From Research to Revenue: Managing the Pharmaceutical Transition

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Brought to you by Travelers. Logo, Travelers. Text, In the Know with Jennifer Ampulski. Scaling Manufacturing.

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Hi, I'm Jennifer Ampulski, Travelers Life Sciences Practice Lead, with a video series designed to help guide pharma companies, like yours, transition from clinical trials to commercialization.

As an early-stage pharma company, you've been focusing on research and development, clinical trials and foundational science. Then you get FDA approval. Congratulations. And the journey begins. As you scale drug production, things can change. While it's an exciting stage, it comes with risks. So what type of liabilities might you encounter on the road ahead?

Without

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Bodily Injury.

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proper risk transfer practices, if you scale up manufacturing with an outside vendor who has production error and that causes injury to a patient, you could be the sole responsible party. But expanding your own production with unvetted suppliers can be just as risky if shipments are unreliable.

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Workers Compensation Claims.

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Also, without proper controls, adding more employees for production potentially increases workers compensation claims, such as those related to repetitive motion injuries and exposure to toxic substances

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First-Party Property Damage.

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Or what if your product supplies or materials become damaged or contaminated? Substandard quality control or storage conditions can lead to a devastating loss.

Travelers has a range of capabilities for pharma companies as you take on this exciting journey.

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Dedicated Claim Professionals.

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Our dedicated Life Sciences Claim professionals understand the challenges of product liability, contractual risk transfer and more. And we're with you every step of the way.

To learn more about Travelers capabilities for life sciences, talk to your independent agent or visit travelers.com/lifesciences.

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Logo, Travelers. Text, To learn more about Travelers capabilities, talk to your independent agent, or visit travelers dot com slash life sciences. The Travelers Indemnity Company and its property casualty affiliates. One Tower Square, Hartford CT, 06183. This material does not amend, or otherwise affect, the provisions or coverages of any insurance policy or bond issued by Travelers. It is not a representation that coverage does or does not exist for any particular claim or loss under any such policy or bond. Coverage depends on the facts and circumstances involved in the claim or loss, all applicable policy or bond provisions, and any other applicable law. Availability of coverage referenced in this material can depend on underwriting qualifications and state regulations. Copyright 2023 The Travelers Indemnity Company. Travelers and the Travelers Umbrella are registered trademarks of The Travelers Indemnity Company in the U.S. and other countries.

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A red umbrella logo. Travelers. Text: In the Know with Jennifer Ampulski, AVP, Life Sciences Practice Lead, Travelers. Off-Label Concerns.

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Hi, I’m Jennifer Ampulski, Travelers Life Sciences Practice Lead, with a video series designed to help guide pharma companies like yours transition from clinical trials to commercialization.

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A montage of videos shows people in laboratory coats, hair nets, gloves and face masks working with equipment and tubes.

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So you’ve launched a new drug. That’s great news. Now what happens when it’s out in the real world?

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A doctor writes on a clipboard while holding a bottle of medication.

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What if doctors start prescribing your drug for off-label use or for conditions you didn’t anticipate?

At first blush that sounds like a great business opportunity, but hold on, it can also present serious risks. Let’s take a closer look.

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Text: Off-Label Risks.

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With off-label use, dosages or frequencies may differ from clinical trials, and these differences can lead to critical side effects. A pharma company may still be liable even if they were unaware of these unforeseen risks.

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A machine caps bottles of a medication. A doctor speaks to a patient.

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You have a duty to stay knowledgeable and warn patients.

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Workers use a microscope and computers in a laboratory.

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You’ll need a post-market surveillance plan to help keep track of unexpected challenges.

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Text: Coverage Includes Off-Label.

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To help protect your business from potential increased risks associated with off-label use, Travelers offers coverage that doesn’t exclude off-label use. Trust our capabilities to help keep you in the know along the way as you transition, including life sciences specialists who can help you monitor and respond to the unexpected. To learn more about Travelers capabilities for life sciences, talk to your independent agent or visit travelers.com/lifesciences.

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A red umbrella logo. Travelers. Text: To learn more about Travelers capabilities, talk to your independent agent, or visit travelers.com slash life sciences. The Travelers Indemnity Company and its property casualty affiliates. One Tower Square, Hartford, CT 06183. This material does not amend, or otherwise affect, the provisions or coverages of any insurance policy or bond issued by Travelers. It is not a representation that coverage does or does not exist for any particular claim or loss under any such policy or bond. Coverage depends on the facts and circumstances involved in the claim or loss, all applicable policy or bond provisions, and any applicable law. Availability of coverage referenced in this material can depend on underwriting qualifications and state regulations. Copyright 2023 The Travelers Indemnity Company. Travelers and the Travelers Umbrella are registered trademarks of The Travelers Indemnity Company in the U.S. and other countries.

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Logo, Travelers. Text: In the Know with Jennifer Ampulski. The Risks of AI.

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Hi, I’m Jennifer Ampulski, Travelers Life Sciences Practice Lead, with a video series designed to help guide pharma companies like yours transition from clinical trials to commercialization. Let’s assume your drug has been in the market for some time now and is doing well. What’s next?

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Text: Artificial Intelligence.

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One of the hottest topics demanding attention these days is artificial intelligence. It’s poised to change our world, and certainly the life sciences industry is no exception.

We know AI will impact pharmaceutical R&D with applications for drug design, drug screening and more, but how will AI impact drug commercialization?

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Text: The Impact of AI on Drug Commercialization.

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AI applications in pharmaceutical manufacturing include product quality monitoring. Also, AI for postmarket surveillance can help identify off-label use and unexpected side effects. All this promises great potential, but with it comes risk.

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Text: The Risks of AI. Potential Cyberattack and Data Contamination.

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For example, a cyberattack could corrupt data used by an AI system, causing the information generated to be incorrect, a situation that could put patients at risk.

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Text: Potential Failure to Warn Lawsuit.

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It could also create false information about your drug’s safety and efficacy, risking a failure to warn lawsuit.

Travelers understands the unique risks you face. We have a wide range of capabilities for pharma companies to help you manage the exposures of AI, including life science specialists and cyber coverage to help protect your business from the potential for increased risk due to AI.

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Text: Life Science Specialists. Cyber Coverage.

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Count on us to be with you as you grow every step of the way. To learn more about Travelers capabilities for life sciences, talk to your independent agent or visit travelers.com/lifesciences.

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Logo, Travelers. Text: To learn more about Travelers capabilities, talk to your independent agent, or visit travelers dot com slash life sciences. The Travelers Indemnity Company and its property casualty affiliates. One Tower Square, Hartford CT, 06183. This material does not amend, or otherwise affect, the provisions or coverages of any insurance policy or bond issued by Travelers. It is not a representation that coverage does or does not exist for any particular claim or loss under any such policy or bond. Coverage depends on the facts and circumstances involved in the claim or loss, all applicable policy or bond provisions, and any other applicable law. Availability of coverage referenced in this material can depend on underwriting qualifications and state regulations. Copyright 2023 The Travelers Indemnity Company. Travelers and the Travelers Umbrella are registered trademarks of The Travelers Indemnity Company in the U.S. and other countries.