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Imagination and Business

Imagination and Business

Starting a business from the ground up is a daunting task. There are a multitude of different aspects to starting up a business that one needs to pay attention to. Just one serious fault in the business plan could destroy the entire strategy. Millions have succeeded in creating their businesses, yet millions have failed. Businesses fail when they do not make any money. They make money from the products or services they sell. So, in turn, businesses need to find out what they are selling and what price point to set their product in order to maximize profits. It is all about positioning oneself in the new market one is entering. The first couple quarters of the business are the most vital. They bring immediate light as to where the faults and flaws are in a company. Businesses need a strong foundation of a reliable market and profit in order to succeed and appeal to investors. The key to creating a solid foundation for a business is to possess human capital. In other words, the success of the company depends on the people in it. The people in the startup process of the company make the decisions on things like price points. Therefore, it is vital to have the right people involved in a business.

A business is like a baby. It does not come with instructions or specific obligations, but it does come with a mountain of responsibility and attention. It the founder’s responsibility to build it up into something investors are interested in. They have free reign as to how they are going to start up their business and what they are going to turn their business into. This brings in the concept of imagination and creativity. Entrepreneurs need to be creative in their development and remain consistent in their mission, values, and business promises and deliverables.

Creating a business requires a lot of thinking. This thinking is usually done by the CEO, CFO, upper-level management, advisors, or investors. At GFTD, the CEO (who is also a philosophy professor), Nina Guise Gerrity, gives the opportunity of generating ideas for the business to a group of all-female interns. These interns are currently enrolled at Loyola University Maryland working on their bachelor’s degrees. They come to meet once a week, fresh out of class, ready to use what they just learned and apply it to a startup business. Interns, as young tech-savvy adults who are ready to hit the ground running, are also included in the ideal demographic of GFTD. The interns at GFTD give a fresh pair of eyes and creative energy to the development of GFTD so that Nina Guise-Gerrity can make certain her strategy is going according to plan and is gearing towards success.

The Fed Makes Inflation Fighting Priority Number One

The Fed Makes Inflation Fighting Priority Number One

The Fed raised its benchmark interest rate by 75 basis points yesterday, to a range between 1.50% and 1.75%, and signaled stronger inflation-fighting measures ahead. We think that policy path will eventually cool inflation—but at a greater cost to economic growth than the Fed expects. And financial markets will likely stay volatile for a while.

Fed Chair Jerome Powell had earlier indicated a likely 50 basis point June hike, but media reports had increasingly pointed to a 75-point hike—and markets priced in the more aggressive outcome. The central bank leader cited recent inflation numbers and rising inflation expectations as drivers of the bigger move. Powell noted that the size of future hikes would depend on incoming information, though he expects a hike of 50 or 75 basis points will likely be appropriate in July.

The Fed Is Serious About This Inflation Battle

The central bank’s actions and statements demonstrate an intensified focus on getting inflation under control. Based on the median forecast in its “dot plot,” the Federal Open Market Committee (FOMC) expects another 1.75% in rate hikes this year, raising the target rate to 3.25%–3.50%.

That’s 150 basis points higher than was expected based on the March dot plot. The committee also upgraded its median expected terminal rate to 3.75%–4.0%, 100 basis points above March’s forecast. The Fed is clearly rattled by the breadth, magnitude and persistence of inflation and expects to respond accordingly, pushing policy into restrictive territory to slow demand.

Powell emphasized that the Fed’s first priority is cooling inflation. He kicked off the post-meeting press conference by calling inflation “far too high,” observing that the FOMC had expected it to be moving sideways or lower by now. Because it isn’t, the policy moves were more aggressive. Inflation will be priority one until the Fed gathers “compelling evidence”—a series of data releases showing decelerating inflation. At that point, the Fed would likely pivot toward a more balanced focus on its dual growth-inflation mandate. Until then, the sights are on inflation.

More Hikes Ahead—with Inflation Expectations a Pressure Point

A July hike of 50 or 75 basis points would raise the policy rate roughly to the Fed’s neutral estimate—giving it more “optionality” on future moves.

Essentially, Powell suggested there will be less urgency to act once reaching the neutral rate even if inflation was still elevated. That tack sounds a bit dovish, since rates could be at neutral as soon as next month. However, the state of the dot plot and the Fed’s requirement for a series of favorable data releases make it less so. Optionality or no optionality, the Fed will keep hiking for the time being.

Powell hammered home that inflation expectations are a key pressure point for the Fed. He specifically referenced the University of Michigan’s inflation expectations gauge and the US Federal Reserve Board’s Index of Common Inflation Expectations as reasons for the more aggressive than expected June hikes. Powell made it clear that any upward drift in expectations will likely trigger even more tightening.

Economic Growth Will Show the Cost of Fighting Inflation

A steeper, more front-loaded tightening cycle makes economic growth likely to cool faster and more deeply than previously thought. The Fed’s median growth forecast for gross domestic product in both 2022 and 2023 (in Q4/Q4 terms) is 1.7%. That rate is 0.1% lower than the central bank’s estimate of the longer-run potential growth rate. And it comes with higher unemployment: up from the current 3.6% to 3.7% at year end, 3.9% for 2023 and 4.1% for 2024.

Powell described the Fed’s forecast path as a “soft landing”: growth barely below potential, inflation coming under control and the labor market remaining strong. He acknowledged that such an outcome has become harder to achieve—and he’s right. What’s more, a soft landing increasingly relies on outside help—if the supply side of the economy doesn’t heal shortly, a soft landing seems implausible, and the supply side is beyond the Fed’s control. Absent supply-side healing, and if inflation doesn’t fall soon, the Fed must keep tightening the screws on the US economy—even as it weakens.

We expect economic growth to slow by more than the Fed anticipates. Given the tightening path the Fed has laid out, combined with our view that inflation won’t come down enough to give the Fed comfort for a while, we see more policy tightening ahead. Those moves will help bring inflation under control over the Fed’s time horizon—though it will come at the cost of a deeper growth slowdown and more volatility in capital markets.

AUTHOR
Eric Winograd
Senior Economist—Fixed Income
Supply chain vulnerabilities exist for antimicrobial medicines: USP Medicine Supply Map analysis

Supply chain vulnerabilities exist for antimicrobial medicines: USP Medicine Supply Map analysis

Antimicrobial resistance (AMR) is named one of the top 10 global health threats facing humanity by the World Health Organization and was associated with nearly 5 million deaths in 2019. With a challenge of this magnitude, it’s critical to have visibility in the supply chain for antimicrobials—medicines used to prevent and treat infections that include antibiotics (also known as antibacterials), antifungals, antivirals and antiparasitics.

USP’s Medicine Supply Map, composed of more than 250 million data points and spanning 92% of generic medicines approved in the United States, provides a dynamic view of the supply chain.

Our latest Vulnerability Insights Series analysis shows both an increased risk of shortages for some types of antimicrobials and the geographic concentration of facilities with active Drug Master Files (DMFs) for antimicrobials.

Antibacterials are at increased risk for shortage

Antibacterials are 42% more likely to be in shortage than the average drug product. Out of the 128 antibacterial drug products in the U.S., 20 are currently in shortage. This constitutes 15.6% of all antibacterials in shortage compared to 10.9% for all drug products in the U.S.

Cephalosporins—a type of antibacterial—are at elevated risk for shortage, with 40% of active pharmaceutical ingredients (APIs) used for cephalosporins currently in shortage. Cephalosporins are listed among the WHO’s critically important microbials for human medicine.

Price drives shortage risk

Across all types of antimicrobials, price is the leading risk factor for shortage. The 25 antimicrobial medications currently in shortage have an average 69.9% likelihood to remain in shortage 12 months from now with price accounting for the majority of that risk.

In general, lower priced drug products have a higher risk of shortage. Low prices of antimicrobials can be a cause of a shortage because margin is not adequate to sustain manufacturing, according to a recent British Medical Journal article.

Substandard and falsified medicines also contribute to AMR. The presence of poor-quality medicines drives AMR primarily through sub-therapeutic dosing. When a patient takes a substandard antimicrobial, pathogens can evolve to become more resistant to them.

Active Drug Master Files are geographically concentrated in India and China

USP mapped DMF registrations to manufacturing facilities. Medicines are categorized according to the USP Drug Classification. Manufacturing facilities in India and China account for 67% of all active antimicrobial API DMFs. Among different types of antimicrobials, 83% of active API DMFs for antivirals and 58% for antibacterials are likely made in sites located in India and China.

DMFs are submissions to FDA used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of human drug products. DMF registrations are used as a proxy for manufacturing capacity in the Medicine Supply Map because they tell us which facilities have submitted data to the FDA to demonstrate their capacity to make an API. However, the Medicine Supply Map does not take volume or market share into account. For example, if two separate facilities are both associated with active DMFs for the same API, one facility could produce 90% or all the API.

As we have seen with the COVID-19 pandemic, infectious diseases do not honor geopolitical borders. Therefore, the emergence of AMR in one part of the globe could be a threat anywhere. Shortages of antimicrobials can contribute to the emergence and exacerbation of AMR, so strategies such as strengthening supply chain resiliency and improving antimicrobial stewardship—among others—are critical.

As policymakers consider how to prepare for this next public health crisis, it’s important to understand the state of the antimicrobial supply chain. Further investigation into the U.S.’ reliance on other countries for intermediates or raw materials used to make APIs would offer a more robust picture of the supply chain for antimicrobials and all drug products used by patients in the U.S.

Learn more about USP’s Medicine Supply Map.

https://qualitymatters.usp.org/supply-chain-vulnerabilities-for-antimicrobial-medicines
The “Longest Day” is June 21: Help Fight the Darkness of Alzheimer’s Disease Through Fundraising

The “Longest Day” is June 21: Help Fight the Darkness of Alzheimer’s Disease Through Fundraising

The Longest Day of the year, or summer solstice, happens on June 21, 2022. For this reason, the Alzheimer’s Association chose this day to raise awareness across the world about fighting the darkness of Alzheimer’s disease (AD) through fundraising.

To shine a light on the physician burden of managing the AD journey for patients, SYNAPS Dx points to DISCERN™, the first autopsy-validated, highly accurate, minimally invasive skin test informing the diagnosis of AD versus other forms of non-AD dementias and those with AD and other degenerative pathologies.

This test is composed of three discrete assays that accurately assess the loss of synaptic activity in the brain due to AD and has been validated through biopsy. What’s more, the AD test’s assays have demonstrated >95% sensitivity and specificity.

Getting an accurate AD diagnosis is important because treatment options for AD patients are specific and distinct compared to treatments for patients with other forms of non-AD dementia.

Understanding Physician Burden

Physicians routinely perform cognitive testing and imaging to reach an AD diagnosis. They note several unmet needs in this process, namely the lack of a definitive diagnosis, the subjectivity with the current diagnostic pathway and the cost burden for unreimbursed procedures.

To effectively address these unmet needs, they require objective, less invasive diagnostic tests to inform a definitive diagnosis of AD. Many recognize that the ability to differentiate earlier between AD and another form of dementia is increasingly essential, even without specific treatments for AD.

The study found a significant level of need:

  • 9 out of 11 physicians believe that the lack of certainty about the true benefit of aducanumab is an unmet need in AD diagnosis
  • 8 out of 11 physicians underscore the utility of an objective, less invasive diagnostic test
  • 7 out of 12 cited the need for a test that can differentiate AD from other forms of dementia

Additionally, this study showed that 8 out of 12 physicians were likely to order the DISCERN™ test to diagnose patients with suspected AD. 

Physicians Would Likely Opt for DISCERN

Many physicians believe DISCERN™ is well-positioned to reduce or replace costly and often invasive diagnostic tests, including PET scans, brain MRI, CT scans and CSF punctures. Clinical utility of DISCERN™ is unique from other common diagnostic tests as it targets factors related to cognitive loss in AD rather than assessing clinical findings associated with AD, such as amyloid plaque.

Both primary care physicians and specialists indicated that strength of evidence, including test performance characteristics, cost and coverage, are the biggest drivers in the decision to adopt DISCERN™. What’s more, they expect that the test would easily fit into the diagnostic pathway before advanced imaging tests of patients diagnosed with dementia are suspected of having AD.

DISCERN™ meets the unmet need for a diagnostic tool that supports early detection and a simple test that is widely accessible and affordable.

Besides relieving physician burden, DISCERN™ gives patients and families the answers they need and supports the establishment of authorization protocols by payers for prescribing and reimbursing treatment. It also helps pharmaceutical companies identify appropriate clinical trial participants and may provide additional metrics to evaluate treatment response.

To learn more visit here.

Posted by
Michael Tunkelrott
Author Bio
Michael Tunkelrott is Vice President of Marketing at SYNAPS Dx.
Upward Trajectory of Remote Hiring: How Senior Roles are Becoming Less Location Dependent

Upward Trajectory of Remote Hiring: How Senior Roles are Becoming Less Location Dependent

There is no denying that the Coronavirus pandemic will continue to reverberate for many years to come. However, one area that has positively progressed considering COVID-19 is the way we work and where we work. There are more remote workers than ever before, and many companies are looking to close or reduce their office spaces to support a better work-life balance. Typically, remote working has been an option for gig workers whose roles are more freelance based or who work in isolation, but as we offer this option to more teams across the US, isn’t it time to do the same for our leaders too? 

Why Remote Leadership is Worth Considering 

It’s no shock to learn that senior roles are often based in an office. This is to give a sense of accountability and provide a team with a figurehead to look up to, but with more remote working comes a contemporary style of leadership – one that can inspire and motivate from afar. 

The great news for life science is that if a workforce is remote, nothing is stopping you from selecting a leader that works remotely too! Remote leadership does not mean an absence of a leader but will give you a greater chance of finding the right leader from a larger pool so that your business can grow in capable hands while respecting their need for a healthy work-life balance! Failing to offer remote roles will not only narrow your potential candidates, but they may be tempted to leave sooner if they find a similar job that allows them to work remotely.  In addition, the life sciences industry is posting more remote ads than ever before.  

Getting Remote Leadership Right 

Many people worry that remote leadership will lead to a lack of good working relationships, but this doesn’t need to be true if a company invests in the right technology and the right leadership. Some of the main considerations a company needs to consider include: 

  • Considering whether their technological investment will support a remote leader’s success. 
  • Ensuring a system where all team members can access support and advice during their working day without delay. 
  • Finding ways to keep their leadership team visible and accessible so that the ethos and values of the business do not get lost in translation. 
  • Being willing to innovate where there may not be a current solution so that remote working and a better work-life balance become a fully supported model. 
  • Ensuring that all training opportunities are as robust remotely as they were in person.

When you find a leader with the drive and passion to take your company forward, it is worthwhile to offer them the way of working that best suits their needs. In return, you can be sure that they will drive success and innovate new ways of working that work for the whole team. 

The time has come to diversify hiring practices, with remote leadership becoming a real possibility. If you want to find out more about making remote leadership work for your business, then the GeneCoda® team are ready to help. Get in touch today and let us help you navigate the potential remote leadership has to offer. 

Showing Candidates the Way You Want to Grow

Showing Candidates the Way You Want to Grow

The ‘Great Resignation’ is proving to be a big challenge for life science businesses all over the globe, and with more roles vacant than ever before, candidates really do have the pick of the bunch! Rather than trying to wow potential employees with packages that may or may not impress, why not show them what you are about and where you are heading so that they feel motivated and inspired at the thought of taking the journey with you?

Why Growth Plans are Important

Typically, when a candidate applies for a position, they are left hoping to be considered and are made to feel that they are lucky to have been shortlisted. However, as the recruitment crisis rumbles on, candidates have become savvier to their potential and now expect much more from a prospective employer than a simple interview – putting you under pressure to perform in a way that impresses them.

One of the best ways to do this is to share your growth plans and clearly defined steps to ensure your combined success. This will help the candidate see that you are well organized and take accountability for the future, but it will also give them the information they need to work out whether there is a place for them to fit in your business model.

In addition, a growth plan will allow a candidate to see their potential career trajectory and work out whether their plans for success marry with what you have to offer. In reality, this will mean that some candidates will not be willing to come on board with you, but those who do will be more likely to stay for longer and work hard to make your plans and theirs become a reality.

Sharing Your Values and Goals Honestly

It can be tempting to share information that has been exaggerated to garner a greater level of interest in job vacancies, but doing this will not just mean a greater turnover of staff, but it may also harm your ability to reach the goals you had originally set.

Candidates are taught to understand their values and goals more than ever before, leaving them in a position of wanting to find a company they can feel appropriately aligned with. When you share your goals and values honestly, the result is a better working partnership between you and your employees and better business outcomes.

Taking the time to show your business has been well considered and your goals well-chosen will always help you appeal to the right candidates, even in the most competitive markets.

Is Your Company Committed to Innovation? Seven Questions

Is Your Company Committed to Innovation? Seven Questions

Innovation is the key to grow any businesses to a significant scale. Many businesses have started with innovative ideas and grown rapidly by disrupting incumbents in their markets. However, as they grow they have instituted management processes along the way which are designed for disciplined execution. They have unknowing migrated to a culture that values predictable outcomes rather than calculated risk taking. At some point, these companies start losing market share to the next innovators, and the cycle repeats. This innovation cycle is well described in the book “The Innovator’s Dilemma” by the late Harvard professor Chris Christensen. It is well understood by many business executives.

In normal times, the slow decline of market share for an incumbent can take many years. It could be hard to get the topic of innovation on the agenda of its senior executives. However, the COVID-19 pandemic has accelerated the innovation cycle. Most business executives believe the pandemic will force them to fundamentally change the way they do business in the next few years because their customers’ needs and wants have changed. In order to continue the growth trajectory businesses need to innovate. In some cases, innovation is no longer a luxury; it is a necessity. But few business executives believe they are well equipped for innovation. According to a McKinsey study, only 21% of executives believe they have the expertise, resources, and commitment to pursue new growth, and two thirds of executives believe now will be the most challenging moment in their executive career.

Behind every crisis is also opportunity. It is the time for business leaders to reflect on their commitment to innovation, diving deep into their own mindset and their company culture and being radically candor about it. In most companies, there are wall posters describing their core values, which often include the word “innovation”, but is it manifested in their day-to-day operations? Most companies will say no, and that’s why only 21% of executives believe they have the expertise, resources, and commitment to pursue new growth.

The first step toward innovation is to commit to doing it. Once the commitment is made, the company’s culture, organization and management processes need to support the commitment. How do you know a company is committed to innovation? Answers to the following questions will reveal a lot:

1. Are the employees feeling motivated and empowered to bring forth new ideas?

2. Do you value and reward employees’ strength in thinking critically and constantly finding new ways to improve?

3. Do you always encourage diversity of thoughts and opinions in meetings to surface hidden opportunities?

4. Do you make it feel safe for employees to experiment and test new ideas, knowing most of them will fail or die due to limited scalability?

5. Do you ask and support allocating dedicated days in a week for employees in technical development or product development areas to focus on innovative projects?

6. Do you make your senior management team accountable for quantifiable innovation results?

7. Do you consistently review your innovation portfolio, and manage resources to improve outcome?

Depending on the answers to these 7 questions, you may find that your company is well positioned to innovate. Congratulations on that! However, if you are being radically candor, you may find that your company is falling short. Then it’s time to ask the question, do you want to change that? Feel free to contact me for an innovation assessment. Jackie@techcomventures.com. Remember – “Unless commitment is made, there are only promises and hopes… but no plans.” – Peter F. Drucker

ICYMI: Takeaways from Final Guidance for Submitting Pre-Launch Activities Importation (PLAIR) Requests to FDA for Drug Products Prior to Anticipated Approval

ICYMI: Takeaways from Final Guidance for Submitting Pre-Launch Activities Importation (PLAIR) Requests to FDA for Drug Products Prior to Anticipated Approval

The U.S. Food and Drug Administration (FDA or Agency) recently announced the final guidance titled “Pre-Launch Activities Importation Requests (PLAIR)” (Final Guidance). The Final Guidance outlines FDA’s policy for the importation of unapproved finished dosage form drug products an applicant is preparing for a U.S. market launch based on anticipated approval of a pending new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics licensing application regulated by FDA’s Center for Drug Evaluation and Research (CDER). The guidance describes the procedures for making such a request to FDA before final approval of the application and provides factors the Agency will consider in granting such requests. FDA offers the following procedural information in the Final Guidance: (1) what information should be submitted to FDA in a PLAIR; (2) when and how to submit a PLAIR; and (3) the circumstances under which the Agency intends to grant a PLAIR.

The Final Guidance finalizes and updates the draft guidance of the same title issued on July 24, 2013. Click the link below for a summary of the major provisions in the Final Guidance, as well as our takeaways to assist industry in preparing and submitting PLAIRs.

Read more here.

Posted by
Amaru J. Sanchez
Author Bio
Amaru counsels domestic and global companies in matters involving products regulated by the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and relevant state agencies. As a former in-house counsel for a publicly traded company, Amaru is well-positioned to help clients navigate complex legal, regulatory, and business issues.
ISPOR Annual Conference: 90% of Physicians Follow Results of DISCERN, First Skin Test for Alzheimer’s Disease

ISPOR Annual Conference: 90% of Physicians Follow Results of DISCERN, First Skin Test for Alzheimer’s Disease

SYNAPS Dx (SDx) is pleased to present “Physicians’ Assessment of the Clinical Utility of a Novel Test to Diagnose Alzheimer’s Disease (AD),” at the Professional Society for Health Economics and Outcomes Research (ISPOR) Annual Conference, May 15-18, 2022, in National Harbor, Maryland.

Our implicit preference study indicates that 90% of physicians would routinely use the results of DISCERN™, a diagnostic test that assesses the factors directly related to the formation of synaptic connections in the brain impacting loss of memory and cognition in people living with AD, as well as regulators of amyloid plaque and tau formation, which are hallmarks of AD at autopsy.

Study Details

Our study showed that DISCERN was an important attribute in physician decision-making and, compared to no DISCERN test, a positive result was associated with significantly higher clinician confidence in an AD diagnosis, even earlier in the disease. This result confirms the test’s value as the most promising breakthrough for early diagnosis of AD.

DISCERN, which has 95% sensitivity and 95% specificity in the diagnosis and management of AD, combines three biomarkers: Morphometric Imaging to measure fibroblasts’ ability to form networks; Protein Kinase C ε to measure synaptic growth; and AD-Index to measure phosphorylation of Erk1 and Erk2 in response to bradykinin. The study also found that a positive DISCERN test was associated with significantly higher odds of prescribing disease modifying agents for AD, with the MMSE score being the most important attribute in the decision to refer a patient to a neurologist.

See You at ISPOR

We are very excited to be part of this important event and to bring an innovative and effective test that has the potential to impact future health economics and outcomes research (HEOR) in patient-driven digital healthcare systems.

This year, ISPOR’s theme will be a “green thread” that is woven throughout the event to bring a fresh and holistic view into the future of HEOR in patient-driven digital healthcare systems.

To learn more visit here.

Posted by
Michael Tunkelrott
Author Bio
To learn more visit https://discerntest.com/.
Why Technology Is Set to Play a Larger Role in Life Sciences

Why Technology Is Set to Play a Larger Role in Life Sciences

Historically the life sciences industry has considered information technology to be a way of completing basic functions, rather than as an intrinsic or vital part of their work.

Over time technology is reaching into the life sciences world as patients become more engaged in their care and data collection and analytics become ever more useful.

Change In the Health Care Sector

The healthcare sector is swiftly being challenged and changed by technological advances. Healthcare providers are increasingly looking to offer new and different methods to provide healthcare to their users and healthcare users are expecting a more personalized service.

Current healthcare users expect their care to be clear to them at every step. They expect transparency, a smooth service, convenience and to be included in decision making at every stage in their healthcare journey.

Data analysis and service automation can lead to an increase in productivity for a life sciences company as well as allowing a more personalized service. With the addition of digital technologies, outcomes can be improved, and patients receive a more engaging experience. If a life sciences company wants to ensure that it is a leader in the healthcare industry, it must consider the service its users expect.

Digital Markets

Digital markets give access to vital data that can be collected, analysed, and used to create solutions for both life sciences companies and their users. Having technological solutions that link with the life sciences will allow the life sciences sector to develop clear strategies and solutions within their service.

Any life science company that wishes to be a leader in its sector would do well to fully embrace digital markets and all the advantages they can bring.

New Platforms

Modern technologies and new ways of looking at technology within the life science sector can allow a company to look at the basic technology they use and decide what needs to change to fulfil its true potential.

To future-proof themselves life sciences companies need to embrace the latest cloud-based technology and consider the newest platforms available. This will boost patient satisfaction while also streamlining operations for staff.

Read more here