Senior Consultant, Biologics Consulting Group, Inc.
Indianapolis, IN.

Director of Regulatory Affairs, Focus Surgery, Indianapolis, IN.

• Directed regulatory efforts for market entry of a first-of-kind electromechanical device targeting oncology.  Development of regulatory and clinical to expedite approval. 
• Developed design strategies to minimize regulatory overhead and engineering costs.  Accomplishments include:
  • Oversaw the company’s first full CE-mark renewal – successful
  • Initiated strategy for addressing post-market surveillance and CAPA
  • Drove introduction of 21CFR §820 into the ISO 13485-based quality system
  • Formulated regulatory options to expedite entry to market and accelerate clinical trials
  • Developed regulatory and quality strategy to decouple software from underlying hardware
• Initiated reimbursement and CPT strategies for product launch

Regulatory Scientist, Cook Inc., Bloomington, IN.

• Development of regulatory strategies for high risk, combination medical devices: drug/device and tissue/device. 
• Development of regulatory strategies for introducing innovative Class III medical technologies.  
• Oversight of preparations for submissions world-wide.  
• Accomplishments include:
  • Formulation of worldwide regulatory strategy for venous stenting,  a new corporate focus
  • Drove submissions and strategy for an in-trial DES
  • Oversight and submission of product portfolios -  PMA, 510k, EU design dossiers, device licenses
  • Pre-emptive strategy for addressing post-market regulatory inquiries and CAPA
  • Regulatory strategy, pre-IDE’s, and submissions for U.S. and Canadian clinical trials involving stem cells
  • Coordinating and planning of development and testing of new and combination  products
  • Development and implementation of  parametric release for sterilization – a company first

Medical Device Fellow, CDRH, FDA.

• Analysis and approval of high risk (PMA) medical devices. Emphasis on IVDs. 
• Review of regulatory strategies for introducing innovative medical technologies.  Development of clinical and regulatory standards. 
• Exploiting opportunities at both the NIH and FDA to develop new contrast agents for cardiovascular imaging.
• Accomplishments include:
  • Premarket approval (PMA) of high risk medical devices including presentations to panel
  • Briefing outside agents on avenues to market for innovative technologies
  • Review and clearance of abbreviated, special, and traditional 510k applications from medical companies
  • Initiated a collaborative partnership to develop x-ray and MRI contrast agents for atherosclerosis
  • Development of software for quality control of clinical laboratory data

Medical Device Fellow, FDA/Medtronic.

• A joint position with the Food & Drug Administration, Stanford, and the Medtronic Foundation. 
• Worked with the FDA to approve and streamline the approval of medical devices and combination medical products with emphasis on IVDs.  
• Accomplishments included:
  • Premarket approval (PMA) of high risk medical devices and combination medical devices
  • Review and clearance of abbreviated, special, and traditional 510k applications from medical companies
  • Development of new software review techniques within the FDA
  • Pre-IDE planning with FDA and corporate partners
  • Drafting and defense of new regulatory statutes

Research Scientist, Applied Physics, Stanford University.

• Exploited small angle x-ray scattering to study protein folding, changes in protein conformations, ligand docking, and RNA folding. 
• Accomplishments included:
  • Increased collaborative and research work by 100%, growth involving collaborations with 10 teams of researchers on 3 continents and 5 countries
  • Reduced turnaround time for results by more than 1000%, achieved by developing a new software system to eliminate bottlenecks in data interpretation
  • Initiated new research projects in protein folding, RNA folding, and protein chaperones
  • Drove new funding initiatives
  • Trained new graduate and post-doctoral students in small angle x-ray scattering and biochemistry

Doctoral Studies, Physical Chemistry, Stanford University.

• Developed new experimental techniques for analyzing and constraining complex dynamical systems.   
• Accomplishments included:
  • Discovered new chemical phenomena in the Briggs-Rauscher reaction 
  • Developed kinetic and computational models to analyze this behavior 
  • Trained a post-doctoral fellow in applying these techniques

Software Engineer, MDL Information Systems, Inc. San Leandro, CA

• Developed new testing methodologies, focusing on challenges in cross-product integration and inter-departmental coordination.  Note: this position was concurrent with my Ph.D. work.  
• Accomplishments included:
  • Identified structural impediments limiting cross-product coordination and hampering productivity
  • Devised and promoted new practices to increase cooperation between departments
  • Initiated the analysis and selection of software to facilitate coordination
  • Determined the vendor and product best able to meet MDL’s organizational requirements

Software Engineer, Talarian Corporation, Mountain View, CA.

• Design and testing of real-time decision systems including an object-oriented rule engine. Note: this position was concurrent with my Ph.D. work. 
• Accomplishments included:
  • Improved quality by initiating the first automated testing system in the company 
  • Increased product quality, implementing a 300% increase in code coverage in 5 programs on 4 platforms
  • Reduced lag time by implementing an overnight testing regime
  • Development of rule-based engine for real-time data processing

Software Engineer, MDL Information Systems, Inc., San Leandro, CA.

• Developed and tested chemical drawing and database systems. 
• Design of user interface.  Creation of large chemical databases.  
• Accomplishments included:
• Oversaw releases of company’s first Windows software
• Designed and created the first databases for the flagship product –still packaged with the system
• Employee of the Month, July 1991
• Sought and controlled a 200% budget increase
• Reorganized a 14-person group to improve effectiveness 
• Improved quality by instituting an automated testing system

HONORS AND AWARDS

Regulatory Affairs Professionals Certification, United States - 2007
Regulatory Affairs Professionals Certification, European Union - 2007
Center for Device and Radiological Health Medical Device Fellow - 2006
Medtronic Medical Device Fellow – 2005

PROFESSIONAL SOCIETIES

American Association for the Advancement of Science
American Association for Clinical Chemistry
American Chemical Society
Regulatory Affairs Professionals Society

INVITED LECTURES

“Mapping Out Preclinical and Human Studies to Support Safety: Getting to First-in-Man Clinical Trials” March, 2008
 RAPS Horizons, San Francisco

“Barriers to Entry: Regulatory Implications for Vaccines and Biologics”October, 2006
National Institute of Allergy and Infectious Diseases

“Elucidations of Protein Folding by Small Angle X-ray Scattering” October, 2005
Dept. of Laboratory Medicine, NIH

“The Security Implications of Education, Innovation and Globalization” April, 2004
Homeland Security Institute, ANSER

1. Jan Lipfert, Ian S. Millett, Soenke Seifert, Sebastian Doniach (2006) “A Sample Holder for Small-Angle X-ray Scattering Static and Flow Cell Measurements” Rev. Sci. Inst., 77(4): 6108-6111

2. Linda Columbus, Jan Lipfert, Heath Klock, Ian Millett, Sebastian Doniach, Scott A. Lesley (2006), “Expression, purification, and characterization of Thermotoga maritima membrane proteins for structure determination” Prot. Sci., 15: 961-975

3. Bojan Zagrovic, Jan Lipfert, Eric J. Sorin, Ian S. Millett, Wilfred F. van Gunsteren, Sebastian Doniach, Vijay S. Pande (2005),“Unusual compactness of a polyproline type II structure” Proc. Nat. Acad. Sci., 102: 11698-11703

4. Bojan Zagrovic, Guha Jayachandran, Ian S. Millett, Sebastian Doniach, Vijay S. Pande (2005), “How large is an α-helix?  Studies of the radii of gyration of helical peptides by SAXS and MD” J. Mol. Bio., 353:232–241

5. Vladimir N. Uversky, Ghiam Yamina, Larissa A. Munishkina, Mikhail A. Karymov, Ian S. Millett, Sebastian Doniach, Yuri L. Lyubchenko, Anthony L. Fink (2005), “Effects of nitration on the structure and aggregation of  α-synuclein” Mol. Brain Res., 134:84-102

6. Yu Bai, Rhiju Das, Ian S. Millett, Daniel Herschlag, Sebastian Doniach (2004), “Probing Counterion Modulated Repulsion and Attraction Between Nucleic Acid Duplexes in Solution” Proc. Nat. Acad. Sci., 102(4): 1035 - 1040

7. Jonathan E. Kohn, Ian S. Millett, Jaby Jacob, Thomas M. Dillon, Nikolina Cingel,Soenke Seifert,P. Thiyagarajan,Tobin R. Sosnick, M. Zahid Hasan, Ingo Ruczinski, Sebastian Doniach, Kevin W. Plaxco (2004), “The dimensional scaling of the large majority of chemically unfolded proteins is indistinguishable from random coil behavior” Proc. Nat. Acad. Sci., 101( 34): 12491-12496

8. Ahmad, A., Millett, I.S., Doniach, S., Uversky, V, .N., Fink, A. L. (2004), “Stimulation of insulin fibrillation by urea-induced intermediates” J. Biol. Chem. 279(15): 14999-5013

9. Ahmad, A., Millett, I.S., Doniach, S., Uversky, V, .N., Fink, A. L. (2003), “Partially folded intermediates in insulin fibrillation” Biochem.,  42(39): 11404-11416. 

10. R. Das, L.W. Kwok, I.S. Millett, Y. Bai, T. T. Mills, J. Jacob, G.S. Maskel, S. Seifert, S.G. Mochrie, P. Thiyagarajan, S. Doniach, L. Pollack, D. Herschlag (2003) “The fastest global events in RNA folding: electrostatic relaxation and tertiary collapse of the Tetrahymena ribozyme” J. Mol. Bio., 332(2): 311-319

11. Permyakov S.E., Millett I.S., Doniach S., Permyakov E.A., Uversky V.N. (2003) “Natively unfolded C-terminal domain of caldesmon remains substantially unstructured after the effective binding to calmodulin” Proteins, 53(4): 855-862

12. J. Goers, A.B. Manning-Bog, A.L. McCormack, I.S. Millett, S. Doniach, D.A. Di Monte, V.N. Uversky, A.L. Fink (2003) “Nuclear localization of alpha-synuclein and its interaction with histones” Biochem., 42(28): 8465-8471 

13. R. Das, T. Mills, L.W. Kwok, G.S. Maskel, I.S. Millett, S. Doniach, K.D. Finkelstein, D. Herschlag, L. Pollack (2003) “Counterion distribution around DNA probed by solution X-ray scattering” Phys. Rev. Lett., 90(18):1881-1883.

14. A.S. Meyer, J.R. Gillespie, D. Walther, I.S. Millett, S. Doniach, J. Frydman (2003) “Closing the folding chamber of the eukaryotic chaperonin requires the transition state of ATP hydrolysis” Cell, 113(3): 369-381

15. Vladimir N. Uversky, Liza Nielsen Garriques, Ian S. Millett, Sven Frokjaer, Jens Brange, Sebastian Doniach, Anthony Fink (2003), “Prediction of the Association State of Insulin Using Spectral Parameters” J. Pharm. Sci.,  92: 847–858

16. Ian S. Millett, Sebastian Doniach, Kevin W. Plaxco (2002) “Toward a Taxonomy of the Denatured State: Small Angle Scattering Studies of Unfolded Proteins” Adv. Protein Chem., 62: 241-262

17. Vyacheslav M. Abramov,  Anatoly M. Vasiliev,  Valentin S. Khlebnikov,  Raisa N. Vasilenko, Nataly L. Kulikova, Igor V. Kosarev,  Alexander T. Ishchenko,  Joel R. Gillespie,  Ian S. Millett, Anthony L. Fink, Vladimir N. Uversky (2002), “Structural and Functional Properties of Yersinia pestis Caf1 Capsular Antigen and Their Possible Role in Fulminant Development of Primary Pneumonic Plague” J. Proteome Res., 1:307-315

18. Pierre O. Souillac, Vladimir N. Uversky, Ian S. Millett, Ritu Khurana, Sebastian Doniach, Anthony L. Fink  (2002), “Effect of association state and conformational stability on the kinetics of immunoglobulin light chain amyloid fibril formation at physiological pH” J. Biol. Chem., 277: 12657-12665

19. Pierre O. Souillac, Vladimir N. Uversky, Ian S. Millett, Ritu Khurana, Sebastian Doniach, Anthony L. Fink (2002), “Elucidation of the molecular mechanism during the early events in immunoglobulin light chain amyloid fibrillation: Evidence for an off-pathway oligomer at acidic pH” J. Biol. Chem., 277: 12666-12679

20. Vladimir N. Uversky, Jie Li, Pierre TSouillacT, Ian S. Millett, Sebastian Doniach, Ross Jakes, Michel Goedert, Anthony L. Fink (2002), “TBiophysical Properties of the Synucleins and Their Propensities to Fibrillate. Inhibition of TaT-synuclein assembly by b- and g-synucleins”T J. Biol. Chem., 277: 11970-11978

21. Wing-Yiu Choy, Frans A. A. Mulder, Karin A. Crowhurst, D. R. Muhandiram, Ian S. Millett, Sebastian Doniach, Julie D. Forman-Kay, Lewis E. KayP P(2002). “Distribution of molecular size within an unfolded state ensemble using small-angle X-ray scattering and pulse field gradient NMR techniques.” J. Mol. Bio., 316(1): 101-112

22. Ian S. Millet, Lara E.Townsley, Fabrizio Chiti, Sebastian Doniach, Kevin W. Plaxco (2002). “Equilibrium collapse and the kinetic ‘foldability’ of proteins” Biochem. 41(1): 321-325

23. Rick Russell, Ian S. Millett, Mark W. Tate, Lisa W. Kwok, Bradley Nakatani, Sol M. Gruner, Simon G.J. Mochrie, Vijay Pande, Sebastian Doniach, Daniel Herschlag, and Lois Pollack (2002). “Rapid Compaction During RNA Folding.”  Proc. Nat. Acad. Sci., 99(7): 4266-4271

24. Rick Russell, Xiaowei Zhuang, Hazen P. Babcock, Ian S. Millett, Sebastian Doniach, Steven Chu, Daniel Herschlag (2002). “Exploring the Folding Landscape of a Structured RNA.” Proc. Nat. Acad. Sci., 99(2): 155-160

25. Ritu Khurana, Joel R. Gillespie, Anupam Talapatra, Lauren J. Minert, Cristian Ionescu-Zanetti, Ian Millett, Anthony L. Fink (2001). “Partially Folded Intermediates as Critical Precursors of Light Chain Amyloid Fibrils and Amorphous Aggregates.”  Biochem., 40(12): 3525-3535

26. Rick Russell, Ian. S. Millett, Sebastian Doniach, Daniel Hershlag (2000). “Small Angle X-ray Scattering Reveals a Compact Intermediate in Folding of the Tetrahemena Group I RNA Enzyme.” Nat. Struct. Bio., 7(5): 367-370.

27. Vladimir N. Uversky, Joel R. Gillespie, Ian S. Millett, Anna V. Khodyakova, Raisa N. Vasilenko, Anatoly M. Vasiliev, Igor L. Rodionov, Galina D. Kozlovskaya, Dmitry A. Dolgikh, Anthony L. Fink, Sebastian Doniach, Eugene A. Permyakov, Vyacheslav M. Abramov (2000). “Zn2+-Mediated Structure Formation and Compaction of the "Natively Unfolded" Human Prothymosin.” Biochem. Biophys. Res. Comm., 267(2): 663-668.

28. Uversky, V. N., Gillespie, J. R., Millett, I. S., Khodyakova, A. V., Vasiliev, A. M., Chernovskaya, T. V., Vasilenko, R. N., Kozlovskaya, G. D., Dolgikh, D. A., Fink, A. L., Doniach, S., Abramov, V. M. (1999). “Unfolded Human Prothymosin Adopts Partially Folded Collapsed Conformation at Acidic pH.” Biochem., 38(45): 15009-15016.

29. Kevin W. Plaxco, Ian. S. Millett, Daniel J. Segel, Sebastian Doniach, David Baker (1999). “Chain Collapse can occur Concomitantly with the Rate-limiting Step in Protein Folding.” Nat.  Struct. Biol., 6(6): 554 - 556.

30. Ian Millett, William Vance, John Ross (1999). “Measurements of Phase Response in an Oscillatory Reaction and Deduction of Components of the Adjoint Eigenvector.” J. Phys. Chem. A, 103(41): 8252-8256.

31. G. Bernstein, S. Labov, D. Landis, N. Madden, I. Millett, E. Silver, P. Richards (1991). “Automated temperature regulation system for adiabatic demagnetization refrigerators.” Cryogenic, 31: 99-102.

32. E. Silver, S. Labov, F. Goulding, N. Madden, D. Landis, J. Beeman, T. Pfafman, L. Melkonian, I. Millett, Y. Wai (1989). “High Resolution X-ray Spectroscopy Using Germanium Microcalorimeters.” Proc. SPIE, 1159: 423-432.