CHARLES S. SWINDELL, PhD
613 Schiller Avenue
Merion, PA 19066
Mobile: +1 484-431-3483
Home: +1 610-667-5104
CSwindell@comcast.net
SENIOR BIOTECH / PHARMACEUTICAL R&D EXECUTIVE
Proven leader of preclinical and clinical product development efforts in revenue and development-stage companies. Effective builder of efficient R&D programs that integrate focused internal teams with external expertise and resources. Demonstrated ability to rapidly grasp new technologies and products, identify attractive commercial opportunities, and build programs that meet strategic objectives. Hands-on manager committed to playing personal role in execution. Entrepreneurial founder of early stage ventures. Key senior management team member on private financing, IPO, M&A, turnaround, technology acquisition, and spin-out initiatives. Invented and licensed a commercialized manufacturing process; invented two products advanced to clinical development; 25 issued US patents (with foreign equivalents); 48 peer-reviewed scholarly publications; 108 scholarly presentations.
Core Knowledge, Skills and Experience:
- Planning and execution of early through clinical product development
- Oncology, endocrinology, other therapeutic areas
- Biologic, small molecule products and technologies
- Plasma half-life extension
- Glyco-engineering
- Complex small molecule chemistry
- Paclitaxel and taxane oncology agents
- Cross-functional project management
- Regulatory interactions
- Recruiting, developing, and motivating teams
- Key opinion leader relationships
- Industry, federal, and academic alliances
- Intellectual property management
- Technical and intellectual property diligence
- R&D representation for finance and partnering
PROFESSIONAL EXPERIENCE
CONSULTANT, MERION, PA, 2012--PRESENT
Hands-on development and execution of strategies for life science initiatives, especially product and technology development, R&D strategies to optimize potential for partnering and finance, presentation of opportunities to strategic and financial partners, IP, operations, out-sourcing, and management for entrepreneurial companies.
Current projects: (1) novel RNA drug discovery technology--development and oversight of R&D strategy to optimize partnering potential; presentation of the opportunity to potential strategic partners; (2) novel diagnostic plasma biomarker technology for early detection of cancer--development and execution of strategy for co-development with CLIA lab partners; presentation of the opportunity to potential strategic partners; (3) rare disease advocacy non-profit--chief scientific officer services; wrote online registry protocol and managing challenging IRB approval and implementation; managing KOL relationships and medical advisory board.
DIFFREGEN LLC, PHLADELPHIA, PA, 2012--PRESENT
Chief Scientific Officer
Diffregen is developing a novel biologic differentiating agent for the treatment of acute myeloid leukemia and other hematologic and solid tumors. Formulating and directing in vivo proof-of-concept, CMC, preclinical safety, and clinical development programs.
GLYCORX PARTNERS LLC, MERION, PA, 2009--2011
Chief Scientific Officer and Founder
GlycoRx Partners was founded to develop products based on a novel early-stage glyco-engineering technology for protein and peptide plasma half-life extension. Acquired control of the technology. Formulated product development and business plans. Advanced opportunity to meeting or diligence stage with over 20 potential venture capital and strategic partners.
Key Achievements:
- Created a differentiated technology story based on superior pharmacokinetics, high in vitro activity, extended pharmacodynamics, absence of immunogenicity, low cost of goods, and favorable formulation characteristics through an evaluation of proof-of-concept applications to interferon alpha, human growth hormone, and a human growth hormone receptor antagonist.
- Identified attractive lead product registration opportunities for short bowel syndrome, hypoparathyroidism and osteoporosis, and multiple sclerosis.
- Developed CMC, non-GLP biological evaluation, preclinical safety, and clinical development plans and budgets for lead products.
PHYTON BIOTECH, INC. (A DFB PHARMACEUTICALS COMPANY), EAST WINDSOR, NJ, 2004--2008
Vice President, Research and Development
Revenue-stage company partnered with Bristol-Myers Squibb. Phyton pioneered plant cell fermentation technology for small molecule pharmaceutical cGMP manufacturing and became the exclusive supplier of paclitaxel API to BMS for Taxol®. Acquired by DFB (a private specialty pharma company) in late 2003. Joined Phyton as a member of a new senior management team that refocused the Company on the development of recombinant biologic products. Accountable for all product and technology development objectives and timelines. Reported to the President.
Key Achievements:
- Positioned Phyton to exploit its core technology for biologics development by rebuilding R&D into a 45-person comprehensive recombinant protein CMC development team; hired 90% of reports; recruited and directed personnel with expertise in cell and molecular biology, cell line development and selection, cryobiology and cell banking, biochemical engineering, fermentation and downstream process development, pilot plant operations, and bioanalytical characterization and assay.
- Launched the Company's first product development program, a long-acting human growth hormone receptor antagonist for acromegaly based on a novel glyco-engineering technology for plasma half-life extension; managed internal CMC development and transfer to German cGMP manufacturing site; directed external in vitro and in vivo biological evaluation; developed preclinical safety and clinical development plans and budgets.
- Drove advancement of the Company from no prior recombinant protein capability to demonstration of a 1500 liter manufacturing process in a cGMP facility and completion of in vivo proof of concept for its first product within 18 months.
- Enabled Phyton's entrée into the monoclonal antibody product space by championing the acquisition of a glyco-engineering patent portfolio from The Dow Chemical Company; led technical and patent diligence; served on the negotiating, joint steering, and intellectual property teams; led the selection of the intellectual property law firm that took over patent prosecution; co-managed prosecution with internal patent counsel.
- Member of the senior team charged with spinning the Company out and which brought two transactions (with a public specialty pharma company and a major healthcare venture firm) to the term sheet stage prior to the financial collapse of fall 2008.
PROTARGA, INC., KING OF PRUSSIA, PA, 1999--2003
Senior Vice President, Research and Development
Clinical-stage company with a small molecule drug targeting technology and a lead taxane oncology product. Accountable for all objectives and timelines for product development and discovery programs in oncology, infectious disease and CNS. Managed intellectual property program. Reported to the CEO.
Key Achievements:
- Promoted to SVP responsible for the clinical-stage R&D program four months after joining the Company.
- Established and led the internal and external R&D capability that advanced the Company's lead product from inception of Phase I into a pivotal Phase III study in three and one-half years.
- Recruited and directed a 30-person team for lead synthesis, process, analytical and bioanalytical development, expert management of external GXP activities, and clinical operations that operated at a cost of less than $120K per laboratory FTE.
- Expanded the clinical program from start of a single-site US Phase I study through launch of a nine-protocol 28-site US/EU Phase II program over two and one-half years.
- Secured clinical supplies manufacture by qualifying five API and drug product CMOs that produced multiple cGMP batches on a fixed-price contractor-financed basis and never limited clinical progress.
- Resolved several CMC and QA batch release issues that threatened to stop clinical studies.
- Concluded successful clinical and CMC End-of-Phase II negotiations with FDA on senior regulatory teams; senior company representative at the End-of-Phase II CMC face-to-face meeting.
- Grew the Company's product portfolio by inventing a second-generation technology platform leading to an additional oncology product advanced into clinical development.
- Sourced crucial clinical pharmacology expertise and identified multiple preclinical oncology and hepatitis B candidates by establishing and directing alliances with eight US and international federal, academic and corporate organizations.
- Member of the senior team that raised more than $55 MM in private financing, filed the S-1 for an anticipated IPO and subsequently sold the business to Daiichi Sankyo.
EARLIER PROFESSIONAL EXPERIENCE
Advanced from Assistant to full Professor and Chair of the chemistry department at Bryn Mawr College, Bryn Mawr, PA, a prestigious small private graduate institution. Directed an internationally recognized research program focused on paclitaxel and the taxane oncology drugs that was continuously funded by grants from the NIH (multiple R01s), NSF, industrial corporations and private organizations. Co-invented Protarga's Phase III oncology product. Invented, patented and licensed a paclitaxel manufacturing process operated by a major generic pharma company. Trained 15 visiting scientists and postdoctoral fellows and 18 PhD and MA students. Received the Cyanamid Academic Award from the American Cyanamid Company for research program. Selected by faculty peers to serve on 15 governance and 10 administration and faculty search committees. Was a Swiss National Science Foundation Postdoctoral Fellow at the ETH-Zürich, Zürich, Switzerland and a postdoctoral fellow at Rice University, Houston, Texas prior to Bryn Mawr.
OTHER PROFESSIONAL ACTIVITIES
- Eleven National Institutes of Health Study Sections.
- Consultant: netScientific; The Sturge-Weber Foundation; Sterne, Kessler, Goldstein & Fox; Phyton Biotech; Luitpold Pharmaceuticals; Protarga; Neuromedica.
- Advisory Board/Committee member: Tapestry Pharmaceuticals; NaPro BioTherapeutics; University of the Sciences in Philadelphia.
- Founder and Partner, DSS Partners, LLC: optioned a late-stage hyperlipidemia product from the University of Pennsylvania, advanced it through an End-of-Phase II meeting with the FDA, subsequently sold the rights to Aegerion Pharmaceuticals.
- Clinical Trials: Principles and Practice, Harvard Medical School, Department of Continuing Education, Boston, MA (four-day course).
- Cyprotex 6th North American Drug Discovery Workshop & Training Course Program, King of Prussia, PA (one and one-half day program).
- Chairman-Elect, Chairman, Philadelphia Organic Chemists' Club.
- Visiting Associate Professor, University of Pennsylvania, Department of Chemistry.
- Editorial Board, Journal of Lipid Research.
HONORS AND AWARDS
- Cyanamid Academic Award, American Cyanamid Company.
- Ex-Student Award, Alvin Community College, Alvin, Texas.
- Swiss National Science Foundation Postdoctoral Fellowship, Swiss National Science Foundation.
- NATO Postdoctoral Fellowship (declined).
- Stauffer Chemical Company Graduate Fellowship, Rice University.
- Sigma Xi.
- Phi Kappa Phi.
- Phi Theta Kappa.
EDUCATION
PhD, Organic Chemistry, Rice University, Houston, TX, 1980
BS, Chemistry, University of Houston, Houston, TX, 1974
- Summa Cum Laude.
- Completed degree 18 months after graduating from high school. |
