Pe­ter Ciriel­lo takes over the reins at Vy­gon USA; Mirum Phar­ma­ceu­ti­cals taps Ian Clements to the role of CFO

Pe­ter Ciriel­lo has climbed to the up­per ech­e­lons of the French med­ical de­vice mak­er Vy­gon Group. He will run the com­pa­ny’s US op­er­a­tions from the com­pa­ny’s head­quar­ters in Penn­syl­va­nia and is al­so tasked with over­see­ing ac­tiv­i­ties at the New Hamp­shire fa­cil­i­ty. Ciriel­lo joined Vy­gon in 2018 and takes over from Les Davies, who served as CEO, Vy­gon UK and VP for the UK/North Amer­i­can re­gion. Ciriel­lo pre­vi­ous­ly served as co-founder and man­ag­ing part­ner at Clear­wa­ter Or­gan­ic Farms.

→ Af­ter re­gain­ing two liv­er dis­ease drugs from Shire and mak­ing its pub­lic de­but with a $67.3 mil­lion IPO, Mirum Phar­ma­ceu­ti­cals has pro­mot­ed SVP, fi­nance of com­mu­ni­ca­tions Ian Clements to CFO. Clements joined the com­pa­ny in May 2019 af­ter a stint as VP of in­vestor re­la­tions at Der­mi­ra. He pre­vi­ous­ly worked with To­bi­ra, Avanir Phar­ma­ceu­ti­cals, Se­quenom and The Trout Group.

Scott Holmes Dis­arm

Dis­arm Ther­a­peu­tics — in­cu­bat­ed out of At­las Ven­ture’s Cam­bridge, MA hatch­ing grounds and led by for­mer CEO of En­zy­vant Alvin Shihhas wel­comed Scott Holmes as CFO. Holmes joins the com­pa­ny af­ter a stint as CFO at Kiadis Phar­ma, where he led the ac­qui­si­tion of Cy­toSen Ther­a­peu­tics. Be­fore that, Holmes served at Keryx Bio­phar­ma­ceu­ti­cals and AM­AG Phar­ma­ceu­ti­cals.

→ Af­ter sign­ing off on €120 mil­lion deal to pur­chase Ex­pe­deon AG‘s pro­teomics and im­munol­o­gy busi­ness last No­vem­ber, Ab­cam has ap­point­ed Michael Bal­dock as CFO and board mem­ber. Bal­dock has tak­en the role af­ter a stint as a found­ing part­ner at On­dra Part­ners, where he ad­vised Ab­cam for sev­er­al years. Bal­dock’s pre­vi­ous­ly worked with HS­BC, Lazard, Bent­ley Health Care, and SG War­burg.

→ Eye-fo­cused Avel­li­no Labs has named Chris Lehman as CFO. Lehman ar­rives at the com­pa­ny as it pre­pares to make its pub­lic de­but on the Ko­re­an stock ex­change. Most re­cent­ly, Lehman served in the same po­si­tion at Eu­re­ka Ther­a­peu­tics. Lehman’s pre­vi­ous ex­pe­ri­ence in­cludes roles at Co­herus Bio­sciences, Quin­tiles and Genen­cor In­ter­na­tion­al (ac­quired by DuPont de Nemours).

→ While prepar­ing for the po­ten­tial ap­proval of their Mul­ti­Stem cell ther­a­py Ather­sys has tapped Ivor Macleod as CFO. Macleod served as CFO and CCO of Ei­sai be­fore mak­ing the leap over to Ather­sys. Pri­or to that, he held roles at Mer­ck, Hoff­man-La Roche, and Boehringer Mannheim Ther­a­peu­tics.

→ Wall Street new­bie BioN­Tech — which ob­tained a €50 mil­lion (around $55 mil­lion) loan from the Eu­ro­pean In­vest­ment Bank last month — has ap­point­ed Ryan Richard­son as CSO and man­ag­ing di­rec­tor. Richard­son joined the com­pa­ny in 2018 as SVP, cor­po­rate de­vel­op­ment & strat­e­gy. Be­fore that, Richard­son was at JP Mor­gan in Lon­don.

→ French life sci­ence VC Sofinno­va Part­ners has pro­mot­ed Michael Krel to part­ner in its in­dus­tri­al biotech­nol­o­gy team. Pre­vi­ous­ly, he served as prin­ci­pal on the team, fo­cus­ing on ear­ly-stage deals in Eu­rope and North Amer­i­ca. Krel joined the com­pa­ny as a se­nior as­so­ciate in 2013.

Rac­quel Brack­en Ven­rock

Ven­rock has pro­mot­ed two mem­bers of their tech team to the po­si­tion of part­ner — Ethan Ba­tras­ki and Rac­quel Brack­en. Ba­tras­ki joined the com­pa­ny in 2017 af­ter stints at Face­book, Box and Ya­hoo! Brack­en hopped over to Ven­rock in 2016,  af­ter serv­ing as CEO of Fed­er­a­tion Bio, lead­ing a Se­ries B round for Cyteir and a stint at Clo­vis On­col­o­gy. In ad­di­tion, the com­pa­ny wel­comed Todd Gra­ham to the tech team as VP in Pa­lo Al­to. Gra­ham makes the leap over to Ven­rock from Cis­co.

At­las-backed Dyne Ther­a­peu­tics has brought on Mol­ly White as VP, med­ical com­mu­ni­ca­tions and ad­vo­ca­cy. White pre­vi­ous­ly served as the CEO of My­oton­ic (for­mer­ly My­oton­ic Dy­s­tro­phy Foun­da­tion)

→ For­mer Gilead ex­ec John Mar­tin is hop­ping on­to the board of di­rec­tors at Sarep­ta Ther­a­peu­tics — which se­cured a $1.15 bil­lion DMD deal with Roche last month. Mar­tin served a 20-year tenure as CEO of Gilead.

→ MIT pro­fes­sor Bob Langer — who, along with Dan An­der­son, li­censed siR­NA de­liv­ery tech to Verseau for $50 mil­lion last Oc­to­ber — has joined the sci­en­tif­ic ad­vi­so­ry board at can­cer-fo­cused  Gen­eMed­i­cine.

→ While blue­bird bio be­gins rolling out its $1.8 mil­lion gene ther­a­py Zyte­glo in Eu­rope, the com­pa­ny has tapped for­mer Cel­gene ex­ec Nico­la Hef­fron to head its Eu­ro­pean op­er­a­tions. Hef­fron is suc­ceed­ing An­drew Oben­shain — new ti­tle of “chief of wings” — who is head­ing to the com­pa­ny’s Boston of­fice to join CEO Nick Leschly.

→ Af­ter los­ing their CEO last month, Ipsen — which is grap­pling with an FDA hold on its lead rare dis­ease drug palo­varotenehas tapped for­mer Mer­ck Serono ex­ec Steven Hilde­mann as EVP, chief med­ical of­fi­cer, head of glob­al med­ical af­fairs and phar­ma­covig­i­lance. Dur­ing his time at Mer­ck, Hilde­mann served as CMO and SVP and head of glob­al med­ical af­fairs and pa­tient safe­ty. His pre­vi­ous ex­pe­ri­ence spans Mer­ck/Scher­ing Plough, Am­gen and Pfiz­er/Phar­ma­cia.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.