What You Should Know:

• Berkeley SkyDeck, the global hub for entrepreneurship and a leading accelerator, today announced that it has welcomed the first three companies for its new SkyDeck LSEC Bio Track: AsparaGlue, Editpep, and MZR Neurotech.
• The inaugural track, created in partnership with the UC Berkeley Life Sciences Entrepreneurship Center (LSEC) through LSEC’s new Venture Grant Program, will assist the UC Berkeley faculty-led teams to launch their own biotech and life sciences startup companies. The startups will receive investment from the SkyDeck Fund, access to Berkeley SkyDeck’s programming and network, and other critical resources. 

Leveraging Berkeley SkyDeck’s Network to Catapult Research into Viable Startups

Selected from a large and strong pool of applicants, each of the three newly formed companies will receive a minimum of $200,000: $100,000 as an academic translational grant from Berkeley LSEC and a $100,000 investment from the SkyDeck Fund, with an option to invest an additional $100,000. 

The LSEC Venture Grant awardees participating in the inaugural SkyDeck LSEC Bio Track are as follows:

AsparaGlue, founded by Professor and Chair of Bioengineering Phillip Messersmith and his postdoc Subhajit Pal. AsparaGlue has developed a superglue-like medical adhesive that can be uniquely used for both external wound closure as well as internal tissue adhesion and sealing. 

Editpep, founded by Innovative Genomics Institute Professor Ross Wilson and Berkeley Haas MBA candidate Malu Kannuswamy. Editpep has developed a class of peptides capable of conveying CRISPR enzymes into clinically-relevant and previously untransfectable cell types.

MZR Neurotech, founded by Electrical Engineering and Computer Sciences Professor Rikky Muller, her postdoc Ryan Kaveh, and PhD candidates Saavan Patel and Arya Reais-Parsi. MZR has developed an in-ear EEG sensor for sleep monitoring and more.

“Berkeley LSEC and Berkeley SkyDeck share the same goals: to amplify and accelerate the growth of companies with world-changing potential. As expected, we had many prominent Berkeley faculty-led teams apply with cutting-edge IP and had to make some difficult decisions. We are excited to see how each of our first three alumni go on to succeed,” said Darren Cooke, Executive Director of Berkeley LSEC and the chair of the Bio Track at Berkeley SkyDeck.

What once seemed like science fiction, interacting with people across the world has become the new normal. While we have become increasingly accustomed to video calls and instant communication in recent years, forays into virtual worlds and extended realities are still relatively novel. 

In a post-Covid world, it seems strange to think that video conferences and calls were not the norm only three years ago. But the value created by virtual interactions during the last several years has driven a worldwide adoption of virtual technology that is here to stay. 

As we move beyond video screens into virtual worlds and extended reality, many are asking if the metaverse has the potential to provide real value in the coming years, or if it is simply another shiny technology that will fade. There is no doubt that engaging in virtual worlds is a level above simple video interactions, but if these enhanced interactions cannot translate to value for both businesses and customers, adoption may lag. 

While the pharmaceutical industry and life sciences are often criticized for slow technological adoption, the metaverse presents an enormous opportunity for early adoption built on a clear understanding of value. 

Virtual worlds and extended reality have the potential to be serious channels that enhance normal day-to-day business, and 82% of executives anticipate that in the next three years, metaverse will be integrated into their business¹. Working to successfully activate the metaverse as an extension of business is an essential part of understanding how this new technology will be fundamental to optimizing business outcomes in the future. Adopting and activating metaverse technology, however, requires that we create an actionable metaverse roadmap where virtual worlds are actively tied to business outcomes, domain expertise, and regulatory knowledge. Each of these must guide the business use cases. Faster speeds to market are also enabled when agile ways of working are deployed and technology best practices are leveraged. 

Understanding the value of specific metaverse use cases in the life sciences can help highlight how developing platforms and implementing virtual worlds have the potential to drive digital transformation in new and effective ways. 

Using virtual worlds for sales rep training

Developing a quality rep training program is foundational for activating a dynamic, effective field force. The Gartner Group has found that retention and learning outcomes improve by 75% when an educational program uses experiential learning². While current rep training is rooted in helping reps learn how to effectively interact with healthcare professionals (HCPs), there are limitations in deploying the traditional training model. By utilizing virtual worlds and extended reality, rep training can be transformed into a highly immersive experience, where reps can model and practice their interactions with HCPs in a number of realistic scenarios. Just like pilots train with simulators so that they can learn how to better anticipate what it will be like to fly in a real plane, providing high-quality simulations for rep training can lead to more rep success in the field and increased revenue. 

Creating immersive patient education experiences

With healthcare costs rising, the need for greater patient education has increased. Patients who have a better understanding about their disease are more likely to better manage their own care and avoid hospitalizations. Patient education is also linked to helping patients feel empowered and more able to cope with the demands of managing their disease. This can reduce mental health concerns and improve patient satisfaction³. 

While patient education can happen in the doctor’s office, the hospital, at home, or through reading materials and videos, these options for education are limited in their ability to engage patients in their education. Virtual worlds open the opportunity for patients to actively participate in their education in an immersive and highly engaging environment. Allowing patients to create digital twins, practice skills, repeat lessons, or join patient communities that offer support all contribute to quality patient education experiences. 

Building interactive engagement capability for HCPs

Metaverse offers a range of opportunities for physicians to access information, training, and professional development opportunities in a virtual environment. One simple use case is the possibility to host virtual conferences and events, which can be attended by physicians from around the world. The real benefit of virtual, however, is when a platform can offer a more immersive experience where HCPs can experience virtual simulations of medical procedures and scenarios. One example of this immersive potential is the traditional mechanism of action (MOA) video. Thanks to metaverse, these topics can be presented in engaging 3D formats. Using metaverse technology, traditional patient battle cards can have an interactive replica, and eDetailing by sales rep has the potential to be done in a virtual world with virtual sales reps or by using a chat bot powered by conversational artificial intelligence (AI) technologies. 

Moving into the future with metaverse

Regulated content has not yet been put on a metaverse platform, and virtual worlds have a long way to go to become more realistic. But embracing metaverse now as a viable channel for business will allow us to optimize its development and experiment with ways to steward the technology so that it can most effectively drive change in the life sciences industry for business, HCPs, and patients.

About Pratik Maroo

At Indegene, a digital-first, life sciences commercialization company, Pratik leads technology product strategy and IP portfolio development. He has 25 years of tech experience, including 16 years in the life sciences industry. Previously, he was the Chief Digital Officer at Cognizant Life Sciences. In the past, he has worked with Sapient (now part of Publicis) and CSC (now DXC). 

About Brooke Anderson

Brooke creates narratives that help life sciences companies engage with consumers, drive optimized go-to-market strategies, and leverage the power of digital transformation. At Indegene, a digital-first, life sciences commercialization company, Brooke leads marketing and demand generation efforts for both Omnichannel Activation and Emerging Biotech. She has over 10 years of marketing experience across industries including consumer products, financial services, technology, and life sciences.

What You Should Know:

– Protai, a proteomics and AI-powered drug discovery startup revolutionizing the way new drugs are discovered, today announced a $12 million extension of its seed round, bringing the total amount to $20M.

– The round includes existing investors Grove Ventures and Pitango Healthcare and was joined by Copenhagen-based Maj Invest Equity Fund. The additional funding will be used to build Protai’s oncology drug discovery pipeline, expand data acquisition as well as increase its discovery activities via pharma partnerships.

Portai Launches Collaborations With Leading Hospitals and Expands Advisory Board

Genomic biomarkers are only relevant for approximately 15% of tumors, thus limited in use. Protein-level biomarkers can predict patient populations not seen by genomic means, by directly measuring proteins, their interactions, and their functions. To tap into the potential of protein-level data, Protai has built a proteomics AI-based platform that comprehensively maps the course of a disease on the protein level. Its technology allows it to better predict which patients will respond to a given drug, as well as discover novel drug targets that were missed by genomic approaches. These discoveries may be the key to significantly accelerating drug discovery and clinical development, lowering the time and costs of R&D.

Since its initial funding last year, Protai has opened laboratories at its Israel R&D center for data acquisition, biological validation and drug discovery activities and recruited an experienced drug discovery team with significant experience in successfully bringing drugs to the clinic. Additionally, Protai established collaborations with several leading hospitals, and now has access to over 100k well-defined banked samples for its comprehensive tumor mapping process, focused on gyno-oncology and lung cancer indications.

With the additional funding, Protai will expand its activities to include an oncology drug discovery pipeline, initially focusing on targets with a clearly-defined novel patient population biomarker, derived from its AI proteomics platform. To help navigate these efforts, the company has added Dr. Sharon Shacham, a serial biotech entrepreneur and Founder of Karyopharm Therapeutics, to Protai’s Board of Directors. In addition, Protai is supported by leading oncology experts, including Prof. Giulio Draetta, Chief Scientific Officer at MD Anderson and former Pharma executive; Prof. Bradley J. Monk, Director of Gynecologic Oncology at the St. Joseph’s Hospital and Director of GOG Partners; Prof. Funda Meric-Bernstam, Chair of the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center, and Dr. Jurgen Moll, former Head Molecular Oncology, Sanofi Vitry.

“We are excited to announce this funding that supports our mission to enhance the drug development pathway from discovery through to commercialization,” said Eran Seger, CEO and co-founder of Protai. “I am extremely proud of our talented team and the achievements we have made to date. We look forward to scaling our organization and its important work towards revolutionizing the drug development landscape.”

Public health crisis communications plans have the power to improve outcomes, reduce long-term healthcare costs, and save lives. These plans should convey crucial health information to impacted groups with recommendations on how and when to seek care and reduce spread. The consequences of ineffective, inconsistent, or absent public health messaging in times of crisis are grave, leading to the mistrust of healthcare institutions, stigmatization of impacted groups, and decreased likelihood of impacted groups seeking care. Over the past few years, the messaging around monkeypox, HIV, and COVID-19 are just a few examples of communications having deadly consequences. What went wrong and how do we make sure it doesn’t happen again?

1. Monkeypox

 In May of this year, healthcare workers identified the first case of monkeypox in Boston, Massachusetts, and as of September 30, there have been 25,851 confirmed monkeypox cases in the United States related to the 2022 outbreak. In early crisis communications messaging, public health officials struggled to communicate risks to impacted groups without stigmatizing the sexual behavior of vulnerable individuals. Guidelines from WHO and the CDC that recommended limiting sexual contact were met with criticism by the LGBTQIA+ community, some of whom pointed to the AIDS epidemic as evidence against abstinence-only guidelines.    

Original crisis messaging only focused on transmission between gay or bisexual men who had sex with multiple or anonymous sex partners, excluding at-risk demographics like sex workers or trans individuals, some who had to wait for vaccination. The stigmatization of men who have sex with men also inadvertently promoted the inaccurate belief that heterosexual people could not contract monkeypox and that monkeypox could only be spread through sexual contact.   

After feedback, government entities like the New York Department of Health revised communications to include messaging and vaccine guidelines for broader at-risk groups. Monkeypox infection numbers are falling in part because stigmatized groups have taken it upon themselves to do what they can to curb the disease. This includes getting vaccinated despite initial government failures to provide enough dosages and choosing behaviors that reduce risk. As happened with the HIV/AIDS crisis, LGBTQIA+ people bore the brunt of monkeypox disease mitigation as well as stigmatization. If initial crisis communications fail to reach impacted groups or stigmatize individuals, additional messaging with input from impacted groups is necessary. This example showcases the paramount importance of defining at-risk groups inclusively, prior to any sort of public communication. Government institutions benefit from consulting specialists, like those trained in gender-affirming care, when carefully crafting their messaging.

2. HIV

The lack of crisis messaging during the first stages of the HIV epidemic in the United States still impacts misinformation spread today. While the first official government report on AIDS came out in June 1981, President Ronald Regan did not publicly mention AIDS until September 1985. This created space for the spread of misinformation around HIV, so in 1987, 43% of Americans agreed with the Pew statement that “AIDS might be God’s punishment for immoral sexual behavior.” (In fringe groups like white evangelicals, 60% believed that AIDS might be a punishment for immoral sexual behavior the same year.)

Furthermore, the tendency to label HIV a “gay disease” continues to shape policy. Texas district judge Reed O’Connor ruled that a Christian company does not have to provide HIV prevention drugs under its employees’ insurance plans, citing the owner’s opposition to “homosexual behavior.” But HIV impacts heterosexual people, who too benefit from accurate information and preventative healthcare. In 2020, people reporting heterosexual contact accounted for 22% (6,626) of the 30,635 new HIV diagnoses in the U.S. according to the CDC. In the U.K., more straight people than gay and bisexual men contract HIV. 

LGBTQIA+ people are often better educated on how to protect against the virus with tools like PrEP and regular HIV testing, and can safely engage in what would have once been considered at-risk behavior. Some of this is linked to the communal trauma of the AIDS epidemic, and the reluctance of government institutions to protect and provide accurate messaging for LGBTQIA+ people, who were forced to seek out their own healthcare solutions. Public health measures have since heavily promoted PrEP use for gay and bisexual men. Meanwhile, only 32.3% of heterosexual adults are aware of PrEP, and less than 1% use it. When accurate and informed messaging fails to keep up with misinformation around HIV/AIDS, less informed heterosexual people can put themselves at greater risk of contracting the virus. 

It’s time to shift messaging. President Biden updated the nation’s comprehensive HIV/AIDS strategy, which includes conscious choices around “person-first language” to reduce stigma against impacted groups and to instead focus on risk behaviors. This updated messaging is crucial in the fight against HIV/AIDS, but the original failure of the Reagan administration to provide accurate information about the crisis has left its mark on future efforts. In the future, governments need to address public health crises early and head-on to prevent public misinterpretation. 

3. COVID-19

Disparities between COVID-19 crisis communications from sources like the CDC versus President Trump’s personal messaging facilitated the stigmatization of vulnerable groups and anti-Asian sentiments. The CDC reported the first laboratory-confirmed case of COVID-19 in the U.S. from samples taken on January 18, 2020, in Washington state, and the Trump Administration declared a nationwide emergency on March 12. However, on March 16, President Donald Trump published a tweet that referred to COVID-19 as “the Chinese virus,” which health experts warned against using. 

We now know that COVID-19 came to New York City from Europe, not China, but New York experienced an increase in harassment and violence against Asian people and communities during the pandemic. Trump’s racialization of the disease led to a precipitous rise in anti-Asian sentiments. A new study from UC San Francisco found that Trump’s personal messaging increased anti-Asian language on Twitter. By 2021, there was a 339% rise in anti-Asian hate crimes across the United States, especially in major cities — and in particular San Francisco.  

As a first-generation Japanese-American woman with parents living in the San Francisco area, my peers and I were terrified for our parents and elders and worried for ourselves. After the Atlanta spa shooting, I started wearing sunglasses in New York City to obfuscate my heritage. Hearing news of another community member being assaulted on the streets or the subway, it was difficult not to let the fear permeate throughout daily life. Would I get assaulted on the subway? Who would protect the Asian grandparents with limited English? Our Asian-American community held rallies and protests, and there were efforts to distribute pepper spray to vulnerable elders. Trump’s offensive messaging was not only an inaccurate distraction but put my community in real danger. When public figures or politicians use racialized or stigmatizing messaging, it erodes trust in government or institutional crisis communications.   

Similarly, personal messaging from conservative elected officials may have influenced vaccine resistance among Republican men. This, along with persistent misinformation across social media, may have contributed to spikes in COVID-19 infections. Crisis messaging from international and national institutions was insufficient without the consistent support of elected officials to combat the spread of misinformation and racialized stigma related to the virus.  

Looking forward

Officials, institutions, and government entities often repeat the same mistakes when it comes to mitigating a public health crisis. Public health crisis communications play a crucial role in disseminating accurate information to help impacted communities identify risk behaviors, seek care, and reduce spread. Indeed, public health crisis communications should focus on behavior rather than identity. Failure to identify and communicate risk behaviors over factors like sexuality or race increases stigma endangers vulnerable groups and jeopardizes overall public health. The anti-Asian sentiment and wave of hate crimes in New York City did nothing to protect New Yorkers from the fallout of COVID-19 but did a lot to make members of my community unsafe.  

In order for public health crisis communications to be effective, they must be timely and, whenever possible, supported publicly by elected officials in addition to public health institutions so that the burden of mitigation doesn’t fall on stigmatized groups. When a crisis communications plan inadvertently stigmatizes or jeopardizes vulnerable groups, it should be reworked with input from those groups. Strong public health messaging can and should protect our most vulnerable.

About Mio Akasako

Mio Akasako is the co-founder and VP of Design at Ash Wellness, a company paving the way for more inclusive and accessible healthcare by enabling and managing at-home diagnostics for the healthcare community. Previously a neuroscience researcher, she spent years studying the circuitry of the visual system before entering the biotech sector to help develop therapeutics that harness the gut-brain axis. She simultaneously earned her graduate degree in Data Visualization at Parsons School of Design. Her desire to combine health and science, tech, and design manifests in her work at Ash Wellness.

What You Should Know:

– One year ago, President Joe Biden and First Lady Jill Biden reignited the Cancer Moonshot, setting an ambitious, achievable goal: to reduce the death rate from cancer by at least 50 percent over the next 25 years, and improve the experience of people and families living with and surviving cancer, ultimately ending cancer as we know it today.

– The Cancer Moonshot has spurred tremendous action across the federal government and from the public and private sectors, building a strong foundation for the work ahead.

Understanding the Biden Administration’s Plans To Combat Cancer

The Biden Administration is announcing new actions from inside and outside of government that will drive additional progress, drawing us closer to ending cancer as we know it today.

Last year, the President stood up the first-ever Cancer Cabinet to mobilize the federal government, and called on individuals, health care providers, and leaders across sectors to step up and take action in five key priority areas: (1) close the screening gap, (2) understand and address environmental exposure, (3) decrease the impact of preventable cancers, (4) bring cutting-edge research through the pipeline to patients and communities, and (5) support patients and caregivers.

To date, the Cancer Moonshot has announced over 25 new programs, policies, and resources to address these five priority areas. The First Lady has traveled the country and the world to hear from cancer patients and their loved ones, as well as the researchers, physicians, nurses, and patient navigators who support them – focusing on the importance of early detection and improving the experience of patients, families, and caregivers. And, the White House and Cancer Cabinet have held more than 50 community conversations and events. More than 60 private companies, non-profits, academic institutions, and patient groups have also stepped up with new actions and collaborations.

These new actions will build on the work done in the first year of the reignited Cancer Moonshot. In addition, today, the President is also announcing his intent to appoint six members to the National Cancer Advisory Board, which plays an important role in guiding the Director of the NCI in setting the course for the national cancer research program.

The Cancer Cabinet is taking the following new actions:

1. National Cancer Institute (NCI) is launching a first-of-its-kind, public-private partnership to bring clinical and patient navigation support to families facing childhood cancer. The National Cancer Institute (NCI) is launching the Childhood Cancer – Data Integration for Research, Education, Care, and Clinical Trials (CC-DIRECT) to support children and Adolescents and Young Adults (AYAs) with cancer throughout their cancer journey; provide patient navigation support to families seeking information and optimal care; facilitate research participation; and establish a portable, shareable, standardized cancer health record. This means families facing childhood cancer can reach out for support and get connected to excellent care and the opportunity to participate in research through clinical trials and data sharing initiatives. This new entity represents a groundbreaking collaboration between NCI, the Office of the National Coordinator for Health Information Technology (ONC), Alliance for Clinical Trials in Oncology (ACTO), American Society of Clinical Oncology (ASCO), American Cancer Society (ACS), the MITRE Corporation, Center for Medicare and Medicaid Services (CMS), Children’s Oncology Group (COG), and the American Association for Cancer Research (AACR).

2. Health Resources and Services Administration (HRSA), is awarding $10 million to improve access to lifesaving cancer screenings and early detection including patient navigation support services. HRSA, a part of the U.S. Department of Health and Human Services (HHS), is doubling its investment in new partnerships to bring community health centers together with NCI-Designated Cancer Centers to facilitate access to lifesaving cancer screenings and early detection services for underserved communities. Health centers that receive funding will conduct patient outreach in these communities to promote early detection of cancer, connect patients to screening services, and provide direct navigation assistance with accessing high quality cancer care and treatment, as needed. Today’s awards total more than $10 million for 22 HRSA-funded health centers, expanding on the $5 million awarded to 11 health centers in 2022

3. HHS is launching “CancerX,” a Public-Private Partnership developed as a national accelerator to boost innovation in the fight against cancer. HHS, ONC and Office of the Assistant Secretary for Health (OASH), is launching the “CancerX” National Innovation Accelerator Initiative, a government wide effort to develop tools, such as digital solutions to improve cancer patient care coordination and communication, new software technology to help community organizations meet cancer patients where they are, or new platforms to support patients with their post-treatment care. This new public-private partnership will drive support for and accelerate the development of biotech and health tech startups solutions focused on the continuum of cancer care, including prevention, detection, treatment, and transitions in care. Organizations whose missions are aligned with the Cancer Moonshot goals will work together to surface innovative solutions and coordinate access to research, mentorship, resources, and other collaborative opportunities. This work will help startups scale their business and work toward creating ‘challenge-focused’ solutions for cancer with health equity in mind. This initiative will build on previous models deployed by successful HHS InnovationX program accelerators such as KidneyX and PandemicX.

The public and private sector is stepping up with the following new actions:

Promoting Cancer Prevention

4. National Minority Quality Forum (NMQF) is launching local community-based activities to increase cancer screenings in at-risk communities. NMQF, a nonprofit, nonpartisan organization that integrates data and expertise in support of initiatives to eliminate health disparities, is releasing a new online hub, which includes several interactive features designed to increase awareness about cancer disparities, innovation in early detection and treatment, and patient- and clinician-oriented resources to close gaps in cancer care delivery. In addition, to help spur action on the ground, the Cancer Stage Shifting Initiative, which was created to move from late stage to early- stage diagnosis and treatment of cancer, improving cancer care and reducing cancer deaths for all, will work together with private and public partners and local advocates to increase awareness of cancer risk and treatment, improve clinical trial diversity, and support efforts to understand the impact of the water crisis on cancer risk in Flint, Michigan.

5. Supergoop! is committing to donate SPF sunscreen to schools and communities across the country to encourage children to start protecting their skin at a young age. Since sun exposure is cumulative throughout a person’s lifetime, Supergoop! is committing to providing the country’s youth the education and resources to keep them protected. Supergoop! is growing the “Ounce by Ounce Program”, designed to give SPF sunscreen to schools for free. So far, Supergoop! has donated more than 6,800 SPF sunscreen pumps to over 1,900 classrooms and youth organizations and is dedicated to expanding this cancer prevention program.

Supporting Patients and Caregivers through their Cancer Fight

6. American Cancer Society and the Richard M. Schulze Family Foundation launch $10 Million challenge grant to benefit five American Cancer Society Hope Lodges. The American Cancer Society and the Richard M. Schulze Family Foundation (RMSFF) announced the launch of a $10 million challenge grant to benefit five American Cancer Society Hope Lodges – in Omaha, NE; Charleston, SC; Lexington, KY; Lubbock, TX; and Kansas City, MO. Funds raised through the RMSFF challenge grant will be used to establish $2 million endowments at each of the five Hope Lodges to support ongoing maintenance of their physical facilities and operations and support physical improvements to those building.

7. Colorectal Cancer Alliance is launching BlueHQ, the first-of-its-kind comprehensive support hub for patients, survivors, and caregivers to navigate colorectal cancer. BlueHQ is a free support service designed to help patients learn, connect, and take action to improve outcomes. The support hub includes features to suggest helpful information and resources that align with the patient’s profile; connects patients to allies with similar experiences, as well as a patient and family support navigator; and safely and securely stores appointments and notes or journal entries, which can be shared with caregivers and healthcare providers.

8. New coalition launches to address the obstacles rural patient communities face accessing care. A broad national advocacy campaign is set to be launched, bringing together a diverse coalition of public-private partners to raise awareness and spur action to address the persistent, underlying issues that have caused rural America to fall behind in healthcare, technology, and infrastructure. The coalition includes Stupid Cancer, the American Cancer Society Cancer Action Network, Prevent Cancer Foundation, Cervivor, National Coalition for Cancer Survivorship, Cancer and Careers, Triage Cancer, Tigerlily Foundation and Fight Colorectal Cancer Patient Advocate Foundation. Underpinning these efforts will be a storytelling campaign led by OffScrip Health, a leading digital health media platform focused on patient engagement, health equity, and access to care, and FINN Partners, a global integrated marketing and communications agency that will tackle critical issues impacting rural communities’ health, such as access to care, broadband infrastructure, consumer goods, clean water, telehealth, and more. The series will also spotlight the new technologies, partnerships, and practices that can make a difference in addressing this crisis of care.

Bringing Cancer Screening to More Communities

9. Prevent Cancer Foundation to launch “Early Detection = Better Outcomes” campaign to improve knowledge and completion of recommended cancer screenings. The Prevent Cancer Foundation is launching a new signature campaign, “Early Detection = Better Outcomes,” to educate Americans on what recommended cancer screenings and cancer-related vaccinations they need and to encourage them to schedule appointments. Better Outcomes shares evidence-based resources, including screening options by age and information on vaccinations to prevent cancer, tools to find free and low-cost cancer screenings, and information on how family history can impact cancer risk. The campaign will address two additional barriers that Americans face — fear of screening examinations and lack of access — and introduce a new, interactive tool to deliver a personalized screening plan that can be shared with a health provider.

10. Siemens Healthineers is committing to address cancer screening disparities in underserved regions. Siemens Healthineers is working to increase breast screening capabilities and capacity by providing a mobile mammography screening truck, as well as dedicated technologists to perform scans and artificial intelligence- (AI-) technology to help read 3D examinations in Pennsylvania and North Carolina. To date 680 free mammography screenings have been administered, in partnership with Penn Medicine and the Office of Children and Families Philadelphia in Southwest Philadelphia and WakeMed Health & Hospitals at Raleigh Medical Park. Expanding on the success of this program, Siemens Healthineers will be purchasing an additional mobile screening truck with the goal to partner on 10-12 additional mobile screening events this year, reaching at least 2,000 women in underserved areas, including urban and rural sites around the country.

Driving Research Advances through Data Sharing and Clinical Trial Expansion

11. CancerLinQ® and Owkin pursue a new research collaboration to improve the care of patients with metastatic non-small cell lung cancer. CancerLinQ®, a health technology platform from the American Society of Clinical Oncology, and Owkin, a French-American AI biotech company, launch an initiative to improve outcomes for people facing metastatic non-small cell lung cancer (NSCLC). They will use data from CancerLinQ Discovery®, a real-world oncology database of de-identified electronic health record (EHR) data from more than 6 million patients with cancer and blood diseases in the United States to identify possible predictive factors of why some patients with NSCLC), the most common form of lung cancer, respond poorly to immunotherapy treatment. The goal is to use the data routinely collected at the point of care to learn how to better tailor treatments for patients with advanced NSCLC.

12. Hyundai Hope On Wheels awards nearly $15 million to accelerate pediatric cancer research and treatments. Hyundai Hope On Wheels, a non-profit organization supported by Hyundai and its U.S. dealers, donated $15 million in research grants to over sixty hospitals and research institutions across the country in 2022. With this contribution, Hyundai Hope On Wheels will surpass $200 million in lifetime funding for research and innovative treatments in pursuit of a cure for pediatric cancer. As Hyundai Hope On Wheels celebrates its 25th anniversary this year, they are more committed than ever to inspire hope around the nation.

13. Susan G. Komen commits resources to improve outcomes and expands services for the breast cancer community. Susan G. Komen awarded $21.7 million to fund 48 new research projects at 26 distinguished academic medical institutions in the United States that are focused on improving patient outcomes – particularly for people with the most aggressive breast cancers, or who have experienced a recurrence or metastasis. With this investment, Komen is now supporting more than 152 active research projects, representing more than $115 million in funding. Additionally, Komen has expanded access and affordability for breast cancer screening and diagnosis by growing its screening and diagnostics program to 12 cities and providing no-cost breast cancer screening mammograms and diagnostic tests to individuals who meet income qualifications.

The material cost of COVID-19 has been at the center of public discourse since the early days of the pandemic. In 2020, growth in federal government spending on healthcare increased 36 percent, compared to the 5.9 percent bump in 2019. While the distribution of vaccines has allowed for a version of pre-pandemic life to resume, hospitals are still not recovered from the high rates of hospitalizations that occurred in March 2020, and the indirect costs of the pandemic continue to loom over the American population as a result of strained health systems. 

During the early days, the cost of hospitalizing a patient seemed obvious: the sheer volume of long stays, expensive ventilators, a lack of one-size-fits-all treatment solutions, and the pause of elective surgeries. Now, Covid-19 continues to wreak havoc on our health systems, but in a more covert way. With only 4% of Americans fully boosted as we move into this winter’s ‘triple-demic’ – and long covid impacting the lives of as many as 16 million people on a daily basis – it’s clear that public health officials need to do more in order to support the American population and our struggling health systems. 

The Cost of Healthcare Provider Burnout 

Across the country, healthcare providers are reporting extreme rates of burnout. It is important to underscore that healthcare providers and hospital systems were stressed prior to Covid-19, but the pandemic has exacerbated it. Employment across healthcare is down 1.3 percent, or 223,000 jobs, from pre-pandemic levels. Over 90 percent of nurses said they are considering quitting their jobs by the end of 2022 in a survey, with 72 percent of nurses stating they had already experienced burnout before March 2020. In addition, the increased stress that doctors have experienced is resulting in worse patient care – with 28% of doctors who reported burnout sharing that the quality of care they are providing has significantly declined. 

We are amid a mass healthcare provider exodus, and, according to estimates, each instance of physician turnover costs healthcare organizations at least $500,000, and each instance of staff registered nurse (RN) turnover costs $46,100. Without proper staffing, hospitals are at risk of closure and patients’ health is at risk of worsening. 

The Cost of Hospital Closures 

Before the pandemic, hospitals closed for several reasons, including insufficient staffing, lack of funding, and/or having a large uninsured patient population. Since March 2020, 21 hospitals across the United States, predominantly in rural areas, have closed. Health systems are still recovering from the significant loss of revenue from canceled appointments – according to a report from The Chartis Center for Rural Health, 82 percent of the rural hospitals surveyed said suspension of outpatient services resulted in a loss of at least $5 million per month. 

So, what happens when hospitals and health systems close? 

Rural areas experience more Covid-19-related deaths than urban communities and public health experts attribute these deaths to the rampant hospital closures, as well as a general lack of healthcare providers. It is a vicious cycle: Covid-19 strains hospital systems, healthcare professionals leave, hospitals close, and more patients will die from infectious diseases like Covid-19, the flu or respiratory syncytial virus (RSV) – not to mention the other reverberating public health complications that come as a result of these closures. Vaccinations have helped these hospitals stabilize, but to keep up with covid fatigue and the ever-evolving variants we need a variety of treatments in our arsenal. 

More Covid-19 Treatments Will Bolster Struggling Health Systems  

Increasing the number of vaccinated individuals around the world, in addition to broadening access to effective non-vaccine treatments, such as antivirals and monoclonal antibody therapies, will significantly lessen the impact of the disease on individuals and lessen the burden on the healthcare system. Antiviral treatments have proven to reduce hospitalization, but diversity in treatments is essential to keep up with the ever-evolving Covid-19 variants. Dr. Andrew Pavia, chief of pediatric infectious diseases at the University of Utah Health, was quoted on the effectiveness of antivirals: “If there is anything we know about viruses and antiviral drugs is that eventually, we will see some sort of resistance.” For the time being, antivirals are effective – this is not a call to leverage one type of therapy over another – this is a call to help patients and our health systems survive by equipping healthcare professionals with as many treatments as possible. 

One such treatment that has proven highly effective when applied properly are neutralizing monoclonal antibody therapies. Like antivirals, monoclonal antibodies reduce hospitalization, the risk of death, and shorten the length of the infection – resulting in better patient outcomes and stronger health systems. 

According to Yale Medicine, it is estimated that about three percent of the United States population, or up to 25 million individuals, is considered moderately-to-severely immunocompromised, making them more at risk for serious illness if they contract Covid-19, or other viruses. Monoclonal antibodies are a highly safe and efficacious treatment, which is extremely important for this vulnerable population, especially as a complement to vaccines for prevention. An infusion can reduce the risk of hospitalization by 80 percent or more in a high-risk person, and unlike antivirals, monoclonal antibodies target specific parts of the virus spike protein leading to fewer side effects and interactions with other drugs. 

Collaboration between the government and the biotech industry will be essential for creating a portfolio of therapies to treat a variety of patient profiles who experience a range of Covid-19-related health issues. With our healthcare systems in such a precarious state, investing resources in the development of these treatments will prepare hospitals for future variants that threaten the health of our nation. The hope is that by bulking up our Covid-19 hospital response strategy, our already volatile health system will have a chance to recover, increase individuals’ access to quality healthcare, and ensure a healthier population. 

About Eugene Y. Chan, MD 

Dr. Chan is a physician-inventor. He is currently Chairman, Co-Founder of Abpro, CEO of rHEALTH, and President, CSO of DNA Medicine Institute, a medical innovation laboratory.  He has been honored as Esquire magazine’s Best and Brightest, one of MIT Technology Review’s Top 100 Innovators, and an XPRIZE winner. His work has contributed to the birth of next-generation sequencing, health monitoring in remote environments, and therapeutics. Dr. Chan holds over 60 patents and publications, with work funded by the NIH, NASA, and USAF.  Dr. Chan received an A.B. in Biochemical Sciences from Harvard College summa cum laude in 1996, received an M.D. from Harvard Medical School with honors in 2007, and trained in medicine at the Brigham and Women’s Hospital.  He is one of few individuals who has been in zero gravity. 

What You Should Know:

– Imprivata, the digital identity company for life- and mission-critical industries, today released new research that reveals over 91% of security leaders agree they can no longer rely solely on perimeter security to combat and respond to cyber threats, with 99% having experienced a cyberattack in the past year.

– The report outlines how healthcare, finance, manufacturing, pharmaceutical, and biotech organizations are approaching cyber and privacy risks. Cross-industry, 58% cite an increased frequency of attacks –to the tune of 21%, on average. Moreover, the rise of remote work has largely contributed to the growth of attack surfaces. Subsequently, 67% are focusing on security beyond the firewall as one of their top three investment priorities this year. Commonly referred to as “identity-based” or “identity” security, this approach is focused on ensuring users are only able to access the data and resources they need –a cornerstone of Zero Trust.

The Growing Concerns Regarding Cyber Threats

Imprivata is the digital identity company for mission- and life-critical industries, redefining how organizations solve complex workflow, security, and compliance challenges with solutions that protect critical data and applications without workflow disruption. The study was conducted by Vanson Bourne on behalf of Imprivata and includes insights from more than 750 IT security leaders spanning healthcare, finance, manufacturing, pharmaceutical, and biotech organizations across the US, UK, Australia, and Germany.

Though the concept of Zero Trust isn’t new, the adoption of technologies to facilitate a Zero Trust Architecture (ZTA) varies. “What we learned from this data is that businesses are under significant strain to mitigate attacks and manage the eye-watering costs when they occur. Yet less than half have the recommended digital identity technologies in place to protect themselves,” said Wes Wright, chief technology officer at Imprivata. “Despite the widespread familiarity with Zero Trust principles, fewer than half of those surveyed have adopted the foundational technologies needed to achieve them.” 

Solutions like identity governance, privileged access management (PAM), vendor privileged access management (VPAM), multifactor authentication (MFA), and single sign-on(SSO) enable greater security and compliance without negatively impacting end-user workflows. The low adoption rates seen in the study may be a result of apprehension; that doing so will hinder user productivity, particularly given the sizable number (57%) who cite user-centric security as a top priority.

Other key findings include:

– Third-party data breaches are a leading attack vector: More organizations are leveraging vendors, partners, and contractors as essential business resources. Interestingly, 40% of those surveyed report falling victim to a third-party data breach in the last 12 months yet just 42% have deployed VPAM to manage and control third-party access.

– Rising cyber insurance costs and insufficient coverage:40% of respondents cite increased cyber insurance costs as the most common negative impact following a cyberattack, adding that their premiums have risen by an average of 35% in the past year alone. Further, 48% say their policy doesn’t cover real-life scenarios.

– Patient lives at risk: For healthcare organizations, the cost of a cyberattack often goes beyond monetary to affect patient care. In fact, three in ten (31%) of those surveyed report that procedures and tests have been delayed that resulted in poor outcomes.

What You Should Know:

– Pangea Biomed, the biotech company behind ENLIGHT, the multi-cancer response predictor improving the effectiveness of precision oncology, announced $5M in additional funding reaching a total seed round of $12M.

– The latest fundraising is led by angel investor Danny Tocatly and existing investor NFX, and will be used to expand US operations, drive commercial partnerships, and scale product offerings.

Expanding US Operations and Fostering Commercial Partnerships Via Funding Extensions

Launching from stealth earlier this year, Pangea aims to improve upon the dismal statistic that, despite significant investment in oncology R&D and approval of a number of efficacious immuno-oncology drugs, less than 10 percent of cancer patients benefit from today’s precision oncology treatments. The company’s ENLIGHT platform combines RNA sequencing with machine learning to pinpoint the best path toward combating a patient’s cancer, with a goal to increase patient benefits from precision oncology by 5x and democratize personalized cancer care. 

The company’s efforts are quickly advancing the potential for all cancer patients, regardless of cancer type, to qualify for personalized treatment regimens. Recently, the company revealed technology that may bring personalized treatment nomination to situations where NGS-based molecular profiling isn’t an option due to a lack of sufficient tissue, time or resources.

“Our technology aims to change the way cancer is treated globally,” said Tuvik Beker, Ph.D., CEO of Pangea. “This seed extension will help us make strides toward improving oncology drug development and making personalized care accessible for all patients.”

Over the last year, Pangea began two clinical trials, published three papers on their newest findings and established partnerships with several pharmaceutical companies. The company is also actively collaborating with clinicians and researchers from some of the world’s best institutes, including Massachusetts General Hospital and Sheba Hospital, the largest hospital in Israel and one of the top ten hospitals in the world.Pangea is focusing efforts on expanding its work in the US to gain access to a greater spread of research partnerships, drug development opportunities and advanced clinical trials. The company plans to hire a Chief Business Officer to scale these US-focused operations.

Clinical Research

The announcement comes on the heels of the peer-reviewed publication of “clinically oriented prediction of patient response to targeted and immunotherapies from the tumor transcriptome” in Cell Press’s flagship clinical and translational research journal, Med. In the published retrospective study, Pangea’s ENLIGHT demonstrably enhances the ability to predict therapeutic response across multiple cancer types from the bulk tumor transcriptome. The findings show that patients on ENLIGHT-matched treatment courses have markedly better response rates than other patients. By excluding non-responders, ENLIGHT can enhance clinical trial success and achieve more than 90% of the response rate attainable under an optimal exclusion strategy.

Making clinical trials equitable is one of the biggest challenges we face as an industry. We see this time and again, with one of the latest examples coming in the form of a study published in JAMA Network Open that found substantial underrepresentation of Black patients enrolled in pivotal trials for CAR-T therapy.  

Women are another demographic negatively affected by inequality in clinical research. Earlier this month [May 2022] the American Heart Association issued a presidential advisory warning that gaps in cardiovascular disease research are putting the lives of female patients at risk.  There are socio-economic disparities, too. For example, those with household incomes below $50,000 dollars per year are 27% less likely to participate in clinical trials.

We have, however, started seeing positive change in recent years, including public commitments to increase recruitment from underrepresented groups. 

Flexible models and the use of virtual tools are vital for increasing equity in clinical trials.  Providing participants with choices around their clinical care is key for reaching groups that have been historically underserved by the clinical trials industry. 

Meeting participants ‘where they are’

Meeting participants where they are on an emotional level calls for us to provide them with a care team that they can relate to and that understands their specific concerns. For example, people are more inclined to volunteer for trials if the clinical trial investigator speaks their native language. Focusing on connecting with people in this way has a direct impact on the success of clinical trials – particularly when it comes to increasing access and reaching underserved groups. 

Approaching recruitment in a holistic way not only enables us to increase access to trials but also boosts retention rates. Developing sensitive, targeted digital content for social media campaigns that engage participants online is a primary focus for recruitment teams. At the same time, we encourage ever greater levels of commitment and creativity when thinking about community engagement and meeting participants in their neighborhoods.

Engaging with communities through a grassroots approach builds personal relationships, scales trust, and provides an opportunity to share information and awareness about the importance of participation in clinical research. . Producing a model for more inclusive clinical trials starts with the human connection. Great strides forward are being made across the industry as a result of implementing new models that have a strategically creative and compassionate approach to clinical research as a healthcare option. The National Center for Biotechnology Information (NCBI) reports that decentralized models recruited participants three times faster than the traditional model. Bringing the trial to the patient accelerates study recruitment times and minimizes attrition, with the NCBI study showing that trial retention rates were 89% for the decentralized model and only 60% for the traditional model.

The importance of ‘the third place

We contend that ‘the third place has the potential to boost these figures even higher, as organizations like ours are actively working to maximize outcomes for participants and sponsors of clinical trials. Sociologist Ray Oldenburg defined “the third place” as an informal public gathering place that serves the community. He said it is the social surrounding that is distinct from the two main social environments of home (the “first place”) and the workplace (the “second place”).  

By giving people the choice of participating in clinical trials at a third place, they are no longer limited by where they live or, in some cases, not comfortable having someone visit them at home. One innovative example of this is MMCs (mobile medical clinics), modified RVs (recreational vehicles) that are fully functional clinical study facilities. MMCs are coming to the forefront along with other community brick-and-mortar sites. Mobile medical clinics are a third place where we can bring people and technology together, effectively and seamlessly, in a clinical trial.

The virtual-first model delivers additional oversight and care that enables us to provide a consistently high level of experience. Flexible approaches, particularly those that incorporate the third place, have the potential to increase access to clinical trials in emerging markets with limited infrastructure. 

These new approaches are helping us to bring clinical trials to all, particularly the most vulnerable populations. They provide participants with a greater sense of support, understanding and confidence about participating in a clinical study.  Removing geographic and logistical burdens scales access which drives equity. Diversity in clinical research is essential for developing medications, treatments and therapies that benefit everyone.

About Rachael Scott

Rachael Scott serves as chief commercial officer at Lightship. She leads customer design solutions, business development and strategic marketing. Rachael excels at the intersection of strategy and operations to develop robust commercial structures designed for successful and streamlined collaboration with sponsors. Rachael’s expertise includes leading business development initiatives and integrated marketing platforms while building departments to scale. Prior to joining Lightship, Rachael served as a partner at PA Consulting Group and a director at Ernst & Young. Rachael delivered results working with pharmaceutical and biotech organizations to deliver operational fitness and market expansion strategies. After launching her career at AstraZeneca, she spent a decade at IMS Health managing key global clients.

Inflammatory skin conditions such as atopic dermatitis, psoriasis, vitiligo, hidradenitis suppurativa and others impact a significant portion of the U.S. population. In fact, nearly half of all visits to primary care physicians include some level of dermatological indication. Many of these dermatologic conditions are accompanied by pain and severe discomfort for affected patients, and the resulting morbidity of the condition may have a negative impact on mental health, self-esteem and overall quality of life. 

As the prevalence of various inflammatory skin conditions grows, more non-invasive, precision-based approaches for diagnosis and treatment are critical for improving patients’ lives. 

Existing Methods of Diagnosis and Treatment

To diagnose most dermatological indications, physicians traditionally rely on the combination of visual assessment, a patient’s description of their symptoms and other disease-associated markers. For example, the presence of red, itchy lesions and increased allergen sensitivity is traditionally used by physicians to confer the diagnosis of atopic dermatitis. 

These evaluations are subjective to each physician’s own medical training, experience and opinion. In some instances, inflammatory skin diseases such as atopic dermatitis and psoriasis may present with similar symptoms and visual markers. These factors can make correctly identifying an inflammatory skin condition very difficult and outline the need for additional objective measures.

This traditional diagnostic process often leads to a trial-and-error treatment approach.  More specifically, under this approach, patients cycle through a list of therapeutics until they find one that works best for them.  While the armamentarium of approved therapies continues to grow, the therapeutic benefit for each one varies which leads to the cycling of therapies. The lack of appropriate treatment may be associated with an increased disease burden and/or financial impact. In some cases, administering the wrong therapeutic to the wrong patient can lead to a worsened condition, increased infections within the skin and even hospitalization.

Precision-based diagnostic and treatment approaches in dermatology may allow physicians to interpret skin conditions on a more granular level. We are seeing the tangible benefits it can have for both patients and physicians, and demand is increasing.

Benefits of Non-invasive Technology 

Many clinical trials in dermatology incorporate a skin sample collection to learn more about how therapy works in a skin disorder. While skin biopsies are considered the “gold standard” for many researchers, a host of challenges accompany this practice such as wound repair, skin infections and the general aversion to skin biopsies amongst patients. In fact, less than 20% of patients enrolled in dermatology-focused clinical trials typically volunteer to participate in optional skin biopsy collections. 

In contrast, non-invasive skin sampling is a highly attractive alternative to skin biopsies and can serve as a surrogate for biopsies. 

 
The Potential of Personalized Approaches

The integration of precision-based approaches is driving medicine toward continued innovation and development in dermatology. Furthermore, non-invasive, precision-based approaches to diagnosis and treatment will undoubtedly make medicine more personalized leading to improved outcomes and patient success. 

By understanding the underlying biology of common inflammatory skin conditions, diagnosis and treatment will become more objective and, therefore, more effective. 

About Michael Howell, Ph.D. & Chief Scientific Officer at DermTech

Michael Howell, Ph.D., is an immunologist with more than 20 years of experience in the government, academia, and the biopharma/biotech sectors. Prior to joining DermTech, Dr. Howell was a faculty member at National Jewish Health and held increasing positions of responsibility at Boehringer Ingelheim, MedImmune/AstraZeneca, and Incyte Corporation. Dr. Howell has previously led research and development teams dedicated to the discovery of novel therapies for dermatology and the integration of novel biomarker approaches including adhesive tape strips into clinical development. His efforts have led to the approval of multiple therapies, novel diagnostic approaches to patient treatment, and have been highlighted in more than 50 publications and numerous patents. Dr. Howell received his Ph.D. in Immunology from West Virginia University and completed his post-doctoral training at National Jewish Health

Amazon Launches Amazon Clinic Across 32 States

Amazon launches Amazon Clinic, a virtual care option that will operate across 32 states that offers up-front pricing, and treatment within hours, instead of days—helping customers achieve better health. Welcome to easy-to-use, effective care for common health conditions.

For customers, the cost of consultations will vary by provider and includes ongoing follow-up messages with their clinician for up to two weeks after the initial consultation.  At this time, Amazon Clinic does not accept insurance, but is FSA and HSA eligible. Customers may be able to use their insurance for any prescription medication costs that result from their Amazon Clinic visit.

AWS Launches Imaging, Health Analytics Capabilities

Amazon Web Services (AWS) launches two new capabilities in HealthLake that deliver innovations for medical imaging and analytics:

– Amazon HealthLake Imaging is a new HIPAA-eligible capability that makes it easy to store, access, and analyze medical images at a petabyte scale. This new capability is designed for fast, sub-second medical image retrieval in clinical workflows that can be accessed securely from anywhere (e.g., web, desktop, phone) and with high availability.

– Amazon HealthLake Analytics harnesses multi-modal data, which is highly contextual and complex, is key to making meaningful progress in providing patients with highly personalized and precisely targeted diagnostics and treatments.

General Catalyst Adds 10 New Health System Partners

Healthcare venture capital firm General Catalyst adds 10 new health system partners, bringing the number to 15 in total. This first-of-its-kind strategic ecosystem will encapsulate 10% of the US population across 43 states (as well as the largest academic health system in the UK), with a goal to promote health assurance and deliver accessible, affordable and effective care.

Exo Co-founder and Board Chair, Janusz Bryzek, Ph.D. Passes Away

Exo, a medical imaging software and device company, today announces the death of its Co-Founder and Board Chairman, Janusz Bryzek, Ph.D. Janusz passed away in his home on the morning of November 10, 2022, surrounded by his loving wife and three children. Commonly referred to as the “Father of Sensors” and the “Trillion Sensor Man,” Janusz was a renowned pioneer in the development of micro-mechanical integrated systems (MEMS) technology and a driving force behind innovations that have profoundly reshaped how technology can be used to improve the lives of those around the world.

Verizon and Higi Extend Community Healthcare Access & Services

Verizon and Higi are teaming up to provide digital health solutions and services that will extend care access for communities and help support preventative health, drive literacy, and identify high risk consumers eligible to be managed via home-based monitoring.The partnership will prioritize solution delivery in service of community healthcare stakeholders seeking to scale digital and virtual care delivery offerings.

FDA and MITRE publish updated Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook

The FDA and MITRE published an updated Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact device functions.

Updates to the playbook include:

– Emphasizing the need to have a diverse team participating in cybersecurity preparedness and response exercises – including clinicians, health care technology management professionals, IT, emergency response, and risk management and facilities staff.

– Highlighting considerations for widespread impacts and extended downtimes during cybersecurity incidents which benefit from the use of regional response models and partners.

– Adding a resource appendix making it easier to find tools, references, and other resources to help health care organizations prepare for and respond to medical device cybersecurity incidents (including ransomware).

Penumbra Launches First Hands-Free, Full-Body VR for Rehab

Penumbra, Inc., a global healthcare company focused on innovative therapies, today announced the first full-body, non-tethered immersive virtual reality (VR) healthcare offering. The latest REAL® System y-Series is the only platform to use upper and lower body sensors that allow clinicians to track full body movement and progress in real-time. The expansion of the virtual reality-based healthcare platform, REAL System, will be used to address a broad range of physical, cognitive and mental health needs for patients undergoing physical, occupational and speech therapy.

Included Health Launches All-Included Care™

 Included Health launches All-Included Care, a new kind of healthcare service that guides and delivers high-quality, in-network care for every health journey, from simple to complex. By combining virtual care and access to in-person care with guidance and advocacy, All-Included Care creates a comprehensive and connected healthcare experience for every healthcare need.

Henry Schein Medical Expands SolutionsHub with Rimidi

Henry Schein Medical today announced the expansion of its Solutions Hub with Rimidi. With this partnership, clinics, medical groups, and health systems served by Henry Schein will have access to Rimidi’s cloud-based software platform, which helps deliver an efficient model of care for patients with chronic conditions.

Turquoise Health Launches Price Transparency Data Solution

Turquoise Health launches Simple Extracts, its first price transparency data product for specialty healthcare businesses. Simple Extracts allows anyone to request and receive precise searches from both the hospital and payer rates data warehouses. The new product eliminates the cost and technical barriers specialty businesses encounter by delivering data to customers directly within the Turquoise Health platform. There they can also store, access, and refresh their extracts whenever needed.

Viz.ai, Illuminate Partner to Improve Care Quality for Aortic Aneurysm Patients

Viz.ai partners with Illuminate, Inc. to enable healthcare providers to make timely, critical decisions for aortic aneurysm patients while improving compliance with pre- and post-surgical surveillance programs. Aortic aneurysms will often cause no obvious symptoms before a life-threatening rupture occurs, so early detection and monitoring are critical. Illuminate’s NLP capability is a complement to Viz.ai’s growing platform, which will now offer healthcare systems a comprehensive solution to detect more suspected aortic aneurysms earlier and ensure that patients have access to the life-saving treatments or surveillance that they need by cross-functional care teams.

Cyclica Awarded $1.8M Grant from Bill & Melinda Gates Foundation to Discover Non-Hormonal Contraceptive

 Cyclica Inc., a neo-biotech that is exploring the entire protein universe to advance a robust and sustainable drug discovery portfolio, has received a $2.4M CAD ($1.8M USD) grant from the Bill & Melinda Gates Foundation to develop new, non-hormonal contraceptives for low-data biological protein targets. The grant enables Cyclica to apply its validated, AI-enabled drug discovery platform towards the discovery of expanded contraceptive options that can give women and girls the ability to better plan their families and their futures.

ConcertAI Names Ronan Brown as its First COO

ConcertAI names Ronan Brown as its first Chief Operations Officer to oversee and enhance day-to-day operations across the company, globally, to assure the quality, performance, and seamless functionality of the company’s solutions as the ConcertAI continues it high growth.

Ascension Partners with Qualtrics for Patient-Centric Care Data

Qualtrics partners with Ascension to provide an increased understanding of patient feedback and experience within the health system. The insights from Qualtrics will uncover patient pain points, allowing Ascension to drive new and improved programs to meet unmatched needs. With eight in 10 patients citing customer service as a decisive factor in healthcare provider loyalty, it’s imperative to understand the range of communities and expectations of those accessing care. Doing so provides patient-centric care, and supports the bottom line of health systems to increase patient retention, and caregiver satisfaction. 

CenExel Creates Clinical Sciences Business Unit

CenExel announces a new Clinical Sciences business unit, composed of early phase and translational medicine scientists, plus the broader network of CenExel therapeutic experts and key opinion leaders (KOLs), providing support to all the CenExel Centers of Excellence as well as standalone consulting services. Clinical Sciences by CenExel (Clinical Sciences) offers a unique opportunity for collaboration with pharmaceutical sponsors, CROs, and vendors, to support study development and conduct within the Sponsor’s clinical development program across the development lifecycle.

Currently, some 22 states have enacted prescription drug transparency laws that require entities across the drug supply chain to report pricing information to state officials. Designed to shed light on the true cost of drugs and to ensure that consumers and insurers aren’t being gouged, drug pricing transparency laws seek to level the playing field by delivering greater visibility into drug costs. And given the fact that prescription drug prices continue to increase, the topic of drug price management is likely to continue to capture the attention of the media and policymakers at the state level, given the current lack of overriding federal regulation.

For example, the AARP Rx Price Watch Report for 2021 revealed that retail prices for brand-name prescription drugs are consistently increasing at a faster pace than that general inflation. These cost increases have a negative effect on patients and overall drug compliance because people tend to avoid taking medications as prescribed when the cost gets too high. This trend is also confirmed by a 2021 GoodRx survey around medication adherence and drug cost, which shows that 18.7% of adults have delayed refilling a prescription after running out, and 16.4% of people ration medication to extend their prescriptions.

What’s Next for Drug Pricing

As drug prices become a broader concern, it becomes even more likely that there will be additional legislative and regulatory activity around drug pricing in the coming months and years. In the absence of comprehensive federal legislation, many states are taking on drug pricing management themselves, and within the next few years, up to 30 states are expected to adopt price transparency regulations. With this, we can expect that each state will have its own set of unique reporting requirements around pricing transparency.

These coming requirements for greater transparency and visibility into drug pricing will help legislators, regulators and the public better understand price increases and help control costs. Price transparency mandates typically require companies to generate reports based on “triggering events,” which include wholesale acquisition cost (WAC) increases and other events that include the release of annual price lists and pricing for new drugs, as well as the rollout of newly acquired products, as well as new drug applications.

However, the requirements for reporting and documentation can vary significantly from state to state, including formats and timing. Different periods of time around reporting on WAC price increases can vary from 30 to 60 days, or reports may be required on a quarterly basis.

Managing these requirements across a large and potentially growing number of states is, of course, challenging for pharmaceutical manufacturing companies. For each state, these firms must generate and deliver mandated reports, correctly formatted and on the correct timetable. Reporting volumes can vary significantly based on drug types and the nature of a given firm’s price increases, and some states may demand different calculations and/or documentation from companies. Accurate reporting also turns on cross-departmental collaboration that can include marketing, research and development, IT, and finance stakeholders from across the organization.

Multiplying these requirements across various states and the numerous drugs in the market illuminates the obvious complexity and show how difficult staying in compliance can be. Even worse for drug manufacturers, there can be substantial financial penalties for non-compliance, with potential fines running into the millions of dollars in some large states. 

What Can Pharmaceutical Companies Do to Stay Compliant?

This increasing pressure means that pharma companies must respond to and meet reporting requirements with solutions that go far beyond labor-intensive, manual processes such as using spreadsheets and maintaining multiple different report templates.

Some companies have addressed this pain point by employing outside experts, in the form of consultants and law firms, to manage compliance efforts. While this can be an effective short-term solution, these consulting organizations typically are not domain experts with core competencies in the drug and pharma space. Additionally, these services can have a substantial price tag for pharma manufacturers, adding further to the financial burdens of compliance. This approach also typically fails to integrate technology to handle the most labor-intensive aspects of compliance, like maintaining document repositories or leveraging automation for tasks like workflow-based approvals.

State Price Transparency Software Solutions

As a result, pharma manufacturers are looking to software vendors to fill the void. Today’s state price transparency management (SPTM) tools can help ease the reporting burden and effectively operationalize these mandates. Modern, cloud-based solutions can be configured to maintain repositories of state-specific reports, filing formats, and critical dates and deadlines. Legislation repositories can also store rules changes and allow for updates as rule changes occur. 

Pharma companies can also rely on automation capabilities within SPTM software to route tasks and approvals across an organization, bringing departments together for collaboration when and where needed. Automation also enables on-demand report generation based on triggering events, which helps user organizations ensure that filings are timely. Governance capabilities within these systems are designed to track and record reporting activity to provide a clear audit trail for regulators should that documentation be needed. What’s more, analytics capabilities within these systems allow for the exploration of what-if scenarios relating to downstream pricing impacts, so companies can plan for future events.

The challenges associated with state-based price transparency rules will continue to be a moving target for pharmaceutical and biotech companies for many years to come. As a result, companies should look to develop agile strategies around responding to these mandates and embrace technology and services – and collaboration between business and IT – as the foundation of their approach. Doing so will enable companies to proactively respond to changes in specific laws on a state-by-state basis, avoid penalties, and maximize revenues. Given the scope and scale of the challenge, there is really no other way for companies to deal with today’s state mandates and plan for the future.

About Kyle Forcier
Kyle Forcier is a senior director of Life Sciences Product Marketing for Model N. For more than 15 years, Forcier has focused his time in the life sciences space helping manufacturers increase their revenue, maintain compliance, and bring innovative ideas to the marketplace. He currently helps shape Model N’s strategic direction focusing on bringing complex, valuable solutions to the market to solve longstanding operational challenges within the medtech industry.

The healthcare market underwent significant changes during the pandemic as patients rethought how they received care, including opting for more telehealth and deferred elective procedures, but patient care is now normalizing as patients return to the office. However, payers are working to reduce the cost of care to reel in healthcare costs and keep premiums lower to remain competitive, driving key changes.

Ambulatory Surgery and Home Care

Surgeries are increasingly moving away from hospitals and into ambulatory settings, where patients are discharged the same day and the cost of care is much cheaper than an acute care hospital stay. Ambulatory surgeries are resulting in less time spent in the high-cost acute care setting, reducing payer costs. Homecare is also growing as patients are being discharged to the lower-cost home care setting earlier in the continuum of care in lieu of being referred to a higher-cost skilled nursing or rehab facility.

Physician Practice Management Consolidation

Private equity and larger platforms are looking to consolidate physician practices to achieve scale reduce costs and achieve more bargaining power with payers. Physicians are motivated to sell to integrate with an organization that has more capability in terms of systems for claims processing, as well as to achieve more efficient management of claims processing, a greater business development capability to acquire practices and add ancillary services, and a focus on clinical medicine instead of paperwork. 

Since many private practices are smaller (one to four physicians), the area is ripe for consolidation, as private equity groups can purchase practices at favorable multiples and grow them through the holding period, streamline operations, and invest in new locations. Another driver of consolidation was the recent conversion to electronic health records resulting from the HITECH Act. The technology investment for small physician practices was significant, and a lot of smaller practices decided they did not want to bear the burden and cost of these systems, leading them to band together, join a larger practice, or seek out a buyer.

Physicians Move to Employed Models

Private practice physicians beleaguered by the burden of managing a practice are therefore opting into employment by a hospital or private-equity-backed medical group rather than owning their own business. This frees them from administrative burdens (billing, managing staff, negotiating rent, etc.), and a salaried position allows them to spend more time with patients. 

A Shift to Value-Based Care

In a traditional fee-for-service billing model, healthcare providers bill payers based on the specific services provided. Now, there is an increasing shift to value-based care, where healthcare providers bill based on the outcome the patient received, with the goal of reducing overall healthcare spending and improving care, helping to ensure that the price of services is commensurate with the actual outcome delivered to the patient. 

Capitated contracting is another alternative to fee-for-service reimbursement models, whereby the provider contracts with the payer (insurance company) for a fixed per-member/per-month payment for all of their covered lives in a particular geography. This approach works to help prevent fraud and abuse by disincentivizing over-utilization that can occur in a fee-for-service model. 

Increased Price Transparency

As required by new legislation, Hospitals and other providers are being compelled to improve the transparency of patient billing, allowing consumers greater ability and convenience to shop around for lower-cost healthcare when they discover that they will be billed a high co-pay, for example. 

Telehealth

Telehealth spiked in popularity during the pandemic; though, as the pandemic wanes, there is an increasing trend of patients returning to in-person care. However, certain specialties still lend themselves to telemedicine (such as psychotherapy), where costs can be cut since the care can be provided without the overhead cost of a facility. 

Technology Allows for Less Invasive Surgeries

On the medical device side, technology now allows for traditionally invasive surgeries to be done in other ways, such as treating issues that used to require open-heart surgery instead of a catheter. This allows for the surgeries to be done less expensively, and a quicker recovery time which means less time in the hospital, and an overall more positive experience for the patient. 

Solutions for the Provider, Payer, and Patient 

Healthcare payers are looking to align reimbursement with patient outcomes. New models of service and developing technologies are being utilized in the marketplace in order to achieve these objectives and control healthcare spending. 

About John Calcagnini

John Calcagnini is a Managing Director in the healthcare practice of Stout’s Investment Banking group. John has extensive experience with mergers, acquisitions, joint ventures, restructurings, leveraged buyouts, recapitalizations, and equity and debt financing. He has executed more than forty transactions in the healthcare industry across a variety of sectors including medical devices & diagnostics, healthcare services, biotech, and specialty pharmaceuticals.

What You Should Know:

– ChristianaCare recently announced it has spun out its first commercial biotechnology private startup company, named CorriXR Therapeutics. The company will use CRISPR gene editing technology to develop new, clinically relevant oncologic therapeutics in areas of unmet medical need, starting with squamous cell carcinoma of the lung. Its close relationship with ChristianaCare and the ChristianaCare Gene Editing Institute uniquely positions it to research and develop innovative, patient-centered therapies.

– The new biotech company has been boosted with $5 million in seed financing from ChristianaCare and Brookhaven Bio.

Heralding Advancements in Gene Editing Technology

The novel way we are using CRISPR-directed gene editing technology in solid tumors, beginning with a hard-to-treat form of lung cancer, has enormous promise as a treatment option to improve the lives of people with a life-threatening disease.”

The CorriXR Therapeutics team includes experienced biotechnology executives and world-renowned scientists and clinicians. The executive team is led by Eric Kmiec, Ph.D., chief executive officer, and Brian Longstreet, chief operating officer.

Kmiec is also the executive director and chief scientific officer of ChristianaCare’s Gene Editing Institute. He is widely recognized for his pioneering work in the fields of molecular medicine and gene editing, having discovered many of the molecular activities that regulate the efficiency of human gene editing.

Longstreet, a graduate of the University of Pennsylvania’s Wharton School of Business, is a seasoned pharma and biotechnology industry veteran with over 30 years’ experience, beginning at Schering-Plough and then Merck & Co. Recently, he has helped to build start-up biotechnology companies. Earlier this year, ChristianaCare restructured its Gene Editing Institute into a wholly owned subsidiary, which positions it to advance research to develop therapies using CRISPR gene editing technology and to fast-track discoveries for commercial application. The new structure also enables it to expand its educational outreach using its CRISPR in a Box™educational toolkit and to develop its analytic software program, DECODR™. The Gene Editing Institute originated in ChristianaCare’s Helen F. Graham Cancer Center & Research Institute in 2015.

“We are excited to spin out CorriXR Therapeutics, which has an enormous opportunity to use the incredible power of gene editing to revolutionize patient care by delivering faster and more accurate diagnoses, targeting treatments and preventing genetic disorders,” said Janice Nevin, M.D., MPH, ChristianaCare president and CEO.

The company has developed unique CRISPR/Cas biomolecular tools that disable the genome of a tumor cell but not the genome of a healthy cell, which enables target selectivity.CorriXR Therapeutics will license technology from the Gene Editing Institute and work closely with its scientific researchers and clinical oncologists at the Helen F. Graham Cancer Center & Research Institute. The Gene Editing Institute’s integrated bench-to-bedside approach connects leading-edge science to patient care.

What You Should Know:

– Pleno, Inc, a multi-omic instrument platform company revolutionizing biological target detection for clinical testing and biomedical research raises $40M in Series A funding led by Deerfield Management and Foresite Capital. 

– The funding will accelerate the development of Pleno’s Hypercoding™ instrument platform, called RAPTOR ™, which is slated for early customer access in 2023 and full availability in 2024. Release below and here. 

The World’s First Hypercoding Instrument Platform

Pleno was founded by Pieter van Rooyen, a well-known biotech engineer who built and sold his last company, Edico Genome, to Illumina for $100 million. Edico’s Dragen technology has become a staple in genetics research. Biotech legend Greg Lucier is chairman of the board. 

Pleno has developed a unique enabling technology called Hypercoding™, which leverages signal processing techniques derived from the telecom industry to deliver ultra-high plexity targeted biological information – including DNA, RNA, methylation, and proteomic content – at unprecedented scale, precision, and performance. The newly raised funds will support the development of Pleno’s Hypercoding™ instrument platform, capable of detecting up to 10,000 targets per sample and processing up to 10,000 samples per day, via a simple, low-cost workflow. This is equivalent to 1,000 times the target multiplexing of polymerase chain reaction technology (PCR) and 100 times the sample throughput of next-generation sequencing (NGS).

Pleno is based in San Diego’s Sorrento Mesa innovation hub proximate to a robust talent pool of experienced scientists, telecommunication engineers, and biotechnology innovators. The company currently employs 24 full-time employees and plans to continue to grow its team rapidly in the coming months.