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Medical Clinical

Location:
Mahwah, New Jersey, 07430, United States
Posted:
October 28, 2016

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MICHAEL S. SILVER, PH.D.

*** ********** ****, ******, ** H: 845-***-**** acw95t@r.postjobfree.com

PROFESSIONAL SUMMARY

More than twenty years of accomplishment and expertise in the pharmaceutical/biotechnology and medical device industries (ten years total international experience with Siemens and Philips Medical Systems), with specific expertise in clinical and pre-clinical research and regulatory strategy.

Experience in Oncology, CNS, and Cardiovascular Therapeutics, and Image-Guided Radiotherapy.

Extensive experience in medical imaging.

Strong negotiating and risk management skills, highly adept contingency planning and conflict management ability to align cross-functional teams on project deliverables and timelines. ACCOMPLISHMENTS

Led, reorganized and re-positioned start-up pharmaceutical company with new business plan, clinical advisory boards, and business development (funding) opportunities.

Developed a new business division which resulted in USD 10 million in revenue within two years

Developed concept and development plans for pre-clinical MRI-Radiotherapy device

Designed a clinical trial of an innovative upright radiotherapy device, and obtained approval from the Ministry of Health (Israel)

Developed new therapeutic line of business (Neurology) to over $ 10 M in less than three years with a proposal win rate of 95%

Fundamental research on MRI selective inversion published in Nature

Executed and completed a pivotal 1200 patient PMA study for Breast imaging device on time, within budget.

Wrote decisive business and marketing analyses for two therapeutic markets saving over

$200,000 in the budget.

Saved over $ 1M in product value as a result of identifying a key patent that was almost allowed to expire.

Authored or co-authored over forty peer reviewed publications and presentations. SKILLS

WORK HISTORY

President, Molecular Innovations Technology, Beit Shemesh, Israel 02/2015 to Present

Expert consulting and mentoring for start-up Medical Imaging Device, imaging biomarkers in Pharmaceutical development, Life Science companies, and Investors

Clinical Trial Preparation

Protocol Development

Quantitative Analysis Clinical Research/CRO Clinical Trial Management

Imaging Physics Medical Devices Radiation Physics

Program Management Regulatory Strategy Business Development

Molecular Imaging Imaging Biomarkers Pre-clinical Imaging Meir (Michael) S. Silver, Ph.D. Page 2 of 9

Regulatory Strategy

Oversight and management of imaging CROs to ensure successful conduct of the imaging aspects of clinical trials, ensuring data integrity and quality.

Working with Imaging CROs for due diligence of central reading and handling outsourcing specification and budgets

Contribute, review and approve core lab documents such as Imaging Charters, Data Transfer Specifications, Communication Plans, Imaging Core Lab Forms and study related documents

Review and design imaging related Case Report Forms and CRF completion guidelines

Author/co-author imaging components of protocol concept sheets, full protocols, amendments and CSRs Program Director, Pre-Clinical Imaging, Aspect Imaging, Ltd. Shoham, Israel 01/2014 to 02/2015

Directly responsible for closing on product sales of over $ 1 million within ten months.

Lead business from a single product distributed exclusively through a large partner to three unique products sold directly to customers

Direct reports in Sales, Marketing in North America and Israel

Reorganized and defined the pre-clinical MRI products and the pre-clinical product plan

Organized major trade conference exhibits Managed Distributor relationships and agreements

Established key business development relationships with three corporations

Provided product direction to R&D Wrote marketing and product requirements. Consultant, Oramed, Ltd., Jerusalem, Israel 08/2011to present

Negotiated agreements with Contract Research Organizations for Phase II studies for Type 1 and Type 2 Diabetes

Provide guidance on protocol and regulatory issues, design of CRF's IVRS.

Made improvements to IND submission

CRO proposal analysis, negotiation, selection, and agreement management. President and Scientific Director, Mazal Plant Pharmaceuticals, Inc. 01/2010 to 10/2013

Key fund-raising executive

Prepared application for 15c211 (U.S. Securities and Exchange Commission) Prepared complete investor documents (business plan, presentations, and term sheets

Reorganized and restarted clinical research plans and regulatory process

Heading CRO recruitment and budget planning, and contracts. Vice President, Clinical Affairs, Azimuth Therapy, Ltd 06/2008 to 02/2014

Designed clinical trials for innovative Radiation Neuro-Oncology Applications (Stereotactic radio-

neurosurgery);

Provides leadership and expertise in key Oncology applications Collaborates with senior internal, academic and external industry based experts and providers who are focusing on translational

radiotherapy research in Radiation Oncology application areas;

Works with project teams to ensure availability to relevant radiotherapy technologies, identifying their scientific and clinical basis;

Provide direction on radiation oncology applications strategies that are suitable for internal decision-making at each stage of drug development;

Specific tasks include implementation of company strategy and agreed procedures; coordination of data collection and interpretation and preparation of the results for recommended action.

Meir (Michael) S. Silver, Ph.D. Page 3 of 9

Consultant (Chief Scientist), TopSpin Medical, Ltd. 07/2006 to 06/2007

Miniature MR device on a catheter for interrogation of the coronary arteries.

Provides regulatory and pre-clinical strategy and guidance.

Design, plan, and implement SOP's and protocols.

Manage third-party laboratories and service providers. Vice President, DOBI Medical International, Inc 01/2005 to 04/2006

Design and organize, and execute breast cancer clinical trial for PMA submission to FDA

Innovative optical tomography technology (near InfraRed) Increased patient enrollment of pivotal trial by a factor of ten

Direct clinical trial staff of six and a budget of more than $ 3.5 M Wrote and implemented several additional international clinical protocols.

Oversight and management of imaging CROs to ensure successful conduct of the imaging aspects of clinical trials, ensuring data integrity and quality.

Working with Imaging CROs for due diligence of central reading and handling outsourcing specification and budgets

Contribute, review and approve core lab documents such as Imaging Charters, Data Transfer Specifications, Communication Plans, Imaging Core Lab Forms and study related documents

Review and design imaging related Case Report Forms and CRF completion guidelines

Author/co-author imaging components of protocol concept sheets, full protocols, amendments and CSRs Director, Scientific Client Services, Synarc, Inc – Maynard, MA, 02/2002 to 12/2004

Led the development of Neurology as a new service and therapeutic area of that resulted in nine neurology clinical trials and over $10M in contracts awarded, with a proposal win rate of 95%.

Produced and submitted over forty oncology, neurology, arthritis, and cardiovascular proposals.

Senior Scientist, Director Bio-Imaging Technologies, Inc – Newtown, PA, 06/1996 to 01/2002

Brought two large pharma clients with repeat business.

Increased new business development in Alzheimer's disease clinical trials by 100%.

Increased the awareness and value of imaging in clinical trials, which resulted in 30% increase in requests for proposals from clients.

Research Assistant Professor, New York University School of Medicine Lectures The Nathan Kline Institute – Orangeburg, NY 01/1996 to 01/2009

Provided lectures on MRI physics and Neuroimaging to medical students and professional staff EDUCATION

Ph.D: The Johns Hopkins University

Electrical Engineering and Computer Science

M. A: The Johns Hopkins University

Biophysics

B. S: Lafayette College

Physics

Meir (Michael) S. Silver, Ph.D. Page 4 of 9

HONORS AND AWARDS

Honors in Physics, Lafayette College

Tau Beta Pi, Honorary Engineering Society, The Johns Hopkins University Sigma Xi, Honorary Scientific Research Society, The Johns Hopkins University AFFILIATIONS

Mentor for Mass Challenge Technological Incubator, Jerusalem, Israel Reviewer of abstracts for annual meetings, and moderator for Society for Magnetic Resonance Imaging

American College of Radiology; Commission on MRI and Neuroradiology, Committee on Research and Technology Assessment.

Member, American Society for Experimental Neurotherapeutics Associate Member, American Academy

European Society of Molecular Imaging

Meir (Michael) S. Silver, Ph.D. Page 5 of 9

PUBLICATIONS

Journals

MR PULSE SEQUENCES, RF PULSES, AND METHODS

1. M. S. Silver, R. I. Joseph, and D.I. Hoult, Highly Selective π/2 and π Pulse Generation, J. Magn. Reson. 1984; 58: 347

2. M. S. Silver, R. I. Joseph, et. al., Highly Selective Spin Inversion in NMR, Nature, 1984; 310:681 3. M. S. Silver, R. I. Joseph, and D.I. Hoult, Selective Spin Inversion in nuclear magnetic resonance and coherent optics, Phys. Rev. A, 1985:31: 2753

4. F. Loaiza, K. T. Lim, W. S. Warren M. S. Silver, H. Egloff, B. Kiefer, and G. Laub, Crafted Pulses and Pulse sequences for MR Imaging, Heath Care Instr. 1986;1:188 5. M. L. Wood, M. S. Silver, and V. M. Runge, Optimization of Spoiler Gradients in Flash MRI, Magn. Reson. Imag., 1987; 5:455

6. F. Loaiza, M. McCoy, M. H. Levitt, M. S. Silver, and W. S. Warren, Excitation in Inhomogeneously broadened systems, J. Magn. Reson. 1988; 76:504

7. R. R. Edelman, D. Atkinson, M. S. Silver, F. Loaiza, and W. S. Warren, Frodo Technique: A New method for artifact reduction, Radiology, 1988; 166:231

8. F Loaiza, MA McCoy, WS Warren, MS Silver, H Egloff Crafted Pulses For Imaging and in-Vivo NMR Spectroscopy, Ann. NY Acad. Sci. 508 (1), 483-***-**** MR SPECTROSCOPY (ONCOLOGY)

9. W. Wolf, M. J. Albright, M. S. Silver, H. Weber, U. Reichhart, and R. Sauer, Flourine-19 NMR spectroscopic studies of 5-Fluorouracil in the liver of patients undergoing chemotherapy, Magn. Reson. Imag., 1987; 5:165

10. W Wolf, MS Silver, MJ Albright, H Weber, U Reichardt, R Sauer A Noninvasive Study of Drug Metabolism in Patients as Studied by 19F NMR Spectroscopy of 5Fluorouracil Ann. NY Acad. of Sci. 508

(1), 491-***-*-****

CLINICAL APPLICATIONS (CNS, CARDIOVASCULAR)

11. V. M. Runge, M. L. Wood, and M. S. Silver, Improvement in lesion detection using Slice profile optimization, Radiology, 1988; 167:382

12. R.R. Edelman, H.P. Mattle, J. Kleefeld, and M. S. Silver, Quantification of blood flow with MR imaging and presaturation bolus tracking, Radiology, 1989; 171(2):551 13. E. K. Yucel, M. S. Silver, and A. P. Carter. MR angiography of normal pelvic arteries: comparison of contrast for three different inflow techniques. Am. J .Roentgenol. 1994; 163:197 14. A.R. Gillams, M. S. Silver, and A. P. Carter. New contrast alternatives from MTC. J. Mag. Res. Imag. 1995;

15. J Gieseke, B Ostertun, L Solymosi, F Trהber, P van Dijk, M Silver, M Reiser MR arterio-and venography: strategies for using 2D and 3D inflow procedures].Biomedizinische Technik. Biomedical engineering 35, 247 1990

16. J Gieseke, B Ostertun, L Solymosi, F Trהber, P van Dijk, M Silver, M Reiser,MR-Arterio-und Venographie: Strategien zum Einsatz von 2D-und 3D-lnflow Verfahren Biomedizinische Meir (Michael) S. Silver, Ph.D. Page 6 of 9

Technik/Biomedical Engineering 35 (s3), 247-***-**** Books and Monographs

17. W. S. Warren and M. S. Silver, The art of Pulse crafting: Applications to Magnetic Resonance and Laser Spectroscopy, In: Waugh, J S, ed., Adv. Magn. Reson., New York: Academic Press, 1988:12 365 18. W. Wolf, M. S. Silver, M. J. Albright, H. Weber. U. Reichardt and R. Sauer. A Non-Invasive Study of Drug Metabolism in Patients as Studied by F-19 NMR Spectroscopy of 5-Fluorouracil. pp. 491-493, in "Physiological NMR Spectroscopy: From Isolated Cells to Man", Sheila M. Cohen and Jeffery R. Alger, ed.. New York Academy of Sciences, New York, 1988.

Dissertation

19. Silver, M. S. Selective Pulse Analysis: Generation of Highly Selective π/2 and π pulses for NMR Imaging and Spectroscopy Applications. Baltimore, Maryland: The Johns Hopkins University 1985. 99p. Magazine Article

20. AR. Gillams and M. S. Silver. Magnetization Transfer Offers Improved Brain Contrast, MR Magazine Nov/Dec 1993.

21. DI Hoult, MS Silver, CN Chen, Nuclear Magnetic Resonance Imaging in Medicine,J. of Comp. Assis. Tom. 6

(4), 862 1982

Abstracts of Presentations

22. M. S. Silver, R. I. Joseph, and D. I. Hoult, Selective pulse creation by inverse solution of the Bloch-Riccati Equation. Magn. Reson. Med. 1984; 1:294

23. M. S. Silver, W. Schajor, and H. Hedwig, Improvement in Image Quality through application of special selective pulses. SMRM Fourth Annual Meeting, Book of Abstracts, 1985; 1058 24. F. Loiaza, M. S. Silver, and W. S. Warren, Optimized 90 and 180 pulses for fast imaging and spectroscopy- a new generation of RF pulses. SMRM Fifth annual meeting, Book of Abstracts, 1986; 1,:480, 25. W. Wolf, J, R. Griffiths, M, Silver and H. Bruckner, Can NMR Contribute to the Radiopharmacokinetics of 5-Fluorouracil (5-FU) in Man?., Presented at the Symposium on Metabolic Imaging with NMR, SPECT and PET, held in Palm Beach, Florida March 3-5, 1986.

26. W. Wolf, M. Silver, M. Albright, H- Weber. U- Reichardt and R. Sauer, NMR Spectroscopy Studies of Fluorinated Drugs. Presented at the conference on "Physiological Spectroscopy: From Isolated Cells to Man, New York Academy of Sciences

27. M. S. Silver, W. Wolf, M. J. Albright, F-19 NMR spectroscopy of Fluorouracil metabolism in the liver. International Symposium on In vivo composition studies, October 1, 1986. 28. M. S. Silver, A. Shetty, R. D. White, and C. Paschal, Optimization of Flow Enhancement and suppression techniques in Cardiac Magnetic Resonance Imaging, SMRM Eighth Annual Meeting, 848 1989 29. M. S. Silver and A. Shetty, Improvement in visualization of the fine structures of the heart, Society of Magnetic Resonance in Medicine Eighth Annual Meeting, Book of Abstracts, WIP- 642, 1989 30. M. S. Silver, B. Ostertun, J. Gieseke, et. al., Improvement in MR Angiography of the Abdomen and extremities using very fast FFE sequence and segmented k space acquisition, Society of Magnetic Resonance in Medicine Tenth Annual Meeting, Book of Abstracts, 133, 1991. 31. B. Ostertun, E. Keller, P. van Dijk, M. S. Silver, and M. Reiser, Magnetic Resonance Angiography in postoperative control of peripheral bypass surgery. Proceedings of the Society of Magnetic Resonance in Medicine Annual Meeting, August 1991

Meir (Michael) S. Silver, Ph.D. Page 7 of 9

32. M. S. Silver, Invited lecture on New Angio techniques, Annual Angio meeting L'Aquila, Italy, October 1991. 33. M. S. Silver, 3D Fast Imaging of the Abdomen: Improvement in segmented k space acquisition, Society of Magnetic Resonance in Medicine Eleventh Annual Meeting, Book of Abstracts, 3243, 1992. 34. J. J. van Vaals, G. van Iperen, M. S. Silver, M. E. Bernardino, R. Nelson, and J. Chesmar, Optimization of T2 - weighted Turbo Spin Echo in Breathhold imaging at 1.5 T and 0.5 T., Society of Magnetic Resonance in Medicine Eleventh Annual Meeting, Book of Abstracts, 3207, 1992 35. AR. Gillams, M. S. Silver, and A. P. Carter, Magnetization Transfer contrast: The Solution for Dark CSF and T2 contrast in the Brain, SMRM Twelfth Annual Meeting, Book of Abstracts, 1433 (1993) 36. M. S. Silver and A. R. Gillams, Clinical Applications of MTC: a Technical Assessment. IEEE symposium on Nuclear Science and Medical Imaging, Proceedings, (1993) 37. R. Gillams, M. S. Silver, and A. P. Carter, Can MTC Provide New Insight into Intervertebral Disc Pathology

Presented MT Workshop SMRI/SMRM July 1993.

38. AR Gillams, M. S. Silver, and A. P. Carter, MTC and Spin-echo Imaging: A Time Efficient Method for Producing Both T2 lesion Contrast and Dark CSF. Presented MT Workshop, SMRI/SMRM July 1993. 39. AR. Gillams, M. S. Silver, and A. P. Carter. Magnetization Transfer Contrast; methods and clinical utility, Presented at the European Congress of Radiology, 1993 40. M. S. Silver, A. R. Gillams, Magnetization Transfer in Clinical Practice. Radiology, 189, (P) 289 (1993). 41. M. S. Silver, A. R. Gillams. Utility of magnetization transfer contrast. Presented at The Institute of Electrical and Electronic Engineers, Conference on Medical Imaging, November 1993 42. AR. Gillams, M. Benjamin, M. S. Silver, and A. P. Carter. Vessel diameter as a functional of MRA technique. Am. J. Radiol. 162, (3) 53, (1994).

43. AR. Gillams and M. S. Silver. On versus off resonance MT in clinical practice. Accepted for presentation at the Radiological Society of North America Annual Meeting, 1994. 44. D. T. Gibbens, A. I. Ahmed, M. S. Silver, E. K. Yucel. Comparison of five techniques for renal MR angiography. ARRS 94th Annual Meeting Proceedings 102 (1994), 45. F. A. Alameddine, E. K. Yucel, R. D'Agostino, L. Skibo, P. Hentzen, M. S. Silver, Carter AP, Accuracy of MRA in aorto-iliac occlusive disease: prospective comparison of three techniques. Association of University Radiologists 42nd Annual Meeting, 1-6 (1994)

Invited Lectures

46. Invited lecture: Advance MRI and Spectroscopy, NJ Chapter of the American Association of Physicists in Medicine, 16 May, 1988.

47. Fast MR Imaging Techniques presented at Montefiore Hospital Department of Radiology, 24 May, 1994. 48. Facing Challenges and Seizing Opportunities: Applications of Diagnostic Imaging to Pharmaceuticals Development and Neuro Science., presented at NIDA, Neuroimaging Section, Baltimore, MD, 1 March, 1995.

49. Lecture series on Medical Physics to Albert Einstein School of Medicine, Bronx, NY 1994 50. Lecture series on Medical Physics to St. Vincent's Medical Center, Department of Radiology, Staten Island, NY 1995.

Meir (Michael) S. Silver, Ph.D. Page 8 of 9

Number of Citations per publication.

Title / Author(s)

No. of

Citations

Year

1. Highly selective π/2 and π pulse generation MS Silver, RI Joseph, DI Hoult J. Magn. Reson. 59 (2), 347-351-***-****

2. Selective spin inversion in nuclear magnetic resonance and coherent optics through an exact solution of the Bloch-Riccati equation MS Silver, RI Joseph, DI Hoult Phys. Rev. A 31 (4), 2753

316 1985

3. Selective population inversion in NMR MS Silver, RI Joseph, CN Chen, VJ Sank, DI Hoult Nature 310 (5979), 681-683 154 1984 4. Fluorine-19 NMR spectroscopic studies of the metabolism of 5- fluorouracil in the liver of patients undergoing chemotherapy W Wolf, MJ Albright, MS Silver, H Weber, U Reichardt, R Sauer Mag. Res. Imag. 5

(3), 165-169

114 1987

5. The art of pulse crafting: applications to magnetic resonance and laser spectroscopy WS Warren, MS Silver Adv. Magn. Reson. 12, 247-384 124 1988 6. Quantification of blood flow with dynamic MR imaging and presaturation bolus tracking. RR Edelman, HP Mattle, J Kleefield, MS Silver Radiology 171 (2), 551-556

135 1989

7. FRODO pulse sequences: a new means of eliminating motion, flow, and wraparound artifacts. RR Edelman, DJ Atkinson, MS Silver, FL Loaiza, WS Warren Radiology 166 (1), 231-236

97 1988

8. MR angiography of normal pelvic arteries: comparison of signal intensity and contrast-to-noise ratio for three different inflow techniques. EK Yucel, MS Silver, AP Carter Am. J. of Roent. 163 (1), 197-***-**-****

9. Optimization of spoiler gradients in FLASH MRI ML Wood, M Silver, VM Runge Mag. Res. Imag. 5 (6), 455-***-**-****

10. MR imaging section profile optimization: improved contrast and detection of lesions. VM Runge, ML Wood, DM Kaufman, MS Silver Radiology 167 (3), 831-834

17 1988

11. Selective pulse creation by inverse solution of the Bloch-Riccati equation M Silver, R Joseph, D Hoult Proc. 2nd SMRM, Works in Progress, 22 13 1983 12. Clinical utility of a new contrast option from magnetization transfer contrast AR Gillams, MS Silver, AP Carter J. of Mag. Res. Imag. 5, 545- 545

9 1995

13. Excitation performance in inhomogeneously broadened systems F Loaiza, MA McCoy, MH Levitt, MS Silver, WS Warren J. of Magn. Reson.

(1969) 76 (3), 504-527

4 1988

14. A Non-invasive Study of Drug Metabolism in Patients as Studied by 19F NMR Spectroscopy of 5-Fluorouracil W Wolf, MS Silver, MJ Albright, H Weber, U Reichardt, R Sauer Ann. NY Acad. of Sci. 508 (1), 491-***-*-****

15. MR arterio-and venography: strategies for using 2D and 3D inflow procedures]. J Gieseke, B Ostertun, L Solymosi, F Trהber, P van Dijk, M Silver, M Reiser Biomedizinische Technik. Biomedical engineering, 35 1990

16. MR-Arterio-und Venographie: Strategien zum Einsatz von 2D-und 3D- lnflow Verfahren J Gieseke, B Ostertun, L Solymosi, F Trהber, P van Dijk, 1990

Meir (Michael) S. Silver, Ph.D. Page 9 of 9

M Silver, M Reiser Biomedizinische Technik/Biomedical Engineering 35

(s3), 247-248

17. Pulse sequence optimization for T2-weighted MR imaging of the brain EC Unger, JS McGlone, MS Silver Mag. Res. Imag. 7 (2), 119-***-****

18. Crafted Pulses For Imaging and in-Vivo NMR Spectroscopy F Loaiza, MA McCOY, WS Warren, MS Silver, H Egloff Ann. NY Acad. Sci. 508

(1), 483-487

1987

19. Selective Pulse Analysis: Generation of Highly Selective π/ 2 and π Pulses for Nuclear Magnetic Resonance Applications MS Silver The Johns Hopkins University

1985

20. Nuclear Magnetic Resonance Imaging in Medicine DI Hoult, MS Silver, CN Chen J. of Comp. Assis. Tom. 6 (4), 862

1982



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