Funding, Deals & Partnerships: BIOLOGICS & MEDICAL DEVICES; BioMed e-Series; Medicine and Life Sciences Scientific Journal – http://PharmaceuticalIntelligence.com
Real Time Coverage @BIOConvention #BIO2019: Issues of Risk and Reproduceability in Translational and Academic Collaboration; 2:30-4:00 June 3 Philadelphia PA
Translating academic research into products and new therapies is a very risky venture as only 1% of academic research has been successfully translated into successful products.
Collaboration from Chicago area universities like U of Chicago, Northwestern, etc. First phase was enhance collaboration between universities by funding faculty recruitment and basic research. Access to core facilities across universities. Have expanded to give alternatives to company formation.
Most academic PI are not as savvy to start a biotech so they bring in biotechs and build project teams as well as developing a team of ex pharma and biotech experts. Derisk as running as one asset project. Partner as early as possible. A third of their pipeline have been successfully partnered. Work with investors and patent attorneys.
Focused on getting PIs to get to startup. Focused on oncology and vaccines and I/O. The result can be liscensing or partnership. Running around 50 to 60 projects. Creating a new company from these US PI partnerships.
Most projects from Harvard have been therapeutics-based. At Harvard they have a network of investors ($50 million). They screen PI proposals based on translateability and what investors are interested in.
In Chicago they solicit multiple projects but are agnostic on area but as they are limited they are focused on projects that will assist in developing a stronger proposal to investor/funding mechanism.
NYU goes around university doing due diligence reaching out to investigators. They shop around their projects to wet their investors, pharma appetite future funding. At Takeda they have five centers around US. They want to have more input so go into the university with their scientists and discuss ideas.
Challenges:
Takeda: Data Validation very important. Second there may be disconnect with the amount of equity the PI wants in the new company as well as management. Third PIs not aware of all steps in drug development.
Harvard: Pharma and biotech have robust research and academic does not have the size or scope of pharma. PIs must be more diligent on e.g. the compounds they get from a screen… they only focus narrowly
NYU: bring in consultants as PIs don’t understand all the management issues. Need to understand development so they bring in the experts to help them. Pharma he feels have to much risk aversion and none of their PIs want 100% equity.
Chicago: they like to publish at early stage so publication freedom is a challenge
Dr. Freedman: Most scientists responding to Nature survey said yes a reproduceability crisis. The reasons: experimental bias, lack of validation techniques, reagents, and protocols etc.
And as he says there is a great ECONOMIC IMPACT of preclinical reproducability issues: to the tune of $56 billion of irreproducable results (paper published in PLOS Biology). If can find the core drivers of this issue they can solve the problem. STANDARDS are constantly used in various industries however academic research are lagging in developing such standards. Just the problem of cell line authentication is costing $4 billion.
Dr. Cousins: There are multiple high throughput screening (HTS) academic centers around the world (150 in US). So where does the industry go for best practices in assays? Eli Lilly had developed a manual for HTS best practices and in 1984 made publicly available (Assay Guidance Manual). To date there have been constant updates to this manual to incorporate new assays. Workshops have been developed to train scientists in these best practices.
NIH has been developing new programs to address these reproducability issues. Developed a method called
“Ring Testing Initiative” where multiple centers involved in sharing reagents as well as assays and allowing scientists to test at multiple facilities.
Dr.Tong: Reproduceability of Microarrays: As microarrays were the only methodology to do high through put genomics in the early 2000s, and although much research had been performed to standardize and achieve best reproduceability of the microarray technology (determining best practices in spotting RNA on glass slides, hybridization protocols, image analysis) little had been done on evaluating the reproducibility of results obtained from microarray experiments involving biological samples. The advent of Artificial Intelligence and Machine Learning though can be used to help validate microarray results. This was done in a Nature Biotechnology paper (Nature Biotechnologyvolume28, pages827–838 (2010)) by an international consortium, the International MAQC (Microarray Quality Control) Society and can be found here
However Dr. Tong feels there is much confusion in how we define reproduceability. Dr. Tong identified a few key points of data reproduceability:
Traceability: what are the practices and procedures from going from point A to point B (steps in a protocol or experimental design)
Repeatability: ability to repeat results within the same laboratory
Replicatablilty: ability to repeat results cross laboratory
Transferability: are the results validated across multiple platforms?
The panel then discussed the role of journals and funders to drive reproduceability in research. They felt that editors have been doing as much as they can do as they receive an end product (the paper) but all agreed funders need to do more to promote data validity, especially in requiring that systematic evaluation and validation of each step in protocols are performed.. There could be more training of PIs with respect to protocol and data validation.
Other Articles on Industry/Academic Research Partnerships and Translational Research on this Open Access Online Journal Include
Please check daily on this OPEN ACCESS JOURNAL for updates on one of the most important BIO Conferences of the year for meeting notes, posts, as well as occasional PODCASTS.
The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry. The event features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities. The Convention also features the BIO Business Forum (One-on-One Partnering), hundreds of sessions covering biotech trends, policy issues and technological innovations, and the world’s largest biotechnology exhibition – the BIO Exhibition.
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BIO has a diverse membership that is comprised of companies from all facets of biotechnology. Corporate R&D members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. The majority of our members are small companies 90 percent have annual revenues of $25 million or less, reflecting the broader biotechnology industry. Learn more about how you can save with BIO Membership.
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66% R&D-Intensive Companies *Of those: 89% have annual revenues under $25 million, 4% have annual revenues between $25 million and $1 billion, 7% have annual revenues over $1 billion.
Translating Genetics into Medicine, April 25, 2019, 8:30 AM – 6:00 PM, The New York Academy of Sciences, 7 World Trade Center, 250 Greenwich St Fl 40, New York
2019 Koch Institute Symposium – Machine Learning and Cancer, June 14, 2019, 8:00 AM-5:00 PM ET MIT Kresge Auditorium, 48 Massachusetts Ave, Cambridge, MA
FDA chief Scott Gottlieb steps down, leaving pet projects behind
FDA Commissioner Scott Gottlieb was appointed by President Trump in 2017. (FDA)
Not quite two years into his stewardship of the FDA, Scott Gottlieb, M.D., is stepping down. His sudden departure will likely send shock waves through biopharma, because the commissioner was popular for his market-based policies to lower drug costs and work to speed new brands to approval.
Gottlieb won Senate confirmation as FDA commissioner back in May 2017, an uncertain time for the drug industry. During the selection process, his name had been favored by a majority of biopharma executives polled by an analyst. At the time, one anonymous executive said he’s the “least likely to rail for the obliteration of the current efficacy, safety, risk-benefit model that is a foundation for advancement of new treatments in the United States”—unlike at least one other candidate for the job.
That preference proved out after Gottlieb took over the agency, as his policies favored speed and competition. And when the news broke Tuesday afternoon, the industry trade group PhRMA praised his “exemplary leadership.”
“During his tenure, he focused on innovation in drug development and review, increased competition, and advanced the regulatory framework for approving novel technologies, including gene therapies,” the organization said in a statement. “His efforts have made a meaningful impact for patients in need of innovative medicines.”
Gottlieb tweeted Tuesday that he’s “immensely grateful” for the opportunity to lead the FDA. In a letter to colleagues, he wrote that “there’s nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and two young children.”
President Donald Trump tweeted that he’s done an “absolutely terrific job” and will be missed.
In his resignation letter, tweeted by STAT reporter Matthew Herper, Gottlieb reviewed his efforts at the agency over the past two years. It’s a long list, but here are a few examples:
The FDA worked to avoid drug shortages after a hurricane struck Puerto Rico,
led a global investigation into drug impurities,
advanced reviews of cell and gene therapies, and
bolstered approvals of complex generic drugs.
Also under his command, the FDA took quick and decisive action on drug costs. The commissioner worked to boost generic approvals and crack down on regulatory “gaming” that stifles competition. He additionally blamed branded drug companies for an “anemic” U.S. biosimilars market and recently blasted insulin pricing.
His sudden departure will likely leave many agency efforts to lower costs up in the air. After the news broke, many pharma watchers posted on Twitter that Gottlieb’s resignation is a loss for the industry.
During his tenure as FDA commissioner, Gottlieb’s name had been floated for HHS chief when former HHS secretary Tom Price resigned due to a travel scandal, but Gottlieb said he was best suited for the FDA commissioner job. Now, former Eli Lilly executive Alex Azar serves as HHS secretary, and on Tuesday afternoon, Azar praised Gottlieb for his work at the agency.
New FDA commissioner Gottlieb unveils price-fighting strategies
New FDA commissioner Scott Gottlieb laid out some approaches the agency will take to fight high prices.
During the campaign and since the U.S. presidential election, President Donald Trump has pledged to bring down drug costs and, in some cases, railed against the industry for its pricing. Now, his new FDA commissioner is laying out some approaches the agency will take to fight high prices.
Importantly, the FDA can’t regulate drug prices, but it can implement measures aimed at deterring the types of price hikes that have made so many headlines over more than a year.
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At a U.S. House of Representatives budget hearing on Thursday, new FDA commissioner Scott Gottlieb said his agency will publish and regularly update a list of medications that are off patent and have no competition, work to improve generic review times and seek to “curtail gaming” of regulations by the industry that allows companies to extend patent monopolies.
On the first point, Gottlieb said a regularly updated list of off-patent meds could “entice competitors into the market” and ultimately lower costs. One such old, off-patent med with no generic competition is infamous to industry watchers: Daraprim.
Back in 2015, after picking up the medication from Marathon Pharma, Martin Shkreli’s Turing Pharma raised Daraprim’s price exponentially, triggering intense backlash.
In his opening remarks at the budget hearing, Gottlieb said he’s working on a “drug competition action plan” that he will unveil soon. However, the new commissioner did offer a few strategies to lower costs.
The FDA will work to “improve processes that enable generic versions of complex drugs to be approved for marketing,” and simplify the overall generic review process, Gottlieb said. He wants the agency to achieve those goals while “completely eliminating” a backlog of generic medications waiting for a review, he told members of Congress.
Further, the FDA will seek to stop misuse of Risk Evaluation Mitigation Strategies that have hurt generic drug developers’ ability to get samples of branded medications needed to develop copycats.
The proposals will likely be welcomed by those who’ve asked for drug pricing reform but have seen little action from Congress despite more than a year of calls from its members to rein in drug prices.
In a Thursday statement, the pharmacy benefit manager industry group PCMA hailed the proposals.
“As the Trump administration seeks to combat high drug costs, we applaud FDA Commissioner Gottlieb’s decision to publish a ‘watch list’ of off-patent drugs,” PCMA CEO Mark Merritt said in a statement. “This move, which PCMA and others have long advocated, will help deter manufacturers from buying the rights to drugs like Daraprim for the explicit purpose of raising their price.”
UPDATED 3/19/2019
National Cancer Chief, Ned Sharpless, Named F.D.A.’s Acting Commissioner
Dr. Norman E. Sharpless was named acting commissioner of the Food and Drug Administration on Tuesday. For the last 18 months, he had been director of the National Cancer Institute.CreditTom Williams/CQ Roll Call, via Getty Images
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Dr. Norman E. Sharpless was named acting commissioner of the Food and Drug Administration on Tuesday. For the last 18 months, he had been director of the National Cancer Institute.CreditCreditTom Williams/CQ Roll Call, via Getty Images
WASHINGTON — Dr. Norman E. (Ned) Sharpless, director of the National Cancer Institute, will serve as acting commissioner of the Food and Drug Administration, Alex M. Azar III, secretary of health and human services, announced on Tuesday.
Dr. Sharpless temporarily will fill the post being vacated by Dr. Scott Gottlieb, who stunned public health experts, lawmakers and consumer groups last week when he abruptly announced that he was resigningfor personal reasons.
Dr. Sharpless has been director of the cancer center, part of the National Institutes of Health, since October 2017. He is also chief of the aging biology and cancer section in the National Institute on Aging’s Laboratory of Genetics and Genomics. His research focuses on the relationship between aging and cancer, and development of new treatments for melanoma, lung cancer and breast cancer.
“Dr. Sharpless’s deep scientific background and expertise will make him a strong leader for F.D.A.,” said Mr. Azar, in a statement. “There will be no let up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”
Dr. Douglas Lowy, known for seminal research on the link between human papillomavirus and multiple cancer types including cervical, and ultimately leading to development of a vaccine, will be named head of the NCI to replace Dr. Sharpless. Dr. Lowy currently is Deputy Director of the NCI.
Other posts on the Food and Drug Administration and FDA Approvals during Dr. Gotlieb’s Tenure on this Open Access Journal Include:
Pharmaceutical Consulting Consortium International Inc. presents their 7th annual Roundtable on Crowdfunding for the Life Sciences and how this funding mechanism applies to early stage life science companies and changes the funding landscape. The conference will examine the types of crowdfunding out there and attempts to answer many questions including:
Which one is right for which new companies at which stage of the funding process?
And how will choosing the right or wrong one influence follow-on funders and funding rounds?
Will the advent of crowdfunding speed up the investment process?
Will it really bridge the yawning “valley of death”?
The panel is made up of notables and practitioners who will be called upon to deal with the pros and cons of crowdfunding in real life and let them discuss how all this is likely to apply to life science entrepreneurs and investors.
The panel includes:
Mark Roderick, Attorney Flaster/Greenberg PC (Moderator)
Valerie Gaydos, President, Capital Growth (represents angel/venture community)
Samuel Wertheimer, Chief Investment Officer, Poliwogg Darrick Mix
Duane Morris, LLP (journalist who covers crowdfunding
Register by clicking on www.rxpcci.com and following directions The event will be webcast.
Leaders in Pharmaceutical Business Intelligence had recently launched a new, real-time based methodology for meeting coverage using social media as a platform to foster discussion and commentary.
This new method was successfully used and curated at the 2nd Annual Sachs Cancer Bio Partnering &Investment Forum at the New York Academy of Sciences and will be featured at the forthcoming Sachs Global Conferences in 2014 and 2015.
These days many research universities are constantly looking for new grant competitions and encouraging their faculty members to apply. On Friday, the University of California at Los Angeles took the unusual step of telling professors not to apply to a major new grant competition from a pharmaceutical company, saying that the program violated university rules.
An e-mail marked “urgent” was sent Friday to all faculty members and deans about the Discovery Fast Track Competition, which was just announced this month and for which the sponsor — GlaxoSmithKline — is approaching faculty members directly, bypassing technology transfer offices at universities.
The company announced that the program was an attempt to reward academic researchers by offering a “fast track” to financing their most creative ideas. Faculty members are invited to submit short proposals and promised a quick decision later this year, leading to funding. The news release announcing the program this month said that grants would start promptly, without contract negotiations between the company, the researchers or their universities.
“To avoid initial contract negotiations, which are often perceived as the biggest bottleneck in the pharma/academia collaborative process, the [GlaxoSmithKline] team conceived the Discovery Fast Track competition as a means to rapidly identify and screen the most promising hypotheses in academia,” it said.
Faculty members just started to receive invitations last week, and when UCLA officials saw the terms of the proposed agreement, they took a step they have not taken previously — and told the entire campus not to apply.
“Please be advised that the terms and conditions do not adhere to UC policy because faculty have prior and ongoing obligations under the patent policy to disclose all discoveries to the university and have assigned patent rights to the university. Participation in the GSK competition would violate these policies and obligations,”said the e-mail, from James S. Economou, vice chancellor for research, and Brendan J. Rauw, associate vice chancellor for research and executive director of entrepreneurship.
In an interview, Rauw said that most proposals for corporate support for faculty members are coordinated through the university, which can negotiate terms consistent with university rules. He said that there was an inherent problem in a company saying that there could be no contract negotiations. Further, Rauw said that faculty members were being asked to give away rights they didn’t necessarily have (since the university has rules both for sharing intellectual property and assuring that agreements are consistent with academic principles). He also said that the phrasing of the grant proposal suggested that “background IP” from past work might be covered — even though it was not clear the company was entitled to those rights.
“This opens up our entire portfolio to a pharma company with no guarantee that our rights will be protected,” he said.
Rauw said UCLA faculty members may be among the first to have received the invitations. When he conferred with colleagues on other UC campuses last week, they had yet to receive grant details.
He noted that there has been “a perception” that universities “have given too much away” when dealing with pharmaceutical companies. Rauw said that UCLA has approved of grant relationships between GlaxoSmithKline and faculty members in the past (without problems), and that UCLA has reached out to the company to talk about how rules might be changed so that faculty members could participate.
“This is a challenging situation for us,” he said. “We are trying as a university to be open for industry and find opportunities for increased collaboration. But there is a balance there. We had to make a decision that this went too far.”
A spokeswoman for GlaxoSmithKline Friday said via e-mail Monday that she couldn’t comment on the UCLA concerns directly, but that the program was “designed to balance the playing field and avoid early IP contract negotiations, which can be the biggest obstacle to collaborative drug discovery.” She added that “there may be situations where initial interpretation of the Discovery Fast Track terms & conditions … will preclude some technology transfer officers from allowing researchers affiliated with their institution to participate,” but that she hoped university officials would “make a determined effort to read the competition documents … in detail before coming to a conclusion as to the provisions of these documents and competition outcomes.”
Last week I moderated a panel called “The New Rules of Partnerships and Collaborations” at the Convergence East conference on Cape Cod, and the experience gave me a chance to probe some of the biopharma industry’s top dealmakers about their preferences and prejudices going into talks with other companies. I’ve decided to write down three key observations or “rules” that emerged during the panel and other notes from the Convergence meeting.
1. Competition is heating up for compelling clinical-stage assets–and not just those in Phase III trials. Take Biogen Idec’s ($BIIB) recent buyout of Stromedix for its Phase II-ready antibody STX-100 for combating fibrosis. Apparently, Pfizer ($PFE) was interested in buying the asset, Jose-Carlos Gutierrez-Ramos, senior vice president of biotherapeutics R&D at the drug giant, revealed during the panel. Gutierrez-Ramos and Steven Holtzman, Biogen’s chief dealmaker (who obviously won the Stromedix deal), traded some jabs about why Biogen prevailed. The bottom line: Stromedix had options.
2. Which partners are most coveted among biotechs? At least in oncology, Celgene ($CELG) appears to be winning over collaborators. In one off-the-record conversation, two heads of business development told me that biotechs are warming up to the flexibility and creativity of the Summit, NJ-based drugmaker in deals. Celgene has been quite active with the recent buyout of Avila Therapeutics,partnership deal with Epizyme and ongoing tie-up with Agios Pharmaceuticals. Yet I wonder whether sharp biotech dealmakers in Cambridge, MA, are getting the best of Celgene at the negotiating table.
This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Register Now!
For instance, one of my panelists, Anna Protopapas, executive vice president of global business development at Takeda Pharmaceutical, didn’t think that her company would have bought Avila Therapeutics under the terms that Celgene did early this year. Protopapas noted that the key asset in the deal, Avila’s Phase I Btk inhibitor, is a third-in-class compound, and first-in-class cancer drugs have an edge because of the difficulty that later drugs in the same class face in besting them. Did Celgene–which shelled out $350 million upfront and promised up to $575 million more in milestones–overpay for Avila?
3. Big Pharma can be your friend. Sure, we know about the monumental problems large drugmakers face from expiring patents on key drugs and assaults on their old business models. And, yes, drugmakers are entertaining all kinds of diverse deal structures with biotech companies to soften the blow. Yet every week or so we learn of another strategy drugmakers are using to efficiently develop products. Pfizer’s Gutierrez-Ramos shared one with me (though it wasn’t covered during the panel). He’s now looking for biotech partners that are interested in taking over development of drugs from Pfizer’s pipeline. He’s offering the compounds for free and willing to share in the success of the programs down the line.
Of course, Pfizer’s strategy here builds on the Center for Therapeutic Innovation, which the drug giant expanded last year through several collaborations with academic groups, which work with CTI on translational research. Like CTI, externalizing clinical development of Pfizer compounds at biotech companies, including venture-backed startups, lets the drug giant tap expertise that doesn’t reside under its own roof.
“I think the misperception is that,” outside of large buyouts and tiny deals, “Pfizer is not a great partner to work with because, due to the big acquisitions, we are product-driven [and] that the perception out there is that we just want products,” Gutierrez-Ramos said. “And what we have been trying to re-prove over the last two years is that the new Pfizer is not like that.” — Ryan McBride (Email | Twitter)
Big Pharma companies’ insatiable needs for growing their pipelines and grabbing dibs on hot new science send them running to academic labs. With some pharma groups slashing internal R&D, drugmakers have taken a shining to funding discovery and early R&D work at universities and academic medical centers.
Pharma groups have dabbled in commercializing innovations from academia for decades, but what’s happened more recently is a drive to expand the number and breadth of collaborations with academics and other external groups. Traditional pharma players such as Sanofi ($SNY), Eli Lilly ($LLY) and Pfizer ($PFE) have realized that their internal R&D groups alone aren’t enough.
Here we’ve rounded up 20 notable pharma-academic collaborations from 2012 or those that made headlines this year. Check out the list and learn where Big Pharma is placing its bets and seeding projects that could yield big-time products down the road.
Indiana’s biotech cluster just got a big boost. Eli Lilly ($LLY) and Roche Diagnostics ($RHHBY) have joined an industry consortium that will help launch a new research institute in Indiana that plans to hire a staff of about 100 investigators to pursue new treatments for a slate of metabolic diseases. And they’ll be joined by Notre Dame, Purdue and Indiana University, with the state chipping in the first $25 million of a $50 million startup fund.
Industry and philanthropic groups are being tapped for the second half of that start-up budget, with future bills covered by industry and government-sponsored research programs into cardiovascular disease, diabetes, obesity and nutrition. The Indiana Biosciences Research Institute has already put out feelers for a new director and staff, which will be expected to help lead teams of collaborators drawn from the industry as well as regional universities.
The new institute’s research mission fits neatly into Eli Lilly’s corporate R&D strategy, which is closely focused on diabetes as one of its key disease areas.
INDIVIDUAL SESSION: $129, FULL SERIES: $239This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Register Now!
“The Indiana Biosciences Research Institute will attract local and national scientific leaders beginning with the CEO and the recruitment of research “Indiana Fellows,” says the group’s press release. “These research fellows will lead teams of scientists and partner with industry and universities on research projects. These teams will consist of experts across a spectrum of competencies, including bioengineering, bioinformatics, nanotechnology and agriculture. These cross-functional teams will share resources and research laboratories at the Indiana Biosciences Research Institute and will work onsite at industry and research university labs with academic and industry scientists.”
– here’s the press release
– read the story from the Indianapolis Business Journal
Will ‘gamifying’ drug R&D win more than Facebook fans for Boehringer?
By Tracy Staton, FiercePharma, August 22, 2012
Lots of computer games enlist players in quests to save the world. But how many would-be saviors are developing drugs? We can’t think of any–until now. Boehringer Ingelheim is on the verge of launching Syrum, a Facebook game of test tubes and titrations, not crossbows and assault rifles.
“The health of the world is in your hands,” Boehringer’s director of digital, John Pugh, tells PSRK, in what could be a voice-over for a YouTube promo video for the game. “And you’re the only one who can save it.”
Players have to solve a problem–e.g., a pandemic–via drug development, all the way from early discovery through clinical trials and launch. They can enlist help from Facebook friends, and advance in the game by checking into locations via the social network’s mobile app. “It wasn’t built with a view to being an educational platform,” Pugh says. “It’s very much a game which is meant to be engaging and entertaining … In the same way that Farmville doesn’t just appeal to people who like farms, Syrum isn’t just for people who like the pharmaceutical industry.”
But it was education that drew Pugh and his team into the project; as he points out for PSFK, the industry does a lot of it, whether that’s “educating” doctors about products, or teaching patients how to take their meds properly. Just because the game isn’t designed as an educational platform doesn’t mean it can’t educate, in a stealthy, backhanded way.
Syrum has been in development for two years. On Sept. 13, Boehringer will unveil a beta version at a London conference, aiming to get feedback from players for future iterations. “[T]he game will grow and evolve as more people play it,” Pugh says.
He also says Syrum is a “very unique offering from a highly regulated industry.” True. Whether it will remain unique depends, in part, on how Syrum actually fares. Will it attract a following? And if it does, will gamification of drug development actually benefit Boehringer’s business? Image? Relations with patients? Pharma’s social media advocates (and skeptics) will be watching.
John Pugh, Director of Digital for Boehringer Ingelheim, talks about driving innovation in his large organization with the forthcoming game Syrum – which he will launch at PSFK CONFERENCE LONDON on September 13.
John Pugh is the Director of Digital for Boehringer Ingelheim GmbH – a group of pharmaceutical companies that specialize in research and development for prescription medicine products. He spoke to PSFK recently about driving innovation in a large organization with his forthcoming game Syrum – which he will launch at PSFK CONFERENCE LONDON on September 13.
Your company has a new game, Syrum. What is it – and why is a pharmaceutical company like Boehringer Ingelheim involved in it?
What really sparked my interest in the potential of gaming is that a lot of what we do in pharma is around educating and teaching people; whether that’s teaching doctors about specific products, educating the general public and patients about diseases and healthy ways to live, or teaching people how to take their medication.
Gaming seems to be a useful way and effective way for us to do that. I basically began the journey to try and work out what I could do in gaming that wasn’t an arcade or platform based game — but was something a bit more immersive.
Syrum has been in development for at least two years. At the beginning, we called in lots of experts from different industries, different locations in countries, and with different skill sets. We had various leaders, from specialized futurologists to branding experts, from pharma people to gaming people, and even young entrepreneurs who’d made a million dollars by the age of 17.
We really worked together to create a vision of the future, and one of the strong things that came through was the influence of gaming and gamification.
After two years of hard work, the result is that we are about to launch Syrum, the pharmaceutical industry’s first social game.
Can you tell us a little more about the gameplay in Syrum?
Syrum is a social game. The health of the world is in your hands, and you’re the only one who can save it. In each chapter, you have to solve a particular problem, which could be a disease or a pandemic that is sweeping the world. The player’s goal is to discover cures, create a stable drug, and then create a clinical trial so that you can launch the drug and cure the disease.
It’s a social game, because you can collaborate with friends or other people, and you can give them gifts, even headhunt their staff. As the game progresses, it gets more and more complicated.
What do you think people will get out of it?
First, it’s a fun game. It wasn’t built with a view to being an educational platform or anything like that. It’s very much a game which is meant to be engaging and entertaining to play. In the same way that Farmville doesn’t just appeal to people who like farms, Syrum isn’t just for people who like the pharmaceutical industry. It’s for anyone to play.
It’s built on Facebook because that’s the world’s biggest gaming platform. What we really wanted to do was try to use a lot of the features of Facebook. For example we leverage Facebook Places, a service where people can check into locations. It’s really bridging that offline/online world. Places helps players market the products they make. Wherever the players check in through the Facebook mobile app, that data gets integrated into the game and you get rewarded accordingly.
When will it be available?
September 13. We are taking a Silicon Valley approach, where we know we have got a really good game that’s stable but we’ll launch a beta version. We really want to make it so that we get lots of feedback from the people who are playing.
We’re offering rewards and prizes for people to give feedback so that we can really create the duration of the game, and develop it, and have more of a crowdsourced collaborative effort to develop the future stages of it, so the game will grow and evolve, as more people play it. This is a very unique offering from a highly regulated industry.
Can we finish by understanding your role within the organization – and how you drive change.
My job is anything which is connected to digital, so that includes apps, mobile, websites, gaming, crowdsourcing, and so forth. Our goal is to find applications for all of that. I bring to this company new ideas and I inspire them, educate them, cajole them, prod them to try new things, particularly in digital. I want BI to stretch out beyond the traditional marketing activities because in pharmaceuticals, and particularly at Boehringer, we’re still very traditional in what we do.
After a Facebook PR meltdown two years ago, Sanofi has emerged as a social media leader with a robust community for diabetics. Here’s how they are writing #TheRules while the FDA catches up.
Follow Fast Company’s roadmap to social media: surefire rules, data, and expert wisdom guaranteed to show why this market is completely unpredictable.READ MORE
The biggest challenge to treating patients with diabetes isn’t doling out medications, it’s making sure that people control their habits. Poor diet and lack of exercise generally create complications with the disease. To combat the problems, researchers in the diabetes division of Sanofi US took an unusual step for Big Pharma: they went social, jumping into online networking with a Facebook page, Twitter presence, and eventually three different engagement platforms.
“Treatment is an important aspect to blood sugar management, but it isn’t the only aspect,” says Laura Kolodjeski, Sanofi’s diabetes community manager, who has become the virtual face of the company. “There is a huge community of people already that live with diabetes and are connecting and sharing [online] to improve each other’s experience with the disease.”
Sanofi now helps direct and police those interactions online. The company won’t release total visitor numbers, but it has about 4,000 followers on Facebook and another 4,000 on Twitter, all of whom are sharing links to broader content. And for better or worse that community is going to grow: About 8 percent of Americans or roughly 26 million people have diabetes, and the Centers for Disease Control predicts that as many as one third of us could have the disease by 2050.
But the social frontier is potentially prickly for Sanofi because the FDA has not yet written the rules about how pharmaceuticals are allowed to engage with potential customers and patients. The only guidelines came out in a December 2011 advisory statement declaring that while allowing virtual comments about things like off-label uses isn’t technically illegal, it’s shady territory; basically, pontificate at your own risk. “We are working on the area and it’s something we feel is important but we don’t have a specific timeline right now,” says Ernest Voyard, senior regulatory council at the FDA’s Office of Prescription Drug Promotion.
For Sanofi, drawing up their own social media strategy is also a defensive move: In 2010, the company’s cancer division suffered a PR nightmare after a patient, who claimed to have experienced permanent hair loss from one of their treatment drugs, posted complaints and photos on that group’s unmonitored Facebook page. John Mack, the editor of Pharma Marketing News, which tracks shifts in the pharmaceutical industry, says such hits are common anytime you try to pioneer a new space. “They’ve had some rough times, but they are learning a lot,” he adds.
Mack considers Sanofi a leader in the category, especially compared with the offerings from other companies. Diabetes juggernaut Novo Nordisk sponsors IndyCar driver Charlie Kimball to tweet @racewithinsulin, including when he injects with their products. And Pfizer’s ThinkScienceNow blog about developments and advances in research is wonky but not exactly customer friendly.
Sanofi has created a template they hope will eventually be deemed both acceptable to the FDA and cool for customers. The lessons they’ve learned in the last two years is a valuable addition to The Social Media Roadmap from our current issue.
Be Transparent
When she took over as social media director, one of the first things Kolodjeski did was post a bio with a photo of herself online at DiscussDiabetes to show who was moderating. She also disclosed that she wasn’t diabetic. Why? To build trust, the kind community members might not have for a faceless company run by mostly non-diabetics. The message: “If Laura is going to work every day to solve [issues] on our behalf, then others must be doing the same,” Kolodjeski says.
Rather than just explain the rules of their forums in a jargon-y “terms of use” agreement Kolodjeski also tapped Mark Gaydos, head of the company’s U.S. regulatory affairs for marketed products division, to do a Q&A about how the sites would function. For instance, anytime someone on the site mentions a product, they are technically promoting it, so there needs to be fair balance of potential benefits and risks explained alongside that per FDA guidelines. That means many posts get quarantined internally before posting, so the company can add additional links or annotations to more information. Sanofi only wants to allow discussion of FDA-approved uses for products–any mention of possible side-benefits or bonuses from tweaking the usual dose regimen is prohibited. To make sure everything meets these requirements, there is often a delay–sometimes up to 24 hours–between when users make comments and those comments become publicly visible.
To explain their business interest, Kolodjeski also interviewed Dennis Urbaniak, the head of the company’s U.S. diabetes business unit to explain what he calls the “360-degree partner” principle–an effort to inspire others to talk more and tap into that as a focus group for new ideas.
Let Users Shape Expansion
Sanofi launched their diabetes Facebook and Twitter handles in September 2010 mainly to offer news updates about the company and its offerings. On Facebook, any clinical questions were directed to a separate tab and often answered privately. On Twitter, medical concerns were covered via direct message. What was missing was a way to collect various poster’s lifestyle tips and inspirational messages all in one place. In January 2011, the company launched DiscussDiabetes to address that. They also run their own stories about successes, including highlights from A1C Champions, another company sponsored group of diabetics who have maintain the best or “A1C” target range of blood sugar levels.
By March of this year, the company took a look at the discussions that were being generated and realized that terms like A1C weren’t actually as universally understood as they once thought. To speed that learning curve, they launched Diabetepedia, which provides both simple definitions and links to other sites showing how terms are actually used in other online conversations.
The final step: After noticing how activity at Diabetepedia was spiking, Sanofi launched another site collecting lots of the content they were already linking to all in one place. The DX, which launched at the end of May, hosts daily dispatches by both Kolodjeski and stable of already popular bloggers (none of whom are paid directly) that include everything from a diabetes related comic strip to mommy blogs for parents with diabetic kids. “We really allowed the community to help identify what might be useful to them and where they might go next,” Kolodjeski says.
Give Users Even More Control
The medical glossary at Diabetepedia doesn’t just provide standard definitions to complex terminology, users are encouraged to submit their own entries, creating a sort of slang dictionary that makes complicated stuff more relatable to newcomers. For instance, glucoaster: that’s shorthand for “a rollercoaster of blood glucose levels, with blood sugar lows followed by blood sugar highs.” User contributions have helped the database grow by 30 percent to include more than 150 terms, all of which make it easier to users themselves to better convey thoughts in future postings.
The company also considers each media outpost an exclusive “channel,” which means there is lots of cross-posting of content from different platforms to make sure users who only tune into one place are being best served. “We certainly have people that overlap but for the most part people have selected which channel they feel represented by and communicate through,” Kolodjeski says. But at each stop, the company still tries to crowdsource bigger ideas.
This year, they asked users to help set priorities for the company’s annual Data Design Diabetes Innovation Challenge, which asks individuals, businesses and non-profits to create new initiatives for using big data to help others struggling with the disease. To help brainstorm for that, Sanofi’s social media troop was given the chance to visit a competition homepage and answer questions about what aspects of life with the disease might be consistently overlooked or ignored. Their answers were used to shape a final guideline for contestants that solutions must address the overall wellness and family life of patients, not just symptom mediation. The winner: a program created by the n4a Diabetes Care Center that matches people with certain cost or risk profiles directly to the services they might need to slow the progression or expense of the disease. Mood problems can be addressed by better disease management, hopefully cutting into the 18 percent of all diabetics who require hospitalization each year.
After realizing just how open users are to sharing and connecting, Sanofi also launched their own new product, the iBGStar, a personal blood glucose monitor that plugs directly into an iPhone or iPod Touch with an app that saves data and maps correlations between blood sugar levels and meal times, carb and sugar intake, and physical activity. Users can share results with their family or email them to health care providers. But the product, which hit the market in May 2012, wasn’t just inspired by early community actions; ensuing reviews and comments in their own forums will help refine future updates. “It’s a big hit with the online community,” Kolodjeski says. “It’s also given us a great opportunity to prove back to them that if we hear someone comment about something, we have the ability to engage in a public manner.”
Correction: An earlier version of this article said that iBGStar came on the market in 2011, it was released in May 2012.
Nearly two years after launching its first major foray into the world of social media in the shape of its LillyPad corporate blog, Eli Lilly is developing a company-wide social media strategy.
Lilly has so far had strict rules about who can use social media on behalf of the company, authorising just a handful of people in corporate communications and government affairs, but now wants to empower other departments to do so.
“There are a lot of parts of the company that are getting interested in social media so I’m working on a strategy that will keep these aligned with one another,” Lilly’s director of corporate communications Greg Kueterman told SMI’s Social Media in the Pharmaceutical Industry conference on Monday.
“We don’t want to have eight different social media platforms that all look and sound very different from one another. So we’re going to try and do something where they all have their own identity but are still consistent within the company.”
Kueterman acknowledged LillyPad, launched September 2010, and the company’s Campaign For Modern Medicines, a US health policy initiative Lilly founded last year that uses Twitter, Facebook and YouTube, were set up “before we had a full blown strategy”.
“But sometimes that is important,” he said. “Because you have to know what you have, before you can make it even bigger.”
The company’s Clinical Open Innovation team, a group working to improve the drug development process, also began using social media earlier this year, with a blog and Twitter account.
The next stage for Lilly will be to continue its expansion of LillyPad (as previewed herein March), following the launch in May of a Canadian version of the corporate blog.
“We’ve started to go global with LillyPad and we’re working with a number of our affiliates to do this. Lilly Canada has been the first one out of the box to do that and they’re off to a nice start,” Kueterman said.
Discussions are underway with the company’s European affiliates in the UK and Belgium along with its operations in Mexico. “Hopefully some of those are going to be launching this year, although we don’t have firm dates yet,” Kueterman said.
“We’re excited that this is a programme that’s going to start picking up momentum. Looking ahead there are still things that we can do much better. I’m never really satisfied with the way things are going with LillyPad – I’m happy, because I think we’re doing things the right way, but I also believe that we can be even more proactive than we are.”
On Monday, I had the pleasure of presenting Lilly’s social media history and strategy at a conference in London. The history part was easy: LillyPad — our first major platform — has been around for 22 months. We’re not experiencing the Terrible Twos just yet, but we’ve still got plenty to learn.
The London audience — consisting of European and U.S. communicators and marketing experts at the Social Media for Pharmaceutical Industry conference. — warmly embraced our strategy of addressing issues such as public policy and medical innovation. And the reception was not unusual. Over the last two years, we’ve talked LillyPad in live settings from London to New York to Indianapolis to San Francisco — and our peers typically offer two thumbs up for the good work.
For that, we are grateful. But it’s a good reminder about a couple questions we need to ask more often:
What else can we be doing? What else should we be doing?
As our loyal readers, you know what we offer — and you know what you need to become more informed. We would love to hear more from you: the good, the bad, and the ugly. We’re always looking to enhance LillyPad, and we’ve taken a lot of steps in recent months to do so (more video, more guest blogs, and — we think — clearer, more conversational writing). And while we will remain a non-product communications vehicle, we’re open to any and all ideas that make your LillyPad experience even better.
From London (where I’ve seen more rain in three days than my backyard has seen in two months) thanks for reading!
Last August, UPenn scientists announced the dramatic results of a tiny clinical trial of their immunotherapy approach, describing long-lasting remissions in leukaemia patients for whom standard therapies had stopped working. Trials are also underway for other leukaemias and for lymphoma, mesothelioma, myeloma and neuroblastoma, according to the university.
The therapy developed by UPenn’s Carl June is complicated. Vaccines prompt a patient’s immune system to attack dangerous cells through an approach, called chimeric-antigen-receptor immunotherapy – a genetically redesigned immune cells for a more powerful attack. In this therapy first, blood is collected from leukaemia patients and exposed to substances that activate T cells, powerful cells that launch and coordinate immune attacks. Next, the T cells are genetically modified to recognize and attack leukaemia cells. Finally, the altered cells are returned to the patient, where they are expected to proliferate until the cancer cells are gone.
Drug giant Novartis is making a multimillion dollar bet that a patient’s immune system can be cancer’s worst enemy. It is teaming up with scientists at the University of Pennsylvania (UPenn) in Philadelphia to develop and manufacture cancer immunotherapies.
In the US$20-million collaboration, announced today, Novartis, which is based in Basel, Switzerland, will get exclusive worldwide rights to these technologies.
Last week I moderated a panel called “The New Rules of Partnerships and Collaborations” at the Convergence East conference on Cape Cod, and the experience gave me a chance to probe some of the biopharma industry’s top dealmakers about their preferences and prejudices going into talks with other companies. I’ve decided to write down three key observations or “rules” that emerged during the panel and other notes from the Convergence meeting.
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Amandeep Kaur
Aashir Awan, Phd
Abhisar Anand
Adina Hazan
Alan F. Kaul, PharmD., MS, MBA, FCCP
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aviralvatsa
David Orchard-Webb, PhD
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Demet Sag, Ph.D., CRA, GCP
Dror Nir
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Ethan Coomber
evelinacohn
Gail S Thornton
Irina Robu
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jdpmd
jshertok
kellyperlman
Ed Kislauskis
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Madison Davis
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Dr. Pati
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ritusaxena
Rick Mandahl
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Srinivas Sriram
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Dr. Sudipta Saha
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