Calmour pharmaceutical consulting
Over 200 Years Combined Professional Experience in Pharmaceutical Business
Working with Calmour will help you resolve technical and business issues and result in a quicker time to market.
Our Consulting Services
Calmour Pharmaceutical Consulting Inc. provides expert regulatory affairs, technical services, and compliance to clients worldwide. It will help clients to develop strategies for product development, process, and manufacturing of various dosage forms in compliance with FDA requirements. We offer services in document preparation, review of documents, audits, pharmacokinetic and clinical studies, review of regulatory filings, due diligence services, and audits for strategic acquisitions. We also provide services in quality control/assurance areas.
Launching Successful Brands in Our Lifetime
Calmour intends to be a full-service consulting organization and provide guidance to clients in product development, manufacturing, Chemistry Manufacturing & Controls for regulatory compliance with regulatory agency’s expectations, review product development reports, and risk assessment.
Calmour will assist in design of pharmacokinetic & clinical studies as well as assist with clinical reports and vendor audits.
Ultimately Calmour’s intent is to make product development and manufacturing robust and faster to help ensure a faster timeline to market for clients.
1. Personalized attention to your needs.
We focus on your needs to develop a personalized project plan for discussion with you and your approval. Quick execution in mutually agreed upon timeframe and provide deliverables in the utmost professional manner.
2. Seamless and effective implementation.
Seamless use of experts to move the project along effectively and ensure communications between our experts and the client team are fluid and timely.
3. We make it happen.
Our philosophy is your success is our success and We Will Make it Happen! We are prepared for accidents along the way as accidents happening to prepared minds bring success—such as the discovery of fluorescence, penicillin , structure of benzene ring, etc.
We’re Experts in Our Field
This expertise of the members comes from each of us having 20+ years of experience in our relevant fields. Whether it is product development, pharmaceutical manufacturing, process development, clinical studies, regulatory submissions to agencies, and compliance or market research, our team of experts are well-rounded.
Our Team
The Calmour team came together after having prior experience working together for many years on different projects in the pharmaceutical field, product development, regulatory, manufacturing, and marketing. Learn more about each of the Calmour experts below.
Sharad Govil, Ph.D.
Dr. Sharad K. Govil is a well-known Pharmaceutical Sciences Executive in the US Pharmaceutical Industry with a proven track record of success in technological development, commercialization of Pharmaceutical products, intellectual property strategy, business development and management of enterprises.
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Dr. Govil’s accomplishments include: 19 ANDA Filings; 2 European Approvals; 2 Japanese MRLW Approvals; 1 Indian ANDA Approval; 1 Approved NDA; 1 NDA Pending Approval (Approvable); 2 Products to Phase III Clinical Programs, 7 International Licensing Agreements, 2 U.S. Licensing Agreements.
Dr. Govil was President of Zydus Noveltech, Inc which he started in 2007. Has been involved in Management, working with FDA to bring products to market and clinical research.
Dr. Govil was President of Mylan Technologies Inc. a division of Mylan Laboratories Inc. world’s third largest and fast growing pharmaceutical company, from year 2000 to 2006. Under Dr. Govil’s leadership, Mylan Technologies transformed from a business unit losing $27 million annually to a business unit whose products recorded annual revenues of approximately $400+ million in year 2006 with profits in excess of $200 million. Under Dr. Govil’s leadership, Mylan’s Nitroglycerine Transdermal System (NTS), Nitrek®, Estradoil Transdermal System (ETS) and Fentanyl Transdermal System (FTS) were approved as first ever generic transdermal products by USFDA, While EMSAM® was approved as a first depression patch in the prescription market.
Dr. Govil was responsible for Mylan’s entry into Europe and Japan with first ever European generic patch approvals and for marketing alliances with major European companies and Japan’s #1 generic Pharmaceutical Company.
Dr. Govil was at Schering-Plough for 7 years as Manager of Development.
Dr. Govil holds a Ph.D. in Pharmaceutical Science from University of Michigan at Ann Arbor. He has over 15 issued US Patents, over 10 peer reviewed journal publications and is author of Transdermal Drug Delivery Devices chapter in Marcel Dekker publication.
Dr. Govil was awarded the Luther Hackett Vemont Businessman of the Year Award in 2004. Under his tutelage, Mylan Technologies was the recipient of DIANA Award from US drug Wholesalers and Distributors Association in 2005 for the best generic launch of a Pharmaceutical product-Fentanyl.
Dr. Govil is a member of Controlled Release Society (CRS), Parental Drug Association(PDA), Drug Information Association (DIA), AAPS, Management Forum (EU) and RAPS.
Amanda Gotto
Pharmaceutical process development/ scale-up/validation expert, adept at multi-tasking and working in a matrix environment.
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Experienced at managing Phase I-III development programs and technical support/troubleshooting of marketed products. Projects have included new chemical entities and generics for solid oral dosage, biologics, vaccines, and transdermals. Drug development scope includes generation and implementation of development strategies, timelines, and budgets for Phase I-III products; technical support (process engineering, equipment specification, process validation, technical transfers, materials selection and specifications, and vendor qualification); regulatory support (preparation for regulatory meetings and inspections, dossier preparation, and support of submissions); and clinical support (protocol synopses, data review, and study summaries). Special expertise in transdermal products (process engineering, materials selection and specifications, equipment specification and validation, physical test method development and validation).
David Beach BS Pharm, Ph.D.
With more than 30 years of experience in Ethical and Generic product development, Dr. Beach’s expertise lies in oral solid dosage form research through scale-up to production. Process Analytical Technology, equipment, process and product validation are all areas of expertise. In addition, Dr. Beach possesses a broad background in product and process intellectual property.
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David P. Beach began his pharmaceutical career with a Bachelor of Science degree in Pharmacy from Union University, Albany College of Pharmacy in 1973 and furthered his education earning a Ph.D. in industrial pharmacy with a minor in physical pharmacy from the University of Maryland at Baltimore in 1982. He entered the pharmaceutical industry as a formulation development scientist with DuPont Pharmaceuticals after graduation and progressed his career of more than 35 years through a succession of positions of escalating responsibility, ultimately becoming the President of TorPharm, a division of Apotex Pharmaceuticals in Etobicoke, Ontario, Canada in 1993. David has devoted his professional career to pharmaceutical research and development, and during his career, he has participated in the development of over 50 products, been granted 3 patents, and published a number of journal articles and a textbook chapter on pharmaceutical manufacturing.
Exhibit A ( CV) lists David’s employment history and demonstrates his experience in the development of primarily oral solid dosage pharmaceutical products. Relevant experience in product development includes employment as a Senior Scientist with DuPont Pharmaceuticals; Director of Pharmaceutical Development with Goldline Laboratories; various management roles within Schering Plough; Director of Research and Development with GenPharm; initially Vice President of Pharmaceutical Operations with TorPharm; and finally as President of TorPharm. After leaving the corporate world, David has worked as a consultant to the pharmaceutical industry, and has been involved with issues involving excipients, product development, the successful formulation of pharmaceutical products, and patent litigation within his area of expertise.
David is a past member of the following organizations: APHA, AAPS, ASHP, ASTM Executive Committee E55.1 empanelled for PAT Standards Development, and the Scientific Advisory Board of the NSF Engineering Research Center for Structured Organic Particulate Systems at Rutgers University.
Gary Gemian
More than 30 years of experience in pharmaceutical sales, marketing, advertising, managed markets, business development and consultancy proprietorship including Hye Pharma, LLC where he served as Executive Director, Proprietor.
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Mr. Gemian has more than 30 years of experience in pharmaceutical sales, marketing, advertising, managed markets, business development and consultancy proprietorship including Hye Pharma, LLC where he served as Executive Director, Proprietor. Mr. Gemian led the development of payer access strategies in diabetes, hepatitis, cardiovascular disease and oncology disease states. These strategies resulted in quantified economic value assets allocation and development of Managed Markets Business Solutions for clients across all payer channels, including Commercial, Medicare Part D, Medicaid, Federal, Integrated Delivery Networks and Pharmacy Benefit Managers. On the corporate Pharma side of the industry, his 17 plus years of experience includes positions as Senior Director of Marketing at Merck (formerly Schering-Plough) and Director of Market Development, Allergy-Respiratory Franchise generating sales revenue in excess of $4 billion annually. Mr. Gemian earned his BS degree in Biology in 1974 from Fairleigh Dickinson University.
Mr. Gemian is responsible for the pre-launch and launch commercialization of brands including the marketing strategy, customer segmentation across all commercial channels in the U.S.
Guirag Poochikian, Ph.D.
Guirag Poochikian, Ph.D. is the former FDA Associate Director for Regulatory Science and Policy, Office of New Drug Quality Assessment. He has more than 25 years of regulatory science experience at FDA.
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Guirag Poochikian, Ph.D. is the former FDA Associate Director for Regulatory Science and Policy, Office of New Drug Quality Assessment. He has more than 25 years of regulatory science experience at FDA, which includes regulating oral inhalation and nasal inhalation drug products; assessing compliance with pharmaceutical current Good Manufacturing Practices (cGMPs); developing chemistry, manufacturing, and controls (CMC) Agency guidances; and participating on counterfeit drug and drug quality task forces. He assists pharmaceutical manufacturers in designing research and development efforts, addressing CMC documentation issues for Agency review, complying with cGMPs, preparing for FDA meetings, evaluating excipients in drug products, and formulating inhalation products. Guirag is particularly expert in the development of inhalation drug products, including inhalation aerosols, dry powder inhalers, nasal preparations, and a variety of other dosage forms. During his tenure at FDA, Guirag also served as a Supervisory Chemist in the Division of Oncology and Pulmonary Drug Products and Pulmonary and Allergy Drug Products, a Supervisory Chemist in the Division of Surgical Dental Drug Products, and a Review Chemist in the Division of Oncology and Radiopharmaceutical Drug Products.
Guirag’s specific experience includes the following:
Chemistry, Manufacturing, and Controls
Guirag directed, coordinated, assessed, and endorsed the scientific review and evaluations of those sections of investigational new drug applications (INDs), new drug applications (NDAs), and supplemental applications related to chemistry, manufacturing, processing, controls, packaging, specifications, stability, and container closure systems. He developed and implemented CMC guidances for FDA. He served as Chairperson of the CMC Working Group for the Orally Inhaled and Nasal Drug Products (OINDP) Committee in the FDA Center for Drug Evaluation and Research (CDER) and as the coordinator of the CMC aspects of inhalation drug products in the Center.
Pharmaceutical cGMPs
Guirag was involved in FDA’s initiatives including the current initiative, “Pharmaceutical cGMP for the 21st Century—A Risk-Based Approach.” He was a member of FDA’s Council on Pharmaceutical Quality Manufacturing Science Working Group. He was a member of FDA’s Counterfeit Drug Task Force and Technical Working Group for Drug Quality issues. He was a member of the International Conference on Harmonization (ICH) Quality Expert Working Group.
Inhalation Drug Products
Guirag served as an FDA spokesperson for oral inhalation and nasal drug product CMC related issues. He represented FDA on the Drug Product Technical Committee and related various inhalation drug product work groups within Product Quality Research Institute (PQRI). He played lead role in FDA’s effort to develop strategic policies to implement phase-out of CFC-based inhalation drug products while ensuring availability of high quality drug products. He was a member of USP’s Aerosol and Reference Standards Expert Committees.
Combination Drug Products
Guirag assessed drug-device combination drug products and coordinated related scientific and regulatory issues and policies at FDA.
Other FDA Activities
Guirag managed, organized, and directed regulatory science review issues and activities. He developed, managed, explained, and clarified CMC guidances and policies. He coordinated quality assurance activities of CMC reviews.
Mario A. González, Ph.D., FCP
Dr. González specializes in biopharmaceutics/pharmacokinetics research and clinical study design.
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Dr. González was previously Director of Biopharmaceutics and Pharmacokinetics at Schering Research, Miami (formerly Key Pharmaceuticals,
Inc). His research has concentrated on the pharmacokinetic and
pharmacodynamic evaluation of extended-release oral and transdermal drug delivery systems as well as in vitro/in vivo correlations. Prior to joining the pharmaceutical industry, Dr. González was on the Pharmacy faculty at Purdue University with teaching and graduate research responsibilities in clinical pharmacokinetics. He has been active in AAPS since its inception and was Chair of the Pharmacokinetics Section in 1995. He also serves on the editorial advisory boards of the European Journal of Pharmaceutics and Biopharmaceutics and the International Journal of Clinical Pharmacology and
Therapeutics. The American College of Clinical Pharmacology has elected Dr.
Gonzalez as a Fellow in Clinical Pharmacology.
Ngoc-Anh T. Nguyen, Ph.D.
Principal Consultant with 30+ years of delivering pharmaceutical products to market with global manufacturing leader & CMOs.
A resourceful pharmaceutical development leader who leverages broad based drug development experience and technical formulation expertise to optimize product development and delivery for clinical phases and commercialization.
Delivered numerous clinical formulations/supplies and 7 marketed products.
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Anh’s broad development experience includes developability of drug candidates, drug delivery design for early clinical phase through marketed product, clinical supply manufacture, process development, scale-up, technology transfer, research alliances, development and manufacturing through CMOs, due diligence evaluations, and leadership/management of projects from candidate selection through commercial launch.
Anh has delivered 12+ early clinical formulations/supplies and 7 marketed products including sterile lyophilized product, oral solution, and oral solids. Anh has led multiple CMC matrix teams and New Product Supply teams.
Anh completed her bachelor degree in Chemistry at the University of Michigan and her doctorate degree in Pharmaceutical Sciences at the Ohio State University. She has published peer reviewed research papers, presented at national conferences, and served as reviewer for research journals. She holds a patent on oral formulation and patent applications for controlled release and lyophilized formulation.
Examples of projects completed:
- Successfully delivered a new capability (sterile nanomilled suspension) to support long acting parenteral development for breakthrough HIV treatment
- Led and delivered an accelerated program, complexed by an active Alliance partner, using multiple compounds (3) in FTIH at the same time for best PK profile with QD dosing potential, followed by tablets in phase 2a/b within 2 months using an adaptive clinical design.
- Performed due diligence reviews on in-licensing opportunities (10+) for sterile products and oral dose forms saving money for the company with “No Go” recommendation on 2 assets.
- Led 4 late stage projects (CMC space) successfully through major milestones (pivotal manufacture, file, and transfer to production)
- Provided effective integrated project planning, risk management, and leadership during preparation for launch of a breakthrough product.
- Authored and/or reviewed numerous gap analysis/development reports, and DP modules for IND, IMPD, NDA, MAA, and JNDA
- Provided CMC consultancy and project management for product development and manufacture of registration batches for oral & parenteral dose forms (drug + device combination product, sterile powder fill, sterile solution)
Steve Bannister, Ph.D.
Experienced pharmaceutical-development scientist, leader, with more than 35 years of experience applying the fundamentals of physical and analytical chemistry to the design, development, and analysis of drugs, drug delivery systems, medical devices and other FDA-regulated products. Proven ability to solve problems of solubility, stability, release, bioavailability, and biocompatibility based on a thorough understanding of physical and biological phenomena. Extensive experience in technical and regulatory issues related to prodrugs of cytotoxic anticancer agents including paclitaxel and other taxanes.
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Technical due diligence, program and project technical review, guidance, and regulatory submission.
- Review of existing drug-substance manufacturing, formulation-screening, and bioavailability data for a very lipophilic small molecule development candidate and assessment of regulatory gaps; direction of the necessary analytical work and of the creation of the CMC component of the pre-IND meeting briefing package.
- Analytical and delivery-system technology selection and development including:
- Technology options for an intravenous formulation of a drug with an aqueous solubility of less than one nanogram per milliliter.
- High-bioavailability oral formulation of a BCS Class II compound to insure adequate animal exposure in safety studies.
- Experimental design and execution, data interpretation, and problem-solving, including:
- Execution of ISO 10993 biocompatibility testing on a polymer implanted device.
- Assisted with development of an intravenous cytotoxic product to be filed as a 505(b)(2) New Drug Application (NDA) with advantages over the reference-listed drug (RLD) including being a ready-to-dilute nonaqueous solution product rather than a powder for reconstitution. New related-substance impurities were found and identified as drug-excipient reaction products, and tissue distribution coefficients (logD) leading to NDA approval.
- Formulation, process and bioanalysis Intravenous nanoparticle tumor targeting technology applied to taxane anticancer prodrugs.
Accountable for scientific integrity, technical capability, regulatory compliance and productivity of diversified analytical services group.
Supporting formulation development, GMP manufacturing and product stability studies, including:
- Preformulation characterization of drug.
- Analytical method development for drug substance and drug product – assay, related substances, degradation products, content uniformity, dissolution.
- Qualification and validation of analytical methods to rigorous scientific and compliance (FDA and ICH) standards.
- Drug R&D, process development, and manufacturing technical services.
- Approval of paclitaxel ANDA;
- Development of proprietary oral delivery systems for natural-product drugs;
- Development and installation of semisynthetic paclitaxel manufacturing process meeting or exceeding targets for cost, yield, purity, and impurity profile; and
- Numerous analytical methods, especially chromatographic, capable of specific determination of components in complex natural product mixtures.
Developed methods to characterize new-drug and generic immediate and extended-release oral solid dosage forms and used data in collaborative product optimization.
MEMBERSHIPS
- American Association of Pharmaceutical Scientists
- American Chemical Society
- AOAC International
- Controlled Release Society
- International Society for Biomedical Polymers and Polymeric Biomaterials
- Parenteral Drug Association
Susan Augello-Vaisey
Susan has made her career working first in big Pharma and then at newly emerging pharmaceutical companies developing the processes and procedures for clinical trials and medical affairs functions from the pre-approval stage through product launches and post-marketing support. To a large degree, this involved assessing the needs of the organizations, determining the best solutions for high levels of patient safety, regulatory compliance, and minimal risk and expense for the company, and ultimately implementing the plan on time and within budget.
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Susan’s experience also includes: managing FDA audits; auditing GXPs; responding to GXP observations; extensive medical/regulatory writing for INDs and NDAs; SOP development (medical and clinical); safety profiling of marketed products; due diligence activities for potential product acquisitions; pharmacovigilance and complaint handling software selection; and use of technical solutions for document management.
Susan has built medical and clinical trial operations for emerging companies including staffing, process and procedures, data base implementation, and statistical and database management.
Susan’s team has therapeutic areas of expertise in ophthalmology, asthma and allergy, oncology, and neurology.
She has made presentations on GPvP, disease state training, bringing in Part 11 compliant software systems, CRA and sales force training, and Medical Affairs planning for small Pharma. Susan conducts customized GCP, pharmacovigilance, and medical information training remotely or on site.
Check out her website here: https://www.pharmaconsultingsolutions.com/.
Thomas S. Spencer, Ph.D.
Senior executive pharmaceutical manager with experience in building technical organizations for formulation, process development and manufacture of controlled release delivery and transdermal delivery systems. Experience in training scientists and engineers, guiding product development processes and preparing products for regulatory submissions for product approval. Consulted for transdermal delivery, medical device and investment advisory companies in the US and Asia.
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Senior executive pharmaceutical manager with experience in building technical organizations for
formulation, process development and manufacture of controlled release delivery and transdermal delivery systems. Experience in training scientists and engineers, guiding product development processes and preparing products for regulatory submissions for product approval. Consulted for transdermal delivery, medical device and investment advisory companies in the US and Asia.
- Design and evaluation of skin care products, transdermal delivery systems and topical devices
- Trained transdermal development team and mentored the filing of 2 transdermal ANDA’s
- Coordinated testing and scale-up of new transdermal delivery system for Indian and Japanese companies
- Evaluated regulatory filing and manufacturing capability for a licensed generic transdermal system.
- Completed validation and launched $400M transdermal analgesic transdermal system
- Introduction of experimental designs in process development and applications of systematic designs of experiments in the scale-up of 3 transdermal projects.
- Initiated new polymer characterization technology to understand skin adhesion of transdermal systems.
- Started joint development project for medical device with controlled release drug delivery
- Redesigned topical paclitaxel formulation during Phase 1 clinical studies for psoriasis
- Coordinated paclitaxel-coated stent preclinical studies with NIH patent licensor in collaboration with Boston Scientific and Cook stent partners.
- Research on an electrically assisted transdermal delivery technology
- Built R&D from 5 scientists, to a hundred full time professionals, including process development
- engineering, clinical production, scale-up, validation, formulation, analytical development and new technology research.
- Led R&D organization in commercializing the Nicotrol Transdermal System, filing an NDA for transdermal estradiol, and developing four transdermals for clinical testing.
- Built new dermatological research department to explore new technology for skin and hair products and to guide the formulation of novel dermatological and consumer products.
PROFESSIONAL SOCIETIES
- American Association of Pharmaceutical Scientists
- American Chemical Society
- American Academy of Dermatology
- Society of Cosmetic Chemists
Work with Calmour Pharmaceutical Consulting.
Achieve the success you need in a timeline you need and enter commercialization at a pace faster than you realize.
Industries, Products & Brands
Calmour intends to assist pharmaceutical and medical device (Combination products) industries.
The experts have been involved in over 50 regulatory approvals and launches in the following therapeutic areas :
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Contact Us
Please fill out the form or give us a call at 802-861-4111 and we will get back to you within 2 business days. We look forward to working with you!
Calmour Contact
Susan Lucey
[email protected]
802-861-4111
Calmour Office Address
1775 Williston Road
South Burlington, VT 05403