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Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.

This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing this course participants should have an understanding of:

  • Fundamentals of stem cells
    • What is all the excitement about
    • How to control stem cell differentiation
    • Sources of stem cells
    • Incorporating stem cells into biomaterials
    • Avoiding immune system clearance of stem cells
  • FDA regulatory approvals for the use of stem cells in medicine
    • Currently approved use of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Global approval of stem cell technologies
    • How the FDA regulates regenerative treatments and therapies
    • The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
    • The drug and biological approval process
    • Regenerative products as medical devices
    • How to design appropriate clinical trials
    • Applicable good manufacturing and good laboratory practices
    • Product labeling, marketing and advertising
    • FDA and other federal agency enforcement action
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Remaining hurdles
    • Outlook for new technologies

Who will Benefit:

This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and private labelers
  • Contract manufacturers
  • Importers and custom agents
  • U.S. agents of foreign corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal professionals
  • Financial advisors and institutional investors
  • Patent lawyers
  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Fundamentals of stem cells
    • Definitions
    • What is all the excitement about
    • How to control stem cell differentiation
    • Sources of stem cells
    • Incorporating stem cells into biomaterials
    • Avoiding immune system clearance of stem cells
    • Research examples pre-clinical approval
    • Research examples post-clinical approval
  • FDA regulatory approvals for the use of stem cells in medicine
    • Currently approved use of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Global approval of stem cell technologies
Day 02(8:30 AM - 4:30 PM)
  • FDA regulatory approvals for the use of stem cells in medicine (continued)
    • How the FDA regulates regenerative treatments and therapies
    • The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
    • The drug and biological approval process
    • Regenerative products as medical devices
    • How to design appropriate clinical trials
    • Applicable good manufacturing and good laboratory practices
    • Product labeling, marketing and advertising
    • FDA and other federal agency enforcement action
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Remaining hurdles
    • Outlook for new technologies
    • Strategies for commercializing stem cell technologies
  • Questions
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Debra Webster

Debra Webster,
Principal Scientist, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences | Ex-FDA Professional (Reviewing Pharmacologist)

Debra Webster, PhD, is Principal Scientist, Regulatory Affairs and Product Development, for Cardinal Health Regulatory Sciences. She began her regulatory career at the FDA and has more than 25 years of experience in drug development, focusing on nonclinical toxicology and proof-of-concept. Dr. Webster is responsible for nonclinical and regulatory consulting to guide products from pre-Investigational New Drug (pre-IND) application interactions with the FDA to New Drug Application (NDA) and Biological License Application (BLA) approval.

Prior to joining Cardinal Health, Dr. Webster was a medical writer at Quintiles, where she authored clinical study reports and nonclinical sections of INDs. Previously, she was in private practice, where she authored summaries of nonclinical data to support due diligence and regulatory submissions. Dr. Webster worked for the FDA in the Center for Food Safety and Nutrition, where she evaluated color and food additive petitions. Subsequently, she was a pharmacology/toxicology reviewer in the FDA Division of Antiviral Drugs in the Center for Drug Evaluation and Research, where she received the Commissioner Frank E Young Appreciation recognition for her role in the approval of Foscarnet.

Dr. Webster received a doctorate degree in pharmacology and toxicology at Virginia Commonwealth University, Medical College of Virginia. She received a bachelor’s degree in biology from Virginia Polytechnic and State University, where she graduated with honors and worked as a research associate in the anaerobic microbiology laboratory.

David A. Cummings

David A. Cummings,
RAC, Director, Scientific and Regulatory Consulting

David A. Cummings is Director, Chemistry, Manufacturing and Controls (CMC), for Cardinal Health Regulatory Sciences. He is responsible for scientific and regulatory consulting activities associated with pharmaceutical and biological product development, regulatory affairs strategy development, participation in FDA meetings, preparation of investigational and marketing applications for small molecules and biologics, good manufacturing practice qualification audits and good laboratory practice audits.

Cummings has more than 24 years of experience with development and regulatory affairs of small molecule and biologic products. His biologic experience includes viral antigens, enzymes, monoclonal antibodies, gene therapy products and therapeutic proteins. Prior to joining Cardinal Health in 2008, Cummings worked in several product development and regulatory affairs roles with Chiron Corporation, Gen-Probe, Collateral Therapeutics and Peregrine Pharmaceuticals.

Cummings received a bachelor’s degree in molecular, cellular and developmental biology from the University of Colorado and worked in the laboratory of Dr. Richard G. Ham. Cummings received regulatory affairs certification (RAC) in 2001.

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October 19-20, 2017

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Testimonials

See What People Say About Us

Presenters were encased & open to discussions.

Compliance Director,

Regenerative Medicine Solutions

It was very helpful high level view of historical changes and the new provisions created to support new science.

Manager,

Bluebird Bio

I really enjoyed this conference as I am new to the regenerative medical space & found this was a great source to get up to speed on how FDA is currently reviewing this space.

Associate Product Manager,

Zimmer Biomet

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Local Attractions of Newark, NJ

Newark Museum:

Newark Museum:

The Newark Museum, in Newark, Essex County, is the state's largest museum. It holds fine collections of American art, decorative arts, contemporary art, and art from Asia, Africa, the Americas, and the ancient world. Its extensive collections of American art include works by Hiram Powers, Thomas Cole, John Singer Sargent, Albert Bierstadt, Frederick Church, Childe Hassam, Mary Cassatt, Edward Hopper, Georgia O'Keeffe, Joseph Stella, Tony Smith and Frank Stella. The Newark Museum's Tibetan galleries are considered among the best in the world. The collection was purchased from Christian missionaries in the early twentieth century.

Prudential Center

Prudential Center:

Prudential Center is a multi-purpose indoor arena in the central business district of Newark. Opened in 2007, it is the home of the National Hockey League's (NHL) New Jersey Devils and the NCAA's Seton Hall Pirates men's basketball team. The arena seats 16,592 patrons for hockey and 18,711 for basketball. Fans and sports writers have affectionately nicknamed the arena "The Rock" in reference to the Rock of Gibraltar, the corporate logo of Prudential Financial, a financial institution that owns the naming rights to the arena and is headquartered within walking distance. In December 2013, the arena ranked third nationally and ninth internationally for self-reported annual revenue. It is located two blocks from Newark Penn Station in downtown Newark, just west of Newark's Ironbound district, making it easily accessible via New Jersey Transit, PATH, Newark Light Rail, and Amtrak.

Branch Brook Park

Branch Brook Park:

Branch Brook Park is a county park of Essex County, located in the North Ward of Newark, between the neighborhoods of Forest Hill and Roseville. A portion of the park is also located within the Township of Belleville. At 360 acres, Branch Brook Park is the largest public park in the city of Newark. The park is noted for the largest collection of cherry blossom trees in the United States, with over 4,300 in more than fourteen different varieties collectively called Cherryblossomland, as well as its spectacular Cherry Blossom Festival each April. The festival attracts approximately 10,000 visitors each April. During World War II, the park's grounds served a tent city for recruits, as well as a landing strip for airplanes of the United States Postal Service. To the park’s east is the Cathedral of the Sacred Heart Basilica, one of the largest cathedrals in the United States.

Cathedral Basilica of the Sacred Heart

Cathedral Basilica of the Sacred Heart, Newark, New Jersey:

The Cathedral Basilica of the Sacred Heart, the fifth-largest cathedral in North America, is the seat of the Roman Catholic Archdiocese of Newark. It is located at 89 Ridge Street in the Lower Broadway neighborhood of Newark, New Jersey. Envisioned as a fitting monument to the faith, construction began in 1899 and was finished in 1954. The original design called for an English/Irish-gothic church, but plans were later modified in favor of a French-gothic style. The Cathedral Basilica holds concerts open to the public throughout the year and it has the largest pipe organ ever built by the Schantz Organ Co. which includes 154 ranks playable from two consoles.

Newark Symphony Hall

Newark Symphony Hall:

Newark Symphony Hall at 1020 Broad Street in Newark, Essex County, New Jersey, was built in 1925 and added to the National Register of Historic Places in 1977. Originally built by the Shriners at a cost of more than $2 million as Salaam Temple and colloquially known as The Mosque, the four-story building has been Newark Symphony Hall since 1964. The interior features Greek and Egyptian motifs, marble columns, a crystal chandelier, gold-leaf fret work and two-columned side promenades. The neo-classical building was design by Frank Grad, a prominent Newark architect, whose work includes the Lefcourt Newark Building and many others downtown. The 3,500-seat main concert hall is named for Sarah Vaughan, a native Newarker, and is renowned for its acoustics.

Military Park

Military Park:

Military Park is a 6-acre city park in downtown Newark. It is a nearly triangular park located between Park Place, Rector Street and Broad Street. From 1667, when the city was planned, until 1869 it was a training ground for soldiers. In 1869, it became the town commons. The New Jersey Historical Society, Military Park Building and the New Jersey Performing Arts Center are located across Park Place from the park. A $3.25 million renovation was announced in February 2012 and the park reopened in June 2014.

John Ballantine House

John Ballantine House:

The John Ballantine House was the home of Jeannette Boyd (1838–1919) and John Holme Ballantine (1834–1895). John was the son of Peter Ballantine, founder of the Ballantine beer brewery, and became president of the family business in 1883 after his father died. The house was built in 1885 at 49 Washington Street in the Washington Park section of Newark, Essex County, New Jersey. It is now part of the Newark Museum and is open to the public for tours.

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