Imagining an Unimagined World

A quote by futurist Jamais Cascio struck me as highly relevant to our industry. He likens future thinking to the immune system, saying, “By examining and testing different possible outcomes—potential threats, emerging ideas, exciting opportunities, we strengthen our collective capacity to deal with what really does transpire.”

To take this quote one step beyond—we strengthen our collective capacity to not simply deal with what really does transpire, but also create what will transpire.

As we enter the New Year, let’s use future thinking to keep our industry and patients healthy and progressive. “Digital is transforming our industry at an exponential rate,” states Daniel J. Gandor, Head of Digital Accelerator – USA, Takeda. “It’s not only altering what our product offerings look like and providing new ways to deepen patient and customer relationships, but it’s forcing us to stretch our strategies and internal processes/procedures like never before.”

Science Fiction Becomes Science Fact

Stephanie Bova, Takeda’s European Head of Digital Acceleration, adds, “I like to think back on the science fiction shows we grew up on: Much of the “future” technologic leaps are now a reality: Early telemedicine from The Jetsons; Star Trek’s Tricorder (Scanadu); the Bionic Man’s robotic arm; and Terminator 2’s 3D printing. Science fiction is now just science—not fiction. We believe it’s our responsibility to dream up new ideas for digital healthcare that betters patients’ lives.”

In looking ahead, Donna Wray, Vice President, Digital Marketing at TGaS Advisors, notes pharma will truly go “beyond the pill.” “This has been a buzzword for more than a decade, but it will finally be true—with devices that track adherence, symptoms and related quality of life measures. Healthcare economic models will pay for outcomes rather than just medication.”

Wray adds, “Many future innovations are outside of current regulations. In some cases, companies will have to comply with the spirit of the law, because the letter of the law may not yet be available. We will need to be more nimble to succeed in this environment.”

Regulatory Realities

Bova reflects on how the industry could become stuck in attempts to transform digitally. One Dilbert cartoon, she notes, tells a pointed story: An executive asks staff to think like creative entrepreneurs. Yet, each time the staff comes up with an idea, the executive argues that creative concepts raised are too risky—but they should continue being creative.

This risk adverse mentality is problematic when the mission is to improve patients’ lives. Of course, companies must address regulation realities. Government agencies globally will continue pursuing enforcement actions against marketing materials due to the failure of regulated drug and device firms to comply with laws, guidances and codes. Product liability lawsuits can be filed, alleging that misleading, insufficient company communications are “responsible” for causing injuries. Privacy and adverse reporting laws are stringent worldwide.

Moving from Subject- to Solution-Oriented Decision-making

The industry must move from fear-based, subjective decision-making to solution-focused decision-making and create a measurable roadmap for social media implementation.

“Regulatory ad/promo professionals must provide input to the company, demonstrating how to execute successful, compliant social/digital media,” stresses Tracy Rockney, Co-founder and Managing Partner, OneSource Regulatory, formerly AbbVie’s Vice President of Regulatory Affairs, “It is no longer acceptable to tell the company they cannot do it or wait on more specific guidance from FDA/OPDP.”

“Takeda is taking bold steps to harness the power of digital.” Gandor adds, “Our goal is to embed digital into our DNA, to make it core to everything we do. Like an internal venture capital fund, the Digital Accelerator team finds, funds, nurtures and catapults innovative digitally enabled ideas throughout the company. The best way to learn is to do—we want our colleagues breathing digital into their business as usual, not thinking of it as separate. Across the spectrum—from the earliest R&D; running clinical trials; deepening patient relationships on the marketing side; and even recruiting the best talent—digital must be at the center.”

“When brainstorming for digital, it’s important to work collaboratively and do some real out-of-the-box thinking, particularly from a regulatory perspective. If we want to be at the forefront of the digital evolution, and really use digital to help patients and their caregivers, we must keep the patient at the center of everything we do and collaborate to innovate,” stresses Philomena McArthur, Senior Director, Regulatory Advertising and Promotion, Pharmaceutical Group Health Care Compliance at Johnson & Johnson.

Jennifer De Camara, Assistant General Counsel, at Johnson & Johnson concurs: “Marketing/communication groups can collaborate with regulatory and legal colleagues to shift companies from insecurity and hesitation around social media to developing internal standards and channels that provide clarity of thought and process about how to appropriately balance key issues.”

The Digital Transformation Mindset

Companies must create and nurture the optimal conditions for digital innovation in a regulated industry, with a focus on factors that build trust among cross-functional team members (Medical, Legal, Regulatory, Compliance and Marketing/Commercial Operations).

First, there must be a super-ordinate goal around which everyone rallies. Discussions can’t be about “my process” or “your process” but about desired outcomes and the higher collaborative purpose—a win-win for everyone.

Master Regulatory Fundamentals

Next, team members must be “level set” in terms of mastering fundamentals of regulatory knowledge. Having the same knowledge baseline is particularly important when teams collaborate in the digital realm because regulatory/legal risks and digital platforms are constantly evolving. Without a basic understanding of the regs, it’s harder to contain judgments, impatience and frustration, which become impediments to efficient and successful collaboration as new terrain is explored. Certain non-negotiables cannot be argued.

Finally, a critical factor: Cross-functional team members must appreciate one another’s value when taking new ideas to the next level. It’s critical to suspend judgments about the ideas to advance the vision. Communication must be solution-oriented and interactions built on an understanding of, and adaptation to one another’s behavioral and communication styles.

Learn, Really Learn from Patients

“Patients with rare diseases can teach us about unmet needs for digital innovation, which is why communication with populations that number a few thousand has payoff for patient populations in the millions,” asserts Wendy White, SVP Rare Diseases, Dohmen Life Science Services. “Our precision marketing approach includes a feedback loop so we are always learning how to improve patient outcomes, which ultimately is why we innovate digitally.”

“Digital transformation within is an imperative for the patients and patient advocates who rely on these channels for information about diseases and treatment options. This is particularly true for patients with rare diseases,” says Delyn Long, U.S. Marketing Lead for MPS II and Gaucher at Shire. “We have a moral and commercial responsibility to integrate digital initiatives that meet regulatory requirements into communication strategies globally.”

  • Ilyssa Levins

    Ilyssa Levins is President and Founder of Center for Communication Compliance (CCC). Ilyssa helps manufacturers and their promotional agencies save time, money and manage risk, when promoting drugs and devices. She combines her regulatory compliance, marketing communications, and change management expertise to help clients achieve their goals.


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