MICHAEL C.

DAMASK, MD
24 Gregory Lane, Millwood, New York 10546 * 914-762-
8426 * md6f8bd4@westpost.net
DIRECTOR / SENIOR DIRECTOR - CLINICAL DRUG DEVELOPMENT / MEDICAL AFFAIRS / DRUG
SAFETY
Clinical Development / Product Development / Clinical R&D / Budgets / Global / F
DA / EMEA / Training Negotiations / QA / Drug Safety / Project Management / Comp
liance / Risk Management / Team Building
Successfully developed and globally marketed industry-leading pharmaceutical and
biological products. Managed all phases of clinical drug development and medica
l affairs for Forest Research Institute, LifeCycle Pharma (LCP), Baxter, Knoll,
J&J, Purdue Pharma, Ferring and EpiCept.. Achievements in pharmaceutical, consul
ting, safety and quality operations. Therapeutic area experiences in pain, anest
hetics, critical care products, CNS, respiratory and transplant immunology. Fell
owship-trained in Anesthesiology. Managed budgets to $20M and staff to 15.
* Building special clinical trials programs to speed medicinal products to globa
l markets.
* Integrating R&D with business to optimize investments and commercial outcomes.
* Nurturing strong relationships with opinion leaders, physicians and field-base
d medical liaisons.
* Developing, leading and motivating cross-functional teams.
SELECTED ACCOMPLISHMENTS
For Forest Research Institute:
Provided timely review of package insert/label for New Drug Application (NDA) un
der FDA review. Project leader required prompt review of package insert drug in
volving checking all data in various components of label with source data docume
nts in NDA. On-time completion enabled company to meet previously agreed on fili
ng date for NDA with FDA.
For Life Cycle Pharma:
Negotiated key budget reduction. Successfully led Company negotiation team in ob
taining $4 million reduction in clinical study budget from CRO for Phase III piv
otal Clinical Trial.
Turned around floundering clinical trials program. Multicenter program was perfo
rming poorly Developed systems for timely tracking key clinical site performanc
e metrics and query resolution flow. Implemented strategies for timely initiatio
n and management of multicenter Phase II/III clinical trials. Improved communica
tions between LCP and CRO teams.
Created and developed Drug Safety/SAE reporting function. Clinical development p
rogram supported all LCP drug safety events using CRO resources. Established pro
cesses/systems for timely/accurate reporting/follow up of SAE's to support fast
paced, rapid patient enrolling multicenter Phase II/III global clinical develop
ment programs.
For Baxter:
Built clinical drug development team for Baxter. Impending patent expiration req
uired timely registration and approval of main product. Built talented and motiv
ated team of 14 clinical drug development professionals. Filed NDA of 3200 patie
nts on time, leading to international product approval. Gained credibility with
company and regulatory authorities.
Resolved Knoll safety database problems, driving early NDA submission. Discovere
d major discrepancies in NDA safety data bases potentially delaying submission.
Assembled Knoll/vendor rapid response team that quickly resolved problems and im
proved team communication. Enabled NDA to be submitted month ahead of schedule.
For J&J:
Established risk benefit model for analgesics for J&J. FDA asked for identificat
ion of major risk benefit issues to be included in package insert for major anal
gesic product. Identified most critical risk-benefit aspects and issues. Assuage
d FDA concerns. Package insertion became risk benefit model for other analgesics
in same pharmacological class.
For EpiCept:
Interceded in planned clinical trial to ensure FDA compliance. EpiCept planned c
linical trial of experimental analgesic drug, but had no plans to include it und
er Investigational New Drug (IND) application. Convinced management that General
Clinical Practices (GCPs) required inclusion in IND. Obviated legal and regulat
ory actions.
Halted Phase III clinical trials, circumventing expensive failure of program. Mu
lti-center Phase III clinical trial did not achieve primary outcome needed for m
arketing in Europe. Engaged independent bio-statistician who determined both tes
t drugs exhibited major defect in delivery. Stopped initiation of two large/expe
nsive likely to fail Phase III pivotal trials.
Precluded invalidation of clinical data, avoiding FDA intervention. EpiCept soug
ht to schedule "end of Phase II" meeting with FDA to discuss Phase III analgesic
clinical development plan. Determined one of Phase II trials was poorly perform
ed and GCPs were not enforced. Received approval for new Phase II trial and post
ponement of FDA meeting.
CAREER HISTORY
Project Study Physician in Clinical Drug Development, Forest Research Institute,
2009-2010: Medical Monitor Activities: Served as Study Physician assigned to CO
PD Phase III clinical trials. Due Diligence Activities: Served on Due Diligence
Team evaluating another company's clinical data for an inhaled insulin product.
Medical Writing Activities: Writing to/through Protocol Review Committee evaluat
ions for Phase III COPD trials
* COPD Combination Product Therapy Investigator's Brochure Version 5: Served as
coordinating author working and reviewing sections from individual section autho
rs. Served as primary author, editor, and reviewer for Clinical Efficacy and Sa
fety Sections, Summary of Changes Section.
* Member of clinical team participating in Nycomed/Forest NDA roflumilast prepa
rations: Participant in preparation and review of clinical safety and efficacy
documents for FDA and KOL Advisory Committees.
Consultant and Drug Safety Officer, Life Cycle Pharma, 2008-2009: Developed drug
safety/SAE reporting function responsible and accountable for timely and accura
te reporting of SAE's; developed systems of communication and correspondence wit
h CRO's managing drug safety bases for LCP; assured timely reporting of SAE's/de
aths to US/EU regulatory agencies; presented to LCP on new, ongoing and resolved
SAE's; rewrote LCP Adverse Event and SAE SOPs.
* Revived multi-center Phase II clinical operations challenged by poor dynamics
among company and CRO personnel.
* Developed strategies with CRO to foster timely initiation of patient enrollmen
t at study sites.
* Led negotiation team in obtaining $4M reduction in clinical study budget from
CRO for pivotal Phase III clinical trial.
Vice President of Medical Affairs, Chief Medical Officer, EpiCept Corporation, 2
006-2007: Responsible for overall leadership/management of clinical development/
regulatory activities for drug candidates in Phase I-IIIB analgesic and oncologi
c clinical development.
* Provided scientific, clinical, medical, and regulatory support, resources, and
consultation to non-scientific colleagues.
* Fostered relationships with consultants, KOL's, partners, CRO's, vendors, regu
lators and medical community.
Managing Director, Damask and Associates, 2004-2006. Provided consultancy and st
rategies for Phase I-IV clinical drug development activities. Led multidisciplin
ary project teams. Provided medical writing, editing, and seasoned/confident com
munication and interaction with the FDA. Major consultancies included:
* Ferring Pharmaceuticals, 2005-2006. Responsible for Phase II-IIIB protocol dev
elopment, initiation and management for clinical development of biologically eng
ineered sodium hyaluron synovial fluid device for painful chronic osteoarthritis
of knee. Provided Medical Affairs support and Drug Safety support for marketed
products.
* Johnson & Johnson Pharmaceutical Research and Development, LLC, Benefit Risk,
Pain Management, 2004-2005. Responsible for worldwide assessment of safety infor
mation, evaluation of safety signals and collaboration in formulating responses
to regulatory inquiries on product safety issues for analgesic drugs and devices
.
Senior Medical Director, Purdue Pharma LP, 2001-2003. As Clinical Project Leader
directed clinical development and final reporting of clinical research program
involving novel analgesic products. Company medical spokesperson/expert. Fulfill
ed criteria for new drug development and supported marketing efforts (Phase IV c
linical trials).
Senior Director, Clinical R&D, Medical Affairs, Medical Information, Knoll Pharm
aceutical Company, 1998-2001. Responsibilities: Clinical Development (Phases I-I
V) for line extension of analgesic drugs; management and mentoring of clinical d
evelopment staff; primary liaison/support with Marketing for marketed products/n
ew business development.
Associate Director, Senior Associate Director, Director, Clinical Drug Developme
nt, Worldwide Drug Surveillance, Baxter Pharmaceuticals (Ohmeda, Anaquest), Ohme
da Pharmaceutical Products Division, anesthesia, analgesia, critical care drug d
evelopment company, 1988-1998. Responsible for preparing, reviewing, analyzing a
nd submitting serious and non-serious adverse events of investigational and mark
eted products to FDA and worldwide regulatory agencies.
EDUCATION, LICENSES, CERTIFICATIONS, PROFESSIONAL
Education: MD, Chicago Medical School, and BA, Case Western Reserve University.
Academic and Hospital Appointments: Chief Resident/Fellow, Department of Anesthe
siology, Columbia-Presbyterian Medical Center; Assistant Professor, Department o
f Anesthesiology, College of Physicians and Surgeons, Columbia University; Assis
tant Attending Anesthesiologist, Columbia-Presbyterian Medical Center.
Medical Licensure and Certification: New York State-Certificate No. 125518; Dipl
omat, National Board of Medical Examiners, Certificate No. 138567291192
EXTENSIVE PUBLICATIONS LIST FURNISHED UPON RE