“How do I operate a liquid dewar pressure builder?” is one of the most frequently asked questions from gas customers. In this article, we provide a better understanding of what a pressure builder is, how it works, and how to safely and properly use it.  

What is the purpose of the pressure builder?  

Without a pressure builder, a tank’s pressure might take several hours or days to build up to the level needed for a specific application. Using the pressure builder means the tank’s pressure will reach the desired level much more quickly, typically in 10 to 20 minutes. Some of the applications for which you might use the pressure builder include supplying nitrogen to a mass spectrometer or high-pressure manifold.  

How does the pressure builder work?  

When the pressure builder valve is opened, it allows liquid nitrogen to be introduced into the tank’s evaporation coil, which wraps around the inner and outer wall of the tank. This creates heat and builds pressure in the tank.  

How do I locate the pressure builder valve?  

There are several different valves on top of a liquid dewar, each with a tag that identifies what that specific valve is used for. Depending on the manufacturer, the pressure builder valve might look slightly different. It’s critical to read the tags to make sure you identify the correct valve that you are adjusting. If you’re looking for the pressure builder valve, search for the tag labeled “PB.” 

How do I set the tank pressure?  

Some pressure builders are designed so that the end user can adjust the pressure themselves. There are several steps that you should follow to ensure you do this properly and safely.  

1. Wear appropriate protective clothing. At a minimum, this should include a protective face shield or goggles and gloves. If possible, wear boots and a long-sleeve shirt and pants.   

2. Review the safety data sheet (SDS) for liquid nitrogen. This will give you a good understanding of the safety precautions and the emergency response guidelines associated with this product.  

3. Identify the pressure builder valve. There will be several valves on top of the tank, so look for the valve with the tag labeled “PB.”   

4. Check the pressure gauge on the tank to see if it’s at the level needed for the specific process. If it’s below the pressure required, turn on the pressure builder valve. Typically, it will take 10 to 20 minutes for pressure to build to the desired level. As pressure builds, it is normal to see frosting on the valves and base of the tank.  

5. The pressure builder may need to be left on throughout the entire run of the equipment if the process requires a high flow rate. However, you must check the tank regularly to ensure it is maintaining the desired pressure level.  

6. After the equipment completes a run, the pressure builder can be turned off. If you forget to do this, the liquid dewar will continue to freeze up around the valves on the tank as well as around the base of the tank. Typically, you will also hear the safeties blowing off aggressively.  

If I hear a loud hissing or popping noise coming from the safeties, is there an issue?  

This noise is normal and occurs when the tank’s pressure has built up to the maximum pressure setting. If this noise is bothersome, you may want to consider getting a whisper valve. This device can reduce the hissing noise as well as limit the amount of product lost from the safeties on the tank.  

What do I do if I find any leaks?  

Do not under any circumstances attempt to block or remove any of the safety devices on the tank to stop the leak. Immediately set the cylinder aside, mark the defective item with tape or a note, and call customer service at your gas distributor. 

Have additional questions or need more help with your liquid dewar pressure builder? The Middlesex team is happy to be of service, so feel free to contact us.  

Middlesex Gases is a preferred partner through MassBioEdge.

*** 

About Middlesex Gases 

Middlesex Gases is a family-owned, third-generation supplier of specialty, medical, and industrial gases and a variety of gas systems, including Bulk, MicroBulk, and Cryopreservation. The company was founded in 1949 by welder Joseph Martin Sr. as Middlesex Welding Supply, in Everett, Massachusetts. Today, Middlesex still offers expertise in industrial and welding gases and products but has evolved to focus more resources on serving the ever-increasing gas requirements of businesses in life sciences, biotech, and health care. Middlesex is now the preferred vendor for the Massachusetts Biotechnology Council (MassBio), the Massachusetts Medical Device Industry Council (MassMEDIC), and BioCT, Connecticut’s biotechnology community. With three fill plants, five supply stores, a state-of-the-art specialty gas lab and new medical CO₂ lab, and a large fleet of trucks and trailers, Middlesex Gases delivers superior gas products and solutions wherever and whenever its customers need them. 

The post Understanding pressure builders and how to use them: A Q&A with Middlesex Gases appeared first on MassBio.

In recent years, significant shifts in federal policy have had an outsized impact on the biotech and life sciences industries and the patients they serve. Paramount among these is the Inflation Reduction Act (IRA), which has complicated the intricate dance between policymakers, patients, drug developers, and other stakeholders within the healthcare system. The economic implications of the IRA continue to ripple through the industry, influencing everything from affordability to innovation to the relationships between industry and patients.  

MassBio has been at the forefront of these conversations, interacting with agencies like the Centers for Medicare & Medicaid Services (CMS) on the implementation of the drug price negotiation program, working to ensure the life-saving and life-changing work of our member companies isn’t slowed or disincentivized by the IRA’s fine print. 

As part of MassBio’s Patient Advocacy Summit last month, we welcomed a diverse panel of experts across the advocacy, healthcare, and policy spectrums to discuss how our industry can best navigate the challenges between federal policies and patient-driven healthcare. 

Navigating the IRA 

Our panel, which was moderated by Takeda Oncology Head of Global Oncology, Patient Value, Policy and Access Liz Lewis, and featured patient advocate and mother of a child with a rare disease Kayla Klein, Stoke Therapeutics Head of Global Patient Advocacy Parisa Sanandaji, and EveryLife Foundation Director of Public Policy Jamie Sullivan, MPH, shared their thoughts on the IRA and what its complex provisions mean for patients. 

Klein spoke to the uncertainty many patient advocates feel about some of the law’s unintended consequences.  

“There are going to be positives [out] of it but as a rare disease mom, it’s just another layer of what’s going to happen, how we find our voice, what are we going to have to say to amplify that this affects us and could potentially affect our family,” she said.  

Many policies are enacted without their authors fully understanding the implications, especially on the smaller rare disease communities. People like Klein, whose son has Severe Hemophilia A, are left to wonder what the goal of such a federal policy is.  

“There’s many benefits for patients, especially those on Medicare, those who are eligible for larger subsidies,” said Sullivan. “But what we haven’t done is taken a nuanced approach to avoid the [unintended] consequences.” 

Innovation Is Hope 

Innovation in healthcare is not a luxury; it’s a necessity. As federal policies shape the economic framework, the challenge lies in fostering innovation without exacerbating financial burdens on patients. Our panelists talked about the industry imperative to promote cost-effective, sustainable solutions. This may involve incentivizing research and development that specifically targets affordability, encouraging the adoption of technology that streamlines processes and reduces overhead costs, and fostering partnerships between public and private sectors to drive innovation that aligns with economic constraints. 

“You have more misses than hits,” said Sanandaji. “There is a lot of money and investments that go into developing new drugs and solutions to quickly bring to families. The IRA will be nuanced and there will be provisions that are tricky to navigate, so, we need to think about incentives that will help us approach these issues for R&D.”  

Sullivan called for greater transparency from federal policymakers on why certain decisions are being made and greater discourse between patients and policymakers. 

“There is a call to action,” she said. “We need to know what is happening behind closed doors and why policy makers are making certain decisions. We can’t help or inform the public if we don’t know what’s happening ourselves. Knowing the details will help both patient advocates and industry players advocate for the necessary changes that will have the most significant impact.” 

Sullivan spoke about some of the intermediate technical corrections to the IRA her organization is focused on such as expanding the Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act and clarifying that the negotiation clock should start for orphan products only once it loses its exemption.  

“There are 18 drugs on the market for hemophilia and unfortunately, none of them worked for my son,” said Klein, highlighting the importance or rare disease research and innovation. “From January to March in 2020, we were in and out of the hospital until they shut down for COVID. Right before our final discharge, there was a new drug that just launched, and it worked. Innovation is key and because of it, my son is now able to be a child first, and a child with hemophilia second.” 

Industry and Patients: A Symbiotic Relationship for Success 

All our panelists agreed the life sciences industry must broaden its tent, increasing the awareness that policymakers have with patients and bridging the gap between research and the patients who benefit from them. Industry professionals may be the experts in technology, but patient advocates are the experts in living with rare diseases. 

The IRA is a massive piece of legislation and, even those who have steadfastly supported it know that a huge piece of legislation often has significant unintended consequences. Our patient advocacy panelists highlight the need for collaboration between those writing the policies and those whose families are impacted most by them. 

“Putting on my mom hat, innovation really is key to provide what’s best for you or your child when it comes to rare diseases,” said Klein. “We just have to continue to drive innovation forward for families like mine.” 

The post Patients, Policy and the IRA: Navigating an Evolving Federal Landscape appeared first on MassBio.

MassBio considers it an honor to be able to represent the interests of our 1,600+ members. The work that goes on at your companies and organizations is changing the lives of patients around the world and giving hope to those with a yet unmet medical need. Our role is to support you in your endeavors—to do what we can to help you advance your science. We pride ourselves on the programming we offer, the partnering and networking opportunities we provide, and the cost savings we deliver, as well as the industry voice we speak with to lawmakers and journalists alike.

It is during times of difficult business choices, grim headlines, and misguided policy decisions that your membership is perhaps the most valuable. We are a resource that is always here, in the good times and the more challenging ones.

As we turn the page to a new year, I am eager to showcase the new and returning offerings we have on tap for 2024, but I think it is important look back on what we’ve experienced together this past year:

Training a new biotech workforce

• A new training paradigm: Bioversity, a MassBio initiative, is blazing training pathways and creating employer connections for underrepresented populations and individuals traditionally left out of the life sciences to quickly propel them into well-paying jobs and lifelong careers.
• Unlocking talent in Dorchester: In January, Bioversity’s first 8-week program will prepare roughly 24 local residents to join a life sciences company in an entry level role at no cost to them through a curriculum developed with industry input and by the Massachusetts College of Pharmacy and Health Services.

Driving innovation through partnering and mentoring

• Partnering at a higher level: MassBio’s Pharma and R&D Days continue to provide unparalleled opportunities for innovators to connect with world-leading biopharmaceutical companies.
• Helping founders do business: More than 20 emerging startups across a diverse range of focus areas have completed MassBioDrive’s 8-week accelerator, utilizing its business curriculum, mentors, and strategic partners to advance their enterprises.

Delivering on diversity, equity, and inclusion

• Elevating health equity: This year we elevated the conversation around health equity across all our events, including State of Possible, the DEI Conference, and the Patient Advocacy Summit.
• Keeping tabs on progress: We released the second report on the progression of equity and inclusion in our industry, part of our commitment to support members as you launch and scale your DEI initiatives and to do our part to accelerate change.  

Educating and connecting in the Hub and beyond

• An unparalleled member benefit: The MassBioHub as been the place to be this year with countless member-booked gatherings, conferences, board meetings, convenings … you name it, we’ve hosted it, all at below market rates for members.
• Events that run the gamut: We have been proud to offer all-day summits, nuts-and-bolts trainings, inspiring keynotes, timely forums, fascinating pitches, unmatched partnering opportunities, and of course our famous networking mixers, all to the benefit of our members and the ecosystem at large.

Representing industry on both Beacon Hill and Capitol Hill

• Protecting patient driven innovation: We’ve engaged all year with the Massachusetts congressional delegation, the White House, and federal agencies to spotlight the unintended consequences of the IRA and lobby for fixes to the law’s most problematic elements.
• Lengthening our Bay State lead: From supporting the state’s efforts to successfully attract ARPA-H to working closely with the Healey Administration on a possible reauthorization of the Life Sciences Initiative, MassBio’s government affairs team has continued to nurture strong relationships with policymakers.

Expanding cost savings and benefit options

• Rev’ing up HR solutions: MassBio now offers RevHR, a PEO like program, as a new EdgeBenefits partner to provide market competitive benefits, including health insurance, coupled with support and resources created specifically for Massachusetts life sciences companies.
• Introducing new preferred vendors: Corporate Traveler USA, the corporate travel partner of MassBio, has joined Morgan Stanley, Vizi, Globalization Partners, The Hartford, and Mercury as part of MassBioEdge to deliver best in class plans and competitive discounts to MassBio members.

Massachusetts is the hotbed of innovation because of the businesses and the people that call this Commonwealth home. MassBio, likewise, is able to be successful in our charge to advance Massachusetts’ leadership because of our members. I love nothing more than seeing our MassBio family at events and watching our industry continue to rewrite what is possible in the pursuit of human health.

The post A retrospective on MassBio’s 2023 appeared first on MassBio.

I’ve enjoyed seeing the coverage given in the press to our 2023 DEI report since its release late last month. Anyone who’s produced a report like this knows that it takes months to create, yet seconds to put out in the world without knowing how it’ll be utilized. I’m pleased that it has provided a point of reference to the debate about representation in the life sciences, and the level of commitment to DEI in corporate America.

While this report certainly adds to the larger discussion of DEI in the life sciences industry and can inform decisions, the small number of respondents in the data set does mean it should not be used exclusively to draw conclusions or as a basis for all actions. We’ve shared some reasons for non-completion and part of our charge is to investigate how we can increase participation in the future, especially regarding our data collection methodology. However, it’s important to note that this is only one way we solicit information from our members to gain insights on the status of DEI in the industry and what investments need to be made.

I have the pleasure of consulting individually with our companies, both large and small, and I can say that some are doing incredible work in implementing DEI initiatives and best practices, above and beyond the averages shared in the report. And despite the SCOTUS ruling, many of these companies have told me they won’t be changing their commitment to this in any way. Though many of those companies chose not to participate in the survey themselves, some of the good news coming from the report definitely reflects the individual interactions I’ve had with member companies.

At the same time, with the current season for the biotech companies presenting new economic challenges, I’ve observed that some companies have been unable or unwilling to provide their DEI leads with the bandwidth and resources needed to be successful. I’m hesitant to say that some companies don’t value DEI outcomes that highly, but few have taken the leap to connect executive compensation with those outcomes. When I meet with DEI leads who feel limited in their power to execute, I frequently recommend that they narrow their focus so that they can devote the care and consideration that a DEI initiative needs to be implemented sincerely and effectively.

For this year’s report, I did spot a few surprises that warrant discussion:

• Only 18% of respondents suggested that the survey identified sustainability [of DEI initiatives] as needing more attention right now compared to the other survey options. Yet my own interactions lead me to believe much concern and trepidation exists with the individuals who are carrying most of the responsibility for their company’s DEI work. How long can they keep going if they aren’t resourced for success? If companies are going to start cutting back on DEI officers as some suggest, what will exist in their place to sustain any DEI progress made?
• 32% of respondents in the survey suggested “more respecting and accepting the differences of others” would improve the implementation or success of any best practices or new diversity, equity, and inclusion initiatives. The majority of the “crises” that are shared with me during member engagements often stem from contentions around the differences of others and a lack of respect or acceptance for those differences. Those experiences would have led me to expect many more respondents to say that improved implementation or success of any best practices or new DEI initiatives is dependent on individuals being “more respecting and accepting the difference of others.” Yet, that response stood at just 32%.
• I’ve heard countless members tell me about the processes they have in place to make spend opportunities more accessible to minority owned businesses, yet the report suggests that only 21% have a supplier diversity program. That tells me I might need to help members to formalize those processes into something they can confidently call and promote as a supplier diversity program open to interest from diverse businesses.  

MassBio’s report, though not perfect, really is something that contributes to discussions about corporate DEI efforts and if we in the life sciences are making meaningful progress. Going forward I will be working with our partners, members companies, and the DEI and health equity board committee to consider what will be the most meaningful information to collect and share. Are we asking the right questions, in the right way, not only to help our members benchmark, but to ensure we’re providing insights about the industry to support our partners across the state as they look to engage with the life sciences? How can we track the effectiveness of workforce development initiatives like Bioversity in improving representation at all levels in our companies? And how can we influence the implementation of DEI initiatives and the sharing of data so that the pledges made in our open letter and observations I see and hear firsthand are reflected in survey results in years to come?

The post Reflecting on certain findings in MassBio’s DEI report appeared first on MassBio.

The “let’s circle back after the holidays” season has officially arrived. But one thing you shouldn’t be pushing to next year is your biotech company’s 2024 social media strategy.

Social media is one of the best ways to get your work, culture, and key focuses out there. Q4 is the perfect time to start mapping out your social media strategy and content for 2024 so you can rest easy over the holidays — despite craziness elsewhere in the business, you can know your social plans are in place.

Plan for 2024

Create a timeline laying out the 2024 calendar year. Add key dates, events you’ll be attending, company milestones, and DEI national days/months that you want to amplify on social media. For example: January is National Blood Donor Month, February 29 is Rare Disease Day, June 14 is World Blood Donor Day, and November is National Caregivers Month. Include national/global days for your disease areas of focus. Here is a calendar of health observances in 2024.

For company milestones, map out any anticipated clinical trial milestones, BLA submissions, FDA ad comms, earnings releases, and any other company announcements. Map out dates of key events/conferences you’ll be attending so you can share those on social media. Finally, highlight key DEI moments, such as Black History Month (February), Women’s History Month (March), and Pride (June). Here is a diversity calendar for 2024.

Once you have your year mapped out and approved by the appropriate stakeholders, you’re all set to create monthly content calendars to keep your content on track.

Refresh Your Social Media Goals + Content Pillars

A good social media strategy starts with clearly defined goals. An easy way to start is with the goal of increasing brand awareness of your biotech on social media. If you’re hiring frequently, supporting recruitment efforts is a good second goal. You can do this with targeted ads and initiatives on social, and generally with highlighting the people & culture of your company. Here’s an example of 5 goals for social media:

1. Increase brand awareness of the company (support company news & announcements, quarterly earnings, etc.)
2. Support recruitment efforts (with hiring paid social ads, showing the people & culture, DEI initiatives, why people would want to work here)
3. Highlight commitment to [XX disease] community (patient features, attendance at patients/caregiver/HCP events)
4. Support key submissions and launches in 2024
5. Underscore XX leadership (highlight thought leaders at your company, what they’re doing for the disease community/health equity & access, and opinions on other hot topics)

Content pillars are a good way to develop balance within your social content. You want to have a mix of “here’s what we’re doing” and “here’s how we’re supporting others, like our patient communities”. We’d recommend choosing 4-5 content pillars and making your content a balance between them. Here’s a good example of content pillars for a biotech company:

1. People & Culture (team spotlights, what it’s like to work here)
2. Our Science (products, launches, research)
3. Gene therapy leadership (conferences, events, thought leadership)
4. Disease areas of focus (patient spotlights, disease education)
5. DEI (ERGs, company initiatives, helpful for recruitment)

Identify How You’ll Track Success

First, it’s helpful to define your target audience. This can be different per social channel. On Facebook and Instagram, you’re probably targeting patients, caregivers, and PAOs, while on LinkedIn you’re probably targeting HCPs and investors. Next, list out your key performance indicators for social media (or KPIs). Here’s a good starting point:

1. Engagements
2. Engagement Rate
3. Impressions
4. Clicks to website
5. Clicks to careers page (if you care about recruiting)

It’s important to have a tool or program to track social metrics. We use Sprout Social at Metter Media, but there are other affordable tools out there that can easily pull these metrics for you. You’ll want to pull results regularly to look at top performing posts and adjust your strategy accordingly.

Identify Key Employees to Highlight

I’m sure there are some employees at your biotech company who are surprisingly willing to participate in social media — they may even get excited about it! Start with them when it comes to who to highlight on social. It can be as simple as them sending some photos from the lab or from conferences, all the way to getting them to film a day in their life. If you have interns, they may be a good place to start in terms of willingness to participate.

Create a designated “social media team” of people who meet monthly to create content calendars for the month ahead and who can help execute content.

Look for Ideas to Inspire Your Content

One of the best ways to come up with new ideas for your social content is to look at other companies who are doing it right. We’ll give you a list of some to check out now, but it’s also important to note that you can find inspiration on social media from other industries and apply it to your company. Ideas, formats, and concepts can be repurposed across industries. Anyone who’s doing cool/innovative things can be a source of inspiration for your social content.

Here are some accounts to follow now for inspiration:

• Amgen on TikTok
• Takeda on LinkedIn
• bluebird bio on Instagram
• Aetna on Instagram
• Target on LinkedIn
• Delta Airlines on LinkedIn

After finishing this blog, we realize this is a TON of information about how to plan your 2024 social strategy for your biotech. With social media, it’s all about planning more and being less reactive — there’s nothing worse than seeing Rare Disease Day is next week and you have no idea what your company is doing to participate.

Putting the time in now will set you up for success next year.

About the Author

Lauren Metter is the founder and CEO of Metter Media. For over 10 years, Lauren and team have guided brands on their social media strategy, from Takeda to Microsoft to bluebird bio. She’d love to hear more about your biotech company and talk about how you can work together to blow your competitors away on social media.

The post 5 things your biotech company should be doing on social media right now appeared first on MassBio.

As the ever-changing biotechnology and pharmaceutical landscape continues to evolve and explode with new technology, it is more important than ever to keep the end goal of our work in mind – patient outcomes. The improvement of people’s lives is the overall upshot of all the time, resources, money and brainpower that our industry employs. And we know there’s a long way to go, as patient outcomes remain deeply disparate based on factors like race, ethnicity, geography, socioeconomic status and other identities. For an industry at the forefront of so many breakthroughs, our progress on health equity is simply not sufficient.

One small but illustrative example: cancer rates among Latinos are expected to rise 142% by 2030, but Latinos often represent less than 10% of oncological clinical trial participants. We can’t expect to address significant health challenges if we’re not seeking to bring the groups most impacted by them to the table when it comes to drug development, trials, treatments and more.

How, then, as the ecosystem of companies developing breakthrough treatments and medicines for our communities, can we do our part to center the voices, experiences and health needs of our most disadvantaged patients and make measurable differences in their lives?

Putting Patients First: Health Equity in Drug Development

As part of our Patient Advocacy Summit, we welcomed a diverse panel of some of Massachusetts’ top leaders championing health equity in clinical research and moving the needle towards unbiased patient health outcomes.

Moderna’s Senior Manager of Clinical Trial Diversity & Inclusion Nubia Whitaker moderated our “Putting Patients First: Health Equity in Drug Development” panel, with Dr. Rosa Colon-Kolacko, President and Founder of Global Equity Learning and a Health Equity Compact member; Ann-Marie La Ronde-Richard, Director & Patient Engagement Lead of the Internal Medicine Research Unit at Pfizer; and Rohita Sharma, Global Senior Director in Patient Insights & Solutions at Alexion AstraZeneca Rare Disease speaking to our collective duty to advance health equity in drug development, and defining the steps that need to be taken to do so.

Our ultimate responsibility is just that – putting patients first. As more and more patients expect to be involved in the drug development process, it is our duty to engage them throughout the process with equity top of mind.

In our industry, decisions and priorities that directly impact health outcomes are made based on data, and that data needs to be representative of and responsive to the communities it serves. All of them. When certain communities are not actively involved in the full drug development process, progress is not made with their experiences in mind, nor the slew of health and healthcare challenges that may affect them disproportionately.

The Answer: A Patient-Centric Drug Development Approach

With all this said, how do we imbue equitable patient-centricity into our drug development process? Here are a few key takeaways from the conversation.

Engaging Patients Throughout Entire Process

For the panelists, connecting with patient communities means acknowledging them as experts. Patients are the true subject matter experts as those experiencing illness and rare disease firsthand.

“When we listen and learn from patients and embed their perspectives into our drug development programs from end to end, we do better science,” said La Ronde-Richard. “Because we understand the value of the questions that we are asking from the patient’s perspective.”

The work the biotech and pharmaceutical companies do and the drugs we develop must remain responsive to the unique needs, identities and experiences of the patients we are ultimately treating. This means understanding the patient experience, the intersections of systemic health inequities with various identities, and the urgency required to make patients the agents of their own health outcomes.

Building Trust

Sharma spoke about the necessity of building trust in order to fully engage patients and encourage their participation. This includes circling back to communities surveyed with updates on how their data is being used to advance research, educating them about how exactly the process will work, and taking the time to listen and create a bi-directional experience.

“They need those questions answered before they even contemplate joining a clinical trial,” said Sharma. “For example, will I have to take time off work? Is there going to be transportation? How is this going to impact my life and my family’s life? And so if you want to build trust, it’s almost a step back for you to actually step forward.”

Institutional Intentionality

At MassBio, we know from our soon-to-be-released State of Racial, Ethnic & Gender Diversity Report that DEI initiatives are on the rise throughout the industry – but there is so much more to be done.

Colon-Kolacko echoed this, leaning into the need for internal processes that lend themselves to clinical trial diversity and health equity in drug development.

“We need to define what is it that equitable research experiences will look like, and how that is defined by the communities that you serve,” said Colon-Kolacko. “We need to start showing [patients] more authentically that we are co-leading with you, because you have your experiences that we respect, and then we can make antiracism a priority.”

Your company’s investigators and decision-makers should, at least to some degree, reflect the communities for whom you are doing the research. Beyond recording demographics, consider whether your team is truly taking that data and surrounding cultural context into account when analyzing it.

Intentional institutional practices and policies might look like programs such as Alexion’s LEAP, a series of immersive learning sessions that help employees understand the patient experience. Or Pfizer’s Patient InSight Committee, which centers patients, caregivers and advocates in clinical trial feedback. There’s also Tufts University’s Patient Friction Coefficient, which measures the burden of clinical trial participation, just to name a few.

Taking Responsibility for Health Equity

It is our responsibility as those developing lifesaving drugs and treatments to keep in mind the vast diversity of identity and experience that we are so lucky to have in the Commonwealth and respond accordingly. COVID-19 vaccine developed showed us that diverse enrollment in clinical trials is both possible and effective, and that it drives both economic and societal value. This scientific approach enables better patient outcomes and promotes growth—it is good for patients and for business.

By diversifying clinical trials, prioritizing patients’ voices and driving our industry’s commitment to DEI, we take the first steps toward creating a more equitable drug development process and ultimately, advancing health equity in the Commonwealth.

The post A Disparate Drug Development Landscape appeared first on MassBio.

A decade after MassBio convened its first summit specifically focusing on issues surrounding patient advocacy, an impressive group of advocates, biopharma leaders and executives gathered at the organization’s Kendall Square hub for a day of panels, keynotes and networking. In the time since that first summit, efforts around patient advocacy have evolved and grown, but the work of keeping patients at the forefront of the drug development cycle remains a key mission of the summit and those who participated in it this year.

“Everything MassBio does, everything our industry does, is because of patients,” said MassBio CEO & President Kendalle Burlin O’Connell in her welcome remarks last Thursday morning. O’Connell touched on significant initiatives and investments in Massachusetts, such as the establishment of the ARPA-H investor catalyst hub in Cambridge, to illustrate that the state is looked to as a national leader. With that, she said, comes a commitment to improving lives for patients.

“I speak with so many peers in other states that wish they had what we have,” she said. “So we have big responsibilities on our shoulders…we have to bring solutions to the table and make sure it’s all driven around patients.”

Among panels that touched on everything from federal policies to FDA regulations to health equity, the stories from advocates and their families were those that had the most emotional impact, starting right from the top with Kathleen O’Sullivan Fortin.

In a powerful opening keynote address, O’Sullivan Fortin, co-founder of ALD Connect, shared her journey from advocating for her son John – who was diagnosed with adrenal insufficiency and adrenoleukodystrophy (ALD) – to advocating for all who are diagnosed with the disease.

Fortin spoke to the challenges and unique role advocates can play in everything from drug development to disease awareness to meeting with medical professionals and regulators. When she first became involved in advocacy work, she walked into a meeting with distinguished doctors and was told to make herself a name tag. “My only expertise was, ‘John’s mom,’” she said. So she wrote that on her name tag. “I had tremendous hesitation thinking, ‘I don’t belong here, I don’t deserve a seat here,’” she said.

But over time, she found that role of being John’s mom held incredible power, showing various stakeholders the real people impacted by their decision making. During her keynote, she encouraged other advocates not to be afraid to take that first step and to lean into who they are and their skillsets.

“I’m John’s mom. I’m a talker,” Fortin said, enumerating the ways she can effect change. “I’m not shy. I’m a lawyer, which is usually something I politely flex at people who are not going to give me my way,” she said to laughs from the crowd.

Since starting ALD Connect in 2013, Fortin has used all of those skills to help connect with others in her disease community, organizing the community around various advocacy efforts and pulling in influential friends and professionals across the healthcare community.

Following a networking lunch, patient advocate and Boston resident Lee Greenwood gave a “Possible Talk” about advocating for his daughter Noa, who has Canavan disease, a progressive genetic disorder affecting the central nervous system. Early symptoms include weakness, low muscle tone and loss of head control in infants. The news shattered Lee and his wife. But on the same day that she was diagnosed a new clinical trial for the disease was posted on clinicaltrials.gov.

Noa was one of the first children to receive an investigational gene therapy developed in Massachusetts. Greenwood recounted her meeting with some of the top Canavan researchers at UMass’ Chan Medical School nearly a year after she was dosed at Mass General Hospital (MGH).

Noa’s story encapsulates why Massachusetts’ “State of Possible” story, connecting the innovative research, trials and treatments developed in the Commonwealth to the real people they impact. The investigative gene therapy research for Canavan was led by Dr. Guangping Gao, Ph.D. and Dr. Dominic J. Gessler, Ph.D. at UMass Chan and the principal investigator of the trial is neurologist, Dr. Florian Eichler, at MGH.

“It’s really important I think to show researchers what they’re working for,” Greenwood said. “I want you to know when you are doing your thing, please remember that there is a human being, there are people, there are families, there are communities that rely on you and [Noa] is the face of that and she is real. She has a disease, but she is a person and she deserves everything that everyone else deserves.”

Today, after about a year and half post gene-therapy, Noa, who is now three years old, is improving. She’s able to play with her parents and big sister, feed herself and attend Boston Public Schools. She even walks with a walker (or a parent’s hand), which lets her explore her favorite places— art museums and the science museum.  These are huge tangible changes Lee and his wife have witnessed in their daughter, though they are both quick to point out the therapy is investigational and Noa’s future uncertain.

An afternoon panel on keeping patient advocacy front and center focused on why advocacy is one of the things that can be cut out of an organization’s budget when funding is down, in part because executives don’t fully grasp the range of benefits advocacy can have. The panel – made up of Argenx VP and head of Global Advocacy & Policy Katherine Perez, GBS CIDP Foundation International Associate Director of Research & Advocacy Chelsey Fix, Argenx Associate Director of US Patient Marketing Lindsay Tatnall, and nCeptive Owner and Massachusetts Rare Disease Advisory Council member Glenda Thomas – provided advice for advocates to defend their departments during corporate realignments and how to secure external funding.

“We are trying to make sure the caregivers and the families have their voice heard not just in the clinical phase but all the way through to finding and getting a treatment,” said Perez.

For the panelists, keeping patients front and center means building a company culture that understands the hopes, fears and concerns of patients, one person at a time.

“Who we’re hiring as an organization matters,” said Tatnall. “Do they have that intangible really. You can’t teach that empathy…Who you’re bringing into an organization to deal with patients, to hear from patients. That’s how we show the value of hearing their story.”

In time, advocates say their trepidation about speaking up as “just” someone’s mom or dad gave way to a confidence that advocates belong wherever decisions about their loved one’s health are being discussed.

“Everyone deserves a seat at the table,” Fortin said. “There is no discussion about rare disease we don’t belong in.”

And when it comes to those tables where patient outcomes are being discussed, she implored other advocates to elbow their way in.

“Someone may forget to add your chair,” she said. “But bring your own nametag and just show up.”

The post Patient Stories Front and Center at MassBio’s Patient Advocacy Summit appeared first on MassBio.

For those who might not know, what do you see as the key drivers of change in the field of biologics over the last 20 years?

Within the field of biologics, antibody medicines have become one of the largest and fastest growing classes of drug, thus making a major impact on patient health. Antibody medicines are used across multiple therapeutic areas, such as oncology, inflammation, infectious disease, ophthalmology, cardiovascular disease, autoimmunity, and neurodegeneration.

As the industry matures, the challenges associated with developing innovative antibody medicines are getting harder. Over the past 5 years, more than 25% of approved antibody drugs were for challenging modalities and targets such as antibody drug conjugates and bispecifics, compared to about 15% in the 5 years prior. Novel targets, modalities and innovative targeting strategies will be needed to succeed in these programs and improve the lives of patients.

What should innovators know about successfully bringing biologics to the clinic?

The process of developing drugs is complex and highly regulated, and as a result product development timelines are long. Historically, it has taken more than 10 years for the average biologic drug to go from early discovery to reach the market, at a cost of well over $1 billion (inclusive of the research and development costs of drugs which do not reach the market).

With the number of challenging programs projected to increase in the coming years, efficient development of antibody drugs will increasingly require the integration of highly specialized skills, technology, and infrastructure – something that few firms are able to do successfully.

AbCellera has developed technology platforms to unlock high-value drug classes and targets, including T-cell engagers for cancer and transmembrane proteins for a broad range of conditions, including pain, cardiovascular disease and more.

What does AbCellera bring to the industry?

Over the past decade AbCellera has been building an engine that is capable of repeatedly generating potential first-in-class and best-in-class antibody medicines.

Today, AbCellera is focussed on bringing innovative medicines to the clinic, and patients, faster by advancing its internal pipeline of programs and partnering strategically with companies that have novel science or innovative technology.

Since 2015, AbCellera has worked with more than 40 partners on 100+ antibody drug programs, with 10 candidates reaching the clinic to date. AbCellera’s internal pipeline includes two preclinical programs, ABCL575 and ABCL635, that are advancing into IND-enabling studies. ABCL575 targets OX40 ligand and is being developed as a potential best-in-class therapy for the treatment of atopic dermatitis and other indications in autoimmunity and inflammation. ABCL635 is a potential first-in-class therapy focused on an undisclosed target with an indication in metabolic and endocrine conditions. AbCellera anticipates IND submissions for both ABCL575 and ABCL635 in 2025.

The post Bringing innovative medicines to patients faster: A Q&A with AbCellera appeared first on MassBio.

I often talk about MassBio as a convener – an engine for bringing together talented people, big ideas and powerful resources to help tackle seemingly intractable problems. Part of being a convener is finding the right partners. Collaborating with the Massachusetts Caucus of Women Legislators, which represents 31 percent of the legislature, we were able to bring together the health care and biotech communities, government leaders, and patients at the Statehouse for a long overdue conversation on women’s health.

The symposium on “Why Women’s Health is Different” was equal parts inspiring, thought-provoking and…maddening (I’ll get to why in a minute).

The panel featuring former state representative and Maternal Mental Health Leadership Alliance Founder Jamie Belsito, Equity in Heart Transplant Founder and Brigham and Women’s Hospital Cardiologist Dr. Nasrien E. Ibrahim, and Society for Women’s Health Research President/CEO Kathryn Schubert, was moderated by State Rep. Brandy Fluker Oakley. Kicking off the morning was Rep. Carole Fiola, who co-chairs the caucus with Senator Joan Lovely.

The guests shared invaluable insights into the myriad ways women’s health is viewed as “different.” Acknowledging that women’s health is different from men’s is important. Women have unique health-related needs, and to acknowledge and address them is a key principle of health equity. Treating health conditions that generally pertain to females, including fertility, maternal health, gynecology, and menopause with the importance and specificity they deserve can lead to improved health outcomes in women. This is also true of general health conditions that can affect women differently, such as cardiovascular disease, or disproportionately like migraines and osteoporosis.

But too often women are made to feel disempowered in conversations and crucial decisions about their health.

Belsito spoke from the heart about the difficult challenges she and many other women go through during and after childbirth, the urgent need for mental health resources for women, and that female anatomy and reproductive health are just snippets of a woman’s overall health picture.

“I felt isolated, alone,” she said, of times during her childbirth journey. “I felt that I was just there to give birth to a child or be dismissed if I didn’t have a viable pregnancy and that women’s health was still somewhere in a decade I couldn’t recognize. If that was my experience as a white-presenting, English-speaking, heterosexual, married [woman] living in a home in the suburbs of Boston, what did that mean for everybody else?”

There are also some sobering facts that show treating women’s health as “different” from regular health care can have adverse impacts on patients (buckle up, the data I’m about to share isn’t pretty).

With male physiology being the default in developing modern medicine for so long, women have been found to be 50% more likely than men to be misdiagnosed following a heart attack and more likely than men to die from heart attacks. As Dr. Ibrahim pointed out, even in emergency rooms, women are more likely to be misdiagnosed and have their symptoms minimized compared to men.

“I look at it through an equity lens,” said Dr. Ibrahim. “As a cardiologist, we see this all the time – women are misdiagnosed, women are more likely to be sent home from the emergency room…in every part of cardiology, from prevention of heart disease all the way to who gets transplanted, women have much poorer access.”

So much of this comes down to representation. About three-quarters of clinical trial participants are men (as Schubert of the Society for Women’s Health Research mentioned during the panel, the National Institutes of Health didn’t require women to be involved in clinical trials until 1993 and didn’t require female mice be used in research until just 2016!), so it shouldn’t come as a surprise that women are twice as likely as men to experience adverse events from drugs. Diversity in clinical trials goes far beyond representation and into tangible, adverse effects on women’s diagnoses and health outcomes.

In 2020, just 4% of all biopharmaceutical R&D spending went toward female-specific cancers, with just 1% (less than $2 billion out of $198 billion) going toward female-specific conditions.

Told you it is a little bit maddening, right?

But participating in this crucial conversation in the Great Hall of the State House with so many representatives and influential women in attendance, I felt inspired and invigorated, righteous but not frozen in my anger.

And here’s why: we here in Massachusetts are uniquely positioned to play an outsized role in addressing women’s health and advancing equity. We have more than 1,000 biotechs in the state with 18 of the largest biotech companies having a presence here. Our industry operates 6,000 clinical trials across 100-plus hospitals. We have the resources to prioritize and improve women’s health.

And what do solutions look like in practice? Working with our MassBio members, and grant-making entities like the Life Sciences Center, to increase the R&D spend on therapeutic areas that impact women exclusively or disproportionately and support the academic research teams with the same focuses. Advocating for policies at the state and federal levels that elevate women’s holistic health and wellness. Partnering with community organizations and hospitals on disease awareness and countering biases, especially in the treatment of patients. Getting more women into power-wielding roles.

As Dr. Ibrahim said during the panel, Massachusetts is viewed as the “Mecca of Medicine.” The changes in policy, representation, clinical trials and more that are enacted here are often adopted by the rest of the country.

Here in Massachusetts, we have the will. And where there’s a will – and, I might add, a woman – there’s a way.

Sources:

• Unlocking opportunities in women’s healthcare (McKinsey & Company)
• Women’s Health Initiative (MLSC)
• An economic case for a more women-centric health care system (Deloitte)

The post Why Women’s Health is Different appeared first on MassBio.

RevHR: Enhanced Benefits for Life Sciences, a MassBioEdge Preferred Vendor powered by industry leaders Marsh McLennan Agency and AlphaStaff, is an HR administration outsourcing program created specifically for Massachusetts life sciences companies. RevHR fills a gap in the New England market for life sciences companies by delivering access to best-in-class employee benefits (most often with richer features at a lower cost) while streamlining a catalog of administrative HR functions. RevHR’s services include fully integrated payroll & 401K management, affordable and comprehensive medical, dental and vision plans, multi-state compliance support, single sign-on HR platform, and competitive workers compensation & liability options.

Let’s set the scene: your company is now 50 employees strong and growing. While you are proud of your growth, you still struggle to procure competitive employee benefits offerings to attract the right talent. You are also looking into onboarding a team out of state and seeking new ways to increase efficiency, reduce costs, and improve workforce management.

In comes co-employment. Also known as a Professional Employer Organization (PEO), a co-employer offers a unique approach to managing your business’ HR functions.

Power in Aggregation

One of the primary benefits of co-employment is the ability to pool employee counts to extend the large-group buying power to the individual companies. Aggregation can help insulate employers from small-group market rates and risk, especially for companies in states with strict small-group regulations like Massachusetts. The aggregate buying power can allow your company to access Fortune 500 style employee benefits at a competitive price with health, dental, and vision insurance, retirement plans, and wellness programs. An improved employee benefits package can be a game-changer from a recruiting and retention perspective.

Enhanced Services & Risk Mitigation

Co-employment can do much more than just improve your employee benefits – it also helps simplify the payroll and tax process for your business. Partnering with a PEO means having experts handle all payroll-related tasks, including distributing paychecks and staying on top of payroll taxes. This reduces your risk of costly errors and ensures employees are paid accurately and on time.  A PEO can also help manage HR-related risks, like unemployment and workers’ compensation claims. A co-employer can become a true partner, helping you navigate the complexities of HR to keep you in compliance with constantly changing labor laws – especially now that you are considering staff in other states.

Expert HR Support & Reduced Workload

A co-employer comes with a full team of HR experts. PEOs specialize in HR management, compliance, payroll administration, and many other areas to help provide your business with guidance and support. The right HR provider can become a true extension of your team to tackle to handle your HR, financial, and risk matters while you focus on strategy and growth.

A Program Exclusively for Life Sciences

Not all co-employment offerings are created equal. RevHR is specially designed for life sciences companies, offering best-in-class HR administration, employee benefits, multiple plan options, and a competitive cost structure. RevHR is the only program of its kind that aggregates only life science companies into one favorable risk pool.

Ready to learn more about how we can help your business? Click here to get started.

This blog is cross-posted to the RevHR blog.

The post Preferred Vendor RevHR Guest Blog: Co-Employment is the Solution for Growing Companies appeared first on MassBio.