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Posts Tagged ‘Innovation’


Reporter: Stephen J. Williams, PhD

10:00-10:45 AM The Davids vs. the Cancer Goliath Part 1

Startups from diagnostics, biopharma, medtech, digital health and emerging tech will have 8 minutes to articulate their visions on how they aim to tame the beast.

Start Time End Time Company
10:00 10:08 Belong.Life
10:09 10:17 Care+Wear
10:18 10:26 OncoPower
10:27 10:35 PolyAurum LLC
10:36 10:44 Seeker Health

Speakers:
Karthik Koduru, MD, Co-Founder and Chief Oncologist, OncoPower
Eliran Malki, Co-Founder and CEO, Belong.Life
Chaitenya Razdan, Co-founder and CEO, Care+Wear @_crazdan
Debra Shipley Travers, President & CEO, PolyAurum LLC @polyaurum
Sandra Shpilberg, Founder and CEO, Seeker Health @sandrashpilberg

Belong Life

  • 10,000 cancer patients a month helping patients navigate cancer care with Belong App
  • Belong Eco system includes all their practitioners and using a trigger based content delivery (posts, articles etc)
  • most important taking unstructured health data (images, social activity, patient compilance) and converting to structured data

Care+Wear

personally design picc line cover for oncology patients

partners include NBA Major league baseball, Oscar de la Renta,

designs easy access pic line gowns and shirts

OncoPower :Digital Health in a Blockchain Ecosystem

problems associated with patient adherence and developed a product to address this

  1. OncoPower Blockchain: HIPAA compliant using the coin Oncopower security token to incentiavize patients and oncologists to consult with each other or oncologists with tumor boards; this is not an initial coin offering

PolyArum

  • spinout from UPENN; developing a nanoparticle based radiation therapy; glioblastoma muse model showed great response with gold based nanoparticle and radiation
  • they see enhanced tumor penetration, and retention of the gold nanoparticles
  • however most nanoparticles need to be a large size greater than 5 nm to see effect so they used a polymer based particle; see good uptake but excretion past a week so need to re-dose with Au nanoparticles
  • they are looking for capital and expect to start trials in 2020

Seeker Health

  • tying to improve the efficiency of clinical trial enrollment
  • using social networks to find the patients to enroll in clinical trials
  • steps they use 1) find patients on Facebook, Google, Twitter 2) engage patient screen 3) screening at clinical sites
  • Seeker Portal is a patient management system: patients referred to a clinical site now can be tracked

11:00- 11:45 AM Breakout: How to Scale Precision Medicine

The potential for precision medicine is real, but is limited by access to patient datasets. How are government entities, hospitals and startups bringing the promise of precision medicine to the masses of oncology patients

Moderator: Sandeep Burugupalli, Senior Manager, Real World Data Innovation, Pfizer @sandeepburug
Speakers:
Ingo ​Chakravarty, President and CEO, Navican @IngoChakravarty
Eugean Jiwanmall, Senior Research Analyst for Medical Policy & Technology Evaluation , Independence Blue Cross @IBX
Andrew Norden, M.D., Chief Medical Officer, Cota @ANordenMD
Ankur Parikh M.D, Medical Director of Precision Medicine, Cancer Treatment Centers of America @CancerCenter

Ingo: data is not ordered, only half of patients are tracked in some database, reimbursement a challenge

Eugean: identifying mutations as patients getting more comprehensive genomic coverage, clinical trials are expanding more rapidly as seen in 2018 ASCO

Ingo: general principals related to health outcomes or policy or reimbursement.. human studies are paramount but payers may not allowing for general principals (i.e. an Alk mutation in lung cancer and crizotanib treatment may be covered but maybe not for glioblastoma or another cancer containing similar ALK mutation; payers still depend on clinical trial results)

Andrew: using gene panels and NGS but only want to look for actionable targets; they establish an expert panel which reviews these NGS sequence results to determine actionable mutations

Ankur:  they have molecular tumor boards but still if want to prescribe off label and can’t find a clinical trial there is no reimbursement

Andrew: going beyond actionable mutations, although many are doing WES (whole exome sequencing) can we use machine learning to see if there are actionable data from a WES

Ingo: we forget in datasets is that patients have needs today and we need those payment systems and structures today

Eugean: problem is the start from cost (where the cost starts at and was it truly medically necessary)

Norden: there are not enough data sharing to make a decision; an enormous amount of effort to get businesses and technical limitations in data sharing; possibly there are policies needed to be put in place to assimilate datasets and promote collaborations

Ingo: need to take out the middle men between sequencing of patient tumor and treatment decision; middle men are taking out value out of the ‘supply chain’;

Andrew: PATIENTS DON’T OWN their DATA but MOST clinicians agree THEY SHOULD

Ankur: patients are willing to share data but the HIPAA compliance is a barrier

 

11:50- 12:30 AM Fireside Chat with Michael Pellini, M.D.

Building a Precision Medicine Business from the Ground Up: An Operating and Venture Perspective

Dr. Pellini has spent more than 20 years working on the operating side of four companies, each of which has pushed the boundaries of the standard of care. He will describe his most recent experience at Foundation Medicine, at the forefront of precision medicine, and how that experience can be leveraged on the venture side, where he now evaluates new healthcare technologies.

Speaker:
Michael Pellini, M.D., Managing Partner, Section 32 and Chairman, Foundation Medicine @MichaelPellini

Roche just bought Foundation Medicine for $2.5 billion.  They negotiated over 7 months but aside from critics they felt it was a great deal because it gives them, as a diagnostic venture, the international reach and biotech expertise.  Foundation Medicine offered Roche expertise on the diagnostic space including ability to navigate payers and regulatory aspects of the diagnostic business.  He feels it benefits all aspects of patient care and the work they do with other companies.

Moderatore: Roche is doing multiple deals to ‘own’ a disease state.

Dr. Pellini:  Roche is closing a deal with Flatiron just like how Merck closed deals with genomics companies.  He feels best to build the best company on a stand alone basis and provide for patients, then good things will happen.  However the problem of achieving scale for Precision Medicine is reimbursement by payers.  They still have to keep collecting data and evolving services to suit pharma.  They didn’t know if there model would work but when he met with FDA in 2011 they worked with Precision Medicine, said collect the data and we will keep working with you,

However the payers aren’t contributing to the effort.  They need to assist some of the young companies that can’t raise the billion dollars needed for all the evidence that payers require.  Precision Medicine still have problems, even though they have collected tremendous amounts of data and raised significant money.  From the private payer perspective there is no clear roadmap for success.

They recognized that the payers would be difficult but they had a plan but won’t invest in companies that don’t have a plan for getting reimbursement from payers.

Moderator: What is section 32?

Pellini:  Their investment arm invests in the spectrum of precision healtcare companies including tech companies.  They started with a digital path imaging system that went from looking through a scope and now looking at a monitor with software integrated with medical records. Section 32 has $130 million under management and may go to $400 Million but they want to stay small.

Pellini: we get 4-5 AI pitches a week.

Moderator: Are you interested in companion diagnostics?

Pellini:  There may be 24 expected 2018 drug approvals and 35% of them have a companion diagnostic (CDX) with them.  however going out ten years 70% may have a CDX associated with them.  Payers need to work with companies to figure out how to pay with these CDXs.

 

 

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Ultra-Pure Melatonin Product Helps Maintain Sleep for Up to 7 Hours

Curator: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, Hospital CEOs, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

 

The role of melatonin is important in regulating natural sleep and wake cycles. Typically, melatonin levels decline with age, significantly decreasing after age 40. An estimated 50 to 70 million Americans are affected by sleep difficulties – a process regulated by melatonin — and long-term sleep deprivation has been associated with negative health consequences, including an increased risk of diabetes, hypertension, heart attack, stroke, obesity, and depression.

Clinical data from a new pharmacokinetic study suggests that REMfresh®, the first and only continuous release and absorption melatonin (CRA-melatonin), helps maintain sleep for up to 7 hours. REMfresh® contains 99 percent ultra-pure melatonin and is sourced in Western Europe, a factor that is significant and important to many sleep specialists.

Three research abstracts on the REMfresh® data were published in an online supplement in the journal, Sleep, and were presented recently at the 31st Annual Meeting of the Associated Professional Sleep Societies LLC (APSS).

REMfresh Photo

Image SOURCE: Photograph courtesy of Physician’s Seal®

How REMfresh® Works

REMfresh® (CRA-melatonin) mimics the body’s own 7-hour Mesa Wave™, a natural pattern of melatonin blood levels during a normal night’s sleep cycle.

The study demonstrated the continuous release and absorption of 99 percent ultra-pure melatonin in REMfresh® (CRA-melatonin) was designed to induce sleep onset and provide continuous, lasting restorative sleep over 7 hours.

The scientifically advanced, patented formulation, called Ion Powered Pump (IPP™) technology, replicates the way in which the body naturally releases and absorbs melatonin, unlike conventional melatonin sleep products.

Since REMfresh® (CRA-melatonin) is not a drug, there is no drug hangover.

REMfresh MesaCurveNew-1

Image SOURCE: Diagram courtesy of Physician’s Seal®

 

Data Based on Scientifically Advanced Delivery Technology

According to the primary study author, David C. Brodner, M.D., “These study results represent an unparalleled breakthrough in drug-free, sleep maintenance that physicians and patients have been waiting for in a sleep product.” Dr. Brodner is a sleep specialist who is double board-certified in Otolaryngology – Head and Neck Surgery and Sleep Medicine and is the founder and principle physician at the Center for Sinus, Allergy, and Sleep Wellness in Palm Beach County, Florida.

Dr. Brodner said, “Melatonin products have been used primarily as a chronobiotic to address sleep disorders, such as jet lag and shift work. The patented delivery system in REMfresh mimics the body’s own natural sleep pattern, so individuals may experience consistent, restorative sleep and have an improved quality of life with this drug-free product.”

Study Findings With REMAKT

The study findings are based on REMAKT™ (REM Absorption Kinetics Trial), a U.S.-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults that compared REMfresh® (CRA-melatonin) with a market-leading, immediate-release melatonin (IR-melatonin).

The study found that melatonin levels with REMfresh® exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the leading IR-melatonin. Conversely, the levels of the market-leading IR-melatonin formulation dramatically increased 23 times greater than the targeted levels of exogenous melatonin for sleep maintenance and had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours.

Additional analysis presented showed that REMfresh® (CRA-melatonin) builds upon the body of evidence from prolonged-release melatonin (PR-M), which demonstrated in well-conducted, placebo-controlled studies, statistically significant improvement in sleep quality, morning alertness, sleep latency and quality of life in patients aged 55 years and older compared with placebo.

REMfresh® (CRA-melatonin) was designed to overcome the challenges of absorption in the intestines, thereby extending the continual and gradual release pattern of melatonin through the night (known as the Mesa Wave™, a flat-topped hill with steep sides). There was a faster time to Cmax, which is anticipated to result in improved sleep onset, while the extended median plateau time to 6.7 hours and rapid fall-off in plasma levels at the end of the Mesa Wave™ may help to improve sleep maintenance and morning alertness.

REFERENCE/SOURCE

Physician’s Seal® and REMfresh® (www.remfresh.com)

REMfresh® press release, June 5, 2017 (http://www.prnewswire.com/news-releases/scientifically-advanced-delivery-technology-in-sleep-management-debuts-at-sleep-2017-with-clinical-data-showing-remfresh-the-first-and-only-continuous-release-and-absorption-melatonin-helps-maintain-sleep-for-up-to-7-hours-300468218.html)

Dr. David C. Brodner, Center for Sinus, Allergy, and Sleep Wellness  (http://www.brodnermd.com/sleep-hygiene.html)

Other related articles published in this Open Access Online Scientific Journal include the following:

2017

Sleep Research Society announces 2017 award recipients including Thomas S. Kilduff, PhD, Director, Center for Neuroscience at SRI International in Menlo Park, California

https://pharmaceuticalintelligence.com/2017/04/28/sleep-research-society-announces-2017-award-recipients-including-thomas-s-kilduff-phd-director-center-for-neuroscience-at-sri-international-in-menlo-park-california/

2016

Sleep Science

Genetic link to sleep and mood disorders

https://pharmaceuticalintelligence.com/2016/02/27/genetic-link-to-sleep-and-mood-disorders/

2015

Sleep quality, amyloid and cognitive decline

https://pharmaceuticalintelligence.com/2015/10/31/sleep-quality-amyloid-and-cognitive-decline/

2013

Day and Night Variation in Melatonin Level affects Plasma Membrane Redox System in Red Blood Cells

https://pharmaceuticalintelligence.com/2013/02/23/httpwww-ncbi-nlm-nih-govpubmed22561555/

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Recent Breakthroughs in Cancer Research at the Technion-Israel Institute of Technology- 2015

Curator: Stephen J. Williams, PhD

Below are recent advances which occurred in 2015 on Cancer at the Technion-Israel Institute of Technology

including:

  • role of proteosome, metabolomics, cell signaling and ubiquitin system in cancer progression
  • partnerships with pharma and academic centers around the globe
  • development of early detection kits and novel therapeutic strategies including nanoparticle drug delivery systems

 

At: http://www.technion.ac.il/en/2015/04/breakthrough-in-cancer-research/

 

The ubiquitin system produces a protein that greatly restricts the development of cancerous tumors.

A new study by researchers at the Technion-Israel Institute of Technology could hold one key to control cancer cell growth and development. In a paper published in the April 9, 2015 edition of CELL, the team reports on the discovery of two cancer-suppressing proteins.

Distinguished Professor Aaron Ciechanover. Photographer: Dan Porges

Distinguished Professor Aaron Ciechanover. Photographer: Dan Porges

The research was conducted in the laboratory of Distinguished Professor Aaron Ciechanover, of the Technion Rappaport Faculty of Medicine. The team was led by research associate Dr. Yelena Kravtsova-Ivantsiv and , included additional research students and colleagues, as well as physicians from the Rambam, Carmel and Hadassah Medical Centers, who are studying tumors and their treatment.

The heretofore-undiscovered proteins were found during ongoing research on the ubiquitin system, an important and vital pathway in the life of the cell, which is responsible for the degradation of defective proteins that could damage the cell if not removed. The ubiquitin system tags these proteins and sends them for destruction in the cellular complex known as the proteasome.  The system also removes functional and healthy proteins that are not needed anymore, thereby regulating the processes that these proteins control.

Usually, the proteins that reach the proteasome are completely broken down, but there are some exceptions, and the current line of research examined p105, a long precursor of a key regulator in the cell called NF-κB. It turns out that p105 can be broken down completely in certain cases following its tagging by ubiquitin,  but in other cases it is only cut and shortened and becomes a protein called p50.

NF-κB has been identified as a link between inflammation and cancer. The hypothesis of the connection between inflammatory processes and cancer was first suggested in 1863 by German pathologist Rudolph Virchow, and has been confirmed over the years in a long series of studies. Ever since the discovery (nearly 30 years ago) of NF-κB, numerous articles have been published linking it to malignant transformation. It is involved in tumors of various organs (prostate, breast, lung, head and neck, large intestine, brain, etc.) in several parallel ways, including: inhibition of apoptosis (programmed cell death) normally eliminates transformed cells; acceleration of uncontrolled division of cancer cells; formation of new blood vessels (angiogenesis), which are vital to tumor growth; and increased resistance of cancerous cells to irradiation and chemotherapy.

The dramatic effect of these proteins on cancer growth: above the two tumors in the foreground (the control group) are tumors that express high levels of the proteins

The dramatic effect of these proteins on cancer growth: above the two tumors in the foreground (the control group) are tumors that express high levels of the proteins

As noted, the precursor p105 is “handled” by the ubiquitin system in one of two parallel and equally prevalent ways. It is either destroyed completely, or shortened and transformed to p50. The current research deciphers the decision-making mechanism that determines which process will be applied to the protein: when a ubiquitin system component called KPC1 is involved in the process and attaches ubiquitin to p105, the protein is shortened to become p50. When ubiquitination is mediated by another component of the system (and without KPC1), p105 is degraded.

The ubiquitin molecule within all living cells

The ubiquitin molecule within all living cells

The decision between these two options has significant implications on the cell, as the presence of high levels of KPC1 (which generates p50) and p50 (the product of the process) – with the accompanying disruption of the normal ratios between the processes – suppresses the malignant growth and apparently protects the healthy tissue. The current research was conducted on models of human tumors grown in mice, as well as on samples of human tumors, and a strong connection was discovered between the suppression of malignancy and the level of the two proteins, clearly indicating that the increased presence of KPC1 and/or p50 in the tissue can protect it from cancerous tumors.

Professor Ciechanover, who is also the president of the Israel Cancer Society, notes that many more years are required “to establish the research and gain a solid understanding of the mechanisms behind the suppression of the tumors. The development of a drug based on this discovery is a possibility, although not a certainty, and the road to such a drug is long and far from simple.”

Professor Ciechanover won the Nobel Prize in Chemistry in 2004 (jointly with Professors Avram Hershko – also from the Technion – and Irwin Rose, of the Fox Chase Cancer Center) for the discovery of the ubiquitin system. The current line of research is a continuation of that discovery.

Indian generic drugmaker giant Sun Pharma to work with Technion to explore new ways to fight tumors

By David Shamah April 17, 2015, 3:09 pm 10

President Reuven Rivlin and Indian Prime Minister Narendra Modi, March 29, 2015 (photo credit: Courtesty Tomer Reichmann)

President Reuven Rivlin and Indian Prime Minister Narendra Modi, March 29, 2015 (photo credit: Courtesty Tomer Reichmann)
President Reuven Rivlin and Indian Prime Minister Narendra Modi, March 29, 2015 (photo credit: Courtesty Tomer Reichmann)

 

Days after the Technion announced that a team led by Nobel Prize laureate Professor Aaron Ciechanover had discovered how proteins could be used to suppress cancer and control tumor growth and development, the institute revealed that it had entered into an exclusive agreement with India’s Sun Pharmaceuticals — the world’s fifth-largest specialty generic pharmaceutical company and India’s top pharmaceutical company.

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Under the agreement, researchers from the Technion and Sun will conduct studies on how high concentrations of two proteins can protect tissue from tumors. A study published in the medical journal Cell this week discussed how the proteins can suppress malignancies.

Along with Ciechanover, the research team included Dr. Gila Maor and Professor Ofer Binah. In a statement, Ciechanover said that the research held a great deal of promise of an effective drug for treating cancer, “although this is not a certainty, and the road to such a drug is long and far from simple.”

The deal with Sun is just one of several R&D ventures between Israel and India, on both the business and government levels. So far, the two countries have signed seven bilateral economic and R&D agreements, including one that fosters joint projects on space travel and satellite development.

 

NYU and Technion to forge ‘groundbreaking’ partnership in cancer research

On Wednesday night, they announced a $9 million gift from philanthropists Laura and Isaac Perlmutter that will fund two major, joint research endeavors with potentially far-reaching impact in advancing cancer research. The joint program aims at attracting additional, world-class support from institutions and individuals who are dedicated to eradicating cancer through focused and efficient research, they said in a joint statement.

The first $3 million of the grant will finance six cancer-focused research projects to be conducted by teams spearheaded by co-investigators from both NYU and the Technion. The remaining $6 million will be used to establish a state-of-the-art research facility on Technion’s campus that will support these and other research projects and focus mainly on the emerging field of cancer metabolomics.

“NYU Langone and the Technion have a shared, longstanding commitment to advancing cancer research,” said Dr. Dafna Bar-Sagi, senior vice president and vice dean for science at the New York hospital, chief science officer at NYU School of Medicine and a principal architect of the NYU Langone-Technion partnership.  “We are now at a great moment in our institutions’ illustrious histories, a point from which we can jointly leverage the talent and creativity of our researchers toward accelerating breakthroughs. The foresight and the generosity of the Perlmutters, particularly at this time of financial challenge in funding for basic research, will have tremendous impact.”

“Bringing together the unique expertise of researchers from both NYU and the Technion will hopefully enable us to overcome some of the most difficult challenges in treating cancer patients,” said Technion Prof.  Aaron Ciechanover, the 2004 Nobel Prize Laureate in Chemistry and Distinguished Research Professor and head of the David and Janet Polak Cancer and Vascular Biology Research Center at the Technion Faculty of Medicine.

Renowned cancer biologist Dr. Benjamin Neel, an expert in the field of cell signal transduction, recently joined the Langone faculty as director of the Perlmutter Cancer Center, and Dr. Eyal Gottlieb, a world leader in cancer metabolism, has been recruited to lead the new research facility at the Technion funded by the Perlmutter gift. Neel will work closely with Ciechanover to lead the collaborative cancer research effort between the two institutions, they said.

In addition, Neel will oversee at NYU the building of world-class translational programs in immunotherapy, cancer genetics/targeted therapies and epigenetics, imaging, as well as expanded programs in clinical care, community outreach and supportive oncology.

New technology for early detection of stomach cancer

The innovative method, developed at the Technion, identifies persons at risk for developing stomach cancer and for detecting tumors at an earlier stage. The prestigious journal Gut, which published the research, notes that the detection method is quick, simple, inexpensive and non-invasive.

Innovative gastric cancer-detection technology

Innovative gastric cancer-detection technology

Innovative gastric cancer-detection technology developed by the Technion can be used for the early detection of stomach cancer and for identifying persons at risk for developing the disease. The new detection method, based on breath analysis, has significant advantages over the existing detection technology: Gut reports that the new method is quick, simple, inexpensive and non-invasive.

Gastric cancer is one of the most lethal forms of cancer and in most cases, its diagnosis involves an endoscopy (the insertion of a tube into the esophagus, requiring that the patient fast and receive an intravenous sedative). Treatment is aggressive chemotherapy, radiation and the full or partial removal of the stomach. The disease develops in a series of well-defined steps, but there’s currently no effective, reliable, and non-invasive screening test for picking up these changes early on. Thus, many people succumb to stomach cancer only because it was not diagnosed in time.

The new technology, developed by Prof. Hossam Haick of the Wolfson Faculty of Chemical Engineering, can be used to detect premalignant lesions at the earliest stage, when healthy cells start becoming cancerous.

The research, published in Gut as part of the doctoral thesis of Mr. Haitham Amal, was conducted in conjunction with a Latvian research group headed by Prof. Marcis Leja, based on the largest population sample ever in a trial of this type. 484 people participated in the trial, 99 of whom had already been diagnosed with stomach cancer. All the participants were tested for Helicobacter pylori, a bacterium known to increase the risk for stomach cancer, and two breath samples were taken from each person.

The first sample from each participant was analyzed using the GCMS technique, which measures volatile organic substances in exhaled breath. The researchers noted that GCMS technology cannot be used to detect stomach cancer because the testing is very expensive and requires lengthy processing times and considerable expertise to operate the equipment.

The second breath sample was tested using nanoarray analysis, the unique technology developed by Prof. Haick, combined with a pattern recognition algorithm.

The findings:

  1. Based on the concentrations of 8 specific substances (out of 130) in the oral cavity, the new technology can distinguish between three groups: gastric cancer patients, persons who have precancerous stomach lesions, and healthy individuals.
  2. The new technology accurately distinguishes between the various pre-malignant stages.
  3. The new technology can be used to identify persons at risk for developing gastric cancer.
  4. The diagnosis is accurate, regardless of other factors such as age, sex, smoking habits, alcohol consumption and the use of anti-oxidant drugs.

In short, the nano-array analysis method developed by Prof. Haick is accurate, sensitive technology that provides a simple and inexpensive alternative to existing tests (such as GCMS). This new technology offers early, effective detection of persons at risk for developing stomach cancer, without unnecessary invasive tests (endoscopy). In order to assess the accuracy and effectiveness of the new, a wide-scale clinical trial is currently under way in Europe, with thousands of participants who have cancerous or pre-cancerous tumors.

About Prof. Hossam Haick

Prof. Hossam Haick, who joined the senior staff at the Technion Wolfson Faculty of Chemical Engineering in 2006, has been working since that year on the development of innovative, non-invasive technology for detecting cancer and other diseases. This technology is based on an “electronic nose” – an apparatus capable of detecting illnesses by analyzing a patient’s exhaled breath.

Prof. Haick, a native of Nazareth, completed his Ph.D. studies at the Technion by the time he was 27 and went to the Weizmann Institute of Science in Rehovot and Caltech Institute of Technology in California. He returned to the Technion in 2006 and his research group was awarded one million euros in grants by the European Union, which was very impressed by his research into artificial olfactory systems. Today he heads a consortium that includes Siemens and several universities, research institutes and companies in Germany, Austria, Finland, Ireland, Latvia and Israel. Since joining the senior faculty in the Chemical Engineering Department in 2006, Prof. Haick has won dozens of awards, grants and international honors. These include the Marie Curie Excellence Grant, European Research Council (ERC) grant and the Bill & Melinda Gates Award. Prof. Haick was nominated to MIT’s list of the 35 leading young scientists worldwide, received the Knight of the Order of Academic Palms, from the French Government and won the Hershel Rich Technion Innovation Award (twice), as well as the Tenne Prize for Excellence in the Science of Nanotechnology. He has also been recognized for his outstanding teaching skills and is the recipient of the Yanai Prize for Academic Excellence. In 2014, at the initiative of the president of the Technion, Prof. Haick headed an MOOC (Massive Open Online Course) in nanotechnology and nano-sensors that had an enrollment of 42,000.

meta

Early Warning of Cancer Metastasis

This month is Breast Cancer Awareness Month in Israel and around the world. Innovative technology developed at the Technion Faculty of Biomedical Engineering will enable the prediction of cancer metastasis after the appearance of breast cancer. The technology, whose efficacy has been proven in preliminary laboratory-trials, is entering into advanced testing using cells from patients undergoing surgery.

In contrast to benign cells (right), metastatic cells (left) penetrate into the gel and disappear inside it, thanks to their unique characteristics
In contrast to benign cells (right), metastatic cells (left) penetrate into the gel and disappear inside it, thanks to their unique characteristics

Assistant Professor Daphne Weihs recently achieved a research breakthrough: the unique technology that she developed – a biomechanical method for early detection of metastatic cancer – was approved by the Ethics Committee. This means that the technology that was found to be effective in tests on cell lines will advance to trials with tumor cells collected directly after surgery, in cooperation with Rambam Healthcare Campus.

According to Assistant Professor Weihs, the practical concept is that “during or immediately after a biopsy or surgery on a malignant tumor, the system will enable the medical team to quantitatively evaluate the likelihood of the presence or development of tumor metastases in other organs, and to propose which organ or organs are involved. Such knowledge will make it possible to act at a very early stage to identify and curb these metastases and, moreover, to prevent the primary tumor from metastasizing further.

Cancer is a general name for a wide family of diseases – more than 200 – whose common denominator is that the cell division rate becomes uncontrolled and the cells become immortal. In other words, the cancer mechanism disrupts the normal cell division process and converts it into “wild” and rapid division. Since the cells do not age and do not die, the original, primary tumor expands, invades and takes over more and more nearby tissue. In addition, apart from spreading to its immediate vicinity, a tumor that has become very aggressive “knows” how to send metastases to more distant tissues through the lymph and circulatory systems. Metastases (secondary tumors) are usually more dangerous than the primary tumor because it is difficult to identify them at their inception. When they are detected at an advanced stage, treating them medically is more complicated and the medical prognosis is typically not good.

“In fact, most cancer-related deaths are caused by metastases rather than by the primary tumor, and therefore vast resources are invested in developing methods for early detection of metastases,” explains Assistant Professor Daphne Weihs. “Early detection means timely and more effective treatment. The new approach that we are developing will enable early prediction of the likelihood of the formation of metastases and where in the body their development is probable. This prediction is based on identifying the biomechanics of the primary tumor cells, and does not require us to know the specific genetic makeup of the tumor.”

Mobile SniffPhone will detect cancer on a user’s breath

Diagnostic system developed by Technion professor is to pair with tiny smell-sensitive sensor that can go anywhere
By David Shamah February 3, 2015, 2:05 pm

A patient uses the NaNose breathalyzer (Photo credit: Courtesy Technion)

Writers
David Shamah

An innovative early disease detection system that uses the sense of smell is going mobile.

 

The NaNose breathalyzer technology developed by Professor Hossam Haick of the Technion will soon be installed in a mobile phone – to be called, appropriately, the SniffPhone. A tiny smell-sensitive sensor will be installed onto a phone add-on, and using specially designed software, the phone will be able to “smell” users’ breath to determine if they have cancer, among other serious diseases.

By identifying the special “odor” emitted by cancer cells, the NaNose system can detect the presence of tumors, both benign and malignant, more quickly, efficiently and cheaply than previously possible, said Haick.

“Current cancer diagnosis techniques are ineffective and impractical,” he said. NaNose technology, he said, “could facilitate faster therapeutic intervention, replacing expensive and time-consuming clinical follow-up that would eventually lead to the same intervention.”

According to research done by Haick’s team, the NaNose system has a 90 percent accuracy rate.

The smartphone device is just a vehicle to implement the NaNose technology that can be taken anywhere and used in any circumstances, including in rural areas of the developing world where bringing in sophisticated testing equipment is impossible.

The plan calls for a chip with NaNose technology to be installed in a device that is attached to a smartphone, and for an app to read the sensor data, analyzing it on the device or uploading it to the cloud for processing.

NaNose technology will be especially useful in battling lung cancer, said Haick. According to US government statistics, lung cancer kills more Americans annually than the next three most common cancers — colon, breast, and pancreatic — combined. The reason, doctors say, is because lung cancer is so difficult to detect. Currently, the only way to detect early-stage lung cancer is through an extensive process involving blood tests, biopsies, CT scans, ultrasound tests, and other procedures — and even then, detection is difficult.

“Mostly the patient arrives for diagnosis when the symptoms of the sickness have already begun to appear,” said Haick, describing the drawbacks in current detection protocols. “Months pass before a real analysis in completed. And the process requires complicated and expensive equipment such as CT and mammography imaging devices. Each machine costs millions of dollars, and ends up delivering rough, inaccurate results.”

Dr. Hossam Haick (Photo credit: Courtesy)

Dr. Hossam Haick (Photo credit: Courtesy)

 

The NaNose-based system, on the other hand, doesn’t require anything more than a patient’s breathing into the device in order to come up with an initial diagnosis. Lung cancer tumors produce chemicals called volatile organic compounds (VOCs), which easily evaporate into the air and produce a discernible scent profile. Haick’s NaNose chip detects the unique “signature” of VOCs in exhaled breath. In four out of five cases, the device differentiated between benign and malignant lung lesions and even different cancer subtypes.

The project is being funded by the European Commission, which has given the consortium developing it a six million euro grant. The developers include universities and research institutes from Germany, Austria, Finland, Ireland and Latvia, as well as Irish cell biology research firm Cellix, with the NaNose system the centerpiece of the technology. That Israeli-developed component will be delivered by an Israeli start-up called NanoVation-GS, a spinoff of the Technion. Professor Haick serves as the start-up’s Chief Science Officer.

“The SniffPhone is a winning solution. It will be made tinier and cheaper than disease detection solutions currently, consume little power, and most importantly, it will enable immediate and early diagnosis that is both accurate and non-invasive,” said Haick. “Early diagnosis can save lives, particularly in life-threatening diseases such as cancer.”

 

Nanotech Drug Delivery Method For Cancer Could Replace Conventional Chemotherapy

By NoCamels Team March 03, 2015 5 Comments

at http://nocamels.com/2015/03/nanotech-drug-delivery-method-cancer-replace-chemotherapy-eliminate-side-effects/

Anyone who knows a person in the midst of chemotherapy is aware that anti-cancer drugs often take a very harsh toll on the body. This is one reason scientists have been trying to develop improved means of drug delivery for years. Now, a Technion research team discovered a way to improve drug delivery to tumors using Nanostructured Porous Silicon (PSi) particles (instead of an IV drip), a method that’s emerging as a promising new platform for drug delivery. In the future, PSi could be used in cancer treatments, potentially offering an alternative to traditional chemotherapy, which is notorious for its agonizing side effects.

The silicon “carriers” used in this study to deliver chemotherapy drugs behave differently in cancerous tumors than they do in healthy tissues. Therefore, the findings could help scientists to design nano-carriers that deliver drugs to tumors, instead of treating patients with traditional, intravenous chemotherapy. However, it would take years to develop and apply this new type of drug delivery method, which would potentially be taken orally.

     SEE ALSO: Study: How To Make Chemotherapy Side-Effects Less Deadly

So far, these nano-silicon “containers” have been studied in vitro – outside of a living organism – rather than in an environment that behaves more closely to that of a tumor in a cancer patient’s body. The Technion research team looked at what happens to PSi particles when they’re injected into the area around the tumor in mice. The significant differences in the area around a cancerous growth and regular healthy tissue have been widely described and studied; however, the effect on these porous silicon “containers,” or carriers, was unknown until now.

Prof. Ester Segal of the Technion – Israel Institute of Technology, who led this joint study with the Massachusetts Institute of Technology (MIT) and the Harvard Medical School, said the team has “shown for the first time that bio-materials in general, and Nanostructured Porous Silicon in particular, behave differently when they are injected (or implanted) at the tumor micro-environment.”

Revolutionizing cancer treatments

Silicon materials could revolutionize treatments in a way that no existing drug delivery does. Prof. Segal tells NoCamels that the silicon containers “could deliver drugs over a long period of time – weeks or even months”, something no existing chemotherapeutic delivery mechanism can do currently.

cancer cells

Cancer cells

The special properties of these porous nano-silicon carriers lie in their large surface area, which can ferry many or large drug molecules. Additionally, due to their biodegradability they’re able to break down into harmless silicic acid, which is expelled through urination. They are also biocompatible, so they do not stimulate any inflammation or clotting. Another benefit to these nano-silicon containers is their versatility. They can be ingested, injected or implanted, and they can be designed to carry a wide range of dosage sizes. In the process of their study, lab members also developed an approach to determining how biomaterials will react in settings more similar to their eventual clinical purpose – treating cancer, for example.

     SEE ALSO: Israeli Researchers Create ‘Trojan Horse’ Of Chemotherapy

In a separate study, Tel Aviv University scientists recently found a strategy that would stop brain tumor cell proliferation with similar nano-particles. “It is a basic, elegant mechanism and much less toxic than chemotherapy,” TAU’s Prof. Dan Peer said in a statement.

These works underline the importance of such studies in successfully developing bio-delivery materials that will have therapeutic benefits in the near future.

The ‘Magic Bullet’ of Chemotherapy

http://www.technion.ac.il/en/2015/03/the-magic-bullet-of-chemotherapy/

“Nano-skeletons’ (in red) delivered to human tissue infected by prostate cancer. The infected cells are colored in blue (PIP) and green (cytoplasmic); it is possible to see how the ‘nano-skeletons’ reach them

“Nano-skeletons’ (in red) delivered to human tissue infected by prostate cancer. The infected cells are colored in blue (PIP) and green (cytoplasmic); it is possible to see how the ‘nano-skeletons’ reach them

Florida native Dr. Beth Schoen, is part of a team developing a novel platform for delivering anti-cancerous drugs directly to its mark as part of her postdoctoral research at the Technion

Beth Schoen, born in Hollywood Florida, came to the Technion to conduct her postdoctoral research at age 26. In her very limited spare time she plays soccer for the leading all women’s soccer team – Maccabi Hadera – and studies Hebrew. “The Hebrew thing is no simple matter,” she confesses, “but I’m willing to make the effort, because it’s clear to me that Israel is where I want to live.”

Dr. Beth Schoen completed her undergraduate degree at the University of Florida, and her doctorate at Michigan State University in chemical engineering. “My doctoral studies focused on synthetic organic chemistry, particularly on the development of polymers with unique thermodynamic attributes especially resistant to high temperatures. These types of materials are used in part for the production of jet engine parts, body armor and Nomex (used for making fire-resistant gloves and overalls). One of our tasks was to create soft sheets that were not brittle, to be worn to be both bulletproof and fire resistant. It was a theoretical study, but as part of the process I also produced some of these polymers and tested them.”

Dr. Schoen planned to come to the Technion as part of her doctoral studies, but, she adds, “It didn’t work out, so I started to check where I could best fit in here in my future studies.” She decided to join Prof. Marcelle Machluf’s laboratory, at the Faculty of Biotechnology and Food Engineering, “I was eager to move from chemistry to biology and pursue cancer research in particular. I was very glad for the tremendous opportunity that Marcelle gave me in taking me on – perhaps it was because of my experience in nanomaterials and polymers.”

Prof. Marcelle Machluf’s research team consists of 17 female and 3 males students, researchers and technicians working on two main projects: (1) the development of scaffolds to rehabilitate damaged heart-tissue, and (2) the development of new technology to deliver drug treatment to damaged (sick) tissue (specifically related to cancer therapy). In an interview with her she focused on the second project.

“The current treatment for cancer involves radiotherapy and chemotherapy usually administered through intravenous infusion. The cancer drugs available are extremely effective, yet the way they are put to use in present day treatment, they also cause damage to healthy tissues. These are very potent drugs – they are intended to kill cancer cells – and on their way they also end up killing healthy ones.”

“The greatest damage is caused to rapidly dividing cells, which are similar to cancer cells. Hair follicle cells, for example, are a type of rapidly dividing cells and they damage easily from these types of treatment, which explains the hair loss in patients undergoing chemotherapy. Other side-effects include nausea and hearing loss, sometimes even leading to deafness. The drug Cisplatin for example, is a type of chemo drug used to treat various types of lung and breast cancers; some of its side-effects include damage to renal and immune system functioning, putting patients at risk to infections and diseases.”

These impediments are what fuel Prof. Machluf’s drive to develop a new drug delivery platforms capable of delivering anti-cancer drugs directly to the tumor without damaging healthy tissues on its way. “This is the top priority of cancer treatment: to develop a ‘magic bullet’ that target cancer cells,” explains Prof. Machluf. “And our new platform may be the solution to this great challenge.”

The new platform is based on ‘depleting’ specific cells – mesenchymal stem cells – so that there is nothing left of them save for the membrane. This membrane, called a ghost cells can be down sized to nano-vesicles, termed nano-ghosts, which can be loaded with any drug and delivered by injection directly into the blood stream. The immune system falls for the trap and does not recognize the ‘intruder,’ instead it treats these cells as if they were naturally part of the system and sends them to the afflicted area. On the way to their target they do not release the drug they are carrying and therefore do not do any damage to healthy tissues. Only upon reaching the malignant tissue, which they know how to identify, do they break down and secrete their contents at the site of the tumor cells.

This original idea was tested in a long series of experiments, and the results are very impressive: these nano-ghosts are in fact tumor selective, no matter the type of tumor. They ‘dash’ straight to the malignant tissue without emitting their drug on the way and without damaging healthy cells. Moreover, this unique ‘parcel’ increases the effectiveness of the treatment by ten-fold. Animal studies have shown that the employment of nano-ghosts for anti-cancer drug delivery have led to an 80% delay of prostate cancer – an unprecedented rate.

Still, there is a lot of work ahead, as Prof. Machluf’s research team works on improving the mechanism of this novel new platform: some of them are focusing on compatibility with specific drugs while others, like Dr. Beth Schoen, are concentrating on improving the nano-ghosts “This platform must be very precise,” explains Schoen. “It must be able to endure travelling through the entire human body, and release its contents only inside the tumor.”

The research is being carried out in collaboration with the Russell Berrie Nanotechnology Institute.

For a Full Report From the President of Technion on all Innovations Occurring at Technion during 2015 please click below

http://pard.technion.ac.il/view-the-report/

Other Resources

http://www.technioncancer.co.il/ResearchGroups.php
http://www.ats.org/site/PageServer?pagename=about_research_cancer
http://www.technioncancer.co.il/lab.php?id=3

http://www.rappaport.org.il/Rappaport/Templates/ShowPage.asp?DBID=1&TMID=610&FID=77&PID=0&IID=1268 

Governor Cuomo Delivers Remarks at Zuckerman Scholars Program in STEM Leadership

Other related articles on Cancer Research @Technion were published in this Open Access Online Scientific Journal, including the following:

Medical Breakthrough: Israeli Researcher Predicts Where Cancer Will Spread

Pancreatic Cancer at the Crossroads of Metabolism

Next-generation Universal Cell Immunotherapy startup Adicet Bio, Menlo Park, CA is launched with $51M Funding by OrbiMed

Solutions for Multiple Myeloma – a cancer formed by Malignant Plasma Cells: Collaboration of NYU and Technion Integrative Cancer Center

List of Breakthroughs in Cancer Research and Oncology Drug Development by Awardees of The Israel Cancer Research Fund

Biomarkers of Cancer detected by BreathAnalyzer – An Collaborative effort of three Universities

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Supporting Open Innovation in Pharmaceuticals

Curator: Larry H. Bernstein, MD, FCAP

 

 

Compound Passport Service: supporting corporate collection owners in open innovation
David M. Andrews1 ,Sebastien L. Degorce1 , David J. Drake2 , Magnus Gustafsson3 , Kevin M. Higgins2 and Jon J. Winter1
   1 Oncology iMed Chemistry, AstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TF, UK 2 R&D Information, AstraZeneca, Mereside, Alderley Park, Macclesfield SK10 4TF, UK 3 R&D Information, AstraZeneca, Pepparedsleden 1, 431 83 Molndal, Sweden
A growing number of early discovery collaborative agreements are being put in place between large pharma companies and partners in which the rights for assets can reside with a partner, exclusively or jointly. Our corporate screening collection, like many others, was built on the premise that compounds generated in-house and not the subject of paper or patent disclosure were proprietary to the company. Collaborative screening arrangements and medicinal chemistry now make the origin, ownership rights and usage of compounds difficult to determine and manage. The Compound Passport Service is a dynamic database, managed and accessed through a set of reusable services that borrows from social media concepts to allow sample owners to take control of their samples in a much more active way.
The challenges of discovering and developing novel therapeutics have been well documented [1]; and the combination of the ‘low hanging fruit’ of drug targets having been picked off [2] along with the challenge to maintain the pace of new discovery has led to an increase in the complexity of targets and disease pathways in discovery portfolios. Additionally, the pharmaceutical industry has realigned resources away from early R&D [3], making industry more reliant on collaboration with academic groups to share the risks (and rewards) of conducting discovery and early validation efforts [4].  
These efforts are frequently captured under the generic term ‘open innovation’, first coined by Henry Chesbrough in 2003 [5]. Since then, a huge variety of definitions for open innovation have been suggested; the authors prefer the definition adopted by the Wellcome Trust: ‘The process of innovating with others for shared risk and reward to produce mutual benefits for each organisation, creating new products, processes or ideas that could not otherwise have been achieved alone, or enabling them to be achieved more quickly, cheaply or efficiently’ [6].  
We found that in AstraZeneca (AZ), as is the case across the pharmaceutical industry [7], many more collaborative agreements were being put in place in which the rights for assets could reside with a partner, exclusively or jointly. With more opportunities being investigated to take advantage of our in-house assets, we needed to improve our ability to ensure that compounds subject to a contractual agreement with third parties are managed and used in accordance with AZ’s obligations. Such agreements could mean compounds should be restricted to agreed tests and/or prevented from being shared with other parties.
The problem: compound rights tracking   Many corporate screening collections have been built on the premise that collection members that had been generated in house and were not the subject of paper or patent disclosure were proprietary to the company. Collaborative screening arrangements [8] and medicinal chemistry [9,10] now make the origin, ownership rights and contractually governed usage of compounds difficult to determine and complex to manage. When we looked at the compound management tools available within our own organization (or those available from vendors) we found that, in general, solutions were monolithic one-size-fits-all packages and lacked the information granularity necessary to answer key questions around compound-asset rights: compound and sample restrictions were either single sample or all examples from a project; delegation of approval was difficult and all approval was manual; approval tracking and compliance monitoring was difficult and error-prone; in consequence it was difficult to provide partners with a record of requests for ‘their’ samples.  
The root cause was that the design of the compound asset infrastructure predated the emergence of shared risk, collaborative, open innovation projects and the infrastructure had been designed against a background where there was a presumption that a company could solely own the rights to the portion of its compound library that was not in the public domain. Together, this created the risk that AZ scientists could unwittingly release the structures of early-stage hits to collaborators that were already the subject of an agreement with another collaborator. Put simply, the infrastructure of material transfer agreements and confidential disclosure agreements was very good at tracking the supply of single compounds but could not cope with the tens to thousands of compounds that needed to be correctly tracked as a result of open innovation collaborations. We aimed to design a dynamic database, managed and accessed through a set of reusable services that borrowed from social media concepts to allow sample owners to take control of their samples in a much more active way. Our design is driven by the vision that a greater number of collaborative agreements are being put in place and that, within those agreements, compound rights can be shared or reside with AZ or the collaboration partner. In turn this drove the need to improve our ability to keep our contractual agreements and progress compounds through approval flows in a timely and efficient manner. In addition to making it easy to record and update details of collaborations, we wanted simply and quickly to add, edit and remove compound assets, as well as to provide fast, reliable and automated approval where possible or to alert approvers where a manual approval is required. Finally, we wanted scientists to be able to determine compound status easily; able to request approval to take specific actions (e.g. testing) within the context of a system that maintained a permanent record.  
For the service to function correctly, for each open innovation compound, three pieces of information (metadata) need to be captured and kept up-to-date: (i) who owns any rights to the compound – AZ, the partner or are the rights shared? (ii) Can the compound be tested freely within AZ or does the collaboration agreement indicate that a collaboration coordinator needs to approve test requests? (iii) Has the compound been provided to the partner structure-blinded or has the compound structure been shared with the partner? The service can control ‘trafficking’ as well as maintain a permanent compound ‘life history’. It can be interrogated and receive updates via calls from other systems. Hence, we refer to it as the Compound Passport Service (CPS). Our shared vision and understanding of the underlying metadata allowed us to formulate the main concepts of the system and associated ‘use cases’.  
System concepts and use cases   CPS centres on assets, which are entities reflecting agreed constraints of compound usage by third parties and are grouped together in asset rights groups (ARG). Additionally, an ARG is a group of rights and rules applied to a number of assets. For each ARG a number of roles can be defined: coordinator – sets up and manages the ARG; delegate – a deputy for the coordinator who can add or remove approvers and add or update assets; approver – a person able to approve or reject requests manually, when the system is unable to make an automatic decision. For each ARG it is also possible to delineate request rules that define which requests can be automatically approved or rejected (e.g. that all compounds within an ARG can be tested in a specific test without any manual approval needed). A user in another system that is fully integrated with CPS becomes a requester when asking for approval to perform a specific action, for example to run a test on a specific compound and CPS responds with the following: ‘approved’, ‘rejected’ or ‘manual approval needed’ (Fig. 1).   This structure provides a framework that allows users to take control of their compounds in real-time and in a very granular way. It also has the potential to speed up the flow of compounds through the design-make-test-analyse (DMTA) cycle [11] by giving users the option to set up rules for automatic approval or rejection of tests. To enable these goals, we considered seven critical scenarios (use cases) that the system needed to service (Table 1).  
FIGURE 1   Compound Passport Service (CPS) concepts and definitions. The CPS is based upon assets, which are entities reflecting agreed constraints of compound usage by third parties, and are grouped (together with the rights and rules applying to the assets) in asset rights groups (ARG). For each ARG a number of roles are defined: coordinator – sets up and manages the ARG; delegate – a deputy for the coordinator who can add or remove approvers and add or update assets; approver – a person able to approve or reject requests manually. Within each ARG it is also possible to delineate request rules that define which requests can be automatically approved or rejected. A user in another system that is fully integrated with the CPS becomes a requester when asking for approval to perform a specific action; the CPS responds with the following: ‘approved, ‘rejected’ or ‘manual approval needed.
More-efficient approval flows and search  
The CPS was designed to manage complex compound sharing rules and requirements over the entire lifecycle of a collaboration project. The following is a case history of a recent project that was used to help design a system with the flexibility required. A collaboration project had two chemical series: A and B. Series A originated from screening of the AZ compound collection, and samples were tested by the partner organization in a structure blind format. Synthetic optimisation was performed by AZ but the compounds were never judged to be of sufficient selectivity to merit sharing with the partner. Owing to their origin in a collaboration project, however, series A compounds were not permitted to be tested outside the originating project. Later, the compounds were of no further interest to the project and permitted to be used by AZ projects for any purpose.  
Series B originated from the partner organization, and samples were initially shared for testing by AZ in a structure-blind format. After some months of optimization, the chemical structures were shared with AZ but the ownership of the compounds was retained by the partner. Later still, the series was judged of sufficient quality for the intellectual property to be shared jointly between the two organizations. Finally, after the biological target hypothesis was invalidated, notional ownership of the compounds was returned to the partner organization and no further testing was permitted by AZ (Fig. 2).  
FIGURE 2   The Compound Passport Service (CPS) can be used to manage an asset throughout its lifecycle. In this case study, at the start of the collaboration, compounds were tested at AstraZeneca (AZ) and the collaborator structure-blinded. Over the course of research, SAR failed to develop in series A which became of no further interest and was retained by AZ. Series B provided very productive SAR and, through the course of the collaboration, compound properties were updated in the CPS to note initially that the structures had been shared with AZ, then ownership became shared and therefore the series B compounds were unlocked and freely available for test across both organisations (the figure shows the initial collaboration status).
All of the compound status changes in this scenario are mapped on to three key properties that are captured by the CPS (Table 2). The owner of the ARG is able to change the properties of individual or groups of compounds as required, independently, as the project evolves. Such changes are recorded with time stamps as ‘transitions’, and can be tracked over the lifetime of an ARG. The ability to track all such transitions increases the transparency of compound ownership to AZ and partner organizations, prevents un-authorised testing of samples by other project teams within AZ and enables questions of the provenance of compounds to be easily resolved.    When placing test requests in a dedicated in-house requesting tool, the CPS is called and the sample status is displayed. Users might be presented with a warning that corresponding samples are subject to approval. Depending on the permission status, the requester can either decide to seek approval or cancel their tentative requests. Extreme cases such as auto-rejection (strictly no testing) or auto-approval (green list) are dealt with instantaneously, whereas manual approvals are immediately sought with daily reminders being sent to the approver until a response is obtained. A feature much appreciated by users is that the system sends an approval email to authorisers giving them the full context of the requests to ensure efficient decision making rather than having to access the CPS to gain the wider context.  
Green lists (leading to auto-approvals) are crucial to ensure no impact of sample restrictions on the DMTA cycle. In the case of required manual approvals, the impact of delay is minimised by the creation of project delegates. Green list assays refer to tests agreed with the partner and typically include project assays [primary target, selectivity, in vitro drug metabolism pharmacokinetics (DMPK), among others]. Similarly, a green list of requesters typically includes project members who are fully aware of the collaboration. Delegates have the same approval rights as primary authorisers and requests come to all independently, so that the first person to approve them releases the samples for testing.
Interface with other services   The envisioned central role and future extensibility of asset rights management led to the rapid conclusion that the compound passport solution needed to be delivered as a service [12]. The adoption of a service-orientated architecture has provided a flexible and reusable set of business services that provide access to and management of the compound passport database. Additional commodity services provide master data for projects, people and compounds (Fig. 3).
FIGURE 3   Service-orientated architecture provides a flexible and reusable set of business services that provide access to and management of the Compound Passport Database. Additional commodity services provide master data for projects, people and compounds. In this way, the Compound Passport Service (CPS) sits at the centre of a web of independent services controlling compound registration, distribution and test approval. Utilisation of reusable services allows integration with new systems as they become available in the future.
….
Impact on open innovation   Since the CPS was launched in 2014, it has been uploaded with metadata relating to 15,000–20,000 assets, and compounds are being added almost daily. The ability to track ownership rights along with more-efficient test approval has already enabled faster and more-efficient approval flows. Additionally, in considering whether to unblind the structure of a HTS hit series, we have also been able to identify that more than one external party had an interest in the chemical equity. Based upon an understanding that SAR would probably diverge as potency against the different targets was optimised, we have been able to adopt a risk-management approach to allow both partners to proceed with the investigation and possible optimization of the shared chemical start point.
……

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Medical Breakthrough: Israeli Researcher Predicts Where Cancer Will Spread

Reporter: Evelina Cohn Budu, PhD

 

An innovative technology developed in Israel may soon be able to predict the spread of cancer from one organ to another, potentially saving the lives of millions of people around the world.

The technology, developed at Israel’s Technion – Israel Institute of Technology, has been proven in preliminary laboratory trials, and is now entering into advanced testing using cells from patients undergoing surgery.

Assistant Professor Dr. Daphne Weihs has developed a unique biomechanical method for the early detection of metastatic cancer (a cancer that has already spread). At the metastatic stage, the original, primary tumor expands, invades and takes over more and more nearby tissue. A tumor that has become very aggressive “knows” how to send metastases to more distant tissues through the lymph and circulatory systems.

Metastases (secondary tumors) are usually more dangerous than the primary tumor because it is difficult to identify them at their inception. When they are detected at an advanced stage, treating them medically is more complicated and the medical prognosis is typically not good.

proteinattackscancercell

Photos: Courtesy of the Technion

cancer-cells-

Photos: Courtesy of the Technion

ABOUT THE RESEARCHER

Daphne Weihs , Assistant Professor

Affiliation: Faculty

Link to Lab Web Page:

 

SOURCE

http://nocamels.com/2015/10/israeli-researcher-predicts-spread-cancer/?utm_source=activetrail&utm_medium=email&utm_campaign=nc4/11/15

 

REFERENCES

New Israeli Cancer Vaccine Triggers Response In 90% Of Cancer Types

By Jonathan Neff, NoCamels.com January 01, 2015

http://nocamels.com/2015/01/new-vaccine-for-cancer/

How Elephants’ Genes Are Fighting Cancer In Humans

By Lauren Blanchard, NoCamels October 18, 2015

http://nocamels.com/2015/10/how-elephants-genes-are-helping-fight-cancer-in-humans/

Other related articles published in this Open Access Online Scientific Journal, include the following:

 

https://pharmaceuticalintelligence.com/?s=metastasis

 

Please place here FIVE articles from above link

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Podcast Review: Quiet Innovation Podcast on Obtaining $ for Your Startup

Reporter: Stephen J. Williams, Ph.D.

I wanted to highlight an interesting interview (What it Really Takes to Get Money for Your Startup) with David S. Rose, serial entrepreneur and Founder and CEO of Gust.com, which is a global collaboration platform for early stage angel investing, connecting hundreds of thousands of entrepreneurs and investors in over 75 countries. The interview with David and CFA John P. Gavin was broadcast on the podcast Quiet Innovation (from PodCast Addict @Podcast_Addict) from. I had tweeted it out on my Twitter account below (see the http link)

 

… but will include some notes from the podcast here. In addition you can link to the podcast directly using the links below:

QI-013 David Rose Interview_01.mp3

Or download the mp3

http://t.co/XPjLrJQG7O

This post is a followup from yesterday’s post Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting.

Some highlights from the podcast

  • IDEAS DON’T GET FUNDED

David Rose discusses how there are hundreds of thousands of new ideas, some which are great some which are not… having an idea may be an initial step but for an investor to even consider your idea it is more important to have

  • EXECUTION

This is what David feels is critical to investors, such as himself, to decide whether your idea is investable. A startup needs to show they can accomplish their goal and show at least a rudimentary example of this, whether it is putting up a website or writing up a design blueprint for a new widget. He says starting a business today (either tech or manufacturing) requires a lot less capital than years ago (unless you are starting a biotech). He gives an example of internet startups he had founded in the 90’s versus today… in the 90’s you needed $2 million… today you can do it for $2,000. But the ability to show that you can EXECUTE this plan is CRITICAL.

David sites three aspects which are important to investors:

  1. Integrity – Be humble about yourself. He says there are way too many people who claim ‘our idea is the best’ or ‘we do it better than anyone’ or ‘we are the first to have this idea’. As he says Jeff Bezos of Amazon was not the first to have the idea of selling books over the internet, he just EXECUTED the plan extremely well.
  2. Passion- Investors need to see that you are ‘all in’ and committed. A specific example is angels asking how much money have you put into your idea (skin in the game)
  3. Experience- David says there are TWO important types of experience in developing startups and both valid. The first is how many startups have you done and succeeded and the second is how many startups have failed. He says investors actually like if you have failed because they are learning experiences, just as valuable if not more than having startups always succeed. Investors need to know how you can deal with adversity. All three points goes back to execution.

David Rose gave some reading suggestions as well including

Lucky or Smart? Secrets to an Entrepreneurial Life by Bo Peabody – He highlights this book to help people understand that a startup entrepreneur should always hire someone smarter than themselves.

Derek Sivers post Ideas Are Just a Multiplier of Execution  – where a great idea is worth $20 but a great idea plus execution is worth $20 million.

Eris Reese’s post The Lean Startup in his blog StartUpLessonsLearned – being frugal (gets back to what he said about not needed as much capital as you would think i.e. Don’t Burn Through the Cash) and also get metrics on your startup or idea (as long as you have the IP). He suggests taking out an ad to see what the interest is out there. You can measure the clicks from the ad and use that as a marketing tool to potential investors i.e. Getting Feedback

Some other posts on this site about Investing and Startups include:

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

THE BLOOMBERG INNOVATION INDEX: Country Rankings by Six Measures of the Capacity to Innovate as a Nation

Updated: Investing and Inventing: Is the Tango of Mars and Venus Still on

Sand Hill Angels

The Bioscience Crowdfunding Environment: The Bigger Better VC?

Technion-Cornell Innovation Institute in NYC: Postdocs keep exclusive license to their IP and take a fixed dollar amount of Equity if the researchers create a Spinoff company

Tycho Brahe, where art thou? Today’s Renaissance of the Self-Funded Scientist!

 

 

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Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting


 

Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Achievement Beyond Regulatory Approval – Design for Commercial Success

philly2nightStephen J. Williams, Ph.D.: Reporter

The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.

The meeting was divided into three panel discussions and keynote speech:

  1. Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
  2. Panel 2: Design for Market Success– Commercial Strategy Planning
  3. Panel 3: Design for Investment– Financing Each Stage
  4. Keynote Speaker: Robert Radie, President & CEO Egalet Corporation

Below are Notes from each PANEL Discussion:

For more information about the Life Sciences Collaborative SEE

Website: http://www.lifesciencescollaborative.org/

Or On Facebook

Or On Twitter @LSCollaborative

Panel 1: Design for Market Protection; Intellectual Property Strategy Planning

Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.

Panelists:

John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University

Cozette McAvoy; Senior Attorney Novartis Oncology Pharma Patents

Ryan O’Donnell; Partner Volpe & Koenig

Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC

Notes:

Dr. Nag:

  • Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
  • Naked patent licenses are most profitable when try to sell IP

John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.

  • 30-40% of Princeton’s IP portfolio is related to life sciences
  • Universities will prefer to seek provisional patent status as a quicker process and allows for publication
  • Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
  • Good to cast a wide net when looking at early development partners like pharma
  • Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
  • Last 2 years many universities filing patents for startups as a micro-entity

Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.

Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective

  • Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
  • Good to make a contractual bundle of IP – “days of the $million check is gone”
  • Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR

Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act

  • Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
  • Diagnostics and genes not patentable now – Major shift in patent strategy
  • Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money – BE PROACTIVE about your patents and IP

Panel 2: Design for Market Success; Commercial Strategy Planning

Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.

Panelists:

David Blaszczak; Founder, Precipio Health Strategies

Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals

Paul Firuta; President US Commercial Operations, NPS Pharma

 

Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia

 

Notes:

David Blaszczak:

  • Commercial payers are bundling payment: most important to get clarity from these payers
  • Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
  • When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area

Terri Bernacchi:

  • Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
  • Value-based contracting with manufacturers can save patient and payer $$
  • As most PBMs formularies are 80% generics goal is how to make money off of generics
  • Patent extension would have greatest impact on price, value

Paul Firuta:

  • NPS Pharma developing a pharmacy benefit program for orphan diseases
  • How you pay depends on mix of Medicare, private payers now
  • Most important change which could affect price is change in compliance regulations

Panel 3: Design for Investment; Financing Each Stage

Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.

Panelists:

Ting Pau Oei; Managing Director, Easton Capital (NYC)

Manya Deehr; CEO & Founder, Pediva Therapeutics

Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation

 

Panel Moderator: Shahram Hejazi, PhD; Venture Partner, BioAdvance

  • In 2000 his experience finding 1st capital was what are your assets; now has changed to value

Notes:

Ting Pau Oei:

  • Your very 1st capital is all about VALUE– so plan where you add value
  • Venture Capital is a PERSONAL RELATIONSHIP
  • 1) you need the management team, 2) be able to communicate effectively                  (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
  • VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
  • Best advice: show some phase 2 milestones and VC will knock on your door

Manya Deehr:

  • Investment is more niche oriented so find your niche investors
  • Define your product first and then match the investors
  • Biggest failure she has experienced: companies that go out too early looking for capital

Dr. Dutta: funding from a non-profit patient advocacy group perspective

  • Your First Capital: find alliances which can help you get out of “valley of death
  • Develop a targeted product and patient treatment profile
  • Non-profit groups ask three questions:

1) what is the value to patients (non-profits want to partner)

2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)

3) when can we see return

  • Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
  • Have a plan B every step of the way

Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM
The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy
The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC
The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC
The Bioscience Crowdfunding Environment: The Bigger Better VC?
Foundations as a Funding Source
Venture Capital Funding in the Life Sciences: Phase4 Ventures – A Case Study
10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge
Funding, Deals & Partnerships
Medicare Panel Punts on Best Tx for Carotid Plaque
9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
FDA Commissioner, Dr. Margaret A. Hamburg on HealthCare for 310Million Americans and the Role of Personalized Medicine
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method
The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century

 

 

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