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MUSINGS

The Innovation Imperative

Kate Lumpkin

Innovate or become obsolete. This is especially true in the healthcare industry generally, and in the pharmaceutical/biologics industries specifically. The industry must urgently innovate relative to how it defines itself in a rapidly changing healthcare ecosystem. Individual companies must either aggressively innovate or risk falling behind on a daily basis. Though not everyone agrees on how to do so, everyone does agree on one thing - the time is now.

I was asked numerous times last week what I thought companies should consider while working to create a sustainable future in a morphing environment. For instance, how does the industry as a whole, and the companies working in it, create ideal environments and solutions for issues such as: payer and systems data needs and pricing challenges, metadata use, personalized medicine demands, pricing challenges, globalization, responsibility/ownership continuum for new product development, quality challenges, patent expirations, demands for meaningful clinical differentiation and higher (not lower) quality data, interactions with patients, commercialization, compliance challenges, industry perception, etc.

I do not pretend to have all the answers to these extraordinary challenges. The answers will be ever evolving, and will involve working at the tree AND forest level. We must think of healthcare in the broadest sense, using a wide-angle lens, not simply as drugs and devices - much like it is important to think of transportation as a whole, not just the train system. But I did spend some time contemplating this question last week, and in the spirit of strategic innovation, offer the following three strategies. They are not all-inclusive, but are intended to scratch this very rough surface. But, as with anything intended as a game changer, you have start somewhere.           

1.    Create a culture that demands innovation as an imperative at every level and rewards, embraces, and requires constant improvement.  Every company’s mantra should be, “THE STATUS QUO IS NEVER GOOD ENOUGH.”

According to David Champion in the Harvard Business Review (January 26, 2009), as long ago as 2009, “One Pennsylvania hospital, for example, was able to reduce infections caused by inserting catheters into a patient’s bloodstream from 37 occurrences to just six. Deaths from infections fell from 19 to one. The hospital also saved $1.4 million a year in the direct costs related to treating the infections. Achieving all this required virtually no investment, just six simple changes in procedure, such as requiring staff to completely remove faulty catheters and insert new ones rather than attempt to fix the faulty catheter.”

  • a.    Hire employees based on their ability to innovate and foster innovation, develop them to be even more innovative, reward them for their innovation at every opportunity. Do not allow the old thinking of hiring based only on previous specific job experience to be the primary driver. Look for new ideas and for complimentary skills and strengths. Use hiring as an opportunity to infuse fresh thinking, whether hiring from within the company or outside. Insist on building a widely diverse workforce to enhance innovation.
  • b.    Reward innovation in every department, every process, every small “win”, not just the major breakthroughs.  Ask every day, “How can we improve anything/everything by doing it better, differently, or not at all?”
  • c.     Recognize that seemingly small improvements, even small process improvements, can create huge breakthroughs. Relentlessly search for these opportunities.
  • d.    Determinedly scan the environment for new opportunities, innovations that you might leverage and improve upon, and futuristic business intelligence.
  • e.    Make proactive listening, internally and externally, a cultural imperative. Constantly create opportunities for listening. Listen to learn and understand, not to respond or verify a preconceived idea. Listen, Listen, Listen.

 

2.    Commit to developing and commercializing truly innovative, medically critical, differentiated products with higher quality, value-driven data. The healthcare ecosystem is demanding it.

As Novo Nordisk CEO, Lars Rebien Sørensen, recently told Bloomberg TV, “The next line of products have to have an even greater height of innovation, which means those that do not have that height of innovation will have to be culled. We need to be innovative. Otherwise, it’s going to be difficult for us to get reimbursement for our drugs. Me-too or me-better drugs will not be good enough in the future and hence we need to prioritize.”

  • a.    Develop products, recognizing all data needs, using “backwards planning.” In other words, develop products to demonstrate identified/desired information for approval, promotion and reimbursement.
  • b.    Develop products that are clinically innovative, solve authentic medical challenges, and create demonstrable clinical value, not just variations of established products.
  • c.     Commit resources to create high-quality data that address real value concerns to meet global payer and system expectations. Create these additional resources by decreasing the number of smaller, lesser quality studies that do not meet ecosystem expectations or requirements.
  • d.    Evaluate possible mergers and acquisitions (and product acquisition) objectively with an expectation consistent with this commitment to high quality, innovative assets. Use multi-disciplinary teams for due diligence to honestly and openly evaluate for business success under this rubric, not simply to support an a priori decision to purchase.

 

3.    Change marketing incentive payment and expectations from revenue-based to profit-based. Perhaps the most difficult, it takes true business commitment and cultural change to make this happen. But, especially in light of drug pricing scrutiny, the need for targeted focus to increase profits is essential. It is easier to do this on the business/marketing side than on the sales side, as sales has less control of profitability variables. But, moving boldly moving in this direction, would:

  • a.    Increase return on investment, through driving more careful targeting, planning, resource deployment, market understanding (especially payers and systems), promotional expenditures, and value-based focus.
  • b.    Create a culture of vigorous authentic listening and questioning with all stakeholders throughout the asset’s life cycle, resulting in a clearer understanding of needs and more focused and effective programming.
  • c.     Increase the quality, impact, and longevity of promotional materials and programs, while also increasing the quality of promotional execution and the alignment with compliance requirements
  • d.     Decrease the volume of ineffective materials and programs, thereby preserving resources for more impactful promotion and increased clinical studies quality. 
  • e.    Create vertical business data transparency and marketing alignment with overall business success measurements.

Healthcare delivery is changing at heightened speed. Consider recent innovation breakthroughs, such as - 3D printing, CRISPR, robotic surgeons, needle free dentistry, remote patient monitoring, prosthetic advances, health informatics, and light bulbs that disinfect and kill bacteria, to name a few. This is a defining moment for the healthcare industry. The question is not just one of relevance. More importantly, how does the industry define and structure itself to lead meaningful change that significantly, and authentically, contributes positively to the dynamic healthcare system?

Sharing Safety: A Patient, and Business, Imperative

Kate Lumpkin

Sharing vital safety information in promotional materials and sales representative presentations isn’t just required by law and regulation, it is an undeniable imperative for both patient and commercial success.

So why is minimizing it, or even omitting it, still the most common violation OPDP cites in enforcement letters? The answer I continue to hear most often is, “we need more room for efficacy claims, even at the expense of sharing the safety information.” Highly successful commercial professionals know better.

Acknowledging the obvious need to share efficacy information, sharing important and understandable safety is the most important aspect of overall commercial success. To maximize its success, it should also be relevant, timely, and integrated deeply into the product’s “story.” Consider the three reasons below:

  1. The patients who take a medical product must fully understand the breadth of the treatment, both the efficacy and the safety, to maximize the benefit and improve their health. Patients who fully understand the benefits AND safety are more likely to stay on the product, thus increasing adherence and compliance. It is critical that they have appropriate knowledge and expectations in order to ensure successful treatment. To provide such is an indication of our authenticity regarding true patient centricity. And as we are in the business of improving patient health, a successfully treated patient is our best advocate for our product.
  2. It is in our business best interest to also boldly share, and consistently reinforce, the safety profile of our products with health care providers – not because we have to, but because doing so creates the best opportunity for commercial success. Health care providers know all treatments may cause adverse events, thus we must share the safety to create credibility. Even more importantly, though, is that we must share the safety to enable appropriate patient selection, create appropriate expectations, and encourage appropriate use. It may take a sales representative 7-12 interactions to influence a health care provider to prescribe a new product, but it will take just a couple of unexpected middle of the night patient complaints to cause the provider to return to a previous treatment regimen. Sharing safety in an honest and transparent way creates win-wins for the patient, the health care provider, and the company’s bottom line.
  3. We must share safety in a way that satisfies today’s legal liability environment, as well as the FDA regulations. When sharing safety, it is vital to consider both the content and the prominence. Here is the link to the FDA draft guidance on safety content and presentation for your reference.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

There are still many unanswered questions regarding safety presentation, such as patient recall and comprehension in TV ads, ideal amount of necessary information (without also scaring otherwise appropriate patients from even trying the product), and how to best provide the information in various media. Those challenges still need to be addressed and are valid concerns.

However, one thing is certain. Sharing appropriate safety should not be hidden below a sight line, lost in contrast, placed at the bottom of the ad in paragraph form with no header, left by a sales representative until the end of the presentation when it is clear they will not be able to share it, or especially omitted entirely. In addition to sharing appropriate content, it is an imperative to share safety with prominence reasonably comparable to the efficacy presentation.

Ensuring that health care providers and patients know what to expect from their treatment, both the benefits and the safety, is in the best interest of the patient and the best commercial interest of the company. A patient who stops taking a treatment due to unexpected adverse events will never benefit from its efficacy, yielding the worst outcome for everyone.

Forethought Wins: Strategically Assessing Promotion in a Post-Amarin Ecosystem

Kate Lumpkin

Pharmaceutical and biologic companies are evaluating recent court outcomes (such as the Amarin and Pacira cases) on promoting off label (or expanded or subpopulations) use, using other than the historical interpretation of substantial evidence data. As companies are determining their promotional path forward, they are taking into account the continued requirement to promote in a truthful and non-misleading way, as well as the use of disclaimers. Clearly, there is an industry interest to distribute these data.

However, as companies are evaluating these cases and their interest in data use/distribution decisions, it is also imperative to consider the possible long-term consequences of these decisions.

The following considerations are not all inclusive, but are some of those that must be contemplated as part of on-going deliberations:

  1. Liability considerations – Will the type, level, and quality of data the company shares proactively put it at greater risk for liability challenges? If so, is the company willing and able to defend these suits?
  1. Competitive considerations – As the FDA is taking substantially fewer promotional enforcement actions, is the company prepared, both from a will and resource perspective, to handle competitive promotional challenges? Is the company prepared to bring, and defend, Lanham Act suits? Will the company hold itself and competitors to the same data standard, and how will that be defined?
  1. Payer considerations – At a time when payers are expecting higher quality data, including comparative data, will the quality of data the company provides meet these expectations? What are our expectations for our company’s competitor’s data quality? What internal requirements do we create for promotional data and how do we create executional uniformity?
  1. Additional Governmental Agency considerations – What is the company’s overall marketing strategy, and how might other agencies (such as the DOJ, SEC, OIG, and the states) view this use of/distribution of data in the overall promotional context?
  1. Reputation considerations - How important is the company’s reputation with stakeholders? Will the company’s (and product’s) reputation be harmed by the promotional decision?
  1. Millennial authenticity considerations – Understanding data regarding Millennial promotional expectations, such as authenticity and transparency, will the company’s overall strategy for communicating this data build trust and long-term support with Millennials? If not, what are the long-term consequences for alienating the Millennial consumer base?

The decisions surrounding product promotion, and the evidence required to do so, are challenging for all companies. Each company must carefully consider not only short-term potential gains, but also fully assess possibly damaging long-term consequences.

What is misleading? Recent Court Cases on Off-Label Promotion

Kate Lumpkin

In recent court cases regarding off-label promotion, including the Amarin case, the rulings have upheld the regulatory standard of truthful and non-misleading prescription drug advertising/promotion.

That being the case, what is misleading? How might FDA and the product liability plaintiff attorneys define misleading in all promotional contexts? This question has both deep, and broad, implications. In light of those court cases, as the biopharma industry considers future promotion, companies are meticulously examining the definition/interpretation of misleading to ensure compliance with legal and regulatory standards.

 It would also behoove the industry to strongly consider other agencies and interested parties in these deliberations, such as: the DOJ, HHS, OIG, the SEC, the states, and even the payers. These agencies and groups are concerned about the overall marketing strategy and impact from a reimbursement and shareholder perspective, and might well subsume this type of data presentation as an indicator of a broad strategy. It is essential to understand their definition of misleading in the larger context.

 In the recent court rulings/FDA context, “not misleading” might be defined as stating the information found in a single published study completely and correctly. But is that enough?

 Look out your window. Pretend it is pouring rain – a true torrential downpour. A friend who is en route to your house calls to inquire about the weather. You accurately read the complete weather report to her that states it will be a gorgeous day - no rain predicted. However, you are looking at a flood outside as the rain continues. Though you may have read the weather report “truthfully,” your verbal message is certainly misleading in the overall context of the information.

 Clearly, this is an oversimplification and something no one would actually do. However, this example raises significant questions about misleading, both in the context of one data set, and in the greater context of overall data and promotion. The list below is far from complete, and is not intended to reflect any specific case, but provides a start for the broader conversation regarding misleading. 

  1. Is the study designed appropriately, adequately powered, statistically significant, and clinically relevant to support all of the conclusions (indications, patient subsets, quality of life, patience adherence, etc) used in promotion? If not, might the conclusions be considered misleading?
  2. Is the promotionally presented study data representative of the complete study data set, or is “positive” data selectively presented? If the later, might the claims be considered misleading?
  3. Is the promotionally presented study representative of the known universe of the data for this claim, or is this study selectively chosen due to the positive outcomes when conflicting data exist? If the later, might the claims be considered misleading in the greater promotional context?
  4. Is the promotionally presented study one about which FDA has provided guidance on either design or data interpretation flaws? If so, how does that impact the assessment of misleading?

 The questions surrounding drug promotion are complicated. They become increasingly complicated with individual court rulings. It is vital to remember the decisions are made on individual cases, each with special circumstances. The decisions may or may not be applicable broadly or to other specific considerations. Perhaps the best way to determine what is misleading is also the easiest way. Though drastically oversimplifying again, if we have to spend hours, days, weeks determining whether or not something is misleading, isn’t it? 

Next: Disclaimers

2016 : A Year of Transformation

Kate Lumpkin

As we enter 2016, we are all writing bucket lists, personal resolutions, and professional directives. We are acutely focused, during this small early January window, on the fact that every day is a new opportunity to reinvent. Instead of creating an abundance of disjoined lists, this year I’m purposefully focusing my professional journey on one word: transformation.

To transform something is to change it completely. To look at what has been and to use those insights to create what will become. In our case, the life science industry transformation imperative means to so radically change our thinking and executions that we not only move our companies and industry forward, but that we surpass all expectations for positively disrupting the entire health care ecosystem. We must lead with enlightenment and courage. We must be futurists, and we must reinvent.

I was honored last month by the magazine, Medical Marketing & Media, to be recognized as a Top 40 Healthcare Transformer for 2015. I am grateful to join this impressive group of “40 executives, investors, entrepreneurs, designers, and thinkers who are ushering the industry into its new technological golden era.” From creative pharmaceutical industry executives to entrepreneurial innovators, these 40 people are truly living the transformation mantra.

To that end, I’ve shared some of my 2016 business resolutions below. 

In addition to providing exceptional ad/promo regulatory expertise, I will advise individual companies, and the life sciences industry, to lead healthcaretransformation through: 

  • Facilitating authentic patient involvement, including through the use of innovative digital media, in ways that benefit healthcare and improve development/commercial focus and success.
  • Maximizing the drug development and commercialization processthrough a commitment to fully embracing and using the targeted product profile (TPP) early and throughout the development process, thereby: maximizing product outcomes with the patient, supporting reimbursement, minimizing compliance challenges, and generating commercial success.
  • Increasing communications quality levels in all aspects, supported by appropriate data, resulting in improved patient outcomes, increased commercial success, and enhanced enterprise compliance.
  • Maximizing the Due Diligence Process to more astutely and precisely assess potential return on investment.
  • Generating increased quality data in a more focused and targeted manner that consistently and accurately answer questions of patient benefit, payer expectations, and the overall healthcare system value.
  • Creating and sustaining a culture of compliance commitment in all aspects of the business, from drug development, to interactions with patients and healthcare providers, to commercial messaging, to safety transparency, etc.

There are many avenues for everyone to be a transformer. Whatever your discipline, whatever your position, you can envision and create meaningful change.  Join me this year in creating the most transformative 2016 possible, opening doors to your unprecedented professional success.

What are your transformative business resolutions for 2016?

Beware the "Overstocked Digital Warehouse"

Kate Lumpkin

"Simplicity is the Ultimate Form of Sophistication."  Leonardo da Vinci

If the commercial team wants to evaluate marketing material effectiveness, they need look no further than the inventory warehouse. Sales representatives quickly determine which materials support their sales success and which do not. They order additional copies of those materials that support success. Yet the warehouse sits full of those that do not.

Fast forward to our digital emphasis of today. Beware the digital ‘materials’ warehouse.

I recently provided training for a deeply influential healthcare advertising agency. In preparation for the program, I reviewed some of the excellent videos residing on product sites they had prepared for several clients. In assessing the metrics, I was shocked to find that the two patient videos I randomly chose to review had less than 70 views each, though both had been live on the sites for over 6 months. Imagine the time, money, and other resources that went into the creation of these videos – especially the internal cost of review and legal/regulatory discussion time. Was the lack of commercial impact of these videos predictable? 

The digital world brings endless marketing possibilities. Agencies approach our commercial teams daily with new technology applications. They tout patient involvement and sharing, investigator communities, bloggers, interactivity, connectivity, embedded videos, information gathering, connection with medical apps, measurable metrics, etc. Truly, these tactics are exciting – and endless! Used appropriately and in a targeted fashion, the returns on time and money investment are potentially huge. Alternatively, indiscriminately grabbing at options, is doomed to fail. How might we sift through all of this and determine the maximum return on digital investment, while minimizing time, resource waste, and compliance challenges?

The old fashioned way – beginning with the optimal strategy. 

At the risk of repetition, it is imperative to create the ideal strategy early in drug development so that claims can be clinically tested and incorporated into the labeling. This approach amplifies patient outcomes, maximizes commercialization, and mitigates corporate risk.

The established strategy will inform the most effective, and regulatory appropriate, digital tactics selection. 

Why is it important to consider smart, targeted digital use?

It is essential to maximize commercialization with the smartest use of the overall marketing budget. The digital budget is one component, but not the only component, of the strategy. The “kid in the candy shop” syndrome could be a costly reality if not thoughtfully executed.

An astute, targeted digital strategy, developed consistently with the labeling and with input from all relevant disciplines, will mitigate corporate risk.

It is vital to minimize costs, both direct and indirect, while maximizing return on investment. Costs include those such as the development of too many non-impactful materials and the cost of internal review and agency times. It is simply too expensive to create and execute tactics that will not generate return on investment, no matter how new or exciting they seem, if they are destined to collect dust in the digital warehouse.

Strategic Considerations 

  • Create an optimal targeted strategy early – including appropriate patient selection/identification, narrow vs broad indication, subgroups, quality of life, patient preference claims, differentiating claims, etc. Make sure to include all of the relevant disciplines.
  • Use market research to boldly and honestly measure impact potential and tailor the digital program to utilize the most impactful tactics for your product that are also clearly consistent with regulatory, legal, and compliance standards. Market research participants should include all groups who impact, and are impacted by, the Rx drug/biologic system and utilization/reimbursement of your product.
  • To ensure that the commercial focus is on quality, not quantity, consider overturning the paradigm by compensating commercial on profit, not sales.
  • Insist on measurable return on investment, understanding that the measurements may be nontraditional.
  • Often, less is better – don’t get swayed by the tactic du jour just because it is new. Be smart. Be selective. Be targeted. Use resources wisely.
  • Consider regulatory, legal, and compliance requirements. The FDA is oneinterested agency, not the only interested agency or stakeholder. Also essential to consider organizations such as: DOJ, OIG, SEC, the states, payers, etc. Ensure to include all relevant internal disciplines in all planning and decision-making.
  • Have concept meetings early – have all relevant disciplines in attendance. Remember to aggressively apply the independence standard/question in evaluating digital tactics, such as with our participation in chat rooms, relationships with external bloggers, etc. Successful, honest, concept meetings will lead to more effective, efficient review meetings and support more effective, compliant programs. 

Clearly, thoughtfully targeted digital tactics are essential to a complete and successful marketing strategy.  However, it is imperative to select the most appropriate ones to maximize success, mitigate risk, and contain resources – both direct and indirect. Sometimes less is more. No one can afford to have warehouses sitting full of unused materials. The same is clearly true for our digital footprints in this highly saturated world.

Successful Medical Congress Impact: Strategy and Implementation

Kate Lumpkin

"The achievements of an organization are the results of the combined efforts of each individual"  - Vince Lombardi 

“I know you are in a hurry, but I just need a minute for you to approve this exhibit booth panel. May I walk you to your car?”

ASCO (American Society of Clinical Oncology) is rapidly approaching. Everything is ‘on deadline’. The ad/promo review committee is meeting 10 hours a week and still can’t keep their heads above the proverbial water. Some members can’t attend the scheduled meetings and therefore send a substitute. No one can even remember what was approved last week, much less last month. Ongoing reviews include everything from exhibit panels to hotel key card space, billboards on circling trucks, advisory meeting slide decks, MOA endless loop tapes, disease state materials, satellite speaker program slide decks, pipeline panels, sales representative materials, poster sessions, reprints, etc.

Everything is a rush job. What could possibly go wrong?

Lots. 

Potential Risks

  • Inability to maximize commercial impact secondary to inadequate materials, programs, etc.
  • Review without adequate time and multi-disciplinary discussion: potential for missing risks, therefore increasing regulatory/compliance concerns
  • Review out of context with other materials and activities: no “big picture” coordination
  • Last minute submissions often result in poor quality materials: require greater scrutiny and increased editing, increasing review and production times
  • Minimized opportunity to effectively coordinate with other important departments within the organization, such as with the compliance department

 Which may result in:

  • Increased potential for FDA or other government agency enforcement
  • If unapproved drug or indication, increased risk for impact on final PI wording

Why Improve the Process? What is in it for you?

  • Improved corporate risk management
  • Maximized commercial opportunity with more effective and compliant materials
  • Increased review efficiency
  • Improved resource planning – internally and with agencies
  • Created early agreement for meeting strategy and concepts

Process Improvement suggestions

This takes committed preparation and a well-coordinated, fully functioning team. We know large meeting dates years in advance, and can use this information in our favor.

  • Convene a complete team summit at least 3-6 months in advance of the meeting
    • Ensure EVERYONE is there – commercial, compliance, legal, regulatory, medical, perhaps clinical (if unapproved product, recruiting investigators, etc.), communications, and perhaps lead agencies
  • Plan a full day with a detailed agenda
  • Completely present the overall strategy and everything the company plans to do at this upcoming medical meeting - EVERYTHING (for instance: door drops, hospitality gatherings, key cards, advisory meetings, etc.)
  • Gain buy-in for the strategy, programmatic tactics, and specific claims as possible. Prepare for the changes that may occur over time, while remaining consistent with the core agreements.
  • Select an overall champion/medical meeting lead to ensure smooth process flow, accountabilities, mitigate challenges, etc. This champion should also ensure Commercial has fully reviewed and approved all draft materials before routing for committee review. 
  • Select a project manager and create a project plan with responsibilities, accountabilities, and specific milestones
  • Consider, and plan for, complete ad/promo meeting review coverage for all disciplines throughout the process and set expectations for substitutions – anticipate vacations, parental leave, etc, as possible
  • Ensure there is an agency contact lead (company lead and agency contact) to share project milestones/ expectations, convey importance of meeting all deadlines with compliant materials, etc. and hold them accountable
  • Prepare a strategy for post-congress assessment to enable improved future process

Clearly, these are just a few of the many considerations necessary to create a strong and compliant commercial presence at a medical congress. But the bottom line:

Disciplined preparation and strong teamwork are the imperatives.

"BACKWARDS PLANNING" - A DRUG DEVELOPMENT IMPERATIVE

Kate Lumpkin

“If you don’t know where you are going, any road will get you there.” -  Lewis Carroll   

 I was recently involved in a “mock OPDP” meeting (a meeting of internal and external experts some companies utilize to assess the viability of the proposed launch claims – usually about 6 months before the PDUFA date) where the ad/promo review team informed commercial that virtually none of their essential differentiating claims, other than stating the actual indication, were supported by substantial evidence, the historical regulatory standard. They would be able to market their product with only a very few of the claims they “needed.” The product was not developed to even test those critical claims because they were not pre-identified.

Imagine the pall cast over the room. The commercial team clearly was devastated they could not make the claims they had projected. Other team members were equally as distressed to have to say “no.” But there simply was no supporting data to the level required to support the claims. The draft PI was over inspirational. And draft claims were designed based on that over-reaching draft PI. This was a moment of true corporate crisis.

That meeting reminded of the very first training program I delivered as a consultant for a pharmaceutical company, some 15 years ago. In that program, I coined the phrase “Backwards Planning.” My message was predicated on thecriticality of developing a product with the end goal of including the pre-determined, essential claims in the package insert. Fifteen years ago, the concept was important. 

Fifteen years later, I am more convinced than ever of the business imperative to do so.

The Case for Backwards Planning

I define “Backwards Planning” as developing the product with the end goal as the imperative. Of course, there is no “one size fits all.” And, there are many changes and challenges occurring in the drug development and commercialization world. The drug development road is winding, for sure. However, if there is no clear destination, there is also no clear success.

The end goal is the inclusion of essential data in the package insert, such as the most appropriate indication language, patient subgroups, and a robust clinical trials section, among others. In addition to providing the most beneficial data for patient selection and treatment, this approach provides objective development milestones, maximizes potential commercialization, and minimizes short-term and long-term risk management (compliance) considerations. It is no longer acceptable to just get the drug approved. We must be smarter. We must think strategically. We must get the right product approved with the right attributes. When possible, we must obtain differentiating claims. We must have more metrics to inform us to cut our losses when appropriate. We must do this for our patients, for maximizing commercial success, for risk mitigation, and for the business as a whole. This development strategy is essential, whether developing a NME or using the 505(b)(2) pathway.

Backwards Planning Considerations

 There are many considerations to creating an effective product development strategy using “Backwards Planning”. This takes real courage, requires enlightened leadership, and is certainly not easy. But drug development is expensive, complicated, and long. This method can be a vital tool in mitigating some of the ultimate commercial challenges. Though far from complete, and recognizing space limitations and the fact I am oversimplifying a very complicated process, here are some observations on working from a “Backwards Planning” platform. 

Involve the right people from the beginning

 Form a team charged with defining the global/US development strategy. The team must include all appropriate disciplines, including: clinical, medical, regulatory, market intelligence, legal, compliance, commercial, regulatory, ad/promo regulatory, etc. This team should work with the development team throughout the process to establish “needed” data/claims, to design appropriate studies to test them, to assess the strategy for compliance considerations, to assess the feasibility of inclusion in the final PI, and to provide accurate advice on the likelihood of the data to support a promotional claim.

Clearly define the needed product attributes

 Utilizing market intelligence, demographic knowledge, illness evolution, and predicted payer data and information needs, among other factors, clearly define the desired indication (use) of the asset, the desired patient population, the desired delivery pathway, etc. Determine whether to develop this drug/biologic for a broad indication or a more targeted and focused one. Determine whether or not it is critical to have a superiority claim at launch. Determine whether or not you need to gather data to support patient reported outcome claims, adherence claims, or patient preference claims. If at all possible, work strategically to determine the actual desired claims, using the actual desired language.

Work futuristically, and determine a future-thinking development strategy early. What additional indications or patient groups will be important to study in the future?  Plan for this now.

Design a development strategy to objectively test the desired claims

 After defining the desired product attributes, the team should develop a TPP(Targeted Product Profile) to guide the overall development process and create a best possible development/claims “wish list.”

 If data supports conducting Phase III trials, design trials to effectively test the pre-determined claims. Realizing the numerous business and financial considerations to drug development, including time and need for “first to market”, the more closely the final PI reflects language and data (substantial evidence) to support the essential claims, the better chance for successful commercialization and the more characterized the product will be for patient selection and potential clinical response.

The team should effectively utilize an end of Phase II meeting with the appropriate review division. This is especially essential if the team desires to use an unusual study design, desires to study patient adherence or preference, use an unfamiliar scale, etc. Acknowledging the limitations of this request and commitment, as possible, gain agreement that the study design actually supports the claim testing you have identified as vital.

 No matter how it is done, drug development is an arduous, expensive, and winding road. Having a clear destination in mind, and strategically planning accordingly, is essential for patient and market success.

Maximizing Due Diligence - Think Horses AND Zebras

Kate Lumpkin

Medical students are taught, “When you hear hoofbeats, think horses, not zebras.” When performing due diligence, think horses AND zebras. It is vital to discover, and evaluate, both the obvious and the obscure.

Pharmaceutical and Biotech companies today routinely purchase other companies or products to create a stronger commercial position. They make the determination whether or not to do so through a process known as due diligence. Maximizing due diligence requires continuous rigor to uncover the unexpected, an open mind, corporate honesty regarding business need and potential, involving the correct people, and the willingness to walk away should the opportunity not prove a potential business success.

I once served on a small advisory committee for a major pharmaceutical company. The group was convened to assess the commercial viability of a recently purchased, expensive Rx drug product. The advisors met for a full day in a small room with the company commercial, advertising/promotional regulatory, clinical and medical professionals, as well as internal ad/promo attorneys. The mood was “crisis.” Commercial and clinical/regulatory had made the decision to purchase the approved product, with the advice of the internal due diligence team, composed of commercial, clinical, regulatory professionals and M&A attorneys. Those disciplines are essential to any such due diligence. However, the deal was consummated based on monetary projections ultimately determined to be unrealistic. The decision to purchase was made without conferring with potential purchasers or with the internal medical, compliance, advertising/promotional regulatory professionals, or ad/promo attorneys.

After purchasing the product, the regulatory and legal ad/promo and medical professionals reviewed the desired promotional claims and the supporting data and determined the data would not support the proposed commercial campaign. The payers had not adopted the product, as they perceived it offered no material advantages over current, less expensive products. Clearly, the commercial team identified this as a critical development. They promptly convened our small advisory group, which substantiated the opinions of the internal professionals. The product could not be legally promoted in a manner that would meet commercial projections and needs. Additionally, the payers represented in the group confirmed their unwillingness to purchase the product.

The company determined to abandon the product. Instead of this product adding to the commercial bottom line, the entire purchase was written off as a loss – a small catastrophe to this company – a potential major catastrophe for other companies.

Here are four lessons this experience, and others, have taught me about due diligence. Clearly, there are many additional considerations, but I believe these to be essential. 

Successful due diligence is a MINDSET

 The asset assessment must be unbiased, thorough, and dispassionate. The team must be willing to decide “no.” In fact, the default should be “no”, unless entirely convinced the decision to purchase is a smart one. And, the team must work together to determine the best possible outcome through uncompromising questioning, listening, and evaluating. This mindset emanates from enlightened leadership throughout the organization.

Involve the right people, at the right time, in the evaluation process 

Maximize the due diligence project by involving the appropriate internal professionals from the beginning, which routinely should include: Regulatory ad/promo, medical, ad/promo attorneys, and compliance professionals – in addition to commercial, clinical and M&A attorneys. It is also an imperative to identify critical external stakeholders, as appropriate and possible, and honestly listen to them. Create a highly- effective working team, thoroughly evaluate all information, and carefully consider, all opinions.

Ask the right questions and for the “right,” complete data

Rigorously identify all relevant business questions, based on potential purchase, and meticulously evaluate those questions in an open, unbiased way. If the outcome is predetermined, due diligence, by definition, is unnecessary. As with honest, transparent drug development, it is more commercially beneficial to abort a likely unsuccessful purchase as early as possible. And, demand the complete data necessary for an unbiased, thorough review by all professional disciplines to determine viability and realistic commercial projections. Ask questions such as, “what will our marketing strategy be?” Do the data support that strategy? Do the laws and regulations permit that approach? The team MUST ask the hard questions, and seek the unexpected. They must discover and evaluate both the horses and the zebras. 

Make an honest and smart business decision

Make an objective and smart business decision based on data-driven, appropriate projections. Judiciously pressure test all decisions against a foundation of the legal/regulatory viability of the projected marketing strategy, the competitive intelligence, the compliance environment, the viability of payer purchase, etc.

Effective due diligence teams are excellent at finding horses. The best due diligence teams are also exceptional at discovering, and evaluating the possible impact of, zebras. The most valuable team members are the ones who identify the most insightful and important questions and provide an unbiased, comprehensive evaluation.

BUILDING MEANINGFUL BUSINESS NETWORKS ONE DAY AT A TIME

Kate Lumpkin

"The currency of real networking is not greed but generosity." -  Keith Ferrazzi

The summer is coming to a close, and I am into my annual (ok, truth stretched a bit!) cleaning mode. As to be expected, my office closet always needs the most attention. And so this morning, I threw away over 250 business cards from one of the ever-expanding piles (none were my own old ones, though I have plenty of them!). Each card represented a person who gave it to me with good intentions to follow-up, though almost no one did so. And so the cards simply sat. Through the years, I have done the same with my cards – given them to people with the best of intentions to follow-up, and unfortunately, I almost never did so. It’s hard, especially in our technology–driven world, to remember to make those calls. Developing meaningful relationships takes more time and commitment than all of our technological short-cuts, but it is imperative. This is why networking has become such a large part of our business lexicon.

I believe in networking. I fully understand the goal of creating relationships that support, and often catapult, professional and personal growth. But I do not believe just attending networking events or sharing business cards, or having 1,000 social media “friends,” will translate to new friendships or impactful professional relationships.

Instead, I believe in the power, and pleasure, of creating authentic, mutually beneficial relationships. In the world of science, this is known as mutaualistic symbiotic relationships – relationships that equally benefit both participants. The impact grows logarithmically where there is trust, and when both participants are genuinely “working” for each other.

Here are some ideas I have used through the years to develop those relationships. They are not exhaustive, clearly. And each suggestion requires commitment. As we all know, everything competes for our time. It is not easy to make this the essential priority I know it should be. But the joys and successes of building mutually beneficial relationships far outweigh the shallow, often one-sided definition that many people frequently associate with networking. I am a firm believer that it is not how many people we know, but rather who we know well and how we work together to champion and support each other, that creates the successful symbiosis we desire from networking.

  1. Define your personal networking goals. This is imperative to inform and develop your networking strategy. Why do you want to build relationships? Is professional advancement within your company or outside your company important to you? Do you want to meet people that provide professional support and inspire you to acquire more professional knowledge? Do you want to explore other work related to your skills and experiences? Do you want to try new passions? Do you want to serve in leadership roles in associations?
  2. Develop your networking strategy. With what groups and individuals should you connect? Identify, join, and actively participate in, meaningful groups of professionals with whom you want to build authentic relationships. Proactively seek out those opportunities. These groups may be inside or outside your own company. They may be in your discipline or not. They might also include leadership groups, book clubs, associations, etc. They may also be not at all related to your actual work, but rather to a passion you want to pursue. Those relationships may take you into fields and areas that use your skills and interests in additional interesting ways. For instance, you might join a rock climbing group that renews your energy and passion around your work, while building relationships with extremely interesting leaders and risk takers in other work.
  3. Commit to calling one of your network advocates each week just to catch up. At the beginning of each month, write the date, time and person on your calendar for each week. Make this a consistent priority.
  4. Write a handwritten note to one of your network advocates each week to thank them for something meaningful they have done for you. Reminding ourselves of the professional generosity of others in our circles helps create meaningful pathways for continued connection.
  5. Schedule a “meal meeting” once a month with one of your mutual advocates. Remember breakfast - it may be the most effective time. You can begin early in the morning when you are both fresh, and it is easy to find a quiet place to share in confidence, even in an otherwise busy restaurant. Share your dreams and goals. Listen to theirs. Bottom line, how might you advocate for each other?

Above all, I have learned most clearly that I must authentically care about helping each network friend. I must be vigilant about searching for opportunities that will benefit them. I must be a connector for them throughout their career journeys. I must be their advocate and their champion. And I must be delighted to do all of the above.

Clearly, you don’t have to throw all of those cards away. Some may even cause you to remember an important previous connection or new opportunity. But I am certain that creating authentic, mutually beneficial relationships will be infinitely more fulfilling and rewarding than all of the cards in my stack.

ACT WITH PASSION

Kate Lumpkin

“It is the ultimate luxury to combine passion and contribution. It’s also a very clear path to happiness.” - Sheryl Sandberg

Successful leaders exude authentic passion. They choose to lead the work they do because they simply cannot imagine doing anything else. Their purpose, and the “why” they do it, are clear and aligned. Their compelling passion is what gets them up in the morning, what motivates meaning for their vision, and what stimulates their courage to inspire others to support their goals. Passion ignites leaders’ thinking, emotions, and actions -- causing challenging roadblocks to somehow seem easier, and inspiring perseverance in the face of adversity.

As cliché as it sounds, I truly believe one person, with undying passion, can change our world. Yet I also believe personal passions can cycle and morph over time. Passions can even “recycle” when the time is right. And, sometimes, it can be a brand new passion, when one least expects it, that changes your life.

I am confident it is always the right time (read: “never too early or too late”) to act with passion in a way that improves lives and conditions.

16-year-old Nicole Ticea, from Vancouver Canada, won US$50,000 (and second place) in the Medicine and Health division of the Intel International Science Fair for creating a simple and inexpensive HIV test that can be used by people in low-income communities. Her test appears to detect the virus in babies under 18 months old, as well as adults who've been infected for as little as three months. The disposable device doesn't require electricity, provides results in less than an hour, and should cost less than $5 to produce - just imagine how many millions of lives it might save.

Ticea said, “Scientific research involves dedication, determination, long hours and a deep-rooted love for the field that makes sacrifices worthwhile.” Passion, not age, changes our world.

31-year-old Serena Williams just won her 6th Wimbledon singles title and is the oldest number one women’s tennis player ever. She has accomplished every definable success in tennis. She could quit anytime she wanted, stepping down as arguably the greatest woman tennis player of all time. She has money, and she has created an enduring legacy. But her passion keeps her going. For her, tennis is not just a job. Instead, through her passion for tennis, she inspires young women everywhere to be all that they can be.

I know about passion cycling, and about persistence to hold on to the passionate pieces of your professional self. I am passionate about leadership. Most importantly, I am passionate about developing future leaders to positively change our world. I strategically focused on that passion while working at Bristol Myers and at FDA. And I have continuously served as a leadership mentor to new professionals.

For the past 21 years, though, I have primarily focused on the regulation of prescription drugs. I will continue to do so and am passionate about that work. However, I am thrilled to increase my commitment to leadership development and act again on that original passion in a more focused way. For me, the time is now.

What is your passion? Are you acting consistently with that passion? If you are, congratulations! If not, it is NEVER too late! Choose today to act on that passion, and with great passion. You just might change our world.

LEADERSHIP PARADIGM - REJUVENATE

Kate Lumpkin

A Leadership Paradigm: REJUVENATE!!

True leadership requires a kaleidoscope of skills, qualities, traits, and styles.  The styles certainly vary, and the necessary skills might be different as applied to unique situations and perspectives. But one truth remains constant for all leaders everywhere – great leaders require, and embrace, rejuvenation. 

This weekend, unplug!

I remember as a young district sales manager “sneaking” to the pay phone (yes, a pay phone!) while my husband was filling the car with gas. I just HAD to briefly call a sales representative to check on something that must have been “vitally important.” 

We were on vacation. I was wrong.

That call took my focus away from my family and kept me tethered to work. Even on vacation, I found it very challenging to unplug.

 However, at least in those days, there were no cell phones and no expectation that I find a pay phone every 15 minutes. Upon arrival at any destination, I was able to untether rather quickly. No one could find me. No one could bombard me with emails. Sleep, relaxation, challenging myself with different opportunities, playing with friends and family – these could take center stage. And I so deeply believe, truly make you a BETTER leader.

Fast forward to 2015. We have cell phones. We do not know how to put them down, even during family dinners. We are often expected to check in with work, or finish that last project, even while on vacation.  We are distracted with too much stimulation. This is not a sustainable reality.

Push back. Rejuvenate. Relax and change focus to be a BETTER leader. A tired, out of gas leader, is not an effective leader.

So, this weekend, unplug. Grill something with family and friends. Walk on the beach. Feel the sand. Hug folks you love. Experience a small town parade. Watch fireworks like a child. Look at the stars. Make ice cream. Remember what makes you, you. Remember what amazing attributes you bring to the leadership table – creativity, energy, enthusiasm, passion, zeal.

Enjoy yourself.

And, in the process, become a more effective and inspired leader.