Medical Device Office

Resume/CV

Retford Berko, PhD, Esq.

Home Residence: 2467 State Route 10, Morris Plains, NJ 0950

Cell: 302-***-****; e-mail: ************@*****.*** or **********@*******.***

SUMMARY

• Attorney with expertise in FDA regulations for medical devices, generic drugs application filings

(ANDA), new drug applications (NDAs), biologics and combination products. Experience from FDA

Office of Device Evaluation, medical device submission reviews and FDA clearance and approval

processes such as INDs, NDA, 510k, PMA, IDE MDR and Cmpliance Program activities including

Establishment Inspection Reports reviews, Recalls and cGMPS.

• Scientific expertise in pre-clinical and clinical research involving biochemical, chemical and

pharmaceutical arts, principally concentrating on the use of generic drugs in new formulations.

• International Experience in foreign market regulations for drugs and medical devices acquired from

both FDA’s Office of Compliance and FDA’s Office of Device Evaluation.

• Law Firm experience in client counseling on FDA procedures, filing submissions at FDA and on

patent and trademark litigation.

AREAS OF EXPERTISE:

• FDA submission review and approval decision process.

• Providing guidance to the preparation of submissions to FDA law firm clients in the preparation

and submission of regulatory submissions and supplements involving 510k, IDE, BLAs and PMA

applications and combination products to FDA.

• Product Labeling, Advertisement and Promotion document review for devices and combination

products, Investigation of Trade Complaints.

• Drug, Medical Device (Class I, II, III), Biologic and Combination products regulations for

compliance with CDRH/CBER/CDER Office policy and Agency regulations including: PMAs,

supplements, CMC reviews, 30-Day Notices, software documentation requirements.

• Quality Systems Reviews for compliance to cGMP regulations, EIR Inspection reports, CAPA and

Form 483 violation determinations respecting Part 820 Quality System, particularly for new

devices the use of FDA policy and industry standards for evaluation of design controls, use

hazards, design failure and other environmental use and risks to users, risk analyses and

mitigation strategy evaluation as well as other human factor-device interaction evaluations (i.e.

human factors evaluation and testing).

• 510k Pre-market Notification, IDE, PMA clearance and approval with post-market surveillance

review and approval. with bioresearch monitoring experience.

• Providing Guidance on how to address Form FDA Inspection Observations on Form 483 and

Warning Letters.

• Classify Recalls and Review of post-market issues for all regulated products.

• FDA Establishment pre-Inspection Readiness Preparation and Training in ISO 13485.

• Patent prosecution and examination, infringement analysis, prior art search and review, freedom

to operate and due diligent analysis, Trademark filing at the USPTO.

PROFESSIONAL EXPERIENCE

FDA and Pharmacy Law

(10/20/13 to present)

FDA Subject Matter Expert/Associate, Frier Levitt, LLC; Pine Brook, NJ

• Counseling clients on generic drug applications including filings and use in new compositions in

pharmacy compounding procedures.

• Reviewing advertising and promotion documents and recommending modifications for

compliance with FDA requirements.

• Reviewing client investigator brochures, CMC and formulations and pre-clinical and clinical data

helping client comply with FDA regulations.

• Counseling clients on FDA procedures pertaining to facility inspections, current good

manufacturing practices (cGMPs).

• Counsel clients on determination whether a drug patent has expired or is invalid and implication

on the generic status of brand name drug under the law.

• Counsel clients on compounded compositions for infringement issues.

FDA Law, Drug and Device Product Liability Litigation

(12/05/12-10/20/13)

FDA Attorney, Watts Guerra, LLC, San Antonio, TX

• Reviewed all Product labeling, Advertising and Promotional, other Commercial and Regulatory

Documents submitted to FDA by defendant that formed the basis for obtaining drug product

approval from FDA and determined the relevance for evidence in product liability litigation.

• Timely reviewed assigned documents submitted to FDA by the defendant firm in pradaxa product

liability litigation.

• Provided advice to plaintiff’s lead attorney for preparation of plaintiff’s case.

FDA Law and Biotechnology Practice

(05/15/12-11/20/12)

FDA Attorney, Of Counsel, Dobe Law Group, LLC, Greenbelt, MD

• Food and Drug Law, Contract negotiations and commercial business development: 80%

• Patent Prosecution: 20%

• Reviewed client Advertising & Promotion and commercial documents

• Reviewed client pre-clinical and clinical protocol and advised client on filing section 510k pre-

mark applications.

• Engaged in law practice marketing and development with intention to establish an FDA practice

area in a law firm with focus in patent and prosecution.

• Accomplishments: Developed a list of firms as clients who could be contacted for business in

filing FDA applications and counseling clients on FDA policies regarding medical device, generic

drug application requirements under section 505 (B).2 of the FDCA.

Medical Device Product Development

(07/15/11-04/20/10/12)

FDA Subject Matter Expert/Associate, W.L. Gore & Associates, PharmBio Division, Elkton, MD

• Responsible for all regulatory decisions and strategies for Gore PharmBio medical device

products worldwide.

• FDA Liaison and Contact, Advice clients on Class I, Class II, Class III PMA approval and

submission techniques (Total-life Cycle for Devices).

• Provided FDA in-house knowledge and expert advice and strategies for development of storage

devices for biologic and drug products.

• Reviewed drug master files and updated Gore’s SOPs for manufacturing of drugs and medical

devices products.

• Advice PharmBio Leadership on FDA’s expectations for cGMPs for a drug, medical device and

biologic product development.

• The role was changed upon my arrival and did not entail FDA interaction but I organized and

helped develop strategies on how the firm could implement good manufacturing practices (GMPs)

for manufacture of medical devices consistent to FDA regulations.

FDA Law and Regulatory Practice

(09/17/11-07/15/11)

Compliance Officer, FDA, CDRH

• Reviewed submissions from industry for medical device, biologic and combination products for

Compliance with CDRH/CBER/CDER Office policy and Agency regulations including: PMAs,

supplements, CMC reviews, 30-Day Notices, Change Controls and software documentation

requirements for Class I, II and Class III Devices..

• Conducted Quality Systems Reviews for compliance to cGMP regulations, EIR Inspection reports,

CAPA and Form 483 violation determinations respecting Part 820 Quality System

• Evaluated submissions from industry marketing approval for new devices using FDA policy and

industry standards for evaluation of design controls, use hazards, design failure and other

environmental use and risks to users, risk analyses and mitigation strategy evaluation as well as

other human factor-device interaction evaluations.

• Product Labeling, Advertisement and Promotion for devices and combination products, Investigation

of Trade Complaints.

• Reviewed Recall Documentation and Classified Product.

• Reviewed post-market submissions for medical devices.

• Wrote Warning on Establishment Inspection noncompliance and cGMP violations.

FDA Law and Regulatory Practice

(11/2005-09/2007)

Consultant, Part-time. Medical Regulatory Associates, LLC; Rochester, NY

• Provided expert scientific advice to law firm clients in the preparation and submission of

regulatory submissions and supplements involving 510k, IDE, BLAs and PMA applications and

combination products to FDA. Worked on Class I, II and III Devices in pre-market phase as well

as post-market phases.

• Successfully counseled industry clients and demonstrated and/or guided them on how to prepare

FDA dossiers for medical devices, biologics and drugs applications for submission to FDA.

• Also, successfully devoted time for preparing, sitting for, and passing both the Washington D.C.

Bar and USPTO Patent Bar examinations.

Patent Law and Practice

(06/2003-11/2005)

Patent Examiner, United States Patent & Trademark Office, Alexandria, VA

• Completed training at USPTO Academy for Patent Examiners.

• Examined patent applications and determined patentability for inventions based on statutory and

regulatory requirements under 35 U.S.C. Sections 102 for novelty and utility, Section 103 for non-

obviousness, Section 112 for clarity compliance with USPTO policies in the Manual of Patent

Examination and Procedures (MPEP).

• Reviewed and evaluated International patent application claims for statutory compliance to the

Patent Cooperative Treaty.

• Conducted prior art search necessary for reviewing and evaluating patent applications.

• Examined patent applications and write office actions utilizing both scientific and legal analysis.

• Responded to verbal and written attorney questions and remarks in amendments to applications.

Full Time Law School Student; August, 1998 to May, 2002, University of Missouri-Kansas City Law

School, Kansas City, Missouri

• Successfully completed J.D. Program and earned the degree, enabling me to pass the

Washington, DC Bar and the USPTO Bar for admission to the two Bar Organizations.

FDA Law and Regulatory Practice

(05/1990-07/2005)

Review Chemist, FDA/CDRH, Rockville, MD

• Reviewed over 1000 510ks, 6 IDEs, 4PMAs and 1 BLA applications and made recommendations for

clearance and/or approvals all in IVDs or Biologics by using 21 CFR Part 803, 807 and 809 for

Class I, II and III devices.

• Reviewed Product labeling and Advertising and Promotion and Commercial Documents.

• Made substantial contribution to the writing of IVD Compliance Policy Guide for FDA.

• Reviewed clinical data in submissions (510ks, IDE, PMAs, BLAs), software documentation

requirements for In Vitro Devices and Instrumentation (analyzers).

• Reviewed Compliance documents for GLP, CGMP, and clinical trials data.

• Reviewed Biologic Licensing Application (BLA’s) e.g. for HIV devices.

• Provided scientific, technical, and administrative guidance to industry for compliance with FDA

requirements.

• Collaborated with Office of Science & Technology laboratories in research projects involving

identification of viral DNA in human samples using polymerase chain reaction technology.

Cambridge Scientific Abstracts, Bethesda, MD, Jul 1989 – Jul 1998

Scientific Editor

• Edited scientific and medical papers submitted for publication in journals such as AIDS, Immunology,

Industrial and Applied Microbiology journals.

Louisiana State Board of Regents for Higher Education Baton Rouge LA, Apr 1987 – Jul 1988

Director of Scientific Projects and Contracts Manager

• Provided Leadership and Management of all State of Louisiana State University Board of Regents’

funded programs for enhancement of technology.

• Managed scientific projects for the state of Louisiana’s technology transfer program.

• Negotiated contracts with Principal Investigators and monitored progress of research for continued

funding in engineering, mathematics and biomedical programs.

• Reviewed RFPs and RFAs for scientific and technical merit.

EDUCATION

• University of Missouri, Kansas City Law School, J.D

• University of North Carolina at Chapel Hill, Ph.D.

PUBLICATIONS, HONORS & AWARDS

• 11 published journals and abstracts; one selected for American Association of Clinical Chemists,

Young Investigator Award. List of 11 Publications can be provided upon request.

Areas published in include Oncology, Clinical Chemistry and Pharmacology.

BAR ADMISSIONS

• Washington, D.C. Bar, October, 2008, Eligible to Practice Law.

• Registered as Attorney to practice IP law at USPTO September, 2010.

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