I am working in the field of Pharmaceutical Industries; I am a pharmacist; I am about 16 years real-time; accumulated expert in Regulatory Affairs, Quality Control & Methodology in the Pharmaceutical field. I am dealing with awareness with WHO, ICH, FDA, Eudralex, EMEA, OMCL & ISO 17025 guidelines through real inspection audits from WHO, FDA, EMEA, DNDI,  ISO 17025 & others. Also, I performed GMP audits for API (ICH Q7…

A pharmaceutical executive with over twenty years of experience managing the safety of oncology, neurology, gastroenterology, dermatology, metabolic disease and first-in-human drug products throughout their life cycles for companies including TAP, Abbott, Valeant and Orexigen. • A track record in orchestrating preparation of the safety section of NDA submissions including the new chemical entities Potiga, Uloric, and Uprima, the combination weight loss drug Contrave, and supplemental applications for Napra-Pac, Prevacid Pediatric, and Zevalin. • An expert in evaluating drug safety…

Over 20 years’ experience working with pharmaceutical, biotech, and contract research organizations in both Clinical Programming and Data Management departments providing management and technical expertise to utilize systems, tools, and applications to support the delivery of clinical trials for new and existing drugs in a variety of therapeutic areas

Specialist dedicated to assisting life sciences start ups understand asset valuations. MIT trained PhD in Organic Chemistry, also honed pharmbio strategy acumen at BCG, now available as an independent expert. Passion for helping pharmbio start ups navigate challenging investor dialogues and pathways in order to acquire the investment required to grow the vision to full fruition.

CMC expert

“Comprehensive CMC Consulting”sm services for biologic, oral dosage, cell therapy, veterinary and medical device companies, their investors, throughout the product lifecycle. Virtual to multi-national clients. Experts in all aspects of development, manufacturing, quality, and regulatory CMC. Products and services: Stabilityshiresm, ProcessPadtm, and ARCCtm compliant cloud QMS.

Specialties: Clinical development, pharmacovigilance, risk-benefit, risk management/mitigation, epidemiology, pharmacoepidemiology, clinical trials, drug safety, medical affairs, outcomes research, REMS, MAAs, NDAs, INDs, BLAs, life cycle management, pharmacoeconomics, international and US regulations

Seasoned Biotech Executive with 24 years progressive experience managing Process Development, CMC, Manufacturing Sciences and Technical Operations departments with proven ability to deliver top notch results meeting accelerated timelines. Skills and Experience: Managerial & Leadership Experience: Manage teams of up to 50 scientists and engineers and annual budgets exceeding $20M. I have been a member of multiple steering committees, site leadership teams and safety committees. Process Development / Manufacturing Sciences: Process Development, scale up and technology transfer of over 30…

Highly adaptable and goal oriented Project Manager with CMC, Regulatory and Medical Device experience. SELECTED ACCOMPLISHMENTS • Project Lead for PAREXEL’s flagship and most extensive global large engagement outsourcing regulatory project (60 products, 12M) including Europe, Americas, Asia Pacific, Middle East and Africa; managed global subject matter experts, a large technical team in India and in-country regulatory experts. • Directed the effort in compiling and submitting an IND for combination drug/device product (Anastrozole implant) in 69 days. • Managed the…

A strategic leader with deep technical expertise in biopharmaceutical development who has led global, multi-company development teams to expeditiously bring protein drugs into clinical trials and to commercialization. Successfully developed numerous Antibody Drug Conjugates (ADCs) for all phases of clinical use. Proven track record of success in early and late stage process development, transfer to manufacturing, analytical control strategies and harmonization of regulatory approaches.

I am a task-oriented leader* with nearly 20 years of PhD-level scientific expertise coupled with 13 years of extensive cross-functional (CMC, nonclinical, clinical, regulatory affairs) and integrated development experience from pre-IND through licensure (biologic, biologic-device, drug, device); I work well independently and with others to gets things done right the first time, on time, and within budget. • Major accomplishments*: o 7 FDA market approvals (1 BLA for biologic-device, 6 NDAs) o 8 INDs and full maintenance (2 biologic-device, 2…

•Lead safety physician for global studies of investigational products & devices for oncology, cardiovascular, endocrinology, neurology, rheumatology, infectious diseases, gastroenterology, and rare disease indications •Expert in safety evaluation and detection of safety signals from Phase 1 through Phase 3 •Managed postmarketing SAE and literature review, assessment and processing •Oversaw/wrote DSURs including risk statements for products in oncology, neurology, immunology, metabolism, dermatology •Responsible for safety sections of oncology and metabolism protocols •Operational experiences include responsibility for safety management plans, query design,…

• Analytical method selection, development and troubleshooting • Vendor management • Authorship of Development plans, SOPs, Qualification/Validation protocols and reports • Drafting of Regulatory documents including INDs, DMFs, and RFIs • Reference Standard/Critical Reagent management • OOS/OOT Investigations • Biochemical characterization • Stability studies • Forced degradation studies • Cell based potency assays • Formulation development • Protein production and purification

Main business activities:

Auditor (ISO 9001:2015 Lead Auditor, GCP and regulatory compliance audits, system audits, vendor qualification audits, study site audits, mock inspections, bioequivalence study audits, quality oversight visits) Medical Writer (protocol, ICF, CSR, manuscript, advisory board meeting report, safety narratives, etc.) Trainer (a portfolio of 40+ courses in topics related to clinical operations, GCP (R2) self-attested per TransCelerate requirements, project management, risk management, medical writing, etc.) SME (Risk management implementation in small and medium size pharma and biotech…

Involvement in Industry-Sponsored Clinical Research for 21 years. While at Eli Lilly and company led the only Phase III sepsis trial to result in FDA approval. Created and directed an academic CRO at Rhode Island Hospital/Brown University Medical School to coordinate Phase II and Phase III trials for Industry sponsors. Clinical advisor to numerous companies including ex officio CMO at 3 biotech start-ups.

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Strategically partner with pharma, biotech, and CROs providing consultative expertise including due diligence, corporate pipeline development, scientific operations, clinical operations, quality assurance, and scientific support of commercial operations. Services include but not limited to clinical trial protocol development; clinical data review; review and editing of regulatory and clinical documents; develop regulatory correspondence; project and program management; resource planning; product development; vendor selection and management; SOP development; and CRA/CTA support.

“Perfect Liaison between CMC, Regulatory and Quality” is a phrase that has been used to describe me. Seasoned Quality leader with over 20 years of experience in an FDA regulated environment, including broad expertise in bioanalytical methods with experience leading method qualification/verification/validation, cGMP testing, as well as establishing stability, raw material and environmental monitoring programs. Additionally I am an effective leader with CMC experience in EU and Health Canada submissions and member of audit team that gained EMA approval of…

Regulatory Information Management (Veeva Vault), Clinical Trial Management Products, Clinical Decision Support, Pharmaceutical / FDA, Drug Safety, Healthcare, Pharmacy Benefits, Telematics, Internet / Cable Service, Banking, Mortgage, Private Equity, Compliance & Litigation, Management, Government – Child Welfare among other industries.

Provide strategic leadership and drug development guidance to both large pharma and small biotech companies to drive key assets forward from early development through regulatory submission; create development strategy plans, and implement program management oversight and facilitate regulatory agency interactions and communications.