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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Assess whether the FDA Draft Guidance has
adequately assisted sponsors with opioid drug
product formulation development
Sharpen regulatory liaison best practices for
managing post-submission questions and
responses from the FDA
Examine current ADF collaborations between
industry and congress
Rapidly respond to FDA questions with transparent
and direct answers to facilitate a cleaner review
Utilize formulation technologies and
analytical, clinical and statistical evaluation
methods to achieve FDA approval
Identify appropriate ways to communicate abuse
deterrent claims in product labels
Address the uncertainty in generic drug
development — Will FDA approval be tied to ADF?
Consider options for manipulating drug products
and extended-release formulations to counteract
over-medicating
Featured Thought Leaders:
CHAIRPERSON
Penny Levin,
Director,
Regulatory Intelligence,
Teva
Kevin Sills,
Vice President,
R&D,
Atlantic
Pharmaceuticals
Kevin Healy, Ph.D.,
Director,
Regulatory Affairs,
Mallinckrodt
Pharmaceuticals
Joseph P. Hazelton,
Executive Vice President,
Chief Compliance Officer,
Charleston Laboratories
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.
Media Partners:
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UBM ADVANSTAR
PUBLICATIONS
REGISTER AT WWW.CBINET.COM/ADF • 800-817-8601
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
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.
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 [email protected].
REGISTER AT WWW.CBINET.COM/ADF • 800-817-8601
DAY ONE
Tuesday, May 19, 2015
7:45
Conference Registration and Breakfast
8:45
Chairperson’s Opening Remarks
Penny Levin, Director, Regulatory Intelligence, Teva
Unravel Evolving ADF
Regulatory Requirements to
Minimize Human Abuse Liability
9:00
• What states are leading the way to incentivize
adoption of abuse deterrence formulations?
• What is the industry doing to advance
the cause?
Robert J. Falb, Director, Government and Public Affairs Department,
Teva
10:30
11:00 Understand Pre-Marketing Regulatory
Expectations and Clinical Processes
to Ensure Compliance with FDA
Draft 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
Kevin Healy, Ph.D., Director, Regulatory Affairs,
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 draft guidance
* has the draft guidance adequately assisted
sponsors with opioid drug product
formulation development?
* how are the studies evaluated? What have
been the subsequent labeling claims?
* when can we expect the guidance from
2013 finalized? When can we expect a
generic draft guidance?
• 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
Stacey L. Worthy, Esq., Associate Attorney, DCBA Law & Policy
Kyle Simon, Director, Policy and Advocacy, 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?
Networking and Refreshment Break
Mallinckrodt Pharmaceuticals
11:45
Networking Luncheon
1:00
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
Krishna Devarakonda, Director, Clinical Pharmacology,
Mallinckrodt Pharmaceuticals
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2:00
Roundtable
4:15
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?
• Examine the managed care perspective on the
cost/benefit of ADFs
• Discuss potential payer incentives
(commercial, Medicare, Medicaid) to reimburse
ADF products, rather than generic products
without AD properties
Jonathan Berlent, Former Vice President, Business Development,
Tris Pharma
5:00
DAY TWO
Wednesday, May 20, 2015
8:00 Continental Breakfast
8:30 Chairperson’s Review of Day One
Penny Levin, Director, Regulatory Intelligence, Teva
8:45
Interactive Live Polling
• Gauge the potential for the future of generic
drug development
Kevin Sills, Vice President, R&D, Atlantic Pharmaceuticals
Networking and Refreshment Break
Regulatory Liaison Best Practices for
Managing Post-Submission Questions
and Answers to and from the FDA
Develop Strategies for Label
Claims and Formulations in
New and Existing Drugs
• 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
Penny Levin, Director, Regulatory Intelligence, Teva
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
Dan Cohen, Leader, U.S. Abuse Deterrent Coalition; Head of
North American Government Relations, Grünenthal USA, Inc.
Develop Best Practices to
Achieve FDA Approval and
Ensure Market Success
3:30
Close of Day One
Networking, Wine and Cheese Reception
immediately following the final session on day one
* do the same suggestions that are laid out in
the draft guidance apply to generic products?
3:00
Analyze the Pharmacoeconomic
Cost/Benefit of ADF Development
9:30
Generate and Translate Data from
ADF Development into Label
Claims and Communicate the Data
to Various Stakeholders
• Review the FDA draft guidance on
Abuse Deterrent Opioid Development to
understand the following:
* different categories of
abuse deterrent studies
* different tiers of claims for product labels
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*how the different categories of data
do/do not translate to label claims
• 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
Jeffrey M. Dayno, M.D., Chief Medical Officer,
1:45 • Examine the history of prodrugs with abuse
deterrent properties
• Adapt biochemistry within clinical development to
control abuser preference and enjoyment
CASE * prodrug development and combination
STUDY
of formulations
• Consider options for manipulating drug
products and extended-release formulations
to decrease the ability for oral formulation to
counteract overmedicating
Egalet Corporation
10:15
• Examine potential for use within the opioid
analgesic drug class and the potential to
evolve similar formulations for other
addictive therapeutics
Networking and Refreshment Break
10:45 Achieve Accurate Label Claims
for Meaningful ADF Use
• Review categories of pre-marketing studies
and identify which works best for your
compound submission
* Category 1 — Lab-based in vitro manipulation
and extraction studies
* Category 2 — Pharmacokinetic studies
* Category 3 — Clinical abuse potential studies
• Discover how utilizing one or more of the three
pre-marketing studies can eventually aid with
analyzing post-marketing data to assess impact
of ADF on actual abuse
• Consider what data is necessary to achieve a Tier
4 claim, including how much data is required to
demonstrate reduced abuse in the community
• Brainstorm possible ways to predict
real world effects
Speaker to be announced
Travis Mickle, Ph.D., President and CEO, KemPharm, Inc.
2:45
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?
Impart Abuse Deterrent Properties
and ADF Testing
• What can we learn from studying patient
preference and the effect of different opioids
on different patients types?
• Discuss formulation technologies used in:
* Aversion Oxycodone (formerly Oxecta)
*Remoxy
CASE
STUDY *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
Julie S. Ross, Ph.D., Director, Formulation Development,
• 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?
Joseph P. Hazelton, Executive Vice President, Chief Compliance Officer,
Charleston Laboratories
BioDelivery Sciences International
Networking Luncheon
Roundtable
True Objectives of Abuse
Deterrence — Addiction vs. Abuse?
11:30 Utilize Formulation Technologies to
12:30 Innovative Approaches to Minimize the
Misuse and Abuse Potential of Opioid
Analgesics — Past, Current and Future
Prodrug Breakthroughs
3:30 Close of Conference
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MAY 19-20, 2015 • DOUBLETREE BY HILTON • SILVER SPRING, MD
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Navigate the Rapidly Changing Requirements for
Minimizing the Misuse Potential of Highly Abused Drugs
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Abuse Deterrent Formulations Summit
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the registration fee less the $399 administrative charge can be credited to another CBI conference if
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