Your Local Conference Co-Sponsored by the

FDA Los Angeles District

Learn Regulatory Best Practices in FDA Regulated Industries

from Industry Experts and Regulators

Medical Devices/IVDs

Drugs and Biologics

Dietary Supplements

Clinical Trials

It only happens once a year!

Early Bird Pricing Extended to April 20!

We hope to see you in May.

19th Annual

The Emerging Regulatory Landscape

Orange County Regulatory Affairs and FDA Los Angeles District

FDA-OCRA Educational ConferenceMay 5-6, 2016 NEW LOCATION Westin South Coast Plaza

http://www.ocra-dg.org/

REQUESTED SPEAKERS MODERATOR SYNOPSIS7:00-8:00 AM Registration and

Continental Breakfast

8:00-8:30 AM Opening Remarks

Evelyn De La Vega, Sr. Manager, Regulatory Affairs, Bausch + Lomb

Steven Porter, Acting Director, FDA Los Angeles District

Kimberly Ricks, Manager, Health Science Information, Herbalife

8:30-9:15 AM

FDA Keynote Presentation: CDRH Update and Strategic Plans for 2016

William Maisel, MD, MPH, Deputy Director of Science and Chief CDRH Scientist, FDA (remote presentation)

Ray Brullo, DPM, Compliance Officer, FDA Los Angeles District

9:15-9:30 AM Break

9:30-10:30 AM Fast Track Approvals for Drugs and Devices

Michael Swit, Esq, Senior Director, Legal and Regulatory, Illumina

Trudy Papson, President, Regulatory Consultants Group (former FDA Investigator)

Fast Track Approvals is the FDA’s approach to get important new drugs and devices to patient's earlier. Presented by Michael Swit, Esq., this overview is designed to facilitate the development and process of the Fast Track approvals. FDA's decision within sixty days, may be based on whether the product fills an unmet medical need in a serious condition. Learn about what works and the current rationale.

10:30-11:30 AM

Due Diligence: The Regulatory, Quality, and Clinical Challenges Posed by Transactions Involving Highly-Regulated Biotech Products and Companies

Speakers InvitedMichael Swit, Senior Director, Legal and Regulatory, Illumina

How to handle the difficult scientific and legal issues underlying the regulatory clinical and quality aspects of due diligence involving biotech products and companies.

Transactions involving FDA-regulated firms or products present unique challenges for professionals less familiar with the intricate regulatory, quality, and clinical considerations generated by the deal. This session will explore how to prepare and execute due diligence efforts , including how to separate the essential from the “nice-to-know” in conducting such reviews often with limited resources and subject to tight time lines. Attendees also will hear about other key issues involved in due diligence and learn how to organize internal teams so as to maximize efforts to help management decide if a deal is “GO!” or “no go.”

11:30 AM-12:30 PM

FDA and Government Compliance Panel Discussion

Amanda Bettinelli, Assistant United States Attorney, US States Attorney's Office, US Department of Justice

Other Panelists Invited

Kim Walker, MS, RAC, Global RA and QA Consultant, Kim Walker Consulting

Government officials will participate in a Compliance Panel discussion. Prior to the conference, OCRA will be reaching out to attendees for questions to the panel.

12:30-1:30 PM Lunch

FIRST DAY - Thursday, May 5, 2016

May 5-6, 2016 at The Westin South Coast Plaza, 686 Anton Blvd., Costa Mesa, CA 9262619th Annual FDA-OCRA Educational Conference: The Emerging Regulatory Landscape

Plenary Sessions - Thursday, May 5, 2016

Conference Chair: Kimberly Ricks, Manager, Health Science Information, Herbalife International)

1:30-2:30 PM

Next Generation of Trial Design and FDA Regulations on Personalized Medicine

Razelle Kurzrock, MD, Senior Deputy Center Director, Clinical Science Director, Center for Personalized Cancer Therapy, UC San Diego Moores Cancer Center

You Li, PhD, Scientific Reviewer, Division of Molecular Genetics and Pathology, Office of In vitro Diagnostics and Radiological Health, CDRH, FDA

Lei Zhang, PhD, Global Executive Director, Clinical Development, Zensun USA, Inc.

Dr. Kurrzrock will discuss "Precision Medicine and Next Generation Trial Design:Implications of Biomarkers for Predicting Response and Toxicity"

Precision cancer medicine entails tailoring therapy to the distinct and complex molecular portfolio of each patient and their tumor. Its execution is being enabled by disruptive technological innovations with the rapid emergence of sophisticated "omic" platforms, as well as the increasing availability of compounds that precisely target genomic defects and/or the immune system.

Our recent results show that, amongst 439 patients with metastatic solid cancers, 98.4% were molecular singletons (malignant “snowflakes”), reflecting the inimitability of advanced tumors. Similarly, the host is also complex and unique, a fact that is key to understanding immune responsiveness and susceptibility to toxicity.

In light of these observations, the canonical paradigms for clinical research/practice are a poor fit for the complicated reality that genomics has unveiled. Traditional modes of clinical research/practice are drug centered, with a tactic of identifying commonalities between patients so that they can be grouped together and treated similarly. However, if each patient with metastatic cancer has a unique molecular fingerprint, a new patient-centered approach that deploys individually customized, combination therapy is required.

Herein we will discuss the following strategies for optimization of precision medicine in cancer:1. Fully interrogate the omic underpinnings of both the patient and their tumor.2. Provide individually tailored, combination therapy to patients with complex molecular landscapes.3. Apply the principles of precision medicine earlier in the disease course, preferably at the time of diagnosis, before the tumor has had a chance to evolve and metastasize.4. Move from a drug-centered to a patient-centered, N-of-one treatment approach.

You Li, PhD will present "Regulation of Molecular Dx Devices for Personalized Medicine"

As part of the Precision Medicine Initiative (PMI), FDA is actively engaged to develop a regulatory pathway to advance innovation in precision medicine and protect public health with sufficiently flexible standards to assess performance of In vitro diagnostic Devices. This talk will provide a summary on Molecular Dx devices for personalized medicine, key components to evaluate during Molecular Dx device submission review and a brief update PMI and Precision FDA.

2:30 - 2:45 PM Ice Cream Break

Clinical Trials Breakout Sessions - Thursday, May 5, 2016 (Session Chair: Lei Zhang, PhD, Global Executive Director, Clinical Development, Zensun USA, Inc.)

2:45-4:00 PMClinical Quality System, and Data Integrity

Greg Bennett, MSEd, Director, Global Clinical Operations, Transcend Medical, Inc.

Larry Shen, PhD, pStat®, Senior Statistical Advisor, President & CEO, Pharmapace, Inc.

Ginger Clasby, VP - Clinical & Regulatory Affairs/Quality Assurance, Transcend Medical, Inc.

Greg Bennett's presentation is "Clinical Quality System and its Ulitlity for Clinical Trial Management."

Close monitoring and management of clinical trials from the beginning to end a key component of success. A strong quality system to oversee the monitoring and management of the clinical trial is a vital factor for ensuring the strength of the trail. The prospective approach to quality increases the utility of the entire trial. Quality site selection, robust training for site staff, eligibility review and approval prior to enrollment, study coordinator support, monitoring process oversight, and close data review provide the foundation for data integrity and good inspection outcomes. The presentation will address one company’s clinical quality system that resulted in excellent inspection outcomes for data integrity and clinical study records.

Dr. Shen's presentation will be on "How to Prevent Rescue of Data and Analyses in Your Clinical Trials."

In this presentation he will share some of his observations of quality issues associated with data and analyses in drug development programs. It is well known that the most expensive step in drug development is usually to conduct human experiments in the form of clinical trials to collect efficacy and safety information. This step often costs hundreds of million dollars and is associated with a high failure rate. The end product of this step is clinical data that can be analyzed to draw conclusions about safety and efficacy of the drug candidates, for submissions to regulatory agencies for market authorization, and for writing prescription information.

There have been numerous examples that sponsors choose to cut corners in order to save costs, which had led to poor data quality and inferior statistical analyses that resulted in wrong conclusions, or inclusions in many cases. It often costs more and incur delays to rescue these projects. He will provide some examples and address the right approaches to data and analysis quality to prevent the need for rescue.

4:00-5:15 PMEU Clinical Trials:New Regulations and Operations

Helene Lamielle, MD, MBA, Executive Strategic Consultant, HLaConsulting

Karen Hill, Senior Vice President, Global Therapeutic Leader, Cardiovascular & Late Phase, Worldwide Clinical Trials

Kim Walker, MS, RAC, Global RA and QA Consultant, Kim Walker Consulting

Dr. Lamielle will present "How ICH Guidelines and EU Regulation Changes Will Affect Clinical Trials"

Karen Hill will present "Practical Considerations to Execute Clinical Trials in Europe to Support FDA Submissions"

On April 28, 2008, the FDA amended its regulations on the acceptance of foreign clinical studies not conducted under an IND as support for a “marketing application”. The final rule requires such studies be conducted in accordance with GCP, including review and approval by an independent ethics committee and informed consent from subjects.

But how practical is this to implement and what exactly is required?

Using a case study you will learn how foreign clinical data obtained from Europe, especially Eastern Europe, can support clinical investigations and marketing approvals in the US; and how some sponsors even seek to rely exclusively on foreign clinical data to support their INDs. The trend is that the number of INDs and applications for marketing approvals supported by foreign clinical trials has increased in recent years and will likely continue to increase in the future.

Although clinical research is becoming global, it presents challenges to the US regulators. Restrictions limit the number of foreign clinical site inspections that can be conducted, so how can we make our EU data matter? Some practical considerations will be shared with audience.

1:30-2:45 PM

FDA Update followed by Dietary Supplement Panel Discussion with Industry Experts

FDA InvitedCameron Smith, Senior Director, Counsel, Herbalife

The panel will answer these key questions for the industry. 1. What are the most overlooked elements of study design to support supplement claims?2. How do you market products to consumers who don’t know much of anything about science?3. How do you integrate supplement products into a wellness program?4. What needs to change in current regulation for supplements to deliver more value to consumers?5. What would immediately change if pre-market approval of supplement products were legislated?6. Is there any room for first-amendment arguments to open the market to more aggressive supplement claims?

2:45-3:00 PM Ice Cream Break

3:00-4:15 PMInteractive Workshop: Hands on Claims/Benefits

Industry Leaders InvitedCameron Smith, Senior Director, Counsel, Herbalife

Teams will be tasked to work up draft claims/benefits language after reviewing some hypothetical facts. We will work on two separate products.

4:15-5:15 PM Alternative Pathways for Regulation Speakers Invited

Cameron Smith, Senior Director, Counsel, Herbalife

A critical examination of the EFSA claims assessment model and the Canada NHP regulatory model as ways to improve the quality or value of supplements to the end consumer.

5:30-8:00 PM

Dietary Supplement Breakout Sessions - Thursday, May 5, 2016 (Session Chair: Cameron Smith, Senior Director, Counsel, Herbalife)

Attendees Invited to a separate event, OCRA's Member Appreciation Night with OCRA Members serving Appetizers and Drinks

7:00-8:00 AM Continental Breakfast

8:00-9:15 AM

Changes in EU Medical Device Regulation: The Notified Body Perspective

Peter Havel, PhD, Senior Vice President, MHS Global and Regional Director MHS, TÜV SÜD America Inc.

Tammy Vu, RAC, Senior Regulatory Affairs Specialist, Abbott Medical Optics Inc. (AMO)

Regulatory experts need to be prepared as early as possible for the upcoming regulation changes in Europe. The message was clear - change is underway in the EU and the medical device industry needs to be ready sooner than anticipated. Learn about the status of the current discussions and the remaining regulatory options in the EU Commission, Parliament and Council in anticipation of a possible final decision in 2016. Topics covered both near-term and long-term changes in key requirements critical to demonstrating compliance to existing directives and impending changes as proposed. Contribute to discussions on the status of preparations in the industry and within Notified Bodies, the impact of these changes and how to make relevant decisions.

9:15-10:30 AM 2016 Changes to ISO 13485

John Bis, VP Healthcare Solutions, BSI

James R. Lusk, RAC, Principal, Quality Systems International (QSI)

Do you know that major changes are coming to ISO 13485? Should we also expect subsequent adoption by the European Union (EN ISO…). What about new requirements and more procedures? There are more. This session will provide you with the current status of the changes, the major changes, how to revise the Quality System to support the changes, and with a lot of hope, help you to revise your Quality System two minutes before it must be done.

10:30-10:45 AM Break

10:45-NoonCybersecurity Threats in the Medical Device World

Marcel Hill, Global Director, IoT Services, Intertek

Seth Carmody, Staff Fellow, CDRH, FDA (remote presentation)

Shep Bentley, RAC, President, Bentley Biomedical Consulting, LLC

Paul Kramsky, President, Rockin' Regulatory, Inc.

With the increased use of wireless technology and software, medical devices that are connected to the Internet, hospital networks, and to other medical devices are becoming more vulnerable to cybersecurity breaches, potentially impacting the safety and effectiveness of these devices. The threat is real, as evidenced by a number of recent instances, such as the hacking of implantable insulin pumps reported in 2011, the temporary closure of a Veteran’s Administration Catheter Lab in 2014 caused by malware infected computers used in cardiac procedures, and more recently, confirmation of the potential for remote access of Hospira infusion systems through a hospital’s network.

Because cybersecurity threats cannot be completely eliminated, manufacturers, hospitals and facilities must work to manage them, and this can be especially challenging. As part of its ongoing efforts to protect the public health from cybersecurity vulnerabilities and maintain a balance of protecting patient safety while using innovative technologies, the FDA held a public workshop in October 2014 to seek input from the health care and public health sector on medical device and health care cybersecurity. Very shortly after this workshop, FDA held a webinar and issued two guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software. This program, featuring experts from both FDA and industry, will report on the latest developments in the cybersecurity of medical devices and provide manufacturers with steps they can take to proactively support the safety and effectiveness of their medical devices in this bold new cyber world.

The FDA speaker will speak on Goals and Current Status of the Collaborative Efforts of the FDA.

SECOND DAY - Friday, May 6, 2016

Medical Device Breakout Sessions - Friday, May 6, 2016 (Session Chair: Chris Posin, RAC, Consultant)

19th Annual FDA-OCRA Educational ConferenceMay 5-6, 2016 at The Westin South Coast Plaza, 686 Anton Blvd., Costa Mesa, CA 92626

8:00-9:15 AM Biologics and Quality by Design

FDA Speaker invited

Christopher Watts, Founding Partner, Volpal

Cindy Fisher, PhD, Director, Regulatory Affairs, Vical Incorporated

The first half of this session will examine the application of statistical quality control techniques to ensure the quality of biological products. The second half will cover the applicability and incorporation of quality by design concepts in the management of development and risk in biologics manufacture.

9:15-10:30 AM Quality Metrics in Pharmaceuticals

FDA Speaker Invited

Cylia Chen, Sr. Manager, Amgen

Amy Stanton, Quality Systems Specialist, Amgen

10:30-10:45 AM Break

10:45-Noon Smart Scale-Up Strategies

Rachel Novak, Staff Fellow, FDA

Ruchika Raval, President, Global Biopharm Regulations Inc.

During the Drug Development Process, variations typically exist between early-phase clinical trial material and materials used in Phase III and subsequent market launch. Without a carefully developed scale-up plan, the materials may be so different from one another that the Agency asks the Sponsor to conduct a comparability study before launch, which adds delay and cost to the program. How can Regulatory and Development groups collaborate to reduce the burden? What are some key principals, methodologies, and best practices to minimize the risk?

Noon End of ConferenceOCRA (Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612. Contact Kimberly Syre with any questions: ksyre@cox.net or 949-387-9046

Drugs & Biologics Breakout Sessions - Friday, May 6, 2016 (Session Chair: Cindy Fisher, PhD, Director, Regulatory Affairs, Vical Incorporated)

Step 1: Click on this link: http://www.ocra-dg.org/

Step 2: From the Home Page, enter your user name and password in the two empty fields to the right of the ocean graphic if you have an exist-ing account on our site. If you do not yet have an account, select “sign up” to create a new account. Immediately log in with your user name and password OR Create a new account by selecting “Register” on the top right hand side. If you are not an OCRA Member, it will ask you to join. Please keep in mind that to attend any OCRA meeting, we require you to become a Member.

If you do not know your user name or password, click on “Forgot login?” and follow the steps.

Step 3: Once you have logged on (and paid for membership) select the meeting you would like to attend (See Home Page near the bottom right side of the ocean graphic. Once on the page for the event, scroll to the bottom and click “Register Now!”. Complete the registration process by filling in the appropriate fields.

NON MEMBERSIf you are not an OCRA Member, we require you to join OCRA before registering for this meeting. To join OCRA go to this link: http://www.ocra-dg.org/. Once you have paid for membership, follow the instructions above to register.

MULTIPLE REGISTRATIONS:Our system is set up for one registration at a time. To register multiple people from your company, you can simplify the process by faxing us a cover page on your company letterhead listing the names of your attendees along with their title and email address. Supply a credit card number and expiration date or let us know that a check will be mailed (checks should be received prior to the event). If you need a receipt, please let us know to whom it should be emailed.

To Register With Company or Personal Check: Please submit the online registration form. Mail your check made payable to OCRA to the following address:

Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612Tel: 949-387-9046 Fax: 949-266-8461 Email: ksyre@cox.netOCRA’s non-profit Federal Tax ID# 33-0630455

Cancellation Deadline:For a refund, please email your cancellation request to Rob Fleming (rob.fleming@yahoo.com) by April 22, 2016.

NOTE: If you have reserved a space but do not attend, your payment MUST be remitted. We will ask for a credit card pay-ment for any checks not received by the meeting date.

Group Registrations: This conference is priced to break even, as such, we do not offer discounts for group registrations. Please com-plete the registration form for each attendee.

We also accept faxed registrations. See registration form on the next page.

Venue: The Westin South Coast Plaza686 Anton Blvd., Costa Mesa, CA 92626714-540-2500 - Free shuttle from John Wayne Airport (SNA)http://www.westinsouthcoastplaza.com/Special OCRA Rate $189 single/double occupancy. Reserve by April 13, 2016.https://www.starwoodmeeting.com/Book/FDAOCRAEducationalConferenceDirections:From Los Angeles: Take 405 South, Exit at Bristol. Turn Left on Bristol, Right on Anton, Left on Park Center Dr. Hotel on the Left.From San Diego: Take 5 North to 405 North. Exit at Anton Blvd. Turn Left on Anton. Turn Right on Park Center Dr. Hotel on the Left.

RegistRation instRuctions

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference

Please Provide Complete Contact Information for Each Attendee:

FIRST NAME: LAST NAME:

COMPANY: TITLE:

ADDRESS:

CITY/STATE/ZIP:

PHONE: __________________________________________E-MAIL: _________________________________________________

Vegetarian Meal Requested or List Other Dietary Restrictions:

Please Select Your Breakout Sessions (you can switch sessions at the conference if needed):

May 5 _______Clinical Trial Breakout Sessions _______Dietary Supplements Breakout Sessions

May 6 _______Medical Device/IVD Breakout Sessions _______Drugs and Biologics Breakout Sessions

Registration Fee includes the following: Access to available speaker presentations to download prior to the conference (some will be sent after the conference, breakfast, lunch on first day, breaks and parking.

Please check type of card: ______Visa ______ Master Card ______ American Express

Card #: Exp Date:

Name on Card:

Signature: Name badges and receipts will be provided at the on-site registration desk. If you would like a receipt prior to the event, please use the On-Line or Pay Pal payment option.

Early Bird Registration Rate (If Paid by April 20)_______$ 725 - OCRA Members_______$ 775 - Non-members (includes OCRA membership for one year)_______$ 475 – FDA/Government/Students* (rate not available for online registration, please fax this form)_______$ 475 - Thursday Only - For Dietary Supplement Industry Attendees Only

Regular Registration Rate (After April 20)_______$ 775 - OCRA Members_______$ 825 - Non-members (includes OCRA membership for one year)_______$ 475 – FDA/Government/Students* (rate not available for online registration, please fax this form)_______$ 475 - Thursday - For Dietary Supplement Industry Attendees Only

* Student Rate is for individuals enrolled full time in a Regulatory or Quality related academic program at an accredited institution. The Student Rate does not apply to working professionals taking one or two courses on the side. Student ID and copy of current class schedule are required to register at this rate. Final eligibility determined by OCRA. We do not offer online registration at this rate as it requires approval. Please fax this form with payment and items described above (if applicable).

**The one day rate is available for those attending the Dietary Supplements breakout.

RegistRation FoRm

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference

OCRA (Orange County Regulatory Affairs Discussion Group, 5319 University Dr., Suite 641, Irvine, CA 92612Contact Kimberly Syre with any questions: ksyre@cox.net or 949-387-9046

The Westin South Coast Plaza 686 Anton Blvd., Costa Mesa, CA 92626714-540-2500 Free shuttle from John Wayne Airport (SNA) http://www.westinsouthcoastplaza.com/

Special OCRA Rate $189 single/double occupancy

Extended Deadline for Room Reservations April 20

Reserve Your Room Online:https://www.starwoodmeeting.com/Book/FDAOCRAEducationalConference

Driving Directions to Westin South Coast Plaza

From Los Angeles:Take 405 South,Exit at Bristol.Turn Left on Bristol.Turn Right on AntonTurn Left on Park Center Dr.Hotel will be on the Left.

From San Diego:Take 5 North to 405 North.Exit at Anton Blvd. Turn Left on Anton.Turn Right on Park Center Dr.Hotel will be on the Left.

It is recommended that you look up driving directions from your own starting point.

about the Venue

Orange County Regulatory Affairs and FDA Los Angeles District Presents

2016 FDA-OCRA Educational Conference