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The Active Ingredient features expert insights and commentary from leaders of ZS Associates' global pharmaceuticals practice.

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What It’ll Take to Follow in Gottlieb’s Footsteps: Protect, Innovate and Scale

Posted by Pratap Khedkar on Thu, Mar 21, 2019

Matt Furlow co-wrote this blog post with Pratap Khedkar.

Scott Gottlieb’s nearly two-year stint as commissioner of the FDA is coming to an end, and with the ink on his resignation letter barely dry, Norman Sharpless was appointed acting head. Gottlieb is a tough act for the former director of the National Cancer Institute to follow, even temporarily. Gottlieb brought welcome change to the agency and excelled across three ideal FDA leader focus areas—to protect, innovate and scale up—when historically, the agency’s focus had been heavily skewed to protect, was slow to innovate and was cautious to scale up.

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Topics: generics, Pratap Khedkar, Biosimilars, pharma manufacturer, regulatory, Scott Gottlieb, FDA Commissioner, product approvals

Our Drug Rebate Prediction Is Coming True: Now Can We Turn Our Attention to the Value of Drugs?

Posted by Pratap Khedkar on Tue, Feb 12, 2019

We predicted last year that prescription drug rebates’ days could be numbered as more healthcare stakeholders clamor for price transparency. Judging by the new rule proposed by Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson, this has now come to pass. The proposal aims to wipe out the behind-the-scenes negotiation tool—which has been linked to a growing discrepancy between a drug’s list and net prices—and instead share the savings directly with Medicare patients. 

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Topics: Medicare, Bill Coyle, Pratap Khedkar, Howard Deutsch, price transparency, product value, pharma drug pricing, drug rebates, value discussion

Even in a Favorable Regulatory Environment, Will Biosimilars Gain Traction in the US This Year?

Posted by Pratap Khedkar on Fri, Jan 25, 2019

Christina Corridon co-wrote this blog post with Pratap Khedkar.

Despite 16 approvals in the last four years, just six biosimilars currently are being marketed stateside. The U.S. biosimilars market hasn’t progressed as anticipated, yet some experts are wondering whether the biologic follow-ons can redeem themselves with a breakout year in 2019.

The U.S. biosimilars market has a tough road ahead. The WAC list price differential between biosimilars and the originator drugs is hovering around 30%, on average, which likely isn’t speeding biosimilars’ adoption in the U.S. Rather than playing the long game and waiting for the U.S. landscape to become more attractive, some biosimilar manufacturers like Momenta are choosing to exit the market. And others like Pfizer have shuttered their preclinical biosimilar programs to focus their efforts elsewhere. On the flip side, the Trump administration has zeroed in on drug pricing and biosimilars as priorities—and, of course, the two are intertwined.

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Topics: Pratap Khedkar, Patients, payers, Christina Corridon, FDA, providers, european market, Biosimilars Action Plan, pharma drug pricing, U.S. market

Physicians, Payers and Patients Want Evidence, and Med Affairs Knows How to Deliver

Posted by Pratap Khedkar on Wed, Jan 16, 2019

As the pharmaceutical industry continues to stack up scientific breakthroughs, there’s a growing need for experts within pharma organizations who can articulate deep disease knowledge, link clinical results to outcomes, and demonstrate product value. As luck would have it, a small department that’s well suited to the task has steadily been building its capabilities and expanding its reach into new areas. Medical affairs, once a little-known entity, is making its mark on the industry, but if leveraged properly, its impact could be even greater.

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Topics: Pratap Khedkar, healthcare ecosystem, Sarah Jarvis, medical science liaisons, clinical evidence, collaboration, drug development and commercial, medical affairs, communicate scientific complexity

Pharma’s Commercial Resource Redesign: Managing Timelines and Expectations

Posted by Pratap Khedkar on Wed, Dec 05, 2018

This is the final post in a three-part series on commercial resource planning.

As pharma companies begin to think about reorganizing and deploying their commercial resources to better align with changing customers and an evolving healthcare landscape, their strategy for transforming commercial resource planning can’t be piecemeal, but their approach to implementing the change likely should be. It’s going to take time to develop the right customized approach to suit your company’s specific needs and challenges, and to get buy-in. Data and technology will carry some of the weight, as will coordinating internal processes and roles, and adopting an on-demand, customer-specific mindset.

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Topics: Jude Konzelmann, Pratap Khedkar, change management, commercial resource planning, pharma roles and resources, internal and external coordination

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