CHARLES S.

SWINDELL, PhD
csa68f80@westpost.net
613 Schiller Avenue, Merion, PA 19066
+1 484-431-3483, Mobile
+1 610-667-5104, Home
BIOTECH/PHARMACEUTICAL R&D EXECUTIVE with extensive experience establishing, tur
ning around and playing leadership roles in entrepreneurial companies. Successf
ul direction of product development programs in oncology, endocrinology and othe
r therapeutic areas. Broad personal experience across drug development function
al areas and with both small molecule and recombinant protein products and techn
ologies. Skilled at recruiting and motivating cost-effective R&D teams and inte
grating external experts and resources. Extensive involvement in finance and pa
rtnering efforts. Twenty-three issued patents (US and foreign equivalents); 48
peer-reviewed scholarly publications; 108 scholarly presentations.
PROFESSIONAL EXPERIENCE
GLYCORX PARTNERS, LLC, Merion, PA, 2009 Present
Founder and Partner
GlycoRx Partners was founded to develop and monetize a novel glyco-engineering t
echnology for protein and peptide plasma half-life extension.
Negotiated an exclusive option to license intellectual property from a major US
university.
Wrote the business plan and presentation materials and formulated product devel
opment plans, operating budgets, and financing plans.
Have initiated discussions with over 20 potential venture capital and strategic
partners.
PHYTON BIOTECH, INC. (a DFB Pharmaceuticals Company), East Windsor, NJ, 2004 20
08
Vice President, Research and Development
Phyton pioneered plant cell fermentation technology for small molecule secondary
metabolite manufacturing and became the exclusive supplier of paclitaxel to Bri
stol-Myers Squibb for their Taxol oncology product. Acquired by DFB late 2003.
Member of the senior team that refocused the business strategy on the developme
nt of recombinant protein products. Accountable for all product and technology
development objectives and timelines. Reported to the President.
Conceived and led the restructuring of R&D for the development of recombinant p
rotein products; as a result, the company was able to advance from no protein ca
pability to demonstration of a manufacturing process in a cGMP facility and comp
letion of the non-GLP biological evaluation for its first recombinant protein pr
oduct within 18 months.
Rebuilt the 45-person R&D team (hired 90% of reports) to incorporate expertise
in cell and molecular biology, cryobiology and cell banking, biochemical enginee
ring, fermentation process development and pilot plant operations, protein downs
tream process development, and protein characterization and assay.
Launched the development of a long-acting human growth hormone receptor antagon
ist for acromegaly based on a novel half-life-extending O-glyco-engineering tech
nology; personally directed the external biological evaluation and formulation o
f preclinical safety and clinical development plans.
Successfully championed the acquisition of an N-glyco-engineering patent portfo
lio from The Dow Chemical Company; led technical/IP diligence; served on the neg
otiating team; led the selection of the intellectual property law firm that took
over patent prosecution. Member of the senior management team directed to seek
financing to spin the company out.
DSS PARTNERS, LLC, Merion, PA, 2003 2004
Founder and Partner
DSS Partners optioned a Phase III hyperlipidemia product from the University of
Pennsylvania and later sold the rights to Aegerion Pharmaceuticals.
PROTARGA, INC., King of Prussia, PA, 1999 2003
Senior Vice President, Research and Development
Joined then virtual company with a small-molecule drug targeting technology to e
stablish an internal chemistry group. Promoted to SVP reporting to the CEO with
in four months. Accountable for all objectives and timelines for discovery and
product development programs in oncology, infectious diseases and CNS, including
clinical operations for Taxoprexin oncology product during 1999-2001. Managed
intellectual property program with senior partner at law firm.
Conceived, established and led the R&D capability that advanced Taxoprexin from
a US Phase I study through a US/EU Phase II program into a pivotal Phase III st
udy in three years.
Recruited and directed a 30-person R&D team to carry out internal lead synthesi
s, chemical and analytical development, and expert management of out-sourced bio
logical evaluation and GXP activities; the laboratory group operated in a stand-
alone facility at an annual cost of less than $120K/FTE.
Extensive personal involvement in executing the Taxoprexin clinical program dur
ing its 1999-2001 advancement from early Phase I through mid-Phase II; ran the s
earch that resulted in hiring a board certified oncologist as SVP, Clinical Deve
lopment in late 2001.
Extensive personal involvement in Taxoprexin regulatory interactions: drug pro
duct format change scrutinized by the MCA (UK); End-of-Phase II clinical and CMC
negotiations with the FDA; senior company representative at the End-of-Phase II
CMC meeting.
Personally directed the Taxoprexin clinical pharmacology program; successfully
managed the development/validation of a problematic pharmacokinetics assay at a
CRO; developed collaborations with academic experts for pharmacokinetics data an
alysis.
Solved a serious Taxoprexin containerclosure issue overlooked by a major pharma
ceutical company contractor that threatened to require a hold on the companys fi
rst clinical study.
Expanded Taxoprexin clinical supplies manufacturing to five contractors that pr
oduced multiple cGMP lots on a fixed-price basis through contractor financing an
d never limited the progress of clinical studies.
Established/directed clinical and preclinical collaborations with the National
Cancer Institute (CRADA), The Johns Hopkins Oncology Center, Albert Einstein Col
lege of Medicine, the Royal Marsden Hospital (UK), the Rotterdam Cancer Institut
e (NE), the National Institute of Allergy and Infectious Diseases, and ICOS Corp
oration.
Personally directed the internal synthesis of leads and co-directed their exter
nal in vivo evaluation resulting in the identification of multiple preclinical d
evelopment candidates for oncology, hepatitis B and schizophrenia.
Member of the senior team that drafted the S-1 for an anticipated IPO and subse
quently sold the companys major assets to Sankyo (now Daiichi Sankyo; Luitpold d
ivision).
BRYN MAWR COLLEGE, Bryn Mawr, PA , 1980 1999
Chair, Department of Chemistry, 1992 1994
Professor, 1992 1999
Associate Professor, 1987 1992
Assistant Professor, 1980 1987
Tenured faculty member of the Department of Chemistry. Internationally recogniz
ed research on taxane oncology drugs. Continuously funded by grants from the NI
H (multiple R01s), NSF, industrial corporations and private organizations. Exte
nsive peer-elected leadership in the faculty governance system. Left academic c
areer to take an executive position with Protarga after a four-year collaboratio
n.
Co-invented Protargas targeted taxane (Taxoprexin) oncology product.
Invented, patented and licensed a paclitaxel manufacturing process that is curr
ently used by Hospira to produce their generic product.
Seminal publications on the synthesis of the complex taxane molecular structure
, the identity of the paclitaxel binding site on microtubules, taxane structure-
activity relationships and paclitaxelbinding site structural models.
Asked to serve on 10 National Institutes of Health study sections.
Trained 15 visiting scientists and postdoctoral fellows and 18 PhD and MA stude
nts.
Selected by faculty peers to serve on 15 governance committees and 10 administr
ation and faculty search committees.
Received the Cyanamid Academic Award from the American Cyanamid Company.
ETH ZRICH, Zrich, Switzerland, 1979 1980
Swiss National Science Foundation Postdoctoral Fellow
Awarded a Swiss National Science Foundation Postdoctoral Fellowship.
Also awarded a NATO Postdoctoral Fellowship (declined).
OTHER PROFESSIONAL ACTIVITIES
National Institutes of Health Study Sections:
SBIR/STTR Cancer Drug Development and Therapeutics Study Section, July, 2005
Program Project Review PanelUniversity of Illinois at Chicago, September, 1998
Program Project Site Visit Review PanelUniversity of Illinois at Chicago, Janua
ry, 1998
Chemistry and Related Sciences Special Emphasis Panel ZRG3 BNP, September, 1996
National Cooperative Natural Products Drug Discovery Groups, Special Review Com
mittee, March, 1995
Bio-Organic and Natural Products AHR-M1 Study Section, December, 1993
Medicinal Chemistry AHR-A1 Study Section, November, 1989
National Institute on Drug Abuse, Special Review Committee, June, 1989
Medicinal Chemistry Study Section, ad hoc member, 1987, 1990, 1991
Consultant, Phyton Biotech, Inc., 2008
Tapestry Pharmaceuticals, Inc., Boulder, CO, Chemistry Advisory Board, 2004
Consultant, Luitpold Pharmaceuticals, Inc., Norristown, PA, 2004
Consultant, Protarga, Inc., 2003 2004
University of the Sciences in Philadelphia, Department of Chemistry and Biochemi
stry, Philadelphia, PA, Advisory Committee, 2003
Consultant, Neuromedica, Inc. (became Protarga, Inc.), Conshohocken, PA, 1996 1
999
NaPro BioTherapeutics, Inc., Boulder, CO, Scientific Advisory Board, 1994 1999
Philadelphia Organic Chemists' Club, Chairman-Elect, Chairman, 1992 1993
Journal of Lipid Research Editorial Board, 1986 1995
EDUCATION
PhD, Organic Chemistry, Rice University, Houston, TX, 1980
Recipient of the Stauffer Chemical Company Fellowship.
BS, Chemistry, University of Houston, Houston, TX, 1974
Completed degree program one and one-half years after graduating from high scho
ol.
PROFESSIONAL DEVELOPMENT
Clinical Trials: Principles and Practice, Harvard Medical School, Department of
Continuing Education, Boston, MA (four-day course), November, 2006