Angel L. Rodriguez

Qualifications and Experience Overview

Education/Certifications

B.Sc. in ChemistryUniversity of Mayaguez1985

Regulatory AffairsCertified1998

Experience: Pre-Regulatory

Research and Development Chemist:Development/Validation

Chromatographic (HPLC/GC) analytical methodsDissolutionSpectrophotometric analysis (IR, UV, FTIR, NMR)Miscellaneous (fluorescence, color, particle size)

AccomplishmentsThree publications in Journal of Agriculture of the

University of Puerto RicoIntroduction of innovator reverse engineering to aid in

development of generic drugs

Experience: Pre-RegulatoryProduct Development (Generics)

Cimetidine HCL for injectionNaproxen TabletsTerfenadine TabletsAlbuterol Sulfate Syrup (Paragraph IV)Tussi-Organidin® SyrupGlyburide (micronized) Tablets (Paragraph

IV)Cimetidine TabletsCaptopril TabletsLevothyroxine Sodium TabletsRynatan SuspensionNaproxen SuspensionOTCs:

Tylenol syrup (cherry and Grape)DimetappTriaminicRobitussin

ActivitiesDevelopment of formulasDesign of manufacturing processSelection of packaging componentsScale upWriting batch recordsTraining production personnelWriting validation protocols

ProcessesWet Granulation: High/Low Shear, Fluid

Bed, Spray Dried, Extrusion /Spheronization

Dry Granulation: Direct Compression, Dry Compaction

Coating: tablet, bead.Unit dosing: tableting, encapsulation, soft

gelsMiscellaneous: Emulsification, de-aeration,

Milling (wet and dry), imprinting, sterilization (terminal, aseptic fill), liquid manufacturing.

Regulatory Experience: Pre-ManagementGenerics

Propofol Emulsion for Injection (Paragraph IV)Levothyroxine Sodium TabletsGlyburide (micronized) Tablets (Paragraph IV)Albuterol Sulfate Syrup (Paragraph IV)

NDAsPre-Approval

Paxil CR® (Paroxetine HCl ER Tabs) by GSKViracept® (Nelfinavir Mesylate Tabs) by Agouron

Post-ApprovalMevacor® (Lovastatin Tabs), by MerckZocor® (Sinvastatin Tabs), by MerckVoltaren® (Diclofenac Tabs) by Novartis

Regulatory Experience: Pre-ManagementPre-Approval Activities

CRO selection and auditing PRACS, Phoenix, Novum, University of Virginia, MAYO Clinic

CMC review and approvalMBRs, Analytical Specs/Methods, Method Validation Reports, Stability

protocols/reports, packaging material qualification, labelingBioequivalence

BE requirements search, BE report review, BE summary report preparation, In-Vitro requirements retrieval, BE waiver preparation (product formula review, in vitro data review).

Full ANDA preparationCMC NDA preparationPrincipal company-FDA liaisonDeficiency letter assessment.FDA Pre-Approval Inspection EscortAmendment preparation.

Regulatory Experience: Pre-Management

Post-Approval ActivitiesCMC review and approval

Commercial MBRs, Process Validation Protocols/Reports, Stability Reports

Change ControlReview/Approval of Process Deviations and Out of

Specification Results.Review/Approval of Product Annual ReviewsFull supplement preparationPrincipal company-FDA liaisonAmendment Deficiency letter assessment/preparation

Regulatory Experience: ManagementGenerics

APAP/Codeine SyrupBenazepril HCl TabsBenzonatate Soft Gel CapsBuspirone HCl TabsDextroamphetamine TabsDiltiazem ER Caps (P IV)Doxazosin TabsFluticasone topical creamHydromorphone tabsMetoprolol ER Tabs (P IV)Morphine Sulfate ER TabsPotassium Chloride TabsNystatin Topical PowderOndansetron ODTOxycodone TabsPrednisolone SyrupPrednisolone Sodium Phosphate OSPropafenone Tabs

NDAs Pre-ApprovalClyndesse® (Clyndamycin Vaginal

Cream)Evamist® (Estradiol Transdermal

Spray)Gynazole-1® (Butoconazole Vaginal

Cream)

NDAs Post-ApprovalMicro-K® (Potassium Chloride ER

Caps)

Regulatory Experience: Consulting

Client Base

Regulatory Experience: Consulting

GenericsRoxycodone TabsAPAP & Codeine TabsDextroamphetamine Sulfate ER CapsFentanyl Transdermal PatchHydrocodone & APAP CapsHydromorphone ER Tabs

NDAsProtopic OintmentPrograf (Injectable, capsules - IR and ER)Myrbetric ER TabletsVESIcare ER TabletsPennsaid Topical Solution

Regulatory Experience: Management

KV Pharmaceutical1999 Regulatory

Organization

Angel RodriguezRegulatory Affairs

Director

Regulatory Affairs Associate

Regulatory Affairs Associate

Senior Regulatory Affairs Associate

Regulatory Experience: Management

KV Pharmaceutical2008 Regulatory Organization

Angel RodriguezRegulatory Affairs

Director

Regulatory Affairs Associate Director

Regulatory Assurance Manager

Regulatory Labeling/Advertising

Manager

Senior RA Associate

RA Associate

RA AssociateRA Associate

RA Associate

Sr. RA Associate RA Publishing Associate

RA Support Specialist Labeling Associate Labeling Associate Labeling Associate

Regulatory Experience: ManagementManagement philosophy

Primary Hiring Criteria: Talent over experience Teach to think: Provide emphasis on decision making process over actual

answers. Allow others to reach answers by providing direction, focus and guidance

Allow operational freedom by managing over established philosophies and boundaries of operation. Allow for creativity to flourish (just because I would have done it differently, does not mean that what has been done is wrong)

Accountability: seek solutions not blame, do not repeat mistakes. Act timely on trends.

Personal relationships: You need them more than they need you A little help to the neighbor will go a long way in the future Be consistent, honest and sincere in your approach If I win, we lose People know if you don’t know or if you don’t contribute Your priority is not their priority Influence over authority I need to understand them, they don’t need to understand me Feed the human being…

Regulatory Experience: Post-ManagementStrategic Development (1):

Identification and development of opportunities for internal product development

Identify drugs under investigationStudy potential new applicationsAssess technical/regulatory pathways

Obtain and assess regulatory precedentsIdentify clinical requirements

Types of studies, patient populations, clinical end pointsAssess competitive landscape (approved and under development

products)Lock in pitfalls

Prepare Regulatory Strategic Assessments based on Target Product Profiles

Prepare patent disclosuresDue Diligence

Regulatory Experience: Post-ManagementRegulatory Intelligence(2)

New generic opportunitiesIdentify before NDA approval, candidates for P IV

submissions, including: dosage form, strengths, PK parameters, BE requirements, intellectual information, projected NDA approval date

Marketed products(3)Track competitive landscape.Track, report and train of changes to regulatory

environment.Evaluate Company regulatory performance versus

Industry.

International Regulatory Affairs

Identification of registration requirements PMT Support IRA Support BU Support Work Environment

Identification of registration requirementsLatin America Canada Australia(4)

In-country reference product

Available generics Packaging

presentations Pricing Type of required

product submission.

Fees/licenses Documentation Technical requirements Clinical requirements Labeling requirements

Portfolio Management Team Support Identification and elaboration of synergistic

approaches to multi-region registration requirements.(4)

GAP analysis of US submissions for international submission purposes.

International registration strategizing.(4)

International Regulatory Affairs Support Training

Formal Department Training(5) One on One with Associates

Checklists for US ANDA Evaluation PMT tracking checklist Preparation and submission of international

dossiers

Compliance

Identification of CMC gaps between international and master (US or EMEA) dossiers.

Strategizing and execution of bridging process to bring up to date international dossiers

Business Unit Support

Identification of drug product registration candidates.

Establishment of project budget(6). Assistance to in-country personnel

Documentation Information Evaluation of requirements Document review Brief translations