Why You Need to Start Thinking About Meaningful Differentiation Much Earlier

Posted by Emily Mandell on Mon, Jul 01, 2019

Josh Hattem co-wrote this blog post with Emily Mandell.

“That's the problem with the American dream: It makes everyone concerned for the day they're gonna be rich.”

–President Bartlett, The West Wing

Pharma companies may have a winning asset, a winning development plan and an important disease target with unmet needs, but only one product can be first to market, only one can be the most efficacious and only one will become the standard of care. If your asset is entering a disease area with similar efficacy to an established standard of care, or if your asset is one of multiple products in a class entering within one to two years of one another, it’s critical to have a clear understanding of what it will take to meaningfully differentiate, and to do this early enough—in phase I or II—so there's enough time to correct the development plan.

Read More

Intelligent Process Automation: Starting Is Easy, Scaling Is a Different Ball Game

Posted by Vishal Kabra on Thu, May 09, 2019

Satish Jha co-wrote this blog post with Vishal Kabra 

Today, there is no denying that when it comes to increasing efficiency, reducing cost and offering a better customer experience, intelligent process automation (IPA) is a go-to strategy for businesses, and pharma is no exception. IPA promises that it can free up people to do more value-added work and play more strategic roles within their organizations. At a fundamental level, IPA is an emerging set of new technologies that include robotic process automation (RPA), conversational AI and machine learning to mimic activities carried out by humans. With the evolution in IPA technologies and the broad applicability of such automation, IPA continues to be a buzzword in every industry. Given the many benefits and possibilities, it’s understandable why organizations are jumping onto the IPA bandwagon.

However, most organizations aren’t succeeding at scaling intelligent process automation.

Read More

A New Delivery System for Next-Generation Cell and Gene Therapies

Posted by Maria Whitman on Thu, Apr 25, 2019

Kris Elverum of Turnstone Biologics co-wrote this blog post with Maria Whitman.

The evolution of medicines from small molecules to proteins has greatly advanced patient care, and up until now, our system of therapeutic delivery in the U.S. commercial system has been built with these therapeutics in mind. The next generation of cellular and gene therapies holds tremendous promise for patients, but only if the existing delivery system is revamped. There’s a real risk that most patients won’t benefit from these therapies as stakeholders struggle to find successful business models. In a recent article for Nature’s Gene Therapy, my industry colleague, Kris Elverum, and I take a critical look at the U.S. system and outline what needs to change to make approved cell and gene therapies accessible to patients.

Read More

The Growing Challenge of Product Differentiation

Posted by Emily Mandell on Wed, Apr 17, 2019

Joshua Hattem co-wrote this blog post with Emily Mandell.

The pharma industry faces a growing problem: The return on development investment is declining. The industry is compensating by pivoting to the next disease area (such as NASH) and technological frontiers (like cell and gene therapy). Pharma leaders may be disappointed if they believe that they can fix the problem by simply adding products to their pipeline that target these future opportunities. Take Gilead, which recently had to write down $820 million of its Kite Pharma acquisition as it cut Kite’s leading cell therapy for multiple myeloma. According to FierceBiotech, this decision to terminate the CAR-T’s clinical development “reflects the increasing competition in the anti-BCMA category.”

Read More

Advancements in Data Science and Big Data Technologies Will Change the Way Clinical Decisions Are Made Today

Posted by Venkat Sethuraman on Wed, Apr 03, 2019

Venkat Sethuraman co-wrote this post with Jessica Rine, Sharma R D and Francine Leech

The 10th-annual Summit for Clinical Operations Executives (SCOPE) took place Feb. 18-21 in Orlando, and it drew more than 3,000 participants from life sciences companies around the world. The conference covered advanced and innovative solutions in clinical trial planning, management and operations.

While the attendees represented different functional areas within clinical operations, they were united around a common question: How can data be used to bring value, provide actionable insights and enhance the clinical trial process?

Read More