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YourEncore
- Expert Consultant - Biotechnology & Pharmaceuticals
2016 - maintenant
* Provide consulting advice to mid-sized biotechnology company on the strategy for the development of a nucleic acid based therapy for rare inherited disease.
* Provide commercial, technical, regulatory due diligence support for a major pharmaceutical client for three oncology assets.
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Neorotech USA
- Senior Director Portfolio & Program Management
2015 - 2016
* CTA agreements and budgets negotiated with thirty clinical sites within targeted budget for Phase IIb trial of Neurotech’s Encapsulated Cell Therapy Device for treatment of Wet Age Related Macular Degeneration (AMD).
* Created a Forecasting Tool in Excel for budgetary analysis and clinical supplies demands requirement for Phase IIb trial of Neurotech’s Encapsulated Cell Therapy Device for treatment of AMD.
* Negotiated Material Transfer / Confidentiality and Clinical Trial Agreement for Investigator Initiated Clinical Trial of Neurotech’s Encapsulated Cell Therapy Device for treatment of Glaucoma.
* Designed, Implemented and Administered SharePoint site for projects and external due diligence activities.
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Allergan, Inc.
- Director, GPS Systems and Analytics
2014 - 2014
* Work within Allergan's Global Pharmaceutical Sciences Organization to implement CMC portfolio and project management
processes, practices and infrastructure .
* Liaison with Allergan's Global Portfolio and Project Management (GPPM), Core Indication Project Teams and CMC Teams to
align with CMC activities with Allergan's Corporate Objectives and Allergan's GPPM Organization.
* Technical and operational management of GPS MATT (Metrics & Timeline Tracking ) systems in BD and GPS.
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Allergan, Inc.
- Director, CMC Team Lead
2012 - 2014
* Provide strategic program leadership for two CMC teams using QBD approach in biologics development (Novel 2nd Generation
Toxin and a Targeted Exocytosis Inhibitor for treatment of neuropathic pain.)
* Represent CMC Strategy on Global Core Teams and to decision making executive committees.
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Pfizer
- Director Clinical Research and Clinical New Medicines Development
Paris
2011 - 2012
* Responsible for program / project management and operational execution strategy for Pfizer's late stage Oncology assets in
development.
* Lead multiple tumor asset indication teams - Responsible for program strategy / operational execution for each team each of
which had multiple clinical programs (Phase II -IV).
* Successfully lead team responsible for the start-up activities for a pediatric indication in support of extension to loss of
exclusivity for commercial phase asset.
* Lead team responsible for strategy and operational execution of the close-out of 14 regional and global clinical trials, Phase II-
IV across multiple clinical indications.
* Managed team preparations and budgets for a presentation to the US FDA Oncology Development Advisory Committee as
part of the marketing approval process for a now marketed target therapy for lung cancer.
* Business Operations representative to Clinical Trial Information Repository Operations Team (CTIR).
* Worked with Oncology Business Unit Asset Teams to develop CTIR tactical plans.
* Provided input on an organizational white paper on targeted therapeutics to the Precisions Medicines Work-Stream Team.
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SmartAnalyst
- Senior Director Life
2009 - 2011
Senior Director Life Sciences Business Consultancy
* Life Science Strategy Consultant to the Pharmaceutical/ Biotechnology and Consumer Product Industry.
* Primary interface with client to define scope of work to be performed for client, manage internal projects to insure delivery of the
defined work, present results to client and consult as required.
* Practice focused on 1: Oncology and Immune Modulating Drugs with an emphasis on strategy and portfolio optimization for
targeted therapeutics for these therapeutic areas. 2: Market dynamics analysis and entry strategy for Emerging Markets and biosimilar products.
* Provided Portfolio and Pipeline reviews developed using science based structured market assessments and market landscapes .
* Provided full-scale revenue forecasts, valuation models, and performed Monte Carlo simulations
* Provided strategic decision analysis support to clients
* Worked with Managing Director to explore and develop new business opportunities for SmartAnalytst.
* Implement new best-practices internal QA/QC process aimed at improving SmartAnalyst processes and practices
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Progenics Pharmaceuticals, Inc.
- Director
2007 - 2009
* Project Management responsibility for Progenics' Pharmaceuticals Biologics Products
* Project Manager for PRO 140 Anti-CCR5 Anti-CCR5 IgG4 mAb HIV entry inhibitor Program.
* CMC Team Leader for Progenics' PRO 140 Product- PRO 140 Anti-CCR5 Anti-CCR5 IgG4 mAb HIV entry inhibitor Program.
1: Team developed a micro-infusion device for subcutaneous administration of the PRO 140 product. 2: Technical transfer and
scale-up of a 150L internal process to 2000L process at a contract manufacturer with change in production cell line from SP2/0
to CHO. 3: Successfully submitted a CMC amendment to the IND with comparability data to support use of the CHO material in
Phase III program.
* Project Manager for Recombinant soluble PSMA vaccine (rsPMSA) Program - IND filed for initiation of Phase I Clinical Program
* Project Manager for VRP-PSMA (Replication deficient virus) delivered vaccine program- NIH RAC approval and successful IND
filed for initiation of Phase I Clinical Program.
* Project Manager for PSMA-ADC Product (Anti- Prostate Specific Membrane Antigen (PSMA) Monoclonal Antibody Drug
Conjugate Product- IND filed for initiation of Phase I Clinical Program.Project manager for PRO 206 Program - PRO 206 small
molecule Hepatitis C Virus entry inhibitor drug candidate
* In collaboration with Progenics' Finance group implement a strategic planning process to be used in budget preparation
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Tanox, Inc.
- Associate Director Project Management
2006 - 2007
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Oragenics, Inc.
- Vice President Product Development
2004 - 2006
* Managed technical transfer and outsourcing to CRLs, CROs and CMOs for cGxP performance of production processes, lot
release, stability programs and PK/ADME Tox and Clinical Programs.
* Developed process for the manufacture of Oragenics' live genetically engineered bacterial vaccine (SMaRT- Streptococcus
mutans_Replacement Therapy) in bulk and a formulation to allow distribution of the product in a freeze-dried formulation.
* Developed validated analytical methods to verify the identity, purity and potency of the SMaRT vaccine product.
* Developed validated analytical methodologies to track by genetic identity the transmissibility of the SMaRT vaccine organism.
* Successfully moved the SMaRT vaccine product off of two year clinical hold into the clinic
* Developed both fermentation based and synthetic based processes for the production of Oragnenic's Lantibiotic MU 1140
product produced by S. mutans.
* Developed validated analytical methods to verify the identity, purity and potency of the MU 1140 product.
* Developed validated Mass Spectrometric methodologies (LC/MS/MS) to detect the MU 1140 product in support of animal PK
studies.
* Developed analytical methodologies for physical characterization of the MU 1140 products.
* Developed mass spectrophotometric and ``wet chemical'' analytical methodologies to support Oragenics, small molecule drug
candidate for treatment of obesity.
* Identified and assessed potential partners for out-license or partnering of company's products..
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Lankenau Institute for Medical Research
- Visiting Scientist & Visiting scientist
2003 - maintenant
* Visiting scientist collaborating laboratory of the President of LIMR on the elucidation of the mechanism of action and
PK/ADME Toxicology of a novel new class of immune modulating small molecule drugs that increase the efficacy of antineoplastic agents such as paclitaxol, cisplatin and doxorubicin.
* Consultant to LIMR Development Corporation on technology transfer and commercial development of the institute's research.
An examole is OncoRx which was formed as a Private start-up company to develop LIMR's novel new class of immune
modulating small molecule drugs, IDO inhibitors. OncoRx was subsequently sold to NewLink Genetics.
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Fairleigh Dickinson University
- Adjunct Professor Pharmaceutical Management Sciences
2003 - maintenant
* Taught following courses: 1: Merger, Acquisitions and Partnerships in the Pharmaceutical and Biotechnology Industry 2:
Pharmaceutical Marketing and Product Development 3: Pharmaceutical Industry Structure and Government Regulations. 4:
Management of Research and Technology in the Pharmaceutical-Chemical Industries. 5: Pharmaceutical Supply Chain Strategy
& Pharmaceutical Quality
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Acorda Therapeutics, Inc.
- Director Product Development
2001 - 2004
* Managed in-house areas of process development, formulation development, analytical research & development, Bioanalytical
development, PK/ADME TOX.
* Implemented, managed, and lead project team approach for product development at the company.
* Project Team member for company's Commercial Launch stage clinical product
* Lead Project Team that successfully class-witched two recombinant IgM antibodies that stimulate remyelination to IgG4 .
* Managed Project Team that successfully produced recombinant forms of Chondroitinase and demonstrated preclinical efficacy
of these compounds for the treatment of spinal cord injury
* Wrote strategic business plans, marketing plans, development plans and P&Ls for the company's CNS products.
* Member of company's Business Development and Licensing Team.
* Identified, qualified and negotiated contracts with a globally recognized CMOs for manufacture of Bulk Drug Substance and
Final Formulation of company's products.
* Managed technical transfer and outsourcing to CROs and CMOs for cGxP performance of production processes, lot release,
stability programs and PK/ADME Tox.
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ValiGen, Inc.
- Director Business Development & Human
2001 - 2001
* Implemented cross-functional project team approach to integrate R&D and Product Development activities for ValiGen's four
business units (Plant Genomics & Proteomics (San Diego, CA., Human Proteomics & Genomics , (Paris France), Human
Genomics (Berlin, Germany) and Human Gene Therapy & Healthcare, (Newtown, PA))
* NOTE: Company was undertaking a private finance round at the time of the 9/11 terrorist attacks and as a result of the attacks
the round was not completed and the company ceased to operate post 9/11.
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Bristol-Myers Squibb, Co.
- Senior Research Investigator I & Project Team Leader
1998 - 2001
* Project Team Leader Development Coordinating Team sub-team for the production and preclinical evaluation of Orencia®
(Abatacept) (CTLA4Ig-fusion Protein] produced from the milk of transgenic goats.
* Team member Project Working Group and Development Coordinating Teams for Orencia® (Abatacept) for Solid Organ
Transplant & Rheumatoid Arthritis (Phase III-NDA period).
* Co-scientific liaison between the Pharmaceutical Research Institute of Bristol-Myers Squibb, Co. and its partners for the
development of proteins produced from transgenic animals and plants.
* Coordination of analytical laboratory activities and personnel in accord with cGxP compliance to support the process
development and manufacturing activities of Bristol-Myers Squibb, Co. biologics based pharmaceutical products.
* Developed and automated immunoassays and cell based analytical assays to support Bristol-Myers Squibb, Co. biologics based
pharmaceutical products.
* Implemented 21 CFR part 11 compliant real time data capture system and LIMS for AR&D.
* Developed automated systems for the performance of ELISAs, Sample Preparation, Cell Culture and Cell Based Assays.
* Developed a competitive landscape analysis of the therapeutic markets for Multiple Sclerosis, Solid Organ Transplant, Psoriasis
and other autoimmune disorders.
* Actively participated in the Project Working Group and Development Coordinating Team activities for biologics projects for Solid
Organ Transplant & Rheumatoid Arthritis.
* Developed a strategic plan for BMS relative to the manufacture of its biotechnology products with the Vice-President European
Operations for BMS.
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Amgen Inc.
- Research Scientist
PARIS
1995 - 1998
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Athena Neurosciences, Inc.
- Developmental Scientist
1994 - 1995
* Chief Development Scientist for Antegren (Tysabri) Athena's humanized antibody for the treatment of Multiple Sclerosis .
* Identified, negotiated contract and manage the technical transfer and scale-up to 2000 liter scale manufacture of bulk drug
supplies for a Antegren (Recombinant anti-VLA4 MAb produced through humanization by CDR grafting)
* Identified, negotiated and managed the technical transfer to a CMO for the manufacture of the final formulated drug of the
Antegren used in the clinic.
* Chief Development Scientist for Athena Neurosciences' holo-Botulinum B toxin (MyoBloc , NeuroBloc ) program for the
® ®
treatment of torticollis.
* Member and actively involved in the management of all project teams for company's products under development.
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Bristol-Myers Squibb, Co.
- Research Investigator
1991 - 1994
* Supervised the activities of the analytical cellular and molecular immunology laboratories. Coordinated laboratory activities and
personnel for development, production and validation of cGxP compliant immunochemistry based analytical reagents and
assays to support the development of the company's Biologics products.
* Member cross-functional project teams for numerous projects under development.
* Developed immunoassays, bioassays and BIAcore based assays to support Bulk and Final Product release and stability testing of
BMS biologics products (Products included Chimeri L6 MAb, BR96-Doxorubicin (MAb conjugated with Doxorubicin, TGF-beta,
LEA29Y Ig fusion protein, Anti-CD40 MAb)
* Produced MAbs and polyclonal antibodies for use in the development of assays.
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Vanderbilt University
- Doctorate Research Associate
1990 - 1991
Vanderbilt University, School of Medicine, Department of Biochemistry,
* Conducted research related to determining the functional regulation and activity of the 5' regulatory region of the gene
encoding for EGF.
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Cornell University
- Post- Doctorate Research Associate
1988 - 1990
Cornell University, Biochemistry Molecular & Cellular Biology,
* Conducted research on TGF-B induced cell cycle dependent changes in proteins that interacted with the AP-1 responsive
element.
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West Virginia Emergency Medical Services
- Cave and Mine Rescue Specialist
1981 - 1988
West Virginia, East Cost Cave and Mine Rescue 1984-1988.
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West Mifflin Emergency Services
- Paramedic & Firefighter
1976 - 1988
Rescue: Volunteer Work: EMT/Paramedic 1976-1988 , EMT/Paramedic 1976-1988, Monongahela Emergency Services as EMT/Paramedic 1981-1988, Wilderness Search and Rescue
Rescue: Volunteer Work: EMT/Paramedic 1976-1988, West Mifflin Emergency Services as
EMT/Paramedic 1976-1988 , Monongahela Emergency Services as EMT/Paramedic 1981-1988, Wilderness Search and Rescue
