Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.
As a consultant in his own pharmaceutical development advisory firm for over 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors.
Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.
Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more
Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness and consultant to litigation in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.
T. Kim Parnell, PhD, PE is a Professional Mechanical Engineering consultant and is Principal & Founder of Parnell Engineering & Consulting (PEC). Dr. Parnell holds PhD and MSME degrees in Mechanical Engineering from Stanford University, a BES from Georgia Tech, and is a registered Professional Mechanical Engineer (PE) in the State of California. He is an ASME Fellow, an IEEE Senior Member, and a Member of ASM and SAE. Dr. Parnell is Past-Chair of the IEEE Santa Clara Valley Section (IEEE-SCV) (over 12,000 members) and Past-Chair/Board Member of the IEEE Consultants' Network of Silicon Valley (IEEE-CNSV).
Litigation Support - Dr.Parnell is an experienced Expert Witness, has provided testimony in both trial and deposition, and has authored numerous expert reports and IPR declarations. He has worked extensively as an expert in medical devices, patents, product failure, product liability, and personal injury.
Dr. Parnell has been retained in medical device litigation cases that are in the news and adjudicated in MDLs. Products include IVC Filters (Inferior Vena Cava Filters), Pelvic Mesh, Transvaginal Mesh, Intragastric Abdominal Balloon Weight Loss Systems, Back Pain Reduction Systems, and others. Dr.Parnell brings both breadth and depth of experience to clients. He has over 34 years of professional consulting experience, has taught both graduate and undergraduate University classes (Visiting Professor at Stanford University & Adjunct Professor at Santa Clara University), and has also worked in industry.
Dr. Parnell's industrial positions include sectors such as software, hardware, medical devices, and telecommunications equipment. He has extensive experience in areas including patents, medical devices, Nitinol shape memory alloy material, mechanical failure of products or equipment, and material failure by fracture or fatigue. Dr.Parnell frequently works with early-stage companies as both a technical consultant and a business advisor in sectors including medical devices and flash memory technology.
Areas of Expertise:
Patents and Intellectual Property
Medical Devices; Medical Instrumentation
Shape Memory Alloys; Nitinol
Finite Element Analysis (FEA) & Simulation
Cell Phones, Personal Electronic Devices
Laptop Computers, Keyboards, Keypads
Gas Leaks, Pipe Failure, Vapor Cloud Explosions
Solar Trackers; Solar Energy; Wind Energy;
Battery Technology; Electric Vehicles
Shape Memory Materials; Nitinol
Heavy Truck Crashworthiness
Product Design Refinement
Piping, Pressure Vessels
Failure Analysis; Reliability
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
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.
I am the Managing Partner, Healthcare Practice for our firm. We work with health systems, health IT companies, and health plans. My recent retentions by the U.S. Department of Justice (DOJ). Drug pricing, patent infringement, medical coding and billing, and Qui Tam False Claims Act and fraud case specialties. 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 Privacy Rule, HIPAA Security Rule, HIPAA Breaches, 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 was recently quoted in the Wall Street Journal Venture Capital Dispatch regarding medical coding standards and Wall Street Journal Health Blog regarding venture-backed information-technology companies that serve hospitals and health insurers.
Clinical documentation improvement (CDI) initiatives are underway in healthcare organizations across the country, with the aims of improving care and reducing costs. Are they working? At least one such initiative, at Baptist Health South Florida, is providing solid return on investment.
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.
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)
Peter A. Crosby has over 35 years experience in the Medical Devices Industry. He has been the CEO of six medical device companies (public and private) in four countries, and has been a member of the board (including chairman of the board) of over 10 companies.
Mr. Crosby is an accomplished entrepreneur and company builder, and has brought many medical device products to the world market. In 2017, he retired as CEO from Mainstay Medical, after spending over 8 years as the founding CEO, doing several rounds of financing, taking the company public in Europe, and bringing Mainstay’s ReActiv8 to market in Europe. Although he continues to work with the company on a consulting basis, he has shifted his focus to helping other companies grow, as a board member, advisor, and in interim management.
With a university education in Biomedical Engineering, Mr. Crosby is the inventor on over 30 US patents and applications pending. He has managed the intellectual property portfolio of several companies. His clinical domain experience includes ophthalmology, otolaryngology, cardiology, cardiac surgery, orthopedics, pain management, anesthesia, and intensive care.
Litigation Support - Mr. Crosby has served as an expert witness in many cases including product liability, intellectual property (patent disputes), and commercial contracts disputes. He has testified in three cases in which the outcome hinged on interpretation of “commercially reasonable efforts.” Mr. Crosby's services are available to attorneys representing plaintiff and defendant.
Imagine this scenario: Early stage company Smallco develops an exciting new technology, which it uses to create the prototype of its first product - Brakethroo! A large company in the same field, Bigco, becomes aware of Brakethroo, and realizes that if the product works as hoped, it could be a valuable addition to Bigco's product range. Bigco offers to buy the technology and product from the shareholders of Smallco. The merger and acquisition (M&A) agreement specifies an up-front payment, and one or more payments dependent on achievement of milestones. Bigco agrees to use "commercially reasonable efforts" to achieve the milestones. Smallco and Bigco sign the agreement, the shareholders of Smallco get an immediate payout and look forward to further milestone payments.
William R. Acorn is founder of Acorn Consulting Services, LLC, an engineering firm. As a consulting mechanical engineer, Bill provides project analysis, forensic reconstructions and litigation support services relating to the design, delivery, and functioning of high-tech manufacturing facilities, semiconductor fabrication facilities, institutional laboratories, data centers, health care facilities and a variety of commercial buildings. He is a recognized expert in the evaluation of deficiencies in HVAC systems, cleanrooms, piping systems, refrigeration systems, construction defects, building and fire code compliance, and patent and trade secret disputes. He represents both plaintiffs and defendants.
Bill has more than 40 years of experience as a professional engineer and is a recognized expert in assessing, evaluating, remediating and providing testimony on complex project design, construction and operational matters. His consulting expertise has been influential in shaping approaches to code compliance and life safety in semiconductor and similar advanced technology facilities.
Certifications and Designations:
Registered as a Professional Mechanical Engineer in the States of Arizona, California, Colorado, Illinois, Iowa, Nevada, New Hampshire, New Mexico, Oregon, Texas, Utah and Washington.
Registered with the National Council of Examiners for Engineering and Surveying NCEES (Certificate No. 6999)
Fellow in the HVAC industry leading organization ASHRAE
Visiting lecturer at the Arizona State University Del E. Webb School of Construction in Tempe, AZ
Advisor to CREATE, ACE – Alliance for Construction Excellence and the IAB – Industry Advisory Board, all affiliated with ASU
Building Systems Analysis:
HVAC and Refrigeration
Process and Power Piping
Standard of Care in Design and Construction
Chemical Exposures in the Workplace
Cleanroom Design and Performance
Codes and Standards
Patent and Trade Secret Disputes
Litigation Support: Bill’s pragmatic approach to both forensic and litigation consulting as well as project consulting is based on more than 40 years of real-world experience as a design professional, mentor and forensic analyst, as well as many years as an instructor in professional and academic settings.Represented both plaintiffs and defendants in a variety of jurisdictions throughout the US and Asia. Bill’s ability to explain complex issues to non-technical audiences, including juries, mediators and judges, is a key to successfully solving your litigation challenges.
Strategic Litigation Consulting
Acorn Consulting Services
Consulting Services: Services range from peer review to conceptual design to development of strategies and programs for expedited project delivery.
Bill frequently acts as an owner’s agent and mentor, functioning as an extension of the owner’s project team. On other projects, Bill serves as a subject matter expert assisting project delivery firms in their development of viable solutions and review of construction documents.
As a project consultant, Bill assures the project gets off to the right start and provides his expertise through completion and operation to maximize return on investment.
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
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.