$1,885 – $5,675

Innovative Regulatory Pathways Summit (EXL)

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Location

Hilton Crystal City at Reagan National Airport

2399 Jefferson Davis Hwy

Arlington, VA 22202

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No Refunds

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Description

Innovative Regulatory Pathways Summit

There are regulatory mechanisms to accelerate the review and/or approval of treatments for patients with serious diseases. Accelerated Approval, Breakthrough Therapy Designation, Fast Track Designation, Priority Review, and Orphan Drug Act are designed to expedite treatment availability for medications that provide an increased benefit over existing treatments.

What does this really mean for sponsors and patients? Patients could have improved or novel treatments available sooner. While sponsors have successful tracks to obtain increased communication and collaboration with the FDA, enabling precise decision-making.

These regulatory options are available to ensure that FDA resources are allocated to review and approve therapies as soon as the benefits justify any risks. ExL’s Innovative Regulatory Pathways will serve as a platform to discuss and compare the current regulatory pathways that allow for earlier attention to drugs that have promise in treating serious or life threatening conditions.

Top Five Reasons to Attend

  1. Navigate the regulatory landscape and effectively anticipate the future accelerated options
  2. Discuss the implications of breakthrough therapy designation and other approval tracks
  3. Network with worldwide leading regulatory experts, sponsors and healthcare providers
  4. Discuss regulatory strategies to optimize product development timelines
  5. Learn about best practices to liaise with the FDA on expedited regulatory approvals

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotechnology, and medical device companies and advocacy groups with responsibilities in the following areas:

  • Regulatory Affairs/Strategy/Operations
  • Business Development/Strategy
  • Clinical Operations/Development/Affairs
  • Product Development
  • R&D/Drug Development
  • Patient Advocacy
  • HEOR and Outcomes Research
  • Strategic Planning
  • Competitive Intelligence
  • Oncology Program Management
  • Rare Disease/Orphan Program Management
  • Pipeline/Portfolio Management
  • Pharmacovigilance
  • Medical Information/Affairs

This conference is also of interest to:

  • Regulatory Advisors/Service Providers/Consultants
  • Clinical/Contract Research Organizations
  • Drug Development Service Providers
  • Law Firms
  • Preclinical/Analytical Research Organizations
  • Strategic/Management Consultants

Agenda

Day One

Monday, January 29, 2018

8:00AM – 8:50AM Open Registration and Continental Breakfast

8:50AM – 9:00AM Conference Chair Opening Remarks
Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS

9:00AM – 9:45AM AbbVie’s Experience With Breakthrough Therapy Designation
Andrew Storey, Vice President, Global Regulatory Strategy, ABBVIE

9:45AM – 10:30AM Breakthrough Therapy Designations in Oncology
Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS

10:30AM – 11:00AM Networking Break

11:00AM – 11:45AM Case Study: Impact of Breakthrough Therapy Designation on Clinical Trial Design
Joseph A. Sliman, M.D., MPH, Chief Medical Officer, SYNTHETIC BIOLOGICS

11:45AM – 12:30PM Harmonize Manufacture Readiness Plans With Accelerate Drug Development
Usha Ramesh, Ph.D., PMP, Executive Director, Regulatory Affairs, CMC, PHARMACYCLICS, AN ABBVIE COMPANY

12:30PM – 1:30PM Luncheon

1:30PM – 2:15PM Sakigake Designation System: A Japanese Strategy for Expedited Drug Development
Colin Vechery, Manager, U.S. Regulatory Affairs–Strategy, BIOGEN

2:15PM – 3:15PM Panel: Global Regulatory Options for Accelerated Drug Development

Panelists:
Jennifer Dudinak, Pharm.D., Vice President, Global Regulatory Affairs, Head, Pharma Regulatory Therapeutic Team, GLAXOSMITHKLINE
Dr. Henrietta Ukwu, Senior Vice President, Head of Global Regulatory Affairs, OTSUKA PHARMACEUTICAL COMPANIES
Lawrence Liberti, M.Sc., Executive Director, CENTER FOR INNOVATION IN REGULATORY SCIENCE (CIRS)

3:15PM – 3:45PM Networking Break

3:45PM – 4:30PM Eisai Case Study: Coordinating Global Submissions: How to Reuse Content for Emerging Markets
Sophia A. Kourliouros, Senior Manager, Global Regulatory Operations, EISAI INC.

4:30PM – 5:15PM Interact Effectively With the FDA to Accelerate Development of Novel Malaria Vaccine Candidates for a Global Unmet Need
Stephen Hoffman, CEO, SANARIA INC

5:15PM – Day One Concludes

Day Two

Monday, January 30, 2018

8:00AM – 8:50AM Open Registration and Continental Breakfast

8:50AM – 9:00AM Conference Chair Opening Remarks
Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS

9:00AM – 9:45AM Development and Implementation of Whole-Parasite Malaria Vaccine
Tooba Murshedkar, Senior Director, Regulatory Affairs, SANARIA INC.

9:45AM – 10:30AM A Public Policy Perspective on Regulatory Policies and Market-Shaping Considerations for Emerging Infectious Diseases
John Billington, Director, U.S. Public Policy, Vaccines, GLAXOSMITHKLINE

10:30AM – 11:00AM Networking Break

11:00AM – 11:45AM Panel: Expedited Options for Competitive Generic Therapies

Panelists:
Lisa Parks, R.Ph., Vice President, Sciences and Regulatory Affairs, ASSOCIATION FOR ACCESSIBLE MEDICINES
Nicholas Tantillo, Head, Policy and Regulatory Strategy, SANDOZ INC

11:45AM – 12:30PM Utilize Patient–Focused Drug Development to Build Clinical Trial Frameworks for Breakthrough Therapy Applications
Mark Stewart, Ph.D., Senior Science Policy Analyst, FRIENDS OF CANCER RESEARCH

12:30PM – 1:30PM Luncheon

1:30PM – 2:15PM Integrate Patient Advocacy Groups Into Drug Development Programs to Navigate the Expedited Regulatory Options
Brian E. Harvey, M.D., Ph.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE; Former Vice President U.S. Regulatory Strategy, PFIZER

2:15PM – 3:15PM Panel: Effective Collaboration Between Drug Developers and Patient Advocates

Moderator:
Brian E. Harvey, M.D., Ph.D., Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE; Former Vice President U.S. Regulatory Strategy, PFIZER

Panelists:
Jayne C. Gershkowitz, Senior Vice President and Chief Patient Advocate, AMICUS THERAPEUTICS
Ron Bartek, President and Co-Founder, FRIEDREICH'S ATAXIA RESEARCH ALLIANCE (FARA)
Stacy Woeppel, Advocate in Science, SUSAN G. KOMEN

3:15PM – 3:45PM Networking Break

3:45PM – 4:30PM Utilize Expedited Review Pathways in Precision Medicine
Christopher Adams, CEO, ANDARIX PHARMACEUTICALS

4:30PM – 5:15PM Implications of Personalized Medicine on Clinical Trial Design and Expedited Review Pathways
Chitra Edwin, Ph.D., RAC, Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION, INC

5:15PM – Conference Concludes


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Faculty

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Christopher Adams

CEO, ANDARIX PHARMACEUTICALS
Ron Bartek, President, FRIEDREICH’S ATAXIA RESEARCH ALLIANCE

Ron Bartek
President and Co-Founder, FRIEDREICH’S ATAXIA RESEARCH ALLIANCE (FARA)



John Billington
Director, U.S. Public Policy, Vaccines, GLAXOSMITHKLINE


Jennifer Dudinak, Pharm.D.
Vice President Global Regulatory Affairs Oncology and Head, Pharma Regulatory Therapeutic Teams, GLAXOSMITHKLINE



Chitra Edwin, Director of Regulatory and Quality Affairs, CLEVELAND HEARTLAB

Chitra Edwin
RAC Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION



Jayne C. Gershkowitz
Senior Vice President and Chief Patient Advocate, AMICUS THERAPEUTICS



Brian E. Harvey, M.D., Ph.D.
Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE

Former Vice President U.S. Regulatory Strategy, PFIZER



Stephen Hoffman
CEO, SANARIA INC


Sophia Kourliouros, Senior Manager, Regulatory Submissions, EISAI

Sophia A. Kourliouros
Senior Manager, Global Regulatory Operations, EISAI INC.



Lawrence Liberti, MSc
Executive Director, CENTER FOR INNOVATION IN REGULATORY SCIENCE (CIRS)


Tooba Murshedkar
Senior Director, Regulatory Affairs, SANARIA INC.


Lisa Parks, R.Ph.
Vice President, Sciences and Regulatory Affairs, ASSOCIATION FOR ACCESSIBLE MEDICINES



Usha Ramesh, Ph.D.
PMP Executive Director, Regulatory Affairs, CMC, PHARMACYCLICS, AN ABBVIE COMPANY


Alejandro D. Ricart, M.D.
Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS



Joseph A. Sliman, M.D.
MPH Chief Medical Officer, SYNTHETIC BIOLOGICS


Mark Stewart, Ph.D.
Senior Science Policy Analyst, FRIENDS OF CANCER RESEARCH



Andrew Storey
Vice President, Global Regulatory Strategy, ABBVIE



Nicholas Tantillo
Head, Policy and Regulatory Strategy, SANDOZ INC


Dr. Henrietta Ukwu
Senior Vice President, Head of Global Regulatory Affairs, OTSUKA PHARMACEUTICAL COMPANIES



Colin Vechery
Manager, U.S. Regulatory Affairs–Strategy, BIOGEN



Stacy Woeppel
Advocate in Science, SUSAN G. KOMEN





Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Date and Time

Location

Hilton Crystal City at Reagan National Airport

2399 Jefferson Davis Hwy

Arlington, VA 22202

View Map

Refund Policy

No Refunds

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