What We Do
My Background
Accomplishments
My Background
In graduate school I studied metabolism via plant tissue culture.
I started in industry growing human fibroblast cells on microcarriers in bioreactors to produce/purify interferon for the clinic.
Over the years I worked on monoclonal antibodies (Coulter), radiolabeling, (Centocor), protein conjugation/lyophilized formulation development (St
In graduate school I studied metabolism via plant tissue culture.
I started in industry growing human fibroblast cells on microcarriers in bioreactors to produce/purify interferon for the clinic.
Over the years I worked on monoclonal antibodies (Coulter), radiolabeling, (Centocor), protein conjugation/lyophilized formulation development (Sterling) and included sterile operations for various therapeutics along the way.
I've also worked with antibiotics and solid oral dosage forms (capsules/tablets) at CollaGenex and developed, scaled up and validated the process for its Periostat Tablet NDA, which was FDA approved.
At Enzon I was managed their GMP manufacturing plant for 5+ years producing two FDA approved pegylated proteins for life-threatening diseases and supporting all clinical projects/manufacturing. I was SME for their second generation versions for their approved products with two approved BLAs 2011.
I spent a few years starting my business and worked with various clients.
I joined Aclaris in 2014 and developed, scaled up and validated their applicator product to treat a dermatological disorder. This culminated in the approval of the second NDA.
In 2017 I restarted my consulting business to offer my knowledge and skills to start up, development and late stage companies and am ready to partner with you.
Experience
Accomplishments
My Background
Four+ Successful Decades in Pharma
Hands On Scientist, Management and Executive Positions in Manufacturing Operations
Biologics (native proteins, monoclonal antibodies, recombinant proteins, protein conjugates, derivatized proteins, pegylated proteins)
and
Small Molecules (peptides, oligonucleotides, high potency, antibiotics, PKC inhibito
Four+ Successful Decades in Pharma
Hands On Scientist, Management and Executive Positions in Manufacturing Operations
Biologics (native proteins, monoclonal antibodies, recombinant proteins, protein conjugates, derivatized proteins, pegylated proteins)
and
Small Molecules (peptides, oligonucleotides, high potency, antibiotics, PKC inhibitors, omega 3 fatty acids, oxidizers)
API, Drug Substance and Drug Product
Formulation Development (liquid/lyo) for proteins, conjugates, radioimmunoconjugates and small molecules
Preclinical, Phase I, II and III Processes
Injectables, Orals and Topicals
R&D Facility, Process Development, Scale Up and GMP Plant Operations
Analytical Method Development/Validation
Process/Product Development, Scale Up and Optimization
Process Characterization
and
Process Validation
Prospective and Concurrent Validation
CMO Due Diligence, Inspection and Management
Practical, Direct, Economical, Compliant and Innovative Problem Solving
Accomplishments
Accomplishments
Accomplishments
Two NDA Approvals:
Periostat (20 mg doxycyline hyclate tablets) for Periodontal Disease
and
Eskata (40% Hydrogen Peroxide solution in sealed glass ampules/polymeric applicator) for Seborrheic Keratosis
Two BLA Approvals:
Pegaspargase (pegylated L-asparaginase) for Pediatric Leukemia
and
Revcovi (pegylated recombinant adenosine deaminase) fo
Two NDA Approvals:
Periostat (20 mg doxycyline hyclate tablets) for Periodontal Disease
and
Eskata (40% Hydrogen Peroxide solution in sealed glass ampules/polymeric applicator) for Seborrheic Keratosis
Two BLA Approvals:
Pegaspargase (pegylated L-asparaginase) for Pediatric Leukemia
and
Revcovi (pegylated recombinant adenosine deaminase) for Severe Combined Immunodeficiency Disorder (SCID)
Enzon Pharmaceutical Employee of the Year
Numerous FDA Inspections/PAIs
12 Issued US Patents
B.S. Biology 1977 Univ. South Florida
M.S. Biology 1984 Univ. South Florida
CP Bioprocess Consulting, LLC
My Experience
After 40+ years in the industry, it has been my goal to provide cost effective and efficacious medications which improve the quality of life and treat life threatening diseases. I offer my wide range of development and manufacturing skills, experiences and knowledge from R&D to Commercial Manufacturing to prepare a comprehensive, detailed, product specific and customer-first approach consulting service.
My experience empowers me to generate a quality by design manufacturing portfolio for active ingredients and drug products which will be favorably reviewed by regulators. The best way to describe this strategy is with my company motto of 'SUCCESS by SCIENCE and COMPLIANCE'. Science because every decision is data driven. The foundation of empowering this approach are the analytics and methods and efficient design of experiments which reveal the characteristics of the process and product. As the saying goes, 'the process defines the product'. Compliance because the familiarity with and adherence to domestic and international governmental regulations and guidelines (e.g., CFR, ICH, etc.) is crucial to preparing the most direct path and ensure the best possible outcome with regulators. I am a strong partner with other disciplines (tox, clinical, medical, regulatory, quality, etc.) in order to provide the best customer service on a case-by-case basis. I will prepare a strong manufacturing and stability data package which will enhance your company's and product's credibility with regulators in support of approval.
A most recent accomplishment has been with one of my clients, Flightpath Biosciences ,Inc. After working on developing and scaling up the API and Drug Product processes for over 2 years starting the R&D level, the Company has successfully initiated a Phase I Clinical Trial using their novel antibiotic, FP-100, to treat Lyme Disease. This clinical trial is so significant, it was part of an article in May 2024 Time Magazine (click the hyperlink below, go to 7th to last paragraph, and click 'drug-development company', which will take you to Flightpath).
Lyme disease was long dismissed as a medical mystery. Here’s why that’s changing.
https://time.com/6974403/chronic-lyme-disease-research/
Whatever CMC needs you have, I am ready and available to support your product.
Please give me a call anytime to discuss further.
My Approach
I have learned by being in direct contact and discussions with regulators and inspectors over the years data and good science is paramount.
All recommendations I provide are data driven and compliant.
Regulators need to see and understand the rationale for how decisions were made and trust in your product quality is the first priority.
That is why my motto is 'Success by Science and Compliance'.
Why CP Bioprocess Consulting?
I am committed to providing accurate, data driven and straightforward customer service to my clients.
I will be your product's advocate and do my best to deliver a consulting product which will support the strengthening of your portfolio to attain regulatory approval.
Whether the job includes managing internal operations, third party contractors, technical writing, regulatory communications, or due diligence of prospective assets or facilities, I will deliver the total package.