Un défenseur bélarusse au potentiel incalculable réalise bien malgré lui les défis quotidiens qui accompagnent son physique hors-norme.

New Delhi (AFP) Nov 5, 2024
The toxic smog season in India's capital has just begun, but those unable to escape cancer-causing poisonous fumes say the hazardous impact on health is already taking its toll. New Delhi regularly ranks among the world's most polluted capitals, with a melange of factory and vehicle emissions exacerbated by agricultural fires blanketing the city each winter, stretching from mid-October until

Ottawa aurait laissé trop de liberté aux syndicats, en leur donnant «carte blanche» pour déclencher des grèves dans les ports du pays.

Canada Soccer a définitivement coupé les ponts avec la sélectionneuse de l’équipe féminine Bev Priestman.

Florence et Marianne seront finalement au concert de leur idole, vendredi, à Toronto, mais elles ont eu toute une frousse.

La majorité des billets encore offerts en ligne pour aller voir Taylor Swift à Toronto sont des arnaques, constate un expert en cybersécurité.

Une découverte biochimique intrigante pourrait permettre d’identifier rapidement les patients à haut risque.

In this episode of The FemTech series Olivia Friett is joined by Jane Kennedy and Dr. MaryAnn Ferreux where we will discuss the inequality in women's health and how we can overcome the obstacles that come with this.

Charco Neurotech, a medtech company based in the United Kingdom, has developed CUE1, a non-invasive wearable that is intended to assist those with Parkinson’s disease to manage their motor symptoms. The device is typically affixed to the sternum, and provides vibratory action in a focused region of the body. The technology is based on the […]

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors.

Click here to see the original post from June 2024.

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The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:Read more »

Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx.

Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily.

To learn more, download CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for Shabbir’s insights.
Read more »

The U.S. Food and Drug Administration posted a video:

¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Ever wondered what goes into diligencing a new idea, program, company, or platform? While each diligence is unique and every investor will have

The post Deconstructing the Diligence Process: An Approach to Vetting New Product Theses appeared first on LifeSciVC.

By Jonathan Montagu, CEO of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC HotSpot’s trip to Barcelona for the recent European Society of Medical Oncology (ESMO) Annual Meeting was no ‘European Vacation,’ but it was certainly

The post ESMO Reflections: Glimmers of Hope with the Next Wave of I-O Therapies? appeared first on LifeSciVC.

Today’s market likes products. Platforms aren’t in vogue anymore. Investors, especially in the public markets, only want late stage de-risked assets. Pharma only seems to be buying these kinds of asset. VCs need to focus on clinical stage companies. Or

The post Biotech Risk Cycles: Assets And Platforms appeared first on LifeSciVC.

Are we looking at our enrollment data in the right way?

Session Details:

June 25, 1:45PM - 3:15PM

• Session Number: 241
• Room Number: 205B

1. Enrollment Analytics: Moving Beyond the Funnel
Paul Ivsin
VP, Consulting Director
CAHG Clinical Trials

2. Use of Analytics for Operational Planning
Diana Chung, MSc
Associate Director, Clinical Operations
Gilead
3. Using Enrollment Data to Communicate Effectively with Sites
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services
PRA

This new 10-minute TEDMED talk is getting quite a bit of attention:


 (if embedded video does not work, try the TED site itself.)

In it, Roger Stein claims to have created an approach to advancing drugs through clinical trials that will "fundamentally change the way research for cancer and lots of other things gets done".

Because the costs of bringing a drug to market are so high, time from discovery to marketing is so long, and the chances of success of any individual drug are so grim, betting on any individual drug is foolish, according to Stein. Instead, risks for a large number of potential assets should be pooled, with the eventual winners paying for the losers.

To do this, Stein proposes what he calls a "megafund" - a large collection of assets (candidate therapies). Through some modeling and simulations, Stein suggests some of the qualities of an ideal megafund: it would need in the neighborhood of $3-15 billion to acquire and manage 80-150 drugs. A fund of this size and with these assets would be able to provide an equity yield of about 12%, which would be "right in the investment sweet spot of pension funds and 401(k) plans".

Here's what I find striking about those numbers: let's compare Stein's Megafund to everyone's favorite Megalosaurus, the old-fashioned Big Pharma dinosaur sometimes known as Pfizer:

	Megafund (Stein)	Megalosaurus (Pfizer)
Funding	$3-15 billion	$9 billion estimated 2013 R&D spend
Assets	80-150	81 (in pipeline, plus many more in preclinical)
Return on Equity	12% (estimated)	9.2% (last 10 years) to 13.2% (last 5)

Since Pfizer's a dinosaur, it can't possibly compete with the sleek, modern Megafund, right? Right?

These numbers look remarkably similar. Pfizer - and a number of its peers - are spending Megafund-sized budget each year to shepherd through a Megafund-sized number of compounds. (Note many of Pfizer's peers have substantially fewer drugs in their published pipelines, but they own many times more compounds - the pipeline is just the drugs what they've elected to file an IND on.)

What am I missing here? I understand that a fund is not a company, and there may be some benefits to decoupling asset management decisions from actual operations, but this won't be a tremendous gain, and would presumably be at least partially offset by increased transaction costs (Megafund has to source, contract, manage, and audit vendors to design and run all its trials, after all, and I don't know why I'd think it could do that any more cheaply than Big Pharma can). And having a giant drug pipeline's go/no go decisions made by "financial engineers" rather than pharma industry folks would seem like a scenario that's only really seen as an upgrade by the financial engineers themselves.
A tweet from V.S. Schulz pointed me to a post on Derek Lowe's In the Pipeline blog. which lead to a link to this paper by Stein and 2 others in Nature Biotechnology from a year and a half ago. The authors spend most of their time differentiating themselves from other structures in the technical, financial details rather than explaining why megafund would work better at finding new drugs. However, they definitely think this is qualitatively different from existing pharma companies, and offer a couple reasons. First,

[D]ebt financing can be structured to be more “patient” than private or public equity by specifying longer maturities; 10- to 20-year maturities are not atypical for corporate bonds. ... Such long horizons contrast sharply with the considerably shorter horizons of venture capitalists, and the even shorter quarterly earnings cycle and intra-daily price fluctuations faced by public companies.

I'm not sure where this line of though is coming from. Certainly all big pharma companies' plans extend decades into the future - there may be quarterly earnings reports to file, but that's a force exerted far more on sales and marketing teams than on drug development. The financing of pharmaceutical development is already extremely long term.

Even in the venture-backed world, Stein and team are wrong if they believe there is pervasive pressure to magically deliver drugs in record time. Investors and biotech management are both keenly aware of the tradeoffs between speed and regulatory success. Even this week's came-from-nowhere Cinderella story, Intercept Pharmaceuticals, was founded with venture money over a decade ago - these "longer maturities" are standard issue in biotech. We aren't making iPhone apps here, guys.

Second,

Although big pharma companies are central to the later stages of drug development and the marketing and distributing of approved drugs, they do not currently play as active a role at the riskier preclinical and early stages of development

Again, I'm unsure why this is supposed to be so. Of Pfizer's 81 pipeline compounds, 55 are in Phase 1 or 2 - a ratio that's pretty heavy on early, risky project, and that's not too different from industry as a whole. Pfizer does not publish data on the number of compounds it currently has undergoing preclinical testing, but there's no clear reason I can think of to assume it's a small number.

So, is Megafund truly a revolutionary idea, or is it basically a mathematical deck-chair-rearrangement for the "efficiencies of scale" behemoths we've already got?

[Image: the world's first known dino, Megalosaurus, via Wikipedia.]

Sudan's civil war has displaced 10 million citizens. Here are profiles of two young people from the most vulnerable groups: an unaccompanied minor caring for twin brothers, a woman who was raped.

In the spirit of the Halloween season, IEEE Spectrum presents a pair of stories that—although grounded in scientific truth rather than the macabre—were no less harrowing for those who lived them. In today’s installment, Robert Langer had to push back against his field’s conventional wisdom to pioneer a drug-delivery mechanism vital to modern medicine.

Nicknamed the Edison of Medicine, Robert Langer is one of the world’s most-cited researchers, with over 1,600 published papers, 1,400 patents, and a top-dog role as one of MIT’s nine prestigious Institute Professors. Langer pioneered the now-ubiquitous drug delivery systems used in modern cancer treatments and vaccines, indirectly saving countless lives throughout his 50-year career.

But, much like Edison and other inventors, Langer’s big ideas were initially met with skepticism from the scientific establishment.

He came up in the 1970s as a chemical engineering postdoc working in the lab of Dr. Judah Folkman, a pediatric surgeon at the Boston Children’s Hospital. Langer was tasked with solving what many believed was an impossible problem—isolating angiogenesis inhibitors to halt cancer growth. Folkman’s vision of stopping tumors from forming their own self-sustaining blood vessels was compelling enough, but few believed it possible.

Langer encountered both practical and social challenges before his first breakthrough. One day, a lab technician accidentally spilled six months’ worth of samples onto the floor, forcing him to repeat the painstaking process of dialyzing extracts. Those months of additional work steered Langer’s development of novel microspheres that could deliver large molecules of medicine directly to tumors.

In the 1970s, Langer developed these tiny microspheres to release large molecules through solid materials, a groundbreaking proof-of-concept for drug delivery.Robert Langer

Langer then submitted the discovery to prestigious journals and was invited to speak at a conference in Michigan in 1976. He practiced the 20-minute presentation for weeks, hoping for positive feedback from respected materials scientists. But when he stepped off the podium, a group approached him and said bluntly, “We don’t believe anything you just said.” They insisted that macromolecules were simply too large to pass through solid materials, and his choice of organic solvents would destroy many inputs. Conventional wisdom said so.

Nature published Langer’s paper three months later, demonstrating for the first time that non-inflammatory polymers could enable the sustained release of proteins and other macromolecules. The same year, Science published his isolation mechanism to restrict tumor growth.

Langer and Folkman’s research paved the way for modern drug delivery.MIT and Boston Children’s Hospital

Even with impressive publications, Langer still struggled to secure funding for his work in controlling macromolecule delivery, isolating the first angiogenesis inhibitors, and testing their behavior. His first two grant proposals were rejected on the same day, a devastating blow for a young academic. The reviewers doubted his experience as “just an engineer” who knew nothing about cancer or biology. One colleague tried to cheer him up, saying, “It’s probably good those grants were rejected early in your career. Since you’re not supporting any graduate students, you don’t have to let anyone go.” Langer thought the colleague was probably right, but the rejections still stung.

His patent applications, filed alongside Folkman at the Boston Children’s Hospital, were rejected five years in a row. After all, it’s difficult to prove you’ve got something good if you’re the only one doing it. Langer remembers feeling disappointed but not crushed entirely. Eventually, other scientists cited his findings and expanded upon them, giving Langer and Folkman the validation needed for intellectual property development. As of this writing, the pair’s two studies from 1976 have been cited nearly 2,000 times.

As the head of MIT’s Langer Lab, he often shares these same stories of rejection with early-career students and researchers. He leads a team of over 100 undergrads, grad students, postdoctoral fellows, and visiting scientists, all finding new ways to deliver genetically engineered proteins, DNA, and RNA, among other research areas. Langer’s reputation is further bolstered by the many successful companies he co-founded or advised, like mRNA leader Moderna, which rose to prominence after developing its widely used COVID-19 vaccine.

Langer sometimes thinks back to those early days—the shattered samples, the cold rejections, and the criticism from senior scientists. He maintains that “Conventional wisdom isn’t always correct, and it’s important to never give up—(almost) regardless of what others say.”

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading

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The Public Service has expressed its commitment to implementing flexible work arrangements (FWAs) for its employees, taking into account the workforce's changing needs. In a written answer to a Parliamentary question posed by Choa Chu Kang GRC MP Zhulkarnain Abdul Rahim on Monday (Nov 11), Minister-in-charge of the Public Service Chan Chun Sing said the Government recognises the growing need for FWAs, given Singapore's demographic changes and its ever-changing demands on Singaporeans. Zhulkarnain had asked whether the Civil Service will continue to support flexible working arrangements despite some companies in the private sector requiring employees to work from the office five days a week. Grab Singapore, for example, said it will enforce its five-day return-to-office mandate starting Dec 2, reported CNA. Referencing the Tripartite Guidelines on FWA Requests (TG-FWAR), which will be enforced starting Dec 1, Chan stressed the importance of such arrangements in supporting working caregivers, encouraging workforce re-entry, sustaining labour force participation, and attracting and retaining talent.

Oct 27, 2022

Kennedy’s statecraft in the missile crisis provides a rich source of clues that can help illuminate the challenge the United States now faces, and the choices President Joe Biden is making.

My first editor, Rukun Advani, once described himself as ‘a composite hybrid of the Indian and the Anglo-European’, who sought to reconcile ‘within himself those varying cultural influences which chauvinistic nationalists could only see as contradictions.’ This self-characterization I might avow as my own. One mark of the Anglo-European in me is that, unlike members [...]

Jun 10, 2022

This book is intended to advance the next phase of the U.S.-Colombia relationship. In a rapidly changing world, the following chapters present a roadmap for a new type of engagement that challenges our ambitions and extends the ties that bind our countries. 

Jun 1, 2024

How can scholars write effective policy recommendations? Despite the potential importance of academic work to the policy debate, many scholars receive little training on why and how to make policy recommendations. To remedy this problem, here are steps to guide scholars as they begin developing policy recommendations for their articles. 

Aug 10, 2016

"African countries are already at the forefront of harnessing these technologies. For example, Rwanda has set itself the ambitious goal of building the first drone airport in the world. An increasing number of African countries are leveraging drone technology to address a variety of resource mapping, delivery and agricultural services. It is through such efforts that salient basic research challenges are likely to emerge."

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.

Apr 9, 2024

This paper delves into the evolution and future prospects of Global Navigation Satellite Systems (GNSS), with a particular focus on the United States' Global Positioning System (GPS) and Europe's Galileo. As GPS celebrates its 50th anniversary, it is a timely moment to assess its historical trajectory, current status, and future directions, especially considering the emergence of new competitors like China's BeiDou. Based on interviews with two GNSS experts from the European Commission, this study aims to analyze the potential for cooperation between GPS and Galileo, exploring avenues for collaboration and mutual learning.

Apr 29, 2024

Kyrgyzstan is currently at a critical geopolitical juncture in which it is forced to
confront its longstanding ties with Russia against a backdrop of internal and external
pressures towards autocracy. Once celebrated as the ‘island of democracy’ in Central
Asia, the small nation faces significant challenges in light of internal authoritarian
tendencies and external pressure following Russia’s full-scale invasion of Ukraine in
February 2022. This report, therefore, examines the role of Kyrgyzstan within the
global democracy versus autocracy debate that has intensified in the past two years
and assesses President Japarov’s neutrality with regards to Russia’s invasion and
Bishkek’s shifting allegiances.

This report relies on a qualitative methodology that builds on field research conducted
in Kyrgyzstan in August 2023. As such, this report incorporates interviews with
Kyrgyz civil society organizations and other stakeholders working on issues
including, but not limited to, democratization, corruption, human rights, media, and
the rule of law. The report presents an in-depth analysis of the Russian influence with
regards to the Kyrgyz political system, civil society, and strategic relationship with
Moscow, underpinned by the historical context of Kyrgyz-Russian relations.

Apr 25, 2024

On April 23, the final session examined healthcare access policies and public health initiatives across Africa. In our discussions, we explored the politics of health and healthcare policy, particularly in light of the COVID-19 pandemic. We identified political barriers to expanding healthcare coverage and access, and the dialogue centered on areas of progress in addressing infectious and chronic diseases. Beyond focusing on the challenges in implementing effective healthcare policies, in this session we invited participants to propose policy solutions as we look towards the future. The study group counted with the presence of external expert guest Dr. Salma Abdalla. Dr. Abdalla is a Sudanese medical doctor and Assistant Professor in Global Health and Epidemiology at Boston University School of Public Health. She was the Director of the Rockefeller-Boston University 3-D Commission on Determinants of health, Data science, and Decision making. She also served as a secretariat member for the WHO Independent Panel for Pandemic Preparedness and Response during the COVID-19 pandemic. Furthermore, Katie Chen, Master in Public Administration/ International Development Candidate at Harvard Kennedy School, delivered a memo briefing on how to boost childhood immunization rates in African countries, including through increased vaccine manufacturing, drone delivery., and behavioural interventions to combat vaccine hesitancy.

Jun 28, 2024

Ensuring that space remains a domain for peaceful exploration and mutual benefit rather than a new frontier for conflict will significantly depend on the global community's ability to navigate the complex interplay of technological advancements, regulatory frameworks, economic opportunities, and geopolitical challenges. 

This paper was written for the final assignment of IGA-250, a Harvard Kennedy School course on emerging technology: security, strategy, and risk.

Mar 28, 2024

On March 26, the study group met for the first time to examine recent democratic progress and backsliding in African countries. The session focused on ongoing conflicts in different regions of Africa and examined their political underpinnings. Participants also discussed the role of third-party actors in supporting and facilitating conflict mediation and peacebuilding efforts in the continent. The study group counted with the presence of external expert guest Dr. Antje Herrberg, Chief of Staff of the European Union Capacity Building Mission in Niger (EUCAP Sahel Niger). Dr. Herrberg brings more than two decades of professional and personal experience in transition and conflict resolution, intractable conflict, and terrorism with a deep interest to alleviate the suffering of people. Furthermore, Florian Dirmayer, Master in Public Policy Candidate at Harvard Kennedy School, delivered a memo briefing on European Union Security Cooperation with Niger After the 2023 Military Coup.

Apr 9, 2024

On April 2, the study group met for the second time to evaluate the role of international humanitarian groups in shaping political and social outcomes in Africa. The group examined how these organizations deal with emergencies, crises, and conflict situations across the continent, and scrutinized their influence on policy decisions and discuss the potential benefits and drawbacks of their involvement. Discussions covered the expanding influence of organizations like the United Nations High Commissioner for Refugees (UNHCR), Médecins Sans Frontières (Doctors Without Borders), and the International Rescue Committee (ICR). The study group counted with the presence of external expert guest Professor Sabs K. Quereshi, a senior-level leader with 17+ years of experience in global health, gender equality, health policy and equity, national security, humanitarian response, and government and multilateral affairs sectors in the U.S., with the UN, and worldwide.

Apr 18, 2024

The human tragedy continuing to unfold in Gaza and Israel reminds us how important it is to get strategic forecasting right. While in no way excusing Hamas’ culpability for 7 October, we also cannot dismiss the fact that the failure to anticipate and prepare for such an attack has had grave consequences for communities on both sides of this conflict, undermined efforts to bring peace and prosperity to the region, and affected global interests through the expansion of the conflict to the Red Sea and potentially beyond. 

Jun 14, 2024

Dr. Gloria Ayee led a study group over the course of five sessions during the Spring of 2024, exploring the current pivotal moment on the African continent. Participants of the study group were invited to reflect on the role that international cooperation must play in supporting inclusive, sustainable development in Africa, as well as to move beyond outdated perspectives and learn about Africa’s profound transformation through trade, investments in clean energy and health, and youth empowerment initiatives.

Jun 21, 2024

Dr. Gloria Ayee led a study group over the course of five sessions during the Spring of 2024, exploring the current pivotal moment on the African continent. Reflecting back, Dr. Ayee highlights the key takeaways from the study group.

Jun 4, 2024

Would the world be safer if the United States pledged to never use nuclear weapons first? Supporters say a credible pledge would strengthen crisis stability, decrease hostility, and bolster nonproliferation and arms control. But reactions to no-first-use pledges by the Soviet Union, China, and India suggest that adversaries perceive pledges as credible only when the political relationship between a state and its adversary is already relatively benign, or when the state’s military has no ability to engage in nuclear first use against the adversary. 

Apr 8, 2024

Behavioral economist Hunt Allcott, Professor of Global Environmental Policy at the Doerr School of Sustainability at Stanford University, questioned the impact of new and used electric vehicle (EV) subsidies in the latest episode of “Environmental Insights: Discussions on Policy and Practice from the Harvard Environmental Economics Program.”

Jun 14, 2024

China produces more than half of the world’s coal and employs more coal workers than any other country. China will need to develop alternative economic opportunities for workers displaced by the transition away from coal. This report examines the experiences of Tongchuan, Shaanxi, and Wuhai, Inner Mongolia in addressing unemployment problems and diversifying their economies, offering lessons for how other coal-producing cities and regions around the world can ensure a just transition for fossil fuel industry workers. 

Aug 5, 2024

This original primer, conducted as research for The Africa Futures Project, is an initial exploration into the evolving roles and increasing influence of “middle powers” in Africa. It covers a diverse array of existing and aspiring middle powers, presenting key points for each nation under four distinct analytical lenses.

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