August Event: Companion Diagnostics: Building a Successful Regulatory Strategy
July 26, 2018
Monthly Program:
Wednesday, August 15th, 2018
Companion Diagnostics: Building a Successful Regulatory Strategy
Program Speaker:
Brad Fox, BSME, MSML
Founder and President, Fox Consulting Network, LLC
Event Agenda:
Date:
Wednesday, August 15th, 2018
Time:
5:15 – 6:00 PM Registration & Snacks
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A
LOCATION:
BD (former CareFusion)
3770 Torrey View Court
San Diego, CA 92130
View Map
Program Topic:
With the growth of Personalized Medicine and the rapid pace of targeted therapies, the drug development process often relies on a Companion Diagnostic (CoDx). The FDA defines a CoDx as an in vitro diagnostic medical device that provides information deemed essential for the safe and effective use of a corresponding drug or biological product. The CoDx helps health care professionals determine if a potential therapy’s benefits outweigh the risks for an individual patient. Importantly, most new targeted therapies will not be approved by the FDA without a CoDx. Come learn key considerations for the development and regulatory approval of CoDx technologies.
Program Summary:
This talk will provide an overview of crucial CoDx product development and regulatory information to provide a systematic and successful approval process, including:
Historical perspective of Companion Diagnostics
Defining Companion and Complementary Diagnostics
The importance of FDA’s term “contemporaneous development”
Understanding the FDA: Drug and Device Regulatory timelines
Defining the right Regulatory strategy
How to prepare for and leverage FDA meetings on CoDx
The 3 most important take-aways for successful CoDx strategy
Speaker Biography:
Brad Fox: Brad Fox is an experienced and energetic consultant, manager and leadership professional with over 25 years experience in technology commercialization of life science related products. Mr. Fox is the Founder and President of Fox Consulting Network, LLC; a company dedicated to assisting companies and organizations set and meet Regulatory (FDA and CE) plans and objectives. Mr. Fox’s expertise is primarily in medical devices and he has taken an industry leadership role in developing effective Regulatory strategies for Companion and Complementary Diagnostics. Mr. Fox has received a B.S. in Mechanical Engineering and a M.S. in Management and Leadership.
Tom Stergar: Tom Stergar is business development professional with more than 25 years experience connecting people with solutions in the technical and life science services. Early on, Tom started, grew and exited a virtual nutraceutical manufacturing company that served patients in diabetes, immune system enhancement and cholesterol. Using that experience, he grew territories for Safis Solutions as a Director and then Maetrics as a Vice President. Today, he serves as Director of Partnerships for Greenlight Guru. In this role he works with medical device consultants and service providers helping them incorporate the Greenlight Guru QMS software into their service offerings.
Please make your reservation early. The online registration due date is Monday, August 13th, 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door.
Online Pre-registration (through Monday August 13th, 2018):
$15 SDRAN Member, $25 Non-Member
Onsite Registration:
$25 SDRAN Member, $35 Non-Member
For Questions Email: programs@sdran.org
DIRECTIONS:
From the North 5:
I-5 South toward San Diego
Exit toward Carmel Mountain Rd
Left onto Carmel Mountain Rd
Left onto Torrey View Court
Facility is on the right
From the South 5:
I-5 North toward Del Mar
Merge onto I-5 local Bypass
Take Carmel Mountain Rd exit (32)
Turn right onto Carmel Mountain Rd
Turn left onto Torrey View Court
Facility is on the right