DATE: THURSDAY, FEBRUARY 6TH

TIME: 1:30 - 5:00 PM

LOCATION: CHRISTIANACARE

TODAY & TOMORROW

BRINGING GENE EDITING TECHNOLOGY FROM LABORATORY TO BEDSIDE

2020-PRECISION-MEDICINE-LINE

This program will provide an overview of the opportunities and challenges expected in bringing genome editing from the laboratory to the beside. Hear from leading experts on the science behind genome editing; challenges in the IP landscape; learn about what is happening at NIST to set industry standards; hear about anticipated challenges from a public policy perspective, and gain a high-level overview on product development strategies to ensure plans are scientifically sound and meet regulatory expectations and clinical objectives.

GUEST

MODERATOR

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MAIKEN SCOTT

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HOST & CREATIVE DIRECTOR
THE PULSE ON WHYY

MAIKEN SCOTT BIO

Maiken Scott hosts WHYY’s The Pulse - a national health and science radio show and podcast that explores the people and places at the heart of health and science. Since its launch in December 2013, The  Pulse has crafted a unique, “ground-level” approach to telling compelling stories and breaking down complicated issues. For the Pulse, Maiken has explored Natural History museums as ‘time capsules for our planet,’ Thomas Jefferson’s ill-fated attempts to study Native American languages, and why so many patients cry after waking up from anesthesia, just to name a few topics.

WHYY is Greater Philadelphia’s leading public media provider and PBS/NPR member station, serving southeastern Pennsylvania, southern New Jersey and all of Delaware.

GUEST

SPEAKERS

2020-PRECISION-MEDICINE-LINE
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ERIC KMIEC, PH.D.

2020-PRECISION-MEDICINE-LINE
DIRECTOR
GENE EDITING INSTITUTE

ERIC KMIEC, PH.D. BIO

Eric B. Kmiec, Ph.D., is well known for his pioneering work in the fields of molecular medicine and gene editing. Since 2015 he has directed the Gene Editing Institute of the Helen F. Graham Cancer Center & Research Institute at ChristianaCare.

Under Dr. Kmiec’s leadership, the Gene Editing Institute has become a leader in gene editing and biomedical research in cancer and other inherited disease. It is the only institute of its kind embedded in a community cancer center where interactions among oncologists, genetic counselors and patients take place. This unique collaboration brings translational cancer research – from innovative basic science directly to patient treatment – to an entirely new level.

In April 2018, the team announced a major new development in the CRISPR Journal of the first CRISPR gene-editing tool to allow DNA repairs outside the human cell. The new “cell free” technology uses a protein called Cpf1 or Cas12a, that allows researchers to make multiple edits to DNA samples quickly and more precisely in vitro, that is, in a test tube or petri dish. This capability has generated unprecedented excitement about developing different CRISPR tools that could produce breakthrough treatments for a wide range of diseases by repairing a damaged gene, modifying it or deleting it entirely.

Thanks to a $1 million grant from the National Science Foundation in 2017, the Gene Editing Institute is collaborating with Delaware Technical Community College to develop the first-ever gene editing curriculum for community college students in Delaware and across the nation.

Dr. Kmiec is the recipient of multiple research awards from the National Institutes of Health (RO1s, R21s), the American Cancer Society, the Binational Industrial Research and Development (BIRD) Foundation and other private foundations including the 2012 Proudford Foundation Unsung Hero Award in Sickle Cell Disease. He has been a member of numerous editorial boards, NIH study sections and review boards and is the (primary or corresponding) author of more than 155 scientific publications (mostly in genetic recombination and gene editing).

Dr. Kmiec has been the primary mentor for 18 Ph.D. students and 4 MS students, all of whom have attained scientific positions. He has held or holds major administrative posts on various NIH regional and state biomedical research grants, including IDeA Network of Biomedical Research (INBRE) and Centers of Biomedical Research Excellence (COBRE). Dr. Kmiec was also honored as the Eminent Scholar in residence at Marshall University (Huntington, West Virginia) in 2009-2011 and was elected as an Honorary Commander of the 436th Air Wing at Dover Air Force Base in Dover, Delaware for in 2013 and again in 2014.

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SAMANTHA MARAGH, PH.D.

2020-PRECISION-MEDICINE-LINE
LEADER, GENOME EDITING PROGRAM
NATIONAL INSTITUTE OF STANDARDS & TECHNOLOGY (NIST)

SAMANTHA MARAGH, PH.D. BIO

Samantha leads NIST’s programs supporting genome editing technologies with a primary focus on innovation in genome editing and measurements for the field of gene and cell therapies. She also works on projects supporting better measurements and assays for early detection of cancer biomarkers in collaboration with the National Cancer Institute’s Early Detection Research Network. Her research is focused on measurement assurance and technology development for genome editing, bioassay and biomarker validation, with applications in engineering biology, precision/regenerative medicine, and cancer biology.

Samantha also represents the U.S. as a technical expert to the International Standards Organizations Technical Committee on Biotechnology (ISO TC 276). She is currently the U.S. liaison representing the interests and expertise of the U.S. on standards relating to nucleic acids measurements.

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MARITZA MCINTYRE, PH.D.

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PRESIDENT
ADVANCED THERAPIES PARTNERS, LLC.

MARITZA MCINTYRE, PH.D. BIO

Maritza McIntyre, Ph.D. is the owner and operator of Advanced Therapies Partners. She has 20 years of experience in the development of cell and gene therapies, including as an FDA reviewer and in several gene therapy start-ups including RegenxBio and Bamboo Therapeutics. She currently serves as the outgoing chair of the Clinical Trials and Regulatory Affairs Committee, which has led ASGCT commentary on numerous FDA guidance documents, co-developed the first FDA liaison meeting with the Government Affairs committee, assisted in the development of various webinars and online educational materials, and represented the society in standards-setting efforts in the field.
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ROBERT OAKES, ESQUIRE

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PRINCIPAL
FISH & RICHARDSON

ROBERT OAKES BIO

Robert Oakes is a Principal in the Delaware office of Fish & Richardson, with extensive experience in patent litigation, counseling, patentability and freedom to operate analyses, and licensing matters. His practice encompasses a full range of technologies, with a particular focus on the life sciences industry. Mr. Oakes has substantial experience in all aspects of patent litigation, including case management, document collection and production, managing teams of attorneys handling fact and expert discovery, trial work, and appeal. Mr. Oakes has substantial courtroom experience, including presenting witnesses at trial, presenting claim construction arguments, and arguing discovery motions. Mr. Oakes regularly counsels clients regarding intellectual property and patent strategy. He has significant experience conducting patentability analyses and freedom to operate analyses, and drafting and negotiating intellectual property licenses. Mr. Oakes also counsels business executives, scientists, and engineers regarding patent strategy, risk assessment, patentability and freedom to operate.

Prior to joining the firm, Mr. Oakes worked in the legal department of Johnson & Johnson (2006), and obtained technical experience at the Louis Berger Group (2004-2005) and Kansas State University (2002-2003).

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CARTIER ESHAM

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EXECUTIVE VICE PRESIDENT, EMERGING COMPANIES
BIOTECHNOLOGY INNOVATION ORGANIZATION

CARTIER ESHAM BIO

Cartier Esham serves as Executive Vice President for Emerging Companies at the Biotechnology Innovation Organization (BIO). In this role, Dr. Esham manages and directs BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies, which comprise approximately 90% of BIO’s membership. This includes capital formation policy and health policy impacting emerging companies, as well as research and analysis of the biopharmaceutical industry and life-science investment and financing. Among the priorities of BIO’s Emerging Companies Section are: promoting a science-based FDA regulatory environment; supporting NIH funding and programs/initiatives such as SBIR and NCATS that promote the effective transfer of technology; and working to create a public and private market environment that incentivizes the research and development of innovative treatments and therapies. Prior to joining BIO, Dr. Esham was a Vice President and Director of Research at Dutko Worldwide, a private consulting firm in Washington, D.C. There she worked on a variety of environmental, education, science, technology and health care-related issues both on the federal and state/local levels. Esham has a Ph.D. in Microbiology from the University of Georgia, a Master’s degree in Marine Biology from the University of North Carolina at Wilmington and a Bachelor of Science Degree from the University of Kentucky. She has published papers in peer-reviewed scientific journals on water quality, marine microbial ecology, and bacterial phylogeny.

WHO SHOULD ATTEND

People interested in educating themselves on the challenges of bringing products utilizing genome editing to the market.

WHY YOU SHOULD ATTEND

This program will provide an overview of the science behind Genome Editing and CRISPR.  Supporting topics include the IP landscape, setting industry standards, and anticipated challenges from a public policy perspective. A high level overview on product development strategies to ensure plans are scientifically sound and meet regulatory expctations and clinical objectives.

SCHEDULE OF EVENTS

1:30 PM | Kick-off

1:45 – 2:15 PM | Intro to Genome Editing and CRISPR

2:15 – 2:30 PM | Standard Setting for Genome Editing and CRISPR

2:30 – 2:45 PM | The Legal Challenges and Breakthroughs for Genome Editing and CRISPR

2:45 – 3:00 PM | Regulatory Process for Drug Approval and Special Considerations for Gene Editing Therapeutics

3:00 – 3:15 PM | Break

3:15 – 3:30 PM | Public Policy Perspective for Genome Editing and CRISPR

3:30 – 5:00 | Moderated Panel and Audience Questions

EVENT TICKETS

All Tickets | $25

EVENT POLICIES

Registration Policy & No Walk-Ins
You must register in advance in order to attend this event.  Walk-ins will not be accepted. Thank you!

Refund Policy
Cancellations must be made in writing, via email to Yvette Murray at [email protected], more than one (1) week prior to the event to receive a refund minus 25% for registration/administrative costs. If the cancellation is made within one week of the event or the attendee is a no-show, Delaware Bio will not issue a refund. If you have any questions or concerns, please contact Yvette Murray at [email protected].

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