Can the glob­al­ly in­flu­en­tial Google rev­o­lu­tion­ize the multi­bil­lion-dol­lar clin­i­cal tri­al busi­ness?

Some of the biggest phar­mas out there think so, look­ing to Google’s sis­ter out­fit Ver­i­ly — op­er­at­ing un­der Al­pha­bet, the par­ent com­pa­ny — to guide the in­dus­try in­to the dig­i­tal age with its ex­tra­or­di­nary reach in­to the lives of bil­lions of peo­ple on the plan­et.

This morn­ing, No­var­tis, Pfiz­er, Sanofi and Ot­su­ka all lined up to jump on the Pro­ject Base­line plat­form at the Google-re­lat­ed life sci­ences di­vi­sion, look­ing to em­ploy the dig­i­tal Go­liath’s tech ser­vices in re­cruit­ing pa­tients and or­ga­niz­ing the mass of da­ta com­ing out of the glob­al tri­al sys­tem.

Build­ing on Base­line’s ini­tial plans to an­a­lyze da­ta on 10,000 vol­un­teers, the Google op­er­a­tion is now look­ing to steer peo­ple to drug stud­ies as they search for more in­for­ma­tion on the dis­eases that plague them. That can ex­tend Big Phar­ma’s reach — and in­flu­ence — in­to mil­lions of house­holds.

Just how big is that reach? One re­cent as­sess­ment con­clud­ed that Google con­trols 90% of the search en­gine mar­ket, with 63,000 search­es per sec­ond, while the av­er­age per­son makes 3 to 4 search­es per day. And health­care is one of their biggest sin­gle fo­cus­es.

Jes­si­ca Mega

This ini­tia­tive is hap­pen­ing at a time the FDA has been en­cour­ag­ing a fresh look at the way tri­als are de­signed and ex­e­cut­ed, look­ing to short­en the de­vel­op­ment path for the most promis­ing ther­a­pies — or trig­ger­ing a fast ex­e­cu­tion of the weak­est drug can­di­dates. 

For all the talk about change, though, the de­vel­op­ment path­way for new drugs has large­ly stuck with a tra­di­tion­al gold stan­dard in use for years. Ver­i­ly will see if it can steer a new di­rec­tion, and that has the po­ten­tial to make for some dra­mat­ic changes in the CRO world.

“No­var­tis, Ot­su­ka, Pfiz­er and Sanofi have been ear­ly adopters of ad­vanced tech­nol­o­gy and dig­i­tal tools to im­prove clin­i­cal re­search op­er­a­tions, and to­geth­er we’re tak­ing an­oth­er step to­wards mak­ing re­search ac­ces­si­ble and gen­er­at­ing ev­i­dence to in­form bet­ter treat­ments and care,” not­ed Ver­i­ly CMO Jes­si­ca Mega in a pre­pared state­ment.

Im­age Source: Sipa USA via AP

Bayer committed $300 million to set up a joint venture on CRISPR/Cas9 tech with CRISPR Therapeutics $CRSP. But they’re handing off control now to the smaller biotech while retaining a couple of opt-ins for programs nearing an IND.

Bayer $BAY made much of the fact that they were going all-in on gene editing when they did their deal 3 years ago with CRISPR Therapeutics, which pitched $35 million in on their end. This was the cornerstone of their plan to set up new JVs that could make some serious leap forwards in hot new R&D spaces. Now CRISPR will have full management control of Casebia as they pursue programs in hemophilia, ophthalmology and autoimmune diseases.
Samarth Kulkarni, the CEO at CRISPR, made it sound like a natural progression.

J&J’s Stelara, which is set to be in the top ten list of blockbusters come 2025, is now cleared by the FDA for use in ulcerative colitis (UC), an inflammatory disease of the large intestine.

The biologic targets interleukin (IL)-12 and IL-23 cytokines, which are known to play a key role in inflammatory and immune responses. Stelara, which generated about $4.7 billion in the first nine months of 2019, is a key player in the crowded marketplace of drugs to treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease. AbbVie’s star therapy, Humira, continues to dominate, despite its looming patent cliff in the United States, while others including J&J’s $JNJ own anti-IL23 Tremfya, Lilly’s $LLY anti-IL-17 Taltz and AbbVie’s $ABBV recently approved anti-IL-23 antibody Skyrizi carve out a slice of market share.

→ Hours before the first federal opioid trial was set to begin, three drug distributors and an opioid manufacturer agreed to a $260 million agreement settlement, the Wall Street Journal was the first to report. The deal — which will see McKesson, Cardinal Health and AmerisourceBergen pay $215 million to Summit and Cuyahoga counties, and Teva deal out $35 million in cash and addiction treatments — does not resolve the pending, nationwide litigation that may result in a settlement worth upwards of $40 billion. Negotiators in that case, brought by 2,300 tribes, counties and cities nationwide and led by several states’ attorneys general, worked through much of Friday without success. Josh Stein, the attorney general for North Carolina, said they were trying to put together a $48 billion deal.

GlaxoSmithKline is leaving the deep dark woods and its viruses behind.

GSK has agreed to divest its vaccines for rabies, RabAvert, and tick-born encephalitis vaccine, Encepur, to Bavarian Nordic, part of the company’s broader efforts to narrow its pipeline and focus on oncology and immunology.

The deal is worth up to nearly $1.1 billion, with a $336 million upfront payment. GSK acquired the vaccines from Novartis as part of an exchange for their late-stage oncology programs in 2015 under former chief Sir Andrew Witty.

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.