Managing Director, *****17 ***** *****, LLC
General management of consultancy operations, including providing services and support for clients, securing financial capitalization, new business development, conducting marketing, regulatory and/or reimbursement analyses

• Demonstrated entrepreneurial excellence by developing and implementing a business plan for a global consultancy operation, signing first clients within 30 days of initiating commercial activity, securing angel funding sufficient to support 1st 12 months of business operations, and selection as a finalist and winner of best overall pitch in an international business plan competition for a novel orthopedic technology out 100+ entrants
• Projects included working with Australian, Indian and Chinese universities to transfer ***** ***** technologies to the US market through licensing and/or acquisition to medical device industry companies, and working with Chinese SFDA to train inspectors on FDA regulations
• Additional project work included technology transfer/IP commercialization activities of orthopedic and women’s health technologies from a prominent Boston-based University, design and implementation of a distance learning system to significantly increase effectiveness and reduce costs o***** training operations, and development and launch of a unique medical device and combination product launch/commercialization system that dramatically increases the efficiency o***** personnel

Executive Director of Marketing, Anika Therapetics (*****)

• Responsibilities were global in scope and included leadership of Anika's Marketing Department; Portfolio included device/drug pre-filled injectables for orthopedic, ophthalmic, aesthetics, anti-adhesion, and veterinary use; Accomplishments included leading the company to record revenue growth, building global commercialization strategies for Anika’s product franchises and revamping the company's distribution partner network. This encompassed organizational and product pipeline development, clinical and regulatory strategy, creation of sales and marketing strategies, development and implementation of reimbursement and pricing strategies, design of promotional approaches, and establishment of KOL and product champion relationships
• Responsibilities also included managing Anika's global distribution partner network, expanding product distribution into new and emerging international markets and supporting the establishment of a direct commercialization arm; Efforts resulted in 20% annual revenue growth in the US and 40% annual revenue growth internationally
• Accomplishments also included building brand identities for the Joint Health Franchise, initiating development of a direct commercialization function in the EU, building collaborative partnerships with new and existing product distributors in the US, Canada, Latin America, Europe, the Middle East and Asia

Group Director of Marketing, Smith & Nephew (*****)

• Managed a $140 million global arthroscopy business and a $1M supporting expense budget; Product lines included implants as well as fluid management, visualization, repair and resection capital and disposables; Developed and implemented a 3 year growth strategy for arthroscopic Knee Repair that resulted in high teens annual revenue growth
• Responsible for the activities of 3 direct reports and a Global Market Team consisting of 7 additional marketing professionals in Smith & Nephew direct markets
• Managed a 20+ cross-functional employee surgical technique development team that created and launched a novel women's health/gynecology diagnostic and operative product platform with 1st year revenue of $7 million and triple digit annual growth
• Built direct US sales force of 15 representatives and 4 clinical specialists in target US regional markets; Drove and participated in multiple business development activities including acquisition of an orthopedic company as well as multiple licensing opportunities; led several supply and distribution contract negotiation processes
• Drove efforts to receive new reimbursement coverage and CMS HCPCS codes for various biological implants; Spearheaded over 25 new product introductions including management of 510(k) submissions and direction of product portfolio *****cycle management activities


Visible Genetics, Inc. (VGI), Toronto, Canada *****
Developer, manufacturer, and marketer of diagnostic products for infectious disease and oncology markets. Acquired by Bayer Diagnostics in 2001, which was later acquired by Siemens in 2004.

Product Manager (*****)
Advanced key ***** ***** marketing and business development goals; Managed HPV genotyping diagnostic testing platform, which included setting up and maintaining testing collaborations with pharmaceutical companies, academic organizations and reference laboratories; Directed SNP analysis and DNA sequencing projects; conducted market analyses for emerging applications

• Drove $5M in revenues by leading development and commercialization of HPV testing kit, including both unique sample preparation methods as well as differentiated patient management software solutions
• Played instrumental role in growing US clinical specialist and sales representative network; authored product sales and marketing literature and delivered product seminars at key conferences

Senior Applications Specialist/Sales Representative (*****)
Worked with sales organization to maximize market penetration of ***** *****-based genomic analysis products. Conducted market feedback analysis; initiated several key product improvements

• Developed and implemented infectious disease application and DNA sequencing software solutions
• Initiatives increased throughput time for clinical samples from 30 per minute to 60 per minute, improved ease of use for sequencing gel technology, and reduced end user cost-per-sample by 20%

Critical Therapeutics, Lexington, MA *****
Developer, manufacturer, and marketer of specialty small molecule pharmaceutical therapeutics for respiratory and anti-inflammatory pathology, merged with Cornerstone BioPharma in 2008
Senior Research Associate

• Led development of IVD assays and therapeutic interventions for gram negative sepsis infections
• Assisted with preparation of business plans for presentation to venture capital and angel investors

• Master of Business Administration (MBA), Carroll School of Management, Boston College, 2001
Awarded a Fellowship in Marketing; Won a team business plan competition by developing a software venture named KidSci; Finalist in the Dianne Weiss Team Consulting competition; Elected to Beta Gamma Sigma Honor Society, GPA 3.7/4.0

• Doctor of Philosophy (Ph.D.) in Molecular and Cellular Biology, Graduate School of Arts & *****, Boston College, 1997
Doctoral Dissertation: junB Transcriptional Regulation in Mature B Lymphocytes: The Role of Protein Kinase A and a mIg-Regulated Protein Phosphatase
President, Biology Graduate Organization, *****

• Bachelor of Arts (A.B.) in Biochemical *****, Harvard University, 1990
Studied Japanese and earned a Private Pilot’s License; Current section chair Harvard College Admissions Interview Committee

Head of Faculty, Regulatory Affairs and Market Access Program, Northeastern University

Lead a group of 50+ Northeastern University faculty members in global regulatory affairs with a curriculum that includes regulation of medical device, pharmaceutical and biologic product commercialization in the US, Canada, EU, China, India, Singapore & Latin America, regulation of biosimilars, social media & promotional regulations and global reimbursement issues.

Senior Consultant, Bridgehead International (*****)

Project work was global in scope and included leading market access projects from a regulatory, pricing & reimbursement perspective for drugs, devices and biologic products. Projects led included a drug pricing, regulatory and reimbursement study in the EU, Australia & Brazil, a US plastic & colorectal surgery market access study for tissue adhesives, development of a formulary kit for a radiopharmaceutical product in the US market, a US and EU5 reimbursement landscape and ROI assessment for a wound care device, and a reimbursement landscape assessment in the Chinese market for a US device manufacturer.

Abstracts/Presentations

Poster: A Role For FosB in Antigen Receptor-Mediated Nuclear Signal Transduction in Murine Bal17 B Cells, 1995 FASEB meeting, Atlanta, GA, April 9, 1995.

Oral Presentation: Transcriptional Regulation of the junB Promoter in Mature B Lymphocytes: Activation Through a CRE-like Binding Site. 1996 Boston Area Graduate Symposium in Biology, Boston University, Boston, MA, March 16, 1996.

Oral Presentation: Transcriptional Regulation of the junB Gene in B Lymphocytes: Role of Protein
Kinase A and a Membrane Ig-Regulated Protein Phosphatase. 1997 Boston Area Graduate Symposium in Biology, Boston University, Boston, MA, March 20, 1996.

Poster: Antigen Receptor-Mediated Regulation of CREB/ATF Family Proteins in Mature B Lymphocytes, 1996 AAI meeting, New Orleans, LA, June 4, 1996.

Poster: Transient Stimulation of the JNK/AP-1 Pathway and Inhibition of ERK and its Effects on Paclitaxel-Mediated Apoptosis in Human B-Lymphoblasts, 1997 AAI meeting, San Francisco, CA, June, 6, 1997.

Poster: Characterization of T-Cell Receptors Using the Open GeneTM System, 1998 ASM Meeting, Chicago, IL, May 23, 1998.

Poster: Use of the Open GeneTM System to Characterize HLA antigens, 1998 ICAAC Meeting, San Francisco, CA, September 18, 1998.

Oral Presentation: The History of the FDA - Its Fundamental Functions and Responsibilities, The FDA Field Offices - Roles and Responsibilities, Overview of ORA Company Inspections, FDA Compliance and Judicial Actions, Chinese State Food & Drug Administration (SFDA), Wuhan, China, October *****, 2010.

Oral Presentation: The US Food & Drug Administration – Role in Biomedical Product Commercialization, Fudan University, Shanghai, China, October 20, 2010.

Oral Presentation: Current Topics in FDA Regulation, - Proposed 510(k) Premarket Notification Changes Delhi Institute of Pharmaceutical ***** and Research (DIPSAR), Delhi, India, November 17, 2010.

Oral Presentation: Current Topics in FDA Regulation – Recent Biosimilars Legislation, Ramgopal College of Pharmacy, Gurgaon, India, November 18, 2010.

Oral Presentation: The FDA and Biomedical Product Commercialization, Sri Ramachandra University, Chennai, India, November 20, 2010.

Oral Presentation: Current Topics in the Regulation, Reimbursement and Pricing of Biologics, Singapore, April 15, 2011.

Oral Presentation: The Evolving Diagnostics Market Access Landscape in the US: Reimbursement and Pricing Issues, Beijing, September 26, 2011.

Publications

Warren, H.S., Glennon, M.L., Wainwright, N., *****, S.F, Black, K.M., Kirsch, S.J., Riveau, G.R., Whyte, R.I., Zapol, W.M., and Novitsky, T.J. (1992) Binding and Neutralization of Endotoxin by Limulus Antilipopolysaccharide Factor. Infection and Immunity 60:*****.

Warren, H.S., *****, S.F., Fitting, C., Black, K.M., Loiselle, P.M., Pasternack, M.S., and Cavaillon, J.M. (1993) Assessment of Ability of Murine and Human Anti-Lipid A Monoclonal Antibodies to Bind and Neutralize Lipopolysaccharide. Journal of Experimental Medicine 177:*****.

Sweadner, K.J., Herrera, V.L.M., *****, S.F., Moellmann, A., Gibbons, D. and Repke, K.R. (1994) Immunological Identification of Na+, K+-ATPase Isoforms in Myocardium. Circulation Research 74:*****.

Dickinson, J.A., *****, S.F., McManus, B.J. and Chiles, T.C. (1995) Membrane Immunoglobulin Receptor Cross-Linking Induces fosB mRNA Expression in Mature B Lymphocytes: Assembly of Distinct fosB-Containing Nucleoprotein Complexes During B Cell Stimulation. Cellular Immunology 165:*****.

Fletcher, M.A., Kloczewiak, M., Loiselle, P.M., *****, S.F., Black, K.M., and Warren, H.S. (1996) TALF Peptide-Immunoglobulin Conjugates that Bind Lipopolysaccharide. Journal of Endotoxin Research 3:*****.

*****, S.F., Hirano, T., Nakajima, H., and Chiles, T.C. (1996) Transcriptional Regulation of the junB Promoter in Mature B Lymphocytes: Activation Through a CRE-Like Binding Site. Journal of Immunology 157:*****.

Ge, Y., Ezzell, R.M., Clark, B.D., Loiselle, P.M., *****, S.F., and Warren, H.S. (1997) Relationship of Tissue and Cellular Interleukin-1 and Lipopolysaccharide After Endotoxemia and Bacteremia. Journal of Infectious Diseases 176:*****.

Hellman, J., Zanzot, E.M., Loiselle, P.M., *****, S.F., Black, K.M., Ge, Y., Kurnick, J.T., and Warren, H.S. (1997) Antiserum Against Escherichia coli J5 Contains Antibodies Reactive with Outer Membrane Proteins of Heterologous Gram-negative Bacteria. Journal of Infectious Diseases 176:*****.

*****, S.F., Nakajima, K., and Chiles, T.C. (1997) Transcriptional Regulation of the junB Gene in B Lymphocytes: Role of Protein Kinase A and a Membrane Ig-Regulated Protein Phosphatase. Journal of Immunology 159:*****.

*****, S.F., Swart, J.M., Berg M., Wanebo, H.J., Chiles, T.C. and Mehta, S.R. (1997) Transient Stimulation of the c-Jun-NH2-Terminal Kinase/Activator Protein 1 Pathway and Inhibition of Extracellular Signal-regulated Kinase are Early Effects in Paclitaxel-mediated Apoptosis in Human B-Lymphoblasts. Cancer Research 58:*****.