Ther­mo Fish­er aims to boost its clin­i­cal of­fer­ings with Ger­man ex­pan­sion — in­clud­ing cold chain for the Covid-19 ef­fort

Just days af­ter an­nounc­ing wide-rang­ing ex­pan­sions at four fa­cil­i­ties in the US and Eu­rope, man­u­fac­tur­ing gi­ant Ther­mo Fish­er isn’t slow­ing down. Aim­ing to ramp up its clin­i­cal sup­ply chain of­fer­ings — par­tic­u­lar­ly to aid the Covid-19 re­sponse ef­fort — the CD­MO is spread­ing out in Ger­many with two new fa­cil­i­ties.

Ther­mo has two new fa­cil­i­ties in Rhe­in­felden and Weil am Rhein, Ger­many, go­ing on­line this month and next, re­spec­tive­ly. Like the four re­cent­ly an­nounced site ex­pan­sions, Ther­mo is keep­ing the cost close to the chest.

The new fa­cil­i­ties, the com­pa­ny said, will bring “much-need­ed clin­i­cal sup­ply chain con­ti­nu­ity,” name­ly in spe­cial­ized cold-chain and cryo­genic ex­per­tise across Eu­rope and glob­al­ly. That fo­cus, com­bined with last week’s an­nounced ex­pan­sions fo­cused in part on vac­cine de­vel­op­ment ca­pa­bil­i­ties, un­der­scores Ther­mo’s ever-grow­ing mar­ket for vi­able and ster­ile vac­cine pro­duc­tion, even out­side of the cur­rent break­neck ef­forts to pro­duce a Covid-19 vac­cine.

Ther­mo’s Rhe­in­felden site, open­ing this month, con­sists of an 86,000-square-foot fa­cil­i­ty that will in­crease the com­pa­ny’s foot­print for sec­ondary pack­ag­ing, stor­age, lo­gis­tics and dis­tri­b­u­tion of clin­i­cal sup­plies to in­ves­ti­ga­tor sites across Eu­rope, the com­pa­ny said in a news re­lease.

A 9,600-square-foot cry­ocen­ter high­lights the Weil am Rhein fa­cil­i­ty and will al­low for spe­cial­ized ul­tra-low-tem­per­a­ture, cryo­genic stor­age and cold-chain ex­per­tise for clin­i­cal-sup­ply chain needs for cell and gene ther­a­pies, in­clud­ing Covid-19 vac­cine can­di­dates, Ther­mo said. The site will fea­ture -80 de­gree Cel­sius freez­ers, liq­uid ni­tro­gen cryo­genic stor­age tanks and walk-in 2-8 de­grees Cel­sius and -20 de­grees Cel­sius cold stor­age tech­nol­o­gy. That fa­cil­i­ty is set to open in Jan­u­ary.

The Mass­a­chu­setts com­pa­ny late last week un­veiled ex­pan­sion projects at its fa­cil­i­ties in Greenville, NC; Fer­enti­no and Mon­za, Italy; and Swin­don, Eng­land, to widen the range of op­tions avail­able to its cus­tomers, sig­nal­ing a suc­cess­ful run for the com­pa­ny in a high-paced year for con­tract man­u­fac­tur­ers.

In ad­di­tion to the four pro­duc­tion site ex­pan­sions and the new sup­ply-chain ad­di­tions, Ther­mo al­so re­cent­ly an­nounced an ex­pan­sion in Sin­ga­pore that in­cludes a high-speed ster­ile line for live-virus fill­ing. The com­pa­ny al­so agreed to a joint ven­ture with In­no­force to build a new phar­ma­ceu­ti­cal ser­vices fa­cil­i­ty in Hangzhou, Chi­na that fo­cus­es on in­te­grat­ed bi­o­log­ics drug sub­stance and ster­ile drug prod­uct de­vel­op­ment and man­u­fac­tur­ing.

Both of those sites are ex­pect­ed to be com­plet­ed in 2022.

“These fa­cil­i­ties, com­bined with our es­tab­lished reg­u­la­to­ry ex­per­tise, will give cus­tomers the con­ti­nu­ity and in-re­gion ca­pa­bil­i­ties to sup­port clin­i­cal tri­als across mul­ti­ple ther­a­py ar­eas,” said Mike Shafer, Ther­mo Fish­er’s SVP and pres­i­dent of phar­ma ser­vices. “Ul­ti­mate­ly, we are en­abling our cus­tomers to make the world health­i­er by bring­ing new med­i­cines to pa­tients with ex­cep­tion­al speed, ef­fi­cien­cy and qual­i­ty.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.