physician. That is no longer the case. You now have to make sure it is in the EHR and can be easily accessed by your physicians in their normal work flows. Understanding this channel—its update schedule, ensuring your product is in their favorites, providing the appropriate educational support—is now critical to a successful launch.

SHALINI SHARAD: It’s an era of consumerization and a “more aware patient” who seeks second opinion from Dr. Google. Some of the challenges in launching a product arise when a traditional sales and marketing model is followed. This model would focus on heavy promotions into the doctor’s office in order to achieve the launch year win. Traditional customers are targeted through front line field reps without focus on the pyramid of other stakeholders who influence perceptions of the product. This model lacks information on disease management that a patient is seeking today and hence is not successful beyond the launch year.

How is launching a product for a smaller indication different from launching one for a larger indication?

HARRIS KAPLAN: Smaller indications require a greater degree of focus and execution as there’s little room for error. However, beyond that, there’s often greater opportunities to innovate in smaller indications than larger ones because it’s possible to know the customers better and understand the unmet need and the value your product brings.

DAVID BAKER: I don’t see a major difference in the effort for a smaller vs. larger indication. Perhaps there are differences in the size of sales force support required and there may be a need for better targeting and efforts spent on patient identification with a smaller indication.

PAUL MURASKO: I don’t distinguish much between a big or small indication; I distinguish between new indication and new product launch. Each requires tremendous coordinated cross-functional efforts and solid strategy. However, I believe that a new indication to an existing established product requires different and sometimes less key deliverables compared to a full launch, which requires taking a product from development through the pre-commercial phase and then to commercialization.

What are some of the successful strategies for streamlining the launch timeline?

DAVID BAKER: This is a major challenge. In the past companies would start investing money and building launch teams much further in advance of an approval. However, with more small companies launching products, they can’t always invest by blindly assuming success. Even larger companies have had high profile late stage development failures in recent years that may make them hesitate to fully invest in a launch before they are more confident that they will gain approval on time.

PAUL MURASKO: A key component of any launch is communication and teamwork across the various teams. Although a launch may be led by the brand team, if there is not alignment and full support from the other key groups the launch will not go smoothly and can fail. Just as we need alignment between the sales and marketing teams, it is also paramount to ensure there is tremendous coordinated effort between the pre-commercial and commercial teams to ensure a smooth transition and successful launch.

SHALINI SHARAD: Launch campaigns should start from Phase II or III of clinical trials. Disease management campaigns in the trial phase through the use of digital and internet solutions can help key opinion leaders with treatment information, who further influence other stakeholders in the ecosystem. Moving beyond traditional launch strategy and focusing on disease education, awareness, better QALY (quality adjusted life year), and a more engaged payer and patient can prepare for a successful launch well ahead of time. A well-educated network of healthcare ecosystem participants would prepare the product market for commercialization and long-term prescription as well as reimbursement.

HARRIS KAPLAN: True. My favorite is building product anticipation in advance of the launch by informing relevant audiences of a new drug or therapeutic modality that might be in development. Done well, this can accelerate product uptake.

What products or categories have you worked on, and what were the significant markers of progress along the way?

PAUL MURASKO: I have led product launches in med device as well as supported med device and pharma launches (both new product and new indications) through my role leading the digital center of excellence and multi-channel marketing. A significant change over recent years is the importance of a solid digital strategy that leads to a flawless execution of the required customer experience. And by customer I am referring to all key customer segments, not just patient and HCP. Digital can no longer be an afterthought. It is key to driving a successful launch or new indication release.

HARRIS KAPLAN: In working on the development and launch of over 100 new products, including many that have become household names, what I see is that the successful launching of new products has become more complex, involving many more stakeholders, such as payers and patients in addition to physicians. Sadly, while companies devote entire teams focused on understanding each of the relevant customers, only 10% of new products achieve their pre-launch forecasts. What’s needed is a more integrated view of how each of the stakeholders interact with and impact the other. One approach I’ve seen recently was the appointment of a launch czar whose job it was to develop a cohesive and comprehensive strategy across all of the stakeholder groups. More companies should take this approach.

SHALINI SHARAD: I have worked on different archetypes such as “specialized oncology drugs” and “stand out from the crowd.” The strategy and commitment in a rare disease product launch is different from “stand out from the crowd,” where there is a need to create edge.

It is important to take a customer-centric view which is organized around market stakeholders, and continuous learning in real time as the market evolves. Is the product working to maximize value for all stakeholders? Digital health is a key component in enabling a multi-factorial launch that focuses on treatment benefits to patient and outcome-based contracting with payers. A commitment to unmet needs, barriers, the patient journey, access for orphan drug patients, are all important factors. Populations that lack timely healthcare access can be reached through digital patient support solutions and can be a success factor for launch uptake. Partnership with advocacy groups provides access and support to patients and helps them manage everyday life tasks better. Investing in real-world evidence, typically in the case of products like specialized oncology rare disease drugs, helps with market access. All this can be achieved if from development onward patient-centric design is maintained that can continue through commercial stages.

DAVID BAKER: I’ve worked on hypercholesterolemia, osteoporosis, migraine, ADHD. The classic launch metric was New Rxs, often weekly New Rxs. Now we have New Patient Start data, New to Brand, and Switching data, which is an even earlier indicator. One of the most interesting metrics I have seen in recent years is coupon redemptions. Once coupons are adjudicated in the pharmacy, the data can be almost instantly made available to a company through their coupon vendor/partner, which can provide an even earlier read. The trends here provide tremendous insight.

Now that launching a pharma product costs upwards of $2 billion, according to some estimates, how and with whom are companies collaborating to keep those costs manageable?

DAVID BAKER: I think pharma companies, out of necessity, are putting more pressure on their agencies/strategic partners to keep hourly rates and total hours down. And I think a lot of tactics which used be standard practice, but perhaps of questionable return, are being pared back. One example: giant, fancy exhibits and medical meetings. You still see them for many product launches, but my observation is that companies are spending less here.

HARRIS KAPLAN: There are a lot of elements in this $2B number, including drugs that have failed in development. But critical collaborators are the company’s advertising and medical education agencies. A movement from expensive media such as TV to less expensive and more focused digital approaches will be key to both keeping costs down as well as reaching audiences who no longer watch traditional TV (Superbowl excluded) but spend time and get ads through social media channels.

PAUL MURASKO: The closer the marketing team is to the clinical and managed markets team, the better the launch. Launches are a team sport. Also the old pharma playbook of massive TV and spend to drive in Rx (Humira was one of the first) is now inefficient and has more waste than benefit. The need is to be hyper-focused on the data that holds the insights and behaviors of each customer target and execute to that. Finally, accept innovation from all your partners; but filter it with the eye on the long game…which may only be 18-24 months, but these days, 18 months in marketing and launches is a lifetime.

Is there a significant effort to identify orphan population indications in order to fast-track a launch?

DAVID BAKER: There is a significant effort to identify orphan populations because of the attractiveness of those indications— more easily targeted populations, smaller sales force requirements, stronger regulatory exclusivity, and favorable pricing. I think it is the overall attractiveness of orphan indications that is driving the push there, not the ability to fast-track a launch. While orphan indications generally require fewer and smaller studies, the time to enroll and complete those studies is typically longer, and ultimately time to launch may not be shorter than with non-orphan indications.

HARRIS KAPLAN: Orphan and rare diseases have been a hot market in the last five years, spurred on by a development tax credit. The opportunity to get a high price per patient due to the limited population, fast track designation from the FDA and possibly a priority review voucher all have accelerated interest in orphan drugs. The challenge going forward is with the tax credit now gone and payers beginning to push back on high prices (note challenges faced by both Vertex with its CF portfolio and Sarepta with Exondys 51), will pharma’s interest in this sector begin to wane?

SHALINI SHARAD: There is a significant effort to access patients who are geographically spread and to ensure that they have access to medicine & treatment they need. Due to a small population size of orphan patients, pharma is also trying to access markets and patients through managed entry agreements. This strategy helps in early patient access and a better reach to orphan patients. It also helps in reimbursement from the payer as value of the treatment is proven through real world evidence.

How are the specific challenges different for getting a pharma, device, or digital product to market?

PAUL MURASKO: Some would argue the challenges among the three are very different, but I believe the core challenges are universal. Change is the norm, and that is unnerving to an industry with such long established rules and roles. A great example of this is Samsung as the manufacturer of the first truly challenging biosimilar. Samsung? Yet they did it.

HARRIS KAPLAN: Drugs typically have a much greater and longer degree of patent protection than devices, which can usually be more readily imitated. So devices need a shorter time between launch and peak than drugs. They also usually have a lower cost of development, and sales rarely achieve the revenues associated with the most successful drugs. In the old days, a physician could just order the new device. No longer. Devices used in the hospital need to be presented to the VAC (Value Analysis Committee) which comprises procurement, finance, and various members of the medical staff. Companies don’t present directly but a physician advocating use is required to make the presentation. That, in and of itself, is a huge challenge. As a result, many devices have lagged in market uptake which has significantly hurt the ROI of newly launched products in the sector.

Diagnostics is a broad category. There are those aimed at populations directly such as Exact Sciences Cologuard, which can be used to diagnose early signs of colorectal cancer and reaches a broad population who may be unwilling to undergo a colonoscopy. Some diagnostics are really prognostic, indicating potential risk of patients developing a certain diseases such as Myriad Genetics BRACA1 and 2 for breast cancer, or Astute Medical, which flags early risk of acute kidney injury to patients in the hospital. And still others support the utilization of drugs by identifying which patients will get the best response to a particular therapy. This latter category has become vital for many high-priced drugs as a means of controlling the overall cost of the drugs to the payers.

SHALINI SHARAD: Patients want to access disease management information through internet and social channels. They are looking for a solution to meet their everyday complications, unmet needs, financial access, lack of confidence on treatment, etc. Companies are launching many “drug-device-digital” personalized care solutions for patients. Challenges arise as these solutions have objectives like improved adherence, better patient access, improved health outcomes, better quality of life(QOL), however the regulatory blueprint has still not caught up to such innovative launches. A strict regulatory process to govern launches which deal with sensitive patient health information is a challenge the industry is trying work on.

DAVID BAKER: The regulatory requirements for a device are generally much lower than with a pharma product, however, the companies developing devices typically have fewer resources and are judged by investors much more strictly on sales performance and growth from an earlier timepoint. In other words, investors won’t attribute much value to a device or its owner until it is approved, launched, and generating a sales trajectory. With a device, there is often more latitude in promotional messaging, however this is counterbalanced by the challenge of having a physician buy and bill a device and integrate it into their practice, and reimbursement for a course of treatment which may require multiple visits can also be quite challenging for a new device.

For digital products, the challenges include the uncertain regulatory environment with very few precedents or regulatory pathways that have been paved. Reimbursement is also a whole new world with payers, and figuring out the pricing model with physicians and patients can be quite challenging, especially in a world where most of us are used to free apps for our phones and tablets.

How has the regulatory atmosphere changed to assist or impede the launch?

DAVID BAKER: Over the past few years, the regulatory approval process seems to be fairly similar, although perhaps more challenging. Recent commentary and even action since Scott Gottlieb became FDA commissioner has been encouraging and we may see a more favorable approval environment. On the other hand, the regulatory promotional environment continues to get tougher with norms for claims and other promotional language becoming stricter. Much of this seems to be self-imposed by company medical-legal-regulatory boards, perhaps as the industry has become tired of OIG (Office of the Inspector General) investigations that carry much more serious consequences than NOV (Notice of Violation) or warning letters from FDA.

HARRIS KAPLAN: While it’s too early to assess what the appointment of Scott Gottlieb will mean, the number of approvals in 2017 was quite high and there is a promise of a more expedited approval process going forward.

SHALINI SHARAD: To impede the innovative “drug-device-digital” personalized care launch, CDRH has established Digital Health Program. This promises to provide clarity and guidance on regulations around digital health outreach and developing and implementing digital health technologies. This will provide regulations around mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Commissioner Gottlieb has said “The plan outlines the FDA’s vision for fostering digital health innovation while continuing to protect and promote public health by providing clarity on medical software provisions of federal legislation passed in 2016 (21st Century Cures), adding expertise to the digital health unit and initiating the FDA Pre-cert pilot program.”

Who in the industry do you admire for doing innovative things to get products to market affordably or quickly?

SHALINI SHARAD: Pfizer launched its Alzheimer treatment Aricept with a focus on virtual nurse support, disease management & medication adherence. Aricept became world’s best-selling treatment with $4B in revenue in 2009. Zoladex by TerSera therapeutics is a three-month injectable prostate cancer treatment. Some of the unique tactics were targeting urologists and not oncologists, changing Rx behavior, and getting prior authorization/reimbursement from third party insurers along with federal government. Merck launched Gardasil and focused on educating women on the connection between cervical cancer and HPV through digital and social health platforms and population health management.

HARRIS KAPLAN: I think Kite Pharmaceuticals (recently acquired by Gilead) should be held up as an example of a company that received approval of its breakthrough CAR-T therapy utilizing much less capital than is normally the case. Other companies, wishing to accelerate uptake of their new products, are shifting to value based payments where payers only pay if the drug or device works. Novartis most recently has done this with its CAR-T program, and Medtronic has implemented similar programs to accelerate uptake of some of its devices. While it’s still early for these programs, we can expect to see more of these in the future.

PAUL MURASKO: There are a lot of good examples. If I were to pick one it would be Merck and its launch of Januvia. One of the reason for this success was its new commercial model, focused more on targeted and coordinated HCP communication through the field, e-detailing and video detailing, as well as an approach to digital that was significantly ahead of its competitors at the time.

DAVID BAKER: I am very eager to see how the rollout goes for Spark Therapeutics’ new genetic treatment, Luxturna, for a rare blindness condition. As a potential one-time treatment, it will be interesting to see how their bold pricing and reimbursement approach is accepted.

What are some of the lessons we have learned based on recent history?

PAUL MURASKO: The clinical and commercial teams should begin working together at least 36 months before launch. And by together, I mean a degree of collaboration that is still the exception rather than the rule in pharma. They must align on the endpoints that will represent maximal value to payers, providers, and patients at launch and which will be the directional beacon throughout development and commercialization. They must work together to forge a comprehensive, integrated, data-informed roadmap with specific plans for each function — regulatory, medical affairs, distribution, market access, marketing, sales, and patient engagement — along with the major milestones for each function. (E.g., distribution plan 12 months prior to launch, medical affairs plan nine months prior, payer engagement plan six months prior, sales plan three months prior, etc.) This roadmap formalizes what each function is accountable for, what they can expect from other functions, and most important the aligned metrics, incentives, and processes by which they will be measured and which will drive collaboration. Needless to say, none of this happens without direct and ongoing C-level leadership that sets the expectation of collaboration across silos… and, until the organization’s DNA is rewritten in collaborative terms, meets regularly with clinical and commercial leadership to ensure that it happens.

HARRIS KAPLAN: Neither payers nor patients are morons. They are perfectly willing to pay premiums for products that deliver real value, and not all differentiation represents value. So the challenge is understanding what is valuable to each of the stakeholders and building that into the product’s pivotal clinical trials so the label at launch highlights the product’s differentiation. The battle for market share is often fought and won before Phase III. This presents a difficult tradeoff. The more differentiated the label a company aims for, the higher the potential risk that the product will miss its endpoints and the greater the cost in both time lost and money spent. Our company works with many smaller companies bringing commercial perspective and implications to help them make these tradeoffs. The challenge is one of pay now or pay later. Companies introducing a new product using a placebo comparator vs. a recognized and widely used standard of care will likely face significant hurdles getting payer acceptance and patient willingness to pay post-launch.

DAVID BAKER: Start early, don’t assume managed care will be enthusiastic about paying for your product, do payer research, be prepared to accept more narrow or second line indications to get established. Lesson: Don’t just assume that they will put your product on Tier 3 from launch because it is novel. Be prepared to experience much lower net-gross ratios and prepare your finance team and management accordingly. On the other hand, despite managed care’s objection to co-pay coupon programs, they haven’t found a truly effective way to stop them.

MEET OUR PANEL OF EXPERTS

DAVID BAKER

President

DB BioPharma Consulting

David is President of DB BioPharma Consulting LLC, a life sciences consulting practice with a focus on marketing, commercial assessment, and business development. David served as interim CEO of Alcobra from June—November 2017, during which he led the strategic M&A process leading to the reverse merger of Alcobra with Arcturus Therapeutics and the divestiture of Alcobra’s ADAIR developmental ADHD compound. He originally joined Alcobra as Chief Commercial Officer in 2014, responsible for all aspects of pre-launch marketing planning and business development. Prior to joining Alcobra, he worked at Shire for 10 years, most recently as Vice President of Commercial Strategy and New Business in the Neuroscience Business Unit. He led the commercial assessment of neuroscience licensing opportunities, managed commercial efforts on pipeline CNS products, and led the long term strategic planning process. Previously, he served as Global General Manager for Vyvanse® where he led the launch of Vyvanse, led global expansion efforts including successful establishment of a partnership in Japan and launches in Canada and Brazil. Prior to that, he served as Vice President of Marketing for all of Shire’s ADHD products. From 1990-2004, David worked at Merck where he held positions of increasing responsibility in marketing, sales, market research, and business development. He has been directly involved with the marketing of five prescription drug brands with annual sales in excess of $1 billion each.

david@dbpharmaconsult.com

HARRIS KAPLAN

Managing Partner

Red Team Associates

Harris Kaplan is Managing Partner at Red Team Associates, a life sciences commercial strategy consulting firm. Harris is also the CEO of Healogix, a leading industry marketing research and strategic planning company, and was formerly the co-founder of Migliara-Kaplan Associates which was the largest custom marketing research company in pharma before it was acquired by TNS (now Kantar). Having worked on the launch and development of over 100 Rx products, Harris has spoken frequently and authored a number of articles on developing and launching new products. He was selected as one of PharmaVoice’s 100 most inspiring leaders in 2011.

harris.kaplan@redteamassociates.com

RED TEAM specializes in helping clients maximize the value of their product assets and works with companies that have both early stage and on the market products. The commercial and financial success of companies like Kite Pharma, Vertex Pharmaceuticals, Sarepta Therapeutics, and a host of others is a testament to the value Red Team creates for its clients.

PAUL MURASKO

Senior Director, Multi-Channel

Marketing

Sunovion

Paul leads NPP, digital strategy and execution as well as the telesales team for all Sunovion brands. Previously he was with Johnson & Johnson, primarily in the Medical Device and Diagnostics (MD&D) space. While Director of Digital Marketing for J&J, he lead the digital integration for $19.8 billion acquisition of Synthes and was chairman of the Digital Acceleration team for the MD&D sector. An innovative healthcare marketing and sales leader, he is experienced in digital strategy, integration and activation, with a solid understanding of the digital ecosystem to drive business results, achieve efficiencies, and build a competitive advantage.

Paul.Murasko@sunovion.com

SUNOVION has contributed clinical advances and new treatment options, and has led advocacy and educational initiatives with cross-sector coalitions focused on the advancement of research, innovation and improvements in healthcare. Its contributions include pioneering a unique approach to discovery in the CNS space based on a systems neurobiology platform that facilitates rapid clinical development; actively supporting the introduction and passage of legislation for patient protection, and championing efforts to codify the six protected classes in Medicare Part D in the U.S.; developing and supporting leading advocacy programs, working with national advocacy partners in the U.S. including the Be Vocal: Speak Up for Mental Health, COPD Together, and Talk About It for Epilepsy! initiatives.

Partner, Commercial Launch

Excellence & Patient Centricity

Wipro

Shalini is a thought leader, author & speaker on patient centricity. Changing healthcare has motivated her to focus on newer ways to engage patients and drive better outcomes. She holds IP on patient engagement solution which has helped in innovative commercialization of drugs from Phase II to launch excellence, enhancing patient adherence, driving better patient-doctor relationships, and improving health outcomes/QOL/QALY solution sets in value-based care/FDA digital health regulations. She has implemented commercial solutions in many pharmaceutical organizations across clinical and commercial programs – CVM, oncology, CNS, respiratory, and specialty/rare disease.

shalini.sharad@gmail.com

WIPRO LIMITED is a leading global information technology, consulting and business process services company that harnesses the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help clients adapt to the digital world. Wipro is recognized globally for its comprehensive portfolio of services and strong commitment to sustainability and good corporate citizenship. It has over 160,000 dedicated employees serving clients across six continents. It offers IT, platforms & consulting solutions to the healthcare and life sciences industries.

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