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Archive for the ‘BioTechnology – Venture Creation, Venture Capital’ Category

Success of the life sciences industry in Massachusetts: Governor Charlie Baker – A new 5 year, $500 million investment

Reporter: Aviva Lev-Ari, PhD, RN

 

We are thrilled to share this exciting news with you. Earlier today, Governor Charlie Baker announced he will be filing legislation to establish the next phase of the life sciences initiative with a new 5 year, $500 million investment. As the original 10-year, $1 billion program expires next year, this action is critical to the continued success of the life sciences industry in Massachusetts, and to patients around the world who continue to seek new treatments and cures they need and deserve.

As noted by the Governor’s office, the focus of this next phase of the life science initiative will include strengthening investments in human capital to fortify the state’s skilled workforce pipeline, expanding opportunities for companies to access both private investment capital and dynamic public infrastructure resources, developing new scientific innovations that deliver higher outcome, affordable therapies to patients, and leading the convergence revolution in digital health, biopharma, medical devices and engineering.

Over the last nine years the life science initiative and the Massachusetts Life Sciences Center has cemented Massachusetts as the life sciences leader nationally and across the world. In Cambridge and Boston we have the best, most dense biotech cluster in the world. In Worcester, we have a cluster which can stand on its own as one of the biggest in the country. And in the northern and southern parts of the state, jobs in the life sciences are growing faster than anywhere else in the state. With a $147,000 average salary, $9 billion in total payroll, and an expected 11,600 new jobs over the next five years, the life sciences is a huge economic engine for this state. With today’s announcement, we know that companies will continue to come and expand in Massachusetts for years to come and make our economy grow. 

Most importantly, the continuation of the life sciences initiative ensures that patients across the world will continue to receive the breakthrough cures and treatments that are being developed every day in Massachusetts. 

Today’s an exciting day for Massachusetts. We’re thrilled to be part of it.

– Bob Coughlin

 

SOURCE
From:
MassBio <communications@massbio.ccsend.com> on behalf of MassBio <robert.coughlin@massbio.org>

Reply-To: <communications@massbio.org>

Date: Monday, June 19, 2017 at 1:06 PM

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

Subject: Breaking News: Gov. Baker Announces Next Phase of Life Sciences Initiative

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VC Investment in BioTech MegaHubs and Top R&D Spenders among Big Pharma

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 4/26/2017

The top 10 pharma R&D budgets in 2016

The Top 10 Pharma R&D Budgets in 2016

Read More:

SOURCE

http://www.fiercebiotech.com/special-report/top-10-pharma-r-d-budgets-2016?utm_medium=nl&utm_source=internal&mrkid=993697&mkt_tok=eyJpIjoiT1RSbE9ESTRNR1pqWTJFNCIsInQiOiJFcUx4MFhxSFVGbVZhUkRGdUdRMTJMUGxFSEkrR0VTMEdXbjRvZkxmdXM4em4wRkg5QXZIOWJJWTgwNHR1a1dVbTRIUFwvNWRIXC9ZTkF5dHlpUUZ4bG1lS2c2NkszQk9oeGtRczhLcnYyalRSZEFjOEl6U3dUY2VaakxUbDdkNGNwIn0%3D

Book traversal links for The top 10 pharma R&D budgets in 2016

 

 

 

Table SOURCE: Thomson Reuters abd ENDPOINTS

According to both sources:

  • $3.5 billion for Silicon Valley plus the Bay Area and
  • $2.8 billion for New England.

Broken down by city, $6.1 billion went to

  • Boston ($2.7 billion),
  • San Jose ($2.5 billion) and
  • San Francisco/Berkeley ($1 billion).
  • San Diego ($725 million),
  • New York ($454 million) and
  • the Great Lakes area ($412 million)

SOURCE

Where the money is: Biotech’s megahubs command VC’s billions by john carrollJune 30, 2016 10:41 AM EDT, Updated: November 17, 2016 07:32 PM

The top 15 spenders in the global drug R&D business: 2017

by john carroll

April 24, 2017 05:22 AM EDT, Updated: 05:27 AM

The top five in the business saw their collective spending jump by more than $5 billion, from 2015 to 2016, based on the annual numbers filed largely — though not entirely — with the SEC and gathered by Endpoints News. Two of those companies,

  • Roche and the new number 2, a hard charging
  • Merck, accounted for the lion’s share of the increase. (To be sure, some onetime non-R&D spending, such as Merck’s patent settlement with Bristol-Myers on Keytruda, figured in. But so did bread and butter spending.)
  • Gilead also saw a significant increase in research costs, with
  • Eli Lilly — now off course following two bad setbacks for solanezumab and baricitinib — and the ever aggressive
  • Celgene joining the action as they pressed the accelerator on new drug programs.

Curiously, the added spending coincided with a bad drop in new drug approvals in 2016. But they don’t correlate, and we’ve already seen that turnaround under way as regulators get busy with a brand new year — and soon a brand new FDA commissioner.

SOURCE

https://endpts.com/special/top-research-budgets-in-pharma-and-biotech/

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Chan-Zuckerberg (CZ) Biohub Selects Researchers to Receive $50 Million to Fight Disease & consortium aimed at immunotherapy research

 

Reporter: Aviva Lev-Ari, PhD, RN

 

 

02/10/2017 – 4:33pm

 

Selecting the Candidates

It wasn’t easy to narrow down the applicant pool, according to Quake.

“Over 750 people submitted a three-page application proposing risky but innovative ideas. In return, we’d provide them with the funding to work on their ideas in an unrestricted capacity,” said Quake regarding the application process.

A panel comprised of 60 prominent engineers and scientists sifted through the applications that came from the three universities. Submissions came from a diverse array of departments, including computer science, engineering and mathematics before settling on the final 47 participants.

“It’s a phenomenal gathering of talent working on issues like using computer science to help understand human health through the use of wearables,” added Quake.

One notable member of this program is Jure Leskovec, Ph.D., who is a computer scientist at Stanford and the chief scientist at Pinterest. His work at the biohub will focus on using data to help biologists comprehend the interactions between the genes and proteins exposed to drugs or disease, according to Nature.

Other investigators include Ada Poon, Ph.D., hailing from Stanford who is studying new techniques for miniaturing bioelectronics devices, and Markita Landry, Ph.D., who is working on nanosensor technology and near infrared imaging platforms designed to visualize neurotransmitters in the brain.

The CZ Biohub will institute policies that enable quick dissemination of research papers through pre-print servers. This will help inform other researchers of their work and expedite the discovery process.

Next Steps

Investigators will gain a five-year appointment and up to $1.5 million in funding to kick start their research projects.

There are other research institutes forming in Silicon Valley, but with slightly different approaches. Sean Parker, the entrepreneur behind notorious music-sharing service Napster, launched a consortium aimed at immunotherapy research as well as a separate operation geared towards allergy research.

However, Quake said the Biohub concept appeals to a lot of researchers.

“There’s only a small number of faculty positions available each year and not everyone wants to teach, so we want the Biohub to be an alternate career path for researchers who love science,” he said.

http://www.rdmag.com/article/2017/02/chan-zuckerberg-biohub-selects-researchers-receive-50-million-fight-disease?et_cid=5825577&et_rid=461755519&type=cta&et_cid=5825577&et_rid=461755519&linkid=content

 

RELATED READS

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Independent Public Relations Professionals with extensive experience in the biotechnology/drug development sector – Please Contact Me

Reporter: Aviva Lev-Ari, PhD, RN

We are seeking an independent public relations professional with extensive experience in the biotechnology/drug development sector to assist on a freelance basis to

  • promote an on line resource in drug development and personalized medicine in the global oncology sector. 

Responsibilities include working with agencies such as PR Newswire to distribute press releases prepared by us in house, and managing our proprietary mailing list and our social media accounts. 

Please, provide a detailed resume with contact information to knowledgebase@newmedinc.com.

 

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Institutional Capital Raised by Female Founders in 2016 – A Global Perspective vs the US Economy: Globally 1,272 in the United States 600

Reporter: Aviva Lev-Ari, PhD, RN

2016 REVIEW OF FEMALE FOUNDERS RAISING INSTITUTIONAL CAPITAL

– See more at:

http://femalefoundersfund.com/2016-review-of-female-founders-raising-institutional-capital/#sthash.Pcuj7rVB.dpuf

 

The Data Reflects Several Key Trends
Key Takeaways

Raising a Series A led by an institutional VC remains difficult, but female founders in NYC continued to be the most successful (compared to those in other cities) in 2016.
At 17%, the percentage of total A rounds led by female CEOs in 2016 represents the highest total percentage since Female Founders Fund started tracking the data in 2013.
In addition, New York saw a record number of Series B and C rounds led by female founders in 2016.
Female Founders Fund remains the most active institutional VC firm investing in early-stage female-led companies.
Funds that have traditionally been uninterested in e-commerce have renewed interest in the e-commerce sector following the Dollar Shave Club and Jet.com acquisitions by large strategic investors.

2016 Series A Rounds — NYC — Female CEO
Rockets of Awesome — $12.5 million — December — Rachel Blumenthal
Ellevest — $9.0 million — September — Sallie Krawcheck
CoheroHealth — $9.0 million — November — Melissa Manice
Away — $8.5 million — September — Steph Korey
Primary– $8.0 million — June — Galyn Bernard
goTenna — $7.5 million — March — Daniela Perdomo
LOLA — $7.0 million — December — Alex Friedman and Jordana Kier
Uncharted Play — $7.0 million — September — Jessica Matthews
Thrive Global — $7.0 million — August — Arianna Huffington
Everplans — $6.4 million — June — Abby Schneiderman
pymetrics — $6.1 million — February — Frida Polli
Sakara Life — $4.8 million — January — Whitney Tingle, Danielle DuBoise
Shoppable — $3.5 million — August — Heather Marie
MMLaFleur — Sarah LaFleur

2016 Series A Rounds — Bay Area — Female CEO

Cortexyme — $15.0 million — January — Casey Lynch
FOVE — $11.0 million — March — Yuka Kojima
Front — $10.0 million — May — Mathilde Collin
REBBL — $10.0 million — December — Sheryl O’Loughlin
Nima — $9.2 million — May — Shireen Yates
Rocksbox — $8.7 million — March — Meaghan Rose
LaunchDarkly — $8.7 million — December — Edith Harbaugh
Modsy — $8.0 million — February — Shanna Tellerman
ThirdLove — $8.0 million — February — Heidi Zak
Node — $7.5 million — June — Falon Fatemi
Shippo — $7.0 million — September — Laura Behrens Wu
Mobilize — $6.5 million — September — Sharon Savariego
Neurotrack — $6.5 million — January — Elli Kaplan
Sourcery — $5.0 million — September — Na’ama Moran
Luka — $4.4 million — April — Eugenia Kuyda
SupportPay — $4.1 million — December — Sheri Atwood
Zybooks — $4.0 million — February — Smita Bakshi
Schoola — $3.6 million — May — Stacey Boyd

– See more at:

http://femalefoundersfund.com/2016-review-of-female-founders-raising-institutional-capital/#sthash.Pcuj7rVB.dpuf

 

 

Series A Rounds in 2016

Our 2016 analysis began with an overall review of Series A rounds globally, nationally and regionally.

2017 Research Graph 1

Series A Rounds Raised Globally, Nationally and Regionally in 2016

Series A Rounds in 2016:

 

 

 

2016 Series A Rounds in 2016:

Globally: 1,272
United States: 600
Bay Area: 187
NYC: 84
Boston: 31
Los Angeles: 38
Seattle: 26
Austin: 7
Washington D.C.: 17

2015 Series A Rounds in 2015:

Globally: 1,164

United States: 664

Bay Area: 205

NYC: 96

Boston: 50

Los Angeles: 40

Seattle: 25

Austin: 22

Washington D.C.: 17

– See more at:

http://femalefoundersfund.com/2016-review-of-female-founders-raising-institutional-capital/#sthash.Pcuj7rVB.dpuf

The total number of Series A rounds in the U.S. decreased by 10% in 2016. Of the seven regions that we track in the U.S., Seattle is the only region that experienced an increase in the number of Series A raises in 2016, at 4%.

While overall Series A activity declined slightly in Los Angeles, there were two large Series A raises for female-led businesses — (i) HopSkipDrive, led by CEO Joanna McFarland, which raised $10.2 million in January 2016 from Upfront Ventures and FirstMark Capital; and (ii) Hutch, led by CEO Beatrice Fischel-Bock, which raised $5 million in July 2016 from Founders Fund. Los Angeles remains among the most female entrepreneur-friendly cities in the U.S.

 

VC’s investing in female-led companies in 2016.

Female Founders Fund remained the most active investor, participating in 3 of the 14 — or 21% — of all female-led A rounds in NYC. – See more at: http://femalefoundersfund.com/2016-review-of-female-founders-raising-institutional-capital/#sthash.Pcuj7rVB.dpuf

– See more at:

http://femalefoundersfund.com/2016-review-of-female-founders-raising-institutional-capital/#sthash.Pcuj7rVB.dpuf

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On Investment Platforms for Private Funds and Investment Platforms for Private Placements – SEC Update

Reporter: Aviva Lev-Ari, PhD, RN

 

SEC Update

In the last few years, we have seen a number of important developments in the securities laws related to finders and broker-dealer registration requirements. Below we provide an overview of the broker-dealer registration requirement as it relates to finders who assist in matching issuers with investors or buyers and the latest developments in this area.

Overview

The distinction between being classified as a finder and a broker-dealer can have significant consequences. An unregistered broker-dealer may face sanctions from the Securities and Exchange Commission (SEC), and it may be unable to enforce payment for its services. In addition, transactions involving an unregistered broker-dealer may create a right of rescission in favor of the investors, allowing the investors the right to require the issuer to return the money invested. One example of the consequences of an unregistered broker-dealer occurred in the Ranieri Partners SEC enforcement action. In that action the SEC brought charges against a private-equity firm, its managing director, and a consultant because of the consultant’s failure to register as a broker-dealer. The SEC’s order found that the private equity firm paid transaction-based fees to a consultant, who was not registered as a broker-dealer, for soliciting investors for private fund investments.1

The federal securities laws do not specifically define the term “finder” or outline what finders can do. Instead, finders must avoid being deemed a broker or dealer under the federal securities laws unless they register as such with the SEC and the Financial Industry Regulatory Authority (FINRA). A broker is defined as “any person engaged in the business of effecting transactions in securities for the accounts of others.”2 A dealer is defined as a person that is “engaged in the business of buying and selling securities … for such person’s own account,” but excludes a person that buys and sells securities for its own account, but not as part of a regular business.3Because the broker definition is the one that finders have the most trouble with, this discussion is focused on what activities may cause a finder to fall within the definition of a broker required to register with the SEC and FINRA.

  • M&A Brokers
  • FINRA Guidance
  • Investment Platforms for Private Placements
  • Investment Platforms for Private Funds
  • Crowdfunding
  • Potential Regulatory Action
Conclusion

A determination of whether an intermediary is acting as a finder or an unregistered broker-dealer is a very fact-specific analysis and can often be very complex. Unfortunately for unwary entrepreneurs, company executives, and equity fund sponsors, frequently a third party assisting with capital-raising will be acting as a broker-dealer, not a finder, and therefore should not be engaged unless properly registered. It is likely that we will see further clarification or new rules from regulators in the future; regardless, it is important to always carefully consider the involvement of finders or broker-dealers in any capital-raising endeavor.

If you have any questions regarding the use of finders, or capital raising in general, please contact the Venable lawyer with whom you work, one of the authors of this article, or a member of our Corporate Finance and Securities Group.

SOURCE
https://www.venable.com/finders-and-unregistered-broker-dealers-12-04-2015/?utm_source=Mondaq&utm_medium=syndication&utm_campaign=View-Original

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Funding Oncorus’s Immunotherapy Platform: Next-generation Oncolytic Herpes Simplex Virus (oHSV) for Brain Cancer, Glioblastoma Multiforme (GBM)

Reporter: Aviva Lev-Ari, PhD, RN

 

Series A  Funding in July 2016 and in December 2016

Jul 20, 2016 at 2:19 PM

  • raised $57M to battle cancer —

SOURCE

http://medcitynews.com/2016/07/qa-ceo-oncorus-just-raised-57m-battle-cancer/?rf=1

 

MPM Capital

MPM Capital, which has around $2 billion in assets, is already working with drugmakers on funding healthcare startups. This  includes a venture fund it closed last year at $400 million that included Novartis ($NVS) Astellas Pharma as investors.

http://www.fiercebiotech.com/biotech/ubs-raises-471m-for-a-new-kind-cancer-research-fund

(with equal contributions from MPM BV2014 and the Oncology Impact Fund), and included Deerfield Management, Arkin Bio Ventures, Celgene, Inc., Excelyrate Capital, Long March Investment Fund and MPM’s SunStates Fund.

  1. MPM BV2014  – OIF will co-invest with MPM’s BV2014 venture fund in private oncology company investments.

http://finance.yahoo.com/news/mpm-launches-471-million-social-194500117.html

  1. MPM Oncology Impact Fund (OIF)

https://www.ft.com/content/b5e1e678-0c6a-11e6-b0f1-61f222853ff3

 

 

COINVESTORS:

 

SOURCE

http://medcitynews.com/2016/07/qa-ceo-oncorus-just-raised-57m-battle-cancer/?rf=1

http://www.finsmes.com/2016/07/immuno-oncology-company-oncorus-completes-57m-series-a-financing.html

 

December 15, 2016

 

Oncorus®, Inc. Announces Additional Series A Financing Support From Astellas Venture Management LLC (AVM)

  • AVM (61-57 = $4Million) – Now all proceeds are $61Million

 

Oncorus Management – “We are thrilled to have AVM join this outstanding group of high-quality investors.

http://www.oncorus.com/board-of-directors

 

  • Industry veteran and Oncorus co-founder Mitchell H. Finer, Ph.D., leads the Oncorus management team as Chief Executive Officer and Chief Scientific Officer and
  • Cyrus D. Mozayeni, M.D., serves as President and Chief Business Officer.

 

Finer serves on Oncorus’s Board of Directors along with:
– Luke Evnin, Ph.D., MPM Capital co-founder and Chairman,
– Briggs Morrison, CEO, Syndax;
– Cameron Wheeler, Ph.D., Principal, Deerfield Management; and,
– Alon Lazarus, Ph.D., Biotech Investment Manager, Arkin Bio Ventures.

This additional funding will help advance our immunotherapy platform as we discover innovative new therapies which we hope will be of benefit to patients in need and the physicians who treat them,” said Dr. Finer.

 

Oncorus licensed certain patent rights from the University of Pittsburgh based upon the work of renowned scientists Joseph Glorioso III, Ph.D., and Paola Grandi, Ph.D., who will join Oncorus’s Scientific Advisory Board.

The company will invest in researching and developing oncolytic viral constructs which will move through preclinical development and ultimately into clinical trials. Currently, the company’s lead candidate is in preclinical development for GBM. The company will also expand and improve its technology platform and accelerate the development of pipeline programs in other forms of cancer.

 

About AVM Astellas Venture Management LLC., based in Menlo Park, California, is a corporate venture capital of Astellas Pharma Inc. (“API”), headquartered in Tokyo, Japan. For over 15 years, AVM has been making strategic investments to achieve its mission to explore emerging innovative companies, which have potential to become API’s collaboration partners in R&D. For more information, please visit the website at www.astellasventure.com.

About Oncorus, Inc. Oncorus, Inc. is an early-stage biotechnology company developing a next-generation immunotherapy platform of oncolytic viruses to treat several types of cancer, including highly malignant and aggressive cancers. A leader in corporate philanthropy, Oncorus has taken a pledge to donate a portion of product sales revenue to fund promising cancer research and to support cancer care in the developing world. The company is located in Kendall Square, Cambridge, Massachusetts. Visit www.oncorus.com, for more information.

 

SOURCE

https://static1.squarespace.com/static/574456597c65e4f329ea6950/t/5852b919d1758eb23d44fdd1/1481816345729/Oncorus+Series+A+Astellas+Press+Release+FINAL+12-15-16.pdf

http://www.oncorus.com/news-items/2016/12/15/oncorus-inc-announces-additional-series-a-financing-support-from-astellas-venture-management-llc

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Runway: a unique startup incubator in NYC – JACOBS TECHNION-CORNELL INSTITUTE  @CORNELL TECH

 

Jacobs Technion-Cornell Institute

campus-view-from-manhattan-aerial

 

Author: Shuli (Shoulamit) C. Shwartz, PhD

Entrepreneur in Residence, CornellTech, NYC

Co-managing Runway Startup Postdoc  program

Jacobs Technion-Cornell Institute

 

The Runway  is a 1-3 years tech incubator in the Jacobs Technion-Cornell Institute at CornellTech. It is an innovative hybrid of a postdoc educational program and a startup incubator, highly competitive, providing PhD graduates with a supportive environment that includes

  • funding,
  • high level mentoring in technology,
  • business and entrepreneurship,
  • space and more. 

Application is now open for 2017 Fall’s cohort. 

More details are available here.

 

Shuli (Shoulamit) C. Shwartz, PhD

Entrepreneur in Residence, CornellTech, NYC

Co-managing Runway Startup Postdoc  program

Jacobs Technion-Cornell Institute

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Real Time Coverage and eProceedings of Presentations on 9/19-9/21 @CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

Curator: Aviva Lev-Ari, PhD, RN

2.1.5.11

2.1.5.11   Real Time Coverage and eProceedings of Presentations on 9/19-9/21 @CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston, 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

LIVE 9/19 8AM – 10AM USING CRISPR/Cas9 FOR FUNCTIONAL SCREENING at CHI’s 2nd Annual Symposium CRISPR: Mechanisms and Applications @CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/19/live-919-8am-10am-using-crisprcas9-for-functional-screening-at-chis-2nd-annual-symposium-crispr-mechanisms-and-applications-chis-14th-discovery-on-target-919-9222/

LIVE 9/19 9:40 – noon CRISPR Engineering Lymphoma Lines & Will Interference from CRISPR Silence RNAi? CHI’s 2nd Annual Symposium CRISPR: Mechanisms and Applications @ CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/19/live-919-940-noon-crispr-engineering-lymphoma-lines-will-interference-from-crispr-silence-rnai-chis-2nd-annual-symposium-crispr-mechanisms-and-applications-chis-14th/

LIVE 9/19 1:40 – 3:20 EMERGING APPLICATIONS OF CRISPR/CAS9 at CHI’s 2nd Annual Symposium CRISPR: Mechanisms and Applications @ CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/19/live-919-140-320-emerging-applications-of-crisprcas9-at-chis-2nd-annual-symposium-crispr-mechanisms-and-applications-chis-14th-discovery-on-target-919-9222016/

LIVE 9/19 4PM – 5:30PM NK CELL-BASED CANCER IMMUNOTHERAPY @CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/19/live-919-4pm-530pm-nk-cell-based-cancer-immunotherapy-chis-14th-discovery-on-target-919-9222016-westin-boston-waterfront-boston/

LIVE 9/20 8AM to noon GENE THERAPIES BREAKTHROUGHS at CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/20/live-920-8am-to-noon-gene-therapies-breakthroughs-at-chis-14th-discovery-on-target-919-9222016-westin-boston-waterfront-boston/

LIVE 9/20 2PM to 5:30PM New Viruses for Therapeutic Gene Delivery at CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/20/live-920-2pm-to-530pm-new-viruses-for-therapeutic-gene-delivery-at-chis-14th-discovery-on-target-919-9222016-westin-boston-waterfront-boston/

LIVE 9/21 8AM to 10:55 AM Expoloring the Versatility of CRISPR/Cas9 at CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/21/live-921-8am-to-1055-am-expoloring-the-versatility-of-crisprcas9-at-chis-14th-discovery-on-target-919-9222016-westin-boston-waterfront-boston/

LIVE 9/21 8AM to 2:40PM Targeting Cardio-Metabolic Diseases: A focus on Liver Fibrosis and NASH Targets at CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/21/live-921-8am-to-240pm-targeting-cardio-metabolic-diseases-a-focus-on-liver-fibrosis-and-nash-targets-at-chis-14th-discovery-on-target-919-9222016-westin-boston-waterfront-b/

LIVE 9/21 12:50 pm Plenary Keynote Program at CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/21/live-921-1250-pm-plenary-keynote-program-at-chis-14th-discovery-on-target-919-9222016-westin-boston-waterfront-boston/

LIVE 9/21 3:20PM to 6:40PM KINASE INHIBITORS FOR CANCER IMMUNOTHERAPY COMBINATIONS & KINASE INHIBITORS FOR AUTOIMMUNE AND INFLAMMATORY DISEASES at CHI’s 14th Discovery On Target, 9/19 – 9/22/2016, Westin Boston Waterfront, Boston

https://pharmaceuticalintelligence.com/2016/09/21/live-921-320pm-to-640pm-kinase-inhibitors-for-cancer-immunotherapy-combinations-kinase-inhibitors-for-autoimmune-and-inflammatory-diseases-at-chis-14th-discovery-on-target-919/

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Real Time Coverage of the AGENDA for Powering Precision Health (PPH) with Science, 9/26/2016, Cambridge Marriott Hotel, Cambridge, MA

Reporter: Aviva Lev-Ari, PhD, RN

Boston Marriott Cambridge – September 26, 2016

@PPHSUMMIT

7:00-8:15         Coffee & Registration

8:30-9:30         Opening
                         Kevin Hrusovsky
                         PPH Summit Founder and Chair, CEO Quanterix    

LIVE @ Marriott, Cambridge Aviva Lev-Ari streaming live from Powering Precision Health Summit

Apple and Steve Jobs – Returned to Apple after Pixar – Jobs has teamed up with Microsoft.

Innovations @Apple: iPhone, iPad, iPod, TV Apple,

Innovations @High Tech Industry in the World: Uber, Facebook, Robots,

Science – leads the revolution and DISRUPTIVE innovations

Medicine – Cardiology, Neurology, Oncology: INFLAMMATION markers

  • Speakers Affiliations
  • Collaborations
  • Leaders in the field
  • 5% Patient Advocacy; 10% Investors, 20% Providers, SCIENTISTS

PRECISION HEALTH: DIGITAL REVOLUTION AND HEALTH

  • lower costs on HC 40%, shift to prevention, 60% better access
  • Sick care: Japan and France HC more productive – Life expectency is 8 yrs hight than the US
  • Cancer, diabetes, In the US 31 out of 100,ooo reaches +100 yrs of age
  • Cancer Women: BRCA
  • Cancer Men: Prostate Cancer: PSA >10 – riskhigher
  • Sugar consumption in the USA  – 216 Liters/person
  • Obesity and Diabetes
  • Food addiction: Salt, fat, sugar: 2/3 of the populations are obese
  • Omega 6 overload – inflammation
  • Neurological disease:
  1. AD starts at 50 in some cases
  2. Concussions in Sports 5-10% – leading to neurodegenerative diseases
  3. Bicycle accidents at kids: no monitoring
  4. Drug as environmental factor – TOXICITY: depression, Schisophrenia, cardiac Arythmia
  • Digitizing biomarkers & Analytics: extreme specificity and sensitivity of Inflammation markers: Lowest DETECTION marker levels
  • LIQUID BIOPSY – ACCURATE NON-INVASIVE – 20B THE MARKET FOR LIQUID BIOPSY
  • Epigenetics: Twin Studies: Proteins – detections –
  1. Suppression Inflammation Surveilence
  2. Braf mutations – therapy
  3. Cardiology: Mediteranean diet
  4. Troponin-I: Can be seen before symptoms emerges
  5. WEARABLE DEVICES: Detection >> Prevention >> Treatment Sick Care >>> HealthCare
  6. unique opportunity to REVOLUTIONIZE MEDICINE – help patients sooner

Powering Precision Health with Science                          
Compelling technological and scientific advances are fueling a proposition that today’s healthcare can be radically improved and made more effective, accessible and economical by deploying disruptive technologies to carefully guide healthy living.  The potential for shifting our innovation focus from disease diagnostics and treatment (sick care) to early detection and disease prevention (precision healthcare) will be explored in oncology, neurology and cardiology as well as their underlying inflammation pathways.  Mobilizing this transformation requires the democratization of health assessments with digital technology, big data and wellness studies coupled with comprehensive policy and provider reconfiguration that incentivizes healthy living and “accountable” care.  Significant precision health advances are being realized in certain parts of the world and providing a credible blueprint for its potential.   Catalyzing our Precision Health initiative requires scientists, innovators, physicians, providers, regulators, investors and patient advocates to unite and build a collective vision for Precision Health.

Oncology                                         
9:30-10:45
9:30- 9:40       Introductions: Oncology Innovator Panel
                        Kevin Hrusovsky PPH Summit Founder and Chair, CEO Quanterix

 David Walt, PhD, Tufts University

Infectious disease 

  1. Single molecule array (simoa) – digitization of signals beads in Alisas – beads loaded on disc array
  2. Serum Cytokines – IL-10 and IL-8: at sub-femtomolar concentrations

Vaccination study: injection of these Cytokines: Human serum cytokine, baseline – COntrol Healthy Samples

Variation inter subjects in cytokine levels: Day One response evolution of th eImmune response

  • day reported illness
  • cytokine fluctuation
  • cytokine expression levels
  • IgG Simoa sensitivity (secondary infection); IgM (primary infection)

ONCOLOGY: Early Detection of Breast Cancer

Future technology:

  • sensitive detection for BRCA
  • 6-12% false positive in Mamography
  • Breast cancer Biomarkers: Singleplex Simeo assays
  • 8X-1000X improved sensitivity
  • Assay tested in commercial kits
  • SimOa for miRNA detection: 66 patients tested, prior to therapy: Marker 1,2,3

Individual protein assay were multiplexed

  1. Three protein Signature: PLS-DA Classification: 84% precision Health vs BRCA Stage II
  2. Sensitivity/specificity: on Biomarkers in BLOOD: 95.9% accuraccy Health vs. diagnosed BRCA

Protein Biomarkers in serum samples – cells secret, cells are invovled with mutations

  • find binding agents

                                                   

Robert Weinberg, PhD,  MIT /Whitehead Institute

  •  Early detection in colonoscopy is significant
  • Breast CA – early detection  and effect on mortality: 705 OF WOMEN AT 85 have BRCA
  • response to drugs in Cancer; diagnosis of relapse
  • reduce Cancer Mortality ONLY by reduction of inscidence not early detection which – DX and TX does not change mortality – acquired somatic mutation
  • Circulating tumor Cells & CIrculating DNA – Sequencing is very limited in its applicability for BRCA
  • Genomics data integration iwth gene expression
  • Reincentivise the young  – Pharma and Diagnostics — need to fund Postdocs in Academia

John Houston, PhD
                         Formerly SVP Bristol Myers Squibb   

  • What is real and what is doable
  • Advanced   Melanoma: markable accomplishments
  • why some patients respond and why others do not – Biomarkers
  • Combination drug  therapy in Oncology
  • signature for response and non-response is critical
  • Platform to capture data in retrospect

Phil Stephens, PhD
Foundation Medicine

  1. 10,000 patients with cancer mutations
  2. biomarkers for Target Therapy
  3. combinations need be Target and immuno
  4. Bladder Cancer is example were sequencing did help
  5. RNA and DNA and beyond: making sequencing data on metastatic disease
  6. diagnostic Industry needs regulation – Some Texts are not accurate and do not assists

Discussion Moderator: Kevin   – Biomarkers other Technologies mRNA, Liquid Biopsy                                      
                                                                                                                
9:40-10:00       Keynote Address Oncology:
                         David Walt, PhD
                         Tufts University

Beyond Genomics: Disruptive Approaches to Cancer and Infectious Disease Diagnostics
We have used the single molecule array  technology to screen dozens of potential biomarkers for their ability to diagnose various diseases and predict clinical outcomes.  The single molecule array technology has been used primarily for protein detection but is also applicable to the detection of nucleic acids, including DNA, mRNA, and microRNA, without any amplification.  Ultra-high sensitivity enables the detection of both protein and nucleic acid biomarkers at concentrations previously undetectable in blood. After measuring the candidate biomarkers, we employ classification algorithms to down-select the most informative biomarkers that correlate with the clinical information.  We have employed this approach to discover serum biomarkers for monitoring individuals over extended periods for infectious disease and for early detection of breast cancer.

10:00-10:45     Oncology Innovator Panel Discussion
Revolutionizing Oncology with Disruptive Technologies to Prevent, Detect, and Treat Cancer

10:45-11:15      Coffee break

Neurology                                       
11:15-12:30     Introductions: Neurology Innovator Panel
                      Kevin Hrusovsky
                      PPH Summit Founder and Chair, CEO Quanterix

Robert Stern, PhD
Boston University, School of Medicine, BU Alzheimer’s Disease and CTE Center
                                               

Doug Cole, MD – Neurologist and investor – Flagship Ventures
                                              

  1. no powerful tools to understand AD 20 years ago,
  2. Tools are now available – in 5-20 years tools will allow for Treatment development
  3. Societal issue – leadership at University Presidents, Sports organization – grass root pressure like with No Smoking
  4. commonality needs be explore across diseases to establish syndroms shared that will enable development of disease management and treatment

 

Jesse M. Cedarbaum, MD – Biogen 
                                                

  1. Neurologist – worked with MS, Parkinson, AD – did not work with CTE
  2. Soccer – Contact with the ball  – effect the structure of exon, synapsis, beta protein
  3. TOOLS: Genetic risk allowing to play short or long durations
  4. Football, soccer, baseball and tennis
  5. WE NEED LARGE POOLS OF NEUROLOGICAL DISEASES IN PATIENTS – BECAUSE  there are common proteins involved and comorbidities vs present participation in clinical trials by diagnosis
  6. all studies for Parkinson are not analysed in the context of AD
  7. PCP needs tool to diagnose AD better than today the diagnosis is done
  8. in Military training vibrations that causes CTE
                                                 

Tim Fox
                                               Former NFL Safety, Sports Commentator                                                  
           Peter Cronin
                                               Former NFL Linebacker                                       

11:15-11:25     Tim Fox
                       Former NFL Safety, Sports Commentator  
                       Personal Perspective on The Impact of Repeated Concussions and CTE                 

11:25-11:45      Keynote Address Neurology:
                        Robert Stern, PhD
                        Boston University, School of Medicine, BU Alzheimer’s Disease and CTE Center

Diagnosing Chronic Traumatic Encephalopathy (CTE) During Life: Potential Fluid and Neuroimaging Biomarkers                           
Chronic Traumatic Encephalopathy (CTE) is a unique neurodegenerative disease associated with a history of repetitive head impacts, including concussive and sub-concussive trauma, such as that experienced by contact sport athletes (e.g., American football players, boxers). Currently CTE can only be diagnosed through postmortem neuropathological examination demonstrating the pathognomonic lesions of perivascular phosphorylated tau (p-tau) at the depths of the cortical sulci. The ability to diagnose CTE during life is critically important to understanding the epidemiology of the disease, as well as the examination of specific risk factors (e.g., head impact exposure, genetics) and the ability to conduct clinical trials for treatment and prevention. This talk will describe recent findings in the development of possible in vivo biomarkers for CTE, including Simoa plasma total tau, plasma exosomal tau, as well as tau PET imaging.

LIVE @PPHSUMMIT 

  • $60Million NIH Grants
  • Awareness, Prevention, Management
  • Repetitive Head Impacts vs Concussions
  1. effect on neuronal functioning
  2. even one season causes cognitive, physiological changes in the brain
  3. Boxing for long time
  4. long time consecquences – Neuropathology
  5. CTE – brain trauma, leads to progressive neuro-degeneration
  • post consussion disease without symptoms of concussion
  • like AD, microtubule-Associated Protein Tau – misfolded hyperphosphorilated form of tau (p-tau): Perivascular and Depth of Solci — >>>> Spread of areas with distruction
  • Why it was not commonly observed ??
  • CTE and Public Health: Contact Sports – REPETITIVE IMPACT
  • Exposure: Severity and type of trauma
  • rest between hits
  • CTE vs PTSD, other injuries
  • Diagnose during life: develop in vivo biomarkers
  • How to create Biomarkers: DETECT Study: 100 NFL players vs Control – no sport involvement
  • All imaging were not specific to Tau detection –
  • Brain PET Tau Imaging developed: Invasive, expensive, we need a blood test
  • Tau deposits
  • Blood based Biomarkers for CTE – high sensitivity — FOllow up blood screening
  • Plasma Exosomal Tau: Exosomes are cell-derived nanovescicles: Blood, saliva, urine
  • generation of Neuronal Exosomes – extracellular space
  • Exosomes isolation required – Measure Tau in Blood
  • Quanterix_ Plasma total Tau – simoa HD-1
  • Results: plasma T-Tau – difference NFL and control – NFL – Extreme T-Tau COncentration
  • How to refine and validate Plasma T-Tau?
  • relevance to AD – modify early predict sympthoms – Using DIgital Biomarkers
  • Precision Health: Prevention and Tx of CTE:
  • Concussions & subconclusive Hits >>> PreClinical, >>> Clinical CTE not dimented >> CTE Dementia= synaptic loss

11:45-11:55        Peter Cronin
Former NFL Linebacker
Personal Perspective on The Urgent Need For Detection and Treatment of CTE

  • concussion with memory loss, mood changes,

11:55-12:30     Neurology Innovator Panel Discussion
Revolutionizing Neurology with Disruptive Technologies: Prevent, Detect and Treat
Concussions/CTE

  • AD – we know what the proteins are, subtype of diseases – tools and technology
  • Advancement when a test will allow to discern

 

 

12:30-1:15       Buffet style lunch

1:15-3:30         Scientific Tracks

Track 1 – Neurology – not attended
1:15-1:40         Jessica Gill, PhD, RN                 The Role of Proteomic Biomarkers of Brain Injuries
                         National Institute of Health
1:40-2:05         Danielle Graham, PhD               Accelerating exploratory fluid biomarker assay development in
Biogen                                       Neurodegenerative Disease
2:05-2:25         Alison Joyce, PhD                      Development of a Sensitive Homebrew Simoa Assay to Detect
Pfizer Inc                                    Leucine-Rich Repeat Kinase 2 (LRRK2)
2:25–3:00         Cheryl Wellington, PhD              Toward Precision Medicine in Canada: Two vignettes
                         University of British Columbia                   
3:00-3:25         Miriam Moscovitch-Lopatin       An Ultra-Sensitive Simoa Immunoassay for Quantifying BDNF
                          MGH                                          Levels in CSF in Early Huntington Disease: A Longitudinal PRE-
CELL Biomarker Study

Track 2 – Cardiology, Oncology, Inflammation, Infectious Disease

1:30-2:00         Ralph McDade, PhD      Ex-Luminex    Myriad RBM     

Triphase approach to biomarker pattern discovery for cancer immunotherapy and autoimmune disease

  • Bi-Polar vs Depression – Diagnosis
  • nostics for Depression Kit to determine which anti-depressant drug to prescribe
  • xMAP Technology – immuno-assays
  • 96 well plate
  • robotic liquid handling – assay precision and reproducability
  • proprietary matrix blockers
  • Myriad Genetics is the Parent company
  • Validation Parameters
  • CLIA certified ELISA Amono assay
  • Analyte: TNF-alpha, IFN-gamma (no marker in RA), IL-1 beta, IL-6, IL-17A
  • DIsease state samples – RA – IL-1Betta
  • Multiplexing
                                                             

2:00-2:30         John Yan                                     An Ultrasensitive Assay Format for Detecting PD/Biomarkers in
Takeda Pharmaceutical Co          Cell and Xenograft Tumor

  • ULK1 important Autophage Initiating Kinase
  • mTOR – -/+mTor treated with ULK1

                       
2:30-3:00         Rama Boyanapalli, PhD              The long and winding road to a highly sensitive RANKL Assay
                         Shire Company

  • RANKL IS A PART OF THE NECROTIC FACTOR (TNF)
  • PROTEIN BIOMARKER RANKL AND BONE STRENGTH (bone resorption) and bone formation – Vitamin D PGE@
  • Commercial Kits available:Recombinant and Serum based
  • IMOA technology ultrasensitive
  • Antibody Selection: R&D System DUoSet human RANKL ELISA selection-
  1. Capture Ab sonjugate to beads – MOUSE MONCLONAL
  2. Detector Ab – GOAT POLYCLONAL
  3. tested 12 commercially available Abs
  4. Additional assay optimization
  5. Criteria for QUALIFYING AN ASSAY:
  • ASSAY SPECIFICITY
  • MINIMUM REQUIRED DILUTION
  • PRECISION
  • Calibration curves with varying calibrator levels – for precision studies
  • Comparing Simoa to ELISA Kit: RANKL concentration

 

3:00-3:30         Bonnie J. Howell, PhD                 Ultrasensitive Detection of Viral p24 Following Reactivation of
Merck                                          Latent HIV

  • HIV Biology
  • tratment
  • reservoir detection
  • HIV — affects t-Cells — AIDS
  • life cycle of HIV-1
  • Viral RNA, recapaged to virom and start another cycle of infection
  • Treatment of ANtiviral therapies (ART)
  • Persistent replication of the virus
  • HIV Vure Means?
  • Sterilization / eradicated of HIV free
  • Remission/Functional
  • get of ART for few years
  • latent vells survuve deceased activation
  • latent reservoir homeostatic proliferation
  • latent cell reactivation
  • reactivation
  • Where do they hide?
  • HIV – CNS, Gut, GI, GU, Bone marrow,
  • Estimation 1 per million resting CD4 – Quantifying the HIV Rservoir
  1. different PCR- and Culture based assays used to measure reservoir
  2. poor correlation between assay
  3. >95% provirus is defective – does not produce Vyron
  4. Quanterix SImoa digital ELISA for ultrasensitive HIV p24 protein detection
  5. serum convert stage – makes measurement of reservoir difficult
  6. Merck optimized ultrasensitive p24 immunoasay
  7. p24 detectd in gnotypically diverse HIV clinical isolates
  8. HIV-1, CPZ, HIV-2, SIV-MM
  9. Virus to kill strategy: IMMUNO-therapy – measuring protein so importent
  10. Shock and kill
  • Cells with latent HIV with
  • cells with activated HIV
  • Induction in ART-suppresant
  • T-cell activation with stimulation Suppresant p24 Increases with reservoir size in most pt.
  • PMA/Ionomycin, CD4+ T-cell Lysate as measured by TILDA
  • HDACi induces p24 Expression in ART Suppressed HIV + Patients CD4+
  • Latency-Reversing Agents
  • Treatment with Multiple doses of Vorinostat
  • Gag RNA – Assay: Baseline vs Post-VOR – HIV pt received 10 doses VOR administared in 72 hours
  • Two doses of Vorinostat
  • Dilution series

SUMMARY

p24 digital ELISA improves assay sensitivity and selectivity

p24 detected in genotypically diverse HIV clinical isolates
                         
3:30-4:00         Coffee Break

 

Cardiology and Inflammation

                                     
4:00-4:10         Introductions: Cardiology/Inflammation Panel
                         Kevin Hrusovsky
PPH Summit Founder and Chair

                                                  Dennis Ausiello, MD
                                                  Mass General HospitalEmeritus
                                                   Petr Jarolim, MD, PhD
 
Brigham and Women’s HospitalDana Farber Cancer Institute 
Grace Colon, PhD
 InCarda Therapeutics, Inc. and ProterixBio, Inc.                                                            

4:10-4:30        Keynote Address Cardiology/Inflammation
                        Dennis Ausiello, MD
                        Mass General HospitalEmeritus

Mobilizing Precision Health is Within Reach
The data revolution, from genetic to digital, has provided a compelling need to assess wellness and its progression to disease. This is in direct contrast to the long standing approach in medicine of episodic and symptomatic measurement of disease and its progression to morbidity and mortality. Compelling data and science are fueling a proposition that today’s healthcare can be radically improved and made more effective, accessible and economical by deploying disruptive technologies to carefully monitor and guide healthy living.  We will explore the real potential of pre-symptomatic assessment of the human condition independent of time and place, with an improvement in disease prevention. Democratizing health assessments and monitoring with mobile devices, smart phones and community drug stores is an important opportunity for enabling early detection, preventative medicine and precision health.  Establishing disruptive detection technology and sampling strategies across multiple biomarker panels is key to enabling this vision.

4:30 -5:15        Cardiology and Inflammation Innovator Panel Discussion
Revolutionizing Cardiology with Disruptive Technologies: Prevent, Detect and Treat Cardiovascular
Disorders and Diabetes

5:15-5:30         Chair Summary and Summit Close

5:30-7:30         Cocktail Reception

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