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Rao S. Bezwada, Ph.D.
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President
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Bezwada
Biomedical, LLC
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Tel:
908-334-1575
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P.O.
Box 6357
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Fax:
908-534-5789
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Hillsborough,
NJ 08844
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E-mail:
rao@bezwadabiomedical.com
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EXECUTIVE SUMMARY
| q |
Invented and championed a new ultra-limp synthetic absorbable suture (for
Ethicon, a J & J company) known as MONOCRYL that is being
sold commercially all over the world. Total worldwide sales of
MONOCRYL suture since its 1993 introduction are over $250 million,
and current annual sales are over $60 million. |
| q |
Received J&J most prestigious R&D award, the JOHNSON MEDAL, in 1996
for the research, development and commercialization of MONOCRYL
suture. |
| q |
71 issued U.S. patents and sixteen published articles and eight presentations
on polyurethane chemistry and absorbable polymers. |
| q |
Received J&J's Philip B. Hofmann Research Scientist Award in 1987 for research
in the area of radiation sterilizable absorbable polymers, a new
absorbable coating (polyglecaprone 90), and a new VICRYL-Like,
monofilament. |
| q |
Invented a class of absorbable coatings for biomedical applications, absorbable
liquid polymers, absorbable elastomers, absorbable polyoxaesters,
absorbable adhesion prevention barriers, radiation sterilizable
absorbable polymers and various absorbable resins for suture applications.
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| q |
Made major contributions to Johnson & Johnson's business, and contributed
to the advancement of the science of synthetic absorbable polymers. |
EXPERIENCE
President (2003-Present),
Bezwada Biomedical, LLC
Research
Fellow (1996-2003), Ethicon, Inc., Somerville, NJ
Principal
Scientist (1985-1995), Ethicon, Inc., Somerville, NJ
Senior
Scientist (1982-1985), Ethicon Inc., Somerville, NJ
Research
Scientist (1981-1982), American Cyanamid, Bound Brook, NJ
Scientist
(1977-1979), American Cyanamid, Bound Brook, NJ
Supervisor
(1974-1976), American Cyanamid, Bound Brook, NJ
Chemist
(1969-1973), A.J. & J.O. Pilar, Inc., Newark, NJ
EDUCATION
Stevens
Institute of Technology, Ph.D., Polymer Chemistry
Stevens
Institute of Technology, M.S., Chemistry
University
of Madras, India, 1968, B. Tech. (Bachelor of Technology)
AWARDS:
| q |
The
Johnson Medal for the research, development and commercialization
of MONOCRYL Suture, 1996
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| q |
Philip B. Hofmann Research Award for outstanding contributions to the development
of new proprietary absorbable sutures, and coatings, 1987 |
| q |
American
Cyanamid Junior Education Award, 1979-1981 |
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Kannamal
Krishnaswamy Memorial Prize, 1968 |
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State
Government Scholarship, 1964-1968 |
| q |
Madras
Leather Club Endowment Medal, 1968 |
| q |
Gold Medal
for University First Rank, University of Madras, 1968 |
RESEARCH INTERESTS
Invent and develop new
biomedical devices targeted towards coatings, new sutures, drug delivery
and other novel concepts. Provide contract research in the areas of
drug/device research and drug delivery research, and tissue engineering.
Conduct basic and product-focused research on new absorbable polymers
for biomedical devices. Conduct natural products research in identifying
new chemical entities (NCE) for drug research. Invent and develop
new polyurethane polymers for biomedical applications.
SKILLS/TECHNIQUES
Organic synthesis, small and medium scale polymer synthesis
(ring-opening and polycondensation). Synthesis of radiolabelled polymers.
Synthesis and characterization of polyurethanes as well as their structure/property
relationships.
SIGNIFICANT
ACCOMPLISHMENTS
Experience
includes elastomers and rubber technology, leather technology,
and polyurethane science. Expertise has been directed toward
polymer science and organic chemistry over the past 20 years
to biomaterials, especially the synthesis of new absorbable
monomers and polymers for absorbable sutures and coatings.Invented
and developed a family of new, low cost, single component adhesion
promoters for bonding steel cords to rubber. Five U. S. patents
were awarded. Returned to school to pursue a doctorate, dissertation
entitled, "Synthesis and Characterization of Model
Comb-Branched Polyurethanes" (Stevens Institute of Technology),
resulted in four papers and one presentation.Reentered industry
and developed a new polyurethane system for American Cyanamid (U.S.
patent,
"Storage Stable, One Package, Heat Curable Polyurea/Urethane
Coating Compositions and Method of Preparation"). Joined Johnson
and Johnson (Ethicon), and invented and developed a new class of "Radiation
Sterilizable Absorbable Polymers" for biomedical applications.
Discovered and developed a new class of absorbable liquid polymers
and controlled delivery for drugs and wound healing agents, and
a new class of absorbable elastomers. Invented and championed
a new Ultra limp Absorbable Sutures known as MONOCRYL, a new coating
(Polyglecaprone 90), a new class of absorbable polymers, known as
Polyoxaesters. Seventy-One U.S. Patents have been issued and several
U.S. patents are pending on absorbable polymers. Published sixteen
articles and presented eight times on polyurethane chemistry and
absorbable polymers.
MONOCRYL
Invented
and championed MONOCRYL suture by making major contributions in a number
of areas:
(a) Made
several key discoveries in the research and development of MONOCRYL
Monofilament Suture. The copolymer of glycolide/e-caprolactone
had to be prepared in a two-stage process, with the prepolymer molecular
weight being very high, at least 1.2 dl/g, and the conversion essentially
complete. The composition of the prepolymer was also selected in such
a way that it is easily soluble in glycolide in the second stage polymerization.
Finally, the selection of the prepolymer composition and the overall
composition were critical in order to get the best overall properties.
These key inventive contributions led to the development of MONOCRYL
suture and resulted in an important U.S. patent issued to ETHICON in
the area of glycolide/e-caprolactone copolymers (i.e., "the MONOCRYL"
patent).
(b) In addition
to developing an excellent synthetic method for preparing MONOCRYL,
led the project in the concept stage and was responsible for the management
of all phases of the MONOCRYL developmental work which included small
scale fiber spinning, biological testing, and initial polymer scale-up.
Presented the project to the ETHICON board and got approval soon after
the presentation.
(c) Led the
team that produced the radiolabelled suture needed for the ADME (Absorption
Distribution, Metabolism, and Elimination) studies working with more
than 14 associates of various disciplines.
New
VICRYL Coating (NVC)
Responsible
for the development of New Vicryl Coating (Polyglecaprone 90). This,
like MONOCRYL, has been approved by the FDA, and can be used as a coating
material for VICRYL. A U.S. patent was issued on the use of the e-caprolactone/glycolide
90/10 composition as a coating for sutures.
VICRYL
Like Monofilament (VLM)
Invented
and championed a unique monofilament derived from p-dioxanone and glycolide.
The monofilament exhibits a breaking strength retention (BSR) profile
equivalent to VICRYL with tensile and handling properties better than
PDS-II. A U.S. Patent was issued to Ethicon.
PDS-Melt/Lactide Copolymer
Invented
and developed a pliable monofilament derived from p-dioxanone and lactide
that has the following property profile: BSR profile between VICRYL
and PDS-II, tensile properties equivalent to PDS-II, and handling properties
equivalent to MONOCRYL. A U.S. Patent was issued to Ethicon on compositions
of PDO/lactide.
Absorbable Elastomers
Discovered
certain compositions of e-caprolactone and glycolide that exhibit unique elastomeric
properties. Many biomedical device prototypes have been developed from
these fast-absorbing elastomers. Two U.S. Patents were issued.
Liquid Absorbable
Polymers
The
first to discover that absorbable liquid copolymers can be prepared
from certain monomers and at certain compositions. Many applications
such as drug delivery, coatings, lubricants, and injectables are being
examined. Several U.S. Patents were issued on compositions and applications.
Absorbable Polyoxaesters
The
first to discover a new class of absorbable polymers, “polyoxaesters”,
which exhibit unique properties, such as liquids, low melts, high melts,
microdispersions, and elastomers. Many biomedical devices are being
developed from this new class of polymers. Over sixteen U.S. Patents
have issued on composition of matter and applications of these polymers.
Research
Interests/Technical Skills:
One
of the few individuals throughout the world who has in-depth knowledge
of synthetic absorbable sutures and absorbable coatings. Through his
creative capabilities, significant contributions in absorbable materials
for biomedical applications have been achieved.
Research
interests include the synthesis and characterization of bioabsorbable
polymers as well as their structure/property relationships, and polyurethane
chemistry. Technical skills include general problem solving, small-scale
organic synthesis, small and medium scale polymer synthesis (ring opening
and polycondensation), and radiotracer studies.
Professional Societies:
American
Chemical Society
Society
for Biomaterials
The
New York Academy of Science
Technical
Presentations / Publications:
Presented
five times at national technical meetings and as an invited speaker
at two section meetings. Published thirteen technical articles, and
co-authored chapters in two ACS books. The attached Appendix contains
information on patents, presentations and technical papers.
Appendix
- Patents, Presentations and Papers Granted US Patents:
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4,228,045
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10/14/80
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METHOD OF ADHESION
OF RUBBER TO REINFORCING MATERIALS
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4,292,111
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9/29/81
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METHOD OF ADHESION
OF RUBBER TO REINFORCING MATERIALS
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4,284,536
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8/18/81
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COMPOSITION FOR ADHESION OF RUBBER TO REINFORCING MATERIALS
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4,300,973
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11/17/81
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METHOD OF ADHESION
OF RUBBER TO REINFORCING MATERIALS
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4,339,359
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7/13/82
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COMPOSITION FOR THE ADHESIONS OF RUBBER TO REINFORCING
MATERIALS
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4,523,003
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6/11/85
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STORAGE STABLE, ONE PACKAGE, HEAT CURABLE POLYUREA/URETHANE
COATING COMPOSITIONS AND METHOD OF PREPARATION
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4,510,295
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4/9/85
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ABSORBABLE POLYMERS OF SUBSTITUTED BENZOIC ACID
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4,532,928
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8/6/85
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SURGICAL SUTURES MADE FROM ABSORBABLE POLYMERS OF SUBSTITUTED
BENZOIC ACID
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4,546,152
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10/8/85
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POLY(P-DIOXANONE) POLYMERS HAVING IMPROVED RADIATION
RESISTANCE
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4,643,191
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2/17/87
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CRYSTALLINE COPOLYMERS OF P-DIOXANONE AND LACTIDE AND
SURGICAL DEVICES MADE THEREFROM
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4,649,921
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3/17/87
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POLY(P-DIOXANONE) POLYMERS HAVING IMPROVED RADIATION
RESISTANCE
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4,653,497
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3/31/87
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CRYSTALLINE P-DIOXANONE/GLYCOLIDE
COPOLYMERS AND SURGICAL DEVICES MADE THEREFROM
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4,838,267
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6/13/89
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GLYCOLIDE/P-DIOXANONE BLOCK COPOLYMERS
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4,994,074
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2/19/91
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COPOLYMERS OF e-CAPROLACTONE ,GLYCOLIDE
AND GLYCOLIC ACID FOR SUTURE COATINGS
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5,007,923
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4/16/91
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CRYSTALLINE COPOLYMERS
OF AMORPHOUS (LACTIDE/GLYCOLIDE)AND P-DIOXANONE
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5,019,094
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5/28/91
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CRYSTALLINE COPOLYMERS OF P-DIOXANONE AND POLY(ALKYLENE
OXIDES)
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5,037,950
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8/6/91
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BIOABSORBABLE COPOLYMERS
OF POLYALKYLENE CARBONATE/P-DIOXANONE FOR SUTURES AND COATINGS
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5,047,048
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9/10/91
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CRYSTALLINE COPOLYMERS OF P-DIOXANONE AND CAPROLACTONE
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5,076,807
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12/31/91
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RANDOM COPOLYMERS OF P-DIOXANONE, LACTIDE AND/OR GLYCOLIDE
AS COATING COPOLYMERS FOR SURGICAL FILAMENTS
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5,089,013
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2/18/92
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SUTURE COATED WITH POLYVINYL ESTER
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5,100,433
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3/31/92
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SUTURE COATED WITH A COPOLYMER COATING COMPOSITION
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5,133,739
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7/28/92
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SEGMENTED COPOLYMERS
OF CAPROLACTONE AND GLYCOLIDE
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5,147,383
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9/15/92
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SUTURE COATED WITH POLYVINYL ESTER
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5,371,176
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12/6/94
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CASTOR OIL POLYMERS
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5,411,554
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5/2/95
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LIQUID FILLED ENVELOPES FOR USE AS SURGICAL IMPLANTS
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5,427,778
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6/27/95
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GEL FORMULATIONS CONTANING GROWTH FACTORS AND ACRYLAMID
POLYMER
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5,442,032
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8/15/95
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COPOLYMERS OF 1,4-DIOXEPANE-2-ONE and 1,5,8,12-TETRAOXACYCLOTETRADECANE-7,14-DIONE
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5,442,033
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8/15/95
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LIQUID COPOLYMERS OF CAPROLACTONE/LACTIDE
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5,464,929
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11/7/95
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ABSORBABLE POLYOXAESTERS
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5,468,253
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11/21/95
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ELASTOMERIC MEDICAL DEVICES
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5,470,340
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11/28/95
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COPOLYMERS OF(p-DIOXANONE/GLYCOLIDE and/or LACTIDE)
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5,595,751
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01/21/97
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ABSORBABLE POLYOXAESTERS CONTAINING AMINES and/or AMIDO
GROUPS
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5,597,579
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01/28/97
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BLENDS OF ABSORBABLE
POLYOXAAMIDES
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5,599,852
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02/04/97
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INJECTABLE MICRODISPERSIONS
FOR SOFT TISSUE REPAIR AND AUGMENTATION
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5,607,687
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03/04/97
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POLYMER BLENDS CONTAINING ABSORBABLE POLYOXAESTERS
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5,618,552
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04/08/97
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ABSORBABLE POLYOXAESTERS
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5,620,698
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04/15/97
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BLENDS OF ABSORBABLE POLYOXAESTERS CONTAINING AMINES
AND/OR AMIDO GROUPS
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5,631,015
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05/20/97
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LIQUID ABSORBABLE COPOLYMERS FOR PARENTERAL APPLICATIONS
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5,633,343
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05/27/97
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HIGH STRENGTH, FAST ABSORBING, MELT PROCESSABLE, GLYCOLIDE
RICH, POLY(GLYCOLIDE-CO-p-DIOXANONE) COPOLYMERS
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5,639,851
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06/17/97
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HIGH STRENGTH, MELT PROCESSABLE, LACTIDE-RICH, POLY(LACTIDE-CO-p-DIOXANONE)
COPOLYMERS
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5,645,850
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07/08/97
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BLENDS CONTAINING ABSORBABLE POLYOXAAMIDES
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5,648,088
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07/15/97
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BLENDS OF ABSORBABLE POLYOXAESTERS CONTAINING AMINES
AND/OR AMIDE GROUPS
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5,653,992
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08/05/97
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LIQUID ABSORBABLE COPOLYMERS FOR PARENTERAL APPLICATIONS
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5,674,921
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10/07/97
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RADIATION-CURABLE, URETHANE-ACRYLATE PREPOLYMERS AND
CROSSLINKED POLYMERS
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5,698,213
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12/16/97
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HYDROGELS OF ABSORBABLE POLYOXAESTERS
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5,700,583
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12/23/97
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HYDROGELS OF ABSORBABLE POLYOXESTERS CONTAINING AMINES
OR AMIDO GROUPS
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5,703,200
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12/30/97
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ABSORBABLE COPOLYMERS AND BLENDS OF 6,6-DIALKYL-1,4-DIOXEPAN-2-ONE
AND ITS CYCLIC DIMER
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5,713,920
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02/03/98
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ELASTOMERIC MEDICAL DEVICE
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5,714,551
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02/03/98
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HIGH STRENGTH, MELT PROCESSABLE, LACTIDE-RICH, POLY(LACTIDE-CO-p-DIOXANONE)
COPOLYMERS
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5,728,752
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02/17/98
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INJECTABLE MICRODISPERSIONS FOR SOFT TISSUE REPAIR AND
AUGMENTATION
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5,824,333
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10/20/98
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INJECTABLE LIQUID COPOLYMERS FOR SOFT TISSUE REPAIR AND
AGGMENTATION
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5,844,017
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12/01/98
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PREPOLYMERS OF ABSORBABLE POLYOXAESTERS CONTAINING AMINES
AND/OR AMIDO GROUPS
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5,859,150
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01/12/99
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PREPOLYMERS OF ABSORBABLE POLYOXAESTERS
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5,868,788
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02/09/99
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HIGH STRENGTH, MELT PROCESSABLE, LACTIDE-RICH, POLY(LACTIDE-CO-p-DIOXANONE)
COPOLYMERS
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5,951,997
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09/14/99
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ALIPHATIC POLYESTERS OF e-CAPROLACTONE, p-DIOXANONE AND GLYCOLIDE
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5,962,023
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10/05/99
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HYDROGELS CONTAINING ABSORBABLE POLYOXAAMIDES
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| 6,031,018 |
02/29/2000 |
SOLVENTLESS TIPPING OF BRAIDED SURGICAL LIGATURE |
| 6,074,660 |
06/13/2000 |
ABSORBABLE POLYOXAESTERS CONTAINING AMINES AND/OR AMIDO GROUPS |
| 6,100,346 |
08/08/2000 |
COPOLYMERS OF POLYOXAAMIDES |
| 6,113,624 |
09/05/2000 |
ABSORBABLE ELASTOMERIC POLYMER |
| 6,147,168 |
11/14/2001 |
COPOLYMERS OF ABSORBABLE POLYOXAESTERS |
| 6,224,894 |
05/01/2001 |
COPOLYMERS OF ABSORBABLE POLYOXAESTERS |
| 6,251,435 |
06/26/2001 |
HYDROGELS CONTAINING ABSORBABLE POLYOXAAMIDES |
| 6,325,810 |
12/04/2001 |
FOAM BUTTRESS FOR STAPLING APPARATUS |
| 6,335,383 |
01/01/2002 |
MICRODISPERSIONS FOR COATING SURGICAL DEVICES |
| 6,372,256 |
04/16/2002 |
HYDROGELS CONTAINING ABSORBABLE POLYOXAMIDES |
| 6,403,655 |
06/11/2002 |
METHOD OF PREVENTINGADHESIONS WITH ABSORBABLE POLYOXAESTERS |
| 6,458,385 |
10/01/2002 |
HYDROGELS CONTAINING ABSORBABLE POLYOXAMIDES |
| 6,712,838 |
03/30/2004 |
BRAIDED SUTURE WITH IMPROVED KNOT STRENGTH AND PROCESS TO
PRODUCE THE SAME |
6,794,484 |
09/21/2004 |
CRYSTALLIZABLE POLYLACTONE COPOLYMERS
PREPARED FROM MONO- AND DI-FUNCTIONAL POLYMERIZATION INITIATORS |
| 6,831,149 |
12/14/2004 |
POLYMERIZATION PROCESS USING MONO-
AND DI-FUNCTIONAL INITIATORS TO PREPARE FAST CRYSTALLIZING POLYLACTONE
COPOLYMERS |
| 6,932,974 |
8/23/2005 |
METHOD OF PREVENTING ADHESIONS
WITH ABSORBABALE POLYOXAESTERS |
Chapters
in Books:
1.
Rao
S. Bezwada, Dennis D. Jamiolkowski and Kevin Cooper "Poly(p-Dioxanone)
and its Copolymers" in Handbook of Biodegradable Polymer, Harwood
Academic Publishers, Australia, 1997, Abraham J. Domb, Joseph Kost,
David M. Wiseman, eds., Chapter 2, pages 29-61.
2.
Dennis
D. Jamiolkowski, Rao S. Bezwada, and Shalaby W. Shalaby "Copolymerization
of Glycolide with Polymeric Radiostabilizers for the Preparation of
Radiation Sterilizable Braided Sutures", in Irradiation of Polymeric
Materials; Process, Mechanisms, and Applications, ACS Symposium Series
No. 527; American Chemical Society, Washington DC, 1993; Chapter 21.
Presentations:
Las Vegas, 1982 National ACS Meeting
Dallas. Texas, 1989 National ACS Meeting
Charleston, SC, May 1990 Annual Meeting of the Society
for Biomaterials
Scottsdale,
Arizona, May 1991 Annual Meeting of the Society for Biomaterials
Alabama, GA, May 1993 Annual Meeting of the Society for
Biomaterials
Invited
Speaker at the fall 1991 Lecture Series, "Advances in Biotechnology
and Bioengineering" sponsored by the North Jersey section of American
Institute of Chemical Engineers. Delivered a talk entitled, "Synthetic
Absorbable Polymers for Biomedical Applications".
Invited
Speaker at the US-Australia Bilateral Workshop on "Radiation Effects
on Polymeric Materials", August 18-22, 1991, sponsored by the Australia
Department of Science and the US National Science Foundation at Stanford
University. Delivered a talk entitled, "Copolymerization of Glycolide
with Polymeric Radiostabilizers for the Preparation of Radiation Sterilizable
Absorbable Braided Sutures".
Visiting
professor at Stevens Institute of Technology and taught graduate courses
in polyurethane chemistry during 1981-1982 and 1983-84 fall semesters.
Technical Publications:
R.S.
Bezwada and S.S. Stivala, "Selective reaction of Isocyanates with
the Amino groups of 2-Amino-2-Methyl-1,3-Propane diol", J. Chem.
Eng. Data, 25, 292 (1980).
R.S.
Bezwada and S.S. Stivala, "Synthesis and Characterization of Model
Comb-Branched Polyurethanes", ACS National Spring Meeting, 278-279,
23, (1982).
R.S.
Bezwada and S.S. Stivala, "Synthesis and Characterization of Model
Comb-Branched Polyurethanes: 1. Synthesis of Model Comb-Branched Polyurethanes",
Polymer Communications, 84, 26, (1985).
R.S.
Bezwada and S.S. Stivala, "Synthesis and Characterization of Model
Comb-Branched Polyurethanes: 2. Dilute Solution and Viscoelastic Properties",
Polymer Communications, 91, 26, (1985).
R.S.
Bezwada, S.W. Shalaby, and H.D. Newman Jr., "Bioabsorbable Fibers
of p-Dioxanone Copolymers", Agric. Synth. Polym.-ACS Symp. Ser.,
433, 167-173 (1990).
R.S. Bezwada, S.W. Shalaby, H.D. Newman Jr., and A. Kafrawy,
"Bioabsorbable copolymers of p-Dioxanone and Lactide for surgical
Devices", Transactions of the 16th Annual Meeting of the Society
for Biomaterials, 1990, XV, 194.
R.S. Bezwada, S.W. Shalaby, and H.D. Newman Jr., "Bioabsorbable
copolymers of p-Dioxanone: Effect of Composition and Microstructure
of physical and biological properties of Copolymeric p-Dioxanone/Glycolide
Fibers", 197th ACS National Meeting, 197, 39 BTEC (1989).
D.F. Koelmel, D.D. Jamiolkowski, S.W. Shalaby, and R.S.
Bezwada, "Low Modulus Radiation Sterilizable Monofilament Sutures",
Polym. Prepr. 1991, 32 (2) 235.
D.D. Jamiolkowski, S.W. Shalaby, R.S. Bezwada, and H.D.
Newman Jr., "Bioabsorbable Block Copolymers of p-Dioxanone and
Glycolide For Surgical Devices", Transactions of the 16th Annual
Meeting of the Society for Biomaterials, 1990, XV, 193.
R.S. Bezwada, and D.D. Jamiolkowski, "Radiation Sterilizable
Bioabsorbable Sutures" Transactions of the 17th Annual Meeting
of the Society for Biomaterials, 1991, XIV, 186.
R.S. Bezwada, and D.D. Jamiolkowski, "Segmented Copolymers
of e-Caprolactone
and Glycolide For New Absorbable Monofilament Sutures", Transactions
of the 19th Annual Meeting of the Society for Biomaterials, 1993, XVI,
40.
Rao
S. Bezwada, Dennis D. Jamiolkowski, and In-Young Lee, "Preparation,
Absorption, Distribution, Metabolism, and Elimination (ADME) of 14C
Labeled MONOCRYL Suture", Transactions of the 21st Annual Meeting
of the Society for Biomaterials, 1995, XVIII, 209.
Rao
S. Bezwada, Dennis D. Jamiolkowski, In-Young Lee, Vishvaroop Agarwal,
Joseph Persivale, Susan Trenka-Benthin, Modesto Erneta, Jogendra Suryadevara,
Alan Yang, and Sylvia Liu, "MONOCRYL™ Suture,
a New Ultra-Pliable Absorbable Monofilament Suture", BIOMATERIALS
16, 1141-1148 (1995)
Rao S. Bezwada and
Dennis D. Jamiolkowski, “Hydrophilic Synthetic Absorbable Polyoxa-esters”,
Transactions of the Sixth World Biomaterials Congress (2000) Vol. 2,
page 430.
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