Pharma USA (formerly eyeforpharma Philadelphia)

May 25, 2021 - Jun 4, 2021, Digital Conference, Networking and Exhibition

North America’s premier gathering for pharma pioneers and health innovators

How US pharma is charting a new course in a changed world

Post-Trump and post pandemic, pharma in the US is eyeing emerging commercial and clinical opportunities, but must reckon with potential storms ahead



With a new administration now in place and the many effects of the pandemic to reflect on, it looks like pharma in the US stands on the cusp of a new era. 
 
The fall of barriers to remote health care is just one outcome from the destruction, creative and otherwise, arising from the pandemic. Innovation in supply chains, manufacturing paradigms and regulatory processes has been forged in the heat of crisis. 
 
New therapeutic and commercial opportunities beckon, along with smarter ways of running trials. 
 
Leaders who had been slogging to drive innovation forward at scale pre-pandemic, now find the wind at their back as everyone recognises the need for, and possibility of, change.
 
But the industry must also keep a weather eye out for squalls ahead. Future funding constraints, political posturing and a poor standing with the public all loom menacingly in the offing.
 
The sense of change is profound and wide ranging. “COVID has reinvented the pathways to digital communication and digital engagement by all kinds of regulatory barriers going down and access to data [that] really allow you to reinvent commercial models,” says Jim Lang, CEO of Eversana.
 
Help in the void
A range of patient needs are ripe for addressing in the aftermath of lockdowns that have caused waistlines to expand and mental health to fray. “There is a void in disease areas where there are large patient populations that are suffering. Just think about obesity. Over 600 million people in the world are clinically obese without really good therapeutics that can help them manage their disease,” says Lang.
 
“Substance use disorder is another big area. There are over 20 million Americans that have some kind of substance use disorder, whether it's alcohol or cocaine or opioids, without a lot of good therapies. There's a big opportunity in large patient population disease areas that are not getting addressed.”
 
Additionally, the pandemic has demonstrated a new model for how pharma and government can work together to drive future innovation, adds Lang. “The partnerships that you're starting to see now between government and the industry hopefully will not go away after this crisis is over. It's led to unbelievable levels of of partnerships to bring therapies and vaccines to market faster than anybody thought possible.”
 
This is also looking like a new era for research innovation thanks to new tools that pharma is finally starting to apply with great effect, says Lang. “R&D is exploding partly because of advanced analytics and the ability to target drugs like we've never been able to target them before. And that's going to continue. So there's going to be more discovery in research, I believe, over the next five years than any company can develop.
 
“I think we're now entering a digital age where drug development can be completely rethought. There are companies out there that are changing the way that drugs are developed, faster [and at] lower cost. Look at the ability to do risk-based monitoring to change the way we develop drugs, that uses information and data in ways that 10 years ago we weren't able to do. The tools are out there.”
 
Harnessing technology
Clinical trials are a critical area of focus for both pharma and regulators alike, agrees Kathleen Sebelius, Former United States Secretary of Health and Human Services. “We have to rethink clinical trials. They are too cumbersome, too costly and too slow. 
 
“The clinical trial structure is outmoded, outdated and doesn't use the advantages of technology, of artificial intelligence, of large patient groups that you can tap into. I think the the tie between manufacturing and clinical trials could go a lot faster and you could sherpa people through the FDA system, but have the payer at the table almost simultaneously.”
 
There is much to be excited about then. 
 
But realising all this potential requires changing the Byzantine world of US insurance, says Lang. “We're going to have to do some sort of industry insurance reform or underwriting for these kinds of products. You couldn't have designed a worse system, where the effect on the population and its cost benefit is completely disconnected from who pays in a majority of circumstances.
 
“Opening up insurance may [involve]…underwriting a safety net above a certain cost. There has to be some drastic things happen, which the  industry has to do in partnership with government and other industry players to improve that agency disconnect we have right now.”
 
Such reform is essential, says Kabir Nath, Senior Managing Director, Global Pharmaceutical Business, Otsuka Pharmaceutical Co. “There is an opportunity to realign some of the fundamentally misaligned incentives with all the different players within the health care ecosystem, which is, as we know, chaotic, dysfunctional and beset by misaligned incentives between the industry, between CDMs, between providers and so on.”
 
This is also a precious moment in which pharma can reboot its outmoded commercial model, adds Nath. “We've got to have the courage to start testing. Some of the leaders in the industry are starting to do that. Companies like Genentech have done a radical transformation of how they go to market. We’ve got to to bring the disciplines from tech, to fail fast . As an industry, we've had a chronic failure to scale up and to stop doing things that don't work.”
 
Shifting the conversation 
Pharma must address its failures in the sphere of public sentiment too, where political as well as consumer attitudes have the potential to turn even more hostile than they already are in some quarters. “There's a growing sentiment that the prices American consumers pay are unsustainable,” says Sebelius. 
 
“And I think the political focus in the United States is too often on the end point, the price point, which definitely needs attention, but not enough on the whole pipeline. And that absolutely needs attention and can bring down the price point at the end of the day.”
 
The industry has an opportunity to shift the conversation by broadening the focus away solely from the cost of medications and to make the case for the value of the therapies it provides far more robustly, says Joe Jimenez, Ex-Novartis CEO, and CEO & Co-Founder, Aditum Bio.
 
“It's the pharmaceutical industry's responsibility to show how their drug can lower total costs through the system, whether it's reducing hospitalization or whether it is reducing other health care costs and comorbidities that lead to ever increasing budgets. If the industry focuses on that, I think I think that's going to result in better launch success in the next few years.”
 
Public perceptions of pharma’s arguably skewed priorities matter here too, adds Sebelius. “There is a recognition that advertising drugs that have to be prescribed has overtaken even some of the R&D spend that the pharma companies have. And that seems to be totally out of place and out of sync and often drives providers’ prescribing patterns in a way that isn't particularly patient centered or helpful.”
 
For Sebelius this ultimately gets in the way of the more positive story that pharma should be telling. “You’re creating life changing differences in people, giving people a whole different life expectation. And that isn't nearly as well known as it should be at the end of the day.” 

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Pharma USA (formerly eyeforpharma Philadelphia)

May 25, 2021 - Jun 4, 2021, Digital Conference, Networking and Exhibition

North America’s premier gathering for pharma pioneers and health innovators