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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

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?

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.
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

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

Importance of Early Planning for Cell Therapy Clinical Trials

Importance of Early Planning for Cell Therapy Clinical Trials

Early planning is critical, both for cell therapy clinical trials and commercial-scale operations. By addressing how activities will be managed early on, it can minimize risk and cost, and optimize downstream processes. However, oftentimes clients are unsure of which components are critical to address early on.

In this blog I’ll address the top question clients often ask me, “What are the key components of a cell therapy clinical trial that I should consider early on, and why?”

There are several factors but the most important include:

Study Protocol
The way the study is designed is the crux of the clinical trial.  It will directly affect the execution and logistics as you navigate through the development phases so it’s important that significant time and thought is put towards this step early on.

The more complex the study protocol design is (i.e. double blinding), the earlier it needs to be communicated.  If not communicated, it can lead to logistical challenges such as packaging, labeling, as well as misinformed study personnel, all of which can cause delays in kickoff and/or implementation.

Site Location
Early planning for the number of clinical sites and their locations has a direct impact on the execution of a cell therapy clinical trial.  Remote or inaccessible clinical site locations will affect distribution of material as well as recruitment and treatment.

A team of qualified individuals are needed to support the clinical trial; especially a Principal Investigator. A PI with significant experience in study participant recruitment, patient follow-up and strong regulatory knowledge is important in choosing a study site.

The on-site personnel also affects the site location as they need proper clinical trials skills and on-going or up-to-date regulatory training.  Without training, the cost of the trial can increase due to poor paperwork documentation, poor management of study product, and non-compliance with protocols.

Supply Chain Management
It is important to consider a coordinated supply chain management plan as early as possible within the therapies development. This will give you peace of mind that your product is delivered to the right patient at the right time, location, and temperature.

Additionally, as you scale it’s important that your vendors scale with you.  When searching for an ideal supply chain partner to support, consider the following characteristics:

By considering these key components early on in your cell therapy clinical trial planning, it will lead to proper implementation, smooth operations and attainment of study objectives.

Posted by
Moronke Iyoha
Author Bio
My background is in clinical trial coordination and management, with 8 years of experience ensuring delivery of all services and technical aspects of large multi-center projects. While I trained as a Physician, I believed in the words of Dr. Riffenburgh; "When you treat a patient, you have treated a patient. When you do research, you have treated ten thousand patients.” Growing up in a developing country with many dying from easily preventable diseases, I was determined to be part of any change that promotes and enhances health. I received my medical degree from Olabis Onabanjo University, Nigeria and my Masters degree in Public Health from Johns Hopkins University. As a Project Manager with Fisher BioServices, I get to facilitate successful implementation of projects which could ultimately impact the lives of thousands. Effective communication and organizational skills are keys to a project's success.
Big Announcements from Maryland Tech Council

Big Announcements from Maryland Tech Council

Please see important information below regarding our office move, guest blogs and member videos! Let me know if you have questions.  I’m looking forward to seeing you soon!

  • Big Move

    Maryland Tech Council is saying goodbye to our old digs on September 20, 2017.  Please make note, our communications will be down that day and we will resume full activity on September 21, 2017.  MTC’s new headquarters will be located at Launch Workplaces in Gaithersburg MD, 9841 Washingtonian Boulevard, Suite 200, Gaithersburg MD 20878.

  • Be a Guest Blogger

    Maryland Tech Council is launching the Member Point of View (POV) guest blogs.  We are inviting members to submit content for our blog page.  The content will be focused on your niche/industry where you can add a new POV for the MTC audience. Our goal is to position you as an authority and well-known name in the industry. And for us, we will have fresh new content for the page and get new readers to our blogger community.  It’s simple and a win-win.  We will have numerous categories that you can write articles for; those will be available in the next few weeks.  We are kicking off the Member POV blogs during Cyber Security Awareness month in October.  If you are interested in submitting a blog on that topic, please let me know and we will get you started.

  • Become a Familiar Face in the Community

    Maryland Tech Council is revitalizing the “member spotlight” that is featured in the VIBE E-newsletter. We now offer the opportunity to feature you, the member, through our new and exciting video blog or vlog.  The video will be 30-45 seconds, prerecorded at our offices, about your company. We will then feature the vlog in our monthly VIBE E-newsletter.  The vlogs allow us to distribute the member spotlight through other formats such as twitter, Facebook, etc. to get you more exposure.  I mean, we are the Tech Council, right?  

 

Remember, everyone in your company is a member of MTC. Please share this important information with your team.

Warm Wishes,
Michelle

Michelle Ferrone
EVP, Operations
Maryland Tech Council
240-243-4047