Daniel Mufson
 Daniel
Mufson has 40 years experience in the development and registration
of drug, device, combination and biological products. Skilled
in creating and leading multi-disciplined, technical teams
to create new drug delivery technologies and products—he
built Liposome Technology and Alexza MDC into successful drug
delivery companies. He is President of APOTHERX®
LLC a product development and regulatory consultancy in Napa,
CA and is currently guiding R&D for a start-up ophthalmic
drug delivery company.
Most recently he served as Chief Scientific
Officer of Alexza Molecular Delivery Corporation where he led
the development of Staccato™ thermally generated aerosols
and directed the Company to its first IND. He helped to found
Molecular Delivery Corp. which merged with Alexza, founded
by Alex Zaffaroni, in 2002.
For 10 years he headed APOTHERX providing
product development expertise to numerous start-up and global
pharma companies including Cusi (Alcon), DepoMed, ISIS, Japan
Tobacco, Ligand, Neurex (Elan), Novartis, Q.P. Fine Chemicals
(Kewpie), Santen and St. Jude Medical.
He was Senior Vice President
of Corporate Development and Vice President for R&D at Liposome Technology, Inc. (ALZA/JNJ)
where he led development to the first INDs for inhalation and
ophthalmic products. Dr. Mufson was Director of Pharmacy R & D
at Revlon Health Care Research (Aventis) and had worked for Smith
Kline & French Laboratories (GSK) and for Parke Davis & Co.
(Pfizer).
Dr. Mufson received his Doctorate in Pharmaceutical
Chemistry from the University of Michigan and his B.S. and M.S.
degrees in Pharmacy from Columbia University. He is a Fellow
of the American Association of Pharmaceutical Scientists. He
recently completed a chapter, Integrated Drug Product Development—From
Lead Candidate Selection to Life-Cycle Management forThe Process
of New Drug Discovery and Development (Second Edition), editors
Charles G. Smith and J.T. O’Donnell, CRC Press, in-press
(2005).
Product Experience
With years
in Big Pharma and leading drug delivery companies, Dan has expertise
in the formulation and manufacturing of all dosage forms--aerosols,
injections, ophthalmics, tablets and topicals. He headed R&D
for two major drug delivery companies, Liposome Technology, Inc.
and Alexza Molecular Delivery Corporation.
Some relevant experience
is highlighted below:
Product Development:
Many of his clients at APOTHERX have been companies developing
their first product for whom he served to completely coordinate
all of the chemistry and pharmacy issues (CMC) leading to their
first IND(s). Several of these formulations have been approved
including Prialt® (Ziconotide intrathecal infusion) (Neurex/Elan);
Abreva® (docosanol creme) (Lidak/Avanir) and Panretin®
(alitretinoin gel) (Ligand). He formulated the first antisense
oligonucleotide and the first vomerophermone to be administered
to man.
Michael Forman
 Michael
Forman has been an active inventor in the field of catheter-based
drug delivery. He has worked for Schneider U.S.A. (now a part
of Scimed/BSC) and Xoft among others. His focus has been on delivery
of drugs to the heart by percutaneous methods
His patents include:
- Combination x-ray radiation
and drug delivery devices and methods for inhibiting hyperplasia
(No: 6,537,195).
- Thrombolytic filtration and drug delivery catheter
with a self-expanding portion (No: 6,280,413).
- Systems and methods
for drug delivery including treating thrombosis by driving
a drug or lytic a (No: 5,925,016).
- Nickel titanium guide wires
for occlusion and drug delivery (No: 5,776,100).
- Dilation-drug
delivery catheter (No: 5,772,632).
- Drug delivery guidewire
(No: 5,569,197).
- Drug delivery and dilatation-drug delivery
catheters in a rapid exchange configuration (No: 5,514,092).
- Dilation-drug
delivery catheter (No: 5,415,636).
Circle Medical Provides Fully Integrated Product Development
Services
| Feasibility |
Regulatory |
Human Factors |
Design/Design
for
Mfg. |
Safety |
Testing |
Clinical Production |
Technical Transfer |
| Breadboards |
Initial Review & Planning |
Focus Groups |
Product Requirement Definition Document |
Risks & Hazards Testing |
Design Verification Testing |
CTM** for Phase 1 |
MPIs*** |
| Prototypes |
Prepare 'Request for Designation' Letter |
Human Factors Analysis |
Finite Element Analysis |
Biocompatibility Testing |
Sterilization Validation |
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Assembly Fixtures |
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FDA Meeting |
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Thermal Analysis |
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Package Validation |
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Test Fixtures |
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IND/IDE Preparation |
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Mechanisms Design |
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Design Validation |
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Training |
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STED Preparation* |
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Component Selection |
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Disposables |
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* Standard Technical Document
** Clinical Trial Material
*** Manufacturing Process Instructions
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