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FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies: 2-Day In-person Seminar

By:
DR. Thomas J. Webster, Department Chair and Professor of Chemical Engineering at Northeastern University
Location :-
Courtyard Newark Downtown, NJ
| Thursday, October 20, 2016 | Friday, October 21, 2016

Course "FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

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.



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

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



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




Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4.30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 AM: Session Start

  1. Fundamentals of stem cells
    1. Definitions
    2. What is all the excitement about
    3. How to control stem cell differentiation
    4. Sources of stem cells
    5. Incorporating stem cells into biomaterials
    6. Avoiding immune system clearance of stem cells
    7. Research examples pre-clinical approval
    8. Research examples post-clinical approval
  2. FDA regulatory approvals for the use of stem cells in medicine
    1. Currently approved use of stem cells in medicine
    2. FDA guidance documents for stem cell technologies
    3. Global approval of stem cell technologies

  1. FDA regulatory approvals for the use of stem cells in medicine (continued)
    1. How the FDA regulates regenerative treatments and therapies
    2. The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
    3. The drug and biological approval process
    4. Regenerative products as medical devices
    5. How to design appropriate clinical trials
    6. Applicable good manufacturing and good laboratory practices
    7. Product labeling, marketing and advertising
    8. FDA and other federal agency enforcement action
  2. Future thoughts on approaches for regulatory approval of stem cell technologies
    1. Remaining hurdles
    2. Outlook for new technologies
    3. Strategies for commercializing stem cell technologies
  3. Questions




Meet Your Instructor

DR. Thomas J. Webster,
Department Chair and Professor of Chemical Engineering at Northeastern University

Dr. Thomas J. Webster’s degrees are in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). He is currently the Department Chair and Professor of Chemical Engineering at Northeastern University in Boston. His research explores the use of nanotechnology in numerous applications. Specifically, his research addresses the design, synthesis, and evaluation of nanophase materials (that is, materials with fundamental length scales less than 100 nm) as more effective biomedical devices. He has completed extensive studies on the use of nanophase materials to regenerate tissues and has graduated/supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing B.S., M.S., and Ph.D. students. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles, at least 567 conference presentations, and 32 provisional or full patents. His H index is 47. Some of these patents led to the formation of 9 companies. His research on nanomedicine has received attention in recent media publications including MSNBC (October 10, 2005), NBC Nightly News (May 14, 2007), PBS DragonFly TV (covered across the US during the winter, 2008), and ABC Nightly News via the Ivanhoe Medical Breakthrough Segment (covered across the US during the winters of 2008 and separate research segments in 2010 and 2011). His work has been on display at the London and Boston Science Museums. He is the founding editor-in-chief of the International Journal of Nanomedicine (the first international journal in nanomedicine which in five years has achieved an impact factor of 4.97), serves on the editorial board of 15 additional journals, has helped to organize 22 conferences emphasizing nanotechnology in medicine, and has organized over 53 symposia at numerous conferences emphasizing biological interactions with nanomaterials. He also recently chaired the 2011 Annual Biomedical Engineering Society (BMES) Conference and has organized numerous symposia for AIChE, IEEE, MRS and ASME Annual Meetings. He has received numerous honors including, but not limited to: 2002, Biomedical Engineering Society Rita Schaffer Young Investigator Award; 2003, Outstanding Young Investigator Award Purdue University College of Engineering; 2005, American Association of Nanomedicine Young Investigator Award Finalist; 2005, Coulter Foundation Young Investigator Award; 2006, Fellow, American Association of Nanomedicine; 2010, Distinguished Lecturer in Nanomedicine, University of South Florida; 2011, Oustanding Leadership Award for the Biomedical Engineering Society (BMES); and Fellow, American Institute for Medical and Biological Engineering (AIMBE, representing the top 2% of all medical and biological engineers).






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$1,699.00

Seminar One Registration

October 20-21, 2016, Newark, NJ
(For Registrations till October 5, 2016 - $1699)
(For Registrations after October 5, 2016 - $1899)

$1,999.00

Seminar One Registration (With 2 Nights Stay)

October 20-21, 2016, Newark, NJ

$7,799.00
$10,194.00
You Save: $2,395.00 (23%)*

Special Group Discount Register for Six attendees

October 20-21, 2016, Newark, NJ
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left



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Venue

Location:

Special Offer for the attendees of this seminar:

Rooms available at only USD 159 per night.

You must book by 28th September 2016

Hotel rooms are limited and based on availability



View Larger Map


How to Reach

General Driving Directions:

Driving Directions from Newark Liberty International Airport - EWR: 3.9 miles N
  • Head northeast on Buses toward Express Rd.
  • Travel 0.5 miles and take a slight right.
  • Travel 0.2 miles. Keep LEFT at the fork, follow signs for US-1 N/US-9 N/US-22/NJ-21.
  • Travel 0.5 miles and continue on the ramp.
  • Take a slight left toward NJ-21 N.
  • Travel 0.3 miles and keep right at the fork and merge onto NJ-21 N. Travel 0.7 miles and exit onto Broad St.
  • The hotel will be 1.3 miles ahead on the right.

Other Transportation:

Bus Station
  • Newark Penn Station - 0.7 miles NE

Train Station
  • Newark Penn Station - 0.7 miles NE

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.





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Local Attractions

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 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 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.




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 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 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.




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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