Using Novel Endpoints to Transform Oncology Clinical Trials

Posted by Malik Kaman on Jun 28, 2018 8:00:00 AM

Joshua Hattem and Matt Furlow co-authored this post with Malik Kaman.

To match the rapid changes occurring in cancer therapy development, oncology clinical trials are making a few changes of their own. As contemporary clinical trials break with tradition by infusing new, or different, outcome measures to better assess clinical efficacy, the results are encouraging: Single-arm phase I/II trials are gaining accelerated approvals using overall response rate (ORR) and duration of response (DoR) as proxies for survival and 72% of the oncology treatments reviewed by the FDA since 2006 gained approval based on response rate and progression-free survival endpoints.


>
Read More

Behind the Consultant Curtain: Leveraging Your Segment’s Strengths

Posted by Malik Kaman on Jan 8, 2018 8:00:00 AM

Maria Whitman and Sankalp Sethi co-wrote this blog post with Malik Kaman. This blog post is part two in a two-part series.

In our previous post, we discussed the four typical “segments” of oncology companies:

  1. Original Innovators: High prior oncology success, low commercial sophistication
  2. The Space Invaders: Low prior oncology success, high commercial sophistication
  3. The New Kids on the Block: Low prior oncology success, low commercial sophistication
  4. The Vanguard: High prior oncology success, high commercial sophistication

>
Read More

Behind the Consultant Curtain: What Kind of Oncology Company Are You?

Posted by Malik Kaman on Dec 12, 2017 2:21:03 PM

Maria Whitman and Sankalp Sethi co-wrote this blog post with Malik Kaman. This blog post is part one in a two-part series.

At ZS, we’ve advised companies on more than 90% of the launches in oncology over the past five years, so manufacturers frequently ask us how they compare to others in terms of their people, their processes and their capabilities. This is a great question. With the pace of oncology investment worldwide—oncology is expected to be 21.25% of total pharma sales in 2020 globally, according to a Quintiles analysis—the level of competition in this space has risen to a whole new level. As we think about what it will take to compete and win in the new reality, it’s important to consider the commercial advantages and disadvantages of who you are as a company—your people, processes and capabilities—not just what scientific innovations you can bring.


>
Read More

Improving Drug Development: A Call to Action

Posted by Malik Kaman on Nov 9, 2017 9:39:46 AM

Joe Keller, Chris Crabtree and Sarah Jegasothy co-wrote this article with Malik Kaman. 

If you’ve missed the transformation of the oncology therapeutic landscape over the past five years, you’ve had your head in the sand. While many recent advancements are hugely beneficial, one result of this tidal wave of investment is that some new drugs offer only marginal improvements yet command outrageous price tags. This is a controversial issue and should give everyone in oncology pause. 


>
Read More

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? 


>
Read More