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MEDICAL REGULATORY WRITING

IND COMPONENTS

CMC Section

Product Development History and Manufacturing Strategy

Stellar Biotechnologies, Inc. (Stellar): DMF/protein purification - Product development history (scientific; manufacturing process development) and initial manufacturing strategy. Roles: Acting-COO, sections author and editor for manufacturing, QC analytical , safety, non-clinical studies

International Medical Innovations (IMI): IPX-750/small molecule API/organic synthesis. Roles: CSO, author and editor

TransCell Therapeutics, Inc. (TransCell): TCTx150/peptide API/ solid phase synthesis/30mer peptide API/ developed regulatory strategy, authored manufacturing process instructions and QC analytical tests, contracted for process development, analytical assays and manufacturing; co-authored CMC section. Roles: CEO; product development investigator; CMC editor/co-author (virtual company)

PrimeGen Biotech, LLC (PrimeGen): stem cell therapeutics/ in vitro cell culture. Roles: CEO, CMC author, strategic RA planner  

Phage Therapeutics, Inc. (PhageTx): PTX101/bacterial fermentation/ bacteriophage purification. Roles: Co-founder, purification scientist, author manufacturing and quality sections

TumorEnd, Inc.: CM101/bacterial fermentation/ carbohydrate purification. Roles: Board Member, Regulatory Consultant; reviewer/editor/co-author; assembly of new IND for Phase I/II (academic Phase I completed under an earlier now expired IND)

Non-Clinical Studies

Animal models and results (relevance of model; toxicology; pharmacology; biodistribution; functionality; safety)

Stellar: vaccine carrier and adjuvant/rabbit/rat/mouse/hamster (co-author toxicology quality sections)

IMI: Parkinson’s/transgenic mouse/rat/rabbit (project leader; author for toxicology/safety and summary peer-reviewed publication in the J. Clinical Neurol. 2004)

TransCell: ophthalmic indication/ rodent/ rabbit eye

Collagen Corporation (Collagen): process change immunology safety studies/ cosmetic surgical/rat/mouse/guinea pig/rabbit (protocol author; scientific investigator; summary author)

Prior Human Studies

TumorEnd, Inc.: Oncology/Phase-I (Phase-I conducted and published from Vanderbilt; co-author Phase I/II under new IND)

Collagen: clinical data reviewer, author internal Safety Report detailing post-PMA review of clinical adverse reactions (abstracted and later published in J. Investigative Dermatol.)

Characterization of Raw Materials and Substrates (author)

QC Testing, Results, Appropriateness (author)

Qualities/Properties of the Product (author)

Detailed information on the API; Detailed physical, chemical, pharmacologic and biodistribution; Formulation additives, buffers, stabilizers; Dose form as supplied (liquid, single dose, vial); Quality control profile and strategy; Preliminary stability studies; Manufacturer

Future Manufacturing Process Development Plans (author)

Scale-up plans; ICH Q5E Comparability; Path to defining product specifications; Critical process parameters; Manufacturing process validation; QC assay validation; Dose definition, potency assay; Form, fill, seal; ICH Q6B acceptance criteria

 

INVESTIGATOR

BROCHURES

Summary Description of the Clinical Indication Roles: editor/co-author/member regulatory strategy team)

Brief Description of the Early-Stage First-In-Class Drug Substances (small molecule, biologics, vaccines), formulations and structures Roles: author and co-author, team member

o API descriptions

o Descriptions of product qualities/properties and putative mechanism of action

o Summaries of physical and chemical properties

o Summaries of non-clinical toxicology and pharmacologic properties – ADMEPK, absorption, distribution, metabolism, excretion, pharmacokinetics; general toxicology (acute and chronic); genetic toxicology (AMES- S. typhimurium and E. coli mutagenicity; mammalian CHO and EL4; rodent hematopoietic); reproductive toxicology; ICH M3R2; S5R2, S6 and S8

o Summaries non-clinical safety pharmacology: in vitro, CNS, cardiovascular, pulmonary (dogs/rodents)

o Statement of pharmacologic relevance and possibilities for exaggerated pharmacologic effects (e.g. possible CNS, vasculitis, hepatotoxicity, nephrotoxicity, immune suppression and/or autoimmunity issues with different APIs)

Information Related to Safety (Roles: author and co-author)

o Minimum dose, maximum calculated dose; schedule; routes

o Possible dose limiting toxicities

Information Related to Efficacy (Roles: author and co-author)

Entry Criteria (Roles: team member, co-author)

o Contra-indications (e.g. OTC drugs, vitamins, sex, health, prior history)

Route and Dosing Schedule, Amounts (volume/dose/potency) (Roles: reviewer, editor, team member)

o TumorEnd: iv/escalating dose/ Phase I/II/ sarcoma

o IMI: topical gel/ escalating dose/ Phase I/II/ diabetic paresthesia

o PrimeGen: injectable/ escalating dose/ Phase I/ Stardt’s and Reiter’s diseases; spinal cord injury; cardiac ischemia

 

STUDY PROTOCOLS

Medical Science Liaison

REQUESTS FOR MEDICAL INFORMATION

 

Investigational Plan (Roles: co-author, team member)

IRB Summary Documents (Roles: co-author, team member)

Study Protocol (Roles: co-author, team member)

Study Protocol Violations (Roles: co-audit reviewer, co-author of findings and change control corrective actions, team member)

Study Protocol Amendments (Roles: co-author, team member)

IRB Protocol Amendments (Roles: co-author, team member)

Clinical lnvestigator “New Observations” memos (Roles: co-author, team member)

Revised Case Histories, Diaries, Patient Records (Roles: audit team member, co-author findings, suggested revisions)

Adverse Events (Roles: reviewer/editor/immunology expert/co-author of findings)

Medical Information (Roles: Manager, medical writer, reviewer, editor, regulatory reviewer, liaison with corporate compliance and legal)

Medical Science Liaison (Roles: MSL Pulmonology; territory development, national and international outreach, ARD/COPD/sarcoidosis, autoimmune lung diseases).