R.P.
Chiacchierini & Associates, LLC
Statistical
and Regulatory Consulting
15825 Shady Grove Road • Suite 30 • Rockville, MD
20850
(240) 683-3738 – Office • (240)
683-9236 – Facsimile
The professionals at R.P.
Chiacchierini & Associates have a unique depth and breadth of experience in
all aspects of statistical consulting and regulatory affairs. R.P. Chiacchierini & Associates offers a
full range of services for device and biologic products.
Services
Known for its staff of former FDA
senior management, policy makers, reviewers and industry personnel, the
professional staff of R.P. Chiacchierini & Associates has assisted over 700
domestic and international clients. We
have first-hand knowledge of how the FDA views submissions and regulatory
issues. In fact, our principals actually
wrote and approved many of the processes and policies currently in use by the FDA.
Our
services include:
Ø
Device Regulatory Affairs
Ø
Biostatistical
Services
Ø
Quality Systems & Compliance
Ø
Biologics Regulatory Affairs
Professional
CVs
Ø
Richard P. Chiacchierini, PhD
Ø
Richard E. Lippman,
OD, FAAO
Device Regulatory Affairs
The regulatory services provided to our clients (sponsors of medical
devices) span a broad range of diagnostic and therapeutic specialties. Our capabilities include developing regulatory
strategies for successful submissions, preparing plans for FDA interactions
and resource planning. We can prepare
an entire regulatory submission, individual sections of a submission, or
simply review the submission the sponsor has prepared.
Our services include:
Ø
Strategic
regulatory consulting and planning, including:
·
Development
of preclinical and clinical trial design
·
Medical
device classification
·
Submission
classification for products with combined regulatory status
·
Interpretation
of legislation, regulations, and guidelines, including import and export
applications
·
Regulatory
review of advertising and promotional material
·
Due
diligence and consultation with venture communities and law firms on
acquisition and compliance issues
·
Guidance on
access to investigational devices during regulatory application preparation
and review
Ø
FDA
Submission: Complete or partial submission management, preparation and
evaluation (E.G., IDEs, 510(k)s,
PMAs, Supplements, Updates, Amendments, Petitions,
etc.).
Ø
FDA
Representation: Preparation and coordination of meetings with regulatory
authorities including “relationship” guidance and panel meetings.
Ø
Post-market
surveillance program evaluation and guidance, including post-approval studies,
safety issues and alerts, and labeling review.
Ø
Humanitarian
Device Exemption guidance and assistance.
|
Statistical Services
The Statistical Services group provides statistical support for
device and biologic products. Our
statisticians, former FDA and industry professionals have decades of
experience in a wide range of therapeutic areas. We can provide full service from a study
design to final report and representation or provide services on a consultancy
basis. However, when our services are
utilized, our senior-level staff is directly involved and the client benefits
from their expertise.
Statistical services include:
Ø
Preparation
of responses to FDA inquiries regarding statistical issues or deficiencies
Ø
Preparation and
coordination of meetings with regulatory authorities
Ø
Assistance
in protocol development, including refinement of research questions, study
design, sample size justification, and description of statistical analysis
methods
Ø
Assistance
with product development strategies to optimize likelihood of regulatory
approval
Ø
Pre-clinical
and clinical study design and analysis
Ø
Statistical
analysis, programming and reports
Ø
Product
applications and guidelines
Ø
FDA
relationship guidance and dispute resolution
Ø
Performance
of interim analysis for regulatory authorities and Data Safety Monitoring
Boards
Ø
Comprehensive
final data analysis and report suitable for inclusion in regulatory
applications, submissions, presentation and publication
Ø
Support for
preparation of regulatory and submissions
Ø
Computerized
patient randomization
Ø
Design,
analysis and interpretation of experimental pre-clinical studies
Ø
Design of
experiments for manufacturing in-process, end-stage quality control, and
product development and evaluation
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Quality Systems & Compliance
R.P. Chiacchierini &
Associates, with support from affiliated consultants, offers numerous
services relating to quality systems and compliance for medical devices and
biologic products. These services
include:
Quality Systems:
¨
The design,
development and implementation of complete or partial quality systems that
satisfy FDA, ISO 9000 and EN 46000 requirements, including Standard Operation
Procedures, QA manuals and clinical trial systems, Design control systems,
corrective action systems and product compliant reporting systems.
¨
CE Mark
preparation and submissions
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Verification
and validation assessments
¨
Process
validation review and assistance
¨
Statistical
process control
¨
Internal
Quality Systems Audits
¨
Due diligence
audits for suppliers, potential suppliers, acquisitions and CROs
¨
Pharmaceutical
and device facility design, including controlled environments for sterile and
non-sterile products
Compliance:
¨
Audits of
clinical data contained in regulatory submissions
¨
Quality
assurance of internal operations, trial protocols/case report forms, sponsor
to agency study reports and submissions, protocol implementation at trial
sites and IRBs
¨
FDA
compliance management, including FDA 483s, warning letters, consent decrees
and recall strategies
¨
Assessment
and preparation for regulatory inspections
¨
Assistance
with agency representation and negotiation
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Biologics Regulatory Services
R. P. Chiacchierini & Associates, with support from affiliated consultants,
provides a broad range of regulatory and clinical consulting services to
companies who are involved with or manufacture biologic products.
These services include:
¨
Strategic
product development and regulatory planning
¨
Product development
guidance
-
Blood and
blood products
-
Blood
banking and transfusion services
-
Infectious
disease diagnostic test kits (e.g., serologic, NAT, markers, etc.)
-
Computer
driven testing devices
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Biologic
devices and biologic/device combinations
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Blood bank stand
alone software
¨
Protocol
development and implementation
¨
Study
monitoring and auditing
¨
Regulatory
submissions [IND, ELA/PLA, BLA, IDE, PMA, and 510(k)]
-
Strategy
development and implementation
-
Document and
submission preparation
-
FDA meeting coordination,
preparation and assistance
¨
Facility
evaluation for the production of biologic products
¨
Due
diligence and consultation with the venture funding communities and law firms
on acquisition, licensing, and compliance issues
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Richard P. Chiacchierini, PhD
President and CEO
Dr.
Chiacchierini has a long list of clients with successful product approvals and
other FDA interactions. The experience
he brings to his clients spans eight years as a very successful consultant and
20 years in FDA senior management. This
combination allows him to guide his clients smoothly through successful FDA
interactions. He has an expert
understanding of the types of clinical studies that must be conducted, the
types of analyses necessary, the proper interpretation of the results, as well
as an understanding of how to interpret FDA requirements and requests. This regulatory insight, together with his
strong statistical knowledge, gives his clients a consulting perspective that
is difficult to duplicate.
Prior
to forming R. P. Chiacchierini & Associates, Dr. Chiacchierini was with CL
McIntosh & Associates as the Senior Vice President, Statistical
Services. Dr. Chiacchierini served with
the FDA in various management positions.
From 1982 to 1994, he directed the Division of Biometric Sciences in the
FDS’s Center for Devices and Radiological
Health. Dr. Chiacchierini’s
Division was responsible for the statistical review of Investigational Devices
Exemption (IDE), Pre-market Notification [510(k)] and pre-market Approval (PMA)
applications. With responsibility for
program direction and policy, he developed and implemented a system of routine
statistical of medical device submissions, including device bench and animal
testing, clinical trials, and manufacturing process validation and
optimization. Dr. Chiacchierini also
developed and implemented the Center’s programs for post-market
surveillance. He is the author and
co-author of agency guidance documents (most of which are still in use today),
and he has given numerous short courses and presentations on the design,
conduct and analysis of device clinical trials for FDA submissions.
With
an appointment from then Surgeon General C. Everett Koop, Dr. Chiacchierini was
also Chief Scientist Officer in the Commissioned Corps of the United States
Public Health Service from 1987 to 1991.
Dr.
Chiacchierini obtained a BS (mathematics) for St. Bonaventure University, an MS
(experimental statistics) from North Carolina State
University, and a PhD (statistics) from Virginia Polytechnic
Institute and State University. He is a member of the
American Statistical Society, Biometric Society, Regulatory Affairs
Professional Society and the Food and Drug Law Institute.
Richard E. Lippman, OD, FAAO
VP Ophthalmic Product
Regulatory Affairs
Dr.
Lippman’s specialty is ophthalmic devices, and he has
worked extensively with IOLs, contact lenses,
ophthalmic lasers, refractive surgery devices, solutions, disinfection units
and diagnostic products. He assists medical
device manufacturers with regulatory strategies and submissions, including IDEs, 510(k)s and PMAs. Dr. Lippman spent eight years as a successful consultant with
C. L. McIntosh & Associates before joining R. P. Chiacchierini &
Associates.
In
addition to his consulting experience, Dr. Lippman
has many years of senior management experience with FDA’s division of
Ophthalmic Devices, Office of Device Evaluation (ODE), and Center for Devices
and Radiological Health (CDRH). From
1986 to 1993, ad Director of this Division, he was responsible for managing the
review of 510(k)s, IDEs, PMAs, and reclassification petitions or ophthalmic
devices. This included developing
strategic approaches to device review, designing and implementing policy on new
products, and managing the related Advisory Panel.
From
1984 to 1986, he was the Chief of the Contact Lens Branch in the same
Division. Prior to that, her served as a Clinical Medical Office.
Before
joining the FDA, Dr. Lippman was Chief Optometrist at
the US Public Health Service Hospital, Staten Island, New
York.
Dr.
Lippman earned a BA (biological sciences) at the
University of Vermont and BS and OD degrees from the New England College of Optometry. He has been awarded fellowship in the
American Academy of Optometry. In addition, Dr.
Lippman is a practicing optometrist.