TO REGISTER, CALL 201-871-0474

EXAMINE THE FDA ADVISORY COMMITTEE SELECTION PROCESS TO UNDERSTAND THE BACKGROUNDS OF ADVISORY COMMITTEE MEMBERS

Elijah Wreh, Regulatory Affairs Manager, Invacare Corporation and Industry Representative, FDA ADVISORY COMMITTEE NEUROLOGICAL DEVICES PANEL

PREPARE YOUR TEAM WITH TRAINING AND TOOLS FOR SUCCESS

Michael Rozycki, Ph.D., Vice President, Regulatory Affairs, PACIRA PHARMACEUTICALS, INC.

NAVIGATE REGULATORY UPDATES AND STANDARDS

Jack Weet, Vice President, Regulatory Affairs and Quality Assurance, COLLEGIUM PHARMACEUTICAL, INC.

PREPARE YOUR CONTENT AND APPLY SCIENTIFIC MESSAGING

Dr. Elizabeth Garner, Chief Medical Officer, Senior Vice President Clinical Development, AGILE THERAPEUTICS

PRESENT YOUR DATA

Diane Murphy, MBA, Contractor and Former Clinical Development Director, ALLERGAN

IDENTIFY YOUR AUDIENCE

MASTER THE MOCK PANEL

Scott Greenfeder, Senior Director Regulatory Affairs, DAIICHI-SANKYO

Aden Asefa, MPH, Regulatory Health Project Manager, U.S. FOOD AND DRUG ADMINISTRATION

KEY EVENT TAKEAWAYS

Navigate Advisory Committee preparation from a safety and pharmacovigilance standpoint

Instill best practices for regulatory submissions

Set the stage for a successful launch with practical models of preparation

Adhere to regulatory updates and standards

Understand the roles of Advisory Committee membership types

Enhance the Likelihood of a Successful Panel Meeting With the FDA

NOVEMBER 5–6, 2018 HILTON WASHINGTON DULLES AIRPORT

HERNDON, VA

TO REGISTER, CALL 201-871-0474

DEAR COLLEAGUE,The Food and Drug Administration’s Advisory Committee holds a vital role in the process, development, and evaluation of new drugs, biologics and medical devices. While the advice of the Advisory Committee is not binding on the FDA, the recommendation of the committee is considered to be a predictor of the agency’s action.

ExL’s FDA Advisory Committee Strategy Summit provides attendees with the tools needed to prepare for an Advisory Committee meeting. The Advisory Committee’s primary purpose is to assist the FDA in evaluating applications for market approvals such as new drug applications for drugs and biologics, product licensing agreements for biologics, or pre-market approvals for medical devices. The Advisory Committee assists the agency in developing these general guidelines.

Our speaking faculty helps you outline the factors that are most applicable for designing an effective preparation strategy for getting to market.

Attendees will learn how to:

ĥ Navigate Advisory Committee preparation from a safety and pharmacovigilance standpoint

ĥ Establish a strong internal and external team to optimize outcomes

ĥ Learn documentation and writing best practices for regulatory submissions

ĥ Select and align clinical, regulatory, safety, medical and marketing teams

ĥ Prepare for potential questions and data concerns

ĥ Establish a strong strategy development

ĥ Manage logistics for project execution

I look forward to welcoming you to Virginia this November!

Sincerely,

Aimee Gutzler Conference Production Director ExL Events, a division of Questex, LLC

WHO SHOULD ATTEND:

This conference is designed for representatives from pharmaceutical and biotechnology companies with responsibilities in the following areas:

ĥ Regulatory Affairs

ĥ Regulatory Submissions

ĥ Regulatory Operations

ĥ Regulatory Compliance

ĥ Regulatory/Medical/Clinical/ Technical Writing

ĥ Medical and Clinical Affairs

ĥ Clinical Development

ĥ Clinical Operations

ĥ Clinical Research Lead

ĥ Safety/Product Safety/Drug Safety

ĥ Product Development

ĥ Pharmacovigilance

ĥ Biostatistics

ĥ Legal/Counsel

ĥ Corporate Executives

ĥ Consultants

ĥ Technology Vendors

HILTON WASHINGTON DULLES AIRPORT 13869 PARK CENTER ROAD, HERNDON, VA 20171

To make reservations, please call 703-478-2900 and request the negotiated rate for ExL November Meetings. You may also make reservations online using the following weblink: https://goo.gl/gwchXB. The group rate is available until October 15, 2018. Please book your room early, as rooms available at this rate are limited.*ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

Do you want to spread the word about your organization’s solutions and services to potential clients attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs.

VENUE INFORMATION

SPONSORSHIP OPPORTUNITIES

TO REGISTER, CALL 201-871-0474

8:00 REGISTRATION AND CONTINENTAL BREAKFAST

9:00CHAIRPERSON’S OPENING REMARKSDr. Elizabeth Garner, Chief Medical Officer, Senior Vice President Clinical Development, AGILE THERAPEUTICS

EFFECTIVELY PREPARE FOR AN ADVISORY COMMITTEE MEETING

9:15NAVIGATE REGULATORY UPDATES AND STANDARDS

ĥ Promote meeting standards to simplify the FDA Review Process for drugs and devices ĥ Review critical FDA Advisory Committee regulatory updates

Jack Weet, Vice President, Regulatory Affairs and Quality Assurance, COLLEGIUM PHARMACEUTICAL, INC.

10:00

EXAMINE THE FDA ADVISORY COMMITTEE SELECTION PROCESS TO UNDERSTAND THE BACKGROUNDS OF ADVISORY COMMITTEE MEMBERS

ĥ Uncover the backgrounds of FDA Advisory Committee members ĥ Analyze the FDA’s competitive selection process for Advisory Committee members by examining the required experience and credentials

ĥ Explain the differences among industry, consumer and patient representatives, and differences between voting and non-voting members

ĥ Discuss the nomination and election process for industry representativesElijah Wreh, Regulatory Affairs Manager, INVACARE CORPORATION; and Industry Representative, FDA ADVISORY COMMITTEE NEUROLOGICAL DEVICES PANEL

10:45 NETWORKING BREAK

11:15

PLAN FOR SUCCESS BY ESTABLISHING A STRONG STRATEGY DEVELOPMENT ĥ Analyze Advisory Committee expectations ĥ Develop an Advisory Committee strategy ĥ Understand Advisory Committee intelligence ĥ Create a playbook as a training tool for a successful strategy

Shoba Ravichandran, M.D., Executive Director – Head, U.S. Oncology Medical – Optimized Indications Franchise, NOVARTIS ONCOLOGY

12:00

PREPARE YOUR CONTENT AND APPLY SCIENTIFIC MESSAGING ĥ Establish “the story:” Key messages and data to support ĥ Understand key questions to be answered ĥ Define core presentations to ensure consistency and avoid redundancy ĥ Prepare and organize background data

Dr. Elizabeth Garner, Chief Medical Officer, Senior Vice President Clinical Development, AGILE THERAPEUTICS

12:45 LUNCHEON

1:45

BUILD YOUR WINNING TEAM ĥ Strategize by understanding and thoughtfully considering these roles ĥ Adjust your team if any inefficiencies exist ĥ Set up clear expectations for team early ĥ Keep all lines of communications open ĥ Train internal and external team to optimize outcomes

Dr. Dennis E. Hruby, Chief Science Officer, SIGA TECHNOLOGIES

DAY 1 MONDAY | NOVEMBER 5

TO REGISTER, CALL 201-871-0474

2:30

PREPARE YOUR TEAM WITH TRAINING AND TOOLS FOR SUCCESS ĥ Outline presentation development to ensure that your team is addressing the most necessary points of interest ĥ Delve into presentation coaching through rehearsal and exchange of constructive criticism ĥ Institute Q&A training as practice in handling spontaneous questions ĥ Track slide creation, indexing, and retrieval and walk through technology and A/V production by calling up slides for questions during a scheduled mock panel

Michael Rozycki, Ph.D., Vice President, Regulatory Affairs, PACIRA PHARMACEUTICALS, INC.

3:15 NETWORKING BREAK

3:45

MANAGE LOGISTICS FOR PROJECT EXECUTION ĥ Refine team organization and establish a strong internal and external team to optimize outcomes ĥ Prioritize project management by selecting and aligning clinical, regulatory, safety, medical and marketing teams ĥ Outline meeting logistics and anticipate strong outcomes by creating clear and concise presentations ĥ Manage open public hearing coordination

Stefan Ochalski, Ph.D., MBA, Vice President, Regulatory Affairs, TAIHO ONCOLOGY, INC.

4:30

MASTER THE MOCK PANEL ĥ Execute mock panel recruitment ĥ Analyze mock panel and team session facilitation ĥ Highlight controversial areas of discussion ĥ Provide attention to spontaneous Q+A regarding company product and reputation ĥ Prioritize time management

Scott Greenfeder, Executive Director, Regulatory Affairs Strategy, Specialty Medicine R&D, BAYER

5:15 DAY ONE CONCLUDES

DAY 1 MONDAY | NOVEMBER 5

DAY 2 TUESDAY | NOVEMBER 6

8:00 CONTINENTAL BREAKFAST

9:00CHAIRPERSON’S RECAP OF DAY ONEDr. Elizabeth Garner, Chief Medical Officer, Senior Vice President Clinical Development, AGILE THERAPEUTICS

APPLICATION OF BEST PRACTICES FOR ADVISORY COMMITTEE MEETINGS

9:15

PRESENT YOUR DATA ĥ Develop your argument to present to the FDA ĥ Show all perspectives and explain weaknesses, if any ĥ Highlight risk-benefit, how your product compares to others, as well as safety and effectiveness of product in review

Diane Murphy, MBA, Contractor and Former Clinical Development Director, ALLERGAN

TO REGISTER, CALL 201-871-0474

10:00

IDENTIFY YOUR AUDIENCE ĥ Share a brief history of Advisory Committee meetings with examples of high-profile meetings ĥ Review Advisory Committee structure within the Office of Commissioner (ACOMS), CDER, CBER, CDRH, CTP — briefly go over the number of advisory committees in FDA

ĥ Provide an overview of Medical Device Law and how Advisory Committee meetings have evolved over the years

ĥ Examine Advisory Committee process overview ĥ Discuss selection of panel members including requirements from patient representatives, consumer representatives and industry representatives, including recruitment efforts

ĥ Address panel member preparation and the expectations from FDA and industry ĥ Explore why submissions/issues go to panel ĥ Utilization of panel results deciding a voting vs. non-voting meeting, follow up after meetings, recent examples of FDA decision based on recommendations from panel meetings

10:45 NETWORKING BREAK

11:15RECOGNIZE CONSULTANTS AS COLLABORATIVE THOUGHT PARTNERS

ĥ Ensure vendors are trusted industry and subject matter experts ĥ Provide expertise, experience, and knowledge as they are representing your company’s product and brand, overall

Naveen Thuramalla, DVP, Regulatory Affairs, ABBOTT

12:00

PRESENT STRATEGY FOR ADVISORY COMMITTEE PREPARATION INVOLVING AN ORPHAN PRODUCT ĥ Review submission and approval process for genetic disease ĥ Discuss unique small biotech approach to FDA interaction ĥ Align support with patient advocacy groups and consultants

Jim Wang, Ph.D., MBA, Head of Regulatory Strategy, SPARK THERAPEUTICS

12:45 LUNCHEON

1:45

UNCOVER COMMON MISTAKES IN PREPARING FOR AN FDA ADVISORY COMMITTEE PRESENTATION ĥ Overemphasis on the core presentation ĥ Review tactics without a strategy and data without a message ĥ Avoid endless discussion, no decisions ĥ Audit insufficient and ineffective rehearsals ĥ Prepare for overestimating presenter effectiveness

Kristin Zielinski Duggan, Adjunct Professor, FDA Regulation of Medical Products, GEORGETOWN UNIVERSITY

2:30

PREPARE WITH A MEETING DAY CHECKLIST ĥ Review meeting space and materials list ĥ Arrange for meals and transportation ĥ Secure debrief space, if applicable

Emmanuel Nyakako, Senior Vice President of Quality and Regulatory Affairs, CONFORMIS, INC.

3:15 CONFERENCE CLOSING REMARKS

DAY 2 TUESDAY | NOVEMBER 6

Aden Asefa, MPH, Regulatory Health Project Manager, U.S. Food and Drug Administration

TO REGISTER, CALL 201-871-0474

TERMS AND CONDITIONS: By registering for an ExL Events (“ExL”) event, you agree to the following set of terms and conditions listed below:REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.PAYMENT: Make checks payable to PMA Conference Management. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:•Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.•Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.•Five days or less: A voucher (minus a $395 processing and documentation fee) to another ExL event valid for 12 months from the voucher issue date.

CREDIT VOUCHERS:Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid. ExL Events does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event. SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference. ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants. ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.

*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

WAYS TO REGISTER 201-871-0474

Click Here

@ register@pmaconference.com

253-663-7224

PMA Conference Management, POB 2303 Falls Church VA 22042

REGISTRATION FEES

GROUP DISCOUNT PROGRAM

MEDIA PARTNERS

EARLY BIRD PRICINGRegister by Friday,

September 21, 2018

$1,895

STANDARD PRICINGRegister After Friday, September 21, 2018

$2,095

ONSITE PRICING

$2,295

SAVE 25% PER PERSON WHEN REGISTERING FOUR

SAVE 15% PER PERSON WHEN REGISTERING THREE

For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time).

This is a savings of 25% per person.

Can only send three? You can still save 15% off every registration.

Offers may not be combined. Early Bird rates do not apply. To find out more about how you can take advantage of these group discounts, please call 201-871-0474.