Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

Jef­frey Hat­field

→ San Diego pro­tein degra­da­tion start­up Vi­vid­ion Ther­a­peu­tics has made a change at the top with Jef­frey Hat­field tak­ing the helm as CEO, re­plac­ing Diego Mi­ralles six months af­ter Roche forked over $135 mil­lion to col­lab­o­rate with Vi­vid­ion on their small mol­e­cule de­graders. Hat­field is chair­man of the board at mi­Ra­gen Ther­a­peu­tics and pre­vi­ous­ly held the CEO job at Zaf­gen and Vi­tae Phar­ma­ceu­ti­cals. He al­so had a se­ries of lead­er­ship roles at Bris­tol My­ers Squibb from 1996-2004, in­clud­ing SVP, im­munol­o­gy and vi­rol­o­gy di­vi­sions.

Launched in Feb­ru­ary 2017 and chaired by Rich Hey­man, Vi­vid­ion fol­lowed with an $82 mil­lion Se­ries B two years lat­er.

Bill Haney’s folks at Drag­on­fly Ther­a­peu­tics — wheel­ing and deal­ing with Bris­tol My­ers Squibb on a $475 mil­lion pact in Au­gust — have brought on Alex Lu­gov­skoy as chief op­er­at­ing of­fi­cer. A Bio­gen vet in drug dis­cov­ery, Lu­gov­skoy spent five years as Mor­phic Ther­a­peu­tic’s chief de­vel­op­ment of­fi­cer be­fore set­tling in at Drag­on­fly. Be­fore that, he had a six-year run as VP of ther­a­peu­tics at Mer­ri­mack Phar­ma­ceu­ti­cals.

Drag­on­fly al­so gave Rob Her­sh­berg a spot on their sci­en­tif­ic ad­vi­so­ry board. Her­sh­berg was EVP and head of busi­ness de­vel­op­ment & glob­al al­liances at Cel­gene un­til the 2019 Bris­tol My­ers buy­out.

Hugh Samp­son

→ It’s been a try­ing year for DBV Tech­nolo­gies with the FDA’s re­jec­tion of their peanut al­ler­gy skin patch along with em­ploy­ee lay­offs while wait­ing to hear from the agency. CFO Ramzi Be­na­mar and chief com­mer­cial of­fi­cer Kevin Trapp bolt­ed in Oc­to­ber. And this week, CSO Hugh Samp­son has ten­dered his res­ig­na­tion ef­fec­tive Dec. 1, head­ing back to the lab at the Jaffe Food Al­ler­gy In­sti­tute at Mount Sinai. Samp­son had been DBV’s chief sci­en­tist for five years, but he’s not leav­ing for good: He will be sci­en­tif­ic ad­vis­er to CEO Daniel Tassé and chair­man of their sci­en­tif­ic ad­vi­so­ry board.

Maky Zan­ganeh

→ Biotech bil­lion­aire Bob Dug­gan is fill­ing out his ex­ec­u­tive team at Sum­mit Ther­a­peu­tics with long­time col­league Maky Zan­ganeh as chief op­er­at­ing of­fi­cer, two weeks af­ter she joined the an­tibi­otics biotech’s board of di­rec­tors. Zan­ganeh has worked with Dug­gan be­fore as VP of busi­ness de­vel­op­ment at Robert Dug­gan & As­so­ci­ates and as COO at Phar­ma­cyclics. She’s al­so a board mem­ber at Pulse Bio­Sciences and Ren­ovoRx.

→ Lon­don-based Mereo Bio­Phar­ma has been pop­ping up in Peer Re­view reg­u­lar­ly, ap­point­ing a CFO and CSO among oth­er ex­ecs. The on­col­o­gy and rare dis­ease out­fit isn’t fin­ished in 2020, nam­ing Su­ba Kr­ish­nan SVP of clin­i­cal de­vel­op­ment. Kr­ish­nan had been glob­al pro­gram head of im­muno-on­col­o­gy at Gen­mab for the last year, hav­ing just spent the year be­fore as clin­i­cal lead in a Phase II Lyn­parza study at Mer­ck. She’s al­so tak­en on lead­er­ship roles at Bris­tol My­ers Squibb and Shire. Mereo is tar­get­ing TIG­IT with a $70 mil­lion pri­vate place­ment they an­nounced in June.

Pen­rose Ther­a­peuTx — fo­cused on the de­vel­op­ment of small mol­e­cule ther­a­pies for the treat­ment of can­cer — has tapped Mark de Souza as its CEO. De Souza joins the com­pa­ny af­ter his most re­cent stint as CEO of cannabis health and well­ness com­pa­ny Rev­o­lu­tion Glob­al.

Ton Berkien

Ton Berkien has been in­stalled as CBO at Nor­we­gian can­cer biotech Ul­ti­movacs, which re­port­ed pos­i­tive Phase I da­ta last month for their pep­tide-based vac­cine UV1 in pa­tients with non-small cell lung can­cer. Be­fore the switch to Ul­ti­movacs, helmed by Car­los de Sousa af­ter his run end­ed at Swe­den-based Im­mu­nicum, Berkien was Am­gen’s di­rec­tor of busi­ness de­vel­op­ment and worked in M&A at Take­da as their act­ing head of cor­po­rate de­vel­op­ment.

→ When last we saw Tarus Ther­a­peu­tics here, the New York biotech had added David Ep­stein and David Nichol­son to the board of di­rec­tors. Now they’ve brought on Bri­an Schwartz as act­ing CMO and head of their sci­en­tif­ic ad­vi­so­ry board. Schwartz was pre­vi­ous­ly CMO at ar­Qule from 2008 un­til Mer­ck bought the com­pa­ny for $2.7 bil­lion, and he had al­so been ar­Qule’s head of R&D since 2013. From 2006-08, the Bay­er vet held dual roles (CMO and SVP, clin­i­cal and reg­u­la­to­ry af­fairs) at Zio­pharm On­col­o­gy.

Alas­tair Maxwell

→ Look­ing to cor­ner the sleep-dis­or­dered break­thing mar­ket with eX­ci­teOSA for mild ob­struc­tive sleep ap­nea and snor­ing, Sig­ni­fi­er Med­ical Tech­nolo­gies has ap­point­ed Alas­tair Maxwell as CFO. Maxwell, a Mor­gan Stan­ley and Gold­man Sachs alum, heads to Sig­ni­fi­er af­ter de­cid­ing not to re­lo­cate to Greece with the rest of se­nior man­age­ment at GasLog and GasLog Part­ners, where he was the group’s CFO.

→ Along with the news of their col­lab­o­ra­tion with cell ther­a­py equip­ment man­u­fac­tur­er BioS­pher­ix, mi­to­chon­dr­i­al dis­ease-fo­cused Mi­novia Ther­a­peu­tics has pegged David O’Don­nell as their glob­al head of man­u­fac­tur­ing and sup­ply chain. O’Don­nell makes the move from be­lea­guered Unum Ther­a­peu­tics (since re­named Co­gent Bio­sciences), where he was their di­rec­tor of tech­nol­o­gy op­er­a­tions. The Agenus vet has al­so been Ova­Science’s se­nior di­rec­tor of op­er­a­tions.

Robert Wal­ter­mire

→ An­tibi­otics-fo­cused Ve­na­torx Phar­ma­ceu­ti­cals out of Malvern, PA has en­list­ed Bris­tol My­ers Squibb vet Robert Wal­ter­mire as SVP, chem­istry, man­u­fac­tur­ing & con­trols (CMC). Wal­ter­mire spent more than 18 years at BMS, in­clud­ing the last 4 years as VP, chem­i­cal & syn­thet­ic de­vel­op­ment. He heads to Ve­na­torx af­ter a brief stint at Palatin Tech­nolo­gies as SVP, prod­uct de­vel­op­ment.

Urvi Rand­har

Prime Ther­a­peu­tics has re­cruit­ed Urvi Rand­har as SVP, chief in­for­ma­tion tech­nol­o­gy and da­ta man­age­ment and an­a­lyt­ics ar­eas; Sam Mo­han­ty as VP and chief da­ta of­fi­cer; and Sarah Tay­lor as VP and chief an­a­lyt­ics of­fi­cer. Rand­har joins the com­pa­ny from Healog­ics, while Mo­han­ty hops aboard af­ter stints at Unit­ed Air­lines and CVS Health. Mean­while, Tay­lor comes to the team with ex­pe­ri­ence at Unit­ed Health­care.

Jayson Dal­las, the for­mer CEO of Aim­mune Ther­a­peu­tics (ac­quired by Nestlé Health Sci­ence), is hop­ping aboard the board of di­rec­tors at Copen­hagen-based Galec­to, which filed for a $100 mil­lion IPO ear­ly last month. Dal­las is cur­rent­ly a mem­ber of the board at Are­na Phar­ma­ceu­ti­cals and has ex­pe­ri­ence from his stints at Pfiz­er, No­var­tis, Roche and Ul­tragenyx Phar­ma­ceu­ti­cals.

Stephen Squin­to

Stephen Squin­to is step­ping in as chair­man of the board at hematopoi­et­ic stem prog­en­i­tor cell gene ther­a­py de­vel­op­er Genen­ta Sci­ence. Squin­to, the Alex­ion co-founder and Or­biMed ex­ec­u­tive part­ner, had more re­cent­ly been cho­sen as vice chair­man of bioAffin­i­ty Tech­nolo­gies. He was al­so in­ter­im CEO of Pas­sage Bio un­til he was suc­ceed­ed by Bruce Gold­smith a month be­fore their mas­sive IPO.

Kathy Reape

Taysha Gene Ther­a­pies is adding Kathy Reape and Mer­ck vet Lau­ra Sepp-Loren­zi­no to its board of di­rec­tors. Reape for­mer­ly served as CMO at Spark Ther­a­peu­tics, while Sepp-Loren­zi­no cur­rent­ly serves as CSO at In­tel­lia Ther­a­peu­tics. In ad­di­tion, Sepp-Loren­zi­no has held stints at Ver­tex and Al­ny­lam.

→ Cam­bridge, MA mi­cro­bio­me drug de­vel­op­er Vedan­ta Bio­sciences, which se­lect­ed Jef­frey Sil­ber as their CMO in Sep­tem­ber, has wel­comed Troy Ignelzi to their board of di­rec­tors. Ignelzi has been CFO at Karuna Ther­a­peu­tics since March 2019.

Ox­ford Bio­med­ica, which inked a CAR-T deal with Beam Ther­a­peu­tics in Au­gust, has reeled in Siya­mak Rasty as non-ex­ec­u­tive di­rec­tor of the board. Rasty cur­rent­ly serves as CEO and pres­i­dent of Platelet­Bio and has pre­vi­ous­ly served in roles at Ho­mol­o­gy, Shire, En­do Phar­ma­ceu­ti­cals and GSK.

Jen­nifer Mc­Nealey

→ A pair of new board mem­bers have been an­nounced at An­tibe Ther­a­peu­tics, a Toron­to-based biotech de­vel­op­ing an­ti-in­flam­ma­to­ries on a hy­dro­gen sul­fide plat­form. Robert Hoff­man re­cent­ly re­tired as CFO of Heron Phar­ma­ceu­ti­cals and is chair­man of Kin­tara Ther­a­peu­tics. Jen­nifer Mc­Nealey is the VP, in­vestor re­la­tions and strat­e­gy at Calithera Bio­sciences.

→ A trio of board mem­bers is glid­ing in­to Philadel­phia AAV gene ther­a­py play­er Swan­Bio Ther­a­peu­tics: Pat­ty Allen, Dan­ny Bar-Zo­har, and Alex Hamil­ton. Allen, the ex-Zaf­gen CFO, is al­so on the board of Anokion, In­ver­sa­go and Yu­man­i­ty. Bar-Zo­har just took the job at Mer­ck KGaA as glob­al head of de­vel­op­ment, while Hamil­ton is a part­ner at Syn­cona.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Henrietta Lacks

UP­DAT­ED: Fed­er­al judge weighs mo­tion to dis­miss HeLa law­suit against Ther­mo Fish­er

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.