Conference Co-Chairs:

FDA coverage of “Final Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products”

Processes for navigating intellectual property framework

Translate abuse deterrent (AD) data into AD label claims

Transformative technologies that protect against oral abuse

Breakthrough formulation technologies that target the source of abuse

Demonstrate correlations between in vitro results and in vivo performance of manipulated extended release abuse deterrence

Strategies for data interpretation and primary analysis of abuse potential

Penny Levin, Director, Global Regulatory Intelligence and Policy, Teva Pharmaceuticals

Dan Cohen, Executive Vice President, Government & Public Relations, KemPharm; Chair, Abuse Deterrent Coalition Forum

Transformative Thought Leadership on:

FDA Keynote Address Douglas Throckmorton, M.D.,

Deputy Director for Regulatory Programs, FDA

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Media Partners:Executive Sponsor:

A division ofUBM Americas

Achieve ADF Labeling • Reduce Abuse Potential • Integrate Technologies to Support Deterrence

MARCH 7-8, 2017 • EMBASSY SUITES BY HILTON OLD TOWN • ALEXANDRIA, VA

Unparalleled Multi-Stakeholder Insights from:

American Academy of Pain Management • Amneal Pharmaceuticals • Blue Cross Blue Shield Center for Lawful Access and Abuse Deterrence • Center for Medicine in the Public Interest Egalet Corp • Elysium Therapeutics • GPhA • Inflexxion • KemPharm • Teva • Grünenthal

“The best CBI conference I’ve attended.” — Vice President, Collegium Pharmaceuticals

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 Karen Hanover at 339-298-2184 or email karen.hanover@cbinet.com.

Executive Sponsor:

The Grünenthal Group: International, successful, innovativeThe Grünenthal Group is an independent, privately-owned, international research-

based pharmaceutical company headquartered in Aachen, Germany. We are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, we are committing to innovation in order to treat unmet medical needs and bring value-adding products to markets.

Grünenthal’s research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies.

Altogether, the Grünenthal Group is present in 32 countries with affiliates in Europe, Australia, Latin America and the US. Grünenthal products are sold in more than 155 countries and currently approx. 5,300 employees are working for the Grünenthal Group worldwide. In 2014, Grünenthal achieved revenues of € 1.154 bn (> $ 1.25 bn).

Grünenthal USA, Inc., the US affiliate of the Grünenthal Group, is strategically located in Morristown, New Jersey (www.grunenthal.us).

Since 2010, Grünenthal is marketing its proprietary abuse-deterrent technology under the brand INTAC® (http://intac.grunenthal.com). INTAC® is an innovative delivery platform which restricts manipulation and impedes abuse due to its high mechanical stability. INTAC® has been licensed by several US pharmaceutical companies and is utilized in a number of extended release (ER) prescription opioids in the US market which makes INTAC® the market leading technology in abuse-deterrence for ER opioids.

Meanwhile INTAC® has been advanced to also provide application solutions for immediate (IR) and modified release (MR/XR) products as well as for combinations of different APIs in the same proven platform. This makes INTAC® the only abuse-deterrent platform that can offer seamless delivery solutions for a broad range of abused prescription drugs like opioids, prescription stimulants and others.

CBI’s Abuse-Deterrent Formulations Summit provides clarity on the evolving regulatory expectations for both branded and generic opioid manufacturers to obtain an ADF label. Join us to explore best practices to reduce abuse potential through innovative study designs, technology utilization and the latest developments from CMS and Congress impacting access.

Who Should Attend:

You will benefit from attending this

event if you have responsibilities or

involvement in the following areas:

• Regulatory Affairs

• Regulatory Intelligence

• Regulatory Compliance

• Clinical Operations/Development

• Risk Management/REMS

• Pharmacovigilance/Drug Safety

• Formulation

• Epidemiology

• Pharmacology

• 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.

Additional Sponsors Include:

®

7:30 Conference Registration & Continental Breakfast

8:15 Co-Chairs’ Welcome and Opening RemarksPenny Levin, Director, Global Regulatory Intelligence and Policy, Teva Pharmaceuticals

Dan Cohen, Executive Vice President, Government & Public Relations, KemPharm; Chair, Abuse Deterrent Coalition Forum

8:30 Protecting Against Oral Abuse and Overdose with Next Generation TechnologiesCurrent abuse deterrent technologies do not address oral overdose and abuse, the most common route of abuse. Join in this discussion about a new class of opioids designed to do what few thought possible — protect against oral abuse and fatal overdose. With dramatic improvements in safety, this new class of opioids could save thousands of lives each year, and provide pain relief to patients throughout the world that currently do not have access to effective therapy due to fears over opioid abuse and overdose.Greg Sturmer, President and CEO, Elysium Therapeutics

9:15 State of the Industry — An FDA Regulatory Exposition This session summarizes key learnings from recent FDA public and advisory meetings, and illustrates how the FDA has supported the development and use of ADF technology. Attendees consider how to navigate the industry landscape, address nuances in intellectual property rights for innovator drugs and note potential approval timelines for their generic counterparts. Coverage of the Final Guidance on General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products is provided.Douglas Throckmorton, M.D., Deputy Center Director for Sciences and Regulatory Programs, U.S. Food and Drug Administration

10:00 Networking and Refreshment Break

10:30 Foundation for Innovation — A Simple Approach to ChangeConsider manufacturer and regulatory actions and initiatives to date regarding the development and adoption of abuse deterrent technology for opioid drug products. Understand how to move forward designing products by recognizing all key players in the value chain of drug abuse. Emphasize how the work of the scientist in abuse deterrence impacts not only the patient, but society as a whole.

• Evaluate the stigma of abuse• Confront challenges of oral overdose• Manage the abuse deterrent paradigmIsa Odidi, Ph.D., D.Sc., MBA, Chief Executive Officer, IntelliPharmaCeutics International Inc.

11:15 Forward Steps in the Generic ADF Lifecycle Patient safety and improving health outcomes is the primary concern of drug manufacturers. The proactive relationship between the FDA and generic drug companies has provided a notable savings for our healthcare system. Join us to learn about the generic industry’s perspective on the role they play in the marketplace through advancement in pricing and innovation in abuse deterrent formulations. • Ensure timely and affordable access to high

quality, approved drugs • Establish processes and policies that enable

savings and bolster competition * intellectual property framework, label claims

• Enhance market by removing barriers to competition

• FDA policies past and futureMark Hendrickson, Director for Sciences and Regulatory Affairs at Generic Pharmaceutical Association, GPhA Candis Edwards, Senior Vice President, Clinical Regulatory Affairs, Amneal Pharmaceuticals Gregg DeRosa, Vice President, Global Clinical R&DGlobal Generic Medicines, Teva Pharmaceuticals

12:15 Networking Luncheon

1:30 Align Market Objectives and Policy for International Public HealthIn the U.S., prescription opioid abuse results in approximately 46 deaths per day. One in three adults experience chronic pain. In 2015, nearly 2.4 million Americans identified as having an opioid use disorder. In 2016 in response to the public health crisis, the Obama Administration introduced a $133 million dollar budget to combat the national epidemic of opioid abuse. So, while approved individuals must have access to medications in a pain management setting, abuse deterrent formulations are an adept course for reducing the attractiveness of a controlled substance. As a result of encouragement from federal regulators and a dual recognition of the public health necessity, pharmaceutical manufacturers have taken thoughtful steps to creating ADFs. However,

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DAY ONE TUESDAY, MARCH 7, 2017

market uncertainty has impeded particular advancements in patient access and ADF technology development. Join us to examine the challenges of producing an ADF product in light of industry and government actions. • Navigate challenges of cross-border

trade agreements• Consider the potential impact of the new

federal administration• Ensure that we move forward with

ensuring access to high quality medicines for pain management

Shruti Kulkarni, J.D., Policy Director, Center for Lawful Access and Abuse Deterrence (CLAAD)

2:15 Scaling the Value of Abuse Deterrent Formulations in Treatment and PreventionOver 100 million individuals across the U.S. suffer from acute and persistent pain that arises from a variety of causes. Although opioids are effectively used to provide relief to patients who suffer from chronic pain, they are also frequently diverted, misused and/or abused. That is why all key stakeholders including patients, physicians, payers, pharmaceutical manufacturers, policy makers, law enforcement and public health experts are working together to mediate the public health crisis of opioid abuse. Peter Pitts, President & Co Founder, Center for Medicine in the Public Interest Anshu Choudhri, Managing Director, Legislative and Regulatory Policy, Blue Cross Blue Shield

3:00 Networking and Refreshment Break

3:30 Is Category 4 Labeling for an ADF Ever Going to Be Achieved? Reality or Chimera?The highest level of opioid abuse deterrent labeling is Category 4. Although it is still vague as to what evidence would allow for such labeling, data that supports Category 4 would indicate that a product has been shown to reduce abuse in the “real world.” To date, no product has been able to support such a claim. This presentation focuses on the complexity of determining whether a given product has a causal link with reduced abuse in the community. Further, what kind of real world evidence is useful? How much evidence is enough? A few other difficult (but not exhaustive) questions are discussed including: • What are the incentives for a company to

achieve such labeling? • In a dynamic and changing environment is

Category 4 labeling “forever”, or since the real world is a constantly changing place does this labeling need to be renewed periodically?

• Will Category 4 labeling of a given product above change its abuse?

Inflexxion

4:15 Identifying Key Characteristics and Habits of the Recreational Drug User:Subjects under investigation in human abuse potential studies are a select group of drug users who recreationally abuse drugs but are not physically dependent. Understanding their characteristics and behaviors is key to understanding their translatability to the real world of drug abusers. This presentation will provide an overview of who the non-dependent recreational drug user is and what behaviors and patterns of drug use they exhibit that differ from novice and dependent users.Beatrice Setnik, PhD, Vice President Scientific Affairs , Early Phase, INC Research

5:00 Close Day One

Networking, Wine and Cheese Receptionimmediately following the final session on day one

DAY TWO WEDNESDAY, MARCH 8, 2017

7:30 Continental Breakfast

8:15 Co-Chairs’ Opening RemarksPenny Levin, Director, Global Regulatory Intelligence and Policy, Teva Pharmaceuticals

Dan Cohen, Executive Vice President, Government & Public Relations, KemPharm; Chair, Abuse Deterrent Coalition Forum

8:30 Looking Beyond the Opioid Epidemic — Minimize Risk of Abuse Across Multiple CategoriesThe epidemic of opioid abuse has received significant attention by the public, policy makers, regulators and pharmaceutical industry over the past several years. Measures have been taken in different areas including prescriber and patient education, policy implementation, treatment of addiction and prevention including technology options like abuse-deterrent technology with the first positive results on the impact of those integrated measures becoming apparent. At the same time we might see the next significant abuse epidemic coming up on the horizon. This session provides:• An overview into abuse prevalence and patterns

of other abuse prescription products with an emphasis on prescription stimulant products used in the treatment of ADHD

• Drivers for misuse and abuse of prescription stimulants

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EXTENDED SESSION

CASE STUDY

REGISTER AT WWW.CBINET.COM/ADF • 800-817-8601• Measures and learnings applied to opioids that

might be suitable in helping to curb prescription stimulant abuse

Alexander Kraus, Vice President Product Development, Technical and Government Affairs, Grünenthal USA

9:15 Design and Interpretation of Category 1 Data Balance the need for standardization and individualization in in vitro studies for abuse deterrent solid opioid products. • Optimize data through study design

* next phase interpretation • Understand how small differences can

impact results * data dumping

• Establish Category 1 AD profile • Interpret protocol for advertising

communications * what data to present from category 1

• Category 1 focus group updates and next stepsKarsten Lindhardt, Senior Vice President R&D, Site Management, Egalet Corp. Torben Elhauge, Senior Science Specialist, Egalet Corp.

10:00 Networking and Refreshment Break

10:30 Supporting REMs from Clinical to Reporting to Demonstrate Abuse DeterrenceA well implemented and closely managed Risk Evaluation and Mitigation Strategy (REMS) for extended release (ER) and long acting (LA) opioid is an effective strategy in managing to ensuring that the benefits outweigh risks. Learn how to design, develop and implement a forward thinking REMs program to remain compliant and demonstrate abuse deterrence.

• Patient Education — Safe use, risk and proper maintenance of opioid analgesics

• Create accessible medical communications for community safety

• Evaluate additional tools needed for effective risk management

12:15 Networking Luncheon

1:30 An Interdisciplinary Team Approach to Safely and Effectively Treat Chronic Pain and Reduce the Potential for Opioid Abuse• Describe the impact of the opioid overdose

problem and how pharmacist as clinicians can effectively collaborate with the healthcare team to prevent unforeseen risks

• Discuss roles for pharmacists to become more active on the pain management interdisciplinary team, citing specific examples in an advanced practice

• Illustrate weaknesses and potential harms of a universally accepted MEDD as outlined in the CDC Guidelines, and describe the pseudoscience on which they are based

• Recognize new software technologies that integrate comprehensive risk assessments into the patient record to evaluate and mitigate risks, including quantification of OIRD, urine monitoring interpretation and naloxone access

Jeffrey Fudin, Pharm.D., DAAPM, FCCP, FASHP, Diplomate, Academy of Integrative Pain Management

3:00 Close Conference

Previous Attendee Acclaim:

“Great conference, very informative and multifaceted perspective on ADF, very impressed. Excellent source of current ADF considerations and technology

from diverse perspectives.” — Formulator, Lannett Company

“The best CBI conference I’ve attended.” — Vice President, Collegium Pharmaceuticals

“It was a well organized conference that brings together KOLs and a broad audience.” — International Project Leader, Grünenthal

“Enjoyed the conference and networking” — CSO, Camargo

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SCAN HERE

CBI 70 Blanchard Road Burlington, MA 01803

A division ofUBM Americas

ABUSE-DETERRENT FORMULATION SUMMIT PC17298

VENUE: Embassy Suites by Hilton Old Town 1900 Diagonal RoadAlexandria, Virginia 22314Phone Reservations: (800) 445-8667Hotel Direct Line: (703) 684-5900

ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to:

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Book Now! The Embassy Suites by Hilton Old Town 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 Onsite Conference $1999 $2299 $2399

Register by January 27, 2017 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. 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.

GROUP RATE: Looking to bring your team? Contact Information Services to learn about potential group savings. Call 800-817-8601 or email cbireg@cbinet.com.

* 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. All 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. Cancellation of a conference due to events beyond our control* are subject to a $399 administrative charge should you or a colleague be unable to attend the rescheduled date. 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. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI.

*Events beyond our control include: severe weather conditions, natural and man-made disasters and any other similar events.

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Achieve ADF Labeling • Reduce Abuse Potential • Integrate Technologies to Support Deterrence

MARCH 7-8, 2017 • EMBASSY SUITES BY HILTON OLD TOWN • ALEXANDRIA, VA

ANY QUESTIONS OR TO REGISTERCONTACT: Christian Alongi

phone 339-298-2131 email christian.alongi@cbinet.com