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8 | AUGUST 2014 | GENengnews.com | Genetic Engineering & Biotechnology News Alex Philippidis Despite all the hype about its transforming business relationships, half of the top 50 phar- maceutical companies make no use of social media, according to an IMS report released in January. The report showed only one pharma using social media effectively—Johnson & Johnson, whose score of "70" was almost three times that of the next highest-scoring pharma (25 for GlaxoSmithKline). That percentage of nonusers should be expected to decrease now that big phar- mas—not to mention biotechs and medical device companies—have some detailed ad- vice for how to use social media in two key instances. In a pair of draft guidances issued June 17, the FDA offered overdue param- eters for what is acceptable speech, and what isn't, on social media outlets. One guidance makes recommendations on presenting risk-and-beneft information for drugs or devices using social media that rely on character-limited messages, such as Twitter and paid search result links on Google or Yahoo. The other guidance fo- cused on recommendations for companies attempting to counter misinformation spread by critics or other users on third-party sites. The sheer volume and speed of social me- dia commentary, plus the additional challenge on some forums of limited character space, pose formidable challenges for biopharmas that the draft guidances partially address. "Companies are looking for some guidance from the agency on how to deal with that. Cer- tainly, these draft guidance documents are an important frst step in that direction," Glenn M. Engelmann, a senior counsel with the law frm McDermott Will & Emery based at its Washington, DC, offce, told GEN. "I suspect you'll see companies being more engaged in social media than they have in the past," said Engelmann, who is vice chair of the law frm's Life Sciences Industry Group and a former member of AstraZen- eca's executive leadership team responsible for managing the U.S. business."Until now, companies have held back in terms of cor- recting misinformation because they were not confdent as to how FDA would treat their involvement." He added that the guid- ances won't make companies more or less likely to escalate social-media disputes with critics into lawsuits. Risk-Benet Analysis Two industry groups representing U.S. bi- opharmas said they are evaluating the guid- ances and reviewing them with members, in advance of comments to be submitted later this year to the website www.regulations. gov. FDA has set a 90-day period for feed- back that ends September 16. "We are encouraged that FDA is proceed- ing with providing us with much needed guidance in this area," Tracy Cooley, a spokeswoman for the Biotechnology Indus- try Organization (BIO), told GEN. Jeffrey K. Francer, vp and senior counsel with Pharmaceutical Research and Manu- facturers of America (PhRMA), told GEN that his group had yet to fully vet the draft guidances with members, but did say the draft guidance for limited-character media was especially helpful. "It's been very challenging for companies to use Twitter in a way that the FDA pre- scribes, because the FDA wants to see both beneft and risk information everywhere, not just after the link," Francer said. Francer said PhRMA has proposed in the past that companies be allowed to use graph- ic symbols to indicate risk, with a short state- ment about what the drug does, and a link to more detailed risk-beneft information. Such character-limited messages would be along the lines of the FDA's Twitter tweets every time the agency approves a new drug, which include links with the details about risks and benefts rather than embedding info within the tweets. "The companies want to provide informa- tion that's useful to physicians and that's use- ful to patients, and they should be able to use all the different media that the government uses itself," Francer said. "I assume that the FDA believes that its own tweets are truthful and not misleading. If they believe that, then why couldn't a company use Twitter in the same way that the FDA is using Twitter?" "It actually raises, I think, important First Ammendment issues," Francer con- tended. PhRMA also cited free-speech concerns with a January draft guidance in which FDA advised companies on regulatory requirements for post-marketing submissions for prescription human and animal drugs and biologics to "interactive promotional me- dia"—not only social media but blogs and podcasts. Addressing the agency, PhRMA said that draft guidance "could chill truthful and nonmisleading communication protected by the First Amendment" by assuming that all manufacturer statements about prescription medicines on social media constituted promo- tional labeling or advertising. Winning and Losing The latest draft guidances give drug de- velopers both a serious logistical hurdle in limited-space communication, and some needed help for companies faced with untrue criticism on social media that allow for more than 140-character responses. Unfortunately for biopharmas, the limit- ed-character draft guidance insists on con- veying equally a drug's risk and beneft infor- mation within a single tweet, as well as a link to complete information. That may work for some drugs with relatively few risks, but for others, the draft may serve to discourage Twitter communication altogether, or reduce it to a drug name and indication. The agency should instead consider al- lowing biopharmas to communicate risks and benefts through separate but simultane- ous tweets. Another idea might be to allow tweets conveying drug benefts as responses to critical tweets conveying only risks. Companies receive a fairer shake from FDA in the draft guidance focused on cor- recting misinformation. Here, the FDA sets helpful standards: • Offer "appropriate corrective informa- tion" that is relevant, responsive, limited, and tailored to the misinformation, as well as accu- rate and nonpromotional, yet consistent with FDA labeling and supported by evidence. • Corrective information should either be posted in response to a post containing information, or presented to an administra- tor for posting as a response, by persons who disclose their affliation with the company involved. • A company should pinpoint what in- FDA Gets Social with Biopharmas POINT OF VIEW Much to "Like" in Draft Guidance on Misinformation, But Not on Limited-Space Forums formation it is correcting, and where—the portion of a social media forum, such as a thread on Facebook, for example. (Compa- nies, however, are not expected to correct all misinformation throughout a forum.) • When companies correct misinforma- tion, they may respond directly on the forum or request that the authors remove their mis- information or allow comments in response. "Regardless of the Internet source used to communicate about medical products, the public health is best served by clear, accurate, truthful and nonmisleading information about them," Thomas Abrams, director of the FDA's Offce of Prescription Drug Pro- motion, wrote on the agency's blog. The FDA should keep an open mind as biopharmas weigh in on social media, and companies should develop their own policies. Writing in Social Media Examiner on July 1, Johns Hopkins University professor and re- searcher Keith Quesenberry offered eight tips to companies that included sharing personal stories, saying "thank you," personalizing re- sponses, and probably the toughest of them all, owning up to mistakes. All of which, combined with the guidances, should enable biopharmas to effectively get social with phy- sicians and, especially, customers. > Protea Biosciences and InSphero inked a collaboration that will combine each company's respective 3D technology. InSphe- ro is a supplier of 3D organotypic microtissues for in vitro toxicology and efcacy studies, with models derived from liver, pancreas, tu- mor, and brain tissue. The collaboration will use Protea's LAESI® direct molecular imaging platform to analyze InSphero's 3D InSight™ microtissues, creating 3D molecular profles for tissue characterization, drug metabolism and distribution, and pharmacokinetic and toxicity applications. > Horizon Discovery entered into a non- exclusive agreement with Stanford University to access intellectual property related to the use of a serotype of AAV (adeno-associated virus) for commercial applications involving homologous recombination in gene editing. Created by Professor Mark Kay at Stanford, this artifcial serotype of AAV known as AAV- DJ efectively transduces a broader range of mammalian cells (>80%) than any naturally occurring AAV serotype, enabling Horizon to target an increased range of cell types. > The Translational Genomics Research Institute (TGen) and Ceres Nanosciences (Ceres) entered a development collaboration to beneft patients with cancer, infectious diseases, and other life-threatening illnesses. The Nanotrap technology was invented at George Mason University (Mason) un- der funding from the National Institutes of Health (NIH) for biomarker discovery applica- tions, and currently is being developed into commercial-grade products by Ceres with continuing support from NIH, the Defense Advanced Research Projects Agency (DAR- PA), the Department of Homeland Security (DHS), and the Commonwealth of Virginia. > Integrated DNA Technologies (IDT) acquired the SURVEYOR® enzyme business of Transgenomic. IDT is expanding its molecular biology product oferings by adding the SUR- VEYOR enzyme and kits. As part of the agree- ment, IDT will acquire the SURVEYOR product line and intellectual property. Transgenomic will receive an exclusive license for clinical and diagnostic use of SURVEYOR products. The key component of SURVEYOR prod- ucts is SURVEYOR Nuclease, a member of the CEL nuclease family of mismatch-specifc nucleases isolated from celery. SURVEYOR Nuclease has been shown to recognize and cleave mismatches arising from single nucle- otide polymorphisms or small insertions or deletions, according to the comapny. IDT will sell SURVEYOR Mutation Detec- tion Kits for both gel electrophoresis analysis and use on Transgenomic's WAVE and WAVE HS systems. Transgenomic will continue to sell and support the WAVE and WAVE HS systems. n News PRODUCTS & SERVICES DEALS