at applications, but these events are
almost impossible to predict.
A longer-term question is what
this trend means for the quality of
the medicines reaching the market. “A lot of this bull market has
been driven by a super-permissive
FDA. This has emboldened risk-taking by both biotech companies
and investors,” one investor, who
preferred not to be named, told
Perhaps growing payer pushback is
another sign that the approval bar
has been lowered. The FDA would
argue that its primary function is
to ensure that new medicines are
safe, but some counter that this
priority is being marginalized in
the push to get new drugs to patients at an ever-faster pace.
It is undeniable that industry has
unashamedly been using expedited
pathways to get faster access to
revenue streams, and FDA approvals based on surrogate endpoints
have been growing.
THE NEW NORMAL?
Biopharma headed into 2019 on a
decidedly downbeat footing. But
despite the ongoing stock market
volatility and risk of a rise in drug
price rhetoric in the US, many are
maintaining an optimistic stance.
“Macro concerns keep us on our
toes. In this environment we have
to adjust. Science is progressing at
an exponential rate, and there are
a lot of positives to be found,” says
Nextech’s Mr. Schroeder.
Mr. Loncar agrees. “Biotech goes
through peaks and valleys, and
we’ve been in a pretty rough valley
for the last six months or so. But
the thing about our sector is that
one piece of good news can turn it
all around,” he says.
At the end of the day, biopharma
thrives or dies by the advances
being made. “People need to see
[investors] who look so much at
issues like drug pricing,” Mizuho’s
Mr. Syed says.
It seems highly unlikely that rising
stock market tides will buoy the
life science sector in 2019. Innovation needs to be delivered. Over to
you, biopharma. •