Category Archives: Science: Biology

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Vici Health Sciences Expands Staff and Footprint in Maryland to Meet Customer Demands


A FULL SERVICE PHARMACEUTICAL R&D COMPANY

We work hard to provide our clients innovative R&D solutions to bring their drugs to the market. Our clients want to develop high quality pharmaceutical drug products rapidly and clearly recognize the value we are able to provide.

Vici Health Sciences announces it is breaking ground in expanding its pharmaceutical product development lab in Maryland. Emphasis will be in expanding capabilities in both oral and parenteral dosage forms. With the increased size and expanded capabilities, Vici Health Sciences will be well positioned to meet the growing demand for its pharmaceutical formulation and analytical method development services. Founded in 2016 with the aim of rapidly developing drugs to meet acute and long-term market needs, Vici currently works with over 10 different pharmaceutical companies and continues to expand its client base. The current expansion is focused on improving capabilities in manufacturing GMP clinical supplies and increases Vici’s ability to handle additional clients simultaneously.

Dr Anish Dhanarajan, CEO and co-founder stated: “We work hard to provide our clients innovative R&D solutions to bring their drugs to the market. Our clients want to develop high quality pharmaceutical drug products rapidly and clearly recognize the value we are able to provide. This expansion will allow us to meet the growing demand for our services.”

About Vici Health Sciences LLC

Vici Health Sciences (Vici) is a U.S. based pharmaceutical research and development company. Vici is focused on providing innovative, flexible, high quality, and low-cost R&D services to small and mid-sized pharmaceutical companies that need to grow their product portfolio. Vici currently focuses on oral and injectable dosage forms and operates an R&D and GMP facility capable of developing formulations, analytical methods, and manufacturing phase 1/pilot clinical supplies.

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First Alzheimer’s Disease Gene Therapy Human Study Provided by Maximum Life Foundation, Offers 10 Free Therapies for Qualifying Patients


MaxLife Foundation Offers Free Gene Therapy for 10 Patients

“If successful, this treatment could potentially be used on other diseases such as Parkinson’s and ALS.”

Cure Now ━ Instead of Palliative Care

According to the Alzheimer’s Association:


  •     Alzheimer’s disease is the 6th leading cause of death in the United States.
  •     More than 16 million Americans provide unpaid care for people with Alzheimer’s or other dementia.
  •     These caregivers provided an estimated 18.5 billion hours of care valued at nearly $234 billion.
  •     Between 2000 and 2017 deaths from heart disease have decreased 9% while deaths from Alzheimer’s have increased 145%.
  •     1 in 3 seniors dies with Alzheimer’s or another dementia. It kills more than breast cancer and prostate cancer combined.


Alzheimer’s costs Americans $277 billion a year – and rising. Sharp increases in Alzheimer’s disease cases, deaths and costs are stressing the U.S. healthcare system and caregivers. About 5.7 million Americans have Alzheimer’s disease. To date, no one has survived it.

Improvements of AD symptoms and the recovery of normal brain functions have been demonstrated in-vivo in mouse experiments, and in-vitro in human cell experiments through the rejuvenation of microglia (the brain’s first line of defense against infection) and neurons as well as stimulating mitochondrial function using the telomerase reverse transcriptase (TERT) protein.

One human patient received a lower dose therapy in August 2018 with no adverse side effects. To date, the patient’s disease has not progressed. MaxLife hopes to see symptom reversals in the next patients.

“If we can prove a benefit to patients that have no other option now, we can potentially treat Alzheimer’s Disease in people in early to mid-stage Alzheimer’s, finally creating effective medicine at the cellular level,” states Kekich. “If successful, this treatment could potentially be used on other diseases such as Parkinson’s and ALS.”

The unique difference is developing treatments against the cellular degeneration caused by aging as the root cause of most major diseases. Studies have proven aging is the leading risk factor for many life-threatening diseases, including Alzheimer’s.

With a world class Scientific Advisory Board, MaxLife is ready to push forward into practical solutions. A gene therapy facilitator, Integrated Health Systems plans to treat other adult aging-related diseases with no previous cure such as Sarcopenia, Atherosclerosis, Chronic Kidney Disease (CKD)… and even aging itself with gene therapies.

“This technology could halt many of the big age associated killers in industrialized countries’” states Kekich. “Compassionate care helps patients with no other option to get access to experimental therapies that may benefit both themselves and society as a whole.”

MaxLife also seeks grants and donations for human gene therapy studies for atherosclerosis, sarcopenia and chronic kidney disease as well as for human aging. The protocols have already been developed. Please Click Here and scroll to the bottom of the page to see how to donate.

To apply for a free therapy or for more information, see http://www.maxlife.org/alzheimers-disease/ and https://maxlife.org/how-to-register-and-qualify-for-the-alzheimers-human-study/.

For Further Information, Contact: David Kekich, CEO Maximum Life Foundation.

Maximum Life Foundation is a 501(c)(3) Not-For-Profit corporation founded in 1999.

Tax I.D. #31-1656405. David A. Kekich Tel. #949-706-2468. Info@MaxLife.org

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Leak Detection Associates Announces New SIMS 21 CFR Part 11 Compliant System Software


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Dedicating the time and resources to development of a complete Part 11 compliant instrument operation program allows us to stand as a leader in the marketplace and deliver a solution to exceed client expectations

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is pleased to announce the release of its new SIMS Version 1.11.19 21 CFR Part 11 compliant software program specific to the custom-built helium leak testing systems it designs and manufactures. The new program, which was developed to support both existing SIMS 1284+ models and the new SIMS 1915+ units, makes LDA the sole marketplace supplier of helium-based leak testing systems that meet all of the 21 CFR Part 11 software requirements as dictated by the Food & Drug Administration (FDA).

“Meeting the strict regulatory demands now in place for any computer-driven analytical instrument is a critical factor in terms of quality system compliance. Dedicating the time and resources to development of a complete Part 11 compliant instrument operation program allows us to stand as a leader in the marketplace and deliver a solution to exceed client expectations, ” commented Alan Weiss, Chief Financial Officer of LDA.

Over the past twenty years, with the increasing use of computer systems and electronic records, the FDA has issued a number of guidance documents and directives that outline specific requirement for electronic data management. Systems must account for multiple level login of users, application of electronic signature and approval, secure data management that prevents alteration of existing results and an electronic audit trail that records all relevant events in a time and date stamped pattern. Contracting with a development team that specializes in development of instrument operation software programs and with extensive experience in the Part 11 area, LDA was able to design a robust and comprehensive program specific to helium leak testing on our custom-designed and manufactured systems, while improving functionality and usability compared to existing software options.

For existing SIMS units in the marketplace, LDA is offering a system software upgrade program for easy installation performed onsite for a client’s existing install base. All new instruments ordered, inclusive of new models – the SIMS 1915+ and SIMS 1915+ LT – will come with the new 21 CFR Part 11 program.

About Leak Detection Associates, LLC

For over 20 years, Leak Detection Associates has been the premier manufacturer of custom helium leak detection instruments for the pharmaceutical, biotechnology, medical device and food packaging industries. LDA’s well-established technology has been incorporated into ASTM and compendia guidance documents. This robust industry experience, combined with the advanced capabilities of its newest model the SIMS 1915+ helium leak detection unit, provides companies with tools to quantitatively evaluate leakage, improve the package development cycle, establish manufacturing controls, and ultimately reduce risk to the product and consumer throughout the lifecycle.

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Study shows how diabetes developed in pregnancy might program baby’s stem cells for health issues in adulthood


Researchers have come to suspect that women who contract gestational diabetes mellitus (GDM) during pregnancy pass along to their offspring a preponderance for type 2 diabetes and other health complications while the child is still in the womb. A new study released today in STEM CELLS Translational Medicine further lends credence to that idea.

GDM, a type of diabetes that happens only during pregnancy, results from hormones released by the placenta that prevents the body from using insulin effectively. It affects about 6 to 15 percent of all pregnant women. This condition is associated with short-term adverse obstetric and perinatal complications, and with long-term health consequences for offspring.

“Recent studies revealed the significant impact of GDM on human umbilical cord-derived stromal cells,” said Sonia Fernández-Veledo, Ph.D. She and her University Hospital of Tarragona Joan XXIII colleague Ana Megía, M.D., Ph.D., were senior authors of the SCTM study. “Our investigation sought to determine whether GDM might leave an imprint in fetal precursor cells found in the amniotic membrane and, if so, whether it might be related to adverse outcomes in offspring including diabetes, obesity and cardiovascular disease.”

The study involved 18 pregnant women scheduled for caesarean delivery; half had GDM and half had normal glucose tolerance (as the control). The researchers isolated amniotic mesenchymal stem cells (AMSCs) and resident macrophages (a type of white blood cell that plays a key role in the body’s immune response to foreign invaders) from the two groups, then analyzed and correlated the AMSCs’ functional characteristics with the anthropometry and clinical parameters from both mother and offspring.

“The results provided evidence that maternal metabolic derangements during gestation disturb the biological properties of the AMSCs,” Dr. Megía reported. “Of note, these results suggest that GDM environment could program stem cells and subsequently put the offspring at risk for metabolic dysfunction later in life.”

Dr. Fernández-Veledo added, “Our study also tells us that AMSCs might be a powerful tool for the indirect study of fetal cells in the context of hyperglycemia and insulin resistance, opening the possibility of new predictor or diagnostic approaches.”

“This study using amniotic membrane stem cells to show how gestational diabetes can impact the fetus is certainly interesting,” said Anthony Atala, M.D., Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. “The findings are promising and open the opportunity for the development of a translational medicine approach that could reduce the risk of type 2 diabetes developing.”

The full article, “Gestational diabetes impacts fetal precursor cell responses with potential consequences for offspring,” can be accessed at https://stemcellsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/sctm.19-0242.

About STEM CELLS Translational Medicine: STEM CELLS Translational Medicine (SCTM), co-published by AlphaMed Press and Wiley, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices. SCTM is the official journal partner of Regenerative Medicine Foundation.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS® (http://www.StemCells.com), celebrating its 37th year, is the world’s first journal devoted to this fast paced field of research. The Oncologist® (http://www.TheOncologist.com), also a monthly peer-reviewed publication, entering its 24th year, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

About Wiley: Wiley, a global company, helps people and organizations develop the skills and knowledge they need to succeed. Our online scientific, technical, medical and scholarly journals, combined with our digital learning, assessment and certification solutions, help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 200 years, we have delivered consistent performance to our stakeholders. The company’s website can be accessed at http://www.wiley.com.

About Regenerative Medicine Foundation (RMF): The non-profit Regenerative Medicine Foundation fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honouring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives.

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Leak Detection Associates Celebrates Major 2019 Milestones


As 2019 comes to a close, we are proud of our new facility and fresh product line which a platform for continued success in providing solutions for our clients worldwide

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is excited to celebrate the completion of its first calendar year under new management. Following acquisition by CLJ Holdings in February, 2019, a comprehensive and aggressive reorganization plan was implemented by CEO Brian Mulhall, intended expand and improve product and service offerings to a global market. Multiple major milestones were achieved over the course of 2019, including opening a new company headquarters, strategic partnerships for global distribution and support, new product offerings including the Agilent-based SIMS 1915+ and low temperature (-80°C) testing systems, and the launch of newly developed Part-11 compliant SIMS software.

“Entering 2019, we outlined ambitious goals that, if accomplished, would reaffirm LDA’s position as the premier manufacturer of helium leak test instruments specifically tailored to the regulated life sciences industries” commented Alan Weiss, Chief Financial Officer of LDA. “As 2019 comes to a close, we are proud of our new facility and fresh product line which a platform for continued success in providing solutions for our clients worldwide.”

While helium leak detection has a longstanding history of use in pharmaceutical packaging operations, with ASTM F2391-05 being written by LDA founder Dr. Darrell Morrow, recent industry guidelines such as USP 1207 and the proposed revision to EU Annex 1 continue to drive adoption of more sensitive and deterministic leak tests worldwide. To better connect with this market, LDA launched a redesigned website in 2019 and has made a commitment to participating in industry events, such as Interphex and Parenteral Drug Association (PDA) Workshops on CCIT. To better cater to LDA’s client base with global site networks, newly established strategic partnerships were forged, including an agreement with IPP for instrument distribution and support across the UK and Ireland.

Critical to the 2020 product line, Director of Engineering Jeff Morrow-Lucas and his team created two new hardware offerings in 2019; notably the SIMS 1915+ Helium Leak Detection System packaged with LDA’s newly released, Part-11 compliant SIMS software. Incorporating Agilent Technologies components, the new system, completely redesigned, marks improvements in instrument performance, intuitive operation, and access to Agilent’s global maintenance and service network, while the newly developed SIMS software ensures data integrity. In addition, the newly released LT80 add-on system enables testing of pharmaceutical package systems at temperatures as low as -80°C, critical for many biologics, cell and gene therapies, which require storage or shipment at aggressive temperatures that can cause leakage.

As clients have come to expect, each new SIMS 1915+ will be customized to client’s specific testing needs, whether testing vials, blister cards, cartridges, or pre-filled syringes. Each SIMS 1915+ can be complimented with Leak Detection Associates’ robust and ever-expanding catalog of accessories, service, and contract offerings to provide end-to-end leak testing solutions.

About Leak Detection Associates, LLC

For over 20 years, Leak Detection Associates has been the premier manufacturer of custom helium leak detection instruments for the pharmaceutical, biotechnology, medical device and food packaging industries. LDA’s well-established technology has been incorporated into ASTM and compendia guidance documents. This robust industry experience, combined with the advanced capabilities of its newest model the SIMS 1915+ helium leak detection unit, provides companies with tools to quantitatively evaluate leakage, improve the package development cycle, establish manufacturing controls, and ultimately reduce risk to the product and consumer throughout the lifecycle.

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Futurist Betting On Anti-Aging Stem Cells Pens “New Breed of Homo Sapiens”


Anti-aging therapies are a new emerging era of science that seem to benefit society using the power of stem cells, cytokines, and growth, regenerative, and life-extending factors. Regenerative therapies and exogenous stem cell transplantation into damaged tissues will also improve the wear and tear of aging.

New Breed of Homo Sapiens paves the way for revolutionary stem cell treatments that could vastly improve health in the twilight years. The contemporary series of books could be the key to understanding how the aging process works.

The multifaceted award-winning and internationally known author, Lou Baron is able to address one of the first questions individuals contemplating stem cell therapy for aging may have, “Could stem cells be the Holy Grail of medicine?”

Lourdes takes the battle against aging to of all places; stem cell therapy, with the expectation that scientists will master the technique of using stem cells to retard the aging process.

Researchers hope the results will lead to new, ‘personalized medicine’ approaches to the unfolding of slowing the aging process.

As humans, we persist in being baffled by the steady aging of our bodies, which sometimes seems to occur at a faster rate than we might expect. Consequently, we often do our best to try to stall or cheat the process, using a wide range of remedies, from improving our diets to undergoing plastic surgery.

Today, researchers are looking into how stem cells found in a region of our brain called the hypothalamus might play a key role in how swiftly we age. Dr. Dongsheng Cai, from the Albert Einstein College of Medicine, in New York City, New York, alongside a team of specialists, have found that adding fresh stem cells to the hypothalamus might be the way to go if we want to delay old age.

Ground breaking studies like these have already shown that the hypothalamus does in fact play a crucial role in controlling aging. Stem cells in the brain determine how quickly our bodies debilitate, researchers have noted. But, by introducing fresh stem cells, part of the aging process could be slowed down or reversed.

New Breed of Homo Sapiens outlines a range of topics that analyze and expound on human aging and the various disorders associated with the natural biological process. While dealing with an immensely scientific subject, Lou Baron, leaves the beaten path and instead addresses her readers in clear, in-depth and easy to follow directive.

“I want my readers to fully understand and grasp the importance of this medical breakthrough,” she said. “We are talking about the future generations and the new breed of humans, and I want to bring the knowledge to the public’s door step,” she added.

Lou Baron, at 72 years young, is a sprightly, vivacious woman, defying her age – she credits stem cells. “I am living proof that stem cell based therapy really works.” Elucidating how this was the spark that brought about the idea to write, New Breed of Homo Sapiens.

“Stem cells will reverse aging and improve the quality of life for many, but it is not a ticket to immortality,” Baron noted.

The Feeling Good At Any Age crooner, reinvented by the experience that delivers the kind of energy and fearlessness that made her successful as a singer, to an entirely different issue, with huge effect. “Stem cells hold enormous promise, the potential to overcome age related deterioration of the body in regenerative medicine is astounding, something we must pursue,” the author said in a recent interview.

Baron has studied tirelessly to research and promote advances in stem cell research. “We need to do more,” she said. “Let’s continue to take risks. Let’s tackle the issues. In ways our music and film communities can do it better than anyone else. There is no challenge, artistic or otherwise, that we can’t meet,” she added.

Baron provides hope, inspiration and unclouded steps on confronting the aging process. Her greatest role may be as champion for baby boomers – an advocate of stem cell therapy.

As reported in Nature:

New research reveals how increasing brain stiffness as we age causes brain stem cell dysfunction, and demonstrates new ways to reverse older stem cells to a younger, healthier state.

The results have far-reaching implications for how we understand the aging process, and how we might develop much-needed treatments for age related brain diseases.

As our bodies age, muscles and joints can become stiff, making everyday movements more difficult. This study shows the same is true in our brains, and that age-related brain stiffening has a significant impact on the function of brain stem cells.

A multi-disciplinary research team, based at the Wellcome-MRC Cambridge Stem Cell Institute (University of Cambridge), studied young and old rat brains to understand the impact of age-related brain stiffening on the function of oligodendrocyte progenitor cells (OPCs).

These cells are a type of brain stem cell important for maintaining normal brain function, and for the regeneration of myelin — the fatty sheath that surrounds our nerves, which is damaged in multiple sclerosis (MS). The effects of age on these cells contributes to MS, but their function also declines with age in healthy people.

To determine whether the loss of function in aged OPCs was reversible, the researchers transplanted older OPCs from aged rats into the soft, spongy brains of younger animals. Remarkably, the older brain cells were rejuvenated, and began to behave like the younger, more vigorous cells.

Could stem cell based therapies be the answer to unleashing the New Breed of Homo Sapiens?

Discover the answers in this exciting treatise, set for release, the spring of 2020.

Excerpts from New Breed of Homo Sapiens.

Stem Cells Determine Man’s Biological Age

Aging is a biological process that affects all living organisms. However, while the questions of why and how we age have baffled scientists for decades, the field of aging and longevity research have stayed in the back-burner for many years until not too long ago when it attracted the attention of some of the world’s most serious scientists. Today, medicines and therapies aimed at slowing down the process of aging and targeting age-related diseases are being developed, with some already launched in clinical trials in humans.

Aging is associated with the decline of all the physical and biological processes and functions over time. With the aim of slowing down the aging process, scientists have turned to studying stem cells for their regenerative abilities. However, while stem cells over potential solutions to retard or reverse the aging process, they also appear to be either the cause or part of the problem that cause aging. Stem cells, which are essential parts of the body’s repair system due to their ability to differentiate into many other cell types, lose their regenerative potency as our body ages. Additionally, their self-renewing ability triggers mutations that affect every cell in the body. And once these mutations accumulate they can lead to disease.

With money and investments continuously pouring in, the field of stem cell biology is still developing. However, focus has veered away from what scientists thought was stem cells greatest promise: that their ability to grow replacement organs and tissues that are damaged due to diseases or injuries. Today focused has shifted dramatically and researchers are now harnessing stem cells for their potentially powerful uses in modeling disease for drug discovery as well as in targeting treatment for personalized medicine. Using easily accessible cells – such as skin or blood – from the sick, researchers are reprogramming them into the affected tissue types and using them as models to study the disease and test interventions on major disorders, including heart disease, stroke, diabetes, and cancer, as well as rare conditions such as amyotrophic lateral sclerosis (ALS).

In addition, knowledge of stem cell biology is continuously evolving. Previous understanding was that once embryonic stem cells has differentiated into stem cells for muscle, skin, blood, and other tissue, those stem cells maintain their flexibility to further develop into various cells within the tissue, when required. Recent works, however, indicate that this ability may be more limited, with different stem cells possessing different capabilities, and or their capabilities diminished with age. If this were the case, then this would probably explain why aging varies from person to person. But the science of stem cell research is evolving, disease profiles are changing, and the tools of knowledge of physicians are readily at their disposal, more powerful and targeted. It would not be a far-fetched idea that one day the full potential of stem cell science will transform our biological landscape and the way humans develop and grow old.

Anti Aging and Stem Cells

A little over two decades ago, Dr. Michael West, stumbled upon a major scientific breakthrough when his lab scientists successfully isolated the active component for the gene that confers immortality to cells: the telomerase. Fast forward to today, when a new field has emerged: the science of longevity and healthspan, when people can live longer, free of age related diseases. Backed with substantial investments from some of the world’s largest companies, numerous pre-clinical researchers are developing and various clinical trials are underway, with the aim of developing therapeutics to target human aging and age related disorders.

While the biggest challenge for the field is the complexity of the aging process, scientists are making great progress in the context of individual aspects of aging with some of the most promising areas of research and discoveries in aging, which we are highlighting below:

Pluripotent stem cells have paved the way to manufacture young cells and tissue of any kind. Twenty years after the isolation of the first human embryonic stem cells, there is an explosion of research and applications all aimed at making different cell types of the human body.

Early human development could be the key that will unlock the mystery of aging. Cells possesses not only the ability to replicate, but to regenerate. There are animals in nature whose regenerative ability is never turned off — like the flatworm, which can grow back it’s head if it gets cut off, and it doesn’t show signs of aging either. Discovering and undertstanding how the cells regeneration ability gets turned on or off may unlock this mystery.

Companies are pouring in their resources into anti-aging research. Major companies are investing heavily in anti-aging research with the aim of devising interventions to slow down the aging process. Some of these companies are AgeX, a subsidiary of BioTime, Calico, AbbVie Inc., Unity Biotechnology, Samumed, Human Longevity Inc., RestorBio, Rejuvenate Bio, and Juvenescence, among others.

The majority of clinical applications will not be happening soon. However, despite the mad rush to develop potentially beneficial interventions, majority of these applications will require years of clinical trials before they can be made available to the populace.

There are very few medical interventions that are proven to slow the aging proves today. Because there is a huge marketplace out there, there are companies with claims of stem cell products that will extend your life. However, it is important to understand that they are likely not based on pluripotent stem cell technology or are products which are not approved by the FDA.

Ethical issues still hound this new science. Could genetic engineering be used one day to program longer lifespans by modifying or reprogramming human embryos? Despite advances in technology, people should take note that there remain major ethical issues regarding interventions aimed to prolong life. Dr. Michael West said that while it is entirely possible to engineer babies, but when you make modifications, it is an experiment, and you put a human life at risk.

Interventions in human aging face major cultural challenge. While aging affects all people of all races, we humans have adapted to the fact that death is part and the end of life, which people generally see as inevitable. This precept is anchored on different belief systems based on one’s culture and traditions.

Healthy children born today could enjoy a lifespan never before seen in human history. It is highly possible that in the foreseeable future, people will live up to at least 150 years of age. And as more advances and powerful therapies are designed and developed, the prospect of people enjoying longer and healthier lifespan is highly possible.

For more information and to reserve your copy, email: timelessentinc1@gmail.com

Experienced CEO Dr. Angel Iscovich Announces A New Book Titled Routineology


Dr. Angel Iscovich Routineology

Dr. Angel Iscovich, (Dr. I to his fans) an experienced CEO with professional experiences in various industries, is publishing a new book titled Routineology scheduled for summer, 2020. It is intended for audiences interested in the daily choices we make. Individuals can reserve their copy on his website: https://www.angeliscovich.com/

Routineology’s book suggests the best way to navigate our noisy new world is through rejecting novelty and instead creating our own “time bubble,” a mental barrier between the person and the world, comprising activities we use to occupy our days.

From his work in the medical and technology sectors, Dr. I developed a keen eye for tapping into the cultural zeitgeist. He’s been featured in Forbes, Entrepreneur, guested on Dr. Drew’s nationally syndicated radio show and appeared on the Dummies podcast.

His disruptive idea holds that people must carve out mental space to find meaning and purpose. This book will show us humans don’t just require structure but thrive in it.

As Dr. I explains, “The reality is, as biological organisms, our bodies and minds perform well when maintaining an equilibrium. We feel best when our environment is familiar and our lives possess consistency.”

About Dr. I:

Dr. Angel Iscovich was born in Buenos Aires, Argentina. As a young immigrant to the US, a world of opportunity led him to explore Philosophy and Medicine. Graduating with a Bachelor of Arts in Philosophy (Summa Cum Laude) from the University of Puget Sound brought him to the University of California San Francisco School of Medicine, and post graduate training in Psychiatry, and his interest in Human Behavior; most notably the focus on Emergency Medicine. He served as a part-time teacher and mentor as Associate Clinical Professor at USC Keck School of Medicine over a period of ten years at Los Angeles County Medical Center. Interest in leadership, organizational development, and strategy was exercised in the corporate health care sector over many years, as well as in philanthropy, serving most recently as the Chair of Direct Relief, the top-rated charity in the United States.

Those interested in receiving a copy of Routineology or wishing to know more about Dr. Angel Iscovich and his teachings, please call 805-698-9030 or email: iscoza@gmail.com.

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Leak Detection Associates to Serve as Technical Presenter at PDA Europe CCIT Training Course


Leak Detection Associates at PDF Europe - Helium Leak Detection

We are extremely excited to be part of this highly educational event to specifically represent a key test method for container and package integrity testing specific to USP 1207 requirements

Leak Detection Associates, the leading global supplier of helium based leak detection systems for the Pharmaceutical, Biotechnology and Medical Device Industries, is excited to announce that it will be a contributing instrument manufacturer and technical presenter at the Parenteral Drug Association (PDA) Container Closure Integrity Testing Basic Training Course. Held in conjunction with PDA Europe’s 10th Parenteral Packaging Conference, the two-day training program encompasses presentations on theory and real-life applications of all deterministic container closure integrity test (CCIT) technologies referenced in USP 1207. Critically, participating attendees are given the opportunity to witness demonstrations of actual instrumentation, with the unique opportunity for hands-on use in an engaging and learning-based environment.

The PDA 10th Parenteral Packaging Conference will be held in Basel, Switzerland on February 25th & 26th and the CCI specific training course is scheduled to follow on February 26th & 27th. Presenting on behalf of Leak Detection Associates will be Brian Mulhall, CEO and former Founder/President of Whitehouse Analytical Laboratories, while Jeff Morrow Lucas, LDA’s Director of Engineering, will host the hands-on technical training for attendees. In support of these technical presentations and hands-on activities, Leak Detection Associates will be providing its newest model, the SIMS 1915+ Helium Leak Detection System. Attendees will gain an understanding of how the system can be used to establish inherent integrity, optimize manufacturing, and more for a range of package systems and at extreme levels of sensitivity. LDA will also be featuring its new, low temperature add-on system that enables analysis of packages down to -80°C, critical for product-packages stored at these aggressive temperatures.

“We are extremely excited to be part of this highly educational event to specifically represent a key test method for container and package integrity testing specific to USP 1207 requirements,” commented Brian Mulhall, LDA’s CEO. “For more than 20 years, Leak Detection Associates has held a leadership role in the development and use of helium technology for container leak testing and having the opportunity to advance our knowledge and experience as part of a unique training seminar such as this will enable the value of helium leak testing to be shared with many relevant participants who are looking for CCI solutions in this highly regulated area.”

This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to apply these testing methods for CCI verification throughout drug product lifecycles. The course, as a whole, will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendial requirements. In this course, participants gain critical problem-solving skills through:


  •     Interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
  •     Hands-on testing training on the newest innovations and state-of-the-art instruments
  •     Real-world case studies

Being held in conjunction with the 10th Parenteral Packaging Conference, this training course will utilize lectures, case studies, and interactive hands-on training on testing instruments to provide insight into the latest developments of Container Closure Integrity (CCI) Testing. It is expected that participants will develop an understanding of the most up-to-date regulatory and pharmacopeia requirements on CCIT while learning how to define CCI requirements for various container and drug product types using a risk-based approach. The key focus will be on practical applications using the deterministic methods such as tracer gas detection (e.g. helium leak detection), electrical conductivity and capacitance (HVLD), vacuum decay leak detection, laser-based gas headspace analysis, and mass extraction leak tests. Other key topic areas to be covered include selecting and applying appropriate testing methods for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles, defining CCI testing method development and validation approaches and best practices, and avoiding common issues and pitfalls in CCI testing applications. To learn more about the conference and to register for attendance at this valuable training course, please visit http://www.pda.org.

About Leak Detection Associates, LLC

For over 20 years, Leak Detection Associates has been the premier manufacturer of custom helium leak detection instruments for the pharmaceutical, biotechnology, medical device and food packaging industries. LDA’s well-established technology has been incorporated into ASTM and compendial guidance documents. This robust industry experience, combined with the advanced capabilities of its newest model, the SIMS 1915+ helium leak detection unit, provides companies with tools to quantitatively evaluate leakage, improve the package development cycle, establish manufacturing controls, and ultimately reduce risk to the product and consumer throughout the lifecycle.

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Improved Pharma now offers the detection of small amounts of amorphous material in crystalline samples


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Overall, due to techniques developed in-house and also by our collaborators, Improved Pharma’s problem-solving capabilities now extend to determining the amount of amorphous materials in crystalline materials

Detecting a small amount of a crystalline component in a predominantly amorphous material is relatively straight-forward, but the reverse situation can be quite daunting. Over the years, several methodologies have been developed to address this challenge. Below, Improved Pharma describes some of these approaches and announces advances of their own and also that of one of their primary collaborators, Excelsus Structure Solutions. 

In several of the early SSCI courses on Pharmaceutical Solids, the late David Grant advanced the microcalorimetric method for analyzing the amorphous content of crystalline samples. This method required that the amorphous material crystallized with a detectable energy response. This method is still utilized today and is described in USP 696. With the advent of powerful Synchrotron X-ray powder diffraction (S-XRPD) methods, several new approaches for analysis for amorphous material in a crystalline phase have been developed.

Three methods are of particular interest: (1) Methods based on pattern analysis that typically use software for spectral pattern analysis, (2) PDF-based methods, and (3) controlled measurements of S-XRPD data. The spectral pattern analysis method utilizes standard patterns of the crystalline and amorphous phases collected on a Synchrotron. This software-based approach fits the crystalline and amorphous standards to the observed data and calculates a percentage amorphous material. The PDF method has been advanced by our collaborators, Excelsus Structure Solutions. Excelsus has recently demonstrated that it was possible to perform quantitative phase analysis on a mixture of poorly- and non-crystalline excipients via conventional S-XRPD and pair distribution function analysis, provided that the experimental setup, data collection and analysis strategy were carefully optimized. A third method, optimized at Improved Pharma, involves collecting Synchrotron X-ray diffraction data under certain controlled conditions, and then performing mathematical techniques on the data to provide the reliable detection of amorphous materials. Currently, this approach is qualitative in nature, allowing for the ranking of multiple samples for their relative amorphous content. Improved Pharma is further developing the technique to provide quantitative information.

A fourth method utilizing the publicly available program AMORPH has been utilized for inorganic samples. AMORPH utilizes a new Bayesian statistical approach to interpreting X-ray diffraction results of samples with both crystalline and amorphous components (see Rowe and Brewer in Computers and Geosciences). AMORPH fits X-ray diffraction patterns with a mixture of narrow and wide components, simultaneously inferring all of the model parameters and quantifying their uncertainties. Unfortunately, to date, this program has not been utilized for drugs or organic materials.

Overall, due to techniques developed in-house and also by our collaborators, Improved Pharma’s problem-solving capabilities now extend to determining the amount of amorphous materials in crystalline materials. Contact us for problems involving crystalline and amorphous materials.

About Improved Pharma

Improved Pharma is a research and information company dedicated to improving pharmaceutical methods, formulations, and processes. Dr. Stephen Byrn and Sarah Byrn founded the company in 2006 after the successful acquisition of their first company, SSCI. Dr. Pamela Smith joined the company in 2018 after an 18-year tenure with SSCI. Improved Pharma offers services such as analytical testing, synchrotron-based formulation design, and expert consulting aiding the development and defense of intellectual property matters.

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R3 Stem Cell Offering Complimentary Exosome Procedure at MSK Ultrasound Injection Course


msk ultrasound injection training course

MSK Ultrasound Injection Course Jan 26, 2020 in Las Vegas (844) GET-STEM

When a patient is receiving a regenerative therapy, it’s an investment on their part and the provider should make sure the biologic is accurately placed. Patients love seeing ultrasound being used, and at our training attendees also get a procedure too!

R3 Stem Cell is now offering attendees a free Exosome procedure at its MSK ultrasound injection courses. The next course is scheduled for January 26th, 2020 in Las Vegas at the M Resort.

Ultrasound guided injections are incredibly helpful for ensuring needle accuracy. The R3 ultrasound training course is hands on, where attendees will get to practice on real patients who have authentic joint arthritis and other pathologies. In addition, real procedures will be performed as well.

Now R3 is offering each attendee the opportunity to receive a procedure as well with exosomes. The biologic comes from an FDA regulated lab with a perfect safety record.

According to R3 Stem Cell CEO David Greene, MD, MBA, “When a patient is receiving a regenerative therapy, it’s an investment on their part and the provider should make sure the biologic is accurately placed. Ultrasound is great because it can also be used as a diagnostic tool! Patients love seeing ultrasound being used, and at our training attendees also get a procedure too.”

Both large and small joints will be taught. This includes the knee, hip, shoulder, elbow, wrist, ankle and more. A lot of the patients are military veterans, who receive procedures for free as part of the R3 Heroes Program. This will make the experience even more rewarding, as attendees will learn from their stories and associated joint abnormalities.

Signing up for the MSK ultrasound injection training course may be performed online at https://stemcelltrainingcourse.org/registration/ or by calling (844) GET-STEM. R3 offers combo deals if a person desires to also attend the Comprehensive Stem Cell Training Course, which occurs on the same weekend.

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