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MAY 19-20, 2015 • DOUBLETREE BY HILTON • SILVER SPRING, MD
Navigate the Rapidly Changing Requirements for
Minimizing the Misuse Potential of Highly Abused Drugs
Link ADFs that Effectively Decrease Abuse and
Misuse Potential to Optimal Label Claims:
Assess whether the FDA Final Guidance has
adequately assisted sponsors with opioid drug
product formulation development
Examine current ADF collaborations between
industry and congress
Utilize formulation technologies and
analytical, clinical and statistical evaluation
methods to achieve FDA approval
Address the uncertainty in generic drug
development — Will FDA approval be tied to ADF?
Sharpen regulatory liaison best practices for
managing post-submission questions and
responses from the FDA
Rapidly respond to FDA questions with transparent
and direct answers to facilitate a cleaner review
Identify appropriate ways to communicate abuse
deterrent claims in product labels
Consider options for manipulating drug products
and extended-release formulations to counteract
over-medicating
Featured Thought Leaders:
CHAIRPERSON
Penny Levin,
Director, Global Regulatory
Intelligence & Policy
Teva
Kevin Sills,
Vice President,
R&D,
Atlantic
Pharmaceuticals
Kevin Healy, Ph.D.,
Director,
Regulatory Affairs,
Mallinckrodt
Pharmaceuticals
Tim Hermes,
Vice President,
Government Affairs and
Alliance Development,
Collegium
Pharmaceuticals, Inc.
Jeffrey M. Dayno, M.D.,
Chief Medical Officer,
Egalet Corporation
Dan Cohen,
Leader, U.S. Abuse
Deterrent Coalition;
Head of North American
Government Relations,
Grünenthal USA, Inc.
Life Sciences
Association Partner:
2. REGISTER AT WWW.CBINET.COM/ADF • 800-817-8601
A Great Place to Meet Your Market!
Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while demonstrating thought
leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact
Lauren Moras at 339-298-2172 or email lauren.moras@cbinet.com.
Who Should Attend
You will benefit from attending this event if you are a senior executive, senior director, director
or manager from the pharmaceutical or biotech industries with responsibilities or involvement in the
following areas:
Regulatory Affairs • Regulatory Intelligence • Risk Management/REMS
Pharmacovigilance/Drug Safety • Clinical Development • Epidemiology • Pharmacoepidemiology
Formulary Development/CMC • Health/Government Policy • Medical Affairs
This conference will also benefit consultants, CROs, central labs, drug safety service providers and
companies providing services to the above audience.
CBI’s Abuse Deterrent Formulations Summit
focuses on critical abuse and misuse reduction
strategies, including best practices for meeting
regulatory requirements, implementing risk
mitigation, developing protocols to evaluate
liability and achieving an ADF label from
the FDA.
As the FDA continues to focus on reducing the
abuse potential of opioids, it is more important
than ever for bio/pharma manufacturers to
ensure that new and existing products are
meeting regulatory mandates and minimizing
misuse potential and abuse liability.
How will your organization respond?
“While prescription opioids are an important component of pain management,
abuse and misuse of these products have resulted in too many injuries and
deaths across the United States. An important step towards the goal of creating
safer opioids is the development of products that are specifically formulated to
deter abuse.”
- Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs,
Center for Drug Evaluation and Research, FDA *Source: FDA.gov, January, 2013
Conference Sponsors:
3. DAY ONE
Tuesday, May 19, 2015
7:45 Conference Registration and Breakfast
8:45 Chairperson’s Opening Remarks
PennyLevin,Director,GlobalRegulatoryIntelligence&Policy,Teva
Unravel Evolving ADF
Regulatory Requirements to
Minimize Human Abuse Liability
9:00 Policy Address
Setting the Scene — The Future of
Abuse Deterrent Formulations for
Minimizing American Drug Abuse
• Hear an overview of the prescription drug abuse
epidemic, including the FDA’s Abuse Deterrent
Opioids — Evaluation and Labeling final guidance
* does the final guidance adequately assist
sponsors with opioid drug product
formulation development and set forth an
understanding of what is expected?
* how are the studies evaluated? What have
been the subsequent labeling claims?
* why generic draft guidance is so important?
• Discuss how industry can reach the goal of
decreasing abuse and misuse in the community
• Evaluate ADFs as a method to reduce abuse while
ensuring access to medication for
patients with legitimate medical needs
* discuss the extent to which abuse
reduction can be measured
* consider pros and cons of ADFs
• Identify policy recommendations to transition
the market to abuse-deterrent formulations
for both branded and generic products
* assess how policy recommendations
impact market access
StaceyL.Worthy,Esq.,AssociateAttorney,DCBA Law & Policy
KyleSimon,Director,PolicyandAdvocacy,Center for Lawful
Access and Abuse Deterrence (CLAAD)
10:00 State of the Union — What’s Going on in
Congress and the States?
Addressing prescription drug abuse is an issue high
on legislative agendas in Washington, D.C. and in
state legislatures across the country. Topics to be
addressed in this session include:
• What is going to happen in Congress?
• Who are the key policymakers to watch?
• What are they saying?
• What states are leading the way to incentivize
adoption of abuse deterrence formulations?
• What is the industry doing to advance the cause?
RobertJ.Falb,Director,GovernmentandPublicAffairsDepartment,
Teva
10:30 Networking and Refreshment Break
11:00 Understand Pre-Marketing Regulatory
Expectations and Clinical Processes to
Ensure Compliance with FDA
Final Guidance
• Implement early planning and
pre-IND considerations
• Discuss ADF Category 1 Studies —
Formulation analyses and in vitro testing
• Examine ADF Category 2 (PK) and Category 3
(HAP) Studies — Design and FDA protocol review
• Consider overall clinical program requirements —
Collecting and reporting pertinent information
• Prepare for the pre-NDA meeting and organize
the NDA submission
Discuss labeling considerations and the
NDA review
KevinHealy,Ph.D.,SeniorDirector,RegulatoryAffairs,
Mallinckrodt Pharmaceuticals
11:45 Examine the Development of Opioid
and Non-Opioid Abuse Deterrent
Formulations to Reduce Liability and
Meet Regulatory Expectations
• Consider the deterrence science for rapid
evolution of ADFs
• Utilize formulation technologies and analytical,
clinical and statistical evaluation methods to
achieve FDA approval
• Examine general considerations for study design
• Explore the most common routes of abuse
for the particular drug in development
• Evaluate the concept of abuse potential
• Implement approaches to assess the abuse
potential of a drug product
• Perform Human Abuse Potential (HAP) studies for
drugs with addictive potential
• Characterize the pharmacokinetic (PK)/
pharmacodynamic (PD) properties of a
substance and a product
• Discuss which opioid safety recommendations will
be expanded into non-opioid drug development
• Discover pitfalls and successes within the opioid
market and how non-opioid products can learn
from the failures and achievements
TerriL.Morton,Ph.D.,SeniorPrincipalClinicalPharmacologist,
Mallinckrodt Pharmaceuticals
12:30 Networking Luncheon
REGISTER AT WWW.CBINET.COM/ADF • 800-817-8601
4. 1:45 ROUNDTABLE
Consider FDA Future Action for
Generic Opioid Analgesic Treatment —
Will Approval be Tied to ADF?
During this interactive roundtable, attendees
break into discussion groups to share insights
on considerations for generic drug development
with ADF. Participants then reconvene for shared
learning to highlight key insights and discussion
points of each individual group. Topics to be
addressed include:
• Examine FDA’s focus on ADF generic opioid
development and what any changes in
regulation could mean for development
• Identify necessary considerations for generic
product ADFs
* will non-abuse deterrent opioid generics
be kept off the market?
* are there strategies for creating similar
abuse deterrent formulations that may be
able to match the branded product?
* does a generic clinical study, claim and
tier need to match that exactly of the
branded product?
* do the same suggestions that are laid out in
the final guidance apply to generic products?
• Gauge the potential for the future of generic
drug development
KevinSills,VicePresident,R&D,Atlantic Pharmaceuticals
2:45 Networking and Refreshment Break
Develop Best Practices to
Achieve FDA Approval and
Ensure Market Success
3:15 Regulatory Liaison Best Practices for
Managing Post-Submission Questions and
Answers to and from the FDA
• Create a rapid response team, including point
persons for dossier review prior to submission
* go through dossier with fine tooth comb to
identify any potential questions from the FDA
and multiple answers ahead of time
• Ensure that appropriate R&D, regulatory,
commercial, etc., team members are accessible
when needed throughout the lifecycle of the
submission; filing, acceptance, review
• Respond to FDA questions, rapidly, with
transparent and direct answers to facilitate a much
cleaner review
PennyLevin,Director,GlobalRegulatoryIntelligence&Policy,Teva
4:00 The Holy Grail of Abuse Deterrence
• Examine the full extent of abuse deterrence —
Can the current focus of ADF technologies on
external manipulation of oral doses also protect
the motivated abuser from accidental
or intentional overdose?
• Discuss the financial implications of developing
abuse deterrence technologies
RonGuido,CEO,ExxPharma Therapeutics, LLC
4:45 Close of Day One
Networking, Wine and Cheese Reception
immediately following the final session on day one
DAY TWO
Wednesday, May 20, 2015
8:00 Continental Breakfast
8:30 Chairperson’s Review of Day One
PennyLevin,Director,GlobalRegulatoryIntelligence&Policy,Teva
8:45 INTERACTIVE LIVE POLLING
Educate Medical Professionals,
Patients and the Public on the Safe
Use of Opioids and Stimulants
How it works…Make sure to have your mobile
device handy. Text answers to questions and
see your results in real time.
• Address how public policy collaborations with the
government and with regulators need to evolve to
provide the necessary formulated deterrence
• Identify and define abuse deterrent
developers’ role in educating the public for
safe conduct and use of opioid and stimulant
• Establish goals and aims of AD Coalition
public policy initiatives
DanCohen,Leader,U.S. Abuse Deterrent Coalition;Headof
NorthAmericanGovernmentRelations,Grünenthal USA, Inc.
Develop Strategies for Label
Claims and Formulations in
New and Existing Drugs
9:30 Generate and Translate Data from
ADF Development into Label Claims
and Communicate the Data to
Various Stakeholders
• Review the FDA final guidance on Abuse Deterrent
Opioid Development to understand the following:
* different categories of abuse deterrent studies
* different tiers of claims for product labels
* how the different categories of data
do/do not translate to label claims
REGISTER AT WWW.CBINET.COM/ADF • 800-817-8601
5. • Appreciate the current approach and challenges
in abuse deterrent opioid development in the
context of “incremental improvement”
• Identify appropriate ways for sponsors to
communicate abuse deterrent claims in
product labels
• Anticipate challenges in the post-approval
phase of an abuse deterrent opioid:
* Category 4 abuse deterrent studies —
A post-approval requirement
* other ‘real world’ exposure of a product and its
potential impact on its abuse deterrent profile
JeffreyM.Dayno,M.D.,ChiefMedicalOfficer,Egalet Corporation
10:15 Networking and Refreshment Break
10:45 Leverage Pharmacokinetic Studies to
Support Tier 2 Labeling Claims for
Abuse Deterrent Opioids
• Provide an overview of the FDA’s Abuse-
Deterrent Opioids Guidance with respect to
pharmacokinetic studies and Tier 2 labeling
• Discuss the type of pharmacokinetic studies
required to support Tier 2 claims
• Consider different formulation manipulations
and administration routes and how they can
support Tier 2 labeling
• Present strategies of using pharmacokinetic
studies to help support Tier 1 and Tier 3
labeling claims
JohnOldenhof,MSc,Ph.D.,SeniorDirectorScientificAffairs,
INC Research
11:30 Utilize Formulation Technologies to
Impart Abuse Deterrent Properties
and ADF Testing
• Discuss formulation technologies used in:
* Aversion Oxycodone (formerly Oxecta)
* Remoxy
* Embeda
* Bunavail
• Examine the different types of ADF testing
and the need for standards
• Consider the potential for AD labeling
• Deliberate what the future may hold for
AD properties and testing
JulieS.Ross,Ph.D.,Director,FormulationDevelopment,
BioDelivery Sciences International
12:15 Networking Luncheon
1:30 The Search for New Pain Therapeutics
with Low Inherent Abuse Potential —
A Case for Prodrugs
• Examine the history of prodrugs with abuse
deterrent properties
• Adapt biochemistry within clinical development
to control abuser preference and enjoyment
* prodrug development and combination
of formulations
• Consider options for manipulating drug
products and extended-release formulations
to decrease the ability for oral formulation to
counteract overmedicating
• Examine potential for use within the opioid
analgesic drug class and the potential to
evolve similar formulations for other
addictive therapeutics
SvenGuenther,Ph.D.,EVP,ResearchandDevelopment,
KemPharm, Inc.
2:15 ROUNDTABLE
True Objectives of Abuse Deterrence —
Addiction vs. Abuse?
While 15% of opioid abuse is through insufflation
(snorting), or injection, the majority of abuse is that
of quantity of opioid ingested. While the focus has
been on decreasing the street value of opioids,
the larger issue remains taking more opioid than
prescribed. During this interactive roundtable,
attendees break into discussion groups to share
insights on objectives for minimizing abuse.
Participants then reconvene for shared learning to
highlight key insights and discussion points of
each individual group. Questions to be
addressed include:
• Should we be focusing on how to make
effective pain medications that are less
addictive, with lower amounts of euphoria or
withdrawal symptoms?
• What can we learn from studying patient
preference and the effect of different opioids
on different patients types?
• Can we avoid situations where acute patients
become chronic patients with managing
medication therapy management?
• Physical manipulation of opioids only addresses
part of the problem; are likability and abuse
potential truly the same thing?
TimHermes,VicePresident,GovernmentAffairsandAlliance
Development,Collegium Pharmaceuticals, Inc.
3:00 Close of Conference
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PHONE
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E-MAIL
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WEBSITE
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Life Sciences
Abuse Deterrent Formulations Summit PC15098
VENUE:
DoubleTree by Hilton Silver Spring
8727 Colesville Road
Silver Spring, Maryland 20910
Phone Reservations: (800) 222-8733
Hotel Direct Line: (301) 589-5200
ACCOMMODATIONS:
To receive CBI’s special discounted hotel rate online or by phone, please go to:
• Online: www.cbinet.com/adf
• Phone reservations: (800) 222-8733 and mention CBI’s Abuse Deterrent
Formulations.
Book Now! The DoubleTree by Hilton Silver Spring is accepting reservations on a
space and rate availability basis. Rooms are limited, so please book early. All travel
arrangements subject to availability.
PLEASE NOTE: All hotel reservations for this conference should be booked directly
with the hotel. CBI does not use Housing Bureaus and none are authorized to call
on our behalf.
REGISTRATION FEE:
ADVANTAGE PRICING Standard
Conference $1899 $2199
Register by March 27, 2015 and SAVE $300. Fee includes continental breakfast, lunch,
wine and cheese reception, refreshments and conference documentation. Please make checks
(in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)
PLEASE NOTE: All advertised discounts are taken from the full, Standard Rate.
TEAM DISCOUNT:
For every three paying registrations from your company, you will receive a fourth complimentary*
registration to the conference (must register four at same time to qualify). To receive the team discount
you must register with our customer service department by calling 339-298-2100.
* Advantage pricing rates do apply when applicable. Offer may not be combined with any other
special pricing promotions. Offer may be used at CBI co-located events.
SATISFACTION GUARANTEED:
CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference,
a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-
8601 for further information. Advanced preparation for CBI conferences is not required.
SUBSTITUTION AND CANCELLATION:
Your registration may be transferred to a member of your organization up to 24 hours in advance of the
conference. Cancellations received in writing on or before 14 days prior to the start date of the event
will be refunded, less a $399 administrative charge. No refunds will be made after this date; however,
the registration fee less the $399 administrative charge can be credited to another CBI conference if
you register within 30 days from the date of this conference to an alternative CBI conference scheduled
within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the
conference registration fee only. CBI reserves the right to alter this program without prior notice. Please
Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort
to find a suitable replacement will be made without notice. The opinions of the conference faculty do
not necessarily reflect those of the companies they represent or CBI.
REGISTE R AT WWW.CBINET.COM/ADF • 800-817-8601
R E G I S T E R BY M A R C H 2 7, 2 0 1 5 A N D S AV E $ 3 0 0 !
MAY 19-20, 2015 • DOUBLETREE BY HILTON • SILVER SPRING, MD
Navigate the Rapidly Changing Requirements for
Minimizing the Misuse Potential of Highly Abused Drugs
ANY QUESTIONS OR TO REGISTER
CALL Christian Alongi 339-298-2131
or FAX TO MY ATTENTION 781-939-2694
email: christian.alongi@cbinet.com