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11:45AM – 1:30AM The MassBio Annual Award Lunchon – Awards

Reporter: Aviva Lev-Ari, PhD, RN

 

2015 Joshua Boger Innovative School of the Year Award

Presented to Dimon Regional Vocational Technical High School, Fall River, MA

2015 Henri A. Termeer Innovative Leadership Award

Presented to John Maraganore, CEO, Alnylam Pharmaceuticals,  N= 400 employers in Cambridge, new Manufacturing facility in Norton, MA

 

Acceptance Speech by John Maraganore

Innovation and Leadership in MA, entrepreneurs, BioPharma, All Big Pharma has offices in MA, 28 years in Biotech in MA – Central Square or Kendall Square. Competing CEOS meet to cheer community accomplishment.

Innovation new medicines and Therapeutics: Hemophilia

– two drugs in Phase III, raised &2.5 Billion and invested $1.5 Billion, company has multiple products.

  • Science, medical discovery, deeper therapies for disease: i.e., CLL
  • Regulatory: Committed and moving faster
  • 45 approvals by FDA last year
  • Value of Medicines for patients who need them
  • Drugs developed today will be generic for our Children
  • Totality of Health Care cost – drugs are only 10%
  • Insurance company are responsible for making Patients pay Premium and co-pay and drug increase

1:15 -1:30 2o16 MassBio Impact Award Presentation

Introduction by Mark Bamforth, MassBio Board of Director

Novartis – in Cambridge, 2500 employees and increase in square Feet of Labs. Catalyst to growth of other companies, Marc Fischer was Director of Novartis for 13 years, in the audience, Now retired.

Presented to Novartis, accepted by Jeffrey Lockwood, Global Head of Communicaitions, Novartis Institute for BioMedical Research

Appreciate the recognition

 

2016 MassBio LIVE @ Sonesta — Welcome Remarks & Keynote – Kate Marshall @MassBio – Annual Meeting 03/31/2016 8:00 AM – 04/01/2016 3:00 PM Royal Sonesta Hotel, Cambridge, MA 3/31, 9AM – 10:15AM

Reporter: Aviva Lev-Ari, PhD, RN

Twitter:

  • #AM2016,
  • #PatientDriven
  • @MassBio

Welcome Remarks, Overview of Meeting & MassBio Board Election

Robert K. Coughlin , President & CEO, MassBio

The highlight for the Program this year:

  • Microbiome
  • National Landscape

MA is a major player in Biotech as increase in square footage of LABS.

  • Healthcare, Life Sciences Community in MA – uniquely positioned to move ideas cost effectively to Patient Care — Solution, innovation in cost models
  • Saving Life by cure of disease
  • List of Sponsors & Exhibitors

Glenn Batchelder, Founder & Board Member, Civitas Therapeutics, Out going Chairman, MassBio Board of Directors, 2014-2016,

  • Starting a New Start Up in Cardiovascular, XyloCor Therapeutics
  • Kendall Square – Biotech – The Revolution in Life Sciences
  1. HCV – therapy now available
  2. Gene therapy
  3. Immune Therapy in Oncoloyg
  4. Massive capital infusion via IPO
  5. Venture Capital lead to proliferation of start up companies in biotech
  6. MassBio organization is one of a kind in assistance, Executive Committe worked very hard
  7. Vigilent in focus on Patients and focus on lowering costs in HealthCare

Abbie Celniker, President & CEO, Eleven Biotherapeutics, Incoming Chairman, MassBio Board of Directors

  • MassBio is the most honorable biotech organization in the World
  • Honor to Chair the board of MassBio, roadmap and Plan
  1. Innovation and problem solving
  2. Program integration
  3. company formation
  • Acamedia and companies cooperation will continue
  • policy maker and biotech industry
  • hype of Drug Pricing – MassBio will be engaged
  • counsel companies
  • strategic initiative helping small company formation in BioPharma
  • Diversity in labor force and in Biotech Leadership – STEM education for women
  • Leaders have few women and industry is not diverse enough

9:30 – 9:45AM

  • very qualified for his mission – get things done in MA and experience with Patients and HealthCare

Introduced by Robert Ward, CEO, Radius Health, on 3/30/2016 filed for first drug application in Osteoperosis. Other drugs in the Oncology field. Radius Health benefited from MA rich environment, Human Capital from HBS, VC and other LABS around in Cambridge, Waltham and other cities.

 

Opening Remarks – Honorable Charlie Baker, Governor, MA

  • Assistance with donations to Dana Farber
  • 2010 – 2016 public poll 70% said wrong direction even though the economy added jobs, interest rate low, FACTS should lead to statements: right direction, POLLS shows the statement of wrong direction
  • biggest increase in Generics: lowers price of drugs
  • FDA approves Generics, 4,000 on the list
  • execution and follow through in government
  • Marvelous innovation, product development in biotech in MA — in the World, impact of biotech in MA is Worldwide: Science, Chemistry, Biology, IT and Informatics
  • HQS for GE in MA – bug accomplishment to MA, Seaport near an Airport, Financial Center in Boston is big and will support GE, multinational, multiproduct like GE
  • Selection of GE of Bosotn is for 40 years to come not a transaction but a decision to be part of the landscape
  • GE could go anywhere, but they selected MA, because education institutions and research organization in MA and ease of interaction with Boston Mayer and the Governor of MA
  • Education: produce the Talent to have qualifies people at every level
  • Life Science Center: is helping building the Talent
  • Transportation: MBTA is a core system signaling technology some was installed in 1910 !!
  • Energy supply in MA collaborate with initiatives
  • Collaborative — we wish to be investment made to support and leverage opportunities to be in MA
  • Administration: Keep the door open as Partners: MA EcoSystem in Biotech in the World, the most important one !!

Opening Keynote by Kate Marshall, high school honors student, athlete and CF advocate

9:45 AM 10:15 AM

Kate Marshall, high school honors student, athlete and CF advocate, will share her experiences as a patient and how the biotech industry has changed her life.

  • Diagnosis of CF in 4th grade
  • Athlete with excellence – rises above all the time
  • Excellence in Academics

LIVE Kate Marshall –

  • Thanks to CF Foundation – Parents involvement
  • Thanks to Mom
  • Thanks to Dad
  • Testified in front of the FDA
  • FDA approved a Drug
  • All CF Patients regardless of the genotype — are all a big Family
  • Favorable results – Vertex and CF Foundation made that happen
  • College in NC, CF Foundation is also in NC
  • Advancement in Science
  • Looking forward to say CF was my illness and I am cured

A study of gene expression in leukemia cells has identified an RNA binding protein that plays an important role in driving the development of cancer. The protein is normally active in fetal tissue and switched off in adults, but it is reactivated in some cancer cells. This expression pattern makes it an attractive target for cancer-fighting drugs, because blocking its activity is unlikely to cause serious side effects.

 

The new study, published March 14 in the Journal of Clinical Investigation, focused on a particularly aggressive form of B-cell acute lymphoblastic leukemia (B-ALL), the most prevalent type of leukemia in children and young adults. A team led by scientists at UC Santa Cruz and UCLA found an overabundance of the RNA binding protein known as IGF2BP3 in the cancer cells of this subset of B-ALL patients.

 

“This protein, IFG2BP3, has been correlated with many types of malignancies and with the worst prognoses,” said coauthor Jeremy Sanford, associate professor of molecular, cell, and developmental biology at UC Santa Cruz. “What is exciting about this study is that it goes beyond correlation and shows causation, because we demonstrated for the first time that aberrant expression of this protein is sufficient to induce pathology.”

 

The researchers identified genes that are directly regulated by this RNA binding protein, and many of them turn out to be oncogenes that have already been implicated in cancer. In particular, the protein enhances the expression of a well-characterized oncogene called MYC, which in turn regulates a large number of genes involved in cell proliferation.

 

Compared to other proteins involved in regulating gene activity, RNA binding proteins have not been well studied. When a gene is turned on or “expressed,” an RNA copy is made of the gene’s DNA sequence, and the genetic code carried by this “messenger RNA” is then translated into a protein that carries out some cellular function. Many factors are involved in controlling which genes get transcribed into messenger RNA and when, but RNA binding proteins interact with the messenger RNA itself to regulate gene expression after transcription has occurred. Scientists are only beginning to unravel the complexity of this post-transcriptional regulation of gene expression.

 

In the case of IGF2BP3 and B-cell leukemia, the overall effect of the RNA binding protein is to promote the proliferation of B cells by shifting the expression of a large number of genes, Sanford said.

 

Sourced through Scoop.it from: news.ucsc.edu

See on Scoop.itCardiovascular and vascular imaging

Nature-inspired precisely assembled nanotubes

Reporter: Aviva Lev-Ari, PhD, RN

 

@BerkeleyLab

 

Berkeley Lab scientists discovered a polymer composed of two chemically distinct blocks (shown in orange and blue) that assembles itself into complex nanotubes.

 

When placed in water, this new family of nature-inspired polymers spontaneously assemble into hollow crystalline nanotubes up to 100 nanometers long with the same diameter.

 

“Creating uniform structures in high yield is a goal in nanotechnology,” says Ron Zuckermann, who directs the Biological Nanostructures Facility in Berkeley Lab’s Molecular Foundry, where much of this research was conducted. “For example, if you can control the diameter of nanotubes, and the chemical groups exposed in their interior, then you can control what goes through — which could lead to new filtration and desalination technologies, to name a few examples.”

 

Creating a large quantity of nanostructures with the same trait, such as millions of nanotubes with identical diameters, has been difficult. For the past several years, the Berkeley Lab scientists studied a polymer that is a member of the peptoid family. Peptoids are rugged synthetic polymers that mimic peptides, which nature uses to form proteins.

 

The researchers studied a particular type of peptoid, called a diblock copolypeptoid, because it binds with lithium ions and could be used as a battery electrolyte. In their research, they serendipitously found these compounds form nanotubes in water. They don’t know how exactly, but the important thing with this new research is that it sheds light on their structure, and hints at a new design principle that could be used to precisely build nanotubes and other complex nanostructures.

 

Sourced through Scoop.it from: www.kurzweilai.net

See on Scoop.itCardiovascular and vascular imaging

Bio-IT World 2016 – Reception with Dr. Howard Jacob – Aviva Lev-Ari, PhD, RN will attend

Reporter: Aviva Lev-Ari, PhD, RN

Bio-IT World 2016 – Reception with Dr. Howard Jacob – Aviva Lev-Ari, PhD, RN will attend, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 1: Next Generation Sequencing (NGS)

Series B, Volume 2:

Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS & BioInformatics, Simulations and the Genome Ontology

https://www.amazon.com/dp/B08385KF87

ILUMINAimage001

 

From: “Kilke John (Illumina BIOIT2016)” <kilke.john@illumina-bioit2016.com>

Date: Wednesday, March 30, 2016 at 6:31 AM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: Bio-IT World 2016 – drinks reception with Dr. Howard Jacob

Dear Aviva,

Following our brief, previous meeting I am inviting you to an exclusive drinks reception on the second night of this year’s conference in Boston.

It brings together research scientists, life sciences engineers, technologists, operations and data specialists for an evening of peer-to-peer discussions.

The drinks reception will be attended by Dr. Howard Jacob – who was the first in the world to successfully use DNA sequencing to identify and treat an unknown disease and in doing so saved the patient’s life. Under the title of ‘Genomic medicine is a team sport’, Dr. Jacob will be talking about his views on the future of genomics.

Attached is a short invitation PDF including full location details, times, etc.

The drinks reception is open to only 25 people – by invitation only. Therefore, please RSVP me by email or phone to reserve your place.

I look forward to seeing you in Boston 

With kind regards,

Kilke

Kilke John

Bio-IT World event coordinator for Illumina

e: kilke.john@illumina-bioit2016.com

t: +44 20 3100 3578

Wednesday, April 6th 2016 (day two of the Bio-IT World conference)

Time: 6:30 – 8.30PM

Dr. Howard Jacob

Jacob is leading a team that is finding ways to change peoples’ lives. In his research, Jacob verifies that specific DNA changes cause disease. And he wants to find a way to pinpoint those genetic conditions fast enough to benefit a patient.

Jacob combines his team’s research with work from other investigators, bringing genome sequencing, data analysis and basic research together to make a diagnosis possible.

“My role is to integrate the independent work of researchers and create space for them to not only do world class science individually, but also contribute to a larger team,” Jacob says. “It’s one part participant, one part coach, one part motivator.”

“Science is inherently slow and methodical, which is great. But not
if you’re trying to help a sick patient.”

About Dr. Howard Jacob

Jacob has over 240 scientific publications, securing $85M of grant funding from the National Institutes of Health.

Following his PhD at the University of Iowa in 1989 and his postdoctoral work at Harvard, Stanford and MIT, Jacob was the founding director of the Human and Molecular Genetics Center and a professor in the departments of physiology and pediatrics at the Medical College of Wisconsin for nearly 20 years.
He led a team that was the first in the world to successfully use DNA sequencing to identify and treat an unknown disease in a patient. That experience saved the patient’s life and changed Jacob’s too.

“I always believed genomics was going to improve medicine,” he says. “But it went from being a dream to being a passion. I’m frustrated that we’re not helping more people today, when I know we could be changing lives. The good news is that we are going to be changing lives, and changing medicine, through genomics.”

By invitation only

Hosted by Illumina, this exclusive drinks reception is limited to only 25 attendees. It is designed to encourage peer-to-peer discussions among life sciences engineers and research scientists, as well as operations managers, technologists and data specialists.

Discussions will explore how the team sport of genomic medicine is driven on by translational informatics, advances of clinical genomics and next-gen sequencing – and clinical research with a sole focus on saving lives.

 

2nd Annual Translational Gene Editing: Exploiting CRISPR/Cas9 for Building Tools for Drug Discovery & Development: June 16, 2016, Boston, MA

Reporter: Stephen J. Williams, PhD

Translational Gene Editing – June 16-17, 2016 in Boston, MA

YouTubeLinkedInTwitter#CHIWPC16

Learn More | Sponsorship & Exhibit Details | Register by April 29 & SAVE up to $200!

IMPROVING CRISPR FOR BETTER FUNCTIONAL SCREENING

Optimized sgRNA Libraries for Genetic Screens with CRISPR-Cas9
John Doench, Ph.D., Associate Director, Genetic Perturbation Platform, Broad Institute of Harvard and MIT

Optimizing CRISPR for Pooled Genome-Wide Functional Genetic Screens
Paul Diehl, Ph.D., Director, Business Development, Cellecta, Inc.

CRISPR-Cas9 Whole Genome Screening: Going Where No Screen Has Gone Before
Ralph Garippa, Ph.D., Director, RNAi Core Facility, Sloan-Kettering Institute, Memorial Sloan-Kettering Cancer Center

Cross-Species Synthetic Lethal Screens and Applications to Drug Discovery
Norbert Perrimon, Ph.D., Professor, Department of Genetics, Harvard Medical School and Investigator, Howard Hughes Medical Institute

Interactive Breakout Discussion Groups with Continental Breakfast
This session features various discussion groups that are led by a moderator/s who ensures focused conversations around the key issues listed. Attendees choose to join a specific group and the small, informal setting facilitates sharing of ideas and active networking. Continental breakfast is available for all participants.

Topic: CRISPR/Cas9 System for In vivo Drug Discovery
Moderator: Danilo Maddalo, Ph.D., Lab Head, ONC Pharmacology, Novartis Institutes for BioMedical Research

  • Impact of CRISPR/Cas9 system on in vivo mouse models
  • Application of the CRISPR/Cas9 system in in vivo screens
  • Technical limitations/safety issues

Topic: Getting Past CRISPR Pain Points
Moderators: John Doench, Ph.D., Associate Director, Genetic Perturbation Platform, Broad Institute of Harvard and MITStephanie Mohr, Ph.D., Lecturer, Genetics & Director of the Drosophila RNAi Screening Center, Harvard Medical School

  • Challenges and solutions for CRISPR gRNA design
  • Methods for detecting engineered changes

Topic: Cellular Delivery of CRISPR/Cas9
Moderator: Daniel E Bauer M.D., Ph.D., Assistant Professor of Pediatrics, Harvard Medical School and Staff Physician in Pediatric Hematology/Oncology, Boston Children’s Hospital and Dana-Farber Cancer Institute, Principal Faculty, Harvard Stem Cell Institute

GENE EDITING FOR SCREENING DISEASE PATHWAYS AND DRUG TARGETS

Scouring the Non-Coding Genome by Saturating Edits
Daniel E. Bauer, M.D., Ph.D., Assistant Professor of Pediatrics, Harvard Medical School and Staff Physician in Pediatric Hematology/Oncology, Boston Children’s Hospital and Dana-Farber Cancer Institute, Principal Faculty, Harvard Stem Cell Institute

Parallel shRNA and CRISPR/Cas9 Screens Reveal Biology of Stress Pathways and Identify Novel Drug Targets
Michael Bassik, Ph.D., Assistant Professor, Department of Genetics, Stanford University

BUILDING THE CRISPR TOOLBOX

Beyond Cas9: Discovering Single Effector CRISPR Tools
Jonathan Gootenberg, Member, Laboratories of Dr. Aviv Regev and Dr. Feng Zhang, Department of Systems Biology, Harvard Medical School, and Broad Institute of Harvard and MIT

CRISPR-Cas9 Genome Editing Improves Sub-Cellular Localization Studies
Netanya Y. Spencer, M.D., Ph.D., Research Fellow in Medicine, Joslin Diabetes Center, Harvard Medical School

TECHNOLOGY PANEL: Trends in CRISPR Technologies
Panelists to be Announced

This panel will bring together 2-3 technical experts from leading technology and service companies to discuss trends and improvements in CRISPR libraries, reagents and platforms that users can expect to see in the near future. (Opportunities Available for Sponsoring Panelists)

APPLICATIONS OF CRISPR FOR DRUG DISCOVERY

Use of CRISPR and Other Genomic Technologies to Advance Drug Discovery
Namjin Chung, Ph.D., Head, Functional Genomics Platform, Discovery Research, AbbVie, Inc.

Application of Genome Editing Tools to Model Human Genetics Findings in Drug Discovery
Myung Shin, Ph.D., Senior Principal Scientist, Genetics and Pharmacogenomics, Merck & Co. Inc.

In vivo Application of the CRISPR/Cas9 Technology for Translational Research
Danilo Maddalo, Ph.D., Lab Head, ONC Pharmacology, Novartis Institutes for BioMedical Research

DEVELOPING TOOLS FOR BETTER TRANSLATION

Improving CRISPR-Cas9 Precision through Tethered DNA-Binding Domains
Scot A. Wolfe, Ph.D., Associate Professor, Department of Molecular, Cell and Cancer Biology, University of Massachusetts Medical School

Nucleic Acid Delivery Systems for RNA Therapy and Gene Editing
Daniel G. Anderson, Ph.D., Professor, Department of Chemical Engineering, Institute for Medical Engineering & Science, Harvard-MIT Division of Health Sciences & Technology and David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology

Translating CRISPR/Cas9 into Novel Medicines
Alexandra Glucksmann, Ph.D., COO, Editas Medicine

2nd Annual Translational Gene Editing: Exploiting CRISPR/Cas9 for Building Tools for Drug Discovery & Development: June 16, 2016, Boston, MA, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair

Hudson River Valley – My Favorite American Landscape

Curator: Aviva Lev-Ari, PhD, RN

 

 

Selections from my Digital Painting Collection

 

grace_

Grace

logging_trail_

Logging Trail

reflections_of_autumn_ii_

 Reflections of Autumn

sunset_at_oceanside_

Sunset at Oceanside

woodland_stream_waterfall

Woodland Stream Waterfall

Team Profile: DrugDiscovery @LPBI Group – A BioTech Start Up submitted for Funding Competition to MassChallenge Boston 2016 Accelerator

Curator: Aviva Lev-Ari, PhD, RN

MassChallenge Boston 2016 Accelerator

 

From: MassChallenge <apply@masschallenge.org>

Date: Monday, March 28, 2016 at 1:11 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Cc: MassChallenge <apply@masschallenge.org>

Subject: Your MassChallenge 2016 Jun-Oct Program Cycle Application for DrugDiscovery@LPBI Group has been Submitted

Hi Aviva,

Thank you for submitting your application for MassChallenge Boston 2016 Accelerator for your startup, DrugDiscovery@LPBI Group. It has been received and will be reviewed by MassChallenge judges.

Best,

The MassChallenge Team

++

From: MassChallenge <contact@masschallenge.org>

Reply-To: <contact@masschallenge.org>

Date: Saturday, April 2, 2016 at 3:17 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: MC Update – Applications Close 

Click to Browse the 2016 Startup Applicants

@@@@

SBH Sciences, Inc. & LPBI Group’s M3DP, Subsidiary #3

Our Thrusts

  1. Drug Discovery with 3D BioPrinting
  2. Drug Delivery System – One solution for many agents for many indications
  3. Stem Cell Reprogramming & Gene Therapy
  4. Gene Editing for Gene Therapies with 3D BioPrinting
  5. JVIP – TEAM PRESENTATIONS 1/4/2016 – 3/31/2016

Co-Founders

Launcher & Co-Founder: Aviva Lev-Ari, PhD, RN

Expertise for Startup evolution:

  • Management: Team building, Funding, Administration
  • R&D Management: Concept Design Strategy, Combination Drug Therapy

email: avivalev-ari@alum.berkeley.edu

Phone: 617-244-4024

Profile Picture:

Personal LinkedIn URL:

 https://www.linkedin.com/today/author/avivalevari

Personal Facebook URL:

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

Personal Website:

http://pharmaceuticalintelligence.com/

Personal Twitter Handle:

@pharma_BI

@AVIVA1950

Co-Founder: Raphael Nir, PhD, CEO, SBH Sciences, Inc.

Expertise for Startup evolution:

  • Management: Team building, Funding, Decision Making
  • All Aspects of R&D Management
  • Conceptual Leadership

email: rnir@sbhsciences.com

Phone: 508-650-6218 Ext. 214

Profile Picture:

20141123-_53A7246-S

Personal LinkedIn URL:

https://www.linkedin.com/in/raphael-nir-b523a912?trk=nav_responsive_tab_profile

Personal Facebook URL:

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

Personal Website:

http://www.sbhsciences.com

Personal Twitter Handle:

@pharma_BI

Co-Founder: Stephen J. Williams, PhD & Scientist III

Expertise for Startup evolution:

  • Strategic Decision Making
  • All Aspects of Research
  • Conceptual Leadership in Drug Formulation
  • 3D BioPrinting: Drug Dosing and Printing

email: sjwilliamspa@comcast.net

Phone: (215) 487-0259

Profile Picture:

sjw

Personal LinkedIn URL:

https://www.linkedin.com/in/stephen-j-williams-ph-d-43a0b851

Personal Facebook URL:

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

Personal Website:

http://pharmaceuticalintelligence.com/

Personal Twitter Handle:

@StephenJWillia2

Members of Technical Staff

 

Tilda Barliya, PhD – Scientist III

Expertise for Startup evolution:

  • All Aspects of Research
  • Conceptual Leadership in Drug Formulation, nano beads, oncology, genomics

email: tildabarliya@gmail.com

Phone:011-972-50-8622289

Profile Picture:

Me 2014[2]

Personal LinkedIn URL: 

https://www.linkedin.com/in/tilda-barliya-phd-32a8519?trk=hp-identity-name

Personal Facebook URL:

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

Personal Website:

http://pharmaceuticalintelligence.com/

Personal Twitter Handle:

@pharma_BI

Irina Robu, PhD – Scientist II

Expertise for Startup evolution:

  • All Aspects of Research related to Material Science, Tissue Engineering
  • Conceptual Leadership in Drug-Device design for drug delivery, Smart Polymers

emailirina.stefania@gmail.com

Phone: 734-330-8426

Profile Picture:

Irina_Robu

Personal LinkedIn URL:

https://www.linkedin.com/in/irinarobu

Personal Facebook URL:

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

Personal Website:

http://pharmaceuticalintelligence.com/

Personal Twitter Handle:

@irirobu

Danut Dragoi, PhD – Scientist III

Expertise for Startup evolution:

  • All Aspects of Research related to Material Science, Conduction, Structures
  • Conceptual Leadership in Drug-Device design

email: danut.daa@gmail.com

Phone: 818-813-2531

Profile Picture:

Danut's Picture_Danut's Picture

Personal LinkedIn URL:

https://www.linkedin.com/in/danut-dragoi-29475111

Personal Facebook URL:

https://www.facebook.com/danut.dragoi

Personal Website:

http://pharmaceuticalintelligence.com/

Personal Twitter Handle:

https://twitter.com/DanutDaa

Sudipta Saha, PhD – Scientist III

Expertise for Startup evolution:

  • All Aspects of Research related to Cell Biology, Molecular Biology & Physiology
  • Conceptual Leadership in Novel Anti-Cancer Molecule Identification, Purification, Characterization and Application

email: sudiptasaha1977@gmail.com

Phone: +91-9830079019

Profile Picture:

saha-pix

Personal LinkedIn URL: 

https://www.linkedin.com/in/sudipta-saha-30a5a326

Personal Facebook URL:

http://www.facebook.com/LeadersInPharmaceuticalBusinessIntelligence

Personal Website:

http://pharmaceuticalintelligence.com/

Personal Twitter Handle:

@sudiptasaha1977

David Orchard-Webb, PhD – Cancer Scientist III

Expertise for Startup evolution: Anti-Cancer Drug Discovery (CAR-T and TCRL) – Immune-Oncology, Immunotherapy and Genomics

Name: David Orchard-Webb

email: d.orchard-webb@bath.edu 

Phone: +1 438 823 0338

Profile Picture:

ORCHARD-WEBB

Personal LinkedIn URL:

http://ca.linkedin.com/pub/david-orchard-webb/87/a31/a49

Personal Facebook URL:

https://www.facebook.com/david.orchardwebb

Team Website:

http://pharmaceuticalintelligence.com/

Team Twitter Handle:

@pharma_BI

Ziv Raviv, PhD – Scientist III – PENDING

Expertise for Startup evolution: TBD – Oncology and inflammation

Phone:

Profile Picture:

Personal LinkedIn URL:

Personal Facebook URL:

Personal Website:

Personal Twitter Handle:

What drug interfered with the performance of Sharapova?

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

Meldonium — The Drug That Brought Down Sharapova

Gayle Nicholas Scott, PharmD

When tennis player Maria Sharapova recently revealed that she had tested positive for the banned drug meldonium, the reaction of most healthcare providers was, “What is it?”

Meldonium is manufactured and sold as Mildronate by the pharmaceutical company Grindeks in the Baltic nation of Latvia. Meldonium is not available in the United States or elsewhere in the European Union (it was grandfathered in Latvia) other than via purchase on the Internet.

The World Anti-Doping Agency classifies meldonium as a “metabolic modulator” and moved the drug from its watch list to its list of banned substances in January 2016.

Other “metabolic modulators” are insulin and trimetazidine, an anti-ischemic metabolic agent that increases myocardial glucose utilization through inhibition of fatty acid metabolism.[1,2] Trimetazidine is approved in the European Union for the treatment of angina, but it is not approved in the United States.

The chemical name for meldonium is trimethylhydrazinium propionate. Meldonium works by decreasing the availability of levocarnitine (L-carnitine). L-carnitine is found naturally in milk and meats, and also can be synthesized by the body from lysine and methionine with the help of gamma-butyrobetaine hydroxylase. L-carnitine helps move long-chain fatty acids into the mitochondria for oxidation and energy production in the muscles.

Ironically, L-carnitine, which meldonium inhibits, is taken as a dietary supplement alone and as an ingredient in energy drinks to increase athletic performance. (L-carnitine is available in the United States as the prescription drug Carnitor®, which is indicated for carnitine deficiency owing to inborn errors of metabolism and for end-stage renal disease requiring dialysis.) After two decades of research, no consistent evidence has emerged indicating that carnitine supplements can improve exercise or physical performance. Carnitine supplements do not appear to increase the body’s use of oxygen or improve metabolic status when exercising, and may not increase the amount of carnitine in muscle.[3,4]Carnitine is not on the list of banned substances.[1]

As a modulator of L-carnitine metabolism, meldonium inhibits gamma-butyrobetaine hydroxylase and L-carnitine transmembrane transport of long-chain fatty acids, thus decreasing L-carnitine levels in tissue and plasma. Reducing the amount of bioavailable L-carnitine shifts the source of metabolic energy production from fatty acid oxidation to glucose metabolism. Aerobic glucose oxidation consumes less oxygen than fatty acid oxidation and increases the effectiveness of adenosine triphosphate (ATP) generation. Additionally, meldonium appears to increase glucose uptake. In ischemic conditions (hypoxia), meldonium appears to restore the balance between cellular oxygen supply and demand, and prevents ATP transport impairment.[3,5]

All published clinical efficacy studies on meldonium, except one,[6] are in Russian. Abstracts of randomized controlled trials have reported the efficacy of meldonium in reducing angina, arrhythmias, and anxiety and other early sequelae of myocardial infarction[7-10]; as an “adaptogen” in patients with cardiovascular disease[11,12]; and in treating angina and reducing myocardial ischemia after percutaneous coronary intervention,[6,13,14] heart failure,[15] and diabetic peripheral neuropathy.[16] Doses, when included in the abstracts, ranged from 750 to 1000 mg per day. Only one abstract mentioned adverse effects, stating that none occurred.[7]

A pharmacokinetic study of meldonium showed that the drug has a dose-dependent half-life and volume of distribution with accumulation on multiple-dose administration. In eight healthy volunteers who received meldonium for 13 days, almost all reported insomnia, half reported burping, and one quarter reported “dreaminess.” No serious adverse effects were reported.[17]

A study in healthy, nonvegetarian volunteers receiving 1000 mg meldonium per day for 4 weeks showed that plasma concentrations of L-carnitine decreased by 18%. Urine samples showed an increase in L-carnitine excretion. Adverse effects were not mentioned.[18] Meldonium is excreted in the urine largely unchanged, making urine testing a valid monitor presence of meldonium.[19]

No long-term studies on the safety and efficacy of meldonium have been published. No studies on the effect of meldonium on athletic performance in humans have been published. One study on the reliability of urine testing in professional sports[19]mentions an article and an abstract, but neither of those appears in PubMed. The abstract purports to be a review of “recent studies on mildronate especially in fields associated with physical work capabilities and sport” but cites only the study mentioned in the urine testing review.[20] Most articles about meldonium cited on PubMed are by Latvian authors.

Animal research suggests the potential usefulness of meldonium in Alzheimer disease,[21-23] Parkinson disease,[24,25] and diabetes.[26-29] Meldonium increased sexual activity in boars[30] but not in male rats.[31] Research in rodents found that meldonium can cause carnitine deficiency in offspring, so the drug should not be taken in pregnancy.[32]

Because meldonium is excreted renally, serum levels may be higher in patients with reduced kidney function, and the drug may accumulate with repeated dosing.[19] L-carnitine appears to antagonize the effects of meldonium[33]; otherwise, drug interactions are not known.

To recap, meldonium is an interesting drug developed by Latvian researchers. Published research suggests that it may be an effective treatment for cardiovascular diseases, such as angina. Little information about its adverse effects has been published, however, and the long-term safety of meldonium is not known. And although reliable research on meldonium’s use for athletic performance is not available, the World Anti-Doping Agency has declared it a banned substance.

Scalia cause of death undetermined

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

COMMENTARY    
Scalia’s Death and the Value of Autopsy: A Teachable Moment

 

Hello and welcome. I am Dr George Lundberg, and this is At Large at Medscape.

Back in the “good old days,” I was proud to be part of the profession of American medicine—a culture of self- and peer criticism where truth was sought and told, and recognition of error led to individual and group improvement. If a patient was seen by a physician who took a history, conducted a physical examination and ordered tests, diagnosed a nonlethal condition, and provided treatment, and 2 days later that patient was found dead, the physician wanted to know what happened and how he could have done better. An autopsy often provided the answers. Doctors learned. Autopsy rates on hospital deaths in those days were in the 50% range.

In February 2016, a 79-year-old man who had just returned from a vigorous trip to Hong Kong saw his physician with complaints of a head cold and shoulder pain. Examinations and tests were done and treatment provided. Two days later that patient was found dead. If you were that physician, would you not want to know what happened? But no autopsy was performed. (Autopsy rates on nonviolent deaths in the United States in 2014 were down to 3.5%.)

I know nothing about Supreme Court Associate Justice Antonin Scalia’s life or death except what I have read in news reports. It is not my intent here to go into historical detail. However, I do know a lot about the value of an autopsy.

What was the cause of death of Antonin Scalia on February 13 or 14, 2016? I do not know and neither do you. Nor does Presidio County, Texas Judge Cinderella Guevara, who said, from many miles away and without seeing the body, that he died of “natural causes” (which, of course, is not a cause of death at all), and then said that he had a “myocardial infarction.” Nor does his putative physician, Rear Admiral Brian T. Monahan in Washington, DC, with whom Judge Guevara spoke by telephone.

I seize this event as a Teachable Moment about the autopsy, which has, sad to say, become almost nonexistent for most current American physicians and hospitals