Bob Malone Email & Phone Number

Northborough, Massachusetts, Us

Malone Pharma Consulting has a broad range of pharmaceutical product development and quality experience. Whether you need an interim head of quality or product development or simply an audit I can handle it for you with 30+ years of experience from pre-IND, through NDA preparation, product commercialization, launch and beyond. In addition I have extensive experience with respiratory products, including aerosols, suspensions and solutions. Product development; project management; quality system development and SOP writing; budgeting; vendor selection, oversight and qualification; troubleshoot or validate processes and source capital equipment; supply chain management including cold chain; PAI readiness; drug substance and drug product process validation; quality assurance; quality control; test method development and validation; extractables and leachables; regulatory submission preparation, review and submission; commercialization and product launch; complaint investigation and documentation; warning letter remediation.

Relevale Inc. is a private specialty pharmaceutical company whose mission is developing innovative treatments by applying advancements in drug delivery - the way medicine is administered - to drugs that are currently FDA approved. Relevale executed its development strategy and out licensed it's drug/device combination product RLV-113 in 2019. Relevale is currently developing a follow on product, RLV-122, with the potential to improve the efficacy of an important existing product. See www.relevale.com

Us

Meda Pharmaceuticals Inc. is the U.S. subsidiary of Meda AB. The Meda Pharmaceutical product portfolio is focused primarily on respiratory, allergy, central nervous system, gastroenterology, musculoskeletal, rheumatology, erectile dysfunction, and women's health products. Meda acquired Acton Pharmaceuticals in October of 2013, but retained me to support the commercialization and launch of Aerospan Inhalation Aerosol in March of 2014. Meda was acquired by Mylan in 2016.

Acton Pharmaceuticals is a specialty respiratory company focused on the acquisition, development and commercialization of products to treat pulmonary diseases. Acton licensed Aerospan HFA from Forest Labs in 2009. In 2012 Acton received approval to market Aerospan from FDA. In 2011 Acton licensed Nasacort HFA from Sanofi Aventis. In October of 2013 Meda Pharmaceuticals Acquired Acton for $135+ MM.- Co-authored Aerospan PAS submissions- Developed the Quality System in support of product launch- Helped re-establish productive relationships with the dormant supply chain.- Managed numerous CMO's, Contract Labs and Collaborations- Supported the acquisition of the company.

Marlborough, Ma, Us

• Directed GMP quality activities during the development of new small molecule pharmaceutical drug products from phases 1 through 4 for over 10 years.• Extensive experience in the development and commercialization of pressurized Metered Dose Inhalers, actuators and dose indicators.• Author / key contributor to the CMC sections of five NDA submissions, including: Brovana (first round approval $80MM/yr), Xopenex Inhalation Solution ($400MM/YR) and Xopenex HFA MDI (first round approval $80MM/YR) and Zetonna Nasal Aersol (est. $20MM).• Directed development activities with annual budgets of up to $10MM annually dealing directly with US and ex-US development partners.• Experienced in the areas of Seasonal and Perennial Allergic Rhinitis (SAR/PAR), Asthma, Chronic Obstructive Pulmonary Disorder (COPD), Restless Leg Syndrome (RLS), Depression and Anxiety.• Experienced in managing and auditing US and Ex-US contract manufacturers and testing facilities. • Prepared numerous US and ex-US CMC sections in support of clinical operations.• Managed up to 20 subordinates as direct reports / contractors including Ph.D.s.• Proficient at risk assessment and the practical application of regulatory guidance’s.• A single risk based, well justified decision approved by FDA saved Sepracor over $1MM.• Proven ability to expand knowledge into new areas and apply it.• Experienced with drug substance, solid oral dosage forms, syrups, sterile inhalation solutions, dry powder, nasal and oral metered dose inhalers. Limited experience with clinical IV formulations.• Supported the development and validation of sterile drug substance and aseptically filled inhalation solution which culminated in submission of the IND within 12 months.• Direct Development (phase 4) activities and provide commercial technical support for Brovana, Xopenex, Omnaris and Alvesco.

Provided technical oversight of the quality aspects involved in the development and clinical use of new drug products. Responsibilities: Managing a direct report and contract laboratories staff; project management; risk identification and prevention; stability testing; OOS investigations; product investigations; specifications; GMP compliance; audits; preparation of methods, specification and stability sections of IND's, annual reports and NDA's in support of IND, CTA and NDA submissions.

Responsibilities: Managed quality control release and stability testing; OOS investigations; methods development, validation and transfer; setting and maintaining specifications; GMP compliance; prepared methods, specification and stability sections of IND's, Annual Reports and NDA's. Audited US and ex-US manufacturing sites and oversaw the pre-approval inspection of an API manufacturer in Scotland.

Supported the research and development of single isomers and metabolites of existing drugs. Developed and validated methods for ICH/FDA compliancePrepared the statistical analysis of stability data for the CMC section of the approved NDA for Xopenex Inhalation Solution* (for the treatment of reversible bronchiospasm

Scaled up pharmaceutical active ingredient syntheses, both wet chemical and fermentation processes at pilot scale to support clinical trials and toxicology.

Ms, Analytical Chemistry

Bs, Chemistry