Dennis Fowler has over 30 years of experience in clinical drug development, pharmacovigilance, and medical affairs in the pharmaceutical industry. He received his MD and PhD from Rush University and has held roles such as Global Patient Safety Physician and Vice President of Medical Affairs. Fowler has extensive experience developing drug safety programs, conducting clinical trials, interacting with regulatory agencies, and preparing regulatory documents such as INDs, NDAs, and PSURs. He has worked in therapeutic areas including oncology, neurology, and pain management.

1. Resume’, July, 2013.
Dennis Fowler, MD, PhD.
Germantown, MD 20876
Phone: 301-515-3168
Cell; 434-872-3189
EDUCATION: Rush Medical College - Chicago, IL. 1985
MD
Rush University Graduate Medical College - Chicago, IL. 1984
Ph.D. in Physiology (Neurophysiology)
Northern Illinois University - DeKalb, IL. 1978
B.G.S. in Biochemistry
Purdue University - West Lafayette and Hammond, IN. 1970
A.A.S. in Chemical Technology
Mayo Clinic - Rochester, MN. 1984-1987
Intern / Resident Physician; General Surgery / Urology
CAREER PROFILE: Experienced Medical Director of Drug Safety-Pharmacovigilance, Clinical Drug Development and Medical
Affairs in the pharmaceutical and biotechnology industry.
• Federal licensed MD to practice medicine and surgery Unrestricted [National Board of Medical
Examiners].Non active
• State of Minnesota licensed MD to practice medicine and surgery, unrestricted. Non active
• Twenty years successful managerial experience in several pharmaceutical industry environments:
Clinical Drug Development, Safety-Pharmacovigilance and Medical Affairs.
• Pharmaceutical Drug Development (conventional drugs, biologics, vaccines);
• Therapeutics areas; Oncology, Neurology, Psychiatry, Pain, Hematology, Medical Diagnostics.
• Medical diagnostics (invitro and in vivo-CT, Radiology, MRI, PET) contrast media clinical
development.
• Medical device clinical development (in-vivo and invitro devices).
LICENSURES:
• Unrestricted Federal Medical Licensed MD; Diplomat - National Board of Medical Examiners no.
318278 [Federal Medical License
• Unrestricted Minnesota [MN] Medical Licensed MD; Diplomat - License to Practice Medicine and
Surgery, State of Minnesota, no. 2014007, [state Medical license] License no. 0300988 (Unrestricted,
inactive practicing physician status).
EMPLOYMENT HISTORY:
1/2012 to MEDIMMUNE, LLC;
6/2014 Global Patient Safety Physician
Drug Safety
Conducting daily Individual Adverse Event report processing [ICSR-Individual Case Safety Report] and
SUSAR’s; US & Ex-US;
• Reviewing / preparing AE reports [IND & marketed products].
• Determining AE Seriousness.
• Determining AE Expectedness.
• Determining AE Relatedness (causality).
• Determining/reporting AE Causality [IND studies]
• Writing SAE Narratives-when needed; SUSARs.
• Using MedRAH coding ICH med terminology [former WHO-ART, Costart].
• Preparing Analysis of Similar Events reports when needed.
• Experienced using, ARGUS, ARISg, Sapphire safety data center [AstraZeneca].

2. Resume’, July, 2013.
Dennis Fowler, MD, PhD.
Germantown, MD 20876
Phone: 301-515-3168
Cell; 434-872-3189
• Preparing ongoing literature reviews and summaries [mandatory drug related AE’s]-15d & annual.
• Writing Infirmed Consent Forms [ICF].
• Writing/ editing Risk-Benefit Reports
• Ongoing data collection for Aggregate Reporting, continuous updating documents / data management
• dRMPs.
• CCDS-Company Core Data Sheets; ongoing maintenance / DCSI.
• PSUR’s-Periodic Safety Reports; during market Authorization.
• DSUR’s-annual Drug Safety Update Reports; during pre MAH drug development.
• IB & IDB’s-Investigator Drug Brochure; prep and continuous updating.
• PI-Package Inserts; proposed and following MAH.
• SmPC’s-EU package inserts; summary of product characteristics
Pharmacovigilance Activities
• Preparing ASE’s [Analysis of Similar Events] reports when necessary.
• Conducting ongoing Signal Detection; and Signal Workup, Cluster Surveillance-Epidemiology
• Evaluating, preparing and reporting of regulatory documents for; Signal Detection, Risk- Benefit
Analysis Reports, Risk Assessment-Evaluation, preparing Risk Management Plans (RMPs & reports),
Risk Evaluation and Mitigation Strategy (REMS) reports and Pharmacovigilance Plans (PVP’s).
• Continuous updating / management of “expectedness data” documents’ [IB, PI, SmPC, CCDS,
protocols].
• Follow-up reports of activities for SAE data received after initial AE reporting.
• Preparing ‘Risk-Benefit Analysis’ for NDA’s / BLA’s and ‘AD HOC’ regulatory and IRB requested
safety reports.
• Annual maintenance and updating SOP’s for Safety-Pharmacovigilance.
Product Development Clinical Physician Activities
Key contributor to drafting and updating risk management plans [dRMPs] and pharmacovigilance plans.
• Provide input to others within Patient Safety, Regulatory Affairs and Clinical Collaborates with the
members of Clinical Development, Patient Safety, Regulatory Affairs, Quality Assurance, Sales and
marketing and to aid in the collection, collation, evaluation and expedited and periodic reporting of
clinical trial and post-marketing adverse drug reactions.
• Provide medical and scientific leadership to designing and implementing clinical development
programs. This includes responsibility for designing clinical drug/device development programs that
meet project objectives as defined within the global strategic clinical development plans.
• Contributes to strategic product development plans in conjunction with Clinical Affairs, Patient Safety,
Regulatory, Marketing and Financial personnel to ensure timely entry of new products to the market
and the ongoing market success of existing products.
• Represents the company at FDA discussions regarding the registration of new products.
• Assist with daily assessment of global individual case safety reports (ICSRs) and SUSARs. Provides
medical expertise in the review of adverse events and contributes to global pharmacovigilance
activities.
• Reviews on an ongoing basis accumulating safety data for emerging patient safety signals. Conducts
and facilitates data analyses in collaboration with Biostatistics to detect and analyze adverse event
signals and their potential to be causally associated with the use of MedImmune products.
• Participates in risk assessment activities and collaborates with Regulatory Affairs, Clinical
Development and other departments as needed on the proposed wording for product labeling and
accompanying information to promote and facilitate appropriate use of Medimmune’s products.
• Development regarding clinical activity and safety reporting. Independently implement existing and
new approaches for the analysis of adverse events and summary safety data (pre & post MAH).

3. Resume’, July, 2013.
Dennis Fowler, MD, PhD.
Germantown, MD 20876
Phone: 301-515-3168
Cell; 434-872-3189
7/2007 to PCI- PHARMACEUTICAL CONSULTANTS INTERNATIONAL, INC.
7/2010 to 1/2011 SMITH HANLEY CONSULTING GROUP, LLC
Pharmaceutical Consultants International, Inc. [PCI] and Smith Hanley Consulting Groups are service providers [drug safety-reporting
Pharmacovigilance & Clinical Development] to the pharmaceutical, biotechnology Industry; both domestic and international.
Position; Medical Officer, Consultant – Drug Safety- Pharmacovigilance & Clinical Drug Development,
Clients;
• MacroChem, INC. Boston, MA Acting VP, Drug Safety and Clinical Development.
RE; Transdermal drug delivery development; USA and EU.
• PRA, Pharmaceutical Research Associates, Director, Drug Safety and Clinical Development.
 Orbis Clinical [Maxim Healthcare Services] in support of Millennium Pharmaceutical, Inc. Boston,
MA. Physician Consultant Int. to EU clinical study safety reviews [ICSR’s] and
pharmacovigilance reports. RE; Velcade (bortezomib), EU clinical drug development evaluation and
summary aggregate reports.
Now owned and operated as Takeda Oncology, Inc.
6/2003 to INNEXUSBIOTECH, INC.
7/2007 Co-Founder, Vice President and Chief Medical Officer
InNexus Biotechnology [IXSBF] is a ‘start-up’ biotechnology company developing a new generation of
Immune therapeutic humanized monoclonal antibodies [hmAb's] for oncology therapy.
InNexusbiotech has been divested due to loss of Venture Capital funding
• Assisted in preparing [co-author] of ‘Start-up Business Plan’ [Clinical –Medical Affairs and Patient
Safety].
• Prepared SOP’s [-917 pages] for new Clinical Affairs and Safety / Pharmacovigilance Departments
[using FDA and ICH-EMEA ‘SOP Guidelines’].
• Ongoing business development and venture capital–fund raising presentations.
• Creation of US and EU ‘Regulatory Strategy’ for drug development [oncology].
• Key liaison with FDA- [CBER, CDRH, CDER] regarding the planning of early phases of product
development (CMC, preclinical, IND, and phase I study design).
6/2000 to INC RESEARCH, INC. - Charlottesville, VA
7/2003 UNIVERSITY OF VIRGINIA
Vice President of Medical Affairs, Scientific Affairs and Drug Safety
Therapeutic Areas; Pain Therapy; Neurology, Psychiatry, Oncology.
• Designed and managed Clinical Drug Development activities [conventional drugs and biologic drugs]
including writing drug development plans, clinical study protocols and CRF’s, Informed Consent
Forms, Investigator Brochures and IRB reports / updates.
• Coordination of all clinical research, safety and clinical operational activities for the INC national
network of over 60+ private practice investigator sites and academic clinical research sites.
• Coordination and management of all research and operational clinical activities for the INC national
network of over 60+ private practice investigators [and academic research sites] including oncologists,
neurologists, psychiatrists and pain specialists.
• Medical Director of Clinical Affairs and drug Safety-Pharmacovigilance Department; including daily
[ICSR] clinical study [solicited] and Marketed drugs [unsolicited safety data] AE assessments, drafting

4. Resume’, July, 2013.
Dennis Fowler, MD, PhD.
Germantown, MD 20876
Phone: 301-515-3168
Cell; 434-872-3189
SAE narratives and reports [CIOMS & 3500A] including FDA and EMA reporting. Also, assuring
follow-up reporting and CRF reconciliation.
• Managing Director of Scientific Affairs.
• Managing Director of Pharmacovigilance.
• Safety/Pharmacovigilance Responsibilities
• Safety department daily AE case report [ICSR] evaluations for; seriousness, unexpectedness, causality-
relatedness, expedited reporting, report (3500A and CIOMS) editing for data completeness for
expedited (7d-15d) reporting.
• Managed and maintained Investigational Drug Brochures (IDB’s) for premarket approval and Package
Inserts (USPI, SmPC), preMAH products; also Company Core Safety Information [CCSI]
documents/data bases required in determining: unexpectedness / Listedness, seriousness, causality
[solicited IND safety data reports].
• Drafting and updating annually SOP’s for Clinical Drug Development.
• Created Two Clinical Device Development Plans [CDDPs] and including writing protocols, CRF’s and
conducted 7 clinical studies for two implantable class III devices:
• Implantable device used to treat subjects who are multi-drug treatment failures with depression;
clinical phases II and III studies for PMA submission.
• Implantable device Clinical Development Plan (CDP) and medical monitor for 4 studies evaluating
anti-seizure therapy in subjects with multi-drug treatment- failure [irretraceable] epileptic seizures;
phase III-PMA [CBER-CDRH].
• The FDA has now approved the device for treatment of depression.
3/1995 to PCI, INC., [PHARMACEUTICAL CONSULTANTS & INVESTMENTS, INC.] - Raleigh, NC
6/2000 Chief Medical Officer and Principal Associate
• Created two Clinical Development Programs (CDP’s) for two analgesic pain (opioid and combined
opioid medications) for acute, moderate to severe pain; short term-post op and dental extraction. Two
studies for moderate to severe cancer pain (opioid)
• Drafted 14 clinical study protocols with CRF’s, Informed Consent forms and Investigational Drug
Brochures for each Drug under investigation.
• Medical Monitor for three of the clinical studies.
• Created and conducted CDP including writing 3 separate clinical study protocols & CRF’s, and ID for
an IND Phase III, multicenter, double blind, comparative clinical trial for the use of
immunosuppressant Protograf following cardiac transplant.
• Established and implemented an Adverse Event Reporting Center [Safety Center] for Investigational
studies (IND regulated studies-solicited safety data) and Marketing Approved product drug safety
reporting [MAH approved-unsolicited SAE data] and Surveillance Center conducting ADE -case
assessment, determining AE seriousness, AE listedness, causality reporting by investigator, data
completeness for expedited reporting and case follow-up.
• Acting CEO and V.P. Medical Affairs at Receptagen Ltd., I Created a Business Plan incorporating the
three business units of Receptagen Ltd. (Receptagen Corp., Ryan Pharmaceuticals and Vancouver
Wholesale Drugs).
11/1991 to BRISTOL, MYERS –SQUIBB - Princeton, NJ
3/1995 Medical Director and Director, Strategic Project Planning
Medical Diagnostics Division, Sold to Bracco Pharmaceuticals-US in 1995
• Drafted and conducted 3 Clinical Drug Development Plans [CDP’s].
• Managing Director of all clinical study project teams (x7) for US drug development and EU.
• Management and oversight of all clinical trials for global BMS Diagnostics preclinical and clinical
projects.
• Director / Medical Monitor of U.S. and European business units of BMS Diagnostics-Munich,
Germany (reporting personnel; 22 U.S. 3 MD’s, 3 PhD’s, 6 RN-MSNs 1 Pharmacist and 12 European
professional-3 MD’s, 4 PhD’s, 5 RN-MSNs- and support staff).

5. Resume’, July, 2013.
Dennis Fowler, MD, PhD.
Germantown, MD 20876
Phone: 301-515-3168
Cell; 434-872-3189
• Management for all Associate Medical Monitors [x5] for BMS Diagnostics Medical Affairs.
• Creating, editing and timely up-dating of Investigational Drug Brochures (IDB’s) for all seven drugs
under investigation-global.
• Drafted five IND applications; all approved.
• Providing BMS medical /scientific consultation during evaluation of potential products during In-
Licensing / Out-Placement of BMS drug candidates.
8/1990 to IMMUNO, US. INC.
7/1991 Director, Medical Affairs, Scientific Affairs and Drug Safety
Immuno US is a subsidiary of Immuno AG;-Vienna, Austria providing blood products and vaccines
worldwide. Now owned and operated by to Baxter, Deerfield, IL. USA.
Safety Responsibilities:
• Providing daily review, processing, evaluating and reporting of all ICSR’s (market approved products
and products in clinical development.) AE reports
• Managed and updating product Core Data Sheet and Company Core Safety Information [CCSI]
required with Package Insert (PI) and CCDS used to determine Listedness.
• Clinical Drug Development [blood products]
• Medical Director and Medical Monitor of an AIDS vaccine clinical trial [Phase I] at 3 university
Medical Centers conducted with support from the HHS HIV / AIDS Working Group (NIAID Group
for HIV/AIDS research in NIH). The clinical trials were halted following a twenty subject exposure
that indicating insufficient humoral and cellular immune response lasting beyond 30 days following
inoculation.
• Designing and conducting a Clinical Drug Development Program, drafted study protocols, CRF’s, IDB
and project team management [Medical Monitor] of a Human IgG (blood product) clinical trial for
therapy in acute Kawasaki Disease [pediatrics]; IND Phases II / III.
• Drafted the Integrated Efficacy [IES] and Integrated Safety [ISS] summary reports for BLA
application. The FDA has approved the BLA licensing IgG as treatment for Kawasaki’s disease in
Pediatric patients. Now available in US [also marketed in EU, Far East].
1/1987 to MALLINCKRODT, INC.
8/1990 Director, Clinical Research and Director, Patient Safety Department
Now owned and operating as Covidien-a subdivision of Tyco International., St. Louis, MO.
• Created the Clinical Development Plan (CDP), all study protocols and CRF’s, Investigational
Brochures, Informed Consent Forms and designed data analysis plan for MAG3 (a novel NME; NDA-
new chemical entity] for renal disease diagnostic testing and renal imaging. Clinical development
conducted and now approved globally.
• Identified and recruiting all clinical investigators [9 USA and 5 EU] for phases I-III IND studies.
• Initiating and managed study project teams [as Medical Monitor and project team director] during
clinical investigation of MAG3 IND phases I-III clinical trials.
• Drafted Integrated Summary reports of Integrated Efficacy and Safety summaries [IES and ISS
sections] of NDA-now approved.
• Medical reviewer and associate writer of Integrated Efficacy and Safety summary sections [IES & ISS]
of Optiray™ [Ioversol] NDA –NCE. Optiray™ is an injectable contrast agent that is lower osmolar,
lower viscosity and nonionic contrast media for X-ray and CT.
• Managing Director for Global Safety Department for all Mallinckrodt chemicals, marketed drugs
[MAH approved], IND regulated clinical study drugs and devices; [radiology IV catheters, cardiac
catheters,
• Managed and maintain product Core Data Sheet and Company Core Safety Information [CCSI]
required with Package Insert (USPI and EU-SmPC) to determine Listedness.

6. Resume’, July, 2013.
Dennis Fowler, MD, PhD.
Germantown, MD 20876
Phone: 301-515-3168
Cell; 434-872-3189
ACADEMIC ACTIVITIES:
Instructor, Rush Medical College, 9/1981 -9/1984
• General physiology [cellular physiology].
• Neurophysiology and neurology.
• Immune-physiology.
• Gastrointestinal physiology
• Endocrine physiology.
• Cardiovascular-physiology.
Instructor, Rush Graduate College of Nursing, 9/1980 – 9/1983.
• General Physiology;
• Endocrine,
• Digestive,
• Cardiac,
• Muscle,
• Neurophysiology and
• Neurology Instructor. 1981 - 1983.
• General Physiology and Neurophysiology.
• Endocrinology.
Instructor, University of Illinois; Graduate College of Nursing, 9/1984-6/1985.
• Graduate Physiology
REFERENCES: Available upon request.

7. Resume’, July, 2013.
Dennis Fowler, MD, PhD.
Germantown, MD 20876
Phone: 301-515-3168
Cell; 434-872-3189
ACADEMIC ACTIVITIES:
Instructor, Rush Medical College, 9/1981 -9/1984
• General physiology [cellular physiology].
• Neurophysiology and neurology.
• Immune-physiology.
• Gastrointestinal physiology
• Endocrine physiology.
• Cardiovascular-physiology.
Instructor, Rush Graduate College of Nursing, 9/1980 – 9/1983.
• General Physiology;
• Endocrine,
• Digestive,
• Cardiac,
• Muscle,
• Neurophysiology and
• Neurology Instructor. 1981 - 1983.
• General Physiology and Neurophysiology.
• Endocrinology.
Instructor, University of Illinois; Graduate College of Nursing, 9/1984-6/1985.
• Graduate Physiology
REFERENCES: Available upon request.