On June 25th, Rhode Island Governor Daniel McKee transmitted without signature (effectively a pocket veto) the Rhode Island Data Transparency and Privacy Protection Act (SB 2500 / HB 7787). The act is based on the Washington Privacy Act model but diverges from the prevalent forms of that model in two ways. First, the act contains a unique […]

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>

<p>In May 2024, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) announced that it will trial new timelines for variation applications&nbsp;of registered pharmaceutical products and natural health supplements (TMHS).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

Some 180 women were prescribed valproate, a medicine used to treat epilepsy and bipolar disorder, during their pregnancy within a 2.5 year interval, NHS data has revealed.

Consultations on the reclassification of two progestogen-only contraceptive pills from prescription-only to pharmacy medicines have been launched.

Around half of Wales’ community pharmacies have expressed interest to health boards in providing COVID-19 vaccinations as part of the national programme.

Community pharmacies able to administer up to 400 COVID-19 vaccines per week can now apply to become designated vaccination sites, NHS England has said.

By Mike Cloonan, CEO of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC An insightful piece on this blog following the JPM healthcare conference noted the “refreshing burst of enthusiasm” in the biotech sector. It’s true

The post Lessons From A Private Funding Round: Science, Relationships, And Experience appeared first on LifeSciVC.

Novartis recently announced the acquisition of Mariana Oncology, an emerging biotech focused on advancing a radioligand therapeutics platform, for up to $1.75 billion in upfronts and future milestones. The capstone of its three short years of operations, this acquisition represents

The post Mariana Oncology’s Radiopharm Platform Acquired By Novartis appeared first on LifeSciVC.

PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty.

I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.

However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama.

Two words that make us mistrust Duke:  Anil Potti Christian Laettner

Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue).  And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail.

The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti:

I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. 

(One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?)

Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach.

I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented.

And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone?

• Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive?
• Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks?

I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators.

Where is this coming from?

As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data:

When they're frothing at the mouth, even Atticus doesn't let them publish a review

A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information.

(Emphasis mine.)

Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency.

The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack:

In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013.

I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor.

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:

This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:

My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?

That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:

What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?

This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs

Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS

are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:

What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?

This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.

• Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
• Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 

But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.

This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]

In 2010, Melanie Reid fell off a horse and was paralyzed below the shoulders.

“You think, ‘I am where I am; nothing’s going to change,’ ” she said, but many years after her accident, she participated in a medical trial of a new, noninvasive rehabilitative device that can deliver more electrical stimulation than similar devices without harming the user. For Reid, use of the device has led to small improvements in her ability to use her hands, and meaningful changes to her daily life.

“Everyone thinks with spinal injury all you want to do is be able to walk again, but if you’re a tetraplegic or quadriplegic, what matters most is working hands,” said Reid, a columnist for The Times, as part of a press briefing. “There’s no miracles in spinal injury, but tiny gains can be life-changing.”

For the study, Reid used a new noninvasive therapeutic device produced by Onward Medical. The device, ARC-EX (“EX” indicating “external”), uses electrodes placed along the spine near the site of injury—in the case of quadriplegia, the neck—to promote nerve activity and growth during physical-therapy exercises. The goal is to not only increase motor function while the device is attached and operating, but the long-term effectiveness of rehabilitation drills. A study focused on arm and hand abilities in patients with quadriplegia was published 20 May in Nature Medicine.

Researchers have been investigating electrical stimulation as a treatment for spinal cord injury for roughly 40 years, but “one of the innovations in this system is using a very high-frequency waveform,” said coauthor Chet Moritz, a neurotechnologist at the University of Washington. The ARC-EX uses a 10-kilohertz carrier frequency overlay, which researchers think may numb the skin beneath the electrode, allowing patients to tolerate five times as much amperage as from similar exploratory devices. For Reid, this manifested as a noticeable “buzz,” which felt strange, but not painful.

The study included 60 participants across 14 sites around the world. Each participant undertook two months of standard physical therapy, followed by two months of therapy combined with the ARC-EX. Although aspects of treatment such as electrode placement were fairly standardized, the current amplitude was personalized to each patient, and sometimes individual exercises, said Moritz.

The ARC-EX uses a 10-kilohertz current to provider stronger stimulation for people with spinal cord injuries.

Over 70 percent of patients showed an increase in at least one measurement of both strength and function between standard therapy and ARC-EX therapy. These changes also meant that 87 percent of study participants noted some improvement in quality of life in a followup questionnaire. No major safety concerns tied to the device or rehabilitation process were reported.

Onward will seek approval from the U.S. Food and Drug Administration for the device by the end of 2024, said study coauthor Grégoire Courtine, a neuroscientist and cofounder of Onward Medical. Onward is also working on an implantable spinal stimulator called ARC-IM; other prosthetic approaches, such as robotic exoskeletons, are being investigated elsewhere. ARC-EX was presented as a potentially important cost-accessible, noninvasive treatment option, especially in the critical window for recovery a year or so after a spinal cord injury. However, the price to insurers or patients of a commercial version is still subject to negotiation.

The World Health Organization says there are over 15 million people with spinal cord injuries. Moritz estimates that around 90 percent of patients, even many with no movement in their hands, could benefit from the new therapy.

Dimitry Sayenko, who studies spinal cord injury recovery at Houston Methodist and was not involved in the study, praised the relatively large sample size and clear concern for patient safety. But he stresses that the mechanisms underlying spinal stimulation are not well understood. “So far it’s literally plug and play,” said Sayenko. “We don’t understand what’s happening under the electrodes for sure—we can only indirectly assume or speculate.”

The new study supports the idea that noninvasive spinal cord stimulation can provide some benefit to some people but was not designed to help predict who will benefit, precisely how people will benefit, or how to optimize care. The study authors acknowledged the limited scope and need for further research, which might help turn currently “tiny gains” into what Sayenko calls “larger, more dramatic, robust effects.”

Over the past 20 years, technological advances have enabled inventors to go from strength to strength. And yet, according to the legendary inventor Dean Kamen, innovation has stalled. Kamen made a name for himself with inventions including the first portable insulin pump for diabetics, an advanced wheelchair that can climb steps, and the Segway mobility device. Here, he talks about his plan for enabling innovators.

How has inventing changed since you started in the 1990s?

Dean Kamen: Kids all over the world can now be inventing in the world of synthetic biology the way we played with Tinkertoys and Erector Sets and Lego. I used to put pins and smelly formaldehyde in frogs in high school. Today in high school, kids will do experiments that would have won you the Nobel Prize in Medicine 40 years ago. But none of those kids are likely in any short time to be on the market with a pharmaceutical that will have global impact. Today, while invention is getting easier and easier, I think there are some aspects of innovation that have gotten much more difficult.

Can you explain the difference?

Kamen: Most people think those two words mean the same thing. Invention is coming up with an idea or a thing or a process that has never been done that way before. [Thanks to] more access to technology and 3D printers and simulation programs and virtual ways to make things, the threshold to be able to create something new and different has dramatically lowered.

Historically, inventions were only the starting point to get to innovation. And I’ll define an innovation as something that reached a scale where it impacted a piece of the world, or transformed it: the wheel, steam, electricity, Internet. Getting an invention to the scale it needs to be to become an innovation has gotten easier—if it’s software. But if it’s sophisticated technology that requires mechanical or physical structure in a very competitive world? It’s getting harder and harder to do due to competition, due to global regulatory environments.

[For example,] in proteomics [the study of proteins] and genomics and biomedical engineering, the invention part is, believe it or not, getting a little easier because we know so much, because there are development platforms now to do it. But getting a biotech product cleared by the Food and Drug Administration is getting more expensive and time consuming, and the risks involved are making the investment community much more likely to invest in the next version of Angry Birds than curing cancer.

A lot of ink has been spilled about how AI is changing inventing. Why hasn’t that helped?

Kamen: AI is an incredibly valuable tool. As long as the value you’re looking for is to be able to collect massive amounts of data and being able to process that data effectively. That’s very different than what a lot of people believe, which is that AI is inventing and creating from whole cloth new and different ideas.

How are you using AI to help with innovation?

Kamen: Every medical school has incredibly brilliant professors and grad students with petri dishes. “Look, I can make nephrons. We can grow people a new kidney. They won’t need dialysis.” But they only have petri dishes full of the stuff. And the scale they need is hundreds and hundreds of liters.

I started a not-for-profit called ARMI—the Advanced Regenerative Manufacturing Institute—to help make it practical to manufacture human cells, tissues, and organs. We are using artificial intelligence to speed up our development processes and eliminate going down frustratingly long and expensive [dead-end] paths. We figure out how to bring tissue manufacturing to scale. We build the bioreactors, sensor technologies, robotics, and controls. We’re going to put them together and create an industry that can manufacture hundreds of thousands of replacement kidneys, livers, pancreases, lungs, blood, bone, you name it.

So ARMI’s purpose is to help would-be innovators?

Kamen: We are not going to make a product. We’re not even going to make a whole company. We’re going to create baseline core technologies that will enable all sorts of products and companies to emerge to create an entire new industry. It will be an innovation in health care that will lower costs because cures are much cheaper than chronic treatments. We have to break down the barriers so that these fantastic inventions can become global innovations.

This article appears in the November 2024 print issue as “The Inventor’s Inventor.”

CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. Avid specializes in manufacturing biologic products for companies at all stages of development.

The post Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition appeared first on MedCity News.

Value-based care contracting is especially difficult for behavioral health providers, Taft Parsons III, chief psychiatric officer at CVS Health/Aetna, pointed out during a conference this week.

The post CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care appeared first on MedCity News.

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.

The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

AbbVie schizophrenia drug candidate emraclidine failed to beat a placebo in two Phase 2 clinical trials. The drug, once projected to compete with Bristol Myers Squibb’s Cobenfy, is from AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics.

The post AbbVie Drug Expected to Rival Bristol Myers’s New Schizophrenia Med Flunks Phase 2 Test appeared first on MedCity News.

Now is the time for health plans to step up and embrace the tools and strategies that will not only meet regulatory demands, but also drive innovation in care delivery. 

The post Where Medicare Advantage Goes From Here appeared first on MedCity News.

Social media has become a significant source of health-related content. But while it connects people to news, updates, […]

The post Do People Believe Misinformation on Vaccines? appeared first on World of DTC Marketing.

We’ve all seen Medicare Advantage (MA) plans become a significant player in the healthcare industry. Yet, with the […]

The post The Dark Side of Medicare Advantage Incentives appeared first on World of DTC Marketing.

This paper begins with a look at both optimization modeling and discrete-event simulation modeling, and explores how they can most effectively work together to create additional analytic value. It then considers two examples of a combined optimization and simulation approach and discusses the resulting benefits.

Armie Hammer's mom got him a vasectomy for his birthday. The Call Me by Your Name actor — who has two children, Harper, nine, and Ford, seven, with his ex-wife Elizabeth Chambers — has revealed the bizarre gift Dru Hammer got him for his 38th birthday in August. Speaking to his mom on the second episode of a two-part chat on his new podcast Armie HammerTime Podcast, she said: "Let's talk about what I gave you for your birthday this year." She continued: "I call Armie, and I go, 'What would you like for your birthday this year?' He was like, 'I don't know. Maybe money. Whatever.' And I was like, 'I believe I'm going to give you a vasectomy.'"

UNITED NATIONS — The United States stressed at the United Nations (UN) on Tuesday (Nov 12) that "there must be no forcible displacement, nor policy of starvation in Gaza" by Israel, warning such policies would have grave implications under US and international law. The remarks by US Ambassador to the UN Linda Thomas-Greenfield came just hours after Washington said its ally Israel was doing enough to address the humanitarian crisis in Israel to avoid facing potential restrictions on US military aid. "Still, Israel must ensure its actions are fully implemented - and its improvements sustained over time," Thomas-Greenfield told the UN Security Council. It was also urgently important that Israel pause implementation of a law banning the operation of the UN Palestinian relief agency UNRWA, she added.

Dec 15, 2023

Calder Walton writes that if proved, Victor Manuel Rocha's espionage would place him among the longest-serving spies in modern times. Allowing him to operate as a spy in the senior echelons of the U.S. government for so long would represent a staggering U.S. security failure.

In recent years, a stream of books and articles have appeared seeking to analyse the theory and practice of Hindutva. They have sought to alternatively explain, critique, or justify the rising influence of the BJP and the RSS. Some have focused on organizational questions, on the building of social networks on the ground and how [...]

The Indian socialist tradition is now moribund, but there was a time when it had a profound and mostly salutary influence on politics and society. Yet few people now know of its past vigour and dynamism. The Congress, the Communists, the regional parties, the Ambedkarites, and (especially in recent years) the Jana Sangh and the [...]

The debate around India’s erosion of democratic values has surfaced again after Congress leader Rahul Gandhi’s remarks in the U.K.

Nov 16, 2023

This report, by Maxwell Simon (MPP '23) and Jayaram Ravi (MPP '23), explores the drivers of setback and success that China has encountered in the process of developing dual-use and military-dedicated naval installations abroad. It looks at cases where China has considered or actively pursued military-dedicated installations to characterize Beijing’s general approach to overseas naval base acquisition.

Feb 20, 2023

U.S. President Joe Biden spent five hours in the Ukrainian capital on Monday, meeting President Volodymyr Zelensky and even taking a stroll through the streets of Kyiv – despite the sound of air sirens – to visit The Wall of Remembrance, which displays portraits of the approximately 4,500 Ukrainian soldiers who have died since Russia annexed Crimea in 2014.

The trip was kept under a media blackout until a few hours after Biden’s arrival, with the president’s official schedule only saying he would fly in the evening to Warsaw for a planned visit. The New York Times reported, quoting an anonymous official source, that Biden arrived in Kyiv early this morning after making the same 10-hour long journey from Poland that every world leader visiting Ukraine since the start of the war has.

Apr 18, 2023

The following is an event write-up about the recent Future of Diplomacy Project (FDP) seminar on “The Future of Ukraine: Reconstruction, Energy Security, and Innovation” moderated by Ambassador Paula J. Dobriansky, Senior Fellow with the Future of Diplomacy Project. 

Sep 3, 2015

The New Harvest argues that Africa can feed itself in a generation and help contribute to global food security despite its history of persistent food shortages and the rising threat of climate change. This new edition provides ideas on how to place agriculture at the center of the continent's long-term economic transformation. It demonstrates how policy coordination can help realize agriculture's full potential as a motherboard for other economic activities.

The full text of The New Harvest is available here.

Sep 10, 2015

"It is estimated that the spotted stem borer and the African stem borer reduce Kenya's maize crop by 13 per cent or 400,000 tonnes annually. Controlling the pest using biotechnology will not only reduce Kenya's food imports, it will also equip the country with new techniques that can be redeployed for other sectors such as drug and vaccine development."

Feb 8, 2016

Africa is a youthful continent: nearly 41% of its population is under the age of 18. To address the unique challenges of this demographic structure, the African Union (AU) hopes to reposition the continent as a strategic player in the global economy through improved education and application of science and technology in development. The paper proposes the creation of “Innovation Universities” that combine research, teaching, community service and commercialization in their missions and operations. They would depart from the common practice where teaching is carried out in universities that do little research, and where research is done in national research institutes that do not undertake teaching. Under this model, there is little connection with productive sectors. The idea therefore is not just to create linkages between those activities but to pursue them in a coordinated way under the same university structure. Innovation universities can be created in diverse fields such as agriculture, health, industry, services, and environment to advance sustainable development and inclusive growth.

Aug 31, 2016

As the African Union develops its long-term agenda 2063 for the continent, science, technology and innovation will play a bigger part in development goal setting, especially in the context of social and economic growth.

Oct 10, 2023

Michael Toffel, Senator John Heinz Professor of Environmental Management and Professor of Business Administration at Harvard Business School (HBS), discusses the many ways in which business and governments can and are working together to address climate change in the latest episode of “Environmental Insights: Discussions on Policy and Practice from the Harvard Environmental Economics Program.” The podcast is produced by the Harvard Environmental Economics Program.

Nov 6, 2023

The Harvard Project on Climate Agreements collaborated with the Salata Institute on Climate and Sustainability at Harvard University to provide financial and logistical support for students to attend the Twenty-Eighth Conference of the Parties (COP-28) to the United Nations Framework Convention on Climate Change (UNFCCC). COP-28 will be held in Dubai, Nov. 30 – Dec. 12, 2023.

Nov 15, 2023

Efforts around and impacts of global methane-emissions abatement will be the focus at an official side event on December 6 co-sponsored by the Harvard Project on Climate Agreements at the 28th Conference of the Parties (COP-28) of the United Nations Framework Convention on Climate Change (UNFCCC) in Dubai. Harvard Project Director Robert Stavins will also participate in a number of other events at COP-28.

Feb 14, 2024

The Harvard Project participates in a major Harvard initiative aimed at reducing emissions of methane, a powerful greenhouse gas. Participating researchers represent a range of academic disciplines and Harvard schools.

Feb 22, 2024

Professors hear a great deal these days about how hard it is to get our students to listen to, much less to engage with, opinions they dislike. The problem, we are told, is that students are either “snowflakes” with fragile psyches or “authoritarians” who care more about their pet causes than about democratic values such as tolerance, compromise and respect for opposing points of view. Students at Harvard, where I teach, returned from winter break in January to an institution that appeared determined to tackle this problem head-on. An email from the undergraduate dean reminded them that “The purpose of a Harvard education is not to shield you from ideas you dislike or to silence people you disagree with; it is to enable you to confront challenging ideas, interrogate your own beliefs, make up your mind and learn to think for yourself."

Mar 7, 2024

Tarek Masoud, who questioned Iriqat’s views of Oct. 7 and how a two-state solution could be achieved during the event, said in an interview later on Thursday that he was “reasonably confident and hopeful” the discussion was an opportunity for learning, and added he appreciated that Iriqat “did not deny the atrocities of Oct. 7.” Understanding the Palestinian perspective is critical for moving toward peace and a two-state solution, Masoud said. Masoud and Iriqat agreed to discuss her controversial social media posts during the dialogue. Iriqat said that she did not intend to justify the violence on Oct. 7, which included kidnappings of children and elderly, beheadings, and massacres of civilians, but meant to place the attack in the context of a decades-long conflict. She was intensely critical of Israel throughout the conversation, saying the “settler-colonial project started 76 years ago.”

May 14, 2024

In a semester-long series, HKS Professor Tarek Masoud interviewed Middle East scholars and policymakers—from a Trump administration strategist to Palestinian intellectuals—on their vastly different views on the war.

Dec 20, 2023

This piece is a series in the Defense, Emerging Technology, and Strategy (DETS) Program’s analysis on the war in Ukraine, including a corresponding policy brief on Ukraine’s Battlefield Technologies and Lessons for the U.S. published in July 2023. 

Jan 24, 2024

The collection and sale of consumer data is too lucrative for companies to say no to participating in the data broker economy. New rules proposed by the Consumer Financial Protection Bureau may help eliminate the incentive for companies to buy and sell consumer data.

Feb 22, 2024

Authors Narayanamurti and Tsao propose a new architecture for how technoscientific knowledge advances, which maps to the actual operational practice of research and development nurtured at the iconic Bell Labs.

Jun 3, 2024

In the wake of a Microsoft spying controversy, it’s time for an ecosystem perspective.