Agenda

General Format

The International Conference on Drug Development (ICD2) utilizes an interactive format that allows for the brief presentations of key perspectives under specific topics followed by round table open discussions where speakers and participants can debate, discuss, and ask questions of all topic presenters and other participants.

Download PDF Copy of the Agenda Here

2018 Conference Theme:

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

2018 Agenda

Agenda subject to change.

Sunday, February 25, 2018 • Optional for Sunday Arrivals

7:00	Check-In
7:00	*Welcome Reception*

Day I • Monday, February 26, 2018

11:oo	Check-In
1:00	Open
	Welcome Conference Theme: Challenges of Public Health and Scientific Advances in Biomedicine in the 21^st Century – Affordability of Drugs by Leveraging Digital Technologies to Transform Drug Development and Regulatory Risk-Benefit Models Model(s) – Innovation in Manufacturing Technologies. Salomon Stavchansky, Ph.D. ICD2 Conference Scientific Chair Alcon Centennial Professor of Pharmaceutics The University of Texas at Austin College of Pharmacy
	ROUND TABLE PRESENTATIONS: Challenges of Digital Technology and Biomedical Sciences in the 21^st Century. Implementation of the 21^st 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 – 21^st 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 21^st Century. Implementation of the 21^st Century Cures Act and PDUFA VI – Leveraging Digital Technologies – Part A Round Table Discussion with Janet Woodcock and Mark McClellan

	Continuing ROUND TABLE PRESENTATIONS: Challenges of Digital Technology and Biomedical Sciences in the 21^st Century. Implementation of the 21^st Century Cures Act and PDUFA VI – Leveraging Digital Technologies – Part B Presentation III: CDRH Perspective -21^st 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 -21^st 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 – 21^st 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 – 21^st 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 21^st Century. Implementation of the 21^st Century Cures Act and PDUFA VI – Leveraging Digital Technologies – Part B Round Table of Afternoon Speakers
6:15	Reception
6:45	Dinner
	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

Please note – the agenda is currently under development as speakers are confirmed. Times, titles, and speakers are subject to change.
To gain a perspectives of speakers who attended in the past, please see past year agendas at the bottom of this page.

ICD2 Logo

Day II • Tuesday, February 27, 2018

7:45	Breakfast
8:15	Welcome
	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

	*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
	Lunch
	*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

	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


	Reception
6:00	Dinner
	FDA AND SPEAKER PANEL DISCUSSION Format: This session is designed for audience members to pose questions to the FDA officials and other speakers attending to discuss topics from the conference Key Topics: Digital technologies – Ability of the FDA to assess effectiveness and safety of emerging technologies. Emerging manufacturing technology regulation to support new clinical development programs and individualized therapies. Manufacturing attributes and Clinical Outcomes Emerging Technologies – Gene Therapies Regulatory harmonization and ICH’s future *Moderator:* Gerald J. Yakatan, Ph.D. Founder & Chairman IriSys, Inc.

Please note – the agenda is currently under development as speakers are confirmed. To gain a perspectives of speakers who attended in the past, please see past year agendas below.

ICD2 Logo

Past Conference Agendas

Past agendas are made available to provide an example of the conference program and history. All agendas are in PDF form.

2017 Agenda: Listening to the Patient: Patient Centricity – Impact on Drug Development and the Drug Regulatory Approval Process

2016 Agenda: Safety, Efficacy and Affordability of Medicines for all Patients– The 21st Century Challenge!

2015 Agenda: Risks to Drug Development and Biomedical Innovation – The 21st Century Challenge!

2014 Agenda: Transformation of Drug Development – Challenges and Opportunities Advancing Innovative Solutions to Meet Patient’s Medical Needs of Serious Conditions and Rare Diseases

2013 Agenda: At the Intersection of Global Policy, Regulation, Innovation and Economics

2012 Agenda: Fostering Innovation and Translational Research in Support of Public Health and Economic Growth

Agenda

General Format

Download PDF Copy of the Agenda Here

2018 Conference Theme:

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

2018 Agenda

Sunday, February 25, 2018 • Optional for Sunday Arrivals

Day I • Monday, February 26, 2018

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

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

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

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

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

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

Day II • Tuesday, February 27, 2018

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

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

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

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

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

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

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

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

FDA AND SPEAKER PANEL DISCUSSION

Past Conference Agendas

General Format

Download PDF Copy of the Agenda Here

2018 Conference Theme:

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

2018 Agenda

Sunday, February 25, 2018 • Optional for Sunday Arrivals

Day I • Monday, February 26, 2018

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 Model(s) – Innovation in Manufacturing Technologies.

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

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

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

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

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

Day II • Tuesday, February 27, 2018

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

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

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

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

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

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

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

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

FDA AND SPEAKER PANEL DISCUSSION

Past Conference Agendas

Footer

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

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

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

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

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