Thomas (Tai) Xie, Ph.D.
Dr. Xie has 16 years of pharmaceutical experience in line of management and
statistical analysis for Phase I-IV clinical trials as well as integrated summaries of safety (ISS) and efficacy (ISE) for new drug applications (NDA) in various therapeutic areas, especially in oncology. Prior to founding Brightech, he held an Associate Director position of Biostatistics and Data Management at ImClone and was
heavily involved in the Erbitux BLA submission. Before ImClone, he also held leadership positions at Wyeth (5 years, Assistant Director) and at PRI JNJ (2 years, Sr. Statistician). Dr. Xie has extensive
experience in clinical and statistical reporting, especially in designing and writing clinical trial protocols and statistical analysis plans and in the preparation of multiple NDA submissions. Since October 2004, Tai has led a team of statisticians and SAS programmers providing statistical/SAS programming services to twelve clients including Novartis, ImClone, Genta, Kyowa and MediWound and Target Health. He is an
active researcher with a number of research papers published in distinguished journals on various topics including cancer prevention, two-stage adaptive design, survival analysis, and more.
Tai is responsible for daily operations and hands-on statistical and SAS programming services to our clients.
Joel Waksman, Ph.D.
VP of Biostatistics and Programming
Joel has over 28 years of experience in the pharmaceutical industry, on both the Rx and OTC sides, in several therapeutic areas. He has been the lead statistician and helped guide strategic planning for several successful NDAs, including Rx-to-OTC switches. Prior to joining Brightech International, Joel was Assistant Vice President of Biostatistics & Data Management at Wyeth Consumer Healthcare, where he helped grow the department and led all statistical, programming, and data management activities for a wide range of clinical trials, marketing support efforts, and advertising litigation. During his tenure there, he represented the Consumer Healthcare Products Association (CHPA) as a lead statistician. He has also worked for Janssen Research Foundation and Ayerst Laboratories (now part of Wyeth Pharmaceuticals). He holds a Ph.D. degree in Statistics from the State University of New York at Stony Brook.
Director of Clinical Data Management
Paula has more than 20 years experience in CRO, Pharmaceutical and academic environments. She has extensive experience with preferred provider, strategic partnership and functional service provider client relationships. Paula has proven the ability to lead teams and manage large and complex trials, global and domestic spanning Phase II-IV studies from study start-up through finalization. She is very experienced with coding dictionaries such as MedDRA and WHO-DD, including oversight of coding activities on the project level for Data Management as well as for ISS and ISE submissions and collaboration with Safety groups. Further, her background also extends to working closely with other disciplines and has participated in a successful NDA application. Paula has strong technical expertise in database systems inclusive serving as the Functional User Lead for system planning, development and implementation for multiple release versions of a proprietary CDMS and CTMS, inclusive of coding module with additional experience in diverse database platforms. She has been involved with the seemless integration of multiple streams of external and legacy data and has a solid working knowledge of CDISC/C-DASH standards. Paula has had the responsibility to evaluate and audit vendors for preferred system and service collaborations. She has led and collaborated with teams (departmental and interdisciplinary) designing and implementing process improvements and initiatives, authored and peer-reviewed SOPs, Working Practices, guidance and training documents, leading one group in corporate re-organization of Controlled Documents. Paula has broad ranging therapeutic expertise includes oncology, CNS, cardiovascular and medical devices.
Paula brings broad-based, cross-functional and diverse data management experience to Brightech with a team oriented focus to achieve value added solutions.
Jian Huang, MS.
Director, Statistical SAS Programming
Jian has over 10 years of experience in the pharmaceutical industry with a leadership role in SAS programming. He has strong skills in SAS programming and development of SAS-based reporting systems and macros and has extensive experience in CDISC implementation and e-submission and in generating submission standard tables/listings/figures. Jian has worked as an independent consultant for several different pharmaceutical companies and has a reputation of producing quick and high-quality delivery.
Jian brings strong SAS programming skills to Brightech.
Director, Medical Writing
Sally has ten years of regulatory medical writing experience and has been a signatory on CSRs for several pharmaceutical companies. She has written for all developmental phases. She has experience in: CSR (including abbreviated, synoptic, integrated), PSUR, IMPD, AR, ISS, ISE, IB, PI, FDA meeting request, extended ICF, CDS, briefing document, executive summary, and interim safety report for DSMB. Therapeutic area experience includes endocrinology, CNS, oncology, respiratory/pulmonary, immunology, cardiology, hematology, gastrointestinal, anti-infectives, cross-therapeutic areas, orphan diseases, vaccines.
Sally brings her medical writing expertise to Brightech.
Jules Mitchel, Ph.D.
Regulatory Affairs Advisor
Dr. Jules T. Mitchel is President and Co-founder, along with Ms. Joyce Hays (CEO), of Target Health Inc. (http://www.targethealth.com
) He brings over 25 years of experience in the pharmaceutical industry
and basic research. Dr. Mitchel has broad base pharmaceutical
experience in drugs, biologics, devices and diagnostics including three
NDA submission, many FDA meetings and IND/IDE submissions, study
reports, manuscripts and strategic planning. Areas of expertise include
but are not limited to, Women’s Health, Dermatology, Antimicrobials,
Pharmacokinetics, Rheumatology, Ophthalmology, Natural Products, Oral
Care, Oncology and Regulatory Affairs. Dr. Mitchel has held industry
positions at American Home Products, Pfizer Laboratories and Pfizer Consumer Health Care and academic positions at New York Medical College, Cornell University School of Medicine and NYU School of Medicine.
Mitchel is a member of member of the American Society of Clinical
Pharmacology and Therapeutics where he is Section Head for Dermatology.
Other memberships include the American Academy of Dermatology,
Society for Investigative Dermatology American Urological
Association, International/American Association for Dental
Research, and the Drug Information Association.
Jules brings exceptional expertise and advice to Brightech in regulatory and pharmaceutical service.
Phil Chaikin, Pharm.D., M.D., F.C.P.
Clinical Development Advisor
Chaikin, Pharm.D., M.D., F.C.P. is President of Chaikin Associates LLC
and has spent the last 25 years in Research and Development in the
Pharmaceutical Industry. Immediately prior to his consulting career, he
was Executive Vice President for Drug Development and International
Drug Development Head for Kyowa Pharmaceutical in Princeton.
Chaikin earned his B.S. and Pharm.D. degrees in Pharmacy from the
University of Maryland and subsequently completed a research fellowship
in Clinical Pharmacology at the same institution. He received his M.D. from the New Jersey Medical School (University
of Medicine and Dentistry of New Jersey) and did his Internal Medicine
training at Robert Wood Johnson University Hospital.
Dr Chaikin joined the Pharmaceutical Industry in 1978 as a Senior Research Scientist in the Department of Drug
Metabolism and Pharmacokinetics at Ortho Pharmaceuticals and has held
positions of increasing responsibility since then. He has served as
Senior Associate Medical Director for Pfizer Pharmaceuticals; Director,
Clinical Pharmacology for Bristol-Myers Squibb; Vice President of
Clinical Development for Hoechst Roussel Pharmaceuticals; Vice
President of Worldwide Clinical Development at Rhone-Poulenc Rorer and
Vice President for Oncology R&D at Elan Pharmaceuticals.
Chaikin was pivotal in the registration of a number of important
pharmaceutical agents, including Sanofi Aventis' Taxotere, a widely
used chemotherapeutic agent for advanced breast and lung cancer and
other solid tumors; Lovenox, a widely used low molecular weight heparin
for the prevention and treatment of venous thrombosis and the treatment
of acute coronary syndrome, and Synercid, a streptrogramin antibiotic
for serious infections. Most recently he
led the development efforts for Istradefylline, a novel adenosine A2A
antagonist for the treatment of Parkinson's Disease.
Dr Chaikin has authored approximately 50 publications and abstracts.
Dr Chaikin brings exceptional expertise and advice to Brightech in clinical development.