Pharma Can Meet Cancer Patients’ and Oncologists’ Unique COVID-19 Needs

Posted by Jon Roffman on Mar 25, 2020 10:30:20 AM

Prashant Poddar co-wrote this blog post with Jon Roffman.

As the SARS-CoV-2 pandemic rages on, questions remain about how the virus is transmitted between people, how quickly it spreads and how contagious it is. But one thing is certain: The elderly and immunosuppressed patient populations, including those with cancer, are among the most at risk.

These patients need oncology manufacturers, healthcare providers and other stakeholders to ensure that they have continued access to care while minimizing exposure to the virus. Together, we can play a critical role in helping to improve and extend the lives of oncology patients. This should be our central focus today, knowing that it likely will change the way that we approach tomorrow and beyond.


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Assessing the Next Wave of Oncology First Launches

Posted by Ben Hohn on Jul 2, 2019 11:39:30 AM

Judith Kulich, Jon Roffman, Cody Powers and Renuka Agarwal co-wrote this blog post with Ben Hohn.

The 2019 BIO International Conference, held June 3-6 in Philadelphia, attracted more than 16,000 attendees from more than 70 countries, with representation from biotechnology and pharmaceutical companies, academic institutions, regulators, investors and other organizations. The conference provided a platform for discovery and discussion, resulting in more than 41,000 partnering meetings.


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‘Me Too’ or Breakthrough? Exploring the Oncology Cell Therapy Pipeline

Posted by Katie Blodgett on Jun 26, 2019 8:00:00 AM

Last year, the American Society of Clinical Oncology (ASCO) designated adoptive cell immunotherapy the 2018 clinical cancer “advance of the year” following the 2017 FDA approvals of Kymriah (Novartis) and Yescarta (Kite, a Gilead company). In the year since, we have seen some incremental, notable approvals in the cell and gene therapy space, but we have yet to see additional cell therapy approvals in oncology. However, like a duck sailing smoothly across the water, the relative inactivity above the surface conceals a flurry of development activity taking place below the surface in the oncology pipeline.


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Oncology M&A: Achieving Better Outcomes?

Posted by Arup Das on Jun 4, 2019 8:00:00 AM

Pranav Srivastava co-wrote this blog post with Arup Das.

Merger and acquisition (M&A) activity for the oncology, pharma and biotech sector is off to a blistering start in 2019. Three huge deals announced in the first two months of the year have set the pace for what could be a record-breaking year: 


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Pedal to the Metal: Assessing the FDA’s Real-Time Oncology Review Program

Posted by Matt Furlow on Apr 24, 2019 8:00:00 AM

Sharon Karlsberg and Manna Fujiu co-authored this post with Matt Furlow.

The FDA review process for oncology therapeutics is necessarily rigorous, but during that process cancer patients may be waiting to access new therapies—a matter of life or death in some cases. The FDA has been attempting to accelerate time to approval for oncology therapeutics for the past several years with accelerated approval, priority review, breakthrough designation and other programs and designations (table 1). Recently, the FDA’s Oncology Center of Excellence launched a pilot program for oncology therapeutics called Real-Time Oncology Review (RTOR). Under this program, manufacturers can submit analyses of their clinical data to the FDA as they become available but before a formal supplemental new drug application or supplemental biologics license application is submitted. After submission, the drug can potentially be approved in a matter of weeks or even days.


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