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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:
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 [email protected].
Who Should AttendYou 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 anddeaths across the United States. An important step towards the goal of creatingsafer opioids is the development of products that are specifically formulated todeter abuse.”
- Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, Center for Drug Evaluation and Research, FDA *Source: FDA.gov, January, 2013
Conference Sponsors:
DAY ONE Tuesday, May 19, 2015
7:45 Conference Registration and Breakfast
8:45 Chairperson’s Opening RemarksPenny Levin, Director, Global Regulatory Intelligence & 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
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?
• 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 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
Kevin Healy, Ph.D., Senior Director, Regulatory Affairs, 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
Terri L. Morton, Ph.D., Senior Principal Clinical Pharmacologist,Mallinckrodt Pharmaceuticals
12:30 Networking Luncheon
REGISTER AT WWW.CBINET.COM/ADF • 800-817-8601
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
Kevin Sills, Vice President, 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
Penny Levin, Director, Global Regulatory Intelligence & 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
Ron Guido, CEO, ExxPharma Therapeutics, LLC
4:45 Close of Day One
Networking, Wine and Cheese Receptionimmediately following the final session on day one
DAY TWO Wednesday, May 20, 2015
8:00 Continental Breakfast
8:30 Chairperson’s Review of Day OnePenny Levin, Director, Global Regulatory Intelligence & Policy, Teva
8:45 INTERACTIVE LIVE POLLING Educate Medical Professionals, Patients and the Public on the Safe Use of Opioids and StimulantsHow 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 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
• 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, 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
John Oldenhof, MSc, Ph.D., Senior Director Scientific Affairs, 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
Julie S. Ross, Ph.D., Director, Formulation Development, 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
Sven Guenther, Ph.D., EVP, Research and Development, 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?
Tim Hermes, Vice President, Government Affairs and Alliance Development, Collegium Pharmaceuticals, Inc.
3:00 Close of Conference
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PHONE800-817-8601 339-298-2100 outside the U.S.
WEBSITEwww.cbinet.com/adf
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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.
REG I STE 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 REGISTERCALL Christian Alongi 339-298-2131
or FAX TO MY ATTENTION 781-939-2694email: [email protected]
