Amnion Life Executive Team
Amir Fassihi M.D.
Dr. Fassihi performed his undergraduate work in the field of biology and ecology at UCLA. He was ranked 161 amongst a pool of nearly 35,000 applicants to UCSF School of Medicine for the 1995 incoming class. Upon obtaining his medical degree from UCSF, he spent a year as an intern in general medicine department at VA/West LA Medical Center followed by residency in field of radiology at Keck/USC Medical Center followed by a year of fellowship in Neuroradiology during which time he was the Chief Fellow.
He is a full-time radiologist working as a teleradiologist for Virtual Radiologic and he plans to continue his full-time work as a radiologist during the upstart stage of Amnion Life. Dr. Fassihi intends to initiate operations as the CEO to ensure a smooth operations transition and to build a culture for employees to share in the same dedication and work towards the success of Amnion Life.
Bradley is a member of the Montgomery County, Maryland Parks and Recreation Advisory Board which advises Montgomery County’s Parks and Recreation departments on a variety of issues. This county’s Recreation Department has an $80 million+ budget, and its Parks Operations, through M-NCPPC has a $135 million+ budget. Bradley has extensive experience in working with foreign investors. He has previously served on the Alumni Board for the Bullis School.
Business & Market Development Consultant
Unicorn Capital - Partner
Amnion Life Team
Amnion Life Engineers
BSc Mechanical engineer, with nine years of experience in R&D and production areas, as well as experience in laboratory as a tester and manager.
Experience in system instrumentation and automation top level and detail design, involving activities such as 3D and 2D CAD design, FEA/CFD and prototyping of new and re-engineering or retrofit of existing products, as well as sizing calculations, material selection, producing workshop drawings and technical data sheets. Supervising prototype manufacturing and testing. Application of relevant standards and codes to a product design. Laboratory setup, testing and management according to ISO 17025
Bachelor of Engineering (B.Eng.), Mechanical engineering | Mechanical Faculty of Nis, Serbia 2003 – 2010
Productions engineering, rapid prototyping, preparation of technical documentation for production, R&D
Mechanical engineer with 30 years of experience in the design of machines, tools and equipment for the production of the civilian sector. 3D/2D CAD SolidWorks as an optimal software for the realization of projects.
Bachelor of Engineering (B.Eng.), projecting and production | Faculty of Engineering 1974 – 1979
PhD in Engineering(FEA,CFD) & Architecture (3D, 2D and Product Design)
Knowledge and experience in the entire design process, from requirements, schematics, simulations, PCB layout, to build and test a physical prototype. Also have skills in programming micro controllers, FPGAs, PLCs, or desktop applications.
Skilled in: Protel, PSpice, Xilinx-ISE, MATLAB, Delphi, Visual Studio.
Programing languages: C, C++, VHDL, Relay Ladder, Pascal, Java, HTML.
– Maintenance of telecommunication systems in telecoms company.
– Work in the company for the production of DDR memory, MP3 player, USB memory. Release in serial production of devices, quality control of products.
– Experience in designing PCB board on the Protel and Altium platform,
– Design of devices based on Microchip and Atmel controller. Creating programs for microcontrollers with 8 bit processor , in the Image Craft environment.
– Design of embedded devices based on 32-bit controller STM 32F407. The application development platform is Keil uVision4.
– Creating applications for the Windows environment in Delphi 7. Applications are intended as HMI for projects where one of the controllers is used.
– 13 years of experience in making applications (ladder diagram and Structured Control Language) for Siemens PLC controllers. Environment is Step7, the Tia portal. Applications have been made for the control and monitoring of pumping plants, drinking water treatment plants, presses, sintering lines, etc ..
– Creating applications for Unitronics PLC controllers in the U90 environment.
– Production of applications for HMI devices manufactured by: Siemes, Wintec and Schneider.
– Creation of SCADA applications in WinCC environment up to 8000 tags.
CAD Design – Drafting
BSc Mechanical engineer with 7 years of experience in the design of tools and equipment for the production of the civilian sector.
3D/2D CAD SolidWorks as an optimal software for the realization of projects.
Telecommunication engineer – Software regulator and engineering consultant
Engineer of chemical technology & pharmaceutical engineering
I worked as engineer of technology in R&D department and as Production manager in plants which manufactured household and industrial chemicals, personal care and cosmetics. Parallelly working for more then 6 years now as chemical adviser for subjects from Serbia and abroad. Possessing national chemical adviser license – REACH EU regulations, related to Registration, Evaluation, Authorization and Restriction of chemicals and biocides in EU. From 2016 I work as independent consultant for chemicals, biocides and cosmetic formulations, as part of ChemEng Pro team(Netherlands), for clients from all over the world from my homeoffice. Through work experience I worked also as responsible person for ISO 9001, 14000, 18000, HACCP and as licensed internal auditor.
Part of my university education was also Medical devices, related regulations and professional practices of it.
I speak English fluently and use it in everyday communication, learned German and Swedish (B1 level) but do not use it.
Michael Drues, Ph.D.
Danny has led teams in small, medium, and large companies at site, divisional, and corporate levels. He has hands-on experience with R&D, Clinical Investigation, Manufacturing, and Post-market Surveillance operations. Danny is passionate about application of this experience, and deep knowledge of regulations, for rapid device commercialization.
Danny holds an engineering degree from RMIT University in Melbourne, Australia and an MBA from IE Business School in Madrid, Spain. He is an ASQ Certified Quality Manager, ASQ Certified Biomedical Auditor, and IAPP Certified Information Privacy Professional.
Quality Management Team
Quality Systems Specialist and Regulatory Affairs Consultant
Auditing, Medical device, Quality Management Systems, Risk Management, Regulatory Requirements, Technical File for CE Mark, Software Validation, ISMS, ITSM, Process Control, System Improving, Quality Assurance process of production medical devices and laboratory devices in accordance to ISO 9001, ISO 13485, FDA QSR 21 CFR Part 820, ISO 14971, MDD (93/42/EEC) and Regulation (EU) 2017/745.
Risk Management, Risk Analysis and Hazard Identification Consultant
Pharmaceutical and Medical Device Consultant having more than 15 years of experience in end to end implementation of:
– Quality Management System Implementation (ISO 9001: 2015, ISO 13485, ICH Q7 & Q9, USFDA, 21CFR part 210, 211, 820, EU GMP) in pharma, bio-pharma and medical device facilities.
Dragan Cibrev, M.D.
MSc in Health Sciences
Having a background in clinical epidemiology, he is eager to address issues regarding translation of novel findings to the clinical practice. His main tools are : IBM SPSS, R studio, Endnote, Microsoft Office.
Sourcing, Supply Chain and Procurement
Procurement and Supply Chain Specialist
Mohamed is an International Procurement and Supply Chain Specialist Consultant with more than 17 years of experience in that field both in North America and Europe. With a focus on technology, consumer products, and industrial systems, Mohamed’s expertise covers several industries such as Oil & Gas, Healthcare, Aircraft, and Energy. As a procurement expert, he helps clients reduce their spending on third-party goods and services across both direct and indirect categories. Also, he has worked with clients on large scale cost reduction programs as well as functional organization transformations.
Mr Reed will be providing assistance in a wide range of executive duties for Dr. Fassihi and the staff of Amnion Life LLC.
Jonathan Abels has 5+ years experience in customer service and recently developed a background in handling administrative duties. He specializes in various administrative tasks, communicating with clients, supporting the scheduling of meetings and various events as well as providing a high level of support and organization to C-suite executives.
Michael Narvey M.D.
Mohamed Hamed M.D.
PhD Pediatrics and Neonatology
Hamed returned to the department of Pediatrics and Neonatology in the Nagoya City University as a lecturer from 2010 to 2013 during which he also worked with the Cure2Children foundation, an international medicinal collaboration with professionals and institutions in developing countries committed to the cure of children with severe hematological diseases, for two years.
From 2013 Hamed joined the Neonatology division of Saitama Medical University as an Assistant Professor of Neonatology. He has special interest in resuscitation and respiratory support of preterm infants.
Joe Kaur M.D.
She has elaborated her competence in clinical research and regulatory writing through her training as a Clinical Research Associate (CRA) and work experience as a research and clinical trials assistant in clinical research related to Bioequivalence/Bioavailability studies and Phase I-IV clinical trials involving different therapeutic areas and medical devices. She got certified with Association of Clinical Research Professionals (ACRP), United States as ACRP Certified Professional and is affiliated as a member with ACRP, Society of Clinical Research Associates (SOCRA) and American Medical Writers Association (AMWA). In addition, the medical and clinical research experience in United States and India developed her insight into research methodologies in the field of clinical trials, Physiology and Psychology, which also boosted her writing and critical thinking skills.
Before focusing on clinical performance analysis, Nathan worked in wide-ranging roles for various medical device companies, with particularly extensive experience in regulatory affairs. He brings a regulatory mindset to each project, and is well-versed in how MEDDEV 2.7/1 r4 and the MDR affect clinical evaluation strategies. As a consultant, he has experience collaborating with individual innovators, startups, and established medical device manufacturers. Nathan has personally authored over 25 CERs and helped numerous companies develop clinical evaluation processes, working closely with internal cross-functional teams and external regulatory entities to ensure deliverables meet the needs of all stakeholders.
He holds a BS in Biomedical Engineering from Bucknell University.
With nearly 7,000 neonatology doctors, nurses and NICU professionals in their membership, 99NICU.org provides Amnion Life an unparalleled access and advice to help us build an international team of medical experts who can oversee the company’s design and development of medical devices for preterm infants and help design and draft the very important clinical trials for our devices.
Corporate Legal Team
Corporate Legal Team
The firm is nationally recognized for providing high-quality services to address the legal solutions required by its enterprise and financial institution clients. Our services include corporate law and governance, public and private offerings of equity and debt securities, mergers and acquisitions, securities class action litigation, intellectual property litigation, antitrust counseling and litigation, joint ventures and strategic alliances, technology licensing and other intellectual property transactions, tax, and employee benefits and employment law, among other areas.
With long-standing roots in Silicon Valley and 15 offices in technology, business, and regulatory hubs worldwide, Wilson Sonsini Goodrich & Rosati has a national presence with a global reach. Over the past five decades, we have developed a wide-ranging international practice, with particular strength in North America, Asia, and Europe.
J.D., University of California, Hastings College of the Law, 2015
Cum Laude; Recipient, CALI and Witkin Award for Highest Grade in Investment Management; Inductee, Pro Bono Society; Executive Managing Editor, Science & Technology Law Journal
B.A., Philosophy, UCLA, 2011
With Highest Honors, College Honors Program; Cum Laude; Departmental Honors in Philosophy
State Bar of California
Jennifer Knapp represents public and private life sciences and technology companies, as well as venture capital and other institutional investors. She focuses on the representation of companies throughout their entire life cycle from formation to exit, and in all manner of strategic and complex transactions, including corporate formation and structuring, venture capital financings, corporate governance, spin-ins and spin-outs, mergers and acquisitions, public offerings, public company disclosure requirements, and SEC compliance matters. She also has significant experience advising investors with respect to venture capital financings and other strategic investments and transactions.
J.D., University of California, Hastings College of the Law, 2001
Magna Cum Laude
B.A., Sociology, University of California, Santa Barbara, 1997
ASSOCIATIONS AND MEMBERSHIPS:
Member, Board of Advisors, Palo Alto Humane Society
Member, Board of Advisors, Food Empowerment Project
Wilson Sonsini Goodrich & Rosati Pro Bono Service Award, 2010-2011
Co-author, “Preparing for an Initial Public Offering” chapter in Advising High-Technology Companies, Practicing Law Institute, 2006
State Bar of California
Zach Jun Hyuk Hong J.D.
Associate at Knobbe and Martens
Cornell Law School (J.D. 2011)
The Johns Hopkins University (B.S. Chemical & Biomolecular Engineering 2008)
Thomas Yee J.D.
Partner at Knobbe and Martens
Bryan Wahl M.D.
Partner at Knobbe and Martens
Other Market and Business Development
Hani Sharestan started his career in public accounting in 1993 with a large national firm, before joining Wright Ford Young & Co. in 2006. He obtained his master in business taxation (MST) degree from the University of Southern California and his undergraduate degree from California State University, Fullerton.
Accountant - Serbia
Faculty of Organizational Sciences – year 2012
– Over 5 years of work experience in accounting and financial reporting working in meat production and trade company. Also I’ve been working in bookkeeping company for 2 years and external associate for audit company from Belgrade.