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

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

Boston-based PureTech had helped Eli Lilly vet Steve Paul launch Karuna and invent its lead program, which combines two old drugs that both act on the muscarinic receptor and balances each other out. Xanomeline, a discard from Lilly, stimulates the M1 and M4 receptors; trospium is an muscarinic receptor antagonist approved to treat overactive bladders.

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.