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International Conference on Drug Development • 2018


2018 International Conference on Drug Development • ICD2
Challenges of Public Health and Scientific Advances in the 21st Century – Leveraging Digital Technologies to Transform Drug Development and Regulatory Risk-Benefit Model(s)-Innovation in Manufacturing Technologies

The University of Texas at Austin College of Pharmacy Division of Pharmaceutics and the distinguished members of the Planning Committee welcome you to the 58th annual International Conference on Drug Development (ICD2), February 26 & 27, 2018 at the Omni Barton Creek Resort and Conference Center in Austin, Texas, USA.

ICD2 continues its tradition of offering an informal forum for the exchange of ideas concerning the drug discovery and drug development process.

The conference brings together national and international scientists from academia, the pharmaceutical industry, the biotechnology industry and regulatory agencies for the opportunity to learn of and discuss new initiatives for finding a better way to develop new drugs as well as to improve the quality of existing drug products.


Government and Local Registration Rates*
Government and Acacemid Employees receive a discount on registration rates.  To utilize this reduced rate, copy this coupon code and enter it into the coupon box on the next page:    acdgov2018icdd
* To qualify for government or academic discount, one must be able to provide a current government or academic institution employee ID.


Lodging Reservations Made Separately


Conference Registration Refund Policy

It is the policy of the College of Pharmacy Continuing Education office to offer refunds for programs based on expense deadlines based on program production and contract commitments. It is our goal to keep refunds dates as late as possible. Based on contract and expense requirements, the following refund restrictions have been made for this conference:

  • A $250 registration and refund fee will be assess to any cancellation and requests for refund made to College of Pharmacy Continuing Education prior to February 2, 2018 5PM CT.
  • From February 2 to February 16, 2018, 5PM CT, a 50% refund will be possible for cancellation and requests for refund made to College of Pharmacy Continuing Education.
  • Refunds will not be made for cancellations received after February 16, 2018; however, substitute registrants will be accepted.
  • UT Austin College of Pharmacy can not be held responsible for speaker cancellations or changes or attendance changes due to inclement weather, and/or travel delays due to weather. If inclement weather results in the cancellation of the entire conference, partial refunds will be issued based on expenses not already encumbered by hotel and speaker commitments.
  • NOTE: Ability for refunds are limited because ICDD does not accept funds from sponsors or exhibitors, or funding support of any kind. In order to provide a commercial and bias free conference, conference expenses are covered solely by registration fees.

For More Information:  Contact the University of Texas at Austin College of Pharmacy, Continuing Pharmacy Education Office at 512-471-6213, or email us

Date: Feb 25, 2018 03:00 PM - Feb 28, 2018 09:00 AM

Fee

$2,495.00

Registration closes on Feb 26, 2018 10:00 AM

Requirements for CE Credit

There are no CE credits with this event

 

 

Registration closes on Feb 26, 2018 at 10:00 AM

Registration Closed  

Date: 02/25/18
Time: 03:00 PM - 08:00 PM
Registration Closed  

Registration Closed  

Weclome and Check-In: Outside Forum Room
Date: 02/25/18
Time: 06:00 PM - 07:00 PM
Registration Closed  

Registration Closed  

Join us for a Welcome Reception in the hall just outside the Forum.
Date: 02/25/18 07:00 PM - 09/24/17 09:00 PM
Registration Closed  

Registration closes on Feb 26, 2018 at 10:00 AM

Registration Closed  

Date: 02/26/18
Time: 01:00 PM - 09:15 PM
Registration Closed  

Registration Closed  

Check In Counter located in the labby outide the Forum Room.
Date: 02/26/18
Time: 10:00 AM - 05:15 PM
Registration Closed  

Registration Closed  

Indicate to hotel staff at Cafe association with ICD2
Date: 02/26/18
Time: 07:30 AM - 08:30 AM
Registration Closed  

Registration Closed  

Indicate ICD2 affiliation at check in desk.

Lunch: Omni Barton Creek Dinning Room
Date: 02/26/18
Time: 12:15 PM - 01:00 PM
Registration Closed  

Registration Closed  

Welcome and Opening Remarks

Conference Theme: Challenges of Public Health and Scientific Advances in Biomedicine in the 21st Century – Affordability of Drugs by Leveraging Digital Technologies to Transform Drug Development and Regulatory Risk-Benefit Models – Innovation in Manufacturing Technologies

Salomon Stavchansky, Ph.D.
ICD2 Conference Scientific Chair
Alcon Centennial Professor of Pharmaceutics 
Molecular Pharmaceutics and Drug Delivery
University of Texas at Austin College of Pharmacy
Date: 02/26/18
Time: 01:00 PM - 01:30 PM
Registration Closed  

Registration Closed  

ROUND TABLE PRESENTATIONS: Challenges of Digital Technology and Biomedical Sciences in the 21st Century. Implementation of the 21st Century Cures Act and PDUFA VI – Leveraging Digital Technologies – Part A

Format: Invited speakers will provide short updates and presentations, followed by a panel discussion with audience involvement.


Presentation I:  CDER Perspective – 21st Century Cures Act and PDUFA VI – Implementation and Deliverables

Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
Federal Drug Administration

Presentation II: Strategic and Policy Reforms to Improve Clinical Outcomes and Access to Quality Drugs and Medical Digital Technologies in the 21st Century

Mark B. McClellan, M.D, Ph.D.
Director and Robert J. Margolis, MD Professor of Business
Medicine and Policy
Duke University


OPENING DISCUSSION:  Challenges of Digital Technology and Biomedical Sciences in the 21st Century. Implementation of the 21st Century Cures Act and PDUFA VI – Leveraging Digital Technologies – Part A

Round Table Discussion with Janet Woodcock and Mark McClellan

Date: 02/26/18
Time: 01:00 PM - 03:15 PM
Registration Closed  

Registration Closed  

Continuing ROUND TABLE PRESENTATIONS: Challenges of Digital Technology and Biomedical Sciences in the 21st Century. Implementation of the 21st Century Cures Act and PDUFA VI – Leveraging Digital Technologies – Part B

Presentation III:  CDRH Perspective -21st Century Cures Act and PDUFA VI – Implementation and Deliverables

Ed Margerrison, Ph.D.
Director
Office of Science and Engineering
Federal Drug Administration


Presentation IV:  CBER Perspective -21st Century Cures Act and PDUFA VI – Implementation and Deliverables

Celia Witten, M.D., Ph.D. 
Deputy Director
Center for Biologics Evaluation and Research
Food and Drug Administration


Presentation V: PhRMA’s Expectations –  21st Century Act and PDUFA VI – Precision Medicine – Implementation and Deliverables

Richard Moscicki, M.D.
Chief Medical Officer
Executive Vice President
Pharmaceutical Research and Manufacturers of America (PhRMA)


Presentation V: BIO Expectations –  21st Century Act and PDUFA VI – Precision Medicine – Implementation and Deliverables

Cartier Esham, Ph.D.
Executive Vice President for Emerging Companies
Biotechnology Innovation Companies (BIO)


ROUND TABLE DISCUSSION:  Challenges of Digital Technology and Biomedical Sciences in the 21st Century. Implementation of the 21st Century Cures Act and PDUFA VI – Leveraging Digital Technologies – Part B

 Round Table of Afternoon Speakers

Date: 02/26/18
Time: 03:30 PM - 06:15 PM
Registration Closed  

Registration Closed  

Reception:  Located outside Forum
Date: 02/26/18
Time: 06:15 PM - 06:45 PM
Registration Closed  

Registration Closed  

Canyons Dinning Room
Date: 02/26/18
Time: 06:45 PM - 08:00 PM
Registration Closed  

Registration Closed  

KEYNOTE PRESENTATION: Communicating Uncertainty in Decision Analytics to Facilitate Drug Development and Regulatory Evaluation.

Baruch Fischhoff, Ph.D.
Howard Heinz University Professor
Department of Engineering and Public Policy
Institute for Politics and Strategy
Carnegie Mellon University

Date: 02/26/18
Time: 07:30 PM - 08:30 PM
Registration Closed  

Registration closes on Feb 26, 2018 at 10:00 AM

Registration Closed  

Date: 02/27/18
Time: 08:00 AM - 09:00 PM
Registration Closed  

Registration Closed  

Contenental Breakfast: Outside the Forum
Date: 02/27/18
Time: 07:30 AM - 08:30 AM
Registration Closed  

Registration Closed  

Date: 02/27/18
Time: 08:15 AM - 08:30 AM
Registration Closed  

Registration Closed  

ROUND TABLE PRESENTATIONS: At the Intersection of Digital Technologies and Therapeutics.  Incorporating Real-World Evidence in Drug Development – Part A

Format: Invited speakers will provide short updates and presentations, followed by a panel discussion with audience involvement.


Presentation I:  Challenges and Opportunities in Chemistry Manufacturing Controls in the Age of Personalized Medicine – FDA Perspective

Wendy Wilson-Lee, Ph.D.
Acting Branch Chief
Office of New Drug Products
Center for Drug Evaluation and Research
Federal Drug Administration


Presentation II:  Drug Development Acceleration Clinical Relevance & Harmonization – ICH Future

Peter Honig, M.D., M.P.H.
Senior Vice President and Head Worldwide Safety and Regulatory
Pfizer


ROUND TABLE DISCUSSION: At the Intersection of Digital Technologies and Therapeutics.  Incorporating Real-World Evidence in Drug Development – Part A

Round Table Discussion with Dr. Wilson-Lee and Dr. Honig – Joined by:

Paul Seo, Ph.D.
Director (Acting), Division of Biopharmaceutics
Office of New Drug Products
FDA, CDER, OPQ

Date: 02/27/18 08:30 AM - 02/14/17 10:30 AM
Registration Closed  

Registration Closed  

Continuing ROUND TABLE PRESENTATIONS: At the Intersection of Digital Technologies and Therapeutics.  Incorporating Real-World Evidence in Drug Development – Part B

Format: Invited speakers will provide short updates and presentations, followed by a panel discussion with audience involvement.


Presentation III:  Industry Perspective – Digital Medicine and Digital Therapeutics

Andrew Wright
Vice President
Digital Medicines
Otuska Pharmaceuticals


Presentation IV:  Pharma’s Perspective of Digital Technologies in Drug Development and Therapeutics

Jake LaPorte, Ph.D.
Head of Digital Development
Global Drug Development
Portfolio Strategy & Innovation
Novartis


Presentation V:  Otsuka’s Regulatory Experience in the Journey of Digital Medicine Drug Development

Henrietta Ukwu, MD, FACP, FRAPS
Senior Vice President
Head of Global Quality & Global Regulatory Affairs
Otsuka Pharmaceutical

 


ROUND TABLE DISCUSSION:  At the Intersection of Digital Technologies and Therapeutics.  Incorporating Real-World Evidence in Drug Development – Part B

Round Table of Topic Speakers

Date: 02/27/18
Time: 10:50 AM - 12:10 PM
Registration Closed  

Registration Closed  

Lunch in the HIll Country Dinning Room
Date: 02/27/18
Time: 12:10 PM - 01:30 PM
Registration Closed  

Registration Closed  

Continuing ROUND TABLE PRESENTATIONS: At the Intersection of Digital Technologies and Therapeutics.  Incorporating Real-World Evidence in Drug Development –  Part C

Format: Invited speakers will provide short updates and presentations, followed by a panel discussion with audience involvement.


Presentation VI:  Innovative Clinical Trial Design for Pediatric Therapeutics – Clinical Endpoints and Digital Therapeutics. Real World Evidence data as the basis for pediatric labeling

Gary Noel, M.D.
Pediatric Infectious Disease
Chair Janssen’s Pediatric Advisory Committee
Drug Development Center of Excellence at Johnson and Johnson


Presentation VII:  Digital Medicine and Translational Science – Real World Evidence – What is the Evidencing Basis for Regulatory Decision Making.  

Justin T. Baker, M.D., Ph.D.
Assistant Professor
Director of Functional Neuroimaging & Bioinformatics
Schizophrenia and Bipolar Disorder Program
Scientific Director, Institute for Technology in Psychiatry
McLean Hospital
Harvard Medical School


Presentation VIII: Applications of AI in Drug Discovery

Henry Chen, MBA
Principal Offering Manager
IBM Watson for Drug Discovery


ROUND TABLE DISCUSSION:  At the Intersection of Digital Technologies and Therapeutics.  Incorporating Real-World Evidence in Drug Development – Part C

Round Table of Topic Speakers

Date: 02/27/18
Time: 01:30 PM - 03:00 PM
Registration Closed  

Registration Closed  

ROUND TABLE PRESENTATIONS: Overcoming Regulatory Challenges in the Age of Personalized Therapy

Format: Invited speakers will provide short updates and presentations, followed by a panel discussion with audience involvement.


Presentation I: CBER Regulatory Perspective.  Ethical, Legal and Regulatory Issues of Personalized Therapies

Celia Witten, M.D., Ph.D. 
Deputy Director
Center for Biologics Evaluation and Research
Food and Drug Administration


Presentation II: Pharma’s Perspective: Overcoming Implementation and CMC Challenges of Personalized Therapy – Case Study I – CAR-T Technologies

Shanthi Ganesham, Ph.D.
Head of Oncology
North American Regulatory Affairs Novartis Pharmaceuticals


Presentation III:  Pharma’s Perspective.  Therapeutic Genome Editing: Prospects and Challenges – Precision of Zinc Finger Nucleases Technology – Case Study II

Michael Holmes, Ph.D.
Vice President, Research
Sangamo Therapeutics


ROUND TABLE DISCUSSION: Overcoming Regulatory Challenges in the Age of Personalized Therapy

 Round Table of Afternoon Speakers

Date: 02/27/18
Time: 03:15 PM - 05:00 PM
Registration Closed  

Registration Closed  

Date: 02/27/18
Time: 05:00 PM - 06:00 PM
Registration Closed  

Registration Closed  

Date: 02/27/18
Time: 06:00 PM - 07:30 PM
Registration Closed  

Registration Closed  

Date: 02/27/18
Time: 07:30 PM - 08:45 PM
Registration Closed  

Registration Closed  

Date: 02/27/18
Time: 08:45 PM - 09:00 PM
Registration Closed  

Registration Closed  

Date: 02/27/18
Time: 09:00 PM - 09:00 PM
Registration Closed  

Registration closes on Feb 26, 2018 at 10:00 AM

Registration Closed  

Hill Country Dinning Room
 
Date: 02/28/18
Time: 08:00 AM - 10:00 AM
Registration Closed  

Registration Closed  

Date: 02/28/18
Time: 06:00 AM - 11:00 AM
Registration Closed