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

UC San Diego’s Rady School of Management Center for Executive Development: Biotech Demystified: The Science Behind Business

Posted in Biomedical Measurement Science, BioSimilars, BioTechnology - Venture Creation, BioTechnology - Venture Creation, Venture Capital, Scientist: Career considerations on August 5, 2015| Leave a Comment »

Three-day Course by UC San Diego’s Rady School of Management Center for Executive Development: Biotech Demystified: The Science Behind Business

Reporter: Aviva Lev-Ari, PhD, RN

Biotech Demystified: The Science Behind Business

Joanna Skubisz

Associate, Communications Planning w firmie Underscore Marketing LLC

This 3-day hands-on educational program on September 14, 15 & 16, 2015 offered by UC San Diego’s Rady School of Management Center for Executive Development is designed specifically for non-scientist business professionals in the Biotech, Pharma and Life Science industries. It provides participants with a practical understanding of the basic science powering their businesses, giving them the essential tools needed to succeed in today’s life science industries. It provides executives, investors and decision makers with a practical understanding of the basic science powering the biotechnology and pharmaceutical industries.

San Diego is one of the nation’s top-ranking biotech centers and is home to more than 500 biotech and four major research institutions. Biotech Demystified is offered through the Rady School of Management Center for Executive Development in collaboration with UC San Diego’s Division of Biological Sciences and Skaggs School of Pharmacy and Pharmaceutical Sciences.

Led by a rich collection of biomedical research faculty from UC San Diego, attendees will dive into a deep pool of contemporary bioscience that include the following topics:

• Science fundamentals

• Cell biology and molecular biology

• Stem cell research

• Personalized medicine and drug delivery

• Cancer and therapeutic approaches

• Biosimilars and biobetters

• Genetic and genome mapping

• Hands-on lab experience with DNA testing

View the course details & register here http://bit.ly/BiotechDemystified.

SOURCE

From: Professionals in the Pharmaceutical and Biotech Industry <groups-noreply@linkedin.com>

Date: Wednesday, August 5, 2015 at 12:32 PM

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

Subject: [New announcement] Biotech Demystified: The Science Behind Business

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Israel’s Chief Scientist on Mastering the Art of Public-Private Partnership

Posted in BioTechnology - Venture Creation, Venture Capital on August 3, 2015| Leave a Comment »

Israel’s Chief Scientist on Mastering the Art of Public-Private Partnership

Reporter: Aviva Lev-Ari, PhD, RN

Israel’s Chief Scientist on Mastering the Art of Public-Private Partnership.

This article was published by Gil Press in Forbes.

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Emerging Life Science Companies in Massachusetts

Posted in BioTechnology - Venture Creation, Venture Capital on March 28, 2015| Leave a Comment »

Emerging Life Science Companies in Massachusetts

Reporter: Aviva Lev-Ari, PhD, RN

https://www.google.com/maps/d/embed?&mid=1-wGKsCdFVi9EkAzwxnJaBN87vy8&ll=42.333255085843746%2C-71.12668330124322&z=11

SOURCE

Venture Development Center
University of Massachusetts Boston
Wheatley Hall, Third Floor
100 Morrissey Blvd. Boston, MA 02125-3393
vdc@umb.edu

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

Posted in Academic Publishing, Affordable Care Act, Bio Instrumentation in Experimental Life Sciences Research, BioSimilars, BioTechnology - Venture Creation, Venture Capital, Commercialization, Conference Coverage with Social Media, Diagnostics and Lab Tests, Drug Delivery Platform Technology, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA, FDA Regulatory Affairs, Global Partnering & Biotech Investment, Health Economics and Outcomes Research, Health Law & Patient Safety, Healthcare costs and reimbursement, HealthCare IT, Healthcare Reform, Intellectual Property, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Interviews with Scientific Leaders, Investment in Technological Breakthrough, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medicare and Medicaid, Patents, Personal Health Applications: Tech Innovations serves HealhCare, Pharmaceutical Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Population Health Management, Prescription Drugs Costs, Scientific & Biotech Conferences: Press Coverage, Scientist: Career considerations, Technology Capital Expenses, Uncategorized, Venture Capital, tagged angel investors, Aviva Lev-Ari, bioinvestment, biotech incubator, biotech startup, Biotechnology and Pharmaceuticals, competetive intelligence, Conditions and Diseases, crowd-funding, diabetes foundaion, Drug discovery, Food and Drug Administration, health, Health Care Delivery, health care spending, Innovation, Intellectual property, Medicare, medicare costs, Patent portfolio, patents, pharmacy benefit managers, philadelphia, Princeton University, Reimbursement, research, science funding, startup, United States Patent and Trademark Office, Venture capital on March 11, 2015| Leave a Comment »

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

Stephen 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:

Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
Panel 2: Design for Market Success– Commercial Strategy Planning
Panel 3: Design for Investment– Financing Each Stage
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 1^st capital was what are your assets; now has changed to value

Notes:

Ting Pau Oei:

Your very 1^st 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 2^nd Venture Capital meeting; VC’s don’t decide anything in 1^st 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

ANNOUNCEMENT – REAL TIME Coverage for the Press of MassBio 2015 Annual Meeting, March 26-27, 2015, Royal Sonesta Hotel, Cambridge, MA by Leaders in Pharmaceutical Business Intelligence

Posted in BioTechnology - Venture Creation, BioTechnology - Venture Creation, Venture Capital, Conference Coverage with Social Media, Scientific & Biotech Conferences: Press Coverage, Technology Transfer: Biotech and Pharmaceutical, Translational Science on March 11, 2015| Leave a Comment »

ANNOUNCEMENT

REAL TIME Coverage for the Press of MassBio 2015 Annual Meeting, March 26-27, 2015, Royal Sonesta Hotel, Cambridge, MA

by

Leaders in Pharmaceutical Business Intelligence

LEADERS IN PHARMACEUTICAL BUSINESS INTELLIGENCE

will cover for the Scientific and Business Press in REAL TIME the MassBio 2015 Annual Meeting, March 26-27, 2015, Royal Sonesta Hotel, Cambridge, MA

AGENDA

http://pharmaceuticalintelligence.com/2015/01/13/massbio-2015-annual-meeting-march-26-27-2015-royal-sonesta-hotel-cambridge-ma/

Dr. Lev-Ari will be in attendance on 3/26/2015 and 3/27/2015

Venture Overview Updated in New Company Page on LinkedIn: Leaders in Pharmaceutical Business Intelligence

http://pharmaceuticalintelligence.com/2015/03/07/venture-overview-updated-on-new-company-page-on-linkedin-leaders-in-pharmaceutical-business-intelligence/

ANNOUNCEMENT

at MassBio 2015 Annual Meeting, March 26-27, 2015, Royal Sonesta Hotel, Cambridge, MA

Forthcoming e-Books on Amazon-Kindle.com

by Experts, Authors, Writers of

LEADERS IN PHARMACEUTICAL BUSINESS INTELLIGENCE

Our Team

http://pharmaceuticalintelligence.com/contributors-biographies/

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Final Agenda: Leaders in Biobanking Congress 2015, Toronto, InterContinental Toronto Centre, July 14-16, 2015

Posted in Academic Publishing, BioBanking, BioTechnology - Venture Creation, BioTechnology - Venture Creation, Venture Capital, Conference Coverage with Social Media, Scientific & Biotech Conferences: Press Coverage on March 6, 2015| Leave a Comment »

Biobanking Congress 2015, Toronto, InterContinental Toronto Centre, July 14-16, 2015

Reporter: Aviva Lev-Ari, PhD, RN

FINAL AGENDA

Cambridge Healthtech Institute’s Seventh International Leaders in Biobanking Congress: Maximizing Your Investment in Biospecimens addresses both the business and science of biobanking, bringing together biomedical and biopharmaceutical researchers, regulators, biorepository managers and practitioners to investigate the best strategies for effective use of biospecimens within today’s cutting-edge biomedical research.

KEYNOTE SESSION: IT TAKES A VILLAGE

The Complexity of Pathologist Responsibilities as Custodians of Biospecimens

Sylvia L. Asa, M.D., Ph.D., Pathologist-in-Chief, Medical Director, Laboratory Medicine Program, University Health Network; Lakeridge Health &

Women’s College Hospital; Senior Scientist, Ontario Cancer Institute; Professor, Laboratory Medicine & Pathobiology, University of Toronto

Discovery and Implementation Using EHR-Linked Biobanks: The eMERGE Experience

Rex L. Chisholm, Ph.D., Vice Dean, Scientific Affairs and Graduate Education; Adam and Richard T. Lind Professor, Medical Genetics, Northwestern

University Feinberg School of Medicine

Preparing Research Samples for Future Use: Innovative Methods for Assessing Functional Quality Control and Biobanking Best Practices

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University

Generating Comprehensive Standard Operating Procedures for a Biorepository Network – The CTRNet Experience

Brent Schacter, M.D., FRCPC, Principal Investigator, CTRNet; Professor, Department of Internal Medicine, Section of Hematology/

Oncology, College of Medicine, University of Manitoba/CancerCare Manitoba

MAINTAINING A QUALITY BIOBANK

Development and Implementation of a National Biospecimen Collection Network in a Community Hospital System

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

Inventory Management; Re-Organization, Consolidation, Quality Assurance and the Cost of Space in the Biorepository

Sherilyn J. Sawyer, Ph.D., Director, BWH/Harvard Cohorts Biorepository, Channing Division of Network Medicine, Brigham and Women’s Hospital

Is There a Web-Based Solution to the Challenge of Informed Consent and Re-Consent of Legacy Biobank Samples?

Daniel B. Thiel, Public Health Researcher, Health Services Organization and Policy, University of Michigan School of Public Health

Tissue Banking, Bioinformatics and EMRs: The Front-End Requirements for Personalized Medicine

K. Stephen Suh, Ph.D., Director, Genomics and Biomarkers Program, John Theurer Cancer Center, Hackensack University Medical Center

PANEL DISCUSSION: Ensuring Biobank Value through Effective Utilization

Moderators:

Marianne K. Henderson, MS, CPC, Chief, Division of Cancer Epidemiology & Genetics, Office of Division Operations and Analysis and the Center for

Global Health, National Cancer Institute; Chair, Organizing Advisory Committee, ISBER

Marianna J. Bledsoe, MA, Adjunct Assistant Professor, Department of Clinical Research and Leadership, George Washington University School of

Medicine and Health Sciences; Co-Chair, Science Policy Committee, ISBER

Panelists:

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

Sherilyn J. Sawyer, Ph.D., Director, BWH/Harvard Cohorts Biorepository, Channing Division of Network Medicine, Brigham and Women’s Hospital

K. Stephen Suh, Ph.D., Director, Genomics and Biomarkers Program, John Theurer Cancer Center, Hackensack University Medical Center

Daniel B. Thiel, Public Health Researcher, Health Services Organization and Policy, University of Michigan School of Public Health

Additional Panelists to be Announced

BIOSAMPLES, BIOMARKERS AND CLINICAL TRIALS

FEATURED PRESENTATION :

TRANSLATING PRECISION MEDICINE STRATEGY INTO OUTCOME THROUGH CLINICAL TRIALS

Lillian L. Siu, M.D., FRCPC, Professor, University of Toronto; Medical Oncologist, Princess Margaret Cancer Centre

Obtaining Biospecimens for Correlative Studies in Multi-Centre Lymphoma Clinical Trials

Koren Mann, Ph.D., Assistant Professor, Oncology, Lady Davis Institute for Medical Research, McGill University

Case Study #1: Biospecimen Sciences, Clinical Trials and Precision Medicine: Examples from Our Practice

Michael H. A. Roehrl, M.D., Ph.D., Director, UHN Program in BioSpecimen Sciences, University Health Network and University of Toronto

Anthony M. Joshua, MBBS, Ph.D., Staff Oncologist/Affiliate Scientist, Princess Margaret Cancer Centre

TOOLS TO ACCESS BIOSPECIMEN QUALITY

From Research to Clinic: (Pre-)Analytical Variables and Assay Development

Veronique Neumeister, M.D., Laboratory Director, Specialized Translational Services Lab, Department of Pathology, Yale University School of Medicine

Experimental Animal Models to Inform Human Biobanking Practices

Galen Hostetter, M.D., FCAP, Associate Director, Pathology Core, Van Andel Research Institute

Freezing under Pressure: A New Method for Cryopreservation

Nickolas Greer, CSO, Rissali LLC

Microfluidic Evaluation of Red Cells Collected and Stored in Modified Processing Solutions Used in Blood Banking

Dana Spence, Ph.D., Associate Professor, Department of Chemistry, Michigan State University

FEATURED PRESENTATION:

PRE-ANALYTICAL VARIABLES IMPACTING PERIPHERAL BLOOD SAMPLES FOR IMMUNE MONITORING IN MULTICENTER STUDIES

Amit Bar-Or, M.D., FRCPC, Professor, Neurology & Neurosurgery; Director, Experimental Therapeutics Program and Scientific Director, Clinical Research

Unit, Montreal Neurological Institute, McGill University

CASE STUDIES: BIOBANKER/BIOUSER PARTNERSHIPS

Biomedical researchers and drug developers require accessible, highquality biospecimens that allow them to extract reliable and useful data.

Oncology experts, for instance, use patient-derived tumor collections to connect datasets, pinpoint and assess variants within cancer patients

post-diagnosis and zero in on the data that matter when tailoring therapies. Early, strategic collaborations with the biobanks that house

specimens can be mutually beneficial, maximizing the financial and technological investments of the operation managers who collect, store,

annotate and distribute the biological samples (“biobankers”) and supporting the research goals of the scientists who need those samples

(“biousers”) – all to fulfill the promise of personalized medicine.

SPECIALTY BIOBANKS

The Future of iPSCs Biobanking

Jonathan Y.H. Loh, Ph.D., Assistant Professor, Department of Biological Sciences, National University of Singapore, A*STAR Institute of

Molecular and Cell Biology

Biobanking to Improve Cardiac Transplant Outcomes

Dawn E. Bowles, Ph.D., Assistant Professor, Department of Surgery, Division of Surgical Sciences and Co-Director, Duke Human Heart Repository

Planning and Implementing an Institutional Hospital for Children and Women: Ethical and Operational Consideration

Suzanne Vercauteren, M.D., Ph.D., FRCPC, Head, Division of Hematopathology, BC Children’s Hospital and Clinical Assistant Professor,

Pathology and Laboratory Medicine, University of British Columbia

The University Health Network Genito-Urinary (GU) BioBank

Neil Fleshner, M.D., MPH, FRCSC, Chair, Urology, Department of Surgery, University of Toronto; Head, Urology, University Health Network; Director,

GU BioBank, Princess Margaret Cancer Centre

Give Life Twice – An Overview of Canada’s National Public Cord Blood Bank

Heidi Elmoazzen, Ph.D., Director, National Public Cord Blood Bank

Toronto Lung Transplant Biobanking Project, What We Are Collecting

Sassan M. Azad, Project Manager, Clinical, Translational & Biobanking Research Office, Toronto Lung Transplant Program, Toronto General Hospital,

University Health Network

MAINTAINING A QUALITY BIOBANK WITH IT

Progress Is Bringing Together Clinical and Biorepository Data in an Expandable Research Data Repository

Maureen E. Lane, Ph.D., Assistant Professor, Medicine; Director, Hem/Onc Translational Core Laboratory, The Leukemia Biorepository and Personalized

Medicine Center, Weill Cornell Medical College

Data Bank and BioRepository for Translational and Basic Research

Annmarie Nowak, Coordinator & Director, Data Bank and Biorepository, Biobanking Systems Integration Cancer Prevention and Population Science,

Roswell Park Cancer Institute

Promoting Quality Biobanks and Biobank Quality: The CRIP Toolbox and the Metabiobank p-BioSPRE

Christina Schröder, Ph.D., Head, Metabiobanks CRIP, Fraunhofer Institute for Cell Therapy and Immunology

For sponsorship and exhibit sales information, contact:

Carolyn Benton

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5412

Email: cbenton@healthtech.com

Healthtech.com/Biobanking

SOURCE

From: Leaders in Biobanking <kerris@healthtech.com>
Date: Fri, 06 Mar 2015 11:36:31 -0500
To: <avivalev-ari@alum.berkeley.edu>
Subject: Final Agenda Now Available