Our People

COO & In Charge of CRO Business Unit

• Master degree of Business Administration from Renmin University of China

  
  

• With over 14 years of experience in business management

  
  

• Worked as Vice President of Finance at Xiaodu Technology, a subsidiary company of Baidu Group; served as Sr. Investment Director at Baidu Group.

  
  

• Worked for Standard Chartered Group and a couple of other well-known investment corporations in the past

Co-founder, VP of Business Development – US & EU

• Ph.D. in Chemistry from Pennsylvania State University

  
  

• 14 years at Merck in drug R&D, manufacturing, and management

  
  

• Expertise in solid-state NMR, maintaining direct responsibilities of solid-state NMR facility at Merck

  
  

• Established first analytical research group in Ireland for Merck

Head of US - NJ Site

• Ph.D. in Materials Science, Georgetown University (Studied chiral separation and crystallization in gels under Professor Jennifer Swift, Ph.D.)

  
  

• Expert in API solid form screening/discovery, crystalline form selection, polymorphism, and chiral separations by crystallization

  
  

• 15 years of working experience in Merck with various leadership positions including Leader of API Development Support Group - Center for Materials Science and Engineering in Merck Manufacturing Division, and Analytical Project Leader - Merck Animal Health

Head of US Business Development - CRO & CDMO Businesses

• B.S. in Biology from Western New England University

  
  

• With over 25 years of senior business development experience in servicing the pharmaceutical and biotechnology industry

• Worked as the Director of Global Sales and Custom Solutions at ATCC; the Global Director for the Health Sciences Division at NSF; the Vice President of Business Development, Marketing, and Global Distribution for Associates of Cape Cod; the Senior Director of Commercial Development at Tripos Inc.

• Held several positions of increasing responsibility in sales & marketing management with IGEN International, Corning Corporation, Costar Corporation and Genetics Institute

• As a Stockbroker and Portfolio Manager with Prudential Bache Securities for 3 years
  

CEO of CFS

• Trained as Chemical Engineer at Lehigh Univ. (PhD) and Tsinghua Univ. (BS)

  
  

• 22 years formulation development and CRO/CDMO/CMO vendor anagement experience at Merck (US) and MSD (China)

  
  

• Expert on solid oral formulations development, analytical and clinical supply

  
  

• Responsible for or supported over 30 new drug development, 4 of which were commercialized.

Head of US Business Development - CRO & CDMO Businesses

• B.S. in Biology from Western New England University

  
  

• With over 25 years of senior business development experience in servicing the pharmaceutical and biotechnology industry

• Worked as the Director of Global Sales and Custom Solutions at ATCC; the Global Director for the Health Sciences Division at NSF; the Vice President of Business Development, Marketing, and Global Distribution for Associates of Cape Cod; the Senior Director of Commercial Development at Tripos Inc.

• Held several positions of increasing responsibility in sales & marketing management with IGEN International, Corning Corporation, Costar Corporation and Genetics Institute

• As a Stockbroker and Portfolio Manager with Prudential Bache Securities for 3 years

COO of CFS

• Trained as Microbiologist at Nanjing Agriculture Univ. (BS)

  
  

• 21 years of pharmaceutical industry experience in project management, QA, QC, and company operation

  
  

• Familiar with global GMP regulations and QMS. Chief Operation Officer of New Drug Founder’s Club

  
  

• Broad management experiences in both pharma and biotech. 

CSO of CFS

• Trained as an engineer(mechanical leaning) at Penn State Univ. (PhD) and China Agricultural Univ. (BE)

  
  

• Significant expertise on oral solid dosage, powder mechanics, dry granulation and pediatric formulation

  
  

• 21 years Phase I-III formulation development experience at Merck (US). Involved in over 50 small molecule NCE drug product development, 15 of which were commercialized

CTO

• Trained as Chemical Engineer (PhD, Univ. of Texas at Austin; BS and MS, Tsinghua University) and Pharmacometrics (MS, Univ. of Maryland at Baltimore)

  
  

• 18 years pre-formulation, formulation (preclinical-III) and process development, regulatory filing and product commercialization experience at Roche, Abbott, Merck, Sunovion and Sage Therapeutics

  
  

• Involved in over 35 early phase and 7 commercial products development

  
  

• Skilled in various delivery systems and unit operations. 

Head of QA

• 25 years quality management experience at GSK (China) and Pfizer (China)

  
  

• Establish and maintain the quality system, manage QA, QC and Compliance Dept.

  
  

• Lead to pass GMP inspections from FDA/PAI (5 times), EMA (6 times), and NMPA (10 times)

  
  

• Familiar with global regulation and registration requirements

  
  

• Extensive experience on tech transfer, QMS, deviation, and vendor management.

Head of Manufacturing

• Hold a master's degree in Pharmaceutical Engineering at Dalian University of Technology.

  
  

• 14 years experience in OSD manufacturing & management at Novartis (China) and Pfizer (China)

  
  

• Rich experience in technology transfer, commercial manufacturing and compliance audit

  
  

• Lead or supported more than 10 new product launches. 

InSciTech Inc.

• 22-year experience at Merck Frosst, former head of Department of Pharmaceutical Research and Development, responsible from early compound characterization to formulation and process development of new chemical entities including the supply of clinical trial materials from phase I through phase III and technical transfer to manufacturing

  
  

• Key contributor on formulation development of SINGULAIR® and several other products that lead to worldwide regulatory approval

  
  

• Past president of CSPS, elected Fellow of AAPS and Fellow of CSPS, adjunct professor of pharmaceutics at the University of Montreal

R. Outcalt Consulting, LLC

• Pursued Ph.D. in Chemistry from Rutgers University

  
  

• 8 years at Merck in R&D and manufacturing division

  
  

• Supported physical characterization, API phase selection and evaluation of more than 50 compounds in all stages of development

  
  

• Expert in solid-state characterization, polymorphism, co-crystal screening, chiral resolution, and nanoparticle engineering

University of Michigan

• Developed a research program based on molecular-mechanistic approaches, founded on the premise that the concepts of supramolecular chemistry and crystal engineering

  
  

• Serve on the FDA Advisory Committee for Pharmaceutical Sciences

  
  

• Serve on the editorial boards of Crystal Growth and Design, Molecular Pharmaceutics and Journal of Pharmaceutical Sciences

  
  

• Awards include Ebert Prize for the best article published in the Journal of Pharmaceutical Sciences in 2005

University of Wisconsin

• Leading researcher on solid-state chemistry

  
  

• Research areas focused on polymorphism, crystallization of organic glasses, and molecular motions in solids.

  
  

• Honors include Elected Fellow of AAPS, Lilly Research Laboratories President's Award, and Invited Visiting Professorship at the University of Manchester, and David Grant Research Achievement Award in Physical Pharmacy from American Association of Pharmaceutical Scientists