David Simmons. PPD via YouTube

What are bio­phar­ma com­pa­nies hir­ing CROs for these days? PPD spells it out in bid for $100M IPO

More than eight years af­ter PPD was tak­en pri­vate in a $3.9 bil­lion deal, the 35-years-old con­tract re­search or­ga­ni­za­tion is brac­ing for the pub­lic mar­ket again with a $100 mil­lion ask.

Hav­ing served all of the top 50 bio­phar­ma com­pa­nies in the world by R&D spend­ing and over 300 biotech fledg­lings, PPD’s fil­ings high­light­ed the en­trenched role CROs play in an in­dus­try chas­ing an ever dwin­dling re­turn on in­vest­ment by push­ing for faster time­lines and tack­ling pay­er re­sis­tance to pricey ther­a­pies.

PPD high­light­ed five key trends that it be­lieves will dri­ve high­er de­mand for its ser­vices:

  • Growth in R&D spend­ing: Be­tween 2008 to 2018, R&D bud­gets rose around 3.3% an­nu­al­ly, PPD reck­oned;
  • In­creased lev­els of out­sourc­ing: “Out­sourc­ing pen­e­tra­tion as a per­cent­age of to­tal de­vel­op­ment spend­ing by bio­phar­ma­ceu­ti­cal com­pa­nies in­creased from ap­prox­i­mate­ly 36% in 2007 to ap­prox­i­mate­ly 49% in 2018”;
  • In­creased com­plex­i­ty in clin­i­cal de­vel­op­ment: New ther­a­peu­tic modal­i­ties, more tar­get­ed drug de­vel­op­ment and new reg­u­la­to­ry re­quire­ments have made clin­i­cal tri­als hard­er to de­sign and re­cruit — high­light­ing the need for ex­perts;
  • Biotech­nol­o­gy sec­tor growth: With over $150 bil­lion of cap­i­tal raised for biotech com­pa­nies in the last three years, there’s plen­ty of fu­el for new play­ers to car­ry on their R&D projects;
  • In­creas­ing im­por­tance to prove val­ue of new ther­a­pies: Re­al-world ev­i­dence is be­com­ing more cen­tral to every drug pro­gram.

It is of course not the on­ly play­er cap­i­tal­iz­ing on this de­mand. On the clin­i­cal de­vel­op­ment side, which ac­counts for rough­ly 80% of its rev­enue, it list­ed IQVIA, ICON, Parex­el, PRA Health Sci­ences, Lab­Corp (Co­v­ance busi­ness), Sy­neos Health and Med­Pace as its ma­jor com­peti­tors. As for lab­o­ra­to­ry ser­vices, Lab­Corp, Sy­neos, Q2 So­lu­tions, ICON, Eu­rofins Sci­en­tif­ic, WuXi AppTec, BioAg­i­lytix and SGS were cit­ed as chief ri­vals.

Christo­pher Scul­ly

Un­like the drug de­vel­op­ers PPD serves, its IPO is not de­signed to fund any ex­pan­sion in ser­vices or ca­pa­bil­i­ties — its rev­enue, which neared $3 bil­lion by Sep­tem­ber of 2019, got it cov­ered — but to re­deem bonds is­sued as part of a re­cap­i­tal­iza­tion en­gi­neered by its biggest pri­vate eq­ui­ty back­ers in 2017.

Hell­man & Fried­man and the Car­lyle Group, the two play­ers re­spon­si­ble for tak­ing PPD off the Nas­daq in 2011, re­main the largest stock­hold­ers. The for­mer holds the li­on’s share at 56.7%, while the lat­ter kept 23.8%. Af­ter jump­ing on board in the 2017 re­cap­i­tal­iza­tion, Blue Spec­trum and GIC — in­vest­ing on be­half of Sin­ga­pore and Abu Dhabi, re­spec­tive­ly — each claimed 9.2% of the stock, to be back on the Nas­daq as $PPD

David Sim­mons, the Pfiz­er vet who took PPD’s helm in 2012, is in for 1.1%. His com­pen­sa­tion pack­age for 2019 to­taled $6.2 mil­lion, dou­ble that of 2018, most­ly thanks to op­tion awards. Fel­low Pfiz­er alum and CFO Christo­pher Scul­ly got $1.2 mil­lion while COO William Shar­baugh re­ceived $1.7 mil­lion.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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