Expert in Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
Expert ID: 725075 Minnesota, USA
Expert has also filed over 30 investigational new drug applications spanning pharmaceutical, biologics, biotechnology, and veterinary medicine with none placed on clinical hold by the FDA. These INDs span indications in oncology, metabolism, antidotes, neurology, gastrointestinal, anesthetics, sepsis, autoimmune disease amongst others.
He has also assisted 4 young previously unlicensed manufacturing and testing firms in obtaining their first FDA establishment licenses. Expert is an inventor on almost 20 patents; at least one with each employer.
Expert and his firm are developing an antisense DNA molecule for use in down regulating the p53 protein initially for treatment of cancer. In addition to his general management responsibilities, Expert manages world wide regulatory strategy, quality assurance, quality control and assists with manufacturing strategy, intellectual property and general management.
Accomplishments: Set up Employer Regulatory and Quality Assurance functions from scratch, hired 2 regulatory and one quality staff. Filed for and obtained chemical abstract registry number which allowed Employer to obtain the cenersen generic name from USAN and the WHO, obtained AML orphan drug designation in the United States and Europe (melanoma & CLL pending), obtained subpart E designation for cenersen US IND positioning drug for fast track and priority NDA review. Conducted two end of phase II meetings with FDA (melanoma, AML), initiated special protocol assistance process with FDA for registration trials in AML, obtained SME status in Europe allowing for complete fee waiver on AML Scientific Advice submission. Two meetings were organized and conducted with the EMEA for cenersen. Scientific advice was obtained for cenersen from the EMEA, COMP and CHMP. A Canadian CTA was filed and approved for AML. Organized internal trade name generation, filed and obtained approval from the US Patent and Trademark Office for Aezea™ (cenersen) for injection. Aezea trade name was filed with both the EMEA and the US FDA for advance regulatory approval (both in process and pending). Statutory patent extension submission prepared positioning cenersen to obtain the full additional 5 years of patent term restoration upon FDA approval of the NDA. Set up Employer for filing electronically via uplink to both the EMEA (Eudralink) and FDA (Electronic Secure Gateway).
In two years the Employer regulatory database includes over 600 entries pertaining to communications with regulatory body’s world wide on the first drug product cenersen. The quality assurance system was initiated and put in place for controlled documents, which now contains over 150 documents including master batch records, methods, specifications, protocols and SOPs.
Awards: Expert received an award from the Minnesota Intellectual Property Lawyers Association February 22, 2006 for his patents in support of Xyrem and Orphan Medical Inc.
Jazz Pharmaceuticals Inc., Palo Alto California June –December 2005
Expert was contracted through the end of 2005 by Jazz to transfer all duties and responsibilities from Minnesota to Palo Alto. These included manufacturing, quality control, quality assurance, regulatory affairs and patent activity following the Jazz acquisition of Orphan Medical. Also, was incentivized by Jazz to obtain FDA approval for a pending Xyrem (sodium oxybate) label expansion clinical supplemental NDA. sNDA005 was approved by Rusty Katz on the user fee deadline with no queries or questions from the FDA Division of Neurology Products.
|Year: 1985||Degree: Ph.D.||Subject: Physical Chemistry||Institution: University of California|
|Years: 2001 to Present||Employer: Undisclosed||Title: Vice President||Department: Regulatory Affairs|
Responsibilities:Employer is developing an antisense DNA molecule for use in down regulating the p53 protein initially for treatment of cancer. In addition to his general management responsibilities, Expert manages world wide regulatory strategy, quality assurance, quality control and assists with manufacturing strategy, intellectual property and general management.
|Years: 1994 to 2005||Employer: ORPHAN MEDICAL, INC.||Title: Vice President||Department: Regulatory Affairs|
Responsibilities:Responsibilities while at Orphan Medical included Global Regulatory Affairs; Intellectual Property; Manufacturing; Quality Control, Quality Assurance and general public company management. Expert also has served on the executive management committee participating in strategic corporate direction and new product selection and development. Expert was appointed by the Board of Directors compliance officer for the firm. Since Expert joined Orphan Medical his firm developed and filed 7 marketing applications (5 NDAs, 1 NADA, 1 510k) and two major efficacy supplements resulting in increased regulatory
exclusivity periods on key products. All FDA applications (INDs, Orphan Drug Applications, marketing applications, user fee waiver requests) have been approved with no rejections, most approved by FDA within 6-12 months. Marketing authorizations for Orphan Medical products have been approved in Australia/New Zealand, Canada, Europe,
Central America, and the Middle East.
Expert also had responsibility for manufacturing, quality control, quality assurance and intellectual property during his tenure at Orphan Medical. Orphan Medical never has any major compliance related audits that resulted in any impact on the patients, products, or shareholders. There were no drug product lot failures, recalls, or backorders nor any meaningful wastage from lot expiry. The intellectual property at Orphan Medical was substantially strengthened through patent filings
and regulatory exclusivity while Expert managed this function.
|Years: 1993 to 1994||Employer: CV THERAPEUTICS, INC.||Title: Director||Department: Development|
Responsibilities:Responsible for all development activities at this 10 person cardiovascular start up company. This included Regulatory Affairs, Manufacturing, Quality Control, Quality Assurance,
Project Management, Preclinical (pharmacology and toxicology), and Process Development. Developed technology which went into manufacturing patent filings, subsequently issued. Set up contract GMP manufacturing for an anti-hyperlipidemic drug including formulation development. Obtained and completed a successful Pre-IND meeting with
FDA. This program culminated in the successful IND filing for this company's first therapeutic development program in less than 12 months from the initiation of the project to the filing of the IND.
|Years: 1984 to 1993||Employer: XOMA CORPORATION||Title: Director||Department: Project Management|
Responsibilities:This new position was created in January of 1989 for the express purpose of implementing tighter controls on the multiplicity of ongoing projects at XOMA Corporation. The responsibilities associated with this position include direct project management of all established product areas, generation of time lines, recommendations to senior management on the allocation of internal resources, and reported directly to Pat Scannon, Founder President and Vice Chairman of XOMA Corporation.
|Associations / Societies|
|Regulatory Affairs Professional Society (RAPS)
1994-present:Regulatory Affairs Certified (RAC)
1995, DIA; FDLI; AAPS; American Association for the
Advancement of Science (AAAS) 1980-present,
American Chemical Society (ACS) 1979-present,
Society of Nuclear Medicine (1985-89), National Ski
Patrol System (1978-1994 retired), National
Association of Underwater Instructors (NAUI)
assistant instructor certification 1975-77).
|Member of Executive Staff Committee (1987, 1989-1991
disbanded), Chairman of the Radiation Safety Committee, (1986, member 1984-1991) which includes many successful audits by the California Department of Health Services, Member of the Outside Preclinical Research Review Board (1986-1992), Chairman of the Cancer Immunotoxin Research Group (1988-1990 disbanded), Chairman of the Immune Related Disorders Immunotoxin Group (1988-1990 disbanded). Managed and participated in the filing of 8 investigational new drug applications and two protein based product license applications with the US Food and drug administration, as well as associated international testing and registration filings.
|Awards / Recognition|
|Expert received an award from the Minnesota Intellectual Property Lawyers Association February 22, 2006 for his patents in support of Xyrem and Orphan Medical Inc.
Expert was twice the recipient of the FDA Commissioners Special Citation, first in 1999 for his work with Orphan Drugs and again in 2004 for his work with Xyrem (sodium oxybate) oral solution. Xyrem was first mentioned when Congress debated and passed the initial Orphan Drug Act in 1984. It was not until Expert and Orphan Medical took on this orphan drug in 1994 that marketing approval (2002) from FDA was granted in the midst of strong opposition due to abuse, and its use as a date rape drug.
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in revenues annually.
|Publications and Patents Summary|
|14 granted patents and 5 pending.
Over 35 publications in the field.
|Expert Witness Experience|
|Developer and initiation of a legal consultant to address delinquent member accounts.|
|He initiated of a newsletter to members, maintenance of fiscal viability for the resort, and on an interim basis overall management of the resort through the resident managers.|
|Other Relevant Experience|
|Interests and Skill include:
Pharmaceutical new product development, including synthesis, preclinical testing, animal testing, new animal model development through to clinical proof of efficacy and regulatory approval. Chemical purification, modification, and analysis of poly- and monoclonal antibodies for use in diagnostic and therapeutic human parenteral products. Development of new and alternative chemical means for protein-protein or protein-drug crosslinking. Pharmacology and toxicology of protein based diagnostic and therapeutic drugs in normal and immunosuppressed animals. Development of new methods for nonisotopic immunoassay (fluorescence and energy transfer), utilizing
monoclonal antibodies. Basic studies on fluorescence and lanthanide luminescence and their applications to biological systems. Circuit design and instrumental development for measuring fluorescence lifetimes. Applications of Argon and dye lasers.
Fields of Expertise
bulk pharmaceutical chemical manufacturing, canons of claim construction, patent claim construction, contributory infringement, Department of Health and Social Security standard, direct infringement, Doctrine of Equivalents, drug analysis, drug development, drug formulation, drug safety testing, drug stability, FDA food labeling regulation, Food and Drug Administration compliance, Food and Drug Administration cosmetic regulation, Food and Drug Administration drug packaging regulation, Food and Drug Administration National Drug Code, Food and Drug Administration new drug code, Food and Drug Administration regulation, Food and Drug Administration validation, copyright infringement, gelatin capsule, generic drug, Good Laboratory Practice, Good Manufacturing Practice, in vitro diagnostics Food and Drug Administration code, induced infringement, literal infringement, new drug application, patent infringement, patent law, patent prosecution, patentability evaluation, pharmaceutical analysis, pharmaceutical drug, pharmaceutical quality control, tablet manufacturing, trade secret law, trademark infringement, trademark law, United States patent, veterinary pharmacology, Chemistry, Manufacturing and Controls, medical device registration, antilipemic agent, date rape drug, intellectual fraud, dispute, 21 CFR Part 11, active pharmaceutical ingredient, patent claim chart, patent specification, international patent law, contract manufacturing, Drug Information Association, trade secret, licensable technology, drug labeling requirement, FDA limulus amebocyte lysate test regulation, intellectual property, copyright, Food and Drug Administration CFR-21 part 175, inventology, patent cost reduction, foreign patent, technology transfer, legal liability, drug testing statute, Food and Drug Administration, new drug, technology licensing, licensing, legal patenting, patent, process inventing, drug regulation, immunoassay, drug screening