Course "Regulatory, Technical and Partnership Management Challenges in the Co-development of Drugs and Diagnostics" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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
Session Start Time: 9:00 AM

  1. Introduction of facilitator and workshop participants
  2. Workshop agenda and objectives
  3. Problem statement: challenges and opportunities in the co-development of Rx and Dx
  4. Attributes, business needs and challenges of the major stakeholders
    1. Large biopharm
    2. Small biotech
    3. Large CROs
    4. “Niche” service providers
    5. Diagnostic developers and manufacturers
    6. Academic/government research centers and research cooperative groups
    7. Regulators
    8. Payers (PBMs, health insurers, government)
    9. Prescribers/health care delivery players
    10. Patients
  5. Key developments in translational science that impact the co-development of Rx and CDx
  6. Requirements and challenges in Rx and CDx development
    1. Access to patients, data and specimens
    2. Integrating molecular markers into clinical trials
    3. Fit for purpose analytical platforms that include rapidly evolving enabling technologies
    4. Solid tissue translational biomarker development and application
    5. Diagnostic development, registration and commercialization
  7. Breakout session #1
  8. Readout of breakout session groups

  1. Review of day one and objectives for day two
  2. Factors critical for the successful co-development of drugs and diagnostics
    1. Intellectual property rights
    2. Informed registration strategy
    3. Access to human specimens
    4. Effective strategic partnership development and management
    5. Organizational effectiveness
  3. The regulatory science of co-developing Rx and CDx
  4. Challenges in the development and management of enabling strategic partnerships for CDx development
  5. Breakout session #2
  6. Readout of breakout session groups
  7. Highlights and takeaways of workshop

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.

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Boston, MA, Local Attractions

Philadelphia, PA, Local Attractions

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

The Philadelphia Museum of Art sits majestically on a rise at the end of the Benjamin Franklin Parkway. The vast collections of this temple of art make it the third-largest art museum in the country, and an absolute must-see on the city's cultural circuit.

Among its impressive holdings in Renaissance, American, Impressionist and Modern art, some standouts include a great Rogier van der Weyden altarpiece, a large Bathers by Cezanne, a room devoted to Philadelphia's own Thomas Eakins, and Marcel Duchamp's notorious mixed-media Bride Stripped Bare by her Bachelors (The Large Glass), exactly as the dada master installed it.

With more than 3,600 acres of rolling hills and well-worn trails, Valley Forge is now a magnet for runners, bicyclists and picnickers as well as history buffs.

The vast expanse of open space links the Schuylkill River Trail to the Horse Shoe Trail, turning the park into a major hub in a 75-mile system linking Philadelphia to the Appalachian Trail.

The Liberty Bell has a new home, and it is as powerful and dramatic as the Bell itself. Throughout the expansive, light-filled Center, larger-than-life historic documents and graphic images explore the facts and the myths surrounding the Bell.

The 160,000-square-foot National Constitution Center explores and explains this amazing document through high-tech exhibits, artifacts, and interactive displays. The Kimmel Theater, a 350-seat star-shaped theater, features “Freedom Rising,” a multimedia production combining film, a live actor and video projection on a 360° screen to tell the stirring story of “We the people.”

An innovator in designing hands-on exhibits before “interactive” became a buzzword, The Franklin Institute is as clever as its namesake. Its eminently touchable attractions explore science in disciplines ranging from sports to space.

Highlights include The Sports Challenge, which uses virtual-reality technology to illustrate the physics of sports; The Train Factory's climb-aboard steam engine; Space Command's simulated earth-orbit research station; a fully equipped weather station; and exhibits on electricity.

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