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1. Regulatory Strategy

Clinical and Regulatory Strategy: FDA Approval Process

A start-up biopharmaceutical company with no marketed drugs was trying to get its first product through the FDA approval process and to market. After 3D worked with the client, the advisory committee voted in favor of approval, and the FDA approved the treatment months later.

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Regulatory Strategy: FDA Medical Device Approval

A device start-up company spent nine years in product development and had yet to receive IDE approval to begin clinical trials in the United States. 3D Communications assigned a scientific lead and a communications lead to the project and helped move the application forward.

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2. FDA Advisory Committee Preparation

FDA Advisory Committee Preparation: Stakeholder Engagement

A specialty biopharmaceutical company was preparing for an Advisory Committee meeting and FDA approval of their self-administered therapy for a rare and potentially life-threatening genetic condition. 3D provided a solution that lead to a 12-1 vote for approval of the product.

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FDA Advisory Committee Preparation: Drug Approval

A start-up biopharmaceutical company with no marketed drugs, was trying to get its first product through the FDA approval process and through the market. After 3D's involvement, the FDA advisory committee voted 12-0 recommending approval. The FDA approved the drug 9 weeks later.

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FDA Advisory Committee Preparation: Drugs (#2)

A pharmaceutical company was seeking approval for an improved formulation of a drug that reduced the number of treatments patients needed per year. After 3D collaborated with the client, the advisory committee vote was in favor of approval with augmentations to the proposed REMS program.

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FDA Advisory Committee Preparation: Devices

A small start-up medical device company with no previously approved devices, worked for more than 15 years to develop and clinically evaluate their novel, first-of-a-kind technology. After 3D's involvement, the FDA panel voted 11-0 recommending approval.

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3. Executive Communications Programs and Training

Media Training

A non-governmental organization (NGO) became aware of a scheme that was creating a health risk to both humans and animals throughout the world. 3D helped the agency position itself as the first step. The organization gained positive coverage on the primetime news, network evening news, and the morning news shows.

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Speaker Training

The Chief Technology Officer at a billion-dollar company was named Chairman and CEO, and thrust into the public spotlight. The new job required that he speak at high-level events and to important audiences. The challenge was he was native Chinese, and English was his third language. Understandably, he suffered from anxiety over speaking in public. We created and executed a comprehensive program specifically tailored to his needs, and turned the shy computer scientist into one his industry’s most sought-after speakers.

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Crisis Communications

Two weeks after reporting record earnings, one of the most respected insurance companies in the world was forced to restate those earnings and explain a $3-billion dollar loss. With its reputation at stake and its stock price spiraling downward the company called us to help restore its credibility.

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Crisis Communications 2

When the FDA fast-tracked a promising cholesterol medication, a public interest group launched a major media campaign to block it. The group’s Medical Director and several FDA physicians claimed the drug was dangerous. The pharmaceutical company that made the drug called upon us to deal with network news coverage that seemed slanted and sensational. We educated reporters and producers on the science, and what the company was doing to mitigate risk. The media changed its tone. The drug was approved.

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Change Management Communications

Two Silicon Valley companies agreed to a merger but neglected to communicate effectively with employees. With no clear understanding of how change could impact them, employees became anxious and fearful. When layoffs came trust was lost. Confronted with a cynical and skeptical workforce, company leadership called on us to craft a change communications plan to restore credibility and confidence.

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Leadership Communications

A young entrepreneur turned a college project into a fast-growing Internet company. As Founder and CEO, he quickly became the company’s public face. He demonstrated uncanny business instincts and grew the enterprise exponentially. As his public profile grew, so did criticism that he was inexperienced and lacked the requisite leadership skills to serve as CEO of a soon-to-be-public company. He turned to us for a crash course in leadership communications.

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4. Market Access and Value Communications

Market Access and Value Communications: Case Study 3

A leading microbiome therapeutics company was preparing for regulatory review and launch of a novel therapy designed to treat recurrent Clostridium difficile infection (RCDI). 3D conducted a thorough market access analysis that included: stakeholder positions, competitor data, and an examination of how RCDI is currently addressed with regards to coverage and quality.

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Market Access and Value Communications: Case Study 2

A large device manufacturer with a product for a heart condition was being threatened with a denial of Medicare coverage. 3D assisted in the organization of communications, messaging, and supporting clinical data to facilitate Medicare coverage, which was granted.

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Market Access and Value Communications: Case Study 1

One of the largest pharmaceutical companies in the world was launching the first drug to show an overall survival benefit in a deadly cancer. 3D conducted a series of messaging and training programs throughout Europe across a wide array of stakeholders and assisted in one of the most successful launches in the company’s history.

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