AstraZeneca’s CRISPR research collaborations are with the following institutions:

The Wellcome Trust Sanger Institute, Cambridge, UK

Under the terms of the collaboration with the Wellcome Trust Sanger Institute, research will focus on deleting specific genes relevant to cancer, cardiovascular, metabolic, respiratory, autoimmune & inflammatory diseases and regenerative medicine to understand their precise role in these conditions. AstraZeneca will provide cell lines that can be targeted using the Sanger Institute’s collection of genome-wide CRISPR guide-RNA libraries to generate populations of cells in which defined genes are switched off. Genes will subsequently be identified by next-generation sequencing and cell populations tested to validate the effects of a given gene on a wide range of physical and biological traits.

“The Sanger Institute’s guide-RNA library enables researchers to target genes with incredible specificity,” said Dr. Kosuke Yusa, Member of Faculty at the Sanger Institute. “CRISPR has transformed the way we study the behaviour of cells and now the application of this powerful technology to the search for effective drugs has the potential to benefit patients.”

The Innovative Genomics Initiative, California

The Innovative Genomics Initiative (IGI) is a joint venture between the University of California, Berkeley and University of California, San Francisco. The research collaboration will focus on either inhibiting (CRISPRi) or activating (CRISPRa) genes to understand their role in disease pathology. The IGI and AstraZeneca will work closely together to identify and validate gene targets relevant to cancer, cardiovascular, metabolic, respiratory, autoimmune and inflammatory diseases and regenerative medicine to understand their precise role in these conditions.

“We are excited to pair the IGI’s premier expertise in CRISPR gene editing and regulation with AstraZeneca’s deep experience in therapeutics,” said Jacob Corn, Scientific Director of the Innovative Genomics Initiative. “I’m confident that, working side-by-side with scientists at AstraZeneca, our collaboration will positively impact drug discovery and development to hasten treatments to patients.”

Thermo Fisher Scientific, Waltham, Massachusetts

Under the terms of the collaboration with Thermo Fisher Scientific, a world-leading reagent and instrument provider, AstraZeneca will receive RNA-guide libraries that target individual known human genes and gene families. AstraZeneca can screen these guides against cell lines to identify new disease targets.

“Through this research collaboration with AstraZeneca, Thermo Fisher is helping to accelerate access to cutting edge genome-editing applications for next generation drug discovery. Enabling more relevant disease models will improve target identification and translation to therapeutics,” said Dr. Jon Chesnut, Director of Synthetic Biology R&D at Thermo Fisher Scientific.

Broad Institute/Whitehead Institute, Cambridge, Massachusetts

The collaboration with the Broad Institute and Whitehead Institute will evaluate a genome-wide CRISPR library against a panel of cancer cell lines with a view to identifying new targets for cancer drug discovery.

In addition to the new collaborations, AstraZeneca’s in-house programme is currently adapting CRISPR technology to streamline and accelerate the production of cell lines and translational models that mimic complex genomic and disease-relevant scenarios.

“Application of the CRISPR technology for precise genome editing in recombinant cell lines and in relevant disease models should enable us to identify novel targets, build better test systems for drug discovery and enhance the translatability of our efficacy and safety models,” said Dr. Lorenz Mayr, Vice President, Reagents & Assay Development, AstraZeneca.

The short video above explaining how CRISPR technology works is available in English, Mandarin and Spanish, and a still image illustrating the technology is available.

Download broadcast video and high-resolution image

About The Wellcome Trust Sanger Institute

The Wellcome Trust Sanger Institute is one of the world’s leading genome centres. Through its ability to conduct research at scale, it is able to engage in bold and long-term exploratory projects that are designed to influence and empower medical science globally. Institute research findings, generated through its own research programmes and through its leading role in international consortia, are being used to develop new diagnostics and treatments for human disease.http://www.sanger.ac.uk/

About Innovative Genomics Initiative

The Innovative Genomics Initiative (IGI) was established in early 2014 at the Li Ka Shing Center for Genomic Engineering at the University of California, Berkeley, and is a joint UC Berkeley/UC San Francisco initiative catalyzing and guiding the global effort in both the academic and commercial research communities to unleash the transformative potential of CRISPR/Cas9 technology for positive human impact.

About the Broad Institute of Harvard and MIT

The Eli and Edythe L. Broad Institute of Harvard and MIT was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods and data openly to the entire scientific community.

Founded by MIT, Harvard and its affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, go to http://www.broadinstitute.org.

About Whitehead Institute

Whitehead Institute is a world-renowned non-profit research institution dedicated to improving human health through basic biomedical research. Wholly independent in its governance, finances, and research programs, Whitehead shares a close affiliation with Massachusetts Institute of Technology through its faculty, who hold joint MIT appointments. http://wi.mit.edu

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our four premier brands – Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.




  • Caribou BioSciences – Jennifer Daudna
  • Intellia

Novartis bought in to Intellia–as well as Caribou, which out-licensed some pioneering CRISPR tech created by Jennifer Doudna at UC Berkeley–with a clear interest in tapping the science for its ambitious CAR-T work reengineering T cells into cancer weapons. John Leonard was wooed in from the Big Pharma world, after a stint in charge of R&D at AbbVie ($ABBV). And gene editing–deleting, repairing and inserting genetic information to correct an ailment–has what is widely viewed as a potent future in devising a new generation of potential cures.

“CRISPR/Cas9 technology has potential to transform medicine by addressing previously untreatable genetic targets and serving as the basis for new and better therapies,” said Leonard in a statement. “This novel technology could potentially eliminate many severely disabling and life-threatening diseases for patients.”

But after the Big Vision, detailed insights into the company’s plans can be hard to glean. Asked about the apparent likelihood of an IPO in the offing, CEO Nessan Bermingham declined comment.




Bayer LifeScience Center (BLSC)

  • ERS Genomics – Emmanuelle Charpentier
  • CRISPR Therapeutics – Emmanuelle Charpentier and

Bayer Inks CRISPR Patent Licensing Agreement

NEW YORK (GenomeWeb) – Bayer and ERS Genomics announced today that they have signed a patent license agreement, giving the Bayer LifeScience Center (BLSC) access to ERS’s foundational CRISPR/Cas9 genome editing technology.

Financial and other details of the agreement were not disclosed.

ERS Genomics was formed to commercialize patents held by CRISPR pioneer Emmanuelle Charpentier, now director of the Max Planck Institute for Infection Biology. She is a co-inventor on a foundational CRISPR/Cas9 patent application currently at the center of a patent interference trial being conducted by the US Patent and Trademark Office. A team led by the Broad Institute currently holds the key patent for CRISPR/Cas9 technology.

The BLSC has also recently created a joint venture with CRISPR Therapeutics, a firm Charpentier co-founded, to develop new CRISPR-based therapies.



Vertex Therapeutics

  • CRISPR Therapeutics – Emmanuelle Charpentier


  • Caribou BioSciences – Jennifer Daudna


  • Caribou BioSciences – Jennifer Daudna


  • Broad Institute


  • ERS Genomics – Emmanuelle Charpentier
  • Intellia – Jennifer Daudna

Licensing deal with Regeneron to accelerate CRISPR biotech Intellia (Jennifer Doudna’s Start Up) for an IPO

Reporter: Aviva Lev-Ari, PhD, RN


Albany Molecular Research (AMRI)

  • Broad Institute



  • Moderna Therapeutics

Cases in Biotech Entrepreneurship: Selective Start Ups in 2016

Reporter: Aviva Lev-Ari, PhD, RN


Moderna Therapeutics Deal with Merck: Are Personalized Vaccines here?

Curator & Reporter: Stephen J. Williams, Ph.D.


at #JPM16 – Moderna Therapeutics turns away an extra $200 million: with AstraZeneca (collaboration) & with Merck ($100 million investment)

Reporter: Aviva Lev-Ari, PhD, RN


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First annual FierceBiotech Drug Development Forum (DDF). This multi-day conference with exhibits will take place at the InterContinental Hotel in Boston this September 19-21, 2016, and is the only event that covers the entire drug development process from basic research through clinical trials. Registration is available by clicking here.

Our primary objective behind this event is to build a program for the industry, by the industry, and we’ve been working very closely with our editorial team, advisory board, readers, and key industry leaders to develop a program that digs into the real issues facing our industry today. Here’s a sample of some of our program panels. Click here to view the full program.

  • Biotech IPOs in 2017
  • Phase I/IIa: Early-stage Strategies and Phase III: The Pivotal Moment
  • The Genomics Package
  • Partnerships in Immuno-Oncology
  • Taking Maximum Advantage of Rare/Orphan Disease R&D Edge
  • 2016 Top Women in Biotech Panel and Awards Reception
  • Jumping Onto the FDA’s Fast Track
  • How to Strike a $1 Billion Deal
  • The Annual Fierce 15 Awards Reception

And here are just a few of our confirmed speakers. Click here to view our full list of speakers.

  • Stacy Coen | Head of Rare Disease Business Development & Licensing | Sanofi Genzyme
  • Luba Greenwood | Vice President, Global Business Development and Mergers & Acquisitions | Roche
  • Lloyd Klickstein MD, PhD | Head of Translational Medicine, NIDU | Novartis Institutes for BioMedical Research, Inc.
  • Issi Rozen | Chief Business Officer | Broad Institute of MIT and Harvard
  • Anna Protopapas | President & CEO | Mersana Therapeutics
  • Brian Hagerty | Senior Director, Head of Healthcare Capital Markets | New York Stock Exchange
  • Marian T. Nakada, PhD, Vice President — Venture Investments, Johnson & Johnson Innovation
  • Steven Tregay, PhD | President & CEO | Forma Therapeutics
  • Murray Alexander Abramson MD, MPH | Vice President, Global Clinical Operations | Biogen
  • David Sherris PhD, President & CEO, GenAdam Therapeutics, Inc.
  • And more…



Quick Links | Register | Speakers | Speaker Marketing Toolkit  | Advisory Board

Leading pharmaceutical and biotech professionals will convene in Boston for the FierceBiotech Drug Development Forum (DDF) to discuss and evaluate the latest challenges, trends and innovation in drug discovery, research, and development. Three distinct tracks (R&D, Partnering & Deals, and Outsourcing) will provide insight into multiple aspects of the drug development process. Check back for updates on Keynote announcements, track information and speakers. Click here to register today.

Research & Development (R&D)

Bringing a new drug to market from drug discovery through pre-clinical research, clinical trials, and regulatory approval has become an increasingly complex process involving an intricate array of stakeholders including industry, academia, investors, and regulatory authorities. In this track we will unravel the complexity by discussing key topics and trends that improve efficiency and streamline the process.

Partnering & Deals (P&D)

Creativity and innovation apply equally to pharmaceutical business strategy as they do to the drug development process. With large pharma, emerging biotech, and investors all questioning traditional business models and approaches, innovative financing and partnership deals have become more the rule rather than the exception. This track will look at this changing landscape from multiple perspectives including Wall Street, venture capital, and the industry.

CROs & Outsourcing (C&O)

With the fully-integrated pharmaceutical company becoming a blip in the rearview mirror and emerging biotechs exploring all organizational options, outsourcing has become a defining trend. CROs have emerged as the big outsourcing player but all functional areas in the drug development process are in play. This track will examine the hurdles, the opportunities, the risks, and the rewards that need to be considered in outsourcing any drug development function or process.

FierceBiotech would like to thank their Advisory Board for helping to shape the groundbreaking content and program at the 2016 FierceBiotech Drug Development Forum.



    1:30PM – 5:00PM


    2:00PM – 5:00PM

    Workshop 1: Drug Development Primer

    Speaker: Simon Tulloch, MD | Chief Medical Officer | Faraday Pharmaceuticals

    This 3-hour workshop focused on the regulatory considerations required to bring a drug successfully to market. The focus will be specifically on the safety studies necessary for IND filing and the clinical studies necessary for NDA/BLA approval. Discussion points feature both small molecule and biologic products. Learn what it takes to get a molecule from the bench into the marketplace by an industry expert who has received drug approvals in both the US and Europe.

    Workshop 2: Financing a Cure

    Speaker: Marc LeMaitre, PhD | Biotech Executive & Independent Consultant

    This 3-hour workshop on the business acumen associated with the financial, IP, and life cycle management of a drug. Learn what it takes to successfully fund, protect, and price your molecule. Numerous personal accounts and war stories are used to illustrate the decision-making process companies use, giving participants a working knowledge of strategic development.

    5:30PM – 6:30PM

    Fierce 15 Awards Presentation & Networking Reception

    The FierceBiotech Fierce 15 is a hunt for the biggest ideas in biotech, the most daring characters in biopharma, and entrepreneurs doing things that haven’t been done before. Fifteen privately held drug developers or platform biotechs with the potential to have a huge impact on the treatment of human diseases. The Fierce 15 celebrates the spirit of being “fierce”–championing innovation and creativity, even in the face of intense competition–and has recognized a number of distinguished biotechs over the years.


    8:00AM – 5:00PM


     8:00AM – 8:45AM

    Morning Coffee Networking

     8:45AM – 9:00AM

    Chairperson’s Welcome

    Speaker: Rebecca Willumson | Publisher | FierceBiotech

    9:00AM – 9:50AM

    KEYNOTE | Shire: Driving Growth by Building the Global Leader in Rare Diseases and Highly Specialized Conditions

    Shire is striving for leadership positions in multiple, high-value franchises and to become the clear partner of choice in rare diseases and highly specialized conditions. 2015 saw the acquisition of NPS Pharmaceuticals and Dyax along with the integration of ViroPharma. 2016 was truly transformative for the Company following the successful combination with Baxalta earlier this year and the FDA approval of ophthalmics drug Xiidra.

    The Baxalta deal gives Shire an impressive pipeline, with franchise operations that extend from hematology to immunology, neuroscience, lysosomal storage disorders and more. The combined company will generate 65% of its revenue from drugs that target rare diseases by 2020. Hear how Shire’s R&D head plans to forge strategic research collaborations and partnerships while reinvesting in targeted and innovative in-house R&D to drive its pipeline forward.

    Phil Vickers | Global Head of Research & Development | Shire Pharmaceuticals

    10:00AM – 10:50AM

    GENERAL SESSION: Biotech IPOs in 2017

    Moderator: Kimberly Ha | Senior Director, Strategic Communications | FTI Consulting

    Bruce Booth | Partner | Atlas Venture
    Wende Hutton | General Partner | Canaan
    Dr. Carol Gallagher, PharmD | Partner | NEA
    Simos Simeonidis, PhD | Managing Director – US Biotechnology Equity Research | RBC Capital Markets
    Brian Hagerty | Senior Director, Head of Healthcare Capital Markets | New York Stock Exchange

    It’s no secret that IPOs have been chilled by the bear market that ravaged biotech stock prices in Q1—but they weren’t eliminated from the scene. Our panel of IPO experts will size up the current market and look at the prospects for 2017. What are the factors that will determine a solid IPO? And when should companies stay away from an S-1?

    10:50AM – 11:10AM

    Networking & Refreshment Break

    11:10AM – 12:00PM

    R&D: Phase I/IIa: Early-stage Strategies and Phase III: The Pivotal Moment

    Moderator: Amirah Al Idrus | Editor | FierceBiotech

    Barry Ticho MD, PhD | Head of Development CVMD | Moderna Therapeutics
    Susan Washer | CEO | Applied Genetic Technologies Corporation
    Jim Roach MD, FACP, FCCP | SVP – Development and Chief Medical Officer | Momenta Pharmaceuticals, Inc.
    Beatrice Setnik | Vice President of Clinical Pharmacology | INC Research

    The standard trial path for drugs has been revolutionized in the past decade. These days, most developers design an early-stage program that can establish safety AND proof-of-concept data at an early stage. Recruit the right number of the right patients, and you can enhance your chances of getting the right partner for a pivotal program. In this session, experts will look at the impact of new technologies and FDA guidances on early-stage studies.

    With the right late-stage development program, it’s possible to cut years out of a clinical pathway to an approval. The FDA has been helping with its new breakthrough program, just the latest in several agency designations aimed at speeding up approvals. And biopharma has responded with aggressive studies that can pinpoint the right surrogate endpoints and identify early signs of efficacy that can be further confirmed in post-marketing studies.

    P&D: BioPharma M&A

    Moderator: Carly Helfand | Senior Editor | FiercePharma & FiercePharmaMarketing

    Mark G. Barrett | Vice President, Global Head of Strategy & Business Development | Genzyme
    Luba Greenwood | Vice President, Global Business Development and Mergers & Acquisitions | Roche
    Samantha Truex | Former CBO | Padlock Therapeutics
    Alan Butcher | Head of Licensing & Business Development | Purdue Pharma

    All the fundamentals are in place for a vibrant M&A market. But, Big Pharma still needs new assets for variable pipelines after years of weak productivity, yet Big Pharma CEOs have been leery about the prices they’re asked to pay. M&A advisers will discuss the art of the deal, and what lies ahead in deal terms.

    C&O: New Tools for Patient Recruitment

    Moderator: Beth Snyder Bulik | Contributing Writer | FiercePharmaMarketing

    John Lewis | SVP – Policy & Public Affairs | Association of Clinical Research Organizations
    Nathan Sanburn | Regional Director Medical-East Oncology, US Medical Affairs | Eli Lilly & Co.
    Paulo Moreira | Vice President – Global Clinical Operations | EMD Serono


    Matthew Howes | Executive Vice President, Strategy & Growth | PALIO, an inVentiv Health Company

    Everyday new tools are being introduced to help companies identify, screen, and recruit patients in clinical trials. New mobile apps and social media networks like Facebook have helped revolutionize the way patients are recruited for clinical trials. The objective of using these approaches and tools is to expedite recruitment of eligible patients. Find out what’s new, and how it might help you.

    12:00 PM – 1:00PM

    Lunch & Sponsor Networking

    1:00PM – 1:50PM

    GENERAL SESSION: The Genomics Package

    Moderator: Stacy Lawrence | Editor-in-Chief | FierceBiotech

    Alex Parker, PhD | Vice President, Business Development | Foundation Medicine
    Issi Rozen | Chief Business Officer | Broad Institute of MIT and Harvard
    Murray Robinson, PhD | President | Molquant, Inc.
    JC Gutierrez-Ramos | CEO | Synlogic

    How are drugmakers working with top sequencing centers and companies? This session will take a look at accomplishments and challenges, with panelists from genomics institutes and drugmakers that are using their data in drug development. How will genomics change the way drugs are identified and developed? And how can small companies take advantage?

    2:00PM – 2:50PM

    R&D: Fine Tuning Remote Patient Monitoring in Clinical Trials

    Moderator: Stacy Lawrence | Editor-in-Chief | FierceBiotech

    Fred Cox | Senior Director – Patient Outcomes and Medical Economics | Sanofi Genzyme
    Yury Rozenman | Director of Business Development | Qualcomm Life
    David Van Sickle | Co-Founder & CEO | Propeller Health
    Jane Rhodes | Senior Director – New Initiatives & Innovation Hub | Biogen

    How are pharma companies using new monitoring technologies to generate trial data? Smart inhalers from a variety of respiratory developers, plus other testing and communications devices can keep track of adherence and patient results for real-time monitoring during clinical studies. What are the advantages and disadvantages of remote monitoring? Is it cost-effective? Find out the answers to these questions and more during this informative session.

    P&D: Partnerships in Immuno-Oncology

    Moderator: Arlene Weintraub | Contributing Writer | FierceBiotech

    David Sherris PhD | President & CEO | GenAdam Therapeutics, Inc.
    Steven Tregay, PhD | President & CEO | Forma Therapeutics
    Anne Altmeyer | VP – Business Development | Shire Pharmaceuticals
    Jeff Albers | President & CEO | Blueprint Medicines
    Etienne Drouet | Vice President Strategic Development | SynteractHCR

    Immunotherapies for cancer are among the hottest drug candidates out there, and this trend has inspired a frenzy of collaborations among biotechs and pharma. In some cases, developers have begun to identify and pursue second-generation approaches before the first generation has even hit the market. How is this field likely to develop over the next 5 years, and what kind of natural boundaries will form as the leaders stake their claims to a share of a multibillion-dollar market?

    C&O: Taking Maximum Advantage of Rare/Orphan Disease R&D Edge

    Moderator: Markus Peters | Associate Partner | Alacrita

    Stacy Coen | Head of Rare Disease Business Development & Licensing | Sanofi Genzyme
    John Orloff | Biopharma R&D Executive
    Mark Baglin | VP – Product Strategy | Shire Pharmaceuticals
    Jeremy Springhorn | Partner – Corporate Development | Flagship Ventures
    Karen Kaucic, MD | Vice President, Global Head | PPD® Consulting

    One ideal approach in biotech is pursuing a new drug for rare/orphan diseases. Trials can be smaller and more affordable. It’s more realistic to blue print a marketing campaign. And Big Biopharma companies are ready and willing to buy in when the data is right. Our experts review some case studies on how this can be done right, and where the pitfalls are.

    3:00PM – 3:50PM

    R&D: Translational R&D Transformation

    Moderator: Arlene Weintraub | Contributing Writer | FierceBiotech

    Kenneth Kaitin, PhD | Professor & Director | Tuft Center for the Study of Drug Development / Tufts University School of Medicine
    Lloyd Klickstein MD, PhD | Head of Translational Medicine, NIDU | Novartis Institutes for BioMedical Research, Inc.
    Michael Kauffman | CEO | Karyopharm
    John Quisel | SVP – Business Development and General Counsel | Acceleron

    Harvard’s recent $20 million deal to out-license a preclinical drug to Merck & Co. underscores the transformation underway in translation research. While venture capital groups had already been cherry-picking some of the best academic research for the IP used to launch new companies, many academic investigators are now going the extra mile in candidate selection to enhance the value of their work, making it clinic-ready for development teams. How will this trend shape the next wave of new drug programs and upstart biotechs?

    P&D: Early Research Analytics to Drive Precision Medicine and Increase PTRS

    Speaker: Mike Mentasana | Pharmaceutical & Life Sciences R&D Advisory Leader, Partner | PwC

    We are at the beginning of a “New Frontier” in biopharma research and development where advanced analytics are embedded into the discovery and development of products tailored to specific patient characteristics with increasing precision. The exponential growth in the volume and variety of medical information combined with recent advances in data storage and computing technology provide an incredibly rich data source and a cost-effective way to analyze it. Today, scientists across the industry are beginning to use these novel techniques to generate new insights about patients and underlying disease biology. Our panel of experts will discuss practical applications of advanced analytics being used today and share their vision for the future.

    C&O: Innovative Drug Delivery Technologies

    Moderator: Cornell Stamoran, Ph.D. | Vice President, Strategy | Catalent, Inc. | Founder and Co-Chair | Catalent Applied Drug Delivery Institute

    Menashe Y. Levy PhD | VP & Chief Technology Officer – Global R&D | Teva
    Ronald L. Smith | Scientific AVP – Pharmaceutical Sciences | Merck Research Laboratories
    Keith Horspool | VP – Pharmaceutics | Boehringer Ingelheim
    Robert Walsh, MD | Medical Director – Pharmacovigilance & Patient Safety | AbbVie

    Better delivery can extend patent control and offer a new lease on life for many older drugs. These technologies are also key to hitting once undruggable targets. Learn what you need to know, now, in this informative session.

    4:00PM – 5:00PM

    GENERAL SESSION: 2016 Top Women in Biotech Panel

    Moderator: Tracy Staton | Editor-in-Chief | FiercePharma

    Anna Protopapas | President & CEO | Mersana Therapeutics
    Cynthia Verst, PharmD | MS President – Clinical Operations | Quintiles
    Susan B. Dillon, PhD | Global Therapeutic Area Head – Immunology Janssen Research & Development | Johnson & Johnson
    Kathrin Jansen PhD | SVP & Head of Vaccine Research & Development | Pfizer

    Over the past decade a group of extraordinary women has put the well-worn cliché that men dominate the top ranks of the biotech industry to the test! Along the way, they’ve learned some very important lessons. Join these top-notch women in the industry address the challenges they’ve faced in their careers and suggest ways companies can recruit talented women and create a working environment that’s friendlier to them.

    5:00PM – 6:30PM

    2016 Top Women in Biopharma Awards Presentation & Networking Reception

    It’s a well-worn cliché that men dominate the top ranks of the biotech industry. But over the past decade a group of extraordinary women has put that cliché to the test. For each of the honorees, there are unique stories about how impressive women have gotten ahead in the competitive biotech field. The FierceBiotech Top Women in Biopharma is a celebration of women in the life sciences industry, academia and regulatory roles who are outstanding members of the field.


     8:00AM – 12:00PM


    8:00AM – 8:45AM

    Morning Coffee Networking

    8:45AM – 9:00PM

    Chairperson’s Welcome & Day 1 Review

    Speaker: Rebecca Willumson | Publisher | FierceBiotech

    9:00AM – 9:45AM

    GENERAL SESSION: The Current State and Future of Big Data

    Moderator: Stacy Lawrence | Editor-in-Chief | FierceBiotech

    Steve Labkoff, MD | Executive Director – Medical Strategy & Medical Affairs | Purdue Pharma LP
    Eric D. Perakslis PhD | Senior Vice President & Head – Takeda R&D Data Science Institute | Takeda Pharmaceuticals International Co.
    Shuvayu Sen | Executive Director, Outcomes Research & Access | Merck & Co.
    Chandra Ramanathan, PhD, MBA | Vice President and Head, East Coast Innovation Center | Bayer HealthCare LLC

    Drugmakers, academic institutes, government-sponsored research programs and tech companies are pouring billions of dollars into big data-producing research and big data tech projects, counting on the investments to pay off—sometimes in ways that can’t even be imagined yet. But the industry has a long list of problems to work through as companies make big data their own. Attendees will hear from experts in the field talk about the state of big data in biopharma and what comes next.

    9:45AM – 10:30AM

    GENERAL SESSION: Jumping Onto the FDA’s Fast Track

    Moderator: Diane M. Beatty, Ph.D. | Managing Director, Regulatory Affairs and Product Development | Cardinal Health

    Robert Ashworth | VP – Regulatory Affairs | Advaxis, Inc.
    Pam Swiggard | VP – Regulatory Affairs | Trevena
    Donald L Raineri, PharmD | VP & Head – Regulatory Affairs-Americas | Astellas Pharma Global Development, Inc.

    More than half of all cancer meds now approved have been on one of several FDA fast tracks. Breakthrough drug designations have shaved months and sometimes years off the research process. And investigators want to know how to get on the inside regulatory lane, and stay there. Our experts will provide some suggestions on what works with regulators, and take a close look at what’s at stake in the proposed 21st Century Cures Act.

    10:30AM – 10:50AM

    Networking & Refreshment Break

    10:50AM – 11:30PM

    GENERAL SESSION: How to Strike a $1 Billion Deal

    Moderator: Steve Dickman | Founder & CEO | CBT Advisors

    Tony Bower | President | BRG, LLC. / Former Vice President, Global Pricing, Reimbursement and Health Economics | Synageva
    Jeb Keiper | Chief Business Officer | Nimbus Therapeutics
    Caroline Stark Beer | Senior Director of Business Development | Alnylam
    David Brush | Senior Director, Transactions | Johnson & Johnson Innovation

    Let’s face it. Every upstart biotech wants to one day be in a position to strike a billion-dollar deal with plenty of that in up-front fees and near-term milestones. What are the key elements that make a billion-dollar deal possible, and how can you position your company to do the same? A group of executives who have been there and done that discuss successes and challenges of doing the deal.

    11:30AM – 12:15PM

    GENERAL SESSION: Navigating Global Logistics of Clinical Trials

    Moderator: Amirah Al Idrus | Editor | FierceBiotech

    Murray Alexander Abramson MD, MPH | Vice President, Global Clinical Operations | Biogen
    Mike Collins | VP of Global R&D Vendor Management | Alexion Pharmaceuticals
    Jonathan Edelman | Vice President – Clinical Development | Seqirus
    Bardia Akbari | Vice President & Global Head of Product Global Development – Oncology | Genentech, Inc.

    China and emerging markets present new opportunities to developers who are looking for more efficient studies and global approvals. Here we’ll discuss those opportunities and identify ways to navigate the challenges that come with global development plans.

    12:15PM – 1:15PM

    Lunch & Sponsor Networking

    1:15PM – 2:00PM

    GENERAL SESSION: The Next Wave in Biotech: How Are Funding Choices Changing?

    Moderator: Eric J. McCafferty | Head of Biotech Client Solutions | PPD

    Michal Preminger, PhD, MBA | Executive Director – Harvard University Office of Technology Development | Harvard Medical School
    John Puziss | Director of Technology Licensing | Yale University
    Deborah Dunsire MD | Principal | Southern Cross Biotech Consulting

    Over the past few years a tidal wave of IPOs has helped transform the biotech industry, ushering in new venture funds that have been financing a host of startups. We’ll bring together some of the top academic investigators and serial entrepreneurs in the industry to look at what is happening in the biotech landscape and how funding sources are changing. How do you determine the right moment to set up a drive to create a commercial product? Who’s getting financing, and who isn’t?

    2:00PM – 2:45PM

    GENERAL SESSION: VCs: Creating Value in 2017 and Beyond

    Moderator: Damian Garde | Reporter | STAT

    Stephen Knight, MD | President & Managing Partner | F-Prime Capital Partners
    Alan Crane | Partner | Polaris Partners
    Todd Foley | Managing Director | MPM Capital
    Marian T. Nakada, PhD | Vice President – Venture Investments | Johnson & Johnson Innovation – JJDC, Inc.

    In the 8 years since the 2008 financial crisis, venture capital circles have tightened to a set of experienced, well financed players who like to back proven biotech execs with strong track records in value creation. But how do you create the ideal syndicate that can back your company all the way to a key catalyst? And what’s the outlook for venture capital in 2017? VCs discuss the fine points around how their world is changing-from how they view TAs, individual therapies vs. platform based technologies toward a variety of indications, deal structures, and ultimately how they drive value for their portfolio companies.

    2:45PM – 3:30PM

    GENERAL SESSION: Going Small Gets Big

    Moderator: Chris Apolito | Partner | Triangle Insights Group, LLC

    Jake Beverage | COO | Sirenas
    Henry Rath| Vice President – Business Development & Strategy | Seres Therapeutics, Inc.
    Nancy Thornberry | CEO | Kallyope
    Steve Paul, M.D. | President & CEO | Voyager Therapeutics

    When Briggs Morrison made the leap from top R&D exec at AstraZeneca to the helm of a much smaller biotech, it was just the latest in a whole series of such moves. As the IPO window stayed open for three long years, the appeal of running your own biotech grew more and more obvious, and the migration included some of the best known people in the business. That trend has been fostered by VCs anxious to put together seasoned teams of veteran drug developers, and even as the IPO window narrows, startups have remained strong. Some top execs who made the switch talk about the pros and cons of going small.

***Schedule and topics subject to change without prior notice.***


Reply-To: <editors@fiercebiotech.com>

Date: Wednesday, August 24, 2016 at 2:33 PM

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

Subject: Your Invitation to attend the first annual Drug Development Forum

Value for Patients – Turning Advances in Science: A Case Study of a Leading Global Pharmaceutical Company – Astellas Pharma Inc.

Astellas Pharma Inc. (https://www.astellas.com/en/) and Astellas Pharma U.S., Inc. (https://www.astellas.us/)

UPDATED on 8/24/2016

Some analysts suggested Pfizer paid too much, particularly since it will split profits from Xtandi with Japan-based Astellas Pharma, which helps market the drug. Pfizer defended the deal, saying it would add 5 cents to its earnings per share in the first full year.

“The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer,” Ian Read, chairman and chief executive of Pfizer, said in the statement on Monday.



Author: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures  https://pharmaceuticalintelligence.com/biomed-e-books/series-e-titles-in-the-strategic-plan-for-2014-1015/2014-the-patients-voice-personal-experience-with-invasive-medical-procedures/


Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company, has a strong, global company legacy, precision focus and patient-centric vision in creating innovative pharmaceuticals in areas of unmet medical need.

2012-05-10 003_Astellas building

Image SOURCE: Photograph of the Astellas Pharma U.S. building. Courtesy of Astellas Pharma U.S., 5/10/2012.   

The company’s commitment to science is based on development of medicines that address high unmet medical needs in therapeutic areas that include:

  • oncology,
  • urology,
  • immunology,
  • nephrology, and
  • neuroscience.

The company is also exploring advancements in new therapeutic areas and related diseases such as,

  • ophthalmology—retinitis pigmentosa (RP), age-related macular degeneration (AMD), diabetic macular edema (DME) and Stargardt’s macular degeneration (SMD) and
  • muscle diseases.

And they are investing in new technologies and modalities, such as,

  • regenerative medicine and cell therapy, and
  • next-generation vaccines.

The company is committed to improving the lives of patients through innovative science and with the highest sense of ethics and integrity. This commitment is reflected in the Astellas Group Code of Conduct, which applies to all employees across the globe and can be accessed through the link below.

Astellas Group Code of Conduct

Boosting research and development productivity remains an important issue for Astellas Pharma Inc., because innovation is vital for the company’s success in developing new therapeutic areas, technologies and modalities of treatment.

Dr. Bernhardt Zeiher, President, Development, is responsible for the more than 800-person development organization that is involved in developing these innovative therapies through cutting-edge clinical research. Dr. Zeiher’s team conducts clinical investigations of novel biological targets and new chemical entities with unique mechanisms of action and looks to determine whether the findings in preclinical testing will translate to benefit for patients.  Clinical studies are conducted globally with operational hubs in the United States, Netherlands and Japan. Astellas relocated their Development headquarters from Japan to the United States in 2008.

Building on its 120-year heritage, Astellas uses creativity and innovation to bring patients new medicines through the more than 17,000 global employees who work to improve the lives of patients and their families. Astellas was formed through the merger of Japan’s third and fifth largest pharmaceutical companies, Yamanouchi, founded in 1923, and Fujisawa, founded in 1894. Yamanouchi brought a record of developing blockbuster drugs, a pipeline full of promising new compounds and a sales and marketing culture of deeply grounded, data-driven expertise. Fujisawa brought dominance in transplantation, a soaring reputation for in-depth understanding of the disease states and treatments within its market niches, and a track record for developing high-profile, market-leading products that become new standards of care.

The company has made steady progress; they reported annual global sales of 1,372,706 million yen (approx. $13.2 billion) through the end of fiscal year 2015, with an annual research and development investment of 225,665 million yen (approx. $2.2 billion) through the end of fiscal year 2015.

Below is my interview with Astellas Dr. Bernhardt Zeiher, President, Development, which occurred in June, 2016.

What is your overall Research & Development (R&D) strategy?

Dr. Zeiher: We are focused on turning innovative science into value for patients in areas of high unmet need where we have, or can quickly acquire, expertise and where Astellas believes new scientific understanding is poised to drive significant innovation. Our commitment to R&D is based on the development of medicines that address high unmet medical needs in our main therapeutic areas of focus: oncology, urology and immunology.  We also have increased efforts to explore advancements in new therapeutic areas such as ophthalmology, nephrology, neuroscience and muscle diseases where there is a high level of unmet medical need. Building on our patient-centric vision, Astellas has been actively investing in new technologies and modalities, such as regenerative medicine and next-generation vaccines.

What are your R&D strengths?

Dr. Zeiher: Astellas is building on its legacy of bringing transformative medications to patients by investing in some of today’s most dynamic areas of scientific exploration. Innovations delivered by Astellas have helped to address and largely solve some of the most significant scientific challenges in urology and transplant. We also have built a strong presence in oncology with treatments for difficult-to-treat cancers, such as prostate and non-small cell lung cancer.

Moving forward in oncology, Astellas has made a deliberate effort to build leadership through organic efforts with a pipeline exemplifying the “follow the biology” approach that includes treatments for prostate, non-small cell lung and pancreatic cancer, and continued research in therapies for breast cancer and acute myeloid leukemia, among others. We also have forged strategic acquisitions and collaborated with industry and academic leaders to further build our portfolio.

In addition, we are leveraging what we know across conditions with similar biologies or mechanisms, building on our expertise to expand into adjacent diseases and proactively seek new opportunities. For example, leveraging our expertise in transplantation and infectious diseases, Astellas is developing the world’s first DNA vaccine for cytomegalovirus (CMV) infections. Currently in clinical trials, ASP0113 is a potential first-in-class agent for immunocompromised individuals undergoing solid organ or hematopoietic stem cell transplant who are at high risk of viral reactivation.

Describe your near-term R&D projects and pipeline activities?

Dr. Zeiher: Currently, the company is working on 35 investigational programs in Phase II and Phase III/registration development, of which half involve new molecular entities. We have a diverse pipeline with a balance of early- and later-stage assets. Later-stage programs include novel therapies/vaccines for cancer, anemia and infectious diseases.

  • Our two most advanced novel oncology agents, ASP2215 and ASP8273, continue to progress through the pipeline. ASP2215 shows promise in the treatment of relapsed or refractory acute myeloid leukemia, and ASP8273 is being evaluated as a treatment for a type of non-small cell lung cancer.
  • Leveraging our expertise in kidney disease, we are developing a first-in-class oral treatment for anemia associated with chronic kidney disease through our licensing agreement with FibroGen.
  • Astellas is developing the world’s first DNA vaccine for cytomegalovirus (CMV) infections. Currently in clinical trials, ASP0113 is a potential first-in-class agent for immunocompromised individuals undergoing solid organ or hematopoietic stem cell transplant who are at risk of viral reactivation. We are also working on a therapeutic vaccine, ASP4070, for Japanese red cedar pollen allergy.

We are building expertise in two new therapeutic areas—ophthalmology and muscle diseases—where there is significant unmet need. Through the Astellas Institute for Regenerative Medicine (AIRM) and external collaborations, we are addressing ophthalmologic diseases with a higher risk of blindness, including age-related and Stargardt’s macular degeneration, retinitis pigmentosa (RP), and diabetic macular edema (DME). In the muscle disease area, we are collaborating with our partner, Cytokinetics, on a skeletal muscle troponin activator which is being investigated in Spinal Muscular Atrophy (SMA). In addition, Astellas and Cytokinetics have agreed to amend their collaboration agreement to enable the development of CK-2127107 for the potential treatment of ALS and to extend their joint research focused on the discovery of additional next-generation skeletal muscle activators through 2017.

The pharmaceutical industry is intensely competitive and it requires an extensive search for technological innovations. How are you positioned to be a leader in developing new medicines that address unmet medical needs in critical therapeutic areas?

Dr. Zeiher: Astellas is focused on accelerating scientific discovery with an open innovation model. The Astellas open innovation model combines in-house R&D with strategic merger and acquisition approaches to advance research in untouched and complex disease states, allowing the company to maintain steady productivity and maximize its return on R&D investment.

With open innovation, Astellas undertakes research activities in the best possible environment. In some cases, the best environment is within the Astellas research laboratories. In many other cases, we look to collaborate with top biotech and academic leaders.  By building partnerships with top researchers and companies that complement our existing expertise, Astellas is able to quickly advance into new technologies and therapeutic areas of research where there is significant unmet medical need.

This approach has helped Astellas credibly enter into, compete and lead in some segments of the most competitive therapeutic areas in the pharmaceutical industry – oncology – and is accelerating the company’s efforts to develop treatments for important emerging therapeutic categories, such as ophthalmology and musculoskeletal disease, as well as leading technologies, such as regenerative medicine and vaccines.

For example, LAMP-vax is a next-generation DNA vaccine that utilizes the body’s natural cellular processing of Lysosomal Associated Membrane Protein (LAMP) to develop a more complete immune response to a target antigen.  The ability to activate a more complete immune response gives the LAMP-vax technology potential across a number of diseases, including allergic disease and cancer immunotherapy.  In 2015, Astellas established a licensing agreement with Immunomic Therapeutics, Inc. for the LAMP-vax products for the treatment or prevention of any and all allergic diseases in humans, including ARA-LAMP-vax for peanut allergy and other research-stage programs for food or environmental allergies.

Earlier this year, Astellas acquired Ocata Therapeutics, Inc., and established the Astellas Institute for Regenerative Medicine (AIRM) to serve as the global hub for Astellas regenerative medicine and cell therapy research. Our most advanced cellular therapy programs are in ophthalmology, but we are exploring other therapeutic areas. We are working on treatments for ophthalmologic diseases that leave patients at risk for blindness, which include retinitis pigmentosa (RP), age-related macular degeneration (AMD), and Stargardt’s macular degeneration (SMD).


Image SOURCE: Photograph of Dr. Bernhardt Zeiher, President of Development, at Astellas. Courtesy of Todd Rosenberg, 11/17/2014. 

Dr. Bernhardt Zeiher serves as President, Development, at Astellas. In this role, he is responsible for all phases of drug development.

Prior to his current role, Dr. Zeiher was executive vice president and Therapeutic Area head, Immunology, Infectious Diseases and Transplantation at Astellas. Of note, he led the development of CRESEMBA® (isavuconazonium sulfate), which received Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration and was approved in 2015 for the treatment of two rare invasive fungal infections. Prior to joining Astellas, he served as vice president of the Inflammation/Immunology therapeutic area at Pfizer.

Dr. Zeiher earned his Doctor of Medicine at the Case Western Reserve University School of Medicine, and completed an internal medicine residency at University Hospitals of Cleveland as well as a fellowship in Pulmonary and Critical Care Medicine at University of Iowa Hospitals and Clinics. Dr. Zeiher has received several awards, including being named a Fellow by American College of Physicians in 2004, awarded to those who demonstrate excellence and contributions to both medicine and the broader community of internists.

Editor’s note:

We would like to thank Jeff Winton, Andrew Lewis and Julie Monzo from the Astellas communications team for the tremendous help and support they provided during this interview.



Astellas Pharma Inc. (https://www.astellas.com/en/) and Astellas Pharma U.S., Inc. (https://www.astellas.us/)

Other related articles:

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Other related articles were published in this Open Access Online Scientific Journal include the following: 


LIVE 4:50 pm – 5:55 pm 4/25/2016 Early Detection and Prevention of Cancer & Innovation Break: Announcing the C³ Prize from Astellas Oncology and the World Medical Innovation Forum @2016 World Medical Innovation Forum: CANCER, April 25-27, 2016, Westin Hotel, Boston


Top Seven Big Pharma in Thomson Reuters 2015 Top 100 Global Innovators


Eye Lens Regenerated




Picturing US-Trained PhDs’ Paths and Pharmaceutical Industry’s Crisis of Productivity: Partnerships between Industry and Academia


Medicines in Development for Cancer in 2012: An Excellent Response from America’s Biopharmaceutical Research Companies


Health Care & Medical Practices need to overcome the status quo: The Medical science is saying we need to do things differently: The Premise of Molecular Diagnostics and Precision Medicine

Reporter: Aviva Lev-Ari, PhD, RN


Medical science is more advanced than at any point in history. Yet the health care system — medical science applied to actual patients — still leaves many people without the best and latest treatments.


The Way Medicine Is Going




Scientists, doctors working to customize treatments — and get those treatments to greater numbers of people


Euan Ashley, a Stanford University Medical Center associate professor of medicine and genetics, in an article last week in Nature Reviews Genetics.


The California program’s website is www.ciapm.org.

At the federal level, Obama’s campaign, called the Precision Medicine Initiative, was unveiled in January 2015.

The initiative’s website is whitehouse.gov/pmi.

The Clearity Foundation, a San Diego nonprofit,Clearity provides these services free of charge, specializes in matching the best drugs to ovarian cancer patients with recurrent tumors. Through partners, Clearity arranges for tumor samples to be genetically analyzed and compared with those of others in a tumor database of hundreds of tumor samples.


*ERIC DISHMAN — Director of the National Institutes of Health’s program linked to President Barack Obama’s Precision Medicine Initiative.

*DR. ELIZABETH BACA — Senior health adviser to the California Governor’s Office of Planning and Research who helps coordinate the California Initiative to Advance Precision Medicine.

*DR. ERIC TOPOL — Director of the Scripps Translational Science Institute and chief academic officer for the San Diego-based Scripps Health network. He is leading a national project, backed by $120 million in federal funding, to enroll 1 million volunteers in a study to deeply explore their health. The aim is to get more data to customize patient care.

*DR. STEPHEN KINGSMORE — Diagnoses genetic childhood diseases at Rady Children’s Hospital-San Diego as president and CEO of the Rady Children’s Institute for Genomic Medicine.

*J. CRAIG VENTER — Genomics pioneer based in La Jolla. Beyond his eponymously named institute, Venter is co-founder of Human Longevity, a company aiming to sequence the DNA of hundreds of thousands of people.

*JAY FLATLEY — Executive chairman of Illumina in San Diego, the world’s leader in making systems that sequence DNA in high volume.

*LAURA SHAWVER — Founder of The Clearity Foundation in San Diego, which uses precision medicine to help match ovarian-cancer patients with drugs targeted to their various types of tumors.

*DR. ATUL BUTTE — Professor at UC San Francisco and principal investigator for the California Initiative to Advance Precision Medicine.



Cell & Gene Therapy BioProcessing & Commercialization

Cell Therapy Bioprocessing – Innovations in Process Technologies, Friday, October 7, 2016, Boston Convention and Exhibition Center

Informa Life Sciences lead the market in providing quality, expert-led conferences; delivering the expert knowledge our clients need to excel in their professional roles and guaranteeing a competitive advantage for their organisations.

Our diverse portfolio covers the Pharmaceutical (Drug Discovery, Clinical Development, Regulatory Affairs, Biopharmaceutical, Generics and Business Strategy), Medical Devices and Diagnostics, Fine Chemicals and Agrochemicals and Veterinary Medicine arenas


8 am 5 mins

Chairperson’s Remarks

  • Jon A. Rowley, Ph.D., RoosterBio Inc.

10 am 30 mins

Applications for Use of the Lovo Cell Processing System in Cell Therapy Process Development and Manufacturing

  • Alaina C. Schlinker, Ph.D., Fresenius Kabi USA, LLC

10:30 am 30 mins


  • Philip G. Vanek, Ph.D., GE Healthcare

11 am 30 mins

Platform Processes for PSC Derived Product Manufacture

  • Nick Timmins

11:30 am 30 mins

Building the 3rd Pillar of Medicine: Bioprocessing for Cell Therapies

  • Steve K.W. Oh, Bioprocessing Technology Institute

12 pm 45 mins

Enabling Technologies for Efficient Downstream Processing of AAV Viral Vectors

  • Orjana Terova, Purification, Thermo Fisher Scientific

1:55 pm 5 mins

Chairperson’s Remarks

  • Dominic Clarke, Charter Medical

2 pm 30 mins

Innovative Device Development for Cell Therapies

  • Jamie Piret, Sc.D., The University of British Columbia

2:30 pm 30 mins

Applying Single-Use Technologies

  • Paula Alves, Ph.D., iBET, Portugal

3 pm 30 mins

Manufacturing Multiple Cell Based Products Simulaneously

  • Gail K. Naughton, Ph.D., Histogen Inc.

3:30 pm 30 mins

Scale Out iPSC Derivation and Differentiation Processes for Cell Therapy

  • Wen Bo Wang, Ph.D., Cellular Dynamics International, a FujiFilm company



The more time a person spends sitting, the higher their risk of death from any cause

Reporter: Aviva Lev-Ari, PhD, RN


A very well-conducted study published in July in The Lancet. These authors took a fresh look at a massive load of data from 16 large studies and including over a million subjects. They aggregated the information, re-ran the analyses, and corrected for individual and population variations. What they found was that 60 to 75 minutes of moderate physical activity like walking to work, walking the dog, riding a stationary bike, line dancing, golf or softball, doubles tennis, or coaching sports eliminates the risk of death related to sitting, even from sitting for more than eight hours per day.

Can’t get in an hour or more of these types of activities per day? Just 25 minutes of moderate activity is somewhat protective, even for people who sit for eight or more hours per day. The way physical activity energy expenditure was calculated, vigorous activities count more, so less time of the most strenuous exercise is needed to be protective.

General Physical Activities Defined by Level of Intensity – CDC and ACSM guidelines

The following is in accordance with CDC and ACSM guidelines.



Related Posts:



The Strategy of Precision Editing the Cancer Cell Glycocalyx using an “antibody–enzyme conjugate” for Cancer Immunotherapy: Research Beyond “augment the activator or remove inhibitor, or both”

Reporter: Aviva Lev-Ari, PhD, RN


Successful tumors are able to evade the immune system, which is otherwise capable of killing transformed cells. Therapies that prevent this evasion have become revolutionary treatments for incurable cancers. One mechanism of evasion is the presentation of sugars, called sialic acids, within the cell surface’s sugar coating, or glycocalyx. Here, we designed biotherapeutic molecules, termed “antibody–enzyme conjugates,” that selectively remove sialic acids from tumor cells. The antibody directs the enzyme to the cancer cells, the enzyme cleaves the sugars, and then the antibody directs immune cells to kill the desialylated cancer cells. The conjugate increased tumor cell killing compared with the antibody alone. Editing the cancer cell glycocalyx with an antibody–enzyme conjugate represents a promising approach to cancer immune therapy.



AUGUST 22, 2016

Stanford chemists develop a new method of cancer immunotherapy

A team of Stanford ChEM-H scientists has discovered a novel form of cancer immunotherapy, which works by removing certain sugars from the surface of cancer cells and making those cells visible to the immune system.

“All of the world of immune therapy is now thinking about the immune system as calculating pluses and minuses. If you want to tilt the scale toward immune activation, you can either augment the activator or remove inhibitor, or both,” said Bertozzi, who is also an investigator with the Howard Hughes Medical Institute.

Current immunotherapies on the market work by blocking one of the inhibitory signals that are recognized by the adaptive immune system. Block those and the balance tilts in such a way that the immune system will attack the now recognizable cancer.

Bertozzi’s approach provides a second way of tiling the balance in favor of attack, this time for the innate immune system. She said this study shows just one example of how it could work, but her sugar-removing lawnmower could be used on a wide variety of cell types, not just those expressing HER2, and on different types of sugars.

“It’s almost always the case that you need a component of both the adaptive and innate immunity to get a robust reaction against infectious pathogens, such as during vaccination,” said Bertozzi. “The smart money suggests that the same will be true with tumors.”

Bertozzi said the approach also highlights the importance of paying attention to the much ignored glycocalyx.


Stanford chemists develop a new method of cancer immunotherapy




A symbolic representation of a glycocalyx chain attached to a cytoskeleton.

IMAGE SOURCE: google images



image glycocalyx

IMAGE SOURCE: google images


Glycocalyx – www.futura-sciences.us576 × 284Search by image

The carbohydrates, glycoproteins and proteoglycans making up the glycocalyx

IMAGE SOURCE: google images

PNAS – Original Article

Precision glycocalyx editing as a strategy for cancer immunotherapy

  1. Han Xiaoa,b,1,
  2. Elliot C. Woodsa,b,1,
  3. Petar Vukojicica,b, and
  4. Carolyn R. Bertozzia,b,2
  1. Edited by Laura L. Kiessling, University of Wisconsin-Madison, Madison, WI, and approved July 11, 2016 (received for review May 24, 2016)


Cell surface sialosides constitute a central axis of immune modulation that is exploited by tumors to evade both innate and adaptive immune destruction. Therapeutic strategies that target tumor-associated sialosides may therefore potentiate antitumor immunity. Here, we report the development of antibody–sialidase conjugates that enhance tumor cell susceptibility to antibody-dependent cell-mediated cytotoxicity (ADCC) by selective desialylation of the tumor cell glycocalyx. We chemically fused a recombinant sialidase to the human epidermal growth factor receptor 2 (HER2)-specific antibody trastuzumab through a C-terminal aldehyde tag. The antibody–sialidase conjugate desialylated tumor cells in a HER2-dependent manner, reduced binding by natural killer (NK) cell inhibitory sialic acid-binding Ig-like lectin (Siglec) receptors, and enhanced binding to the NK-activating receptor natural killer group 2D (NKG2D). Sialidase conjugation to trastuzumab enhanced ADCC against tumor cells expressing moderate levels of HER2, suggesting a therapeutic strategy for cancer patients with lower HER2 levels or inherent trastuzumab resistance. Precision glycocalyx editing with antibody–enzyme conjugates is therefore a promising avenue for cancer immune therapy.


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