For More Information Call: 866-207-6528 | www.exlevents.com/regfiling Event Highlights: 1. Explore the current regulatory landscape to better develop your NDA/IND/ANDA filing strategy and optimize drug development timelines 2. Gain firsthand knowledge from leading regulatory experts on the implications of Breakthrough Therapy Designation and how to correctly file for it 3. File in accordance with FDA Guidances to avoid wasting resources on resubmittals and to demonstrate compliance to build a better relationship 4. Develop clinical trial protocols and REMS to maximize the efficacy of accelerated approval submissions 5. Network with peers to discuss the benefits and drawbacks to accelerated approval tracks and their impact on drug development B r e a k t h r o u g h t h e r a p y d e s i g n a t i o n P R I O R I T Y R E V I E W f a s t t r a c k A C C E L E R A T E D A P P R O V A L REGULATORY FILING STRATEGIES SUMMIT Join 15+ high-level speakers for the industry’s first expedited therapeutic drug filing conference Best Practices for Expedited Drug Approvals Through Competitive Positioning of New Drug Applications for Priority Review, Accelerated Approval, Fast Track Designation and Breakthrough Therapy Designation Expedited Approval February 23-24, 2015 The Rittenhouse Hotel, Philadelphia, PA Stefan Ochalski Senior Director Global Regulatory Affairs, Janssen Janet L. Karlix Vice President, Clinical Sciences, Xhale, Inc. Sophia Kourliouros Senior Manager, Regulatory Submissions, Eisai Chitra Edwin Director of Regulatory and Quality Affairs, Cleveland HeartLab Nanita Cranford Director Regulatory Operations, Jazz Andrew Story Vice President, Regulatory Affairs, Abbvie CONFERENCE CHAIR Ron Trust Executive Director, North America, Durata Therapeutics
Transcript
For More Information Call: 866-207-6528 | www.exlevents.com/regfiling
Event Highlights: 1. Explore the current regulatory landscape to better
develop your NDA/IND/ANDA filing strategy and optimize drug development timelines
2. Gain firsthand knowledge from leading regulatory experts on the implications of Breakthrough Therapy Designation and how to correctly file for it
3. File in accordance with FDA Guidances to avoid wasting resources on resubmittals and to demonstrate compliance to build a better relationship
4. Develop clinical trial protocols and REMS to maximize the efficacy of accelerated approval submissions
5. Network with peers to discuss the benefits and drawbacks to accelerated approval tracks and their impact on drug development
Breakthrough
therapy designation
PRIORITY REVIEW
fast
trac
k
ACCELERATED APPROVAL
REGULATORY FILING STRATEGIES SUMMIT
Join 15+ high-level speakers for the industry’s first expedited therapeutic drug filing conference
Best Practices for Expedited Drug Approvals Through Competitive Positioning of New Drug Applications for Priority Review, Accelerated Approval, Fast Track Designation and Breakthrough Therapy Designation
Expedited Approval
February 23-24, 2015 The Rittenhouse Hotel, Philadelphia, PA
Stefan OchalskiSenior Director Global Regulatory Affairs, Janssen
Janet L. KarlixVice President,Clinical Sciences,Xhale, Inc.
Chitra Edwin Director of Regulatory and Quality Affairs, Cleveland HeartLab
Nanita Cranford Director Regulatory Operations, Jazz
Andrew StoryVice President, Regulatory Affairs,Abbvie
CONFERENCE CHAIR Ron TrustExecutive Director, North America, Durata Therapeutics
To Register Call 866-207-6528 or Visit Us at www.exlevents.com/regfiling
Natasia LangfelderConference ProducerExL Pharma
This conference is designed for professionals from pharmaceutical, biotech, medical device and clinical research organizations with responsibilities in the following areas:
• Regulatory Affairs• Submissions• Legal Counsel, IP and Patents• Compliance• New Product Launch• Medical Writing• Manufacturing• QA/QC• Drug Safety• Clinical Trial Design• Distribution• Post-Approval Marketing• Clinical Trials Management• Research and Development• Product development• Translational Medicine/Clinical
Pharmacology • Clinical Oncology
Dear Colleague,
The regulatory filing process can drain valuable time and resources when developing a drug for approval. Being the first to hit the market with a new therapy before competition emerges is a great advantage. This is reflected in approval rates for FDA filings granted priority review status — drugs granted priority review had a 67.9% first-cycle approval rates, whereas only 40.3% drugs given standard review were approved. Speeding up the FDA approval process is the best route to position a therapy for maximum market share and to ensure people in need receive the highest quality treatment available as quickly as possible.
The FDA knows that speeding up the development and availability of drugs that can treat serious diseases is in everyone’s interest. This is especially true when the therapy is a unique treatment or is more efficacious than treatments currently on the market.
The FDA developed four different paths that companies can leverage to get their New Drug Application (NDA) reviewed and approved or faster: Priority Review, Accelerated Approval, Fast Track Designation and Breakthrough Therapy Designation (BTD). Filing for each of these tracks is complex and requires preparation from a drug’s inception to submission.
The Regulatory Filing Strategies Summit is the only event in the industry that has been designed to help regulatory, submissions and legal professionals understand the ins and outs of each of these options and the criteria drugs must meet in order to file for these accelerated tracks, as well as how to compile that data and submit it for approval. This event provides hard case study evidence on which methods are best and debates which method is optimal for certain new therapies.
You asked for content specifically addressing the topics below. We are delighted to provide you with unique case studies on:
• BTD as a Way of Encouraging the Utilization of New Development Tools and Methodologies
• Document (e-CTD) Format: Investigational New Drug Applications (IND), New Drug Application (NDA) and Abbreviated New Drug Applications (ANDA)
• Planning Process for Simultaneous Global Submissions with a Focus on Emerging Market Support
• Accelerated Track Options for Orphan Drugs
• Responding to FDA Questions: Delegating Roles and Responsibilities for a Submission Rapid Response Process
Join regulatory affairs and clinical operations professionals to discuss best practices for positioning your drug for success in an oversaturated market.
We look forward to seeing you in Philadelphia this February!
Sincerely,
Breakthrough
therapy designation
PRIORITY REVIEW
fast track
ACCELERATED APPROVAL
Expedited Approval
REGULATORY FILING STRATEGIES SUMMIT
Venue:The Rittenhouse Hotel210 West Rittenhouse SquarePhiladelphia, PA 19103
Room Reservations: If you require overnight accommodations please contact the hotel to book your room. ExL Pharma has reserved a block of rooms at a discounted rate for conference participants. We encourage conference participants to make reservations by February 2, 2015. To make reservations guests can call (800) 635-1042 and request the negotiated rate for ExL’s February Meetings. Please book your room early as rooms available at this rate are limited.
For More Information Call: 866-207-6528 | www.exlevents.com/regfiling
8:00 Continental Breakfast and Conference Registration
8:30 Chairperson’s Welcome and Opening RemarksRon Trust, Executive Director, North America, Regulatory Affairs, DURATA THERAPEUTICS
8:45 The Important History Behind the FDA’s Accelerated Track Guidance and Future Trends• When and why accelerated tracks were designed• How has this shaped the market• What impact this has had on R&D and clinical trials • Where the industry is headed Michael Swit, Adjunct Professor, SAN DIEGO UNIVERSITY
9:30 Understand the Process, Perspective and People that Make Measurable Impacts on Regulatory Submissions• Review of the many moving parts to the submission process• Explore the role of the regulatory affairs profession within
the team • Assemble the correct team and enhance communication• Train staff to think critically to achieve maximum efficiency Stefan Ochalski, Senior Director, Global Regulatory Affairs, JANSSEN
10:15 Morning Networking Break
10:45 How Abbvie Achieved Breakthrough Therapy Designation• Clarification of Section 902 of FDASIA to better utilize this
tools to expedite development and review of drugs• Understand the criteria that must be met for designation and
how to provide evidence the therapy meets it• Review the reasons for denials and learn how to avoid these
pitfalls• Explore the potential for adverse impact on non-breakthrough
development program review Andrew Storey, Vice President, Regulatory Affairs, ABBVIE
11:15 Develop a Process for Simultaneous Global Submissions with a Focus on Emerging Market Support when responding to FDA questions• Explore emerging markets as a great source of clinical trial
research• Review the different systems of NDA approvals in various
emerging markets• Work within the system to discover the best way to remain
organized and efficient in order to get your therapy to the market
1:15 Document (e-CTD) Format for Investigational New Drug Applications (IND), New Drug Application (NDA) and Abbreviated New Drug Applications (ANDA)• Learn the ins and outs of electronic formats for all your NDAs• Explore the differences in electronic submissions for NDAs,
ANDAs and INDs • Understand how to submit an error-proof electronic application Olga Alfieri, MBA, RAC, Associate Director, Global Submissions Management (US), EISAI PRODUCT CREATION SYSTEMS
2:15 Networking Break
2:45 Accelerated Track Options for Orphan Drugs • Explore how orphan drugs and rare diseases are two therapies
that can benefit from FDA fast track submission• Learn how to build the case for your orphan drug or rare
disease submission• Review the criteria that should be emphasized to increase
chances of fast track approvalBrian Caselli, Senior Manager, Oncology Regulatory Strategy, PFIZER
3:30 Compare FDA Fast Tracks and Criteria to Better Position Your Drug Pre-Clinical Trial• Assess the properties, market analysis and efficacy of your drug• Review criteria to consider in order to decide which track you
should apply for• Review of a successful submission Ron Trust, Executive Director, North America, Regulatory Affairs, DURATA THERAPEUTICS
4:15 Fast Track Designation for Medical Devices• Discuss the submission criteria for each track• Analyze successful submissions• Review lessons learned from failed submissions while exploring
application fails Chitra Edwin, Director of Regulatory and Quality Affairs, CLEVELAND HEARTLAB
5:00 Successfully Filing for Priority Review • Taking clinical protocol design into account• Understanding the criteria needed in order to meet Priority
Review Filing standards• Briefing your writing team on the goals and criteria for a
successful application • Preparing for submission of the file Richard Guarino, Chief Medical Officer, VALIDUS PHARMACEUTICALS
6:00 Conclusion of Day One
Monday, February 23, 2015 DAY 1
Key
note
Cas
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The webinar we did with ExL was a great source of leads, both quantity and quality. We needed a specific targeted audience and program flexibility that would be imperative to
maximizing ROI. ExL went above and beyond to exceed our expectations!Jason Messinger, Director of Marketing, OpenQ, Inc.
“ ”
Cas
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For More Information Call: 866-207-6528 | www.exlevents.com/regfiling For More Information Call: 866-207-6528 | www.exlevents.com/regfiling
8:15 Registration Opens and Continental Breakfast
9:00 Chairperson’s Welcome and Opening RemarksRon Trust, Executive Director, North America, Regulatory Affairs, DURATA THERAPEUTICS
9:15 BTD as a Way of Encouraging the Utilization of New Development Tools and Methodologies• Understand how BTD is a new track and very few applications
have been successfully submitted• Review ways to successfully apply for BTD designation • Explore the effect on targeted diagnostics and adaptive clinical
trial design
10:00 Leveraging CROs During Filing• Utilize external resources to support pre-IND package
coordination• Collaborate to plan innovative strategies for the most effective
and alternatively, efficient review of your submission • Double and triple check work through presubmission review of
technical documentsCarlos Langezaal, Director Regulatory Affairs, EISAI PHARMACEUTICALS
Jennifer Richards, Associate Director Regulatory Affairs, SALIX PHARMACEUTICALS
10:45 Morning Networking Break
11:15 Delegating Roles and Responsibilities for a Submission Rapid Response Process• Maintain a good relations with the FDA• Remain responsive to questions in a timely manner• Learn how to delegate responsibilities and assign roles to your
team in order to increase your responsiveness and provide the FDA with the information they need to approve your drug
Stefan Ochalski, Senior Director, Global Regulatory Affairs, JANSSEN
Nanita Cranford, Director Regulatory Operations, JAZZ PHARMACEUTICALS
Janet L. Karlix, Vice President, Clinical Services, XHALE, INC.
12:15 Luncheon
1:15 Develop Strong Protocols to Support Accelerated Track Filing• Starting at the clinical design phase — what does your clinical
trial design need to look like to be effective• Proving the efficacy of the drug• Overview of what a market analysis looks likeCarlos Langezaal, Director Regulatory Affairs, EISAI PHARMACEUTICALS
2:00 Clinical Data Management for Expedited Drug Development• Finding the most efficient pathway for generating additional
evidence needed about safety and efficacy• Proving the efficacy in your submission through persuasive
writing and documentsJennifer Richards, Associate Director Regulatory Affairs, SALIX PHARMACEUTICALS
2:45 Risk Management in CMC Planning Breakthrough Therapies• Understand the impact on big pharma if an approved
breakthrough therapy goes wrong• Learn essentials that must be in your risk management plan• Analyze a case study on how do damage controlDay 2 Speakers
3:30 Chairman’s Closing Remarks
3:45 Conference Close
tuesday, February 24, 2015 DAY 2
Questions? Comments? Do you have a question or comment that
you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader?
Please email Conference Producer Natasia Langfelder at
The presentations were informative and the presenters were very experienced,
learned a lot from them.Ling Wang, QC Manager, Consumer Care/Product Development Bayer
“ ” Sponsorship and Exhibition Opportunities Do you want to spread the word about your organization’s solutions
and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact Team Lead, Business Development Manager Steve Decker at 212-400-6234 or [email protected].
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Great Program!Dennis Houghton, Senior Director, National Accounts, Durata Therapeutics“ ”
For More Information Call: 866-207-6528 | www.exlevents.com/regfiling For More Information Call: 866-207-6528 | www.exlevents.com/regfiling
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