prepared for techfire incubator by fda technology transfer ... · 1 fda technology transfer ... 13...
TRANSCRIPT
1
FDA TECHNOLOGY TRANSFER –Startup Maryland Pitch Bus StopTechFire Incubator
Tuesday, October 17, 2017
Prepared for TechFire Incubator by FDA Technology Transfer Program
www.fda.gov
2
What the FDA Does
Protect public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
2
3
What is Regulatory Science?
3
“Regulatory Science is the science of developing new [knowledge], tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products”
4
FDA Centers (6+2)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiologic Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• Center for Veterinary Medicine (CVM)
• Center for Tobacco Products (CTP)
• National Center for Toxicological Research (NCTR)
• Office of Regulatory Affairs (ORA)
4
5
FDA Office of Regulatory Affairs (ORA)
The Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with state, local, tribal, territorial and foreign counterparts.
5
6
13 ORA Lab Locations
ORA Regulatory Lab
ORA Regulatory/Specialty Lab
MANY
OH
MI
GA
PA
AR
KSCOCA
WA
PR
7
FDA Technology Transfer Program Activities
T2 legal and policy frameworks for developing new public health advancesSpecific laws permit patenting and licensing of federal inventions, permit collaborations under CRADAs, and require ethical conduct to avoid conflict of interest situations
Execute agreements to exchange research materials, conduct scientific collaborations, protect government intellectual property
Train FDA scientists on using T2 mechanisms to promote research effots
Meet client T2 needs, serving researchers in all FDA Centers and ORA, along with researchers and staff within the OC
Determine/update T2 policies and carry out FDA T2 policy initiatives (e.g., IP in testing standards) in collaboration T2 offices at PHS level and across federal government
Manage FDA invention portfolio, including intake of inventions, decision making on patent protection, and transitioning inventions into products through partnering
Provide guidance for grants and contracts IP
8
FY16 FDATT
In FY16, FDATT and Center Tech Transfer staff supported science and innovation at FDA by completing over 860 technology transfer actions for programs across the Agency. 614 of these actions were performed by FDATT staff.
www.fda.gov
FY16 Tech Transfer Activities
9
FDA CRADAs in FY16 Overview
9
• 8 new CRADAs established in FY16
• 41 active CRADA collaborations in FY16
Num
ber
of
CR
AD
As
FY16 NEW CRADAsCenters and Collaboration Areas
Protect Food Supply
Enhance Regulatory Capability
Develop Regulatory Tools
0
1
2
3
4
CBER ORA CDER
10
FY16 FDATT
www.fda.gov
FY16 Activities
12 new technologies
43 issued patents
13 new technology licenses
95 new collaborations
>600 intellectual property and collaboration concerns resolved (FDATT not including Center Reps)
>140 transfer agreements to shareout or bring in research materials
Consolidation and Expansion of FDATT
• Fully integrated patenting and licensing activities into FDATT
– Tech transfer knowledge management system installed and in use as of Q1 FY16
– Patent law firm contract awarded in December 2016
• Investment in tech transfer professionals resulted in 2 new FTEs in FY15 and 1 new FTE in FY16.
• Increases in program efficiency through comprehensive program all contained at FDA—results in better partnership with Center T2 reps and scientists
11
Examples
11
1. Development of imaging standards (phantoms that mimic human tissue)
for calibrating imaging for ultrasound, MRIs, and new photo acoustic
imaging devices (CDRH)
2. Confocal laser method for assessing the properties of intraocular lenses
(IOLs) including toric IOLs (CDRH)
3. Improve ways to assess and follow drug performance post-licensure- take
advantage of new sources of data and expand types of information
collected post-licensure (CDER and CBER)
http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/Inventi
ons/ucm464037.htm
12
Examples
12
4. Reducing the failure rate of therapeutic proteins- identify antigenic sites
on bioengineered therapeutic proteins that result in antidrug antibodies
(ADAs) and reducing the immunogenicity of these sites
5. Development of recombinant viruses and antibodies to improve vaccine
development and assess the potency of vaccines- develop mismatched flu
viruses for evaluating the contribution of neuraminidase to vaccine
potency and the development of epitope-specific antibodies.
6. Portable gamma-ray analytical apparatus for determining gamma
radiations and gamma-emitting isotopes present in food and other
samples (ORA)
7. Antimicrobial peptides (CBER and CSFAN)
http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/Inventi
ons/ucm464037.htm
13
Leverage novel ideas, advanced technologies, collaborations with industry:
• Develop & build analytical systems addressing expertise shortage
• Increase nation’s radio-analytical capacity
Design & build features:
• Enabling field applications portability
• Free of knowledge and experience requirement of end-user
• Light-weight, modular, scalable, mobile
• Robust
• User-friendly
• Laboratory analytical data quality
• Real time in-situ high throughput sample data collections
Preparedness and Solutions (ORA)
Counterfeit Device (CD) Evolutions (ORA)
Forensic Chemistry Center(UV-Vis-IR imaging)
Note: visible and invisible to human eye wavelength ranges
Counterfeit
CD3 Real Time Scan
(captured images of actual counterfeit versus authentic finished dosages)
15July 20, 2012 USFDA (Forensic Chemistry Center)
Note: large sample was analyzed quickly
Cialis 20mg
Actual Cases
Authentic
Counterfeit Authentic
Counterfeit Authentic
Counterfeit Authentic
Authentic Counterfeit
Reveal Evidence of Diversion and Fingerprinting(Use of UV-Vis range imaging)
16July 20, 2012 USFDA (Forensic Chemistry Center)
Diverted Product
Actual Case
Note: indistinguishable differences under white lighting but noticeable under UV-Vis
17
MenAfriVac, Meningitis A VaccineCBER, Robert Lee, Carl Frasch
17
Neisseria meningitides A vaccine- conjugation of polysaccharide
and tetanus toxoid protein
Conjugation methodology invented at the FDA
Since vaccine campaign began in Africa in 2010 220 million
people in 20 African countries have been vaccinated1
Only a handful of meningitis cases were reported in 2013/2014
(between 1996 and 1997 the disease infected 250,000 and
killed 25,0001
Costs 50 cents per dose to manufacture
Recently approved for young children and infants by WHO- intend
to routinely immunize infants and young children in Africa
1 Ewen Callaway. New meningitis strains could thrive following vaccine success. Nature. Nov 10, 2012. (viewed
online at http://www.nature.com/news/new-meningitis-strains-could-thrive-following-vaccine-success-1.18757 on Dec
7 2015)
18
MenAfriVac, Meningitis A VaccineCBER, Robert Lee, Carl Frasch
18
MenAfriVac is a product of the Meningitis Vaccine Project (MVP) a
collaboration between PATH and the WHO, in partnership with the
Serum Institute of India
Technology from the FDA Center for Biologics Evaluation and Research
(CBER) (conjugation method), SynCo Bio Partners B.V., Netherlands
(Meningococcal A polysaccharide), and Aerial, France (tetanus toxoid)
The FDA collaborated with PATH (under a CRADA) to scale-up the
conjugation process and the technology was licensed nonexclusive to
PATH and sublicensed to the Serum Institute of India
Developing Innovative Test Method for Preclinical Evaluation of
Fundamental Optical Properties of IOLs (CDRH)
Example #1
6 mm
13 mm
Three-piece Monofocal IOL
F1
P1
ffl
=546 nm IOLrefractive-index
IOLcentral
thickness
IOL Fundamental Optical Properties
dioptric power: DIOL = 1/ffl refractive-index of the IOL material
IOL central thickness
reflected glare
light scattering characteristics
imaging quality
spectral transmittance
An estimated 20.5 million Americans over age 40 have
cataracts in at least one eye
>3 million surgeries/year in US, >3 billion USD/year cost
Critical importance of precise preclinical IOL optical
testing for evaluating the safety and effectiveness
Conventional test methods have specific limitations:
high accuracy both +/- IOL testing, spatial alignment and
subjective imaging
Motivation
Developing Innovative Method for Precise IOL Power Testing
Confocal Laser Method (CLM) for IOL Dioptric Power Testing
(proof-of-concept innovation)
E1
E2
E3
E4
h CONFOCAL MICROSCOPY FIBER-OPTIC SENSORS AUTOCOLLIMATION METHOD
high-magnification imaging
out-of-focus signal rejection
non-contact optical sectioning
submicron resolution
high sensing resolution
micrometer size core diameter
compact, flexible
scanning potential
double increased accuracy
simple and compact design
Ilev, EYE 21, p. 818, 2007, Nature Publishing Group
Ilev, Pending Patent, March, 2006PM
Single-Mode Fiber Coupler
(21, 50/50)
IOLtestOc
Mtotal
ft
Input Gaussian
Laser Beam
ISO Oin
LASER
Operating Principle
stakeholder f-b
patent
proof-of-concept
motivation
21
GenomeTrakr Network and Database (CSFAN)
21
─
GenomeTrakr Fast Facts at:
http://www.fda.gov/Food/FoodScienceResearch/WholeGenomeSequencingProgramWGS/ucm403550.
htm
22
FDA Technology Transfer Contacts
Office/Center T2 Representative or Program Contact
CBER Nisha Narayan
CDER Yolanda Hawkins, Chekesha Clingman
CDRH Annie Saha, James Kolonay, Rochelle Fink
CFSAN LaQuia Geathers, Tashea Brown, Kevin Robinson
CVM John Graham, Dana Gaffney, Michelle Fuller
CTP Matthew Holman, Julia McGinn-Rodriguez
NCTR Ashley Groves, Thomas Flammang
ORA Marilyn Khanna
OC Alice Welch, Bill Ronnenberg, Whitney Hastings, Charlene Maddox, Ken Millburne
More details at: http://www.fda.gov/techtransfer
23 23
Web Resources
FDA Technology Transfer Program
http://www.fda.gov/techtransfer
FDA Technologies Search Page
http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/In
ventions/ucm464037.htm
FDA Technology Transfer Program Contact Page
http://www.fda.gov/ScienceResearch/CollaborativeOpportunities/u
cm149671.htm