Innovation

medicine

RESILIENCE Launches to Change the Future of Medicine through Manufacturing Innovation

SAN DIEGO and BOSTON, Nov. 23, 2020 /PRNewswire/ — RESILIENCE (National Resilience, Inc.), a new company building the world’s most advanced biopharmaceutical manufacturing ecosystem, announced its launch today. 

The company will actively invest in developing powerful new technologies to manufacture complex medicines that are defining the future of therapeutics, including cell and gene therapies, viral vectors, vaccines, and proteins. In doing so, it seeks to overcome one of the biggest challenges the biopharmaceutical industry is facing in pioneering novel treatment modalities – manufacturing. RESILIENCE will dramatically increase overall production capacity for these modalities, ensuring that important medicines are accessible to all patients in need and protecting against supply chain disruption.

“We created RESILIENCE to reimagine biopharmaceutical manufacturing through unprecedented investment in technology and a best-in-class team to execute our vision,” said Robert Nelsen, RESILIENCE founder, Chairman of the Board, and managing director at ARCH Venture Partners. “COVID-19 has exposed critical vulnerabilities in medical supply chains, and today’s manufacturing can’t keep up with scientific innovation, medical discovery, and the need to rapidly produce and distribute critically important drugs at scale. We are committed to tackling these huge problems with a whole new business model.”

Company Focus

RESILIENCE seeks to address today’s challenges while investing in the future of U.S.-led biopharmaceutical innovation. RESILIENCE will offer customized and scalable processes, short lead times, the highest quality and regulatory capabilities, and world-class manufacturing facilities. It will serve partners of all sizes, including pharmaceutical and biotechnology companies, universities, independent research organizations, and government programs. By enabling complex medicine manufacturing that is faster, more flexible, and less risky, RESILIENCE empowers partners to focus on generating discoveries that improve medical outcomes and save patients’ lives.

“Our aim with RESILIENCE is to improve manufacturing of breakthrough medicines so that they are more accessible to patients and to foster scientific innovation that makes new modalities of medicine possible,” said RESILIENCE Co-Founder and CEO Rahul Singhvi, Sc.D. “By providing improved process platforms and the highest quality manufacturing network, RESILIENCE has been designed to help society meet the challenges of tomorrow, whether that’s the next pandemic or high demand for a great new medicine. I am incredibly proud to lead a team of extraordinary professionals with deep and diverse talent to build a more resilient future.”

RESILIENCE has raised over $800 million of capital following the recent Series B raise of approximately $750 million, not tied to milestones, from investors that collectively manage over $5 trillion. Led by ARCH Venture Partners and 8VC with participation by GV and NEA, investors include public mutual funds, some of the largest U.S.-based pharmaceutical companies, foundations, family offices, and pension funds, among others.

“It is critical that we adopt solutions that will protect the manufacturing supply chain, and provide more certainty around drug development and the ability to scale up the manufacturing of safe, effective but also more complex products that science is making possible,” said Scott Gottlieb, M.D., former Commissioner of the Food and Drug Administration and member

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medicine

COVID, Big Medicine Spark Innovation Platforms

Science is a game won with time and patience, through trials where errors far outweigh success. In the race against deadly diseases – COVID-19 among them – time is, of course, of the essence. And high-tech – specifically, high-tech platforms employing machine learning (ML) and artificial intelligence (AI) – can help speed up medical breakthroughs.

Pfizer and Moderna have each reported that vaccines have been developed that act as effective treatments against the coronavirus. Beyond the initial excitement (and hope) that comes with the companies’ claims of the vaccines’ high effectiveness in the latest rounds of trials (at roughly 95 percent) come the additional ripple effects from how these vaccines were developed and what the tech-driven implications might be for future drug development.

As noted by The Wall Street Journal, the Moderna and Pfizer developments show that gene-based technologies can pave the way for a range of new therapies that take aim at scourges like cancer and heart disease. In terms of the science, the gene-based developments – in this case, messenger RNA (or mRNA) – coax cells to produce proteins that are similar to the ones found in the coronavirus, and then set up the body to produce an immune response.

And it is in the development in mRNA that we see the embrace of platforms (specifically vaccine platforms tied to gene sequencing) and the innovation that comes with those platforms, marked by scale and speed.

In Nature Reviews Drug Discovery, for example, comes the observation: “Various mRNA vaccine platforms have been developed in recent years and validated in studies of immunogenicity and efficacy. Engineering of the RNA sequence has rendered synthetic mRNA more translatable than ever before.” This implies that the “classic” system of drug development, focusing on a pathogen-specific approach to develop immunity, can be augmented (or sidestepped, perhaps) with platforms. The result is that promising drug candidates can be developed in weeks, not years.

In a paper published by the Johns Hopkins Center for Health Security, the authors contend that platforms can use the same data to target more than one vaccine: Data is key.

As reported in Drug Development & Delivery: “Platform technologies are considered a valuable tool to improve efficiency and quality in drug product development. The basic idea is that a platform, in combination with a risk-based approach, is the most systematic method to leverage prior knowledge for a given new molecule. Furthermore, such a platform enables a continuous improvement by adding data for every new molecule developed by this approach, increasing the robustness of the platform.”

Moderna, for its part, has said that “if using mRNA as a medicine works for one disease, it should work for many diseases. And, if this is possible – given the right approach and infrastructure – it could meaningfully improve how medicines are discovered, developed and manufactured.” Against that backdrop, the company created its mRNA technology platform, which the company said functions in ways akin to computer operating systems

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health

National Nonprofit SoldierStrong Announces Donation of 10 iBots to Veterans During VHA Innovation Experience Conference

STAMFORD, Conn., Oct. 28, 2020 (GLOBE NEWSWIRE) — SoldierStrong, a national nonprofit dedicated to helping military veterans take their next steps forward through the use of revolutionary medical technology, is teaming up with renowned inventor Dean Kamen and DEKA Research and Development Corp. to donate 10 iBOT wheelchairs to individual wounded veterans, co-founder and chairman Chris Meek said Tuesday.

“The goal of this donation is to create lasting, life-changing impacts on the physical and mental health of those who have served our country,” said Meek, who made the announcement remotely during the Veterans Health Administration’s Innovation Experience (iEX) conference in Washington, D.C.

The iBOT wheelchair, which is the brainchild of Kamen in partnership with his company, DEKA, and Johnson & Johnson’s Independent Technology division, is a one-of-a-kind powered wheelchair that climbs stairs, allows users to rise from sitting level to six feet tall, maintains superior balance compared to other products on the market and can withstand travel through sand and standing water. 

“Dean Kamen is one of the most recognized and sought-after innovators of our time. He’s made it his life’s work to invent technology, like the iBOT, that improves the lives of others,” Meek said. “With such an iconic status in the science and technology communities, it was a tremendous honor to introduce Dean today at the VHA Innovation Experience. It is also with sincerest gratitude that I thank him for his support of SoldierStrong and his commitment to share DEKA’s life-changing iBOT with veterans who desperately deserve access to this type of disruptive technology.” 

The VHA Innovation Experience (iEX) is an annual conference that brings innovators and inventors, medical health experts, veterans, and the public together to showcase and celebrate emerging innovations, partnerships and technologies that improve and save veterans’ lives. 

Donations of the iBOTs are the latest effort by SoldierStrong to provide revolutionary medical technologies to help injured veterans lead full lives. SoldierStrong has donated $3.8 million in state-of-the-art medical devices to individual veterans and Veterans Affairs medical centers across the country. These devices include hyper-advanced prosthetics, specialized rehabilitation, and the organization’s signature device, the SoldierSuit exoskeleton used in the rehabilitation of spinal injuries and strokes and to help paralyzed individuals become more mobile. To date, SoldierStrong has donated 22 SoldierSuits, or exoskeletons, that allow some paralyzed veterans to stand and walk again. 

A four-year mental health study by the VA Eastern Colorado Health Care System that included use of a SoldierSuit found that paralyzed veterans able to maintain an eye-level view of the world experienced better mental and physical health and a decline in suicidal thoughts or attempts.

“This donation of iBOTs allows SoldierStrong to provide technologies that simultaneously address the needs of physical and mental health,” Meek said. “The iBOT’s unique capabilities will allow veterans who receive a donation to feel secure, independent and enjoy a sense of confidence unmatched by other devices.”

CONTACT: CHRISTINA STROBACK
(319)-936-9300

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health

Aridis Pharmaceuticals to Present at the ROTH Capital Partners 2020 MedTech Innovation Forum on a COVID-19 Panel

SAN JOSE, Calif., Oct. 27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. Dr. Hasan Jafri, Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.”

Panel: Direct Antivirals and Other Agents Against SARS-CoV2 Virus
Date: Wednesday, October 28, 2020
Time: 10:30AM-11:50AM ET

Dr. Jafri will present a summary of the Company’s recently published preclinical data of its COVID-19 inhaled mAb (AR-711). He will address the preclinical performance of AR-711, the advantages of direct lung delivery using nebulized aerosols, and the COVID-19 clinical program.

About AR-711

AR-711 is a fully human immunoglobulin 1, or IgG1, monoclonal antibody discovered from screening the antibody secreting B-cells of convalescent COVID-19 patients. AR-711 exhibits high affinity for SARS-CoV-2 spike protein, approximately 10-fold or higher than mAb candidates currently in late stage clinical testing. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. AR-711 is currently being developed as an inhaled, self-administered treatment for non-hospitalized patients suffering from mild to moderate COVID-19. AR-711 is also one the two mAbs in the company’s AR-701 mAb cocktail, which is a separate program being developed as an intravenous treatment of moderate to severe, hospitalized COVID-19 patients.

About Aridis Pharmaceuticals, Inc.

Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary ʎPEXTM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture monoclonal antibody (mAbs) for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor’s immune system; hence, they technically do not require genetic engineering or further optimization to achieve full functionality.

The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company’s pipeline is highlighted below:

Aridis’ Pipeline

AR-301 (VAP). AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive 

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health

Lost cures and innovation, too high a price for Democrats’ drug pricing proposals

Democrats and Republicans alike can agree on one thing: prescription drug prices are unacceptably high. Predictably, however, we cannot seem to agree on a proper solution to this urgent issue.

The Trump administration has, thankfully, kickstarted efforts and approved record numbers of generic drugs while simultaneously lowering overall prescription drug prices by 13 percent. It is our responsibility in Congress to keep this momentum going and establish permanent fixes to the current pharmaceutical pricing standards. Despite the efforts of Republicans to make bipartisan progress to reform the prescription drug standards, our Democrat colleagues refuse to collaborate.

Unfortunately, the so-called “solutions” my Democrat colleagues have presented are inadequate and misguided. Their primary proposal, H.R. 3, The Elijah E. Cummings Lower Drug Costs Now Act, is not only an egregious government overreach, but would negatively affect seniors by expanding entitlements and disregarding the Medicare trust fund. This could risk the ultimate failure of the entire program and almost certainly increase out-of-pocket costs for our seniors.

Perhaps most concerningly, it would strangle innovation among the pharmaceutical industry and therefore prevent potential cures. The Congressional Budget Office (CBO) predicts that H.R. 3 would likely result in 38 fewer cures over the next 20 years. For an American waiting for a cure to save their life, this is unacceptable.

That is why the Republicans presented H.R.19, the Lower Cost, More Cures Act, a common-sense and inclusive drug pricing proposal. H.R. 19 sought to incentivize competition in the market to drive prices down and expand market access for more generic and biosimilar drugs. Despite the fact that each of the individual provisions included within H.R.19 were originally bipartisan bills, this legislation has not been spared the classic politicization of Speaker Nancy PelosiNancy PelosiBrown says Biden’s first moves as president should be COVID relief, voting rights Sunday shows – Spotlight shifts to positive tests among Pence aides Pelosi dismisses talk of White House compromise on stimulus: They ‘keep moving the goal post’ MORE (D-Calif.) and has failed to receive proper consideration on the House floor.

Specifically, this legislation contained more than 40 bipartisan provisions that would have been able to go to the president’s desk immediately to be signed into law and help our families. For drug pricing, it provided language for increased pricing transparency, public disclosure of drug discounts, a study of pharmaceutical supply chain intermediaries and merger activity and makes prescription drug marketing sample information reports available to individuals.

With over 3.5 million of my fellow Floridians enrolled in some form of Medicare prescription drug coverage, these issues have always been a top priority. For Medicare Part B, H.R. 19 would have provided increased pricing transparency by expanding a Medicare online tool to allow beneficiaries to compare costs. Additionally, the legislation would have also created maximum add-on payments for certain drugs and biologicals to help reduce out-of-pocket costs.

My constituents and countless Americans who depend on life-saving prescriptions everyday deserve better than the inadequate solutions that my Democrat colleagues have presented. While I was

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health

The Future of Food With SIAL Insights And SIAL Innovation

SIAL Paris, the world’s foremost food industry trade fair remains true to its mission: federate and guide the transformation of the sector’s companies on a global scale, despite the postponement of its physical edition to October 2022.

“It was important to share in a digital webinar the trendbook ‘SIAL Insights’ which was the culmination of large-scale studies performed in 2020 by our expert partners Kantar, Gira and ProtéinesXTC” said Nicolas Trentesaux, CEO of SIAL Global Network.

“The surveys were conducted with regard to the theme #Ownthechange, which resonates even more deeply today. The results are an important source of information for all those seeking to understand the challenges, trends and innovations that are shaping this period,” pursued Adeline Vancauwelaert, General Manager of SIAL Paris.

The studies show that food is becoming a statement: citizenship, involvement, and commitment are the by-words, and COVID-19 is catalyzing the trend.

73% of consumers have changed their eating habits over the last two years. 63% consider that the way they eat is a societal commitment, meaning choosing the world in which they want to live. 33% have reclaimed their power by adopting at least one major behavioral change or by boycotting certain brands or products. Their motivation? A healthier diet (70%), more local and seasonal food (53%), free of controversial ingredients (44%). The trend extends to stores, where healthy products are increasingly abundant, and to a lesser extent to restaurants, which are putting more emphasis on traceability, local and seasonal products, and shorter menus.

Regarding the food industry, pleasure and health are motors for innovation, with three major trends: back to basics, as local as possible, understated enjoyments.

The SIAL Innovation Awards 2020 shows the intention on the part of industrials to propose products that address the profound consumer desire for change. Out of 500 applications received, the jury awarded 17 prizes among 8 categories and 6 special prizes. The Grands Prix are:

Gold: BOCON (IT) for their frozen vegetable Gnocchi (70% vegetable) and combination of spices.

Silver: PATISSERIE DES FLANDRES (FR) for their Origine labeled Maroilles cheese flavoured mini waffles. A fresh product that only needs 5m in the oven for a quick snack or a cocktail party.

Bronze: TRIUMPH (FR) for Toogood Chewing Gum, a natural gum without aspartame that biodegrades in 3 months versus 5 years.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201026005021/en/

Contacts

Isabelle Cremoux-Mirgalet
[email protected]

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fitness

Curves Celebrates 28 Years of Ingenuity and Innovation in the Women’s Fitness Industry

Enhanced membership options offer franchise owners additional revenue streams. New franchise opportunities for entrepreneurs extend beyond the reach of local clubs.

WACO, Texas, Oct. 22, 2020 (GLOBE NEWSWIRE) — This year, Curves celebrates 28 years of delivering a fitness solution designed specifically for women and 28 years of creating entrepreneurial opportunities for women who want to own their own business, provide for the financial needs of their families, and be a health resource in their communities. Krishea Holloway, President and CEO of Curves NA and Oceania, Inc., says that in 2020, Curves offers even more opportunities for entrepreneurs who have a passion for fitness and healthy living.

When Holloway took ownership of Curves in North America and Oceania in 2019, she introduced changes to help existing franchise owners better manage their businesses, increase their revenue, and improve their members’ gym experience. Now Curves is offering entrepreneurs new ways to engage with the Curves brand.

For franchise owners of local Curves clubs, Holloway’s upgrades include:

State-of-the-Art Operating System
Curves’ partnership with WellnessLiving offers owners an operating system that provides integrated CRM, payment, and member loyalty program tools and enables personalized webpages, reporting, and client communications.  

Enhanced Revenue Opportunities
The MyCurves on Demand program replicates the traditional Curves full body workout using a resistance band in place of the club’s circuit equipment for streaming workouts that can be done anytime, anywhere. When COVID-19 forced gyms to close temporarily, the at-home program provided an ongoing revenue stream for owners and a daily workout for Curves members. The MyCurves On Demand + Coaching Membership add-on includes weekly sessions with a Curves Coach. 

The Curves Health and Wellness Education Series allows Curves Coaches to become health resources in their own communities by delivering the most recent research on important health topics. Courses include dynamic e-leanings, weekly content review, and an extensive library of functional exercises. 

The Curves Strong (USA & Canada) and Curves Strong AU/NZ (Australia & New Zealand) apps provide Curves members with incentives to upgrade to premium status. 

For entrepreneurs looking for a more flexible franchise option, Curves now offers:
Curves Ambassador Program
Curves Ambassadors are independent contractors who develop a network of prospects and subscribers. They earn commissions for direct sales of Curves virtual offerings and products in areas with no Curves gym. 

Curves On The Go

Certified Curves On The Go Coaches lead group fitness classes at convenient “drop-in”, party, or corporate locations throughout their community. 

“I started my first Curves franchise at the age of 21, and I want more ambitious entrepreneurs to see Curves as a place to start and grow,” said Holloway. “My advice to aspiring business owners is, ‘It’s never too early or too late to start. Don’t count yourself or your financial situation out before you try.  I found a way to make the finances work on my own, even at an early age.’” 

Curves is famous for its 30-minute fitness circuit, with a Curves Coach at every workout and accountability to stay on

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health

Omkar Marathe, MD, of The Oncology Institute of Hope and Innovation Selected for 40 Under 40 in Cancer Award

Award recognizes the contributions made by the nation’s most promising oncology professionals under the age of 40

The Oncology Institute of Hope and Innovation (TOI) is proud to announce that Omkar Marathe, MD, a TOI physician, has received the “40 Under 40 in Cancer” award.

The 40 Under 40 in Cancer award celebrates the contributions of emerging leaders in cancer care under the age of 40. The award’s sponsors include the Association for Value-Based Cancer Care.

Dr. Marathe treats patients with cancer and blood disorders in the greater Long Beach Area and has received a teaching award for his work with the St. Mary’s Internal Medicine residency program. He has conducted research and published papers in various disciplines of oncology including ocular melanoma and HER2+ breast cancer and was recently named Director for TOI’s highly esteemed clinical trials program. Dr. Marathe is fluent in English, Spanish, Marathi, and conversational Hindi.

Brad Hively, TOI’s CEO, commented: “All of us at The Oncology Institute are incredibly proud of our colleague Dr. Marathe for being selected for this award. He represents what’s best about our company: a dedicated and talented clinician providing innovative and compassionate cancer care to our patients.”

About The Oncology Institute of Hope and Innovation

Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is one of the largest community oncology practices in the US as well as our nation’s leading value-based oncology services platform. TOI employs 75 physicians and mid-level practitioners in 42 clinic locations, with more than 500 total employees helping to offer leading-edge, evidence-based cancer care to a population of more than 1.5 million patients. TOI brings comprehensive, integrated cancer care into community settings, including clinical trials, palliative care programs, stem cell transplants, transfusions, and other care delivery models traditionally associated with the most advanced tertiary care settings. For more information visit www.theoncologyinstitute.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201021005253/en/

Contacts

Julie Korinke
Senior Manager, Marketing
562.735.3226 x.88806
[email protected]

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health

How Fetal Cells From The 1970s Power Medical Innovation Today

It is no secret that thousands of laboratories around the world use cells derived from a fetus that was aborted decades ago to develop vital medicines.

But it is a contentious topic in the US, where conservatives and anti-abortion activists have long deemed the practice unethical.

The matter is once more under the spotlight after President Donald Trump was treated for Covid-19 using Regeneron’s antibody treatment. The company used aborted fetal cells as part of its testing process.

“It’s becoming annoying,” Andrea Gambotto, a professor at the University of Pittsburgh, said of the controversy.

Gambotto has used a cell line called HEK 293, the same used by Regeneron, as part of his research for 25 years.

“It’d be a crime to ban the use of these cells,” he added. “It never harmed anybody — it was a dead embryo so the cells back then (were used), instead of being discarded, they were used for research.”

The big advantage of these cells, which were developed in the early 1970s, is that they now represent a “gold standard” in the pharmaceutical industry.

If Gambotto — who is leading a Covid-19 vaccine research project himself — one day succeeds, his vaccine can be produced anywhere in the world, thanks to HEK293.

“You can go to India and make a vaccine for all the world,” he said. To those who call for the development of alternatives, he says, “You don’t need to go back 30 years and reinvent the wheel.”

The original cells were transformed and immortalized in January 1973 by a young Canadian postdoc by the name of Frank Graham, who was working at the time in Leiden, the Netherlands in the laboratory of Professor Alex van der Eb.

Vials of the Oxford University Covid-19 vaccine, which was developed using aborted fetal tissue Vials of the Oxford University Covid-19 vaccine, which was developed using aborted fetal tissue Photo: AFP / Vincenzo PINTO

Normally, a cell has a finite number of divisions, but Graham managed to modify these cells so that they divide ad infinitum.

This was his 293rd experiment, hence the name of the line (HEK stands for “human embryonic kidney cells”).

“Use of fetal tissue was not uncommon in that period,” Graham, a professor emeritus at Canada’s McMaster University who now lives in Italy, told AFP.

“Abortion was illegal in the Netherlands until 1984 except to save the life of the mother. Consequently I have always assumed that the HEK cells used by the Leiden lab must have derived from a therapeutic abortion.”

Vaccine developers like HEK293 because the cells are malleable and transformable into virus mini-factories. To grow viruses, you always need a host cell. It can be a chicken egg, but human cells are preferable in human medicine.

In the case of Covid-19 vaccines, several makers have used HEK293 to generate what are called “viral vectors.”

These are weakened versions of common cold-causing adenoviruses that are loaded with the genetic instructions for human cells to manufacture a surface protein of the coronavirus. This elicits an immune response that the body remembers when it encounters

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