Company

Charles (Chuck) Bramlage
President and CEO

Sarvajna Dwivedi, PhD
Co-Founder & Chief Scientific Officer

Colin Reisner, MD, FCCP, FAAAAI
Chief Medical Officer, and Executive Vice President of Clinical Development and Medical Affairs

Michael Golden
Senior Vice President, Regulatory Affairs and Quality

Michael Riebe, PhD
Senior Vice President, Pharmaceutical Development and Research

R. Harris Cummings, Ph.D.
Vice President of Manufacturing

William Picht, Jr.
Vice President, Finance and Administration

Chadwick J. Orevillo, MPH
Vice President and Head of Medical Communications

Robert Schultz
Senior Director of Product Development and Project Leadership

Patrick Darken, PhD
Vice President, Biostatistics

Charles (Chuck) Bramlage

President and CEO

Mr. Bramlage is currently chief executive officer of Pearl Therapeutics. He previously was president of pharmaceutical products at Covidien plc. Earlier, Mr. Bramlage served as president of European operations at Valeant Pharmaceuticals International and president and chief executive officer of BattellePharma, Inc., a specialty pharmaceutical company developing inhaled products. In addition, he was formerly the vice president of respiratory global commercial development and vice president of U.S. respiratory and cardiovascular marketing for GlaxoSmithKline, where he led the team responsible for the global launch of Seretide®/Advair® and the U.S. launch of Flovent®. His earlier career involved various positions at GSK and Merck in product management, sales management, sales, and sales training. He and his teams have launched over 40 brands in 14 therapeutic areas.

Mr. Bramlage holds an MBA from the University of Dayton and a BS Administrative Science in Marketing from The Ohio State University.

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Sarvajna Dwivedi, PhD

Co-Founder & Chief Scientific Officer

Sarvajna Dwivedi has extensive experience in drug development at Glaxo, Dura, Alkermes, and Nektar. He was involved in the development of over 40 molecules in various therapeutic classes and dosage forms from discovery to commercialization. At Nektar, he was the Director of Product Development, responsible for new product identification, design, planning, and development efforts. At Alkermes, he was the Director of Delivery Systems, responsible for the engineering and development of inhalers for multiple products. At Dura, Dr. Dwivedi led and managed formulation design and development efforts for various Spiros programs. Earlier, at Glaxo, Dr. Dwivedi was involved in the development, manufacturing, and approval of Flovent® Diskhaler, Serevent® Diskus, Advair® Diskus, Relenza® Diskhaler, and Ventolin® Evohaler.

In addition to his product development experience, Dr. Dwivedi has led and conducted technical due diligence efforts for in-licensing, out-licensing and acquisition opportunities. Dr. Dwivedi holds MSc and PhD degrees in Pharmaceutical Sciences from the University of British Columbia, and M.Pharm. & B.Pharm.(Hons) from Banaras Hindu University in India.

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Colin Reisner, MD, FCCP, FAAAAI

Chief Medical Officer, and Executive Vice President of Clinical Development and Medical Affairs

Colin Reisner joined Pearl Therapeutics in October 2007, in the capacity of Chief Medical Officer and Executive Vice President of Clinical Development and Medical Affairs. Dr. Reisner is responsible for all of Pearl’s clinical development activities including advancing Pearl’s lead program, a combination bronchodilator, through regulatory submission.

Dr. Reisner has significant experience in the development and commercialization of inhaled respiratory products. Prior to Pearl, he was Executive Director for Global Respiratory Development at Novartis responsible for both clinical development and shaping Novartis’ global strategy for respiratory products. Earlier at Novartis he was the Global Brand Medical Director for Xolair®, the first biologic agent approved for asthma. Prior to Novartis, Dr. Reisner served as Senior Director in the Respiratory Division at GlaxoSmithKline. There he played a key role in the development of market-leading inhaled respiratory products, focusing on Advair® in COPD, and on pediatric drug development. Dr. Reisner began his career in the pharmaceutical industry at Boehringer Ingelheim and worked on a wide variety of programs including Combivent® and on the Respimat® device.

Dr. Reisner graduated from the University of Witwatersrand Medical School in South Africa. He completed his training in Internal Medicine followed by fellowship training in Allergy and Immunology at National Jewish, Denver, Colorado, and was an assistant consulting professor of Allergy and Immunology at Yale University, and also at Duke University. Dr. Reisner is a Diplomat of the American Board of Internal Medicine and the American Board of Allergy and Immunology.

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Michael Golden

Senior Vice President, Regulatory Affairs and Quality

Michael Golden’s experience in the development of respiratory and pharmaceutical products spans over 25 years. Prior to joining Pearl he was at GlaxoSmithKline, where from 1988 he played significant roles in product development, regulatory submission and approval for 8 marketed orally inhaled and nasally delivered drugs including Flovent®, Advair®, Ventolin®, and Veramyst® Nasal Spray. Most recently he was the Director, External Advocacy, Global CMC Submissions, Regulatory Affairs at GSK. In this position he was the principal liaison between GSK and the FDA with regard to Quality by Design initiatives. Additionally, Mr. Golden was a board member of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), a member of the Drug Product Technical Committee of the Product Quality Research Institute (PQRI), and a member of the FDA Advisory Committee for Pharmaceutical Sciences sub-team on Delivered Dose Uniformity for orally inhaled and nasal drug products.

He began his career at GSK as a research investigator leading project teams and helping to establish the Inhalation Product Development group. Prior to joining GSK, Mr. Golden was with The Upjohn Company. He received his MS in Analytical Chemistry from the University of Georgia, Athens.

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Michael Riebe, PhD

Senior Vice President, Pharmaceutical Development and Research

Michael Riebe joined Pearl Therapeutics in January 2013 as Vice President, Pharmaceutical Development & Research. Dr. Riebe is responsible for Pearl’s pharmaceutical and process development, new product research, project management, and manufacturing functions.

Dr. Riebe has a long track record of experience in developing pharmaceutical products, with deep expertise in the development of inhaled respiratory products. Prior to joining Pearl, he was Vice President of R&D at iCeutica where he was responsible for new product development utilizing that company’s proprietary SoluMatrix™ dry nanomilling technology. Prior to iCeutica, Dr. Riebe held various roles including Sr. Scientific Director in Respiratory Product Development, Scientific Strategy Head for Pharmaceutical R&D, and Director of Materials Characterization and Technology Assessment at Merck. Prior to joining Merck, Dr. Riebe was a Director in the Aerosol Science & Technology group at Research Triangle Institute. Dr. Riebe also served as New Product Supply Leader in Respiratory at GSK and Head of Inhalation Product Development in the U.S. for GlaxoWellcome. He has led project teams responsible for inhaled product development for multiple products including Serevent®, Ventolin® HFA, and Seretide®/Advair® HFA. He has also been a consultant for several other companies developing inhaled products and technologies.

Dr. Riebe received his B.A. degree in Chemistry from Kalamazoo College and his Ph.D. in Analytical Chemistry from the University of Wisconsin – Madison. He has served in numerous leadership positions within the American Chemical Society and the American Association for Pharmaceutical Scientists, including Chairman of the AAPS Inhalation and Nasal Technology Focus Group.

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R. Harris Cummings, PhD

Vice President of Manufacturing

Dr. Cummings started working in the pharmaceutical industry in 1988 and has been directly involved in the development of all inhalation dosage forms since 1992. Prior to joining Pearl he provided consulting services to start-ups and small pharmaceutical companies developing inhaled therapeutic products. For 12 years Harris was the head of the inhalation product development group at Magellan Laboratories (later Cardinal Health) which provided method development, analytical testing, formulation development and technical support for DPI’s, MDI’s, nasal sprays and inhalation devices. He also established the clinical and commercial manufacturing program at Cardinal Health including the design and construction of the existing manufacturing facility. Harris has served as a member of the Executive Committee and as Chair of the Inhalation Technology Focus Group of the AAPS, was involved with the ITFG/IPAC collaborations to respond to FDA draft guidances and is currently a member of the <601> Expert Aerosol Committee of the USP.

Before joining Magellan Laboratories, Harris was a senior scientist in the analytical department of Marion Merrell Dow Pharmaceuticals. Harris received bachelor’s degrees in chemistry and German from Bradley University and a PhD in Analytical Chemistry from Purdue University.

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William Picht, Jr.

Vice President, Finance and Administration

William Picht has over 15 years of experience in finance, marketing analytics and strategy in the life sciences industry. Prior to joining Pearl in May 2008 as Senior Director, Finance, he held senior roles in strategic analysis, financial planning, and R&D finance at Nektar Therapeutics, most recently as Director, Finance. Prior to Nektar, he was a consultant with Objective Insights, Inc, where he assisted life sciences companies with new product assessment and developed forecasting and portfolio planning software. Mr. Picht began his career at Syntex Corporation in finance and marketing research. He has an MBA from San Jose State University, and a BA in Economics from the University of Notre Dame.

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Chadwick J. Orevillo, MPH

Vice President and Head of Medical Communications

Chadwick J. Orevillo has over 16 years of global pharmaceutical research and development experience in all phases of pre-clinical and clinical drug development. Prior to joining Pearl Therapeutics, he was a Director of Clinical Development and Respiratory Program Section Leader at Novartis. In this role, he was responsible for Dulera® (mometasone furoate/formoterol fumarate MDI, a joint collaboration with Schering-Plough) and Foradil® where he managed a team of clinical professionals located in the US and abroad. Preceding this role at Novartis he was a Global Clinical Program Leader responsible for the integration of the inhaled tobramycin development programs from Chiron after Novartis’ acquisition of the company, and also worked on a number of other inhaled product development programs for the treatment of asthma and COPD during his tenure. Earlier in his career he worked on various clinical and pre-clinical development programs at Pharmacia, Kendle International, Merck, and Pharmaco-LSR. Mr. Orevillo received his Master of Public Health degree from Tulane University and a BS in Biological Sciences from William Paterson University.

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Robert Schultz

Senior Director of Product Development and Project Leadership

Rob Schultz joined Pearl Therapeutics in October 2007 as Director of Metered Dose Inhaler (MDI) Development. He is currently Senior Director of Product Development and Project Leadership. Mr. Schultz has over 20 years of experience in MDI product development. He started his career at Muro working on a glycopyrrolate CFC MDI formulation. He then joined GlaxoSmithKline in the global Inhalation Product Development group, where he worked for over 12 years on the development of all of GSK's MDI HFA products (Ventolin, Flovent, Serevent, and Advair). He was CMC project team leader for Advair MDI at the time he left GSK in 2004. He then joined Kos and worked with the inhalation product development group up to when the company was acquired by Abbott Labs, where he was project leader for the insulin MDI and Azmacort HFA programs. Mr. Schultz holds a BS degree in biochemistry from Dartmouth College.

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Patrick Darken, PhD

Vice President, Biostatistics

Patrick Darken joined Pearl Therapeutics in March 2013 as Vice President, Biostatistics. Dr. Darken is responsible for the oversight of statistical support for all of Pearl’s Clinical and R&D activities.

Most recently prior to joining Pearl, Dr. Darken was a consultant working mainly with pharmaceutical companies including Pearl. Previously, Dr. Darken spent three years as the Global Head of Biostatistics for Teva Pharmaceuticals leading an organization that supported both clinical and pharmaceutical development of all branded products after spending one year as Senior Director, Biostatistics and Data Management in Teva’s Respiratory R&D organization. Prior to joining Teva, Dr. Darken spent five years as Director/Senior Director, Biostatistics and Data Management for ALTANA/Nycomed managing the US Biostatistics and Data Management functions. Dr. Darken started his pharmaceutical career in 1999 working for four years in the Biostatistics Department at GlaxoWellcome/GSK. During his career in the pharmaceutical industry, Dr. Darken has overseen the statistical support for the submission of several NDAs, sNDAs, and BLAs in the US, and several MAAs for the EU markets in multiple therapeutic areas. Dr. Darken has BS, MS, and PhD degrees in Statistics from Virginia Tech.

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