Biotechnology Consultants: 7

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 43 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 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), 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

Consulting Services: 

View Timothy Anderson's Expert Witness Profile.

Rouzbeh R. Taghizadeh, PhD, has been researching, developing, and bringing to market Cellular and Tissue based Products and Medical Devices for clinical use – as a researcher, scientist, entrepreneur, innovator, and key opinion leader. Dr Taghizadeh is a Scientist, Entrepreneur, Innovator and Subject Matter Expert offering Business Consultant services in the following areas:

Dr. Taghizadeh's research has focused on developing aand patenting a new method to increase the number of hematopoietic (blood forming) stem cells (master cells that produce working cells for the lifespan of an organism) ex vivo (outside the body) for treatment of patients afflicted with blood disorders and cancers. He has investigated various sources containing blood-forming stem cells, including umbilical cord blood, bone marrow, and mobilized peripheral blood.

Dr. Taghizadeh also co-founded a biotechnology company that pioneered the processing and banking of umbilical cord tissue for clinical use. He's worked with various groups including umbilical cord blood & tissue banks, organ procurement organizations (OPO), academic, biotechnology, pharmaceutical, contract manufacturing and medical device groups. Due to the diverse nature of the groups that he has worked with, he has experience in developing, manufacturing and innovating cellular therapeutics, regenerative medicine, allografts (tissue products developed from different donors & recipients), bioengineering, cellular and  tissue engineering products.

View Dr. Rouzbeh R. Taghizadeh's Expert Witness Profile.

Elite Medical Experts works with attorneys to provide 100% Board-Certified physicians and surgeons practicing at the professorial level at the nation's leading universities. From Stanford to Yale, and from every medical and surgical specialty, Elite secures full-time practicing high-level experts from the nation’s most respected medical institutions. Each specialist is truly unique – a Board Certified professor with a dedicated clinical practice, extensive publications, and top-tier credentials from a major U.S. medical center. 

Complex Consulting at the Intersection of Medicine & Business
Elite Medical Experts also consults on complex strategic and tactical issues for enterprises of any size, and has extensive experience securing top-tier Professors of Medicine and Surgery for a range of complex consulting engagements. Elite Medical Experts is mission-critical to:

To learn how you can align with nationally recognized thought leaders from myriad areas of expertise, call Elite today and ask for our Director of Complex Consulting:

Dr. Burton Bentley II, M.D., FAAEM
CEO, Elite Medical Experts, LLC.

View Elite Medical Experts' Expert Witness Profile.

Dr. Divya Chander, MD, PhD,  is a physician, neuroscientist, and futurist who trained at Harvard, UCSF, UCSD, and the Salk Institute. She is currently the Chair of Neuroscience and Faculty in Medicine at Singularity University. She is also a Visiting Scholar in the Stanford Department of Medicine, Biomedical Informatics, and was a member of the Stanford Anesthesiology Faculty for 8 years.

In the operating room, Dr. Chander applies EEG technology to understand what human brains and the underlying networks look like when they lose and regain consciousness. She also has a precision medicine initiative focused on understanding genetic variability in responses to anesthetic drugs and brain oscillations. Her goal is to understand neural mechanisms of consciousness, as well as the evolution of human consciousness secondary to human augmentation. She is working on devices that read and write the brain (brain mapping, neuromodulation) and link to brain machine interfaces for diagnostic and therapeutic purposes.

Keynote Speaking:

• Neuroscience is on the cutting edge of decoding brains, making it possible like never before to peer into brains and hijack their circuitry. In this talk, Dr. Chander explores how old and new technologies make it possible to read visions and dreams, hack thoughts, and plant false memories. She also addresses how modern medicine and science make it possible to restore and enhance function to people who are paralyzed, opening the door to digital and robotic control with the human mind.
• Medicine / Healthcare is being transformed by exponential technologies that often are developed in the non-healthcare space. Dr. Chander explores how breakthroughs in 3D printing, robotics, artificial intelligence, stem cells, augmented and virtual reality, microfluidics, nanotechnology, and brain machine interfaces are pushing medicine into the realm of science fiction. New diagnostics, therapies, and even augmentation are considered, as well as their ethical implications. 

Video: Can You Read My Mind? The Promises & Perils of AI Decoding the Brain: Divya Chander at NextMed Health

• Bioethics has both the near and long-term implications for humanity and the biosphere. This has never been more true as we have gained the ability to rewrite both the genetic and the neural code, fundamentally changing what it means to be human. The ability to implant, read and write functions to humans leaves us vulnerable to losing our privacy, or even being hacked and manipulated. This talk explores the ethical implications of the technology we have developed, which is exploding at an exponential rate, and considers some new solutions.

View Dr. Divya Chander's Expert Witness Profile.

Peter Crosby has over 45 years experience in the medical device industry. He has served as CEO of six medical device companies in four countries (public and private), and brought many products to the world market through clinical trials and regulatory approval.

Through Biomedical Business Resources LLC, he provides many services including:

• Advisory - helping clients with strategy, operations, execution, and business building\
• Mentoring, especially first time CEOs
• Expert Witness - assisting attorneys with multiple expert reports, depositions, and testimony at trial and arbitration. Cases include disputes about intellectual property , product liability, and commercial contracts
• Board Services - offering Independent Board Member services for companies, public or private, with experience in building companies, and helping management teams in times of high growth and rapid change

Mr. Crosby's product experience includes implantable devices (cochlear implants, cardiac pacemakers, implantable defibrillators, artificial heart, neurostimulation), in vitro diagnostics, imaging (ultrasound and X-ray), software, AEDs, and patient monitoring. His clinical domain experience includes ophthalmology, otolaryngology, cardiac surgery, cardiology, orthopedics, pain management, anesthesia and intensive care.

View Peter Crosby's Expert Witness Profile.

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:

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.

• Forensic Analysis
• Strategic Litigation Consulting
• Trial Demonstratives
• Expert Testimony

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.

Consulting Expertise Includes:

• Project Design and Management Consulting
• Forensic Analysis and Litigation Consulting
• Mentoring & Advanced Education