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LIVE Day Two: 2019 MassBio Annual Meeting, State of Possible Conference, Sonesta Hotel, Cambridge, March 28, 2019

http://files.massbio.org/file/MassBio-State-Of-Possible-Conference-Agenda-Feb-22-2019.pdf

Leaders in Pharmaceutical Business Intelligence (LPBI) Group

represented by Founder & Director, Aviva Lev-Ari, PhD, RN will cover this event in REAL TIME using Social Media

@pharma_BI

@AVIVA1950

#StateofPossible19

 

Day 2 Agenda – March 28, 2019

Possible Talk – The New Role of Police: Creating Non-Arrest Pathways to Treatment and Recovery Conference Wide 3/28/2019 8:45:00 AM 3/28/2019 9:00:00 AM
Future of Human Biology: How we are Already Evolving Ourselves Conference Wide 3/28/2019 9:00:00 AM 3/28/2019 9:45:00 AM
Possible Talk – The Evolution of the Investment Landscape to Support Future Innovations in Biotech Conference Wide 3/28/2019 9:45:00 AM 3/28/2019 10:00:00 AM
CFIUS: Proposed Rules Impacting Global Investments for Biotech Breakout – Business Track 3/28/2019 10:15:00 AM 3/28/2019 11:00:00 AM
Exploring the Possibilities of Microbiome Beyond GI Diseases Breakout – Science Track 3/28/2019 10:15:00 AM 3/28/2019 11:00:00 AM
Advancing from ‘R’ to ‘D’: Various Routes to Building Successful Clinical-stage Companies Breakout – Science Track 3/28/2019 11:30:00 AM 3/28/2019 12:15:00 PM
Financing Outlook for 2019-2020: Will the Bubble Burst? Breakout – Business Track 3/28/2019 11:30:00 AM 3/28/2019 12:15:00 PM
Lunch & Henri Termeer Innovative Leadership Award Conference Wide 3/28/2019 12:15:00 PM 3/28/2019 1:15:00 PM
Enabling Digital Health in the Healthcare Value Chain Conference Wide 3/28/2019 1:15:00 PM 3/28/2019 2:00:00 PM

Day 2 Agenda – March 28, 2019

8:15am – 8:45am: Breakfast

8:45am – 9:00am: Possible Talk

Possible Talk – The New Role of Police: Creating Non-Arrest Pathways to Treatment and Recovery

  • Treatment of excellence in opiods draws patients fro all the MA state to Boston Programs and from Outside of MA
  • 94% walking on the door receive referrals to treatment centers in MA
  • Prediction of the future of persistence of the phonomenon
  • Funding partnerships for reducing time in treatment due to efficacy and patients engagement
  • 500 police personnel are involved in Treatment available on Demand referral
  • Substance abuse programs that work using institutions as problem solvers
  • Urgent and important because people die every day

 

9:00am – 9:45am: Future of Human Biology: How we are Already Evolving Ourselves

Megan Thielking, STAT News

  • Ethics of Human germ line
  • George M. Church PhD, Professor of Genetics, Harvard Medical School
  1. Multiplexing and gene editing for reverse aging
  2. Doing to much by adding new forms somatic therapies feedback loop is long from young adults to aging
  3. Small pox: Gene therapy can becaome non expensive
  • Juan Enriquez, Managing Director, Excel Venture Management, Prof. @Harvard in Genomics and Manage Start up in Genomics
  1. conception – identical twins bred 20 years apart
  2. fetus external to body and male can have children
  • Greg Verdine, President, CEO & CSO, Board Member, LifeMine
  1. Embryos IVF,, fully sequence the embroy and
  2. Democratice technologies at high school age –
  3. Educators will play a role for informed decisions public education
  4. AI harder to democratize
  5. Ethics consideration in patient selection for certification

9:45am – 10:00am: Possible Talk – 

Possible Talk – The Evolution of the Investment Landscape to Support Future Innovations in Biotech

  • communication what Biotech do, how position biotech start up and how raise fund
  • Thematic Investing: ALPHA CURRENTS: AI, Medical Technologies, communication technologies
  • Mother test – Communication of thoughts

 

10:15am – 11:00am: CFIUS: Proposed Rules Impacting Global Investment for Biotech [Business Track]

  • Review committee foreign investment, purchasing entire company –
  • new regulation 8% foreign investment is the largest allowed share as equity position and
  • not to negatively affect cyber security and national security
  • In BioTech (i.e. gene editing technologies developed already overseas and all other ecosystems
  • Green Card Holder investor are not excempt of CFIUS is different that US Citizen Investors which are exempts
  • Vikas Goyal, Principal, S. R. One, GlasxoSK Limited
  • Linda Ji, Partner, McDermott Will & Emory
  1. Disclosure about the investment and investors
  2. neurotech, genetics, genomics
  3. Critical tech in Biotech: Foundational vs
  4. US EXPERT CONTROLLED Technology
  5. License needed for licensing US EXPERT CONTROLLED Technology
  6. CFIUS does not handle licensing
  • Lisa Schaefer, Director of Financial Services and Tax Policy, Biotechnology Innovation Organization (BIO)
  1. Expert controlled technology
  2. AI in Drug discovery -is emerging foundational technology
  • Johhy Hu – VC in Boston – FUND owners are Swiss & Italian citizenship

10:15am – 11:00am: Exploring the Possibilities of Microbiome Beyond GI Diseases [Science Track]

  • David Donabedian, Co-founder, CEO & Director, Axial Biotherapeutics
  • Justin Chakma, Head of BD and Strategy, Vedanta
  • Chris Howerton, Biotechnology Equity Analyst, Jeffries

11:00am – 11:30am: Networking Break 

11:30am – 12:15pm: Advancing from ‘R’ to ‘D’: Various Routes to Building Successful Clinical-stage Companies [Science Track]

  • Laura Indolfi, Founder & CEO, PanTher Therapeutics
  • Sven Karlsson, Co-Founder, CEO,& CBO, Platelet Biogenesis
  • Leslie Williams, Director, Founder, President and CEO, ImmusanT

11:30am – 12:15pm: Financing Outlook for 2019-2020: Will the Bubble Burst? [Business Track]

  • Bruce Booth, Partner, Atlas Ventures
  1. Great time of capital rich, 2018 2Q – largest M&A in Biotech
  2. staggering increase in funding
  3. capital is flowing not from VCs, bur large hedge funds and foreign investment – China related 40% and Abu Dabi invest in Biotech
  4. First IPO in 2012 was Biotech
  5. Investor more selective and descerned : Preclinical Phase 1
  6. 2009-2010 – cool off market
  7. 2019 at constructive market for growing companies

 

  • Kathy Bersteinsson, Morgan Stanley 
  1. $30 Billion in 2018
  2. 8 IPO, back
  3. 2019 will be constructive, capital for biotech ecosysytem 50Billion needed, @25 Billion is secured without convertibles
  4. back log of IPO for 2Q in 2019
  5. investors wish 30% returns – adjust IPO valuation some are 1.5 times and fees on top
  6. Investors willing to participate VC not participate in good markets
  7. Good IPO no VCs
  8. Oncology, Selling genes, CNS
  9. Maturing the crop takes time

 

  • Christine Brennan, Partner, MRL Ventures Fund, Merck US
  1. RNA landscape
  2. oncology

 

  • Barbara Dalton, Pfizer Ventures
  1. Neurosciences, Biogen failure, need for new drugs
  2. Newrodegeneration
  3. Venture group does invest in neuro because Pfizer left Neuro
  4. investment in IMMUNITY
  5. M&A pipeline to move the needle does not happens for small biotech
  6. Pfizer and all BIG Pharma do not but even though Tax Reform favor Big Pharma

 

  • Steve Wilcox, Lawyer – largest Biotech
  1. what is hot and not
  2. Option to Purchase is lousy for sellers you cap the upper bound

 

12:15pm – 1:15pm: Lunch and MassBio Innovation Award Presentation

  • Lita Nelson, fear of genetics lead to development of 1980s legislation ownership and Patent exploitation by institutions, Universities started to collect royalties from Tech Transfer, Gov’t supported 120 Billion in basic research since the 70s.
  • 200 Research Universities and Hospitals Tech Transfer Office research shows:
  • 6300 licenses granted
  • early investment in innovations – in MA, 30 years ago no Pharma in MA today 18 of 20 big Pharma are in Cambridge and other locations in mA
  • People: accelerate biotech faced scarce talent not scarce capital
  • networking – dense clusters in Cambridge
  • Cambridge is the envy of the World in BioTech

 

1:15pm – 2:00pm: Enabling Digital Health in the Healthcare Value Chain

Moderator: Hussain Mooraj, Delloitte

  • Jeff Elton, CEO, Concerto Health AI
  • Cluster of centers of excellence
  • Moderna, VP IT
  1. cross pollination =: CS + Biology form MIT
  2. Top management understand technologies in Biotech
  3. data collection
  4. blueprint to design a digital platform – from the start to do it right vs retrofits at later stage

 

  • Luba Greenwood, Google – Verily – IP was the asset in 2019 it is the DATA  not the IP – use of data to improve drug discovery
  1. Starting up a Biotech company
  2. Advice is available

 

  • ThermoFischer – R&D DIgital Science,
  • Pear Therapeutics, Brooke Paige, VP, Alliance ManagementBrooke Page

2:00pm – 2:30pm: Keynote Address

 

2:30pm – 3:00pm: Closing Networking Dessert Reception

@@@@@

8:15am – 8:45am: Breakfast

8:45am – 9:00am: Possible Talk

9:00am – 9:45am: Future of Human Biology: How we are Already Evolving Ourselves Humans began changing our environment early on through fire, agriculture and early medicines, and later with biopharmaceuticals and even CRISPR babies. Come hear futurists in human biology offer provocative thoughts on how we can wisely and ethically embrace next generation science to change our own DNA. – George M. Church Phd, Professor of Genetics, Harvard Medical School – Juan Enriquez, Managing Director, Excel Venture Management – Greg Verdine, President, CEO & CSO, Board Member, LifeMine

9:45am – 10:00am: Possible Talk

10:15am – 11:00am: CFIUS: Will New Regulatory Threats Reduce Global Investment in Biotech? [Business Track] CFIUS’ newly expanded scope and authority have the potential to severely disrupt investment in the U.S. biotech sector. A new federal law now includes biotechnology on a list of 27 “critical” industries where all foreign investment must be reviewed by the CFIUS office. With this new rule in place, questions abound about its impact on the biotech industry. Will raising money take longer? Will it deter foreign investors? Will it limit companies’ leverage during investment negotiations? Come hear legal, investor, and company experts discuss what companies and investors need to know about CFIUS’ impact on future investments in biotech companies. – Vikas Goyal, Principal, S. R. One, Limited – Linda Ji, Partner, McDermott Will & Emory – Lisa Schaefer, Director of Financial Services and Tax Policy, Biotechnology Innovation Organization (BIO)

10:15am – 11:00am: Exploring the Possibilities of Microbiome Beyond GI Diseases [Science Track] The specific balance of bacteria in your gut affects your digestive system, but new research also shows these bacteria affect your behavior, energy, heart, brain and other unexpected organ systems. Pioneers in microbiome expound on the possibilities. – David Donabedian, Co-founder, CEO & Director, Axial Biotherapeutics – Justin Chakma, Head of BD and Strategy, Vedanta – Chris Howerton, Biotechnology Equity Analyst, Jeffries

11:00am – 11:30am: Networking Break

11:30am – 12:15pm: Advancing from ‘R’ to ‘D’: Various Routes to Building Successful Clinical-stage Companies [Science Track] Massachusetts is the epicenter of startup creation for biotech, but it’s not always easy to go from research to commercialization. Come hear founders and industry leaders offer lessons learned on intelligently scaling your company amid rapid growth including when to partner, sell or IPO, or when to build or buy preclinical, manufacturing, and clinical development capabilities. – Laura Indolfi, Founder & CEO, PanTher Therapeutics – Sven Karlsson, Co-Founder, CEO,& CBO, Platelet Biogenesis – Leslie Williams, Director, Founder, President and CEO, ImmusanT

11:30am – 12:15pm: Financing Outlook for 2019-2020: Will the Bubble Burst? [Business Track] 2018 was a record year for biotech IPOs, the XBI hit an all-time high in August, and the FDA approved a record number of novel drugs. What will 2019 bring after late 2018’s many signals of a slowing market? Will M&A pick up? Can new IPOs continue at last year’s pace? How will public markets respond? Investment bankers, private equity, and industry leaders peer into their crystal ball to predict the financial outlook for the next few years. – Bruce Booth, Partner, Atlas Ventures

12:15pm – 1:15pm: Lunch and MassBio Innovation Award Presentation

1:15pm – 2:00pm: Enabling Digital Health in the Healthcare Value Chain At its core, digital technologies are increasingly critical in enabling the growth of biotechnology companies– from the development of better research and development insight engines, to the commercialization of next generation therapies via digital channels. This panel will explore best practices that enable the embedding of digital health technologies in the value chain for both life sciences companies, payers and providers.

2:00pm – 2:30pm: Keynote Address

2:30pm – 3:00pm: Closing Networking Dessert Reception

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LIVE Day One: 2019 MassBio Annual Meeting, State of Possible Conference, Sonesta Hotel, Cambridge, March 27, 2019

http://files.massbio.org/file/MassBio-State-Of-Possible-Conference-Agenda-Feb-22-2019.pdf

Leaders in Pharmaceutical Business Intelligence (LPBI) Group

represented by Founder & Director, Aviva Lev-Ari, PhD, RN will cover this event in REAL TIME using Social Media

@pharma_BI

@AVIVA1950

#StateofPossible19

State of Possible Conference Day 1 Agenda – March 27, 2019

Session Title Session Type Start Time End Time
Breakfast & Registration 3/27/2019 8:15:00 AM 3/27/2019 8:45:00 AM
Breakfast 3/27/2019 8:15:00 AM 3/27/2019 8:45:00 AM
Keynote: State of the State of Possible: Where are we in the history of Biotech and What Lies Ahead? Conference Wide 3/27/2019 9:00:00 AM 3/27/2019 9:30:00 AM
‘Fireside Chat’ on RNAi and CRISPR: What Can the Past Teach Us and What Opportunities Await? Conference Wide 3/27/2019 9:30:00 AM 3/27/2019 10:15:00 AM
Possible Talk – The Possibilities of Gene Editing for Transforming the Practice of Medicine Conference Wide 3/27/2019 10:15:00 AM 3/27/2019 10:30:00 AM
Possible Talk – Leveraging Artificial Intelligence to Revolutionize Drug Discovery Conference Wide 3/27/2019 11:00:00 AM 3/27/2019 11:15:00 AM
Solving the Value Equation to Fix our Broken Healthcare System & Ensure Patient Access Conference Wide 3/27/2019 11:15:00 AM 3/27/2019 12:00:00 PM
Possible Talk: Opening Doors for the Future, a Patient’s Perspective Conference Wide 3/27/2019 12:00:00 PM 3/27/2019 12:15:00 PM
Early Stage Funding in the Era of Venture Creation Breakout – Business Track 3/27/2019 2:00:00 PM 3/27/2019 3:00:00 PM
From Academia to Commercialization: What’s the Threshold of Data Needed to Start a New Company? Breakout – Science Track 3/27/2019 2:00:00 PM 3/27/2019 3:00:00 PM
The Evolving Massachusetts Ecosystem: How Can we Continue to Sustain our Growth? Breakout – Business Track 3/27/2019 3:00:00 PM 3/27/2019 4:00:00 PM
Addressing the challenges of Large Population Diseases. Breakout – Science Track 3/27/2019 3:00:00 PM 3/27/2019 4:00:00 PM
The State of Neurodegenerative Disease: Drug Targets and Alternative, Patient-Centric Clinical Endpo Breakout – Science Track 3/27/2019 4:30:00 PM 3/27/2019 5:30:00 PM
Addressing the Opioid Crisis Breakout – Business Track 3/27/2019 4:30:00 PM 3/27/2019 5:30:00 PM
 

The State of Possible Celebration 3/27/2019 6:00:00 PM 3/27/2019 9:00:00 PM

 

Day 1 Agenda – March 27, 2019

8:45am – 9:00am: Welcome

9:00am – 9:30am: Keynote – State of the State of Possible: Where are we in the History of Biotech and What Lies Ahead?

  • Jeremy Levin, Chairman & CEO, Ovid Therapeutics, Inc.

No way to predict the future: rich and diverse, existential moment

  • impact of life expectancy
  • FDA in 2018 – record of Dr. Gottlieb in approval of new drugs
  • capital is flowing in LARGE amounts into innovations: new medical modalities: Gene therapy, immune oncology, RNA, CAR-T – 2500 clinical trials in immune oncology – product emerging as BIOSIMILARS
  • cell therapy, gene therapy
  • Health Insurers matters, consolidation, CIGNA partners with pharma
  • Insulin is $400 patients that can’t pay — covenant: Health Care must be universal for Economic growth considerations
  • Innovators part of the pie shrinks
  • Drug Pricing shifts the political balance
  • Bipartisan Pressure on the Pharma industry
  • WHAT IS COMING
  1. consolidations
  2. massive innovations
  3. innovations is essential – Financial burden
  4. CNS innovations – Alzermer’s Disease: Epilepsy,
  5. BIOSIMILARS: Crushing wave will create monopolies on OLD molecules PD!
  6. Organizational changes: Patient centricity using AI and precision
  7. Investors in Biotech in 2007 investors did not believe in immuno-oncology
  8. Pricing controversy – access and affordalitiry of cost out of pocket
  9. Bad democracy: if access is not to all
  10. CEO’s compensation need be tied to product innovations not to drug pricing
  11. IP Protection
  12. BIOTECH – matters: Sustainability if patient is the purpose
  13. Democracy is by all and for all

9:30am – 10:15am: ‘Fireside Chat’ on RNAi and CRISPR: What Can the Past Teach Us and What Opportunities Await?

Mike, Nikitas, Moderator

  • John Maraganore, Chief Executive Officer, Alnylam
  1. Tissue to benefit from RNA therapies only the beginning, not yet for cancer
  2. FDA has amazing scientists to continue Dr. Scott Gottlieb’s legacy
  3. Patients at the center and the Team move Science forward

Katrine Bosley, former Chief Executive Officer, Editas MedicineGenetic repair by gene deletions – as advances are achieved knowledge is shared cross projects on multiple indications

    1. regulators need to move faster as they see the innovations for tissue by gene medicine
    2. Dialog with FDA will continue Human germ line is NOT appropriate

10:15am – 10:30am: Possible Talk – Morgan Stanley

Possible Talk – The Possibilities of Gene Editing for Transforming the Practice of Medicine

Base Editing – Repair DNA

Creation of a new base editor – platform creation – platform to enable development – mammal cell lines

  • Cytidine Base Editor: (CxG -> TxA)
  • ApoE4 genetic factor fo rAlzheimer’s DIsease
  • Adenine Base Editor: (AxT ->GxC??)
  • Substrate specificity, delivery, product selectivity
  • @ BEAM Base editing as a Human Therapy 0 genetic disease faulty gene expression
  1. Gene correction,
  2. Gene regulation,
  3. Gene silencing,
  4. Gene reprogramming

Treating genetic disease ONE LETTER AT A TIME

10:30am – 11:00am: Networking Break 

11:00am – 11:15am: Possible Talk

Possible Talk – Leveraging Artificial Intelligence to Revolutionize Drug Discovery

  • Historical evolution of AI started on the 50s
  • Is Pharma ready for AI?
  • Publications on AI in Drug Discovery is th elargest growth in Publishing
  • Pharma Corporations, AI conpanies, Tech corporations
  • Potential contributions of AI to Human Biology

 

11:15am – 12:00pm: Solving the Value Equation to Fix our Broken Healthcare System & Ensure Patient Access

Margaux Hall, Moderator

  • Erin Mistry, Managing Director Pricing and Access, Syneos Health
  • Mike Bonney, Executive Chair, Kaleido Lifesciences
  1. Payers need to change their system for each new product they will reimburse for – IT system change
  2. Value based scheme are challenging due to data collections need by Payer to define contracts for VALUE definition and contract terms
  3. Will the value change on the next year is more enrolled as users?
  4. value-based constructs of therapeutics: population impact when patients start a given therapy – research shows that change in x yield favorable outcomes thus, approval of drug coverage by Payer  – ALWAYS have population effects
  5. Payors can loose cohorts and gain other cohorts by incentives
  6. Healthcare policies must be long term and not by Party election peril ti the Healthcare system
  7. Show progress that business strategy bring scoring on outcomes
  8. Saving life of patients, it is expensive, then it becomes free almost for developing countries, like vaccines and generics
  • Tamar Thompson, Executive Director, State Government Affairs & Federal Payment, Bristol-Myers Squibb
  1. pay less if pay cash without insurance vs pay insurance and pay co-pay — ?? affordability and gaining it fairly

12:00pm – 12:15pm: Possible Talk

Possible Talk: Opening Doors for the Future, a Patient’s Perspective

Make a change in life of Patients every day

12:15pm – 12:45pm: MassBio Presidential Address – Robert K. Coughlin, President and CEO, MassBio

12:45pm – 2:00pm: Lunch

2:00pm – 3:00pm: From Academia to Commercialization: What’s the Threshold of Data Needed to Start a New Company? [Science Track]

  • Irene Abrams, Vice President, Technology Development and New Ventures, Boston Children’s Hospital
  • Irena Ivanovska, Boston Site Head, Celdara Medical
  • Issi Rozen, Chief Business Officer, Broad Institute

2:00pm – 3:00pm: Early Stage Funding in the Era of Venture Creation [Business Track]

  • Todd Zion ex-Smart Cell, CEO
  • Paula Ragan, CEO, X4Pharmaceuticals
  • Rosemary Reilly, Partner, WilmerHale
  • Ramani Varanasi, CEO, X-Biotix

3:00pm – 4:00pm: Addressing the Challenges of Large Population Diseases [Science Track]

  • Calum MacRae, Vice Chair for Scientific Innovation, Brigham and Women’s Hospital, Harvard Medical School

3:00pm – 4:00pm: The Evolving Massachusetts Ecosystem: How Can we Continue to Sustain our Growth? [Business Track]

  • Tanisha Sullivan, Associate General Counsel, Industrial Affairs, Sanofi Genzyme
  • Doug Fambrough
  • Chandra Ramanthan
  • Johannes Fruehauf, Founder & CEO, LabCentral

4:00pm – 4:30pm: Networking Break 

4:30pm – 5:30pm: The State of Neurodegenerative Disease: Drug Targets & Alternative, Patient-Centric Clinical Endpoints [Science Track]

  • Robert Alexander, Vice President and Head, Global Clinical Science Neuroscience, Takeda
  • Joseph J. Higgins, MD FAAN, Vice President, Clinical Development, Huntington’s Disease Program Lead, Uniqure
  • John Torous, Director, Digital Psychiatry Division, Beth Israel Deaconess Medical Center
  • Sally Johnson, Biogen
  • Gilmore O”Neill, Serepta
  • Steve Wood – biomarkers (are LAB specific not regulated by FDA)
  • Ecosystem will continue to make bets, concept of POOLING FUNDING for bedding in paralllel and develop in parallel several therapeutic targets
  • Upside – investment will flow, Novertis and AztraZeneca joined funding on one development
  • Placing bets on Neurological diseases
  • neurogeneration of inherited diseases
  • Earlier intervention is better
  • target identification AUGMENTATION VS REMOVAL not clear what
  • Biogen measuring SNIPS Partnerships Academia and Industry

4:30pm – 5:30pm: Addressing the Opioid Crisis [Business Track]

  • Kerry Wentworth, Chief Regulatory Officer, Flexion Therapeutics

6:00pm – 9:00pm: State of Possible Celebration at the Museum of Science

Join us for drinks, food and networking at the Museum of Science! 

@@@@

8:45am – 9:00am: Welcome

9:00am – 9:30am: Keynote – State of the State of Possible: Where are we in the History of Biotech and What Lies Ahead? – Jeremy Levin, Chairman & CEO, Ovid Therapeutics, Inc.

9:30am – 10:15am: ‘Fireside Chat’ on RNAi and CRISPR: What Can the Past Teach Us and What Opportunities Await? Although researchers have been experimenting with gene therapy since the 1980s, 2018 was a major turning point in making these technologies a reality for patients. Not only was the first therapeutic using RNA interference (RNAi) approved last year, the first human clinical trials started for a CRISPR product. Come hear the two superstars of RNAi and CRISPR compare stories, lessons learned, thoughts on the future of gene editing, and more. – John Maraganore, Chief Executive Officer, Alnylam – Katrine Bosley, former Chief Executive Officer, Editas Medicine

10:15am – 10:30am: Possible Talk – Morgan Stanley

10:30am – 11:00am: Networking Break

11:00am – 11:15am: Possible Talk

11:15am – 12:00pm: Solving the Value Equation to Fix our Broken Healthcare System & Ensure Patient Access FDA approval used to mean access – but that’s no longer the case. More insurers are restricting access to new drugs, all at the expense of patients, using the argument that they do not bring enough value to the healthcare system. But what does value really mean? Experts in pricing and market access offer thoughts on how we might solve the value equation to improve patient access while continuing to reward innovation. – Erin Mistry, Managing Director Pricing and Access, Syneos Health – Mike Bonney, Executive Chair, Kaleido Lifesciences – Tamar Thompson, Executive Director, State Government Affairs & Federal Payment, Bristol-Myers Squibb

12:00pm – 12:15pm: Possible Talk

12:15pm – 12:45pm: MassBio Presidential Address – Robert K. Coughlin, President and CEO, MassBio

12:45pm – 2:00pm: Lunch

2:00pm – 3:00pm: From Academia to Commercialization: What’s the Threshold of Data Needed to Start a New Company? [Science Track] In 2012, Nature famously published a review by a former Amgen head of oncology research that 10% of landmark studies could not be reproduced. Company founders and initial investors must be certain that the academic work underpinning the foundational science and licensed patents are grounded in a sufficiently robust body of multiple lines of evidence can be reproduced. Serial founders and prolific professors discuss how to be sure initial scientific results are both fundable and can be advanced to “pharma grade”. – Irene Abrams, Vice President, Technology Development and New Ventures, Boston Children’s Hospital – Irena Ivanovska, Boston Site Head, Celdara Medical – Issi Rozen, Chief Business Officer, Broad Institute

2:00pm – 3:00pm: Early Stage Funding in the Era of Venture Creation [Business Track] Over the past decade, new biotech company creation has shifted away from investing in entrepreneurs to the venture creation model, where venture investors themselves assess an unmet medical need and create a company to address it. Yet, companies continue to spawn outside the venture creation model. Come hear experts discuss how they’ve raised money outside of the venture creation model through new sources of capital. – Paula Ragan, CEO, X4Pharmaceuticals – Rosemary Reilly, Partner, WilmerHale – Ramani Varanasi, CEO, X-Biotix

3:00pm – 4:00pm: Addressing the challenges of Large Population Diseases. [Science Track] As we better understand the genetics of disease, we can increasingly treat the underlying disease mechanisms rather than the superficial disease etiology. Biomarker testing toward improved drug effectiveness in defined sub-groups have made this a reality. Unlike oncology, where this concept is now mainstream, how might precision medicine apply to large patient populations like cardiovascular and neurodegenerative diseases? This panel will discuss the challenges and opportunities for precision medicine in these widespread maladies. – Calum MacRae, Vice Chair for Scientific Innovation, Brigham and Women’s Hospital, Harvard Medical School

3:00pm – 4:00pm: The Evolving Massachusetts Ecosystem: How Can we Continue to Sustain our Growth? [Business Track] Massachusetts is the #1 life sciences cluster in the world, in large part due to the collaboration and partnership among academia, industry, and government. The vibrant startup scene, along with a wealth of talent, is keeping and attracting big pharma and investors to the area, creating a collaborative environment unlike anywhere else. Yet, major challenges face the industry’s continued success in Massachusetts, from workforce development to sky-high rents to traffic. Come hear Massachusetts leaders discuss how the ecosystem is evolving and what we must do to remain on top. – Tanisha Sullivan, Associate General Counsel, Industrial Affairs, Sanofi Genzyme – Johannes Fruehauf, Founder & CEO, LabCentral

4:00pm – 4:30pm: Networking Break

4:30pm – 5:30pm: The State of Neurodegenerative Disease: Drug Targets & Alternative, Patient-Centric Clinical Endpoints [Science Track] Despite massive investments in research for diseases like Alzheimer’s and Parkinson’s, treatment options for patients are largely non-existent. ‘Soft’ clinical endpoints like Cognitive Impression scores are difficult to demonstrate statistical significance even when underlying biology is being modified. Industry and practicing clinicians share how they are introducing modern imaging and biomarker measurements as ‘harder’ endpoints to the FDA, along with including diverse patients in earlier trials to better predict large pivotal trials. – Robert Alexander, Vice President and Head, Global Clinical Science Neuroscience, Takeda – Joseph J. Higgins, MD FAAN, Vice President, Clinical Development, Huntington’s Disease Program Lead, Uniqure – John Torous, Director, Digital Psychiatry Division, Beth Israel Deaconess Medical Center 4:30pm – 5:30pm: Addressing the Opioid Crisis [Business Track] Pain treatment remains a pressing need, but opioid abuse grew by >10%, killing nearly 50,000 Americans in 2018. Despite decades in the spotlight, how can policy and law enforcement, medical providers and the biopharma industry come together to reverse the trend?

6:00pm – 9:00pm: State of Possible Celebration at the Museum of Science Join us for drinks, food and networking at the Museum of Science!

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The Blavatnik Institute at Harvard Medical School’s 11 basic and social science departments launched in recognition of the transformative $200 million Blavatnik Family Foundation’s committed for scientific research 

Reporter: Aviva Lev-Ari, PhD, RN

“This momentous gift will enable us to accelerate the pace of therapeutic discovery at HMS and advance initiatives aimed at solving some of humanity’s most acute biomedical challenges,” said Daley at the ceremony. “It will help empower our work in service to the world through research that stimulates the development of new knowledge, new therapies and new tools to diagnose and prevent disease.”

Blavatnik, a 1989 graduate of Harvard Business School, said his Harvard education contributed to his success in business and he was happy to give back to the School—not only because of the personal attachment he has to Harvard but also because he sees the commitment as a wise investment in the future.

“One of the lessons from business I acquired is that if you invest in the best people, you will probably get better than average results. You might get the best results,” Blavatnik said. “I am making a bet, which actually I think is a safe bet, that by helping the most talented academics, researchers and scientists that are here, the results will not only be above average but hopefully outstanding.”

Blavatnik added that investing in education is especially important to him because of his own upbringing in a family of academics. His father was a chemistry professor and his mother taught electrical engineering, he said; his first degree was in computer science.

“So, I always felt that science is really what moves this society forward. The technology, the progress of technology, is what really changes people’s lives,” he said. “Now, obviously, medical technology is the frontier of science today.”

Bacow said the Blavatnik gift enables the future discoveries that promise to improve the world for all humanity.

“Harvard did not build itself. It exists because our predecessors were willing to invest their time and their resources to create the institution that we see today,” Bacow said. “I want to thank Len and his foundation because they are very tangibly contributing to a long tradition … of each generation supporting the next, each generation working to enable the next generation to have the same kind of opportunity to make the world a better place.” 

Wilson, who was in the first class of recipients of the Blavatnik National Award for Young Scientists in the Life Sciences, said she felt the gift is a recognition of “the excellence of the science that goes on here every day,” and that with this recognition comes a heightened sense of responsibility. She added that support of this magnitude affords HMS scientists greater freedom to take risks.

“I think it’s really important to realize that excellence in science requires thoughtful, intelligent risk taking, but risky projects are often difficult to fund. You can’t get a federal grant to do a risky project and that creates a kind of perverse incentive to work on small problems rather than big problems,” Wilson said.

She added that Blavatnik’s support has given her lab the freedom to take those risks and, as a result, her team has made discoveries that wouldn’t have been possible without it. Those new discoveries, she said, have led to new federal funding which, in turn, has made new projects and new questions possible. 

“That’s the kind of virtuous cycle that really gives us enthusiasm and optimism about our ability to do science in the future,” she said.

Summers said the new discoveries made at HMS are what is making this “the century of the biomedical and life sciences,” and he said the work enabled by the Blavatnik Family Foundation’s generosity will be transformative.

SOURCE

https://hms.harvard.edu/news/frontier-science?utm_source=Silverpop&utm_medium=email&utm_term=field_news_item_1&utm_content=HMNews02112019

 

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Record Innovations in Drug Discovery by Koch Institute @MIT Members and Affiliates

Reporter: Aviva Lev-Ari, PhD, RN

 

 

In Good Company

Trovagene announced a new patent for the use of the drug onvansertib in combination with other anti-androgen drugs for the treatment of prostate cancer. Last fall, Trovagene secured exclusive rights to develop combination therapies and clinical biomarkers for prostate cancer based in part on Bridge Project-funded research. Read more.

Lyndra Therapeutics, co-founded by KI member Bob Langer, raised $55 million in its Series B round, with new investors including the Bill and Melinda Gates Foundation and Gilead Sciences. Phase 2 trials for its ultra long-acting drug delivery capsule are expected to begin next year. Read more.

Dragonfly Therapeutics, co-founded by KI director Tyler Jacks, has committed $10 million to launch the first clinical studies of its TriNKETs (Tri-specific, NK cell Engager Therapies) platform for both solid tumor and hematological cancers. Read more.

Following its record-breaking IPO, Moderna Therapeutics (co-founded by KI member Bob Langer) published preclinical data in Science Translational Medicine demonstrating the promise of its mRNA-2752 program in several cancers. Read more.

Dewpoint Therapeutics launched with a $60 million Series A, aims to translate recent insights into biomolecular condensates from the laboratory of co-founder and KI member Rick Young to drug discovery. Read more.

KI member Bob Langer and collaborator Omid Farokhzad co-founded Seer— combining nanotechnology, protein chemistry, and machine learning—to develop liquid biopsy tests for the early detection of cancer and other diseases. Read more.

Epizyme, co-founded by KI member Bob Horvitz, is submitting a New Drug Application to gain accelerated approval of tazemetostat for patients with relapsed or refractory follicular lymphoma. Read more.

Ribon Therapeutics, founded by former KI member Paul Chang, launched with $65 million in a Series B funding round with Victoria Richon, a veteran of Sanofi and Epizyme, at the helm. Ribon focuses on developing PARP7 inhibitors for cancer treatment. Read more.

SOURCE

From: MIT Koch Institute for Integrative Cancer Research <cancersolutions=mit.edu@cmail19.com> on behalf of MIT Koch Institute for Integrative Cancer Research <cancersolutions@mit.edu>

Reply-To: <ki-communications@mit.edu>

Date: Wednesday, February 6, 2019 at 3:15 PM

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

Subject: Lung Microbiome Corrupted in Cancer; Angelika Amon wins 2019 Vilcek Award; Lunch Lines of Inquiry

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3rd World Congress on Biotechnology on Novel Insights and Innovations of Biotechnology for Future Challenges, Edinburgh, Scotland, 12 June 2019 – 13 June 2019

 

Guest Request by Miriam Rothschild

 

Name of the Conference: 3rd World Congress on Biotechnology

Venue: Edinburgh, Scotland

Date: 12 June 2019 – 13 June 2019

Website: http://biotechnology.alliedacademies.com/

Theme: Novel Insights and Innovations of Biotechnology for Future Challenges

About the conference:

After the splendid success of Biotechnology 2018, 3rd World Congress on Biotechnology was scheduled at Edinburgh, Scotland during June 12-13, 2019.

Biotechnology 2019 encompasses

  • keynote,
  • Oral presentation,
  • Poster & Video presentation,
  • Workshop & Symposia and
  • exhibition

on the effective theme Novel Insights and Innovations of Biotechnology for Future Challenges.

This Exclusive Professional gathering will provide you an opportunity to meet and socialize with the Research scientists, Experts, Principal investigators, Directors, CEO and R&D Heads from Industries, Pharmacists, Pharmaceutical companies, Drug Industries, Biotechnology association, and societies.

Through a series of plenary sessions and workshops Biotechnology, 2019 will provide a rigorous review of novel therapies in

  • Stem cell Biotechnology,
  • Pharmaceutical Biotechnology,
  • Medical Biotechnology,
  • Biomedical Engineering,
  • Reproductive Biotechnology as well as report on the very latest findings in
  • Nanobiotechnology,
  • Bioinformatics,
  • Biosensor,
  • Bioproducts,
  • Bioenergy,
  • Advancements in Biotechnology.

Engage with us at Edinburgh to get the professional development and worldwide acknowledgment among the scientific research community.

3rd World Congress on Biotechnology is a peculiar forum where eminent researchers, leading academic scientists and industrialists from all over the Globe to exchange and share their recent innovations, experiences, practical challenges, recent research results and advancements in Biotechnology.

Contact:

Miriam Rothschild

Program Manager | Biotechnology 2019

biotechnology@alliedconference.org

Ph: 44 203 7691755

whats-app -441694390013

 

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37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 10, 2019: Deals and Announcements

Reporter: Stephen J. Williams, Ph.D.

From Biospace.com

 

JP Morgan Healthcare Conference Update: Sage, Mersana, Shutdown Woes and Babies

Speaker presenting to audience at a conference

With the J.P. Morgan Healthcare Conference winding down, companies remain busy striking deals and informing investors about pipeline advances. BioSpace snagged some of the interesting news bits to come out of the conference from Wednesday.

SAGE Therapeutics – Following a positive Phase III report that its postpartum depression treatment candidate SAGE-217 hit the mark in its late-stage clinical trial, Sage Therapeutics is eying the potential to have multiple treatment options available for patients. At the start of J.P. Morgan, Sage said that patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression, compared to 13.6 for placebo. The company plans to seek approval for SAGE-2017, but before that, the FDA is expected to make a decision on Zulresso in March. Zulresso already passed muster from advisory committees in November, and if approved, would be the first drug specifically for postpartum depression. In an interview with the Business Journal, Chief Business Officer Mike Cloonan said the company believes there is room in the market for both medications, particularly since the medications address different patient populations.

 

Mersana Therapeutics – After a breakup with Takeda Pharmaceutical and the shelving of its lead product, Cambridge, Mass.-based Mersana is making a new path. Even though a partial clinical hold was lifted following the death of a patient the company opted to shelve development of XMT-1522. During a presentation at JPM, CEO Anna Protopapas noted that many other companies are developing therapies that target the HER2 protein, which led to the decision, according to the Boston Business Journal. Protopapas said the HER2 space is highly competitive and now the company will focus on its other asset, XMT-1536, an ADC targeting NaPi2b, an antigen highly expressed in the majority of non-squamous NSCLC and epithelial ovarian cancer. XMT-1536 is currently in Phase 1 clinical trials for NaPi2b-expressing cancers, including ovarian cancer, non-small cell lung cancer and other cancers. Data on XMT-1536 is expected in the first half of 2019.

Novavax – During a JPM presentation, Stan Erck, CEO of Novavax, pointed to the company’s RSV vaccine, which is in late-stage development. The vaccine is being developed for the mother, in order to protect an infant. The mother transfers the antibodies to the infant, which will provide the baby with protection from RSV in its first six months. Erck called the program historic. He said the Phase III program is in its fourth year and the company has vaccinated 4,636 women. He said they are tracking the women and the babies. Researchers call the mothers every week through the first six months of the baby’s life to acquire data. Erck said the company anticipates announcing trial data this quarter. If approved, Erck said the market for the vaccine could be a significant revenue driver.

“You have 3.9 million birth cohorts and we expect 80 percent to 90 percent of those mothers to be vaccinated as a pediatric vaccine and in the U.S. the market rate is somewhere between $750 million and a $1 billion and then double that for worldwide market. So it’s a large market and we will be first to market in this,” Erck said, according to a transcript of the presentation.

Denali Therapeutics – Denali forged a collaboration with Germany-based SIRION Biotech to develop gene therapies for central nervous disorders. The two companies plan to develop adeno-associated virus (AAV) vectors to enable therapeutics to cross the blood-brain barrier for clinical applications in neurodegenerative diseases including Parkinson’s, Alzheimer’s disease, ALS and certain other diseases of the CNS.

AstraZeneca – Pharma giant AstraZeneca reported that in 2019 net prices on average across the portfolio will decrease versus 2018. With a backdrop of intense public and government scrutiny over pricing, Market Access head Rick Suarez said the company is increasing its pricing transparency. Additionally, he said the company is looking at new ways to price drugs, such as value-based reimbursement agreements with payers, Pink Sheet reported.

Amarin Corporation – As the company eyes a potential label expansion approval for its cardiovascular disease treatment Vascepa, Amarin Corporation has been proactively hiring hundreds of sales reps. In the fourth quarter, the company hired 265 new sales reps, giving the company a sales team of more than 400, CEO John Thero said. Thero noted that is a label expansion is granted by the FDA, “revenues will increase at least 50 percent over what we did in the prior year, which would give us revenues of approximate $350 million in 2019.”

Government Woes – As the partial government shutdown in the United States continues into its third week, biotech leaders at JPM raised concern as the FDA’s carryover funds are dwindling. With no new funding coming in, reviews of New Drug Applications won’t be able to continue past February, Pink Sheet said. While reviews are currently ongoing, no New Drug Applications are being accepted by the FDA at this time. With the halt of NDA applications, that has also caused some companies to delay plans for an initial public offering. It’s hard to raise potential investor excitement without the regulatory support of a potential drug approval. During a panel discussion, Jonathan Leff, a partner at Deerfield Management, noted that the ongoing government shutdown is a reminder of how “overwhelmingly dependent the whole industry of biotech and drug development is on government,” Pink Sheet said.

Other posts on the JP Morgan 2019 Healthcare Conference on this Open Access Journal include:

#JPM19 Conference: Lilly Announces Agreement To Acquire Loxo Oncology

36th Annual J.P. Morgan HEALTHCARE CONFERENCE January 8 – 11, 2018

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: #JPM2019 for Jan. 8, 2019; Opening Videos, Novartis expands Cell Therapies, January 7 – 10, 2019, Westin St. Francis Hotel | San Francisco, California

37th Annual J.P. Morgan HEALTHCARE CONFERENCE: News at #JPM2019 for Jan. 8, 2019: Deals and Announcements

 

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The Value of a Pre-mortem Session with the Management Team

Author: Amnon Danzig,

LPBI Group, Business Development Team

 

What is the Value of a Pre-mortem Session with the Management Team?

When an executive thinks about innovation and growth strategies he/she should hedge themselves against potential failures. One of the recommended tools for it is a Pre-mortem Session with the Management Team.

A Pre-mortem Session with the Management Team is a tool that utilizes the prospective hindsight concept. Prospective Hindsight is an approach to “look forward by looking backward.” One assumes that you have already reached the point of a few years from the Present, and tries to figure out why certain events and processes had took place.  

A Pre-mortem Session with the Management Team is analogous to a human postmortem analysis. In medicine, postmortem is used by medical doctors to understand why they failed after the patient passes away.

Gary Klein (“Performing a Project Premortem”, HBR September 01, 2007) took the postmortem concept one step further and adapted it to managerial situations, hence the Pre-mortem methodology for business management had emerged. Daniel Kahneman (Thinking, Fast and Slow, 2011) made this analytical approach more popular due to its inclusion in his last book .

 

My personal version of A Pre-mortem Session with the Management Team is the following: 
After you finalize your project plan, and everything is ready for kick-off, gather your management team and all the core people that were part of the development of the company’s knowledge base of the project under analysis.

  • Suggested is a Friday evening, just one hour before the end of the workday.
  • Clear all mobile devices: laptops and smart phones
  • Distribute beer,
  • supply a sheet paper and pencils

Here is your pitch:
“Ladies and gentlemen, today is a date three years into the future. You announce that the project has failed. Furthermore, it puts our company at risk. Period.

  • Now you have a budget of seven minutes and one bottle of beer.

In full voice you tell the Team, please, write the chronology of this failure; all the things that caused this dramatic failure. Let’s start.”

  • After seven minutes, gather the papers and thank the participants.

You then take the papers and read them carefully at home. Read and reread until you fully grasp  all the new insights your colleagues have shared with you.
At a glance, this process encapsulates the entire body of knowledge of the project’s shortcomings and drawbacks:

  • You pose and ask: what are the causes of this dramatic failure?

Next Monday morning, you gather the same group: sheet of papers and pencils for each participant. No beer…
You ask them to articulate the project evolution, taking into account what they wrote on Friday evening. Give them one hour. Collect the papers and thank them.

Now you have a fine springboard to re-examine the project. What is the reason to do that?

  • It is pretty simple: while preparing new projects under your strong leadership, all the doubts, critics, annoying facts and unpopular standpoints are moved to the side.
  • Your team can develop group thinking, which is could be very risky while preparing the knowledge base for the new project.
  • In a Pre-mortem session with the Team, you facilitate even negativism about the project, or parts of it.

Daniel Kahneman said in few lectures that executives find this extremely beneficial to them.

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