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Biotechnology Consultants

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William Acorn, P.E., FASHRAE
Principal
10617 N Hayden Rd, Suite B-108
Scottsdale AZ 85260
USA
phone: (602) 888-7250
fax: 520-577-0851
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William Acorn Technology Analysis ExpertWilliam R. Acorn, P.E., FASHRAE, is principal and founder of Acorn Consulting Services, LLC (ACS). For over 35 years, he has been involved in the Engineering Analysis and Design of hundreds of projects ranging from Institutional Laboratories to Cleanroom Facilities for the semiconductor industry.

Mr. Acorn has significant experience as an Expert Analyst of System Design, System Failures, Code Compliance issues and Cause/Effect relationships of problems related to the built environment. Mr. Acorn has received numerous awards for technical excellence and is recognized for his technical achievements, innovation and foresight by peers, associates and clients in the advanced technology industry.

Mr. Acorn is an Adjunct Professor at Arizona State University; the author of the book Code Compliance for Advanced Technology Facilities; and a frequent lecturer to the industry and academia on a variety of technical topics related to building and cleanroom design, construction and project management.

Mr. Acorn is registered as a Professional Mechanical Engineer in the States of Arizona, California, Colorado, Illinois, Iowa, Nevada, New Hampshire, New Mexico, Oregon, Texas and Utah. He is also registered with the National Council of Examiners for Engineering and Surveying.

Forensic & Litigation Consulting

Analysis and evaluation of losses related to failed systems or other facility performance issues is provided on behalf of owners or attorneys. These services are provided with regard to deficiencies in HVAC Systems, Cleanrooms, Piping Systems, Refrigeration Systems, Construction Claims, Building and Fire Codes:
  • Litigation Consulting
  • Technical Analysis and Investigation
  • Claims Preparation and Analysis
  • Expert Testimony
  • Project Consulting

    ACS assists their clients to optimize the outcome of new and retrofit facilities by providing a range of high level services including:
  • Strategic Planning: Conceptual Design; Feasibility Studies & Evaluations; Value Engineering
  • Facility Retrofit and Renovation Strategies
  • Program Management: Project Delivery Strategies; Selection of Design and Construction Teams
  • Design Consulting and Design Review
  • Code Compliance Analysis and Negotiation
  • 4/11/2005 · Construction
    Introduction: In our first Volume of the Forensic Exchanger, we discussed some of the all too many reasons why HVAC systems fail. If you missed that edition and are interested in that topic e-mail us and we will gladly send it to you. We will follow up with more discussion of that important topic in later editions

    William R. Acorn
    Facilities which utilize hazardous liquids and gases represent a significant potential liability to the owner, operator, and general public in terms of personnel safety and preservation of assets. It is obvious that a catastrophic incident or loss of property or personnel is to be avoided at all costs. This book was conceived to give the reader a guide to understanding the requirements of the various codes and regulations that apply to the design, construction, and operation of facilities utilizing hazardous materials in their processes.
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    Esam Z. Dajani, Ph.D., FACG
    Professor
    1549 RFD
    Long Grove IL 60047
    USA
    phone: 847-634-9586; 847-971-7555
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    Professor Esam Z. Dajani, Ph.D., FACG is the President and Founder of IDDC Corporation, a contract research organization, that provides consulting services in Pharmacology, Toxicology, Therapeutics, Biotechnology, Drug Development, Pharmaceutical Patents and Regulatory Affairs to pharmaceutical companies, governmental agencies, and law firms. Professor Dajani is an experienced pharmacologist and toxicologist with extensive knowledge of all phases of drug discovery and development. With over 30 years of experience in pharmaceutical research and development, he has directed global clinical research at major multi-national pharmaceutical companies and led the research teams that discovered and developed misoprostol(Cytotec), a global anti-ulcer drug.

    IDDC Corporation provides broad consulting services related to the development and successful registration of drugs, biological and medical devices. IDDC Corporation generates development plans and preliminary cost evaluation for product commercialization. IDDC Corporation provides consulting services for drug discovery and placement of pre-clinical pharmacology and toxicology and pharmaceutical development studies. IDDC Corporation assists the clients in the clinical development (Phases I-IV)and placement of clinical studies. IDDC selects the appropriate research facility at equitable price for the sponsors. IDDC prepares and reviews protocols design, clinical case report forms, study reports and summaries. The regulatory affairs consulting services include the preparation and filing of regulatory dossiers, e.g., IND's and NDA's. IDDC provides scientific reviews of new health care products and potential in-licensed products to pharmaceutical companies, venture capital firms and investment organizations.

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    2/20/2013 · Medical
    It is well established that the use of traditional nonsteroidal anti-inflammatory drugs (NSAIDs) increases the vulnerability of the gastrointestinal (GI) mucosa for the development of peptic lesions and serious ulcer complications. In addition, selective and traditional NSAIDs have also been associated with increased frequency of cardiovascular toxicity, especially in susceptible patients.

    12/14/2012 · Pharmaceuticals
    During the last twenty-five years, a remarkable revolution in the pathophysiology and treatment of gastric (GU) and duodenal (DU) ulcers has occurred. Effective therapies were developed not only to heal ulcers but also to cure most patients.

    Esam Z. Dajani, N.M. Agrawal
    A chapter in the book: NSAIDs - Mechanisms and Clinical Use. Eds. Lewis AJ, Furst D, Marcel Dekker, New York, PP 159-170, 1994.
    Esam Z. Dajani, H. Gallo-Torres
    Chapter in the book: Ulcer Disease: Investigation And Basis For Therapy. Eds. Szabo S, Swabb E, Marcel Dekker, New York, PP 459-485, 1991
    Esam Z. Dajani (ed.), Gabriele Bianchi Porro (ed.)
    Esam Z. Dajani, PhD, FACG
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    Alan Schwartz
    Executive VP
    55 Northern Blvd.
    Great Neck NY 11021
    USA
    phone: 516-482-9001
    fax: 516-482-0186
    mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

    OUR APPROACH

    We utilize the following three part approach to providing high quality services to our clients:
  • Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients
  • Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment
  • Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)
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    George Yanulis, MEng, MS, DEng
    210 Ashley Run
    Voorhess NJ 08043
    USA
    phone: 216-571-1532
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    Medical Device Consulting, LLC provides Biomedical, Clinical, and Forensic Engineering services to hospital systems, medical device companies, insurance carriers, and legal practitioners in both medical device liability and patent cases.

    Medical Device Consulting, LLC offers Medical Device Research and Development and Clinical Engineering Consulting Services for medical instrumentation devices including:
    • Cardiovascular and neurological device design issuesIntellectual property related to medical devices and imaging systems
    • FDA medical device regulatory compliance controls
    • FDA regulatory issues of medical devices
    • FDA device verification and validation
    Principal, George Yanulis, MEng, MS, DEng, is a nationally recognized Cardiovascular Device Product Development and Research Engineer and has conducted cardiovascular device research at the Cleveland Clinic Foundation. He has published in the areas of atrial fibrillation (AF), cardiac pacing, and congestive heart failure devices.

    Dr. Yanulis has a Doctorate in Engineering in a joint program between Cleveland State University and the Cleveland Clinic Foundation in Biomedical Engineering; a Master of Science from the University of Pittsburgh; and a Master of Engineering in Biomedical Engineering from the University of Virginia.

    Dr. Yanulis’ Medical technology experience has consisted of familiarity with the design, use, and applications associated with a variety of medical devices and software used for: cardiac pacing, ventricular assist, cardiac echocardiography and electrophysiology, vascular stents, physiological monitoring, medical imaging, neurological therapy, surgery, among others. He is currently teaching a cardiac device course in Temple’s Bioengineering Department and has been involved in research and development of cardiac pacing systems at the Cleveland Clinic.

    View Dr. Yanulis' Expert Witness Profile.
    7/12/2017 · Failure Analysis
    Plaintiff was admitted to a health care facility with ventricular tachycardia (VT). He had a normal coronary angiography with moderate left ventricular (LV) function and was referred for an implantable cardiac defibrillator (ICD) implant procedure. A diagnosis of right ventricular outflow tract tachycardia was made. He was then admitted for an ablation procedure in March 2005, which was successful. In April 2005, he was readmitted with a further occurrence of tachycardia which required emergency cardio version due to hemodynamic compromise and a temporary pacing wire was placed. There was a further attempt at ablation that was again successful and the LV function noted now to have deteriorated and was noted as having poor functioning. On this basis he was considered a candidate for an ICD implant. There was a further reoccurrence of an episode of ventricular tachycardia (VT) in March and April 2006 which was treated medically and he was discharged.

    6/13/2017 · Medical
    The Medtronic's Enpulse Model E2DR21P Serial number PMU411109 as well as the Atrial Lead (model #496525, SN: LBT042477R-Epicardial Unipolar and the Ventricular Lead (model #496525, SN: LEN036731R- Bipolar Epicardial had been used to continually pace patient in the DDD pacing mode during patient's lifetime. The expert referred to all Medtronic specifications; warnings; and advisories relevant to both the pacemaker and pacing leads used for pacing this completely pacemaker dependent patient).

    8/30/2012 · Medicine
    Protocols for producing experimental heart failure by rapid ventricular pacing are well established [1]; however, for safety reasons, commonly used clinical pacemakers do not allow pacing rates that are sufficient to induce either heart failure (HF) or atrial fibrillation (AF).

    6/27/2012 · Medical
    Cardiac resynchronization therapy (CRT) has been shown to improve symptoms and survival in patients with systolic dysfunction and prolonged ventricular depolarization (wide QRS).1-8 However, atrial fibrillation (AF) may cause significant problems in these patients, particularly when the ventricular rate exceeds the device programmable rate.

    4/23/2012 · Medical
    Recent studies have demonstrated that ventricular rate control is a viable treatment strategy for patients in atrial fibrillation (AF). The purpose of this study was to determine whether or not the benefits of coupled pacing (ie, a proposed rate control therapy) could be used during persistent AF.

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    Dr. Bruce C. Hemming
    PhD, President/CEO
    See Multiple Addresses Below
    St. Louis MO 63119-3421
    USA
    phone: 314-645-2177 or 800-688-9144
    fax: 314-645-2544
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    Microbe Inotech Laboratories, Inc. (the MiL, Inc.) is a full Microbiological Lab that provides consulting service through five distinct laboratory sectors: Environmental, Food Safety, Industrial Hygiene, Pharmaceutical / Biomedical, and Governmental. The MiL's goal is to solve problems related to microbial detection and identification. They work with many top companies performing research and development as well as microbial testing.

    Dr. Bruce C. Hemming, PhD - President & CEO of Microbe Inotech Laboratories, Inc. (The MiL, Inc.) is an accomplished science and business professional with over 40 years of real-world experience in Microbiology and its practical applications. He currently serves on three biotechnology committees for multi-disciplinary teams involved in original research. He has earned several patents on his research within the field of microbiology.

    Helix Center (Core Lab)
    1100 Corporate Square Drive, Ste. 225
    St. Louis, MO 63132
    Telephone: 800-688-9144
    Microbe Scan, LLC
    1100 Corporate Square Drive, Ste. 224
    St. Louis, MO 63132
    Telephone: 800-688-9144


    View Dr. Hemming's Expert Witness Profile.
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    Michael Arrigo
    620 Newport Center Drive
    Suite 1100
    Newport Beach CA 92662
    USA
    phone: 949-335-5580 x101
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    No World Borders advises clients regarding disruptive regulations and disruptive technology in health care. Their team has worked in hospital systems performing direct observation of front-line clinical staff, and understand the administrative back office environment and how care is delivered. Their Clinically Integrated Solutions facilitate coordination between the siloes to improve health care quality and value.

    Michael Arrigo, CPHIT, CPEMR - Managing Partner, Health care Practice is a Stanford Medical School educated Bio Informaticist who works with health systems, health IT companies, and health plans.

    He has in-depth experience in HIPAA mandates, the HITECH Act and Patient Protection and Affordable Care Act (PPACA) and is a published author and regular speaker. He consults to clients including Health IT investors, Health IT companies, and health plans and hospital systems in matters regarding:
    • HIPAA 5010
    • ICD-10
    • Revenue Cycle Management
    • Meaningful Use of Electronic Health Care Records
    • Quality Measures for Medicare Advantage Hospital Value Based Purchasing
    • Medicare Advantage HEDIS 5-Star Ratings for Health Plans
    Mr. Arrigo is an expert in participatory social media for building brands and crowd sourcing solutions. He was recently quoted in the Wall Street Journal Venture Capital Dispatch and Wall Street Journal Health Blog regarding venture-backed information-technology companies that serve hospitals and health insurers. He provided a macroeconomic analysis of the reimbursement risk of the transition to ICD-10 CM and ICD-10 PCS on the U.S. health care economy in comparison to the impact of the mortgage backed securities devaluation and diligence work for a premier venture capital firm in the U.S on their investment in medical analytics, a health plan, physician group, and accountable care organization solutions.

    View Michael Arrigo's Expert Witness Profile.
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    T. Kim Parnell, PhD, PE
    Principal
    1150 Kelsey Dr.
    Sunnyvale CA 94087
    USA
    phone: 408-203-9443
    Parnell-Engineering-Logo.jpg

    Medical Device, Biotech, Failure Analysis, Mechanical Eng, Materials, Design, Reliability, Consultant

    Kim Parnell Mechanical Engineer Expert PhotoParnell Engineering & Consulting (PEC) is a high-tech Mechanical Engineering Consultancy located in the heart of Silicon Valley. PEC focuses on providing technical support for early stage medical device and technology companies nationally and internationally.

    T. Kim Parnell, PhD, PE, Principal and Founder of PEC, is a Mechanical Engineering consultant with strong experience in a number of technology areas. Dr. Parnell holds PhD and MSME degrees from Stanford University in Mechanical Engineering and a BES from Georgia Tech. He specializes in the mechanical engineering design and behavior of Biomedical Devices, Superelastic and Shape Memory Metals (Nitinol), Bioabsorbable Polymers, Composites, Fiber-Reinforced Materials, Electronics, and Consumer Products.. Dr. Parnell consults actively in these areas using finite element analysis and other advanced technologies to improve designs, to perform failure analysis, and to improve reliability.

    Dr. Parnell served on the Mechanical Engineering faculty at Santa Clara University from 2010-2012 and was previously a Visiting Associate Professor at Stanford University. He lectured in the Stanford Composites Design Program, and is a coach and mentor for the innovative Stanford Biodesign Program. He has worked for companies including MSC Software, Rubicor Medical, Exponent Failure Analysis Associates, SST Systems, ATT Bell Laboratories, Stanford University, and General Motors.

    Areas of Expertise:
    • Medical Device / Biotechnology - Cardiovascular, Orthopedic, Orthodontic
    • Patents & Intellectual Property
    • Plastics, Molding, & Manufacturing
    • Composite Materials Design & Damage
    • Materials & Metallurgy
    • Failure Analysis & Reliability
    • Fracture & Fatigue
    • System Specifications & Test Procedures
    • Telephone Set Design; Keypads
    • User Experience & System Interaction
    • User Interface Design
    • Software Design, Development, QA
    • Green Energy: Wind Energy, Electric Vehicles, Battery technology, Solar
    • Structural Mechanics, Fluid Mechanics, Heat Transfer, & Thermodynamics
    • Finite Element Analysis of Structures and Fluid / Heat Transfer (FEA/CFD)
    • Piezoelectric components
    • Transducers, Accelerometers, MEMs
    • Vehicle & Heavy Truck Crash Worthiness
    • Shock & Vibration Sensitivity
    Selected Professional Memberships:
    • Registered Professional Engineer (Mechanical), California
    • ASME (American Society of Mechanical Engineers), Fellow
    • SAE (Society of Automotive Engineers), Member
    • IEEE (Institute of Electrical & Electronics Engineers), Senior Member
    • ASM International, Member
    • SMST (Shape Memory and Superelastic Technologies), Member
    View Dr. Parnell's Expert Witness Profile.
    Rail residual stress distributions can be complex and variable in nature, as different manufacturing techniques produce varying stress magnitudes and distributions. To evaluate the effect of residual stresses on rail integrity, an analysis technique was sought that could quantify the effect of these stresses on web crack propagation.

    The computer program LS-DYNA3D was used to simulate the behavior of a specific, though representative, heavy truck cab-over tractor-trailer vehicle during a full 180° rollover event. These simulations provide a key component in the development of a physical testing procedure for evaluating structural integrity and occupant crash protection system designs in heavy trucks.

    2/18/2014 · Medical
    The United States Food & Drug Administration (FDA) requirements for Class III implantable medical devices requires a 10 year life, or approximately 400 million cycles of service.