How tri­al in­no­va­tion in Aus­tralia is get­ting ther­a­pies to pa­tients soon­er

You might have heard Aus­tralia is a great place for phase I. No IND re­quire­ment to be­gin phase I tri­als is dri­ving a grow­ing num­ber of com­pa­nies to run their ear­ly phase tri­als in Aus­tralia. With start-up times 3-6 months quick­er than in the US and a favourable cur­ren­cy ex­change, tri­als can be 20% cheap­er. As a bonus, com­pa­nies with an­nu­al rev­enues less than AUD$20M, can re­ceive a 40+% R&D in­cen­tive re­bate. This pro­gram re­turns cash which can make your fi­nal tri­al price less than half com­pared to US al­ter­na­tives

Lin­ear CEO Michael Win­lo

But as Lin­ear CEO Dr Michael Win­lo ar­gues, there are still ways to make ear­ly phase re­search even more ef­fi­cient. “Cloud-based tools like eS­ource can stream­line site process­es and com­press time­frames. We re­cent­ly wrapped up a very com­plex, phase I healthy vol­un­teer study in record time for a ma­jor Bio­phar­ma. The project re­quired groups from around the world to work with tri­al da­ta close to re­al-time and this was on­ly pos­si­ble be­cause of our eS­ource sys­tem.” Dr Win­lo added, “Com­pa­nies tak­ing ad­van­tage of our ge­og­ra­phy and em­brac­ing our tech­nol­o­gy will be able to take promis­ing new ther­a­pies to their pa­tients soon­er.”

In­no­va­tion is cen­tral to Lin­ear’s strat­e­gy and cul­ture. This means be­ing ear­ly adopters of tech­nol­o­gy (first site in Aus­tralia to use eS­ource) but al­so in de­liv­er­ing new ser­vices for pa­tients (first site out­side NSW to par­tic­i­pate in the Aus­tralian Can­cer Ge­nom­ic Med­i­cine Pro­gram). As an award win­ning ser­vices busi­ness[1], Lin­ear al­so recog­nis­es the im­por­tance of hav­ing great peo­ple. “The task of tak­ing an ex­per­i­men­tal drug in­to hu­mans for the first time is a very del­i­cate, high­ly co­or­di­nat­ed process that re­quires very con­sci­en­tious staff, rig­or­ous process­es and ex­ten­sive safe­ty pro­ce­dures,” states Dr Win­lo.

Jay­den Rogers
VP glob­al part­ner­ing

Aus­tralia has seen strong growth in ear­ly phase clin­i­cal tri­als over the last five years. Ini­tial­ly dri­ven by de­mand from the US. “At Lin­ear we are see­ing in­creased de­mand from the US but al­so from Asia, led by Chi­na and Japan” states Jay­den Rogers — VP Glob­al Part­ner­ing at Lin­ear. “What’s re­al­ly ex­cit­ing is we are see­ing a lot of nov­el and po­ten­tial­ly first-in-class com­pounds com­ing out of the Asia-Pa­cif­ic re­gion. It is one of the rea­sons we have built a ded­i­cat­ed Chi­na cus­tomer suc­cess team.”

Lin­ear Clin­i­cal Re­search is a pri­vate, not-for-prof­it tri­al team based in Perth, West­ern Aus­tralia. On the GMT+8 time­zone, Perth is “time-aligned” with 24% of the world’s pop­u­la­tion. Perth is al­so rat­ed as one of the most liv­able cities in the world be­ing home to a world-class health sys­tem, med­ical re­search and great weath­er.

Perth al­so has a dis­tinct­ly en­tre­pre­neur­ial spir­it. This is ev­i­dent in the work done by 2005 No­bel Prize win­ners Bar­ry Mar­shall and Robin War­ren as well as lead­ing mol­e­c­u­lar ge­net­ic sci­en­tists, Steve Wilton and Sue Fletch­er who pi­o­neered ex­on skip­ping lead­ing to the dis­cov­ery of the first tar­get­ed ther­a­py for Duchenne Mus­cu­lar Dy­s­tro­phy. “We think big, and once peo­ple ex­pe­ri­ence Perth’s lifestyle they tend to set­tle, which is cre­at­ing ex­cit­ing col­lab­o­ra­tive net­works to fa­cil­i­tate clin­i­cal tri­als and long-term fol­low up of pa­tients and their fam­i­lies,” says Pro­fes­sor Pe­ter Leed­man, Di­rec­tor of the Har­ry Perkins In­sti­tute of Med­ical Re­search and Chair­man of Lin­ear Clin­i­cal Re­search.

No mat­ter where in the world you are based, if you’re plan­ning an ear­ly phase re­search project, we’d love to help. Please con­tact Lin­ear’s Part­ner­ing and Clin­i­cal So­lu­tions team at part­ner@lin­ or down­load our whitepa­per here.

Lin­ear Re­cruit­ment Team

[1]Lin­ear was win­ner of the 2017 Na­tion­al Ex­port Award for Busi­ness Ser­vices ex­cel­lence.

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This post is brought to you by Lin­ear Clin­i­cal Re­search.

Roger Perlmutter Merck Investor Day 1

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

Eli Casdin, Casdin Capital

Eli Cas­din backs Codex­is' plat­form tech with $50M eq­ui­ty buy

About a month af­ter Codex­is notched a deal with No­var­tis $NVS, the Cal­i­for­nia com­pa­ny $CDXS on Thurs­day said long-time in­vestor Cas­din Cap­i­tal is putting up $50 mil­lion in a pri­vate place­ment, which puts the New York-based in­vest­ment firm in con­trol of more than 5% of the pro­tein en­gi­neer­ing play­er’s stock.

Eli Cas­din start­ed his epony­mous in­vest­ment firm in 2012 and dates his re­la­tion­ship with Codex­is back to at least a decade. About three years ago, Cas­din Cap­i­tal be­gan in­vest­ing in the in­dus­tri­al biotech com­pa­ny, af­ter it piv­ot­ed its fo­cus to the life sci­ences — un­der the aus­pices of new chief John Nicols — away from the en­er­gy in­dus­try.

In­vestors pony up $476M for the lat­est round of biotech IPOs to hit the Street

Three biotechs — and a genome se­quenc­ing play­er — have caught the lat­est tide to the Gold Coast of IPOs, round­ing out the first half of 2019 with 23 new drug de­vel­op­ers mak­ing it on Nas­daq.

Most of these com­pa­nies filed their IPOs al­most si­mul­ta­ne­ous­ly, though we’re still wait­ing on word of fel­low class­mate Bridge­Bio’s pric­ing af­ter CEO Neil Ku­mar set the terms at $14 to $16 a share on Mon­day in search of a $240 mil­lion (or so) wind­fall. If he’s suc­cess­ful, that would take the one-week haul past the $700 mil­lion mark, a fresh sign that in­vestors’ en­thu­si­asm for new­ly coined pub­lic biotechs hasn’t cooled.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

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In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.