Sei sulla pagina 1di 5

JOHN WM. FERKANY, PH.D.

, MAS

11 Chris Drive H 508.528.4969


Franklin, MA 02038 M 857.891.3849
www.jwferkany.com

PRODUCT DEVELOPMENT TO PHASE IIB CLINICAL TRIALS


REGULATORY PHARMACEUTICAL PROGRAM MANAGEMENT/
OPERATIONAL AND STRATEGIC BUSINESS MANAGEMENT

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

Business & Technology


- Intellectual property portfolio development, execution, management & maintenance
- Due diligence, licensing, partnerships & technology transfer
- Private & public venue fund raising

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.

RECENT PROFESSIONAL HISTORY

Surface Logix, Inc., Brighton, MA 2005 – Present

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.

Vice President of Development

- 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.

Page 1 of 5
John Wm. Ferkany, Ph.D., MAS

Vice President of Biology

- 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.

Preclinical Associates LLC, Franklin, MA 1999 – 2000 &


2004 – Present

Consulting services company specializing in start-up formation, technical due diligence, drug candidate selection,
and preclinical regulatory drug development strategy and implementation.

Senior Managing Member

- 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).

VDDI Pharmaceuticals, Brentwood, TN 2000 – 2004

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.

Vice President, Pre-clinical Drug Development

- 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.

Page 2 of 5
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.

Director, Program Management

- 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.

Director, Division of Pharmacology

- 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

Research and development of pharmaceutical products, and contract research.

Vice President, NovaScreen™ Biosciences Corporation

- Participated in acquisition of NovaScreenTM from SciosNova.


- Operational control of NovaScreen TM a multi-million dollar per year international contract research
organization specializing in early stage drug discovery services.
- Reversed 3 year history of declining revenues, revamped marketing and sales strategies, and increased
revenues two-fold.
- Expanded worldwide client base through diversification of services.
- Managed 3-fold increase in staff while maintaining material expenses at prior levels.

Nova Pharmaceutical Corporation, Baltimore, MD 1989 – 1992

Pharmaceutical research and preclinical drug discovery.

Group Leader, Central Nervous System Research

- 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.

Staff Scientist - Directed 5 member pharmacology team including 1 Ph.D. scientist.


Senior Research Associate – Directed 6 BS level scientists.

Page 3 of 5
John Wm. Ferkany, Ph.D., MAS

National Institute for Aging, Bethesda, MD 1983 – 1984

Senior Staff Fellow

Johns Hopkins School of Medicine, Baltimore, MD 1980 – 1983

Postdoctoral Fellow

EDUCATION

Johns Hopkins University MAS, Management Theory 1991


Baltimore, MD

University of Texas Ph.D., Biomedical Sciences 1980


Houston, TX

University of Michigan B.S., Zoology 1976


Ann Arbor, MI

Additional Training:

- SAS Enterprise Guide; multiple courses completed, 2007 - current


- Clinical Trials Training course; Drug Information Association, 2006
- Regulatory Training course; IND Phase; Drug Information Association, 1998
- Accelerating Preclinical Development; Institute for International Research, 1998

PROFESSIONAL AFFILIATIONS and ACTIVITIES

Past and Present Affiliations:

- Drug Information Association


- American Society for Pharmacology and Experimental Therapeutics (past member)
- Society for Neurosciences (past member)
- American Society for Microbiology (past member)

Professional Activities:

Editor:

- Editor: Current Protocols in Pharmacology (1996 – 2010)


- Editor: The Journal of Pharmacology and Experimental Therapeutics (1996 – 2006)
- Grant Reviewer: NIH, NINDS Brain and Spinal Cord Injury (2005 – 2007)
- Reviewer: International Cooperative Biodiversity Groups (ICGB) Program (past member)

Reviewer (ad hoc):

- Biochemical Pharmacology Brain Research


- Brain Research Bulletin Epilepsia
- European Journal of Medicinal Chemistry Life Sciences
- European Journal of Pharmacology Neuroscience
- Journal of Pharmacology and Experimental Therapeutics Journal of Neurochemistry

Page 4 of 5
John Wm. Ferkany, Ph.D., MAS

HONORS and AWARDS

- 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

Over 3 decades of martial arts instruction and teaching.

Page 5 of 5

Potrebbero piacerti anche