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First Line features insights and commentary from ZS Oncology experts.

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Five Observations From Successful Oncology ‘First Launches’

Posted by Ben Hohn on Aug 14, 2017 10:29:32 AM

Nicholas Martinez and Cody Powers co-wrote this blog post with Ben Hohn.

The stakes are high when preparing to launch a new drug, but for a biopharmaceutical company staring down its first-ever oncology launch, the stakes are even higher. Drug launches in the oncology space have grown increasingly competitive and occur more frequently than in any other therapeutic category. And of the 202 novel drugs approved by the FDA from 2011 to 2016, five were oncology drugs launched in the U.S. by publicly traded newcomers—so-called “first launches.”  

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Topics: go-to-market (GTM), Innovation, oncology, Pharma, Pharmaceutical Companies, FDA, biopharmaceuticals, reinvent go-to-market strategy, oncology first launch, oncology launch, 2017 Bio International Convention, oncology partnerships

A Gut Check on the Role of Microbiome in Cancer

Posted by Pranav Srivastava on Jul 26, 2017 11:16:51 AM

Matt Furlow co-authored this post with Pranav Srivastava.

In the novel A Wind in the Door by Madeleine L’Engle, the main character’s younger brother gets sick when fictional symbiotic entities within his mitochondria called farandolae fail to work together to prevent illness. My co-author and I were reminded of that story as we looked for parallels for the symbiotic nature of gut flora and the notion that the gut microbiome can have significant implications on health—a promising area of research that should be on the radar of oncology companies looking to expand their portfolios.

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Topics: oncology, Investment, Health, cancer, oncology manufacturer, cancer research, cancer therapy, fecal transplant, gut microbiome, gut flora

Oncology Biosimilars Outlook: How Key Stakeholders Can Plan for Change

Posted by ZS Editors on Jul 24, 2017 1:04:28 PM

With the oncology biosimilars market poised for expansion, ZS launched an effort to survey the landscape. Our 2017 Biosimilar Adoption Study polled 252 respondents—including 200 oncologists, 25 payers and 27 pharmacy directors—and the results provide a perspective on market perceptions and other factors that could drive or restrict oncology biosimilars’ adoption. 

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Topics: oncology, Biosimilars, change management, Christina Corridon, manufacturers, value-based care, biologics, stakeholders, pavan anne

Accelerating Real-World Evidence to Advance the Trial Landscape

Posted by Maria Whitman on Jul 19, 2017 9:42:04 AM

Mimi Traylor-Knowles co-wrote this blog post with Maria Whitman.

At the 2017 Annual Society of Clinical Oncology Annual Meeting (ASCO), Dr. Sean Khozin, senior medical officer at the FDA, opened his Saturday session with some trivia: When was the first controlled clinical trial? The answer, which surprised many of my fellow attendees, was 1747, when James Lind held a trial to determine if citrus juice would help control the symptoms of scurvy. Dr. Khozin then showed a timeline to demonstrate the history of controlled clinical trials. He concluded his session with a single but poignant visual: a flat line stretching more than 250 years from then until now. As the world has made historic progress in innovation—from steam locomotives to a man on the moon to the internet and all that we have today—controlled clinical trials have remained largely the same. 

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Topics: oncology, Maria Whitman, FDA, clinical trials, patient centricity, RWE, Dr. Yousuf Zafar, Mimi Traylor-Knowles, Annual Society of Clinical Oncology, real-world evidence, ASCO 2017, individualized medicine, randomized clinical trials, CancerLinQ

Beyond PD-L1: In Search of Better Biomarkers

Posted by Sharon Karlsberg on Jul 14, 2017 8:00:00 AM

Tyler Vogt co-wrote this blog post with Sharon Karlsberg. 

Since their first approval in 2014, PD-L1 and PD-1 checkpoint inhibitors have become the backbone therapy in multiple tumor types: melanoma, bladder cancer and non-small-cell lung cancer (NSCLC). Although only 20 to 35% of patients respond to these therapies, approvals in melanoma, bladder cancer and second-line lung cancer didn’t require an associated diagnostic test for PD-L1 status. Until the failure of BMS’s CheckMate-026 trial in first-line NSCLC, oncologists were asking the question, “Should I test for PD-L1?”

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Topics: oncology, ASCO, immunotherapy, ASCO 2017, cancer research, biomarkers, checkpoint inhibitors, mutational load, PD-L1, Suzanne Topalian

Real-World Evidence Today and Tomorrow: The Role of Key Stakeholders

Posted by Maria Whitman on Jul 13, 2017 10:59:32 AM

Mimi Traylor-Knowles co-wrote this blog post with Maria Whitman.

Thomas Edison said: “There is a way to do it better. Find it.” Real-world evidence is a tool to help us do just that.

The theme at this year’s American Society of Clinical Oncology (ASCO) 2017 Annual Meeting (ASCO) was "Making a Difference in Cancer Care With YOU," which highlights the importance of everyone's involvement in improving care for patients with cancer. This theme also reminds us that improving care is part innovation and part application of what we have to do better.

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Topics: oncology, Maria Whitman, ASCO, healthcare partnerships, patient centricity, RWE, Dr. Yousuf Zafar, Mimi Traylor-Knowles, real-world evidence, ASCO 2017, individualized medicine

Real-World Evidence as a Mechanism for Patient-Centric and Individualized Care

Posted by Maria Whitman on Jul 10, 2017 2:31:47 PM

Mimi Traylor-Knowles contributed to this blog post.

Recently, I sat in the audience of an oncology congress and heard a patient survivor and advocate describe critical transitions in his experience living with cancer: At diagnosis, he went from a “person” to a “patient,” and during clinical trial enrollment, he went from a “patient” to a “subject.” 

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Topics: ZS Associates, ZS, Maria Whitman, ASCO, personalized medicine, patient centricity, RWE, Dr. Yousuf Zafar, Mimi Traylor-Knowles, Annual Society of Clinical Oncology, real-world evidence, ASCO 2017

The New Oncology Launch Environment

Posted by Sarah Hamilton on Apr 12, 2017 10:53:55 AM

Dave Cohen co-authored this blog post with Sarah Hamilton. 

With more than 650 new agents in development, oncology has been center stage for many pharmaceutical companies in recent years. Although unmet need remains high for many tumor types, this sizeable pipeline investment is expected to bring tremendous new promise to patients as drugs start hitting the market. Along with that promise, we suspect that it also will bring several commercial challenges for companies that are seeking to successfully launch an oncology asset into this new environment. 

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Topics: go-to-market strategy, ZS Associates, ZS, oncology, pharmaceuticals, Dave Cohen, continuous launch, Sarah Hamilton, always be launching

Showdown at the ‘IO’ Corral

Posted by Malik Kaman on Apr 5, 2017 9:00:00 AM

Checkpoint inhibitors (CPIs) and chimeric antigen receptors (CAR-Ts) have transformed the field of cancer immunotherapy over the past five years. So far, these therapeutic approaches have operated in mutually exclusive landscapes with CPIs focusing on solid tumors and CAR-Ts focusing on hematologic malignancies, but now they’re entering each other’s spaces. As PD-1/L1 therapies enter hematology, and as CAR-Ts expand into solid tumors, should we expect a showdown at the immuno-oncology corral? 

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Topics: ZS Associates, ZS, oncology, cancer, Malik Kaman, CAR-T, immunotherapy, immuno-oncology, CPI

For Triple-Negative Breast Cancer, Success Starts With Patient Centricity

Posted by David Kriesman on Mar 29, 2017 9:23:46 AM

Matt Furlow co-authored this post with David Kriesman.

With its lack of readily identifiable, actionable targets, treatment for triple-negative breast cancer (TNBC) has been limited for decades to chemotherapy, radiation and surgery (when possible). At the same time, targeted treatment for other forms of breast cancer has advanced significantly. Women diagnosed with TNBC quickly come to realize that they’ve drawn the proverbial short straw. Feeling hopeless after recurrence is a common theme that reverberates on patient forums. Many women describe their cancer as the “hardest diagnosis” and acknowledge that “no other treatments” are available to them should their cancer return.

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