Cir­ca 2016, Chi­na se­cured its sta­tus as the sec­ond-biggest mar­ket for pre­scrip­tion drugs. The soar­ing de­mand for med­i­cines has fu­eled the re­turn of key sci­en­tif­ic tal­ent, the ap­petite for spend­ing on drug re­search and de­vel­op­ment, while Chi­na’s cost ad­van­tage has lured multi­na­tion­al phar­ma­ceu­ti­cal mak­ers to set up R&D shops in the re­gion and stim­u­lat­ed the do­mes­tic CRO in­dus­try. In 2007, a for­mer Quin­tiles (now IQVIA) ex­ec­u­tive set up his own CRO in Chi­na — Foun­tain Med­ical De­vel­op­ment Lim­it­ed (FMD) — and on Fri­day, the com­pa­ny un­veiled a $62 mil­lion Se­ries D round of fi­nanc­ing.

Dan Zhang

The com­pa­ny, set up by Dan Zhang, orig­i­nal­ly tar­get­ed a niche mar­ket that has been ne­glect­ed by both glob­al and lo­cal CROs. Glob­al CROs cater large­ly to multi­na­tion­al phar­ma­ceu­ti­cal mak­ers, as lo­cal phar­ma play­ers are of­ten priced out of their ser­vices. Mean­while, do­mes­tic CROs fo­cus on serv­ing lo­cal drug de­vel­op­ers, since they are not usu­al­ly equipped with the re­sources re­quired to con­duct in­ter­na­tion­al mul­ti­cen­ter tri­als.

FMD was cre­at­ed to “an­swer the needs of in­no­v­a­tive, sin­gle com­pound com­pa­nies en­ter­ing the clin­i­cal stage. They are main­ly lo­cal and in­ter­na­tion­al start-ups that are not ful­ly es­tab­lished yet so most of their fi­nanc­ing comes from the gov­ern­ment or grants. Nor­mal­ly, they would be look­ing to start Phase I clin­i­cal tri­als,” Zhang said in an in­ter­view ear­li­er this year with C-suite pub­li­ca­tion PharmaBoard­room.

The CRO in­dus­try in Chi­na — which in­cludes glob­al play­ers such as IQVIA, Lab­Corp and Parex­el and do­mes­tic out­fits in­clud­ing Wuxi AppTec, Phar­maron, and Mei­di­cilon — was worth about $9.7 bil­lion last year, ac­cord­ing to da­ta com­piled by mar­ket re­search com­pa­ny Re­portLink­er, which es­ti­mates that num­ber will climb to rough­ly $34.3 bil­lion by 2025.

In 2017, Chi­na joined the In­ter­na­tion­al Coun­cil for Har­mo­niza­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use (ICH), an or­ga­ni­za­tion that brings to­geth­er reg­u­la­tors of the bio­phar­ma­ceu­ti­cal in­dus­try glob­al­ly to as­sess the sci­en­tif­ic and tech­ni­cal as­pects of drug de­vel­op­ment.

With the stan­dard­iza­tion of clin­i­cal re­search in Chi­na through ICH, FMD is now fo­cused on at­tract­ing bio­phar­ma play­ers — in­clud­ing the small­er sin­gle-com­pound biotechs from the Unit­ed States and Eu­rope who pre­vi­ous­ly would have out-li­censed their prod­ucts to multi­na­tion­al phar­ma com­pa­nies or to lo­cal Chi­nese com­pa­nies — to Chi­na.

The new in­jec­tion of funds will en­able “Foun­tain Med­ical to ex­pand and im­prove our ser­vice of­fer­ings to ex­ist­ing glob­al clients, and bet­ter cater to the needs of Chi­nese phar­ma­ceu­ti­cal com­pa­nies with glob­al as­pi­ra­tions as well as multi­na­tion­al com­pa­nies with Chi­na as­pi­ra­tions,” Zhang said in a state­ment on Fri­day.

This round of fi­nanc­ing for FMD — which has more than 1,700 em­ploy­ees world­wide cov­er­ing 55 cities in Chi­na, as well as ma­jor de­liv­ery cen­ters across the Unit­ed States, Eu­rope, Japan, In­dia, and the Philip­pines — was led by Gold­man Sachs, with Lil­ly Asia Ven­tures as co-in­vestor.

Be­fore co-found­ing FMD, Zhang worked with Sig­ma-Tau Re­search as well as Quin­tiles. He is a mem­ber of the grant re­view com­mit­tee for the Na­tion­al Drug De­vel­op­ment Fund of Chi­na and serves as a con­sul­tant for the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA). He is al­so a mem­ber of the ICH E19 Ex­pert Work­ing Group.

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”