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Knowing the Difference: Alzheimer’s Disease vs. Other Types of Dementia

Knowing the Difference: Alzheimer’s Disease vs. Other Types of Dementia

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Knowing the Difference: Alzheimer’s Disease vs. Other Types of Dementia 

Alzheimer’s disease (AD) is the most common type of dementia, but there are many other kinds of dementia, including Lewy body dementia, Huntington’s disease and non-Alzheimer’s dementias. Not a normal part of aging, dementia is caused by damage to brain cells that affects an individual’s ability to communicate, which can affect thinking, behavior and feelings. AD accounts for 60-80% of dementia cases and afflicts an estimated 5.8 million Americans aged 65 and older.

An early diagnosis of AD can help determine if a patient’s symptoms are truly due to AD or some other conditions that can be curable, such as infections, emotional distress or nutritional deficiencies, such as a vitamin B12 deficiency. What’s more, a definitive AD diagnosis allows patients to start clinical interventions sooner, providing a cost savings for payers, as well as saving time, money and the despair of not knowing for those involved. It has been estimated that early diagnosis of AD could save the health system $7.9 trillion (present value of future costs). Unfortunately, early diagnosis of AD has been costly with poor accuracy.

What is Alzheimer’s Disease?

AD is a type of dementia that affects memory, thinking and behavior. Over time, symptoms tend to increase and start interfering with individuals’ ability to perform everyday activities. In the early stages of AD, memory loss is mild but gradually individuals lose the ability to respond to their environment.

AD is a complex disease with plaques and tau tangles–both abnormal clusters of protein fragments, which many experts believe play a critical role in the clinical symptoms of AD by blocking communication among nerve cells and disrupting processes that cells require. While these are clinical findings associated with AD, there are other factors at work. This is evidenced by a recent paper that demonstrated centenarians with little or no cognitive decline were found to have high levels of plaque and tau at death, while another paper suggested that more than one-third of people studied with mild to moderate AD had minimal levels of plaque accumulation in the cerebral cortex.

Improving Accuracy in Early AD Diagnosis

Unfortunately, most patients with AD are diagnosed in the late stages of the disease, with very few being diagnosed in the preclinical stages when treatment can be the most effective.

Rather than focusing on clinical findings associated with AD, there is a new approach that assesses neural and synaptic loss to diagnose AD in people diagnosed with dementia.  DISCERN™, the first autopsy-validated, highly accurate, minimally invasive test for the definitive diagnosis of AD versus other forms of non-AD dementias and those with AD and other degenerative pathologies, gives patients and families the answers they need, enables providers to make a conclusive diagnosis, and allows payers to establish protocols and prior authorizations for prescribing and reimbursing treatment. It also helps pharmaceutical companies identify appropriate clinical trial participants.

DISCERN™ can be utilized as a tool to manage appropriate patient access to therapies approved in the future, in addition to the clinical and economic benefits of improved early, accurate diagnosis.

Posted by
Michael Tunkelrott
Author Bio
Michael Tunkelrott is Vice President of Marketing, SYNAPS Dx, a privately held company focused on the research, development and commercialization of diagnostics for neurological disorders and conditions, including Alzheimer’s Disease.
Is Agile the Answer to Big Pharma’s Digital Revolution?

Is Agile the Answer to Big Pharma’s Digital Revolution?

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In an age when your daily wants and needs can be delivered by Amazon, we are a culture of instant gratification. This culture has bled into all walks of life, including our medicine. In June of 2018, Amazon bought PillPack out of Cambridge, MA, for $753 million to crack into the $500 billion dollar prescription market. With this acquisition, customers can get meds delivered to their door with automatic refills and 24/7 customer support.

This surge for speed and innovation is forcing large pharma companies to look at all their linear, traditional processes for inefficiencies. Most of these large companies are organized around functional excellence but not value and customer experience. Many are taking notice of other large organizations from different industries reorganizing around value to the customer and having wild success.

Discussing Agile in Pharma

Eliassen’s Agile Practice, where we have 10 years of experience implementing Agile across large, global, complex organizations, held a virtual event with leaders from Novartis, Bristol Myers Squibb, UCB, and Vertex Pharmaceuticals. This was designed to bring together like-minded individuals who are looking to be change agents within their organization. We had our Agile Transformation Coach, Jim Damato, facilitate the meeting where attendees dot voted topics of discussion.

The conversation was centered around two questions:

1. How does big Pharma organize around value?

2. How does leadership align on goals across the organization?

Jim Hlavenka, former Head of Agility Enablement, US Neurology, from UCB, was able to bring leadership together and prioritize their work before selecting Agile as the way to solve their problems. Each company had a different approach. Some went with the traditional grassroots approach, starting with the teams piloting Agile, while others had more formal approaches, such as UCB. One attendee talked about training teams through 2 ways of learning: visual and experiential. He travelled to 16 countries, training 120 people with 4 hour sessions. He let them self-organize, do 3 sprints on their own, and then come back to retro. Once this method of learning began to be successful, interest in adopting Agile spread like wildfire. Leadership didn’t have to push Agile onto the teams – they pulled Agile into the teams themselves.

One consistent roadblock was that leadership wasn’t completely buying into Agile. This is a challenge we see across the industry. Leaders know Agile can help their organization improve quality, customer satisfaction, and speed to market, but often times they haven’t received enough training around how they should go about making the shift. Teams often get the most funding for Agile coaching, but that coaching rarely extends to middle and senior management. Leaders need to learn how to be Agile instead of just doing Agile. They need to decentralize decisions and only focus on the overall goal, major blockers to success, and how to remove the impediments. All the team members closest to the work need to make the decisions about the way the work is accomplished.

→”Leaders need to learn how to be Agile instead of just doing Agile.”

There also has been a lot of hesitation around pharma adopting Agile because of the highly-regulated space that it is. This topic came up during the event, and Jim Hlavenka from UCB explained the importance of building the compliance component into the sprints. “You need to know what the compliance team will say ‘yes’ to, and get them to be a part of the decisions up front.” Jim had compliance, marketing, regulatory, and data scientists all in the initial meeting around change, as he wanted them all to have a say in what value was to them.

Terry Barnhart from Novartis, previously Pfizer, said something I’ve heard from many Agilists: Agile is a risk mitigation tool, so why wouldn’t a group of scientists who make decisions based on data like this approach? Well, it’s not how they have always done things. In large companies that have been around for a long time, it is hard to break old habits and ways things have always been done. There is also something to be said about Agile amidst this pandemic. The government is running a project called “Operation Warp Speed” to generate 100 million COVID-19 vaccines by January 2021. The government believes the only way this is possible is to work with Agile Teams and cutting-edge technologies to aggressively develop several parallel solutions to every technology problem. There is a group of passionate scientists that are fully transparent and cooperating to manage the design, delivery, manufacturing, and distribution logistics. With the teamwork and cooperation of the U.S. Department of Health and Human Services, the Department of Defense, and the FDA, the drug development cycle will need to change from 5-10 years to 18-24 months.

Why Pharma Should Consider Agile

Timing is everything, and big pharma is being forced to innovate in a world suffering from the coronavirus pandemic. Agile has been around for a long time, but now pharma may need to leverage it to keep up with the market demands and the digital revolution in this industry. The pandemic has forced pharma companies to pivot quickly, resulting in a tremendous amount of interest in Agile in this space. Companies don’t have all the answers yet but are working it out. Eliassen sees pharma companies continue to look for guidance and want to learn how this can help their company improve.

Interested in learning how Elaissen Group continues to explore the connections between Agile and BioPharma? Read Jim Damato’s latest post on “Agile in BioPharma,” and learn more about our Agile Consulting Services.

Posted by
Jennifer Mariani
Author Bio
Jennifer is an Agile Engagement Manager responsible for working closely with change agents for large organizations by presenting success patterns and solutions to achieve more value via the Agile Methodology. She has a history of experience working with multi-billion dollar, Fortune 500 companies, supporting their change in process, culture, and mindset to achieve an environment that is able to respond quickly to change and improve the overall customer experience.
Life Sciences Employee Return to Office Survey Results | August 2021

Life Sciences Employee Return to Office Survey Results | August 2021

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One of the top questions that employers in the Life Sciences community within the Capital Region are asking is how companies are approaching bringing employees back to the office. That’s why we asked nearly 30 top employers in the area to share their strategies in a recent survey conducted by BioBuzz Media.

What the data you will see shows is that while there’s still a great deal of indecision in the industry, companies are cutting a wide margin for COVID-19. Remote work, shifting processes, and the focus on safety are still top priorities. However, what you’re starting to see are the impacts it’s having on the long-term strategy for everything from facilities planning to talent acquisition practices.

Approximately what percentage of your workforce is now working remote for at least part of their week (2+ days)?

Read More Here

Posted by
Chris Frew
Author Bio
Leading a team of doers to foster #community, connect the biotech workforce & democratize access to better careers in biotech
Bespoke Cross-border Solutions By FON Valuation Advisory

Bespoke Cross-border Solutions By FON Valuation Advisory

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Companies and individuals entrust FON Valuation Advisory with their unique needs throughout the transaction continuum. The experience of our professionals means that we are able to offer our clients bespoke solutions based on proven techniques and deep industry knowledge. FON Valuation Advisory’s ability to work with our clients on all forms of transactions worldwide sets us apart from our peers.

 

Client Profile

Our client (“Client”) is a publicly listed, multinational company providing critical components for IoT (Internet of Things) intelligence.

 

Objective

Establish an overseas subsidiary in a new key market (“NewCo”) vis-à-vis execution of a global tax strategy that involves multiple countries and the need to manage foreign currency exposure.

 

Our Role

During Phase I of the engagement, the FON Valuation Advisory team valued intercompany loans with an aggregate fair market value in excess of $500 million. The valuation process involved the estimation of the appropriate current market rates to apply to each tranche of the intercompany loans. Our views on current market rates were informed by synthetic credit ratings the valuation team developed through rigorous company and financial analysis, which were then benchmarked against yields on publicly-traded debt issuances of companies from comparable industries with similar terms and features. The loans are held by a subsidiary of the Client (originally issued in connection with an acquisition of a NASDAQ-listed entity) and subsequently reassigned to Newco, as in-kind capital contribution.

 

Phase II of the engagement involved the determination of a foreign exchange hedging strategy to manage NewCo’s exposure to foreign exchange currency fluctuations of future periodic interest payments and principal repayments. In collaboration with the Client and its advisors, our team assisted in the establishment of a foreign exchange hedging strategy that involves four countries on both sides of the Atlantic and features zero cost collars using corresponding foreign exchange option contracts. (A zero cost collar is a form of options strategy designed to protect existing long positions with little or no cost since the premium paid for the protective puts is offset by the premiums received for writing the covered calls.) Our team also assisted in the determination of the arm’s-length settlement payments and required margin levels of the hedge counterparties.

 

Outcome

The Client successfully executed the series of transactions to meet its stated objectives. The analyses prepared by the FON Valuation Advisory team were reviewed and accepted by NewCo’s statutory audit firm.

 

#            #           #

ABOUT US

 

FON is a financial advisory firm dedicated to investment banking, valuation advisory, management consulting, and principal investing across the aerospace, defense, and government services industries. As current and former members of regulatory and standard-setting organizations, FON Valuation Advisory practice provides services informed by decades of experience. In advising high-net-worth individuals, public and private companies, equity and debt investors, transaction advisors, compliance and regulatory agencies, and state and federal courts, our professionals approach each mandate with an appreciation of its unique requirements and challenges. We have performed valuations of assets and business interests throughout the Americas, Europe, Middle East and Africa, and Asia/Pacific.

Posted by
Jouky Chang
Author Bio
Jouky Chang serves as Managing Director and Practice Leader of FON Valuation Advisory. Jouky has more than 20 years of experience in the valuation of business interests and intangible assets for a variety of accounting, tax and other corporate related matters. He has prepared such valuations for purposes of business combinations, impairment testing, acquisitions and divestitures, fairness opinions, federal and state tax planning, estate and gift tax planning, litigation involving shareholder disputes, bankruptcy reorganizations, etc.
Privacy Beyond Compliance: A Business Driver to Gain Consumer Trust and Increase Sales

Privacy Beyond Compliance: A Business Driver to Gain Consumer Trust and Increase Sales

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The greatest modern commodity is no longer gold or oil, it is data. Today’s technology has enabled companies to collect and store massive amounts of consumer data. While there are many benefits and rewards to collecting and monetizing data, there are just as many risks and responsibilities when it comes to handling consumers’ personal information. Data can be a powerful tool to improve a product or service; however, to truly reap the benefits of data, businesses need to collect, store, and use it responsibly. Otherwise, corporations will lose customers’ trust and, ultimately, their business. Read More

Veralox Therapeutics Announces IND Submission for VLX-1005 to Treat Heparin-Inducted Thrombocytopenia

Veralox Therapeutics Announces IND Submission for VLX-1005 to Treat Heparin-Inducted Thrombocytopenia

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Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug  (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

HIT is an immune complication of heparin therapy resulting in low platelet counts caused by antibodies to complexes of platelet factor 4 (PF4) and heparin. Currently, one third of hospitalized patients in the U.S., or about 12 million a year, receive heparin. HIT is the most important and most frequent drug‐induced type of thrombocytopenia.

“This IND submission is a key milestone for Veralox and a tribute to the hard work and dedication of our team to advance VLX-1005 to first in human studies,” said Jeffrey Strovel, Ph.D., Chief Executive Officer of Veralox Therapeutics, Inc.

“We are excited to continue our efforts to further develop this groundbreaking new therapy for patients suffering from HIT,” David Maloney, Ph.D., Chief Scientific Officer of Veralox Therapeutics.

About VLX-1005

VLX-1005 is a first-in-class and selective small molecule inhibitor 12-Lipoxygenase, a key target within the arachidonic acid pathway. Preclinical data has demonstrated that VLX-1005 halts immune driven platelet activation and thrombosis thus offering the potential of a lifesaving treatment for patients with HIT.

About Veralox Therapeutics

VERALOX Therapeutics Inc. (https://veralox.com/) is developing first-in-class therapeutics that target the underlying pathologies of diseases with unmet medical needs. The company’s lead candidate, VLX-1005, will be developed initially to treat patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for T1D and other immune-mediated and inflammatory diseases.

 

Contact:
Jeffrey Strovel, CEO
Jeff@veralox.com

Let the Data Talk

Let the Data Talk

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“Let the Data Talk”

Nick Vass, J29 Inc.

 As companies continue to navigate through unchartered territories in remote work environments, it’s important for some of our teams to stay true to the countless acts that led our success to where it is. While the way we do business has been changed in the moment, the question of how we came to that decision-making process will stay true – by letting data have a seat at the table.

What does this mean? For our team at J29, we like to live by the phrase, “let the data talk.” While cliché at first, it’s important for us to stay true to our model of data driven decision making. From the time I first joined J29 to now, there are some key attributes that stand out:

  • Robust emphasis on collecting several fields of data
  • Consistent investment in improving our tools and skills to comprehend that data
  • Commitment to making data widely accessible
  • Office-wide willingness to listen to data-driven ideas that come through any level of our organization

Lastly, the continuous dedication to decisions being driven by data has always been an ongoing improvement. Simply put, our team strives to make sure that data silos are addressed and resolved before critical problems arise. Data silos can be cultural, technological, or even structural-based inadequacies in any department or organization. More times than not, a silo in place causes wasted resources and limited productivity to take care of a company’s most important asset – data.

Data silos prevent teams from seeing the bigger picture, and more importantly being able to have continued data-driven decision making. For J29, a data silo can prevent us from recognizing a security threats sooner and analyzing traffic for unusual patterns. By definition, a data silo is when only one team is able to access a certain data set or source of that data – creating inefficiencies when cross-collaboration and wide-spread project involvement is necessary.

Currently, J29 is supporting a state-of-the-art data consolidation project revolving around integrations to the State of Maryland’s new Total Human-service Integrated Network (MD THINK) platform. This revolutionary platform will be the first of its kind in the United States, thus solving a data silo issue of Maryland’s Social Service Administration, Family Investment Administration, and Child Support Administration not being able to cross reference data sets in dire times of need. Prior programs were buried deep in conflicting architectures, resulting in massive spending’s on maintenance and restrictions for modifications. Coming full circle with J29’s MD THINK works, the importance of having data drive your team is validly crucial to success. In the case of Maryland, a joint human-service decision to having data on a single, integrated platform will allow user groups access to a modernized cloud-based platform – eliminating duplicate data entry and creating a streamlined eligibility enrollment process.

When the final whistle sounds on developments and integrations, over 30,000 Marylanders will have access to more than 65 application environments and 30 AWS products – eliminating previously restricting data silos and allowing data-driven decision making to lead health and human services throughout Maryland.

In conclusion, for J29 we consider data to have a consistent seat at the “table” that allows for our team to deeply analyze where our decisions could, or could not carry us. Our company’s strong commitment to data-driven decision allows a deeper comprehension into what is truly going on and allowing our decisions to be targeted and fact-based, rather than theoretical and estimated.

Posted by
Nick Vass
Author Bio
Nick is responsible for overseeing J29's strategic development opportunities with partners serving in the government, and commercial sectors
Market Confusion: Understanding the Options for Telco Services

Market Confusion: Understanding the Options for Telco Services

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The telecom industry is a complex matrix of companies and partners providing the hardware, connectivity, services and software required for Unified Communications, including phone, fiber, cable, advanced telephony functionality, and more.

Feel a bit overwhelming?

For corporate decision-makers, a firm grasp of the industry will provide the insight and clarity required to make informed decisions. Knowing who the players are, their roles, and what they actually provide compared to other options goes a long way to knowing you have the best fit for your business.

The competitive layout of telecom is fluid and constantly affected by ongoing changes, acquisitions, and government regulation. Consider this article a snapshot of the current telecommunications landscape.

The ABC’s of The Telecom Industry

While understanding who the providers are for every area of telecom is valuable, we know it can feel like a lot to stay on top of. This is one of the reasons why we work with small and medium-sized businesses, nationwide, to help them determine the best services for their needs.

ILEC PROVIDERS

ILEC – (Incumbent Local Exchange Carriers) telephone companies that held a regional monopoly on providing local service when the Telecommunications Act of 1996 was enacted.

ILEC’s are the legacy phone service providers that are mandated to provide and maintain copper services across the nation. While densely populated areas are moving to fiber optics and wireless services, rural areas still rely on ILECs to provide services over copper wires and T1 lines.

For the most part, any service delivered over copper will use the ILECs maintained network of landlines. ILECs are large regional providers (though the wireless side of their business is nationwide in scope), which means their infrastructure and size can become a weakness. It’s really no surprise that customer service is one of the most common complaints with these behemoth carriers.

However, companies in rural areas, or with offices spread across the nation, no other type of carrier can provide the reach and services those companies may require. Rather than have different providers at each location, many enterprises choose ILEC providers to provide service at all locations. This centralizes their telecom services and makes it easier to manage as a whole.

CLEC PROVIDERS

CLEC – (Competitive Local Exchange Carrier) is a telecommunications provider company (sometimes called a “carrier”) competing with other, already established carriers (usually the ILEC).

After the Telecommunications Act of 1996, a lot of small local carriers began to burst onto the scene. Originally, they provided services, such as Internet or phone service, over copper lines they leased from the ILECs. They could generally provide better pricing to the end customer for a variety of reasons, such as lower infrastructure costs and operational overhead.

Since the rush of the Dot Com Era in the late 90’s, a lot of CLECs have been consolidated into larger companies. These companies are now starting to build their own fiber optic networks (or take over fiber already in the ground), providing services such as cloud-based phone service, fiber Internet connectivity, and data center services, outside of the ILECs copper landline network.

The advancement of fiber optics, wireless and voice-over-IP technology, CLECs are uniquely setup to provide the entire spectrum of telecommunications services to their regions. These companies are much smaller than the ILECs, which usually translates to newer, better-maintained technology and more personalized customer service and support.

Atlantech Online originally started out as an ISP, but has grown into a registered CLEC. We are building our own fiber optic network in the Washington DC area, which allows us to provide direct-connect telecom services to our clients in the region, but we have options for businesses nation-wide. Direct-connect over fiber means fast Internet, crystal-clear cloud-based phone service, as well as data center services with point-to-point fiber connectivity. On top of all that, we are 100% dedicated to providing the best possible customer service and support.

 

INTERNET SERVICE PROVIDERS

ISP – (Internet Service Provider) provides access to the Internet through cable, fiber, wireless or other technology. In addition, some provide other services such as colocation and web hosting.

ISP’s rely on connectivity from ILEC’s & CLEC’s, providing a public connection to the Internet. ISPs are a good fit for smaller businesses and residential internet service.

MULTIPLE SYSTEM OPERATORS

MSO’s primarily provide TV service and sell advertising. They often bundle phone and Internet connectivity together with television service for residential users. Some small businesses also use them.

They operate via a franchise agreement with local jurisdictions to be the registered cable operator in a given geographic area and do not have nationwide footprints. Depending on the region, they can provide coverage to a patchwork of localities.

 

DATA CENTER OPERATORS

Data Center Operator – Privately owned and operated facilities that house floor space for servers and equipment.

Data Center Operators usually don’t have their own networks but offer ILEC, CLEC and ISP services in their data centers. The primary business operation is to provide floor space for servers and switching equipment to be deployed with robust physical security, redundant power systems, complex HVAC systems and “meet me” facilities for telecom carriers to terminate services.

INDEPENDENT AGENTS

Agents are a major player in the telecom industry, although many businesses don’t even know they exist. The agent provides customer referrals to carriers and service providers in exchange for a set percentage of their contract, perpetually.

The relationship can be very lucrative for the agent, earning as high as 25% per referral for the lifetime of the customer’s service. It makes sense from a carrier’s position as well, paying independent referral agents a perpetual commission is expensive, but it’s a secondary option from paying a sales team to accomplish the same results.

Referral agents can be anyone, from tech support contractors to telecommunications consultants. Referrals are generally made with a, “I know a person at x company that can get you better Internet.” The referral is made to a salesperson at the Internet provider, and the silent agent receives his commission.

The difference between an agent and a salesperson, of course, is that a sales team is paid an ongoing salary, and any commissions for sales are usually one-time sums. An agent, on the other hand, receives a set percentage for as long as you have service. Until that customer changes carriers, the referral agent gets a percentage of the monthly bill.

The biggest difference, however, is for the customers that pay for the service. They can easily recognize a salesperson from “Acme Internet Inc.” But they are usually completely unaware when an “agent” is selling to them.

For this reason, dealing with independent referral agents doesn’t always benefit the customer. In some cases, agents are incentivized to sell for the highest commission, not necessarily the best match for the customer’s needs.

It’s important to realize that referrals are commission-based sales in most cases. Anytime you are considering going with a new carrier, it’s important to shop around – regardless of which telecom provider you are being referred to. That way you can be sure you’re getting the best possible service, rather than being an “easy sale.”

What’s Right For Your Business?

Choose a provider that offers the following:

  1. A scalable, flexible solution with easy growth opportunity
  2. Streamlined billing for direct services provided
  3. A trustworthy, established network with a track record of success
  4. An independent, top level data center
  5. Access to cutting edge telephony and connectivity services
  6. Customer service that is proactive, attentive and responsive

The overwhelming amount of choices means there is an ideal solution for every customer. Look for the one that is just right.

If you choose a small-scale provider, chances are you’ll be a big fish in a small pond. But there’s also a chance you’ll just be sold a commodity, or resold white-label services from a 3rd party carrier.

Choose too big, and you’re just an account number in a maze of customer service ambiguity. Not to mention the big guys have legitimate issues with disaster recovery due to massive infrastructure requirements.

Choose a more complicated, multi-vendor solution and you’ve got a confusing bill, multiple providers and your money is going out every month to a varied group of carriers and resellers that aren’t even directly providing you service or assistance.

 

Posted by
Tom Collins
Author Bio
Tom Collins is the Director of Enterprise Sales & Marketing for Atlantech Online. He has over 25 years of professional experience in the Internet Service Provider industry and is known for translating technology into positive results for business. A native of Washington, DC, a graduate from University of Maryland (degrees in Government & Politics and Secondary Education), Tom is also a five-time Ironman finisher.
You’ve Qualified for a PPP Loan, Now What? How to Avoid Non-Compliance as You Begin to Utilize Funds

You’ve Qualified for a PPP Loan, Now What? How to Avoid Non-Compliance as You Begin to Utilize Funds

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As a small business, you may have qualified to receive a piece of the Paycheck Protection Program (PPP) funds that were allocated by the Small Business Administration (SBA) in response to the economic disruption caused by the coronavirus (COVID-19) outbreak. In addition to bolstering cash flow, SBA’s PPP will also forgive loans if all employees are kept on payroll for eight weeks and the funding is utilized specifically for payroll, rent, mortgage interest or utilities.

This past Monday, SBA reported that it had successfully processed more than 100,000 loans from more than 4,000 lenders. Assuming your small business was able to quickly turn around the application, it’s likely you received your funding (or it may be on the way as the SBA preps to process PPP round two – as an additional $310 billion in funding was granted by the SBA this week).

As organizations begin to put this funding to use, it’s imperative that the requirements for where, when and how you use these funds are top of mind as the fear of non-compliance looms. Taking necessary actions now can assist your small business down the road to reach forgiveness – you don’t want a loan (and neither does the bank at these low interest rates), you want forgiveness.

  • FORGIVENESS SURROUNDING EMPLOYEES
    • As referenced prior, one stipulation regarding the PPP loan forgiveness states that “SBA will forgive all loans if all employees are kept on payroll for eight weeks and the money is used for payroll, rent, mortgage interest or utilities.”
    • It’s important to note that the eight-week period that is referenced commences on the exact date that the PPP funds are received.
  • PAID OR INCURRED – BE CONSISTENT IN THE APPROACH
    • The law states that costs must be paid or incurred, which could be two different things depending on timing. For ease of reporting, and to best match up cash flow, it’s likely best to track things on a cash basis.
  • ENSURE RENT, UTILITIES, MORTGAGE INTEREST ARE PAID AND UP TO DATE
    • No more than 25% of the forgivable amount of the loan can be attributable to these non-payroll costs.
    • If your facilities costs include common area maintenance, do your best to get billed by lessor or estimate and pay.
  • CONSIDER PRE-FUNDING BONUSES TO EMPLOYEES THAT WOULD OTHERWISE BE ENTITLED
    • If possible, consider matching contributions to retirement plans, such as 401(k) even if on a discretionary basis. You could also provide additional Health Savings Account (HSA) funding.
  • COMPENSATION IS LIMITED
    • Keep in mind, as a small business you are limited to no more than $100,000 (annualized) for one employee. This works out to $15,384 of compensation during the eight-week period.
  • KEEP TRACK OF HEADCOUNT
    • If you have had a recent reduction in employee headcount, consider bringing those employees back by June 30, 2020. They will count as Full-time equivalent (FTE) for the entire eight-week covered period.
  • SETUP A SEPARATE BANK ACCOUNT
    • While this is not required, it makes this significantly easier for inflow/outflow tracking purposes as you begin to use funding
    • Support for expenditures will need to be shown, but one dedicated account will make this process more painless.
  • NO DOUBLE DIPPING
    • If there are employees on your payroll that receive their salaries in the form of a government grant, they need to be excluded from your total employee count.
  • SOCIAL SECURITY TAX DEFERRAL
    • The Internal Revenue Service (IRS) has clarified that employers receiving PPP loans (that have not have been forgiven), may be able to take advantage of the Social Security tax deferral, without incurring penalties, until the date on which the lender issues a decision to forgive the PPP loan.
    • The tax that is deferred prior to the loan forgiveness date is due under the applicable dates provided in the statute (50% by December 31, 2021 and 50% by December 31, 2022).

Read more on: Assurance & Advisory | Income Tax Services

Top Digital Trends for Life Sceience Business in 2020

Top Digital Trends for Life Sceience Business in 2020

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Life science and health care is the industry which is a late adopter of digital innovation but never left untouched by this. For life sciences companies who are looking to transform digital technology, here are the latest tech trends they should focus on.

 

Artificial Intelligence/Machine Learning

One of the biggest challenges for life sciences companies is the time it takes to develop a product or drug, it varies from 7-10 years.  A lot of this time is spent in reviewing and analyzing data, which can be reduced by using AI and ML. Researchers are focusing on writing AI scripts that can analyze the structures and unstructured data and present the meaningful value to the research community so that they can make faster decisions. AI can be used to select the right patient and sites for clinical trials to accelerate the trial process. Using AI and machine Learning, you can train the system to analyze people, drugs, trial results and regulations to expedite the drug delivery process. 

 

Automated Data Extraction

Data extraction is a critical step for life science companies and regulatory agencies. Companies can use automated scripts to read relevant research data, historical trends to make better business decisions. Regulatory agencies can use it to read the submitted data and analyze it and make decisions like who to send the data for review. Regulatory agencies can use this to inform the drug manufacturer or public as well about the safety concern of a drug or ingredient. 

 

Natural Language Processing

Reading unstructured data and understanding it in context of language and research has always been a challenge for life science companies. Additionally, companies that are submitting drugs in multiple markets have to face the challenge of translating content and labels in different languages. NLP can help this, It can be used to read unstructured data like texts, comments and data collected from kiosk in context of the scenario. NLP can be combined with machine learning to train the system and extract the right meaning. 

 

Blockchain

Managing and securing data is big for life science companies. Blockchain seems to be the right solution for clinical trial, drug delivery and supply chain management. It can be used to secure patient health records, trial outcomes, historical data, communication among stakeholders, and other related data. Some blockchain platforms are being launched to cater to the life sciences, there is more need to understand the use cases and come up with the right solutions.

 

Mobile Apps /Wearables for Data Collection

Last 10 years have seen an explosion in mobile apps and wearable for health and fitness. Life science companies were initially slow to adopt to these technologies, however, they are focusing more on this now. It really makes the clinical trial process faster and accurate. You can give apps and wearables to patients to gather the data in real time and make the right decision. Overall, these technologies make the process faster and less costly. 

Piyush Jain is CEO and Founder of Simpalm, a custom software development company based in Bethesda, MD.

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Piyush Jain
Author Bio
After graduating from Hopkins in 2006, Piyush Jain set out on the path of tech entrepreneurship and founded two companies, Simpalm and Ducknowl in Maryland. His interests are digital tech, IoT, Mobile apps, AI, machine learning, and blockchain.