John Wm. Ferkany, PH.D., Mas: 11 Chris Drive Franklin, MA 02038 M 857.891.3849
John Wm. Ferkany, PH.D., Mas: 11 Chris Drive Franklin, MA 02038 M 857.891.3849
John Wm. Ferkany, PH.D., Mas: 11 Chris Drive Franklin, MA 02038 M 857.891.3849
, MAS
A recognized professional with demonstrated accomplishments in industrial pharmaceutical scientific and business
management including:
Pharmaceutical
- Phase Ia, Ib, IIa & IIb clinical trial design
- Clinical data management & analysis
- Regulatory program design & management for safety pharmacology, genotoxicity, general, reproductive
and specialty toxicology as well as ADME campaigns
- Excellent understanding of CMC and CTM manufacturing
- Substantial FDA IND & European CTA filing experience
- Successful pre-clinical drug research, discovery & translation
A team-oriented, hands-on, executive who has successfully moved products through all stages of the
pharmaceutical process from concept to clinical trials.
A widely published leader (60 plus peer reviewed manuscripts; 16 invited book chapters; 6 patents or applications)
with accomplished graduate and continuing academic credentials in life sciences and business, and over 25 years
of progressive growth in R&D management including lead selection, pre-clinical drug development, regulatory
safety and clinical trial design.
A privately held biopharmaceutical company leveraging proprietary small molecule chemical design
(Pharmacomer™) technology into multiple Phase Ia through IIb clinical investigational products. A therapeutic
focus on vascular, metabolic, and inflammatory diseases.
- Played a key role in the design and writing of multiple Phase Ia to Phase IIb clinical protocols now
successfully completed.
- Responsible for all clinical data management including review, approval and implementation of Statistical
Analysis Plans.
- Lead regulatory filing efforts for Clinical Investigator’s Brochures, IMPDs and Part 8 IND documents
which were accepted by all agencies without major revision.
- Successfully managed over 30 preclinical GLP studies for 3 candidate molecules to support the filing of
multiple CTAs or INDs to the MHRA, BfARM and FDA.
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John Wm. Ferkany, Ph.D., MAS
- Lead R&D efforts during the selection of SLx-4090 and SLx-2119 as candidates for human clinical
metabolic disease trials.
- Designed, managed and executed all regulatory studies required for first corporate CTA filing with SLx-
4090 resulting in a successful CTA in less than 6 months from lead selection to document submission.
- Established SLX in vivo research capability resulting in substantially compressed exploratory timelines and
significant cost savings associated with small animal experimentation.
Consulting services company specializing in start-up formation, technical due diligence, drug candidate selection,
and preclinical regulatory drug development strategy and implementation.
- Reviewed and evaluated client research division; implemented recommendations to restructure group to
better suit client objectives and strategies (privately held, for profit biopharmaceutical).
- Advised on lead candidate selection and design of an IND-directed preclinical program for a novel
antipsychotic (privately held, for profit biopharmaceutical).
- Designed, implemented, and managed pharmacokinetic evaluation of a microbicide-based anti-HIV
product for developing nations and third world markets (biomedical foundation).
- Assisted with technical review, due diligence investigation, license negotiation, and business plan
development leading to the formation of a not-for-profit pharmaceutical company focusing on malaria and
leishmaniasis for third world populations (not-for- profit pharmaceutical).
- Researched and recommended program to investigate an immune suppressing agent for an orphan status
childhood disease (biomedical foundation).
- Assisted with business plan development, due diligence review, and product development plans
instrumental to the formation of VDDI Pharmaceuticals (privately held, for profit biopharmaceutical).
A virtual pharmaceutical development organization specializing in licensing and adding value to discovery to late
stage clinical drug candidates with market potentials of $250 – 500 Mil/annum.
- Responsible for all pre-clinical aspects of the antimicrobial, medical peptide, and GP IIb/IIIa receptor
antagonist programs.
- Principle author and Program Manager of multi-million dollar U.S. Department of Defense biowarfare
therapeutic initiative.
- Strategic and operational oversight of all joint development collaborations.
- Managed corporate Intellectual Property strategy and tactics including FTO assessment; streamlined
portfolio to reduce costs while expanding IP position; co-inventor on 3 patents or applications.
- Assessed new product/licensing opportunity for technical and financial merit, and strategic fit; principal to
in-licensing core antimicrobial peptide technology.
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John Wm. Ferkany, Ph.D., MAS
Oread, Incorporated, Farmington, CT; Lawrence, KS; Palo Alto, CA; Norcross, GA 1996 – 1999
Full service contract research organization providing fee-based products to the pharmaceutical and biotechnology
sectors.
- Assembled and led geographically dispersed multi-disciplinary teams to design and develop successful
IND programs for lead discoveries.
- Managed, coordinated and executed IND programs encompassing regulatory affairs, chemistry and
manufacturing controls, safety pharmacology, toxicology, manufacturing and packaging of clinical trials
materials, as well as preparation of regulatory (IND) documents.
- Successfully executed multiple IND programs to completion on schedule and on budget.
- Played central function in business development including negotiation and procurement of multi-million
dollar contracts.
- Created and managed Oread division including planning, staffing, and directing technical and P&L aspects.
- Successfully took division to profitability.
- Assisted Marketing and Business Development in promoting corporate capabilities.
- Participated in due diligence reviews and technology assessments for acquisition purposes.
NovaScreen™ Biosciences (now a Caliper Life Science Division), Hanover, MD 1993 – 1996
- Operational responsibility for interdisciplinary team of 35 Ph.D. and technical scientists including chemists,
molecular biologists, pharmacologists, and behavioral scientists.
- Authority for budget, planning, staffing, control and coordination of four research projects with
expenditures greater than $4 million per year.
- Advanced 2 compounds to clinical consideration which were licensed by third parties.
- Co-inventor on 3 patents; numerous NIH awards for research activities.
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John Wm. Ferkany, Ph.D., MAS
Postdoctoral Fellow
EDUCATION
Additional Training:
Professional Activities:
Editor:
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John Wm. Ferkany, Ph.D., MAS
- The Edward J. Stegman Award for Excellence at the Graduate Level, Johns Hopkins University, 1991
- NIH Grants: Novel Kainate Receptor Antagonists, 1990 – 1991
- NIH Grant: GABA Receptor Agonists and Antagonists, 1988
- NIH Grant: Excitatory Amino Acid Antagonists as Antiepileptic Drugs, 1985 – 1987
- Individual NIH Postdoctoral Fellowship, 1980 – 1983
- Individual Pre-doctoral Fellowship, 1978 – 1980
- Honors Graduate, University of Michigan, 1976
INTERESTS
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