Course Description:
This highly interactive course on managing challenges in co-development of drugs and diagnostics led by John C. Bloom, Consultant, Office of the Center Director, FDA, will:
- Review the latest advances in translational science and molecular diagnostics that have impacted drug (Rx) and diagnostics (Dx) development;
- Discuss the regulatory-driven processes for developing, registering and commercializing these products;
- Identify the disparate challenges and attributes of the major stakeholders, including Rx sponsors, Dx manufacturers, service providers, research collaborators and regulators;
- Review the emerging role of strategic partnerships critical for successful Dx/Rx development
- Provide the best practices for developing and managing these partnerships.
Learning Objectives:
Upon completing this course participants will:
- Understand the latest advances in translational science and molecular diagnostics that have impacted Rx and Dx development today.
- Understand the regulatory-driven processes for developing, registering and commercializing Rx and companion diagnostics (CDx).
- Recognize the disparate challenges and attributes of the major stakeholders, including Rx sponsors, Dx manufacturers, service providers, research collaborators and regulators.
- Understand the aforementioned critical success factors for co-developing Rx and CDx,
- Learn about the how the rapid evolution of technical analytical platforms and the dynamic vendor environment provide challenges and opportunities for Rx and Dx sponsors.
- Learn the best practices for developing and managing partnerships through examples and interactive discussion.
Who Will Benefit:
This course is designed for professionals in biopharma, pharmaceutical, diagnostics and biotech companies and clinics. The following personnel will find this session valuable:
- Regulatory executive leadership, managers and scientists
- Clinical scientists
- Biopharm clinical development operations and functional leadership
- CRO business development leadership and associates
- Pharmaceutical services leadership and personnel (large and “niche” CROs)
- Specialty analytical service providers
- Diagnostic company leadership and associates
- Academic and government (NCI, NIH) scientists involved in drug discovery and clinical development
- Regulatory scientists in government agencies
- Patient advocacy group representatives
Topic Background:
Advances in translational medicine, including our understanding of the molecular basis of diseases and the development of sophisticated molecular analytical platforms, have transformed drug (Rx) and diagnostics (Dx) development and have ushered in a new era of personalized medicine. This has propelled the emergence of highly-targeted candidate Rx, strategies for phase-appropriate biomarker-driven Rx and Dx development, and the need to co-develop, register and commercialize these Rx and companion diagnostics (CDx) in an integrated fashion. Key to the success of the latter has been understanding the rapidly-evolving regulatory science that prescribe the use of these technologies and registration process for CDx, and the ability to establish and manage enabling partnerships.
These challenges and opportunities are best exemplified in oncology Rx development, which has been transformed by the now-universal assumption that cancer must be characterized and treated as a genetic disease. The principal understandings that underpin this include 1) the fact that the genes and pathways that govern proliferation, cell death and metastasis are being characterized in the major cancers and patients; 2) the importance of this is now recognized in the context of genetics, epigenetics and the cancer microenvironment as key influences; and 3) the fact that molecular profiling tools have enabled genetic and phenotypic characterization that can be used to predict the response to treatment, stratify clinical trial subjects and identify opportunities for development of a CDx.
As the need for these applications expands, they pose a myriad of technical and logistical hurdles to both Rx/Dx development and patient care. Critical factors for successfully co-developing Rx and CDx include freedom to operate through enabling intellectual property (IP), effective strategic partnership development and management, access to human specimens, and organizational effectiveness with functional/technical expertise alignment. Effective sourcing models for Rx and Dx sponsors will be increasingly critical. The latter is in the context of changes in today’s R& D environment that are driving aggressive outsourcing strategies with emphasis on strategic partnerships as a practical, and sometimes the only, option.
The evolving regulatory science that influences how these challenges are managed is addressed in recent FDA guidances, including that issued on the Qualification Process for Drug Development Tools (January, 2014) and the preceding white paper the Agency issued, “FDA Report on Paving the Way for Personalized Medicine” (October, 2013).
Course Outline:
| Day One (8:30 AM – 4:30 PM) | Day Two (8:30 AM – 12:30 PM) | ||
|
Registration Process: 8:30 AM – 9:00 AM
|
|
Meet Your Instructor
 |
John C. Bloom Consultant, Office of the Center Director, FDA and President, Bloom Consulting Services LLC John C. Bloom is President of Bloom Consulting Services, LLC and Consultant, Office of the Center Director, FDA. In the latter capacity he serves on Drug Advisory Committees and special FDA/NIH project assignments. Dr. Bloom holds a B.S. degree in biology from the University of Pittsburgh and doctorates in veterinary medicine and experimental hematology from the University of Pennsylvania. He completed his postdoctoral training at Jefferson Medical College in hematology/oncology and served on the Faculty of the University of Pennsylvania School of Veterinary Medicine as Chief, Clinical Laboratory Medicine, before joining Smith Kline & French Laboratories as Associate Director of Pathology. He later joined Lilly Research Laboratories as Head, Clinical Pathology, in the Toxicology Division, and subsequently moved to the Medical Division, where he established the departments of Clinical Laboratory Medicine, Experimental Medicine and Clinical Diagnostic Services. As Distinguished Medical Fellow (Executive Director), Diagnostic and Experimental Medicine, he was responsible for routine laboratory, ECG, imaging and specimen banking support for global clinical development; and novel clinical biomarker discovery, validation and application in the Division of Translational Medicine and Pharmacogenomics. In that role he also served as executive sponsor for the development of Lilly’s diagnostic strategy, as part of the Company’s broader Tailored Therapeutics Initiative. Dr. Bloom is a past president of the American Society for Veterinary Clinical Pathology; has authored several manuscripts, chapters, reviews and texts on toxicology and clinical biomarkers in drug development; and served on committees sponsored by the National Academy of Sciences, Institute of Medicine, Society of Toxicologic Pathology and PhRMA. He serves on several Scientific Advisory Committees for pharmaceutical, diagnostic and pharmaceutical services companies and holds adjunct academic appointments at the University of Pennsylvania and Purdue University. |
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
|
|
