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Posts Tagged ‘Venture capital’

From Biospace News: GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ)-Backed VC Firm Medicxi Launches $250 Million Fund For Life Science Startups

Reporter: Stephen J. Williams, PhD

original article: http://www.biospace.com/News/glaxosmithkline-and-johnson-johnson-backed-vc-firm/407338/source=TopBreaking


Press release

Medicxi Ventures, Formerly Index Ventures Life Sciences, Launches as an Independent Venture Capital Firm and Announces Closing of a €210m Fund including GSK and Johnson & Johnson Innovation

LONDON, GENEVA and JERSEY, February 2, 2016 /PRNewswire/ —

  • Medicxi Ventures comprises all of the existing life sciences team, portfolio company investments and life sciences funds of Index Ventures
  • GSK and Johnson & Johnson Innovation expand their commitment to the asset-centric approach
  • Index Ventures technology practice remains unchanged

Medicxi Ventures, a new venture capital firm comprising all of the existing life sciences portfolio companies, funds and team from Index Ventures, today announces the close of Medicxi Ventures 1 (MV1), a new €210 million ($250 million) fund that will focus on early-stage life sciences investments. MV1 will predominantly invest in Europe and principally follow the “asset-centric” strategy pioneered by its partners at Index.

By investing in MV1, GlaxoSmithKline (GSK) and Johnson & Johnson Innovation – JJDC, Inc. (JJDC) have renewed and expanded their commitment to the asset-centric approach, following the prior investment in Index Life 6 (IL-6) alongside other financial investors.

Medicxi Ventures starts its operations as one of the largest independent European life sciences focused investment firms. The Company’s mission is to focus on strengthening R&D innovation by providing solutions to unmet medical needs. Collaboration with pharmaceutical companies will continue to be a key strategy helping the firm to deliver on this mission.

Medicxi Ventures will be managed by four General Partners, Francesco De Rubertis, David Grainger, Kevin Johnson and Michèle Ollier, all of whom previously led the life sciences practice of Index Ventures. The four partners will form the executive management of the new firm.

Francesco De Rubertis, General Partner of Medicxi Ventures, said: “We are excited to take this next step in our evolution as a life sciences focused investment firm. A high percentage of the drugs approved every year by the FDA were discovered in European academic labs. By working in close partnership with academia, biotech and the pharmaceutical industry, we are committed to translating this high quality science in Europe into effective new medicines.”

He added: “It has been a privilege working with Neil Rimer, Giuseppe Zocco and the other tech partners at Index Ventures for the last 20 years and we have benefitted from their expertise in investing in and building high growth entrepreneurial companies.”

Dr Moncef Slaoui, Chairman Global Vaccines and GSKs representative on Medicxis Scientific Advisory Board, commented on the announcement: “We are delighted to support the Medicxi team and this early stage investment fund. We believe in the potential to create an exciting pipeline of new medicine candidates by collaborating and investing with an asset-centric model. The team at Medicxi has a proven track record in partnering with world-class entrepreneurs and scientists to translate disruptive science from academia and industry into new medicines with demonstrable patient benefits.”

Dr Richard Mason, Head, Johnson & Johnson Innovation, London, commented: “Johnson & Johnson Innovation is focused on enabling and advancing all stages of science and technology across the world’s most robust innovation ecosystems. We are optimistic that applying the asset-centric investment model of Medicxi across Europe and beyond will uncover the new and highly differentiated science and technology that is needed to turn early stage research into viable products and patient solutions. We are delighted to work closely with the Medicxi team to help increase the productivity and likelihood of success for the life sciences innovation community throughout the region. ”

The Scientific Advisory Board of the new fund will include some of the top R&D and business development executives from the two pharmaceutical companies as well as Medicxi-appointed executives. As in IL-6, the two pharmaceutical companies have not received any specific rights to the portfolio companies.

Neil Rimer, co-founder of Index Ventures, said: “The creation of Medicxi Ventures as a new entity is a natural evolution given that Index’ life sciences team has been operating autonomously within the firm for several years. Whilst Index and Medicxi will operate independently, we retain close ties and look forward to continuing to share ideas and expertise.”

Notes for Editors

About Medicxi Ventures

Medicxi Ventures is based in London, Geneva and Jersey. It comprises all of the legacy portfolio companies, funds and the life sciences team of Index Ventures, and a new €210 million fund (MV1) that will focus on early-stage investments in life sciences. The Company’s mission is to invest and collaborate along the full healthcare continuum focusing on drug discovery and development and pharmaceutical innovation. Leading healthcare companies, GSK and Johnson & Johnson Innovation-JJDC are investors in Medicxi Ventures’ funds.

Medicxi Ventures’ team has been investing in life sciences for over 20 years and has backed many successful companies, including Genmab (Nasdaq Copenhagen: GEN), PanGenetics (sold to AbbVie), Molecular Partners (SWX: MOLN), XO1 (sold to Janssen) Egalet (EGLT), Minerva Neurosciences (NERV) and Versartis (VSAR).

Please see http://www.medicxiventures.com for more information.

About the Medicxi Ventures Executive Team

  • Francesco De Rubertis joined Index in 1997 to lead the firm’s life sciences activity and has been involved with and overseen all of the investments that Index has made in life sciences
  • David Grainger joined Index in 2012. Prior to this, David led an internationally recognised research group in Cambridge University’s Department of Medicine, where he published more than 80 first author papers in leading journals including Nature, Science and Nature Medicine. He is an inventor on more than 150 patents and patent applications.
  • Kevin Johnson has been working with Index since 2003. He focuses on life sciences, especially drug development companies and was part of the management team that floated Cambridge Antibody Technology on the London Stock Exchange. Two of his products, Humira (Abbott Pharmaceutical) and Benlysta (Human Genome Sciences, GSK), are now on the market.
  • Michèle Ollier joined Index in 2006. She has spent more than 15 years in several development and marketing positions at Sanofi International, Bristol-Myers Squibb, RPR/Gencell/Aventis international and Serono International.

For further information, please contact:

Francesco De Rubertis
General Partner, Medicxi Ventures
francesco@medicxiventures.com
+44(0)207-154-2020

Katja Stout, Sylvie Berrebi
Citigate Dewe Rogerson
katja.stout@citigatedr.co.uk
Sylvie.berrebi@citigatedr.co.uk
+44(0)207-638-9571

Bill Douglass
Gotham Communications LLC
bill@gothamcomm.com
+1(646)504-0890

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Philly Biotech Scene: November 2015 PCCI Meeting Showcasing ViFant (Penn Center For Innovation)

Reporter: Stephen J. Williams, PhD

Meeting Announcement: Pharmaceutical Consultant Consortium International Announces Presentation by ViFant and Penn Center For Innovation

As announced on the PCCI website:

PCCI invites you to attend a presentation by:

VIFANT (Penn Center for Innovation)

Monday, November 9, 2015, 6:30PM; at the Chesterbrook (Wayne, PA) Embassy Suites Hotel (directions below)

Sponsored by:

To register please click on www.rxpcci.com and follow directions

Vifant is committed to delivering innovative, cost-effective, mobile solutions for the early identification of vision impairment in verbal, non-verbal and pre-verbal patients as young as two months of age.

Early detection of vision problems improves treatment outcome, simplifies treatment and may prevent irreversible neurological damage and blindness. Accurate vision testing in pre-verbal and non-verbal patients is an unmet goal of pediatricians, family doctors, ophthalmologists, early education programs and parents who are interested in discovering vision programs in infants and children as early as possible in order to optimize vision outcomes. Unfortunately, only one-third of all children in the US have had a vision screening test or visual examination prior to entering school as  existing early childhood screening devices detect only risk factors with high false-positive and false-negative rates.

Vifant’s vision acuity test app uses the established principle of optcokinetic nystagmus (OKN) which is the eyes’ reflexive, spontaneous  response to moving patterns that does not need to be instructed or learned. The app is downloaded to a mobile tablet form and the tablet’s front-facing camera and screen provide stimulus and detection of eye movement to allow for identification of the eyes’ response to moving targets. The Vifant vision acuity test is patent protected and is reimbursable under the existing CPT code 99174. In addition to conventional points of service, Vifant’s mobility and ease of use fit well in a telemedicine strategy broadening the patient pool that will benefit from the test.

PROGRAM

6:30: Cocktails and Dinner; there will be a cash bar and a special two-entrée buffet

8:30 Beth DeSouza, CEO, will deliver the Company”s “Elevator” pitch to the group.

8:20: A panel will address three major issues crucial to helping the Company reach the next level. Vifant has submitted the following questions:

  1. Reimbursement challenges and opportunities:Does return on investment on early detection and intervention for a large number of patients outweigh costly treatments later from the payers perspectives and therefore warrant coverage in health plans? What is the role of consumers (parents, caretakers) as payers.
  2. Business model: Subscription fee per HCP or fee per test? Is there a play for remote result interpretation (telemedicine) right away or should it wait?
  3. Competitive landscape: What will be the competitors’ response to Vifant’s entry into the pediatric vision screening space.

 9:00: Q&A session

Remember to register: click on www.rxpcci.com and follow directions

Dinner price for members is a flat $40; Parking is free!

Lifetime dues for new members are still $100; join PCCI and your first dinner will be ON US!

Bring a friend and/or a business colleague! You know that our meetings a livelier and more interesting than ever.

The Embassy Suites Hotel provides an excellent facility, more room and a fine menu.

Every PCCI meeting is webcast. The webcast recording of the PCCI meetings will be posted on the PCCI website “rxpcci.com” and webcast live via the internet during the event.

Directions: Take Rt 202 to the Chesterbrook exit (that’s two exits South of the Devon exit), turn Right at the end of the Exit ramp and you’ll see the hotel at your Right. If you are going North on 202, get off at the Chesterbrook Exit and turn Left at the traffic light and drive back over Rt 202. You’ll see the hotel at your Right. Proceed to the traffic light and turn Right into the parking lot of the hotel. Their phone is: 610 647 6700.

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

Reporter: Stephen J. Williams, Ph.D.

Article ID #170: Podcast Review: Quiet Innovation Podcast on Obtaining $ for Your Startup. Published on 3/12/2015

WordCloud Image Produced by Adam Tubman

 

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

Reporter: Stephen J. Williams, PhD

Article ID #169: Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting. Published on 3/11/2015

WordCloud Image Produced by Adam Tubman

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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  • Oracle Industry Connect Presents Their 2015 Life Sciences and Healthcare Program

 

Reporter: Stephen J. Williams, Ph.D. and Aviva Lev-Ari, Ph.D., R.N.

oraclehealthcare

Copyright photo Oracle Inc. (TM)

 

Transforming Clinical Research and Clinical Care with Data-Driven Intelligence

March 25-26 Washington, DC

For more information click on the following LINK:

https://www.oracle.com/oracleindustryconnect/life-sciences-healthcare.html

oracle-healthcare-solutions-br-1526409

https://www.oracle.com/industries/health-sciences/index.html  

Oracle Health Sciences: Life Sciences & HealthCare — the Solutions for Big Data

Healthcare and life sciences organizations are facing unprecedented challenges to improve drug development and efficacy while driving toward more targeted and personalized drugs, devices, therapies, and care. Organizations are facing an urgent need to meet the unique demands of patients, regulators, and payers, necessitating a move toward a more patient-centric, value-driven, and personalized healthcare ecosystem.

Meeting these challenges requires redesigning clinical R&D processes, drug therapies, and care delivery through innovative software solutions, IT systems, data analysis, and bench-to-bedside knowledge. The core mission is to improve the health, well-being, and lives of people globally by:

  • Optimizing clinical research and development, speeding time to market, reducing costs, and mitigating risk
  • Accelerating efficiency by using business analytics, costing, and performance management technologies

 

  • Establishing a global infrastructure for collaborative clinical discovery and care delivery models
  • Scaling innovations with world-class, transformative technology solutions
  • Harnessing the power of big data to improve patient experience and outcomes

The Oracle Industry Connect health sciences program features 15 sessions showcasing innovation and transformation of clinical R&D, value-based healthcare, and personalized medicine.

The health sciences program is an invitation-only event for senior-level life sciences and healthcare business and IT executives.

Complete your registration and book your hotel reservation prior to February 27, 2015 in order to secure the Oracle discounted hotel rate.

Learn more about Oracle Healthcare.

General Welcome and Joint Program Agenda

Wednesday, March 25

10:30 a.m.–12:00 p.m.

Oracle Industry Connect Opening Keynote

Mark Hurd, Chief Executive Officer, Oracle

Bob Weiler, Executive Vice President, Global Business Units, Oracle

Warren Berger, Author of “A More Beautiful Question: The Power of Inquiry to Spark Breakthrough Ideas.”

12:00 p.m.–1:45 p.m.

Networking Lunch

1:45 p.m.–2:45 p.m.

Oracle Industry Connect Keynote

Bob Weiler, Executive Vice President, Global Business Units, Oracle

2:45 p.m.–3:45 p.m.

Networking Break

3:45 p.m.–5:45 p.m.

Life Sciences and Healthcare General Session

Robert Robbins, President, Chief Executive Officer, Texas Medical Center

Steve Rosenberg, Senior Vice President and General Manager Health Sciences Global Business Unit, Oracle

7:00 p.m.–10:00 p.m.

Life Sciences and Healthcare Networking Reception

National Museum of American History
14th Street and Constitution Avenue, NW
Washington DC 20001

Life Sciences Agenda

Thursday, March 26

7:00 a.m.–8:00 a.m.

Networking Breakfast

8:00 a.m.–9:15 a.m.

Digital Trials and Research Models of the Future 

Markus Christen, Senior Vice President and Head of Global Development, Proteus

Praveen Raja, Senior Director of Medical Affairs, Proteus Digital Health

Michael Stapleton, Vice President and Chief Information Officer, R&D IT, Merck

9:15 a.m.–10:30 a.m.

Driving Patient Engagement and the Internet of Things 

Howard Golub, Vice President of Clinical Research, Walgreens

Jean-Remy Behaeghel, Senior Director, Client Account Management, Product Development Solutions, Vertex Pharmaceuticals

10:30 a.m.–10:45 a.m.

Break

10:45 a.m.–12:00 p.m.

Leveraging Data and Advanced Analytics to Enable True Pharmacovigilance and Risk Management 

Leonard Reyno, Senior Vice President, Chief Medical Officer, Agensys

 

Accelerating Therapeutic Development Through New Technologies 

Andrew Rut, Chief Executive Officer, Co-Founder and Director, MyMeds&Me

12:45 a.m.–1:45 p.m.

Networking Lunch

1:45 p.m.–2:30 p.m.

Oracle Industry Connect Keynote

2:30 p.m.–2:45 p.m.

Break

2:45 p.m.–3:15 p.m.

Harnessing Big Data to Increase R&D Innovation, Efficiency, and Collaboration 

Sandy Tremps, Executive Director, Global Clinical Development IT, Merck

3:15 p.m.–3:30 p.m.

Break

3:30 p.m.–4:45 p.m.

Transforming Clinical Research from Planning to Postmarketing 

Kenneth Getz, Director of Sponsored Research Programs and Research Associate Professor, Tufts University

Jason Raines, Head, Global Data Operations, Alcon Laboratories

4:45 p.m.–6:00 p.m.

Increasing Efficiency and Pipeline Performance Through Sponsor/CRO Data Transparency and Cloud Collaboration 

Thomas Grundstrom, Vice President, ICONIK, Cross Functional IT Strategies and Innovation, ICON

Margaret Keegan, Senior Vice President, Global Head Data Sciences and Strategy, Quintiles

6:00 p.m.–9:00 p.m.

Oracle Customer Networking Event

Healthcare Agenda

Thursday, March 26

7:00 a.m.–8:15 a.m.

Networking Breakfast

8:30 a.m.–9:15 a.m.

Population Health: A Core Competency for Providers in a Post Fee-for-Service Model 

Margaret Anderson, Executive Director, FasterCures

Balaji Apparsamy, Director, Business Intellegence, Baycare

Leslie Kelly Hall, Senior Vice President, Policy, Healthwise

Peter Pronovost, Senior Vice President, Patient Safety & Quality, Johns Hopkins

Sanjay Udoshi, Healthcare Product Strategy, Oracle

9:15 a.m.–9:30 a.m.

Break

9:30 a.m.–10:15 a.m.

Population Health: A Core Competency for Providers in a Post Fee-for-Service Model (Continued)

10:15 a.m.–10:45 a.m.

Networking Break

10:45 a.m.–11:30 a.m.

Managing Cost of Care in the Era of Healthcare Reform 

Chris Bruerton, Director, Budgeting, Intermountain Healthcare

Tony Byram, Vice President Business Integration, Ascension

Kerri-Lynn Morris, Executive Director, Finance Operations and Strategic Projects, Kaiser Permanente

Kavita Patel, Managing Director, Clinical Transformation, Brookings Institute

Christine Santos, Chief of Strategic Business Analytics, Providence Health & Services

Prashanth Kini, Senior Director, Healthcare Product Strategy, Oracle

11:30 a.m.–11:45 a.m.

Break

11:45 a.m.–12:45 p.m.

Managing Cost of Care in the Era of Healthcare Reform (Continued)

12:45 p.m.–1:45 p.m.

Networking Lunch

1:45 p.m.–2:30 p.m.

Oracle Industry Connect Keynote

2:30 p.m.–2:45 p.m.

Break

2:45 p.m.–3:30 p.m.

Precision Medicine 

Annerose Berndt, Vice President, Analytics and Information, UPMC

James Buntrock, Vice Chair, Information Management and Analytics, Mayo Clinic

Dan Ford, Vice Dean for Clinical Investigation, Johns Hopkins Medicine

Jan Hazelzet, Chief Medical Information Officer, Erasmus MC

Stan Huff, Chief Medical Information Officer, Intermountain Healthcare

Vineesh Khanna, Director, Biomedical Informatics, SIDRA

Brian Wells, Vice President, Health Technology, Penn Medicine

Wanmei Ou, Senior Product Strategist, Healthcare, Oracle

3:30 p.m.–3:45 p.m.

Networking Break

3:45 p.m.–4:30 p.m.

Precision Medicine (Continued)

4:30 p.m.–4:45 p.m.

Break

6:00 p.m.–9:00 p.m.

Oracle Customer Networking Event

Additional Links to Oracle Pharma, Life Sciences and HealthCare

 
Life Sciences | Industry | Oracle <http://www.oracle.com/us/industries/life-sciences/overview/>

http://www.oracle.com/us/industries/life-sciences/overview/

 
Oracle Corporation

 
Oracle Applications for Life Sciences deliver a powerful combination of technology and preintegrated applications.

  • Clinical

<http://www.oracle.com/us/industries/life-sciences/clinical/overview/index.html>

  • Medical Devices

<http://www.oracle.com/us/industries/life-sciences/medical/overview/index.html>

  • Pharmaceuticals

<http://www.oracle.com/us/industries/life-sciences/pharmaceuticals/overview/index.html>

 
Life Sciences Solutions | Pharmaceuticals and … – Oracle <http://www.oracle.com/us/industries/life-sciences/solutions/index.html>

http://www.oracle.com  Industries  Life Sciences

 
Oracle Corporation

 
Life Sciences Pharmaceuticals and Biotechnology.

 
Oracle Life Sciences Data Hub – Overview | Oracle <http://www.oracle.com/us/products/applications/health-sciences/e-clinical/data-hub/index.html>

http://www.oracle.com  …  E-Clinical Solutions

 
Oracle Corporation

 
Oracle Life Sciences Data Hub. Better Insights, More Informed Decision-Making. Provides an integrated environment for clinical data, improving regulatory …

 
Pharmaceuticals and Biotechnology | Oracle Life Sciences <http://www.oracle.com/us/industries/life-sciences/pharmaceuticals/overview/index.html>

http://www.oracle.com/us/…/life-sciences/…/index.html

 
Oracle Corporation

 
Oracle Applications for Pharmaceuticals and Biotechnology deliver a powerful combination of technology and preintegrated applications.

 
Oracle Health Sciences – Healthcare and Life Sciences … <https://www.oracle.com/industries/health-sciences/>

https://www.oracle.com/industries/health-sciences/

 
Oracle Corporation

 
Oracle Health Sciences leverages industry-shaping technologies that optimize clinical R&D, mitigate risk, advance healthcare, and improve patient outcomes.

 
Clinical | Oracle Life Sciences | Oracle <http://www.oracle.com/us/industries/life-sciences/clinical/overview/index.html>

http://www.oracle.com  Industries  Life Sciences  Clinical

 
Oracle Corporation

 
Oracle for Clinical Applications provides an integrated remote data collection facility for site-based entry.

 
Oracle Life Sciences | Knowledge Zone | Oracle … <http://www.oracle.com/partners/en/products/industries/life-sciences/get-started/index.html>

http://www.oracle.com/partners/…/life-sciences/…/index.ht&#8230;

 
Oracle Corporation

 
This Knowledge Zone was specifically developed for partners interested in reselling or specializing in Oracle Life Sciences solutions. To become a specialized …

 
[PDF]Brochure: Oracle Health Sciences Suite of Life Sciences … <http://www.oracle.com/us/industries/life-sciences/oracle-life-sciences-solutions-br-414127.pdf>

http://www.oracle.com/…/life-sciences/oracle-life-sciences-s&#8230;

 
Oracle Corporation

 
Oracle Health Sciences Suite of. Life Sciences Solutions. Integrated Solutions for Global Clinical Trials. Oracle Health Sciences provides the world’s broadest set …

 

 

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The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC

Curator: Stephen J. Williams, Ph.D.

Article ID #166: The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC. Published on 2/10/2015

WordCloud Image Produced by Adam Tubman

 

 

philly philly2night

 

 

 

 

 

 

 

This post is the second in a series of posts highlighting interviews with Philadelphia area biotech startup CEO’s and show how a vibrant biotech startup scene is evolving in the city as well as the Delaware Valley area. Philadelphia has been home to some of the nation’s oldest biotechs including Cephalon, Centocor, hundreds of spinouts from a multitude of universities as well as home of the first cloned animal (a frog), the first transgenic mouse, and Nobel laureates in the field of molecular biology and genetics. Although some recent disheartening news about the fall in rankings of Philadelphia as a biotech hub and recent remarks by CEO’s of former area companies has dominated the news, biotech incubators like the University City Science Center and Bucks County Biotechnology Center as well as a reinvigorated investment community (like PCCI and MABA) are bringing Philadelphia back. And although much work is needed to bring the Philadelphia area back to its former glory days (including political will at the state level) there are many bright spots such as the innovative young companies as outlined in these posts.

efavirenz_med-2In today’s post, I had the opportunity to talk with molecular modeler Charles H. Reynolds, Ph.D., founder and CEO of Gfree Bio LLC, a computational structure-based design and modeling company based in the Pennsylvania Biotech Center of Bucks County. Gfree is actually one of a few molecular modeling companies at the Bucks County Biotech Center (I highlighted another company RabD Biotech which structural computational methods to design antibody therapeutics).

Below is the interview with Dr. Reynolds of Gfree Bio LLC and Leaders in Pharmaceutical Business Intelligence (LPBI):

LPBI: Could you briefly explain, for non-molecular modelers, your business and the advantages you offer over other molecular modeling programs (either academic programs or other biotech companies)? As big pharma outsources more are you finding that your company is filling a needed niche market?

GfreeBio: Gfree develops and deploys innovative computational solutions to accelerate drug discovery. We can offer academic labs a proven partner for developing SBIR/STTR proposals that include a computational or structure-based design component. This can be very helpful in developing a successful proposal. We also provide the same modeling and structure-based design input for small biotechs that do not have these capabilities internally. Working with Gfree is much more cost-effective than trying to develop these capabilities internally. We have helped several small biotechs in the Philadelphia region assess their modeling needs and apply computational tools to advance their discovery programs. (see publication and collaboration list here).

LPBI: Could you offer more information on the nature of your 2014 STTR award?

GfreeBio: Gfree has been involved in three successful SBIR/STTR awards in 2014.   I am the PI for an STTR with Professor Burgess of Texas A&M that is focused on new computational and synthetic approaches to designing inhibitors for protein-protein interactions. Gfree is also collaborating with the Wistar Institute and Phelix Therapeutics on two other Phase II proposals in the areas of oncology and infectious disease.

LPBI: Why did you choose the Bucks County Pennsylvania Biotechnology Center?

GfreeBio: I chose to locate my company at the Biotech Center because it is a regional hub for small biotech companies and it provides a range of shared resources that are very useful to the company. Many of my most valuable collaborations have resulted from contacts at the center.

LPBI: The Blumberg Institute and Natural Products Discovery Institute has acquired a massive phytochemical library. How does this resource benefit the present and future plans for GfreeBio?

GfreeBio: To date Gfree Bio has not been an active collaborator with the Natural Products Insititute, but I have a good relationship with the Director and that could change at any time.

LPBI: Was the state of Pennsylvania and local industry groups support GfreeBio’s move into the Doylestown incubator? Has the partnership with Ben Franklin Partners and the Center provided you with investment and partnership opportunities?

GfreeBio: Gfree Bio has not been actively seeking outside investors, at least to date. We have been focused on growing the company through collaborations and consulting relationships. However, we have benefitted from being part of the Keystone Innovation Zone, a state program that provides incentives for small technology-based businesses in Pennsylvania.

LPBI: You will be speaking at a conference in the UK on reinventing the drug discovery process through tighter collaborations between biotech, academia, and non-profit organizations.  How do you feel the Philadelphia area can increase this type of collaboration to enhance not only the goals and missions of nonprofits, invigorate the Pennsylvania biotech industry, but add much needed funding to the local academic organizations?

GfreeBio: I think this type of collaboration across sectors appears to be one of the most important emerging models for drug discovery.   The Philadelphia region has been in many ways hard hit by the shift of drug discovery from large vertically integrated pharmaceutical companies to smaller biotechs, since this area was at the very center of “Big Pharma.” But I think the region is bouncing back as it shifts more to being a center for biotech. The three ingredients for success in the new pharma model are great universities, a sizeable talent pool, and access to capital. The last item may be the biggest challenge locally. The KIZ program (Keystone Innovation Zone) is a good start, but the region and state could do more to help promote innovation and company creation. Some other states are being much more aggressive.

LPBI: In addition, the Pennsylvania Biotechnology Center in Bucks County appears to have this ecosystem: nonprofit organizations, biotechs, and academic researchers. Does this diversity of researchers/companies under one roof foster the type of collaboration needed, as will be discussed at the UK conference? Do you feel collaborations which are in close physical proximity are more effective and productive than a “virtual-style” (online) collaboration model? Could you comment on some of the collaborations GfreeBio is doing with other area biotechs and academics?

GfreeBio: I do think the “ecosystem” at the Pennsylvania Biotechnology Center is important in fostering new innovative companies. It promotes collaborations that might not happen otherwise, and I think close proximity is always a big plus. As I mentioned before, many of the current efforts of Gfree have come from contacts at the center.   This includes SBIR/STTR collaborations and contract work for local small biotech companies.

LPBI: Thompson Reuters just reported that China’s IQ (Innovation Quotient) has risen dramatically with the greatest patents for pharmaceuticals and compounds from natural products. Have you or your colleagues noticed more competition or business from Chinese pharmaceutical companies?

GfreeBio: The rise of Asia, particularly China, has been one of the most significant recent trends in the pharmaceutical industry. Initially, this was almost exclusively in the CRO space, but now China is aggressively building a fully integrated domestic pharmaceutical industry.

LPBI: How can the Philadelphia ecosystem work closer together to support greater innovation?

GfreeBio: A lot has happened in recent years to promote innovation and company creation in the region. There could always be more opportunities for networking and collaboration within the Philadelphia community. Of course the biggest obstacle in this business is often financing. Philadelphia needs more public and private sources for investment in startups.

LPBI: Thank you Dr. Reynolds.

Please look for future posts in this series on the Philly Biotech Scene on this site

Also, if you would like your Philadelphia biotech startup to be highlighted in this series please contact me: sjwilliamspa@comcast.net or @StephenJWillia2.
Our site is read by ~ 570,000 readers, among them thousand international readers daily and followed by thousands of Twitter followers.

 

Other posts on this site in this VIBRANT PHILLY BIOTECH SCENE SERIES OR referring to PHILADELPHIA BIOTECH include:

RAbD Biotech Presents at 1st Pitch Life Sciences-Philadelphia

The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC

What VCs Think about Your Pitch? Panel Summary of 1st Pitch Life Science Philly

1st Pitch Life Science- Philadelphia- What VCs Really Think of your Pitch

LytPhage Presents at 1st Pitch Life Sciences-Philadelphia

Hastke Inc. Presents at 1st Pitch Life Sciences-Philadelphia

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

Pfizer Cambridge Collaborative Innovation Events: ‘The Role of Innovation Districts in Metropolitan Areas to Drive the Global an | Basecamp Business

Mapping the Universe of Pharmaceutical Business Intelligence: The Model developed by LPBI and the Model of Best Practices LLC

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8:30AM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

8:30 a.m. Harvard Business School Case Study: 23andMe

Harvard Business School Case Study: 23andMe

It is now a tradition and a unique feature of the Harvard Personalized Medicine Conference that Richard Hamermesh, a professor at Harvard Business School,  ‟teaches” a case as he does for the students at HBS. This year Professor Hamermesh has selected a couple of cases that were written about the company 23andMe. As usual, this case study will be highly interactive and educational. If you have not participated in one of these case studies at our Conference, you do not want to miss it!

23andMe – Harvard Business School Case Study

Leader:

Richard Hamermesh, D.B.A. @HarvardHBS

MBA Class of 1961 Professor of Management
Practice; Faculty Chair, HBS Healthcare Initiative, Harvard Business School

Two cases on 23andMe @23andMe

Active Group Discussion:

  • Customer very young in 20s and 30s – curiosity of sophisticated consumers
  • Personal interest in Private medical condition give illnesses in the family
  • Genotyping vs sequencing, only whole sequencing gives all variants
  • False Advertisement of the Service: on MNSBC, other
  • Do you allow your data to be used in Research vs and be sold to Pharma and be paid for sharing the data by the 23andMe
  • Price dropped from $250 to $99
  • 15 years from Now — No harm to Consumer, much data on Human Genome collected and Personal Medical Conditions improved by acting on information revealed by Genomics
  • 23andMe placed the Platform since genetic information was not otherwise available — They Pioneer with innovation on behalf of the Consumer
  • VC encourages Innovators to push the envelop – 23andMe did that with Private funding by Eugene Brin from Google
  • QUALITY OF INTERPRETATION OF GENOMICS information is key and it is improving

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

@HarvardPMConf

#PMConf

@SachsAssociates

@HarvardHBS

@harvardmed

@23andMe

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4:00PM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

4:00 p.m. Panel Discussion Novel Approaches to Personalized Medicine

Novel Approaches to Personalized Medicine

Genetic and genomic knowledge is helping the development of new drugs, therapies and prognostic tests. As a result, there are new approaches, new partnerships and new business models that are emerging. In some cases, diseases that were considered incurable not too long ago are now being tackled with highly targeted therapies. In other cases the uncertainties associated with assessing potential aggressiveness of disease are being eliminated. This panel will provide examples of new business paradigms that are emerging from the application of personalized medicine.

Novel Approaches to Personalized Medicine

Moderator:

Meghan FitzGerald, Ph.D. @cardinalhealth
President, Cardinal Health Specialty Solutions

Chief Genome Officer – next steps in companies, Genomics Index will replace the Biotech Index

Most Interesting person in Genomics: Marc Levin,

Panelists:

2. Chris Garabedian @Sarepta
President and CEO, Sarepta

  • Applications of genomics to Infectious diseases, therapeutics – design of drugs, Duchenne Muscular Dystrophy (DMD)
  • technology safe working, one drug very effective, 60 alternative drugs, not enough patients to power clinical trials

 

4. Shawn Marcell
President & CEO, Metamark Genetics

  • Prostatic Cancer – Use of genomics tools to diagnose and treat Prostate cancer
  • US market is the best for Genomics innovations because venture capital Market is mature, FDA is negotiable, CMP well established
  • Business model: platform, good test big market, commercialize, clinical data — PM has a different Business model: Delivery of Test results need to be different
  • IPO 2016

 

1. Scott Schell, M.D., Ph.D. – surgical oncology @KEWGroup
President and CEO, KEW Group

  • Large scale platform, strategic partnerships with Oncology Practices,
  • Immuno oncologists, repository of data
  • 80% of cancers are treated in the community 20% at Academic centers. Integration of knowledge, patients wish to stay in the community
  • phase I approval at record high levels

3. Gabriel Bien-Willner, M.D., Ph.D. @MolecularHealth
Medical Director, MolecularHealth, Inc.

  • Diagnostics Tools in Analytics. Clinicians do not have the training in Genomics – position firm to create Lab reports and consulting MDs using Analytics for Clinicians

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

@HarvardPMConf

#PMConf

@SachsAssociates

@cardinalhealth

@Sarepta

@KEWGroup

@MolecularHealth

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11:30AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

 

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

11:30 Personalized Medicine Coalition Award &  Award Recipient Speech

Presentation of Personalized Medicine Coalition’s 10th Annual Award for Leadership in Personalized Medicine.

Personalized Medicine Coalition Award Recipient

Mark J. Levin
Co-Founder and Partner
Third Rock Ventures, LLC

Presenter:

Brian Munroe
PMC Founder and Senior Vice President, Government Affairs
Endo

 Award in Science, Business Policy to individual to lead PM – Mark Levin

 

 

  • was at Ely Lilly in the 70s leading supplier of Insulin in the 20s and antibiotics in the 30s,Factor 8, pain drugs, chemotherapy
  • was at Genentech – Human growth Hormone and Human Insulin — both are PM, Interferon,
  • was at Mayfield Ventures
  • was at Millenium, CEO, early 90s, monoclonal antibodies
  • 2000 discussion on the need for PMC
  • Founder of Foundation Medicine – molecular informatics – expands therapeutics and PM
  • NOW — with Third Rock Ventures, LLC

 

Mark Levin – award acceptance speech – Team accomplishments most important

We need to thank the patients participating in Clinical Trials

  1. How I got involved in personalized medicine (PM): High School – Human Biology
  2. Genetics – drive
  3. PM – All diseases – genetic disorders — combination with extreme phenotyping, Muscular Dystrophy – splicing a gene for treatment
  4. Drugability and PM – gene therapy, replace factor, deliver a gene to the brain and the drug. inside CSF
  5. Gene editing – deliver to the Brain correct the gene in the Brain – therapy for ALS, Schizophrenia – understanding the genes involved in this disease, same
  6. Cancer cure – treatment of combination therapies several at the same time vs present time treat one other emerges
  7. cancer vaccine
  8. Sample of blood – proteomics — in Annual Exams at MDs Annual physical
  9. Convergent — comparison of Mutation across to 1000 patient’s mutations
  10. Future is MOST exciting
  11. Challenges of the Future: Biology and Technology, cells in microbiome, 10 million genes, SYSTEM BIOLOGY — will lead the way,
  12. FUNDING SCIENCE via NIH Scientist is the most important National task
  13. Preventative and Prognostics Medicine -need be part of DRUG development
  14. Justification – maximize value for patient vs $$ spent – maximum value – waste and no leadership
  15. Concern — Affordability of Healthcare to All, access to care vs economic Inequality
  16. Leadership and Management: We truly need NATIONAL CONVERSATION — with a Leader with set of goals to solve a problem in certain time
  17. Insurance, Pharma, HMO — budget challenge — attendees inn the room, need to provide leadership at the National Level

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

@HarvardPMConf

#PMConf

@SachsAssociates

@VCapitalGuide

@hgbc_harvard

@MassBio

@MALifeSciences

@FierceBiotech

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Geneticist George Church: A Future Without Limits

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #155: Geneticist George Church: A Future Without Limits. Published on 10/24/2014

WordCloud Image Produced by Adam Tubman

UPDATED 12/05/2020

 

In the future, George Church believes, almost everything will be better because of genetics. If you have a medical problem, your doctor will be able to customize a treatment based on your specific DNA pattern. When you fill up your car, you won’t be draining the world’s dwindling supply of crude oil, because the fuel will come from microbes that have been genetically altered to produce biofuel. When you visit the zoo, you’ll be able to take your children to the woolly mammoth or passenger pigeon exhibits, because these animals will no longer be extinct. You’ll be able to do these things, that is, if the future turns out the way Church envisions it—and he’s doing everything he can to see that it does.

UPDATED 12/05/2020

George Church backs a startup solution to the massive gene therapy manufacturing bottleneck

Source: https://endpts.com/george-church-backs-a-startup-solution-to-the-massive-gene-therapy-manufacturing-bottleneck/
Jason Mast: Associate Editor
George Church and his graduate students have spent the last decade seeding startups on the razor’s edge between biology and science fiction: gene therapy to prevent aging, CRISPRed pigs that can be used to harvest organs for transplant, and home kits to test your poop for healthy or unhealthy bacteria. (OK, maybe they’re not all on that razor’s edge.)

But now a new spinout from the Department of Genetics’ second floor is tackling a far humbler problem — one that major company after major company has stumbled over as they tried to get cures for rare diseases and other gene therapies into the clinic and past regulators: How the hell do you build these?

CEO Lex Vovner of 64x Bio

“There’s a lot happening for new therapies but not enough attention around this problem,” Lex Rovner, who was a post-doc at Church’s lab from 2015 to 2018, told Endpoints News. “And if we don’t figure out how to fix this, many of these therapies won’t even reach patients.”

This week, with Church and a couple other prominent scientists as co-founders, Rovner launched 64x Bio to tackle one key part of the manufacturing bottleneck. They won’t be looking to retrofit plants or build gene therapy factories, as Big Pharma and big biotech are now spending billions to do. Instead, with $4.5 million in seed cash, they will try to engineer the individual cells that churn out a critical component of the therapies.

George Church
The goal is to build cells that are fine-tuned to do nothing but spit out the viral vectors that researchers and drug developers use to shuttle gene therapies into the body. Different vectors have different demands; 64x Bio will look to make efficient cellular factories for each.

“While a few general ways to increase vector production may exist, each unique vector serotype and payload poses a specific challenge,” Church said in an emailed statement. “Our platform enables us to fine tune custom solutions for these distinct combinations that are particularly hard to overcome.”

Before joining Church’s lab, Rovner did her graduate work at Yale, where she studied how to engineer bacteria to produce new kinds of protein for drugs or other purposes. And after leaving Church’s lab in 2018, she initially set out to build a manufacturing startup with a broad focus.

Yet as she spoke with hundreds of biotech executives on LinkedIn and in coffee shops around Cambridge, the same issue kept popping up: They liked their gene therapy technology in the lab but they didn’t know how to scale it up.

“Everyone kept saying the same thing,” Rovner said. “We basically realized there’s this huge problem.”

The issue would soon make headlines in industry publications: bluebird delaying the launch of Zynteglo, Novartis delaying the launch of Zolgensma in the EU, Axovant delaying the start of their Parkinson’s trial.

Part of the problem, Rovner said, is that gene therapies are delivered on viral vectors. You can build these vectors in mammalian cell lines by feeding them a small circular strand of DNA called a plasmid. The problem is that mammalian cells have, over billions of years, evolved tools and defenses precisely to avoid making viruses. (Lest the mammal they live in die of infection).

There are genetic mutations that can turn off some of the internal defenses and unleash a cell’s ability to produce virus, but they’re rare and hard to find. Other platforms, Rovner said, try to find these mutations by using CRISPR to knock out genes in different cells and then screening each of them individually, a process that can require hundreds of thousands of different 100-well plates, with each well containing a different group of mutant cells.

“It’s just not practical, and so these platforms never find the cells,” Rovner said.

64x Bio will try to find them by building a library of millions of mutant mammalian cells and then using a molecular “barcoding” technique to screen those cells in a single pool. The technique, Rovner said, lets them trace how much vector any given cell produces, allowing researchers to quickly identify super-producing cells and their mutations.

The technology was developed partially in-house but draws from IP at Harvard and the Wyss Institute. Harvard’s Pam Silver and Wyss’s Jeffrey Way are co-founders.

The company is now based in SoMa in San Francisco. With the seed cash from Fifty Years, Refactor and First Round Capital, Rovner is recruiting and looking to raise a Series A soon. They’re in talks with pharma and biotech partners, while they try to validate the first preclinical and clinical applications.

Gene therapy is one focus, but Rovner said the platform works for anything that involves viral vector, including vaccines and oncolytic viruses. You just have to find the right mutation.

“It’s the rare cell you’re looking for,” she said.

AUTHOR
Jason Mast
Associate Editor
jason@endpointsnews.com
@JasonMMast
Jason Mas

In 2005 he launched the Personal Genome Project, with the goal of sequencing and sharing the DNA of 100,000 volunteers. With an open-source database of that size, he believes, researchers everywhere will be able to meaningfully pursue the critical task of correlating genetic patterns with physical traits, illnesses, and exposure to environmental factors to find new cures for diseases and to gain basic insights into what makes each of us the way we are. Church, tagged as subject hu43860C, was first in line for testing. Since then, more than 13,000 people in the U.S., Canada, and the U.K. have volunteered to join him, helping to establish what he playfully calls the Facebook of DNA.

Church has made a career of defying the impossible. Propelled by the dizzying speed of technological advancement since then, the Personal Genome Project is just one of Church’s many attempts to overcome obstacles standing between him and the future.

“It’s not for everyone,” he says. “But I see a trend here. Openness has changed since many of us were young. People didn’t use to talk about sexuality or cancer in polite society. This is the Facebook generation.” If individuals were told which diseases or medical conditions they were genetically predisposed to, they could adjust their behavior accordingly, he reasoned. Although universal testing still isn’t practical today, the cost of sequencing an individual genome has dropped dramatically in recent years, from about $7 million in 2007 to as little as $1,000 today.

“It’s all too easy to dismiss the future,” he says. “People confuse what’s impossible today with what’s impossible tomorrow.”, especially through the emerging discipline of “synthetic” biology. The basic idea behind synthetic biology, he explained, was that natural organisms could be reprogrammed to do things they wouldn’t normally do, things that might be useful to people. In pursuit of this, researchers had learned not only how to read the genetic code of organisms but also how to write new code and insert it into organisms. Besides making plastic, microbes altered in this way had produced carpet fibers, treated wastewater, generated electricity, manufactured jet fuel, created hemoglobin, and fabricated new drugs. But this was only the tip of the iceberg, Church wrote. The same technique could also be used on people.

“Every cell in our body, whether it’s a bacterial cell or a human cell, has a genome,” he says. “You can extract that genome—it’s kind of like a linear tape—and you can read it by a variety of methods. Similarly, like a string of letters that you can read, you can also change it. You can write, you can edit it, and then you can put it back in the cell.”

This April, the Broad Institute, where Church holds a faculty appointment, was awarded a patent for a new method of genome editing called CRISPR (clustered regularly interspersed short palindromic repeats), which Church says is one of the most effective tools ever developed for synthetic biology. By studying the way that certain bacteria defend themselves against viruses, researchers figured out how to precisely cut DNA at any location on the genome and insert new material there to alter its function. Last month, researchers at MIT announced they had used CRISPR to cure mice of a rare liver disease that also afflicts humans. At the same time, researchers at Virginia Tech said they were experimenting on plants with CRISPR to control salt tolerance, improve crop yield, and create resistance to pathogens.

The possibilities for CRISPR technology seem almost limitless, Church says. If researchers have stored a genetic sequence in a computer, they can order a robot to produce a piece of DNA from the data. That piece can then be put into a cell to change the genome. Church believes that CRISPR is so promising that last year he co-founded a genome-editing company, Editas, to develop drugs for currently incurable diseases.

Source: news.nationalgeographic.com

See on Scoop.itCardiovascular and vascular imaging

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