04 Oct

Janssen Reaches $250M Deal for Rights to Arrowhead’s Hep B RNAi Drug

Fibrotic Liver

Arrowhead Pharmaceuticals is licensing one of its drug candidates, a hepatitis B treatment, to a subsidiary of pharmaceutical giant Johnson & Johnson in a cash and stock deal valued at $250 million up front.

The agreement announced Thursday comes one month after Pasadena, CA-based Arrowhead, which operates its laboratories in Madison, WI, reported encouraging early data from a small clinical trial suggesting its drug could successfully treat hepatitis B viral infections. It also follows the recent FDA approval of an Alynlam Pharmaceuticals drug that takes the same approach to treating disease as Arrowhead’s experimental therapy.

Under the terms of the deal,… Read more »

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04 Oct

Inducement prize: Online security – Seamless personal authentication

[Source: http://ec.europa.eu/health/ageing/innovation/index_en.htm] Identifier: H2020-OnlineSecurityPrize-2017Pillar: Industrial LeadershipOpening Date: Deadline: Thu, 27 Sep 2018 17:00:00 (Brussels local time)Modification Date: Thu, 4 Oct 2018Latest information: A total of28applications were successfully submitted.

04 Oct

Trump’s Drug Pricing Blueprint to be Explored at Upcoming Summit

In just a few short weeks, BIO will host its annual Patient and Health Advocacy Summit which brings together patient advocacy organizations, academia, regulators, biotechnology industry, and other stakeholders for two days of robust programming to discuss timely policy issues and share best practices.

Organizers announced a panel session for day one that will cover the Trump Administration’s “American Patients First Blueprint”, a proposed plan for addressing the cost of prescription drugs. Moderator Janet McUlsky, Pfizer’s National Alliance Development Senior Director, will be joined by officials from the Trump Administration who will provide updates on the plan and engage with attendees on the merits and whether it will reach the stated objectives.

Administration officials scheduled to participate on the panel are:

  • Dan Best, the Senior Advisor to the Secretary for Drug Pricing Reform, Food and Drug Administration, U.S. Department of Health and Human Services; and
  • John O’Brien, MPH, Advisor to the Secretary for Health Policy, U.S. Department of Health and Human Services

Since the release of the plan in May 2018, discussions around key provisions continue in the media and elsewhere. Both patient advocacy groups and the biopharma community support efforts aimed at ensuring the ability of innovators to discover new cures and treatments while providing access to prescription drugs with affordable out-of-pocket costs. Whether the plan will deliver these outcomes remains to be seen.

BIO applauds the plan’s exclusion of direct government negotiation in Medicare which would lead to price controls and restricted access for America’s seniors. The plan also restricts the use of pharmacy gag clauses, which prevent patients from learning about more affordable options for buying their medicines. There are several other concepts in the plan that have the potential to improve health care delivery, depending on how the details are ironed out. For example, the 340B reform provisions, value-based pricing agreements and greater pass-through of rebates to consumers.

There are some areas of concern. In a three-part blog series authored by Dan Durham, BIO’s Executive Vice President for Health Policy, three proposals in the “Blueprint” that could pose significant challenges to patients were examined in depth. The first one looked at a proposal to restrict access to Medicare Part D, a popular prescription drug program for America’s seniors. The second blog reviewed the proposed reforms to Medicare Part B, and the third looked at reforms that may restrict access to needed medicines for patients enrolled in Medicaid.

The panel session at the upcoming Summit will provide a more in-depth look at these issues and how they may impact the well-being of patients, as well as help shed more light on the Administration’s efforts to provide affordable access to medicines patients need. Registration for the BIO Patient and Health Advocacy Summit is open. It will be held October 25-26 at the Park Hyatt in Washington DC.

04 Oct

Second Genome Promotes Karim Dabbagh to President & CEO

Karim Dabbagh has been appointed president and CEO of microbiome drug developer Second Genome. Dabbagh is also joining the South San Francisco, CA, company’s board of directors. He succeeds Glenn Nedwin, who retired last month. Dabbagh has been Second Genome’s chief scientific officer since 2014. Before joining the company, Dabbagh was vice president and head of the immunoregulation department and external R&D innovation for autoimmune and inflammatory diseases at Pfizer (NYSE: PFE). Second Genome initially tested its lead drug candidate, SGM-1019, as a potential treatment for Crohn’s disease. The company is now preparing the drug for Phase 2 studies… Read more »

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03 Oct

New Member Benefit: Online Marketplace for Custom Scientific Research Services and Products

BIO’s member companies in the pharmaceutical, life sciences, chemicals, and biotechnology sectors routinely and strategically outsource their research needs, driven by a demand to stay competitive, cut costs, increase innovation, and have access to specialized knowledge. Identifying a contract research organization (CRO) requires vendor communication, diligence, legal negotiation, and selection, complimented with market knowledge, defining statement of work (SOW), project tracking, and data reporting.  Overall, this requires a tremendous amount of time and capital-before any work is done.

Enter Scientist.com

Following an extensive due diligence process, BIO has partnered with Scientist.com-the world’s leading online scientific marketplace. The program offers members significant savings in a marketplace populated with 2,600+ suppliers governed by a single legal agreement. Additionally, members receive exclusive access to Scientist.com‘s Research Concierge™, a team of scientific experts that can assist with any order, regardless of complexity. Overall, Scientist.com reduces CRO identification to 1) request service, 2) select service, and 3) collect data in a simple and innovative online platform. Join us in streamlining research and development with Scientist.com.

03 Oct

Pfizer’s Bernard Fermini Joins Novoheart as Chief R&D Officer

Novoheart (TSXV: NVH) has appointed Bernard Fermini to serve as chief research and development officer of the Vancouver, BC, stem cell biotechnology company. Fermini most recently worked at Coyne Scientific, where he was vice president of safety and toxicology and chief scientific officer. His experience also includes 17 years at Pfizer (NYSE: PFE). NovoHeart is developing a “human heart in a jar,” a human heart tissue prototype intended for applications in drug research.

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03 Oct

Arctic Circle Assembly – 19-21 October 2018, Reykjavik, Iceland

[Source: Research & Innovation] The Arctic Circle is the largest network of international dialogue and cooperation on the future of the Arctic bringing together more than 2000 participants.
On the agenda:
•highlight the EU’s engagement in the Arctic research, •highlight the role of the Horizon 2020 programme in the support of the EU Arctic Policy, •inform about the H2020 topics for 2019 related to the Arctic, •showcase major EU funded research and innovation actions by giving visibility to the EU Arctic research cluster.

02 Oct

Delivering Innovative Medicines to Patients

Over the past two years, I lost both my father and my brother to cancer. I know that my situation is not unique; too many others experience the same pain and heartache that I felt as their loved ones fight this terrible disease.

When their cancers struck, I had just joined Bristol-Myers Squibb which meant traveling back and forth frequently from the East to the West coast to manage their care. It was a very difficult time, both emotionally and physically, to say the least.

I was amazed by their practitioners – the healthcare professionals who cared for my dad and brother – and especially took notice of the incredible job they were able to do despite constraints they often faced providing the appropriate care to their patients. At times it was apparent that the amount of red tape it took to secure prescribed treatments inhibited their ability to help their patients.

These constraints were often related to the desire for offering treatment choices targeted to an individual patient’s need which were up against a health-care system that is increasingly focused on a singular “best” treatment solution for all patients. As the head of the Value, Access and Payment organization of a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases I am acutely aware of this issue. I am humbled by the outstanding work of patient advocates in their efforts in Washington, DC and our state capitals to ensure that patients receive the right medicines for their disease at the right time, in conjunction with physician choice.

BMS is investing in precision medicine to ensure we can continue to develop and deliver innovative medicines to physicians and patients. The strong voice of advocates in ensuring patients have the ability to continue to choose their own medical care must continue to be heard.

At BMS, our priority is to ensure that patients have access to our innovative medicines.

We are continuously having conversations with the payor and access community to ensure every patient can access the medicines their provider believes will deliver the best care for their individual disease. We don’t want to see anything impede physician-patient treatment choice, which we believe is essential to delivering optimal patient care.

We are committed to working across the healthcare continuum to ensure patients have access to – and can afford – new breakthrough treatments. We know the advocacy community is a critical partner in this effort and are incredibly grateful for all they do on behalf of patients like my father and brother to ensure access to the care they deserve.

 

 

Dr. Ryan is the Head, Value, Access, Payment and HEOR for Bristol-Myers Squibb. In this role, Dr. Ryan is responsible for all pricing, contracting, payer strategy, and Value and Access Marketing across the U.S. BMS portfolio, as well as all field reimbursement strategy and execution across all US payers.

Michael L. Ryan, Pharm.D.

Dr. Ryan is the Head, Value, Access, Payment and HEOR for Bristol-Myers Squibb. In this role, Dr. Ryan is responsible for all pricing, contracting, payer strategy, and Value and Access Marketing across the U.S. BMS portfolio, as well as all field reimbursement strategy and execution across all US payers.

02 Oct

Synlogic Promotes Aoife Brennan to President & CEO

Aoife Brennan has been appointed president and CEO of synthetic biology company Synlogic (NASDAQ: SYBX), effective immediately, the company announced Tuesday. Brennan had been serving as interim president and chief executive of Cambridge, MA, Synlogic since May. She joined the company as chief medical officer in 2016 after six years at Biogen (NASDAQ: BIIB). Synlogic is engineering bacteria into “living medicines.” The company’s lead drug programs are in development as treatments for hyperammonemia, or elevated levels of ammonia in the blood.

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02 Oct

Everything You Need to Know About Facebook’s Recent Data Breach

When Facebook announced last Friday that 50 million user accounts had been compromised, many of us weren’t sure what to think.

Did that mean 50 million users had been exposed to content from a coordinated misinformation campaign, a la the 2016 U.S. presidential elections?

Or did it mean that their personal data had been improperly harvested by an app developer, as was the case for 87 million users in the Cambridge Analytica scandal?

Neither. This time, the bad actors were hackers — and they were able to take advantage of three separate site bugs in a way that allowed them to take over user accounts, and use them as if they were the account owners themselves.

But it seems as though there’s a widespread misunderstanding around what exactly happened, and just how serious the implications might be. And that’s understandable — it’s a complex hack about which not a ton of information has been revealed, especially by Facebook, leading to a mixed reaction among users.

Here’s what happened — as well as what our data shows about user sentiment in light of the latest breach, and what could be behind that reaction.

A Breakdown of What Happened

Facebook first reported the breach on Friday, September 28 — approximately three days after the full issue was allegedly first discovered, according to an official statement written by VP of Product Management Guy Rosen.

There was an usual spike in activity detected by the site around the middle of September — the 16th, according to remarks made by Rosen during a press call — which led to an investigation and the full discovery on the 28th.

It began with a vulnerability in the site’s “View As” feature, which allows users to see what their profiles might look like to another user.

Facebook-View-As

Source: TechCrunch

Using the View As feature should allow you to do only that — and when functioning properly, it blocks out any ability to enter text into compose boxes or otherwise alter the profile being viewed.

However, due to this first bug, View As provided the opportunity to upload a video.

It’s because of that video uploader being displayed that the second bug occurred.

For the second bug, the video uploader improperly generated an access token.

What’s an access token? Essentially, an access token allows you to use one account (like Facebook, Twitter, or Google) to log into several different services or apps.

You might be familiar with Facebook Login, which allows users to log into an app using their Facebook credentials, whether it’s Facebook itself or another app using these permissions, like Tinder. The images below show what a Facebook Login looks like on Tinder.

Screen Shot 2018-10-01 at 5.07.40 PM

Screen Shot 2018-10-01 at 5.07.50 PM

That access token then provides the third-party app with access to the user’s Facebook data — such as the public profile, friends list, birthday, photos, Page likes, and email address indicated in the Tinder login pictured above.

HubSpot Director of Web Development Dmitry Shamis describes an access token as “a password you don’t have to reenter,” which allows you to stay logged into both Facebook and these other apps without having to go through the process again.

And here’s where the third bug comes in. The access tokens generated by the first and second bugs were actually for the accounts of users whose names were entered in the “View As” box, and not the user whose profile was being viewed.

As Rosen put it: the access token generated “was not for you but the person being looked up. That access token was then available in the HTML of the page, which the attackers were able to extract and exploit to log in as another user.”

Therefore, the hackers could “use the account as if they are the account holder,” Rosen said. The access tokens of roughly 50 million users were taken. Facebook also said that an additional 40 million users were subject to a “View As” look-up over the last year — though it is not clear if access tokens were taken for those accounts.

Why It Might Be Worse Than It Looks

Facebook has outlined the measures it’s taken in response to the breach, starting with repairing the “vulnerability,” removing the View As functionality (for now), and doing a full reset of the access tokens for the 50 million accounts affected by the hack.

According to remarks made by Rosen during a press call last Friday morning, that reset made the access tokens taken by hackers “not usable anymore.”

But according to Jason Polakis, an assistant professor of computer science at the University of Illinois at Chicago, that might not be the case, based on findings from a study he and others at the university conducted.

According to the study’s findings, if the hackers in this Facebook breach did, in fact, gain access to third-party apps as the users whose accounts were compromised — there are ways for them to keep that access, even if the tokens are reset, as Rosen described.

Now, Polakis was sure to specify that this phenomenon might not be “applicable here.” But Facebook has said itself that it has very little information about how these access tokens were used by the hackers, and is uncertain of when the tokens were first obtained.

According to Axios, Tinder has since said it hasn’t found any “evidence to suggest accounts have been accessed based on the limited information Facebook has provided” — but at the same time, Facebook hasn’t provided the app with a list of users affected by the hack. Having that information, Tinder said, would be “very helpful” in determining how the stolen access tokens may have been used on its app.

Spotify, which also offers Facebook Login, also told the publication that it has not experienced a breach as a result of the hack. Facebook says that its investigation into the issue is still in its early stages.

Public Perception: Do People Care About the Hack?

On the Monday after news of the breach first broke, we ran two surveys.

The first survey asked 727 internet users across the U.S., UK, and Canada: “Following Facebook’s site hack announced last week, are you more or less likely to trust Facebook with storing your personally identifiable information?”

Nearly half of the respondents said that they’re less likely to trust Facebook with their personally identifiable information.

Following Facebook's site hack announced last week, are you more or less likely to trust Facebook with storing your personally identifiable information_ (1)

Then, we ran a second survey, where we removed any mention of a site hack. We asked a separate audience of 753 internet users across the U.S., UK, and Canada: Over the past week, how would you measure your overall trust in Facebook?

Over the past week, how would you measure your overall trust in Facebook_

Notice the difference in responses. This time, almost as many people who said that their trust in Facebook has decreased indicated that their trust levels in the company have stayed the same.

So what’s to explain for the discrepancy?

Despite providing an option in the first survey for “I didn’t hear about the site hack,” I wondered how many respondents chose that answer before looking up the Facebook hack.

Was it possible that because we included the hack in the question, it prompted respondents to seek more information before answering the question? Do social media users have to be told that they should be outraged? Or is it just that people aren’t really surprised, given Facebook’s already tumultuous year?

If you ask HubSpot VP of Marketing Jon Dick, the answer may lie in the third answer.

“My feeling here is that people just assume that their data is constantly breached, so the Facebook news didn’t even alarm people. You see that in your second results,” he said. “But when we trigger people that something bad did in fact happen, we elicit more responses.”

Combine that lack of alarm — unless otherwise prompted — with the fact that many users still rely on Facebook for a number of purposes. Monthly active user growth may have slowed, but globally, 223.4 million people are still on the site every month.

“My personal opinion is that people are making mental tradeoffs. It’s a primary connection point to family members, to news, to society at large,” says HubSpot VP of Marketing Meghan Keaney Anderson. “And for now, there is no viable replacement to that. The trade off I’d argue people are making is the very real value of that connection point, versus the not-yet-personally-actualized threat to privacy or security of data.”

What’s Next

As for what’s next, time will tell. As Facebook has said itself — the investigation into the breach is still in its earliest stages.

That could mean that the full impact on users could be yet-to-be-determined or discovered — and as more information is revealed, it could continue to impact the public perception of Facebook.

“I think some people are unlikely to change their behavior until they suffer an acute impact of the loss of privacy,” says Keaney Anderson.

For now, what can the rest of us — marketers included — do to deal with and address the issue?

For her part, Keaney Anderson suggests that the main task is keeping audiences informed.

“Some of the work that could be done at this point is to educate people on what they should be watching out for as a result of this breach in data,” she advises. “That could help people to calibrate their response.”

We’ll continue to cover the issue as more details come forward.