SAN FRANCISCO, CA / ACCESSWIRE / July 8, 2020 / iPharma Labs, Inc. (“iPharma”), a privately-held contract development research organization (CDRO) specializing in inhalation pharmaceutical development services, announced today the addition of two new board members, expansion of the senior management/advisory team and the implementation of GMP testing services. These achievements have contributed to the continued successful growth of iPharma.
Inhaled Covid-19 Treatments – Expanding GMP Development Services
The increasing demand for products to treat respiratory and systemic diseases by the inhaled route, in particular the ongoing Covid-19 pandemic, has highlighted the need for CDROs with the ability to respond rapidly to provide inhalation delivery development services for companies with innovative new therapies against SARS-CoV2. iPharma is well positioned to meet this need. iPharma is currently helping accelerate development of inhaled aerosol medicines for COVID-19 treatments. iPharma can develop and test formulations with a variety of inhalation devices available off the shelf and available for licensing to our clients from various suppliers.
iPharma is now fulfilling our plan to expand into GLP/GMP capabilities just in time to offer expanded development services during this health crisis.
New Board Appointments
As part of strengthening the business, iPharma has expanded its board and management to provide over 150 years of experience/expertise.
John Pritchard, PH.D. – John is a physicist and experienced aerosol scientist who has led teams at GlaxoSmithKline, AstraZeneca, 3M Drug Delivery Systems and Philips Respironics. John’s fingerprints are on a significant number of inhaled products – Advair, Flovent, Symbicort, Dulera, Optichamber Diamond and Aeroneb Go to name just a few. He was a member of the UN science team that brought an end to CFCs, he contributed to the development of oropharyngeal models as a part of the GSK-AstraZeneca-Novartis Consortium, and has been an early advocate of digital health and smart devices to improve patient adherence. John was a Founding Member and President of The Aerosol Society and co-founder of the Drug Delivery to the Lungs conference in Great Britain. John was the 2018 recipient of the Charles G. Thiel Award, the ‘nobel prize’ in the inhalation field, from Virginia Commonwealth University for outstanding research and discovery in respiratory drug delivery.
Samantha Miller – Samantha brings over 25 years of experience in the biopharma industry holding strategic and operational senior management positions with a variety of private and public companies. Currently Samantha is co-founder and chief operating officer of an OTC women’s health company, Cadence Health. She is also a strategic advisor (formerly chief business officer) to InCarda Therapeutics, a clinical stage company treating cardiovascular conditions by the inhalation route. Prior to InCarda and Cadence, Samantha was chief business officer for Dance Biopharm, and led corporate and business development for other pharma companies, including Theravance, Inhale/Nektar, and Onyx. She began her pharmaceutical industry training with Procter & Gamble Pharmaceuticals as a marketing manager.
“We are elated to have John and Samantha on our board. They are both stars of the industry, with deep business and technical experience in our field, each with a brilliant history of helping bring innovative inhalation products to market”
– John Patton, iPharma co-founder and Executive Chairman.
In addition to new board appointments, iPharma is currently implementing GMP testing and has brought on Truc Le as Chief Compliance Officer to help build the quality compliance arm of iPharma, and has brought back Mei-chang Kuo, a co-founder, as SVP Drug CMC Development.
Truc Le – Truc has a long history of working with the FDA and companies. “He can smell non-compliance within minutes of entering a manufacturing facility”, said John Patton. From 2011 to March 2020, Mr. Le was the Chief Technical Operations Officer for Aerami Therapeutics (formerly Dance Biopharm), a leader in aqueous respiratory therapy delivery with Drug and Device combination products. As CTO at Dance, he built the Quality Systems, Manufacturing and Supply Chain, and oversaw IT and Pharmaceutics. From May 2009 to July 2011, Mr. Le was the Chief Operating Officer for Avid Bio services, Inc., a leading CRO. From 2002 to 2007, Mr. Le was SVP of Operations and Quality for Nektar Therapeutics, a biopharmaceutical company, where he led the commercial formulation and device manufacturing for Exubera. From 1981 to 1999, Truc was Worldwide Vice-President of Regulatory Compliance and Quality Systems for a division of J&J. Mr. Le has a B.S. in mechanical engineering, an M.B.A. in Management.
Mei-Chang Kuo, PhD.
With a long track record in pharmaceutical R&D, Mei-Chang Kuo has seen several new and life-cycle-management products through different phases of research and development at a several start-up and mid-size life science companies. From 1994 to 2008 at Inhale/Nektar, Dr. Kuo formulated ultra- stable dry powder insulin for Exubera® (~10 years at room temp) and was responsible for the second and third generation of insulin formulation development. As a SVP at Dance Biopharm, Kuo formulated ultra-stable liquid inhaled insulin formulations (~5 years at refrigeration) and led API management/Drug Product manufacturing. From 1987 to 1994 as Director of Peptide Chemistry at ImmuLogic Pharm, Kuo led the development of the ALLERVAX® drug product programs and CMC drafting in the IND submissions. Kuo earned a Ph.D. in Biochemistry from the University of Wisconsin, Madison, and completed an Arthritis Postdoctoral Fellowship at National Institute of Health (NIH).
“We have always planned to expand our capabilities, from showing clients the very best inhalation system and formulation for their molecule, to providing them the validation of GMP testing as we grow the business. We could not be more pleased to have Truc and Mei-chang lead this effort” – Dr. Keith Ung – iPharma CEO/CTO, Director and co-founder.
iPharma is an inhalation contract development research organization (CDRO) founded in 2016 by a group of former employees of Inhale/Nektar Therapeutics, where they learned how to formulate a wide variety of therapeutic agents for inhalation delivery with state of the art technologies including hydrophobic and hydrophilic small molecules, peptides, large proteins (i.e. monoclonal antibodies), controlled release particles, RNAi, gene delivery constructs, and live viruses. The company is technology agnostic; the goal is to provide clients with the best product options that fit the proposed therapy. The client’s molecule, its chemical and physical properties, along with patient needs and time and cost restraints will dictate the product
SOURCE: iPharma, Ltd.
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