New paper on cross-disciplinary collaboration

The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?

Some advice on how to address the particular challenges and opportunities in interdisciplinary research are described in our recent paper “Ten Simple Rules for a Successful Cross-Disciplinary Collaboration” published in the online open access journal PLOS Computational Biology last month. Please find below and abstract of the paper, which has inter alia been discussed and cited by Times Higher Education.

Abstract:

Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020″ EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.

However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.

Proposed citation:

Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214

Bioethicist Art Caplan: Chinese Scientists Try To Alter Genomes In Human Embryos

A new piece by contributor Art Caplan in Forbes:

Bet you did not know that today is National DNA Day. It is. But before we all begin to party over our biological programming, remember this is also the day when the world is trying to figure out how to respond to a paper from a team of scientists in China stating that they tried to alter the genomes of human embryos using a new technique known as CRISPR.

Without getting bogged down in the details, CRISPR it is a new powerful tool that permits editing or clipping out segments of DNA and inserting novel genetic material. The Chinese group used it for the first time in human embryos, thereby taking a baby step across the line to trying out a technology that someday could be used to change the DNA of our descendants to repair genetic diseases, get rid of traits we don’t like or to try and build better, improved babies. Yes, that is the low moan of eugenics you hear in the background of this CRISPR experiment. Happy National DNA Day to you, too. […]

Read the full article here.

Ethics for CRISPR and the Big Leap Forward

By Kelsey Berry

This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:

The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.

The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.

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Bioethicist Art Caplan: Actress Sofia Vergara Can’t Destroy Her Embryos

A new piece by contributor Art Caplan on NBC News:

Nick Loeb and Sofia Vergara once were a huge item. Today, they are back in the tabloid press because of a dispute over frozen, human embryos.

The 42-year-old actress and star of “Modern Family,” one of the top-earning women in Hollywood, announced her engagement to the wealthy, 40-year old businessman in 2012. Last May, Vergara announced they had split amid a host of abuse allegations.

Their squabble now has grown to include Loeb suing Vergara in California to prevent her from destroying two frozen female embryos, which court documents say they created using in vitro fertilization in November 2013. […]

Read the full article here.

TOMORROW (4/14): The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

15.04.14, Flanzraich poster FINAL DPI AdjustApril 14, 2014 12:00 PM

Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]

Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.

Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.

This event is free and open to the public. Lunch will be provided. Full event details are here.

Watch Mr. Flanzraich’s previous lecture for the Petrie-Flom Center, “Responsibility and Integrity in the Pharmaceutical Industry.”

The Complex Effects Of The FDA’s Proposal To Regulate Laboratory-Developed Tests

A new post by Rachel Sachs on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Last fall, the Food and Drug Administration (FDA) finally took steps toward an action that it had been publicly considering for over four years: the regulation of laboratory-developed tests (LDTs). The FDA defines LDTs as tests which are “designed, manufactured, and used within a single laboratory.”

This definition encompasses a wide range of diagnostics, including complex multigene panels that are performed in just a single laboratory in the United States, and basic diagnostic tests like a complete blood count, which are performed in thousands of laboratories nationwide.

As long as a manufacturer does not make and sell a kit for use in other laboratories, its test can be provided as an LDT. Estimates suggest that tens of thousands of diagnostic tests, including the majority of genetic tests, are currently available as LDTs.

Yet at present, the FDA exercises essentially no regulatory authority over LDTs. As such, they can be performed without any of the safeguards that typically apply to other medical technologies, including pre-market review and adverse event reporting. This is not to say that these tests are entirely unregulated. […]

See the full post here.

Recent Judicial Rulemaking Leaves Life Science Patents Hanging In The Balance

A new post by Claire Laporte of Foley Hoag LLP on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Do patents nurture or stifle innovation?

In a recent series of decisions, the Supreme Court has begun to express concern that some patents suppress innovation. And it has done so in a number of cases that turn on what used to be a sleepy backwater of the patent law: 35 U.S.C. § 101. This statute says, simply, that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, … may obtain a patent therefor, subject to the conditions and requirements of this title [i.e., the other requirements of the patent law].”

You might think that this language means that all you have to do is figure out whether an invention falls into one of the permitted categories. If it does, it’s something that can be patented (assuming you meet the other requirements — which are numerous). But no! Over the past few decades, the Supreme Court has engrafted a whole new set of judge-made requirements onto this statute: you cannot get a patent on something that is a “law of nature,” a “product of nature,” or an “abstract idea.” And starting in 2010, the Court put real teeth into these doctrines. […]

See the full post here.

4/14: The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

The FDA’s Impact on Pharmaceutical Innovation: A Lecture by Neil Flanzraich

15.04.14, Flanzraich poster FINAL DPI AdjustApril 14, 2014 12:00 PM

Harvard Law School
Griswold Hall, Room 110
1525 Massachusetts Ave.
Cambridge, MA [Map]

Please join us for a lecture by Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussing the balance between speed and safety in FDA’s regulation of pharmaceutical products. Topics will include how FDA’s approach has ebbed and flowed over time, the various tools FDA has introduced to reach this balance, and the potential impact of FDA’s various approaches on products and companies, especially start-ups.

Neil Flanzraich graduated from Harvard Law School in 1968 and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012.

This event is free and open to the public. Lunch will be provided. Full event details are here.

Watch Mr. Flanzraich’s previous lecture for the Petrie-Flom Center, “Responsibility and Integrity in the Pharmaceutical Industry.”

Biosecurity in a Globalised World Conference: The Adoption of the Revised International Health Regulations – 10 Years On

ABSTRACT SUBMISSIONS AND REGISTRATION OPEN

In 2015 it will be 10 years since the adoption of the revised International Health Regulations (IHR). To mark this important anniversary, QUT’s Australian Centre for Health Law Research is pleased to invite you to Biosecurity in a Globalised World: The Adoption of the Revised International Health Regulations – 10 Years On.

The conference will be hosted by the Australian Centre for Health Law Research at Queensland University of Technology’s Gardens Point campus in Brisbane from 27-28 July 2015.

The conference will provide a forum for scholars and policy makers to discuss and present on the progress achieved through the IHR to date, and the important work yet to be done.

The keynote address will be delivered by Professor Lawrence O. Gostin, Founding O’Neill Chair in Global Health Law, Georgetown University, USA.

Themes to be discussed at the conference include:

  • Development of IHR core capacities
  • Regulatory responses
  • Securitisation of infectious disease outbreaks
  • Human rights
  • Papers from all disciplines and areas of expertise are welcome.

For further information please visit http://ihr2015.com/

If you have any questions, or require any assistance, please contact ihr2015@qut.edu.au

REGISTER NOW: ReSourcing Big Data – A Symposium and Collaboration Opportunity (3/23)

From Harvard Catalyst:

REGISTER NOW!

March 23: Symposium
9:00 AM – 5:00 PM
Joseph B. Martin Conference Center
Harvard Medical School

Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus of this symposium is to explore this area from various perspectives – privacy and security, policy, open clinical trial data, systems and disease-oriented synthetic efforts and individually-provided, aggregated crowd-sourced data. The goal is to engage our biomedical and public health research community in a more nuanced appreciation of these and similar issues.

Topics include: data aggregation, access, annotation, refocusing on novel or unanticipated questions, and recombination with diverse demographic/epidemiologic data. Continue reading

Two forthcoming publications on (1) European Stem Cell Patenting, and (2) IP issues in Biobanking

I am happy to announce the following publications:

1) Minssen, Timo and Nordberg, A., The Evolution of the CJEU’s Case Law on Stem Cell Patents: Context, Outcome and Implications of Case C‑364/13 International Stem Cell Corporation (March 11, 2015). Available at SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2576807  (under review for journal publication)

Abstract:  

On 18th December 2014, the CJEU rendered its’ much-anticipated decision in C‑364/13 International Stem Cell Corporation v Comptroller General of Patents (ISCC). Qualifying its’ earlier ruling in Brüstle v. Greenpeace (Brüstle) with regard to non-fertilised human ova stimulated by parthenogenesis, the Court held that in order to constitute a ‘human embryo’ – and thus to be unpatentable under the EU Biotechnology Directive – the stimulated ovum must have the “inherent capacity to develop into a human being”. This would allow patents on innovative parthenotes which had not been genetically modified to achieve totipotent capabilities. Hence the judgment establishes a crucial limitation of the broad interpretation of “human embryos” in Brüstle, where the CJEU held that parthenotes are covered by the term “human embryo” since they are “capable of commencing the process of development of a human being”. The ISCC decision is to be welcomed since it provides an ethically justifiable leeway for patenting and offers reasonable support to the commercial viability of European cell therapy research. Yet, ISCC’s impact still depends on national implementations and only applies to certain hESC cells. Thus, further clarifications would be helpful concerning other non-totipotent hESCs.

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Problems with fMRI as a tool of lie detection

by Zachary Shapiro

Functional magnetic resonance imaging (fMRI) evidence of lie detection has, appropriately, faced difficulty gaining evidentiary acceptance in criminal courts. While a comprehensive discussion of the case law is beyond the scope of this post, it is important to note that courts have repeatedly refused to admit such evidence, both under a Daubert test, using Federal Rule of Evidence (FRE) 702, as well as under FRE 403.

Under Daubert, which governs the admissibility of expert testimony, courts have found that fMRI lie detection falls short in meeting the necessary standards, including the identification of error rates and maintenance of uniform testing standards. Courts have also pointed out that the motivation to lie may be different in research v. real-world settings.[1] In a laboratory experiment, one can assume that the participant is complying with investigator directions. However, if the scan is to be used in the courtroom, the subject will have a personal interest in the outcome, and may try to employ counter measures, or disregard instructions, in order to “fool” the scanner. Recent research shows that this task may not be hard, at least not for those who know how to effectively “trick” the scanner.

Judges have highlighted that while there are peer-reviewed studies of fMRI lie detection, said studies have very small patient bases (all N<60), and included a range of participants who were not representative of the general population. Courts recognize that neuroimaging, for the purposes of lie detection, is still not generally accepted by the scientific community.[2] Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.

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Synthetic biology and intellectual property rights: Six recommendations

On 26th November 2013, the Danish Agency for Science, Technology and Innovation organized an expert meeting on “Synthetic Biology & Intellectual Property Rights” in Copenhagen sponsored by the European Research Area Network in Synthetic Biology (ERASynBio). The meeting brought together ten experts from different countries with a variety of professional backgrounds to discuss emerging challenges and opportunities at the interface of synthetic biology and intellectual property rights. The aim of this article is to provide a summary of the major issues and recommendations discussed during the meeting.

The ERASynBio consortium consists of 16 governmental funding bodies from 12 EU Member States (Austria, Denmark, Finland, France, Germany, Greece, Latvia, Netherlands, Portugal, Spain, Slovenia, and UK) and two Associated Countries (Norway and Switzerland)

Timo Minssen, Berthold Rutz and Esther van Zimmeren: Synthetic biology and intellectual property rights: Six recommendations. (2015) Biotechnology Journal Special Issue: Synthetic Biology Volume 10, Issue 2, pages 236–241

Summary of the recommendations addressed in the publication: Continue reading

fMRI as a Tool of Lie-Detection

by Zachary Shapiro

The United States legal system places a great deal of importance on juries. With this faith comes a belief that juries are effective and reliable in determining the credibility of witnesses that testify in front of them. However, research has found that people, while generally good at lying, are terrible at detecting the lies of others.[1] Scientific research has found that, in a face-to-face meeting, the average person is able to detect deception at only a slightly better than 50% rate, meaning that most people are no better at detecting deception than would be expected from pure guessing.[2]

This tension has led courts to search for a technology-based method of lie detection, which could objectively improve on human’s natural inability to detect deception.[3] While polygraphs have been around for a long time, there is tremendous (and well deserved) skepticism of this modality. In 2003, a National Academy of Sciences report found there was a startling lack of research in regards to the accuracy of polygraph machines under varying conditions.[4] This study estimated that the accuracy of polygraphs was roughly 75%, but could be as high as 99% or as low as 55% depending on a variety of factors. These factors include the experience of the operator, the setting of the test (experimental vs. forensic), and what questioning format is employed.[5]

The skepticism towards polygraphs partially explains the hope that one day, new and more accurate technology will replace them. Today, this enthusiasm is primarily aimed at the potential for functional neuroimaging to serve as an effective lie detector. Functional magnetic resonance imaging (fMRI) for lie detection is different from using a polygraph, in that neuroimaging measures the central (brain) rather than the peripheral (blood pressure, heart rate, respiration rate and galvanic skin response) correlates of nervous system activity.[6] While, brain-based lie detection was pioneered in the late 1980s, using the method of EEG,[7] fMRI is now touted as the preferred method, due to its superior ability to localize signals in the brain. Continue reading

Art Caplan: Is It Ethical to Create Babies From Three DNA Sources? Absolutely

A new piece by Art Caplan, via Wired:

The House of Commons in the U.K. has now voted to permit mitochondrial DNA replacement, which enables babies to be born who have DNA from three people.

Mitochondria are the batteries of our cells that provide energy for cell division and growth. We get ours from our mother’s genes. If there is a defect in a mother’s mitochondria, it can have devastating consequences for her children, resulting in almost certain death. But, by extracting a mitochondrion from a healthy donor egg, scientists are now able to conduct a miniature organ transplant on the cellular level to create a healthy baby through in vitro fertilization. Such a baby has its parents’ genes, except for one small but crucial portion obtained from a donor.

If the House of Lords also approves, Britain will be the first nation to authorize the procedure. The United States is studying mitochondrial transplants. A series of meetings began last week at the Institute of Medicine at the request by the Food and Drug Administration.

To continue reading, click here.

Tomorrow: 3rd Annual Health Law Year in P/Review

P-Review_2015_poster_with_borderJanuary 30, 2015 7:45 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

The full agenda with speakers is available on our website.

Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact petrie-flom@law.harvard.edu with questions.

Should patients be able to limit doctor access to medical records?

by Vadim Shteyler 

The growing accessibility of Electronic Health Records (EHRs) across hospitals and practitioners raises new concerns about patient privacy. Before EHRs, patients had control over how much information they shared with each healthcare provider. Receiving patient information from other practitioners has required a signed consent form specifying the information patients are comfortable sharing (e.g., radiological studies, mental health history, sexual history, etc.). And hospitalists have been expected to request the minimal necessary information to provide good care. With growing networks and increasing compatibility across EHRs, more providers now have access to information without the patients’ express permission or even awareness.

Recent works published in the Journal of General Internal Medicine reported the results of a study that designed and recorded patient and provider experiences with a patient-controlled EHR (in which patients chose which providers could access which data in their medical records). A preliminary survey showed that, before the study, only 10 percent of patients had access to their medical records. Half of surveyed patients did not know what information their EHR contained. However, all patients wanted access to their EHRs. Meanwhile, another study reported that only one-third of physicians thought patients should have EHR access. Continue reading

Two new publications on “European patent strategies under the UPCA” and on “Synthetic Biology & Intellectual Property Rights”

I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2)  “Synthetic Biology & Intellectual Property Rights”:

1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published  in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.

Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.

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FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)

The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public procedures for classification and prioritization, and 3) quality system regulation.

Many issues that had been raised during Thursday’s sessions reappeared in the context of these new subjects.  Commenters considered whether and when laboratories should be able to submit one (rather than many) LDT notifications and/or registrations, the relationship between clinical use and risk classification, and the need to be sensitive to the diversity of LDTs and their providers in formulating the final guidelines.  Other, more legal aspects were also raised again, including concerns about redundancy between FDA regulations and those already promulgated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, whether the FDA possesses the legal authority to regulate most LDTs, and whether the FDA is required to proceed by notice-and-comment rulemaking rather than acting through the guidance process.  (Litigation is almost certain to arise on these last two topics, about which I’ll have more to say in future posts.)

But I want to briefly highlight one theme that cropped up on both days more frequently than I had anticipated: the role of insurers and insurance reimbursement.  Panelists considered whether insurers or other payers should have a seat at the table when advisory committees are convened to classify and prioritize LDTs for review.  They discussed the effect of FDA approval on insurance coverage, debating whether the proposed regulations would increase or decrease access to FDA-approved LDTs.  But most importantly (at least in my view), they explicitly considered the way in which increased FDA regulation would combine with decreasing insurance reimbursement to decrease incentives for innovation in diagnostic testing.

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FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)

Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs).  Since the release of the draft guidance framework in October, serious arguments have been made on opposing sides of the issue, and industry groups have made additional moves in opposition to the proposed regulation.  And now, today (and tomorrow), the FDA is holding a public workshop on their draft guidance framework, focusing on a wide range of issues.

Today’s workshop featured sessions on three main issues: 1) labeling considerations, 2) clinical validity and intended use, and 3) categories for continued enforcement discretion.  Many commenters simply presented the unique concerns of their organization and urged the FDA to consider them in finalizing the guidelines, which was helpful when it did seem as if the draft guidance may have insufficiently considered the needs of a particular set of laboratories, such as public health laboratories that focus on testing for infectious diseases like Ebola and chikungunya (about which I’ve also blogged, here and here).

More helpful, though (at least in my view), were the comments of those who sought to provide concrete recommendations for the FDA on the basis of 1) the policy concerns they saw underlying the guidance and 2) the practical effects of implementation that they foresaw.  I’ll illustrate with an example, which hopefully will display the complexity inherent in even the simplest questions that the FDA must answer here.

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