Meet the Faculty

Sunny Tam, PhD has 20 years of biotechnology and academic experiences in early stage R&D, preclinical testing, assay and technology development following his training from the Harvard University School of Public Health. He has held numerous scientific and management positions in small molecule discovery and protein therapeutic companies including Mitotix, Inc., Texas Biotechology Corporation and Tanox Inc. Dr. Tam is a pioneer in protein microarray development and application of proteomic tools in drug discovery, biomarker discovery and assay development.  He is well published and has contributed significantly toward a number of issued patents and federally awarded grants.  During his tenure as Program Director at Charles River Laboratories and then University of Massachusetts Medical School, Dr. Tam successfully completed numerous projects for major US biopharmaceutical and government sponsors in new protein technology development, further advancing biomarker discovery and product applications in a number of chronic human diseases.  More recently serving as the VP of R&D at Nuclea Bio, he has built a GLP facility for the development of FDA regulated clinical diagnostic assays with novel biomarkers.  At Clark University as a Research Associate Professor, he has established a state of art Proteomic and Metabolomic laboratory for internal research and student teaching. Currently, he is the Director of the Professional Science Master’s (PSM) program in Biotechnology at Framingham State University.

Dr. Doerre is an all-round life scientist with over 30 years of combined experience in research and teaching. Growing up in Germany Stefan completed studies of chemistry and biochemistry with a master’s thesis in X-ray crystallography and a Ph.D. thesis on the engraftment of the hematopoietic system after bone marrow transplantation in leukemia patients. He then joined the Howard Hughes Medical Institute at Duke University as a postdoctoral fellow to work on the transcriptional regulation of HIV in T cells. He continued his work on the transcriptional regulation of viruses in lymphocytes as an Assistant Professor at Boston University.  In 2000, coinciding with the birth of his twin daughters, Dr. Doerre shifted his career to teaching, a lifelong passion of his. After receiving training from the Massachusetts Institute for New Teachers, he worked as a middle school science teacher for a year, followed by a four-year NIH-funded position as Curriculum Developer for CityLab, a high school outreach program in biotechnology at Boston University. In parallel and thereafter, Dr. Doerre has been teaching undergraduate life sciences to adult learners at Boston University with a focus on practical lab skills, inquiry-based learning, and critical data analysis. He expanded the program’s teaching labs with equipment for bioimaging and built a bioprocessing teaching facility with input from industry partners Shire and Biogen where students produce recombinant antibodies.

Taylor Burtis, Senior Consultant of BPTC’s advanceONE™ Division, has over 30 years of regulatory and senior management experience. She has developed and implemented regulatory, GxP compliance, and inspection readiness strategies at multiple life science companies of biosimilars, vaccines, cell therapy, fusion proteins, antibodies, and other recombinant protein drug products. Before joining BPTC as an independent Senior Consultant she worked with virtual and large Pharma companies managing IND/CTA, BLA/NDA/ MAA filings and FDA Type A,B, C and EU Scientific Advice meetings. Prior to her consulting role, Ms. Burtis has held senior-level regulatory positions in the biopharmaceutical industry as: Vice President of Regulatory and Quality Affairs and Compliance at both Tokai Pharmaceuticals, Inc. and Novelos Therapeutics; Associate Director for World Wide Regulatory Affairs at, Wyeth BioPharma (now Pfizer); and Senior Manager of Regulatory Affairs at, Genentech. In addition, Ms. Burtis was an FDA Consumer Safety Officer in the Office of Compliance at the Center for Biologics Evaluation and Research (CBER). Before entering the life science industry, she spent 18 years as a laboratory manager and research technologist at Duke Medical Center, North Carolina Medical Center, Yale-New Haven Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, New England Medical Center, and the National American Red Cross. Ms. Burtis has a BS in Biology and Secondary Education from Framingham State College and a MBA from Simmons College. She has also held certifications from the American Society of Clinical Pathology as a Medical Technologist, Specialist in Hematology, and Specialist in Immunohematology.

Walter Carney received his Ph.D. in Medical Microbiology and Infectious Diseases from Thomas Jefferson Medical School in Philadelphia.   From 1978-1982, he was a Harvard and NIH Fellow in the Department of Infectious Diseases at MGH where he trained extensively in virology and was one of the early scientists investigating the immunological responses to HIV. In 1982, Walt joined DuPont Medical Products where he managed a group focused on HIV and oncogenes and created a product line known as “TuMark Antibodies.” In 1991, Walt joined OSI Pharmaceuticals where he held various management positions including Vice President and General Manager of the Diagnostics and Research Products Division, President of Oncogene Science Diagnostics and Vice President of Proprietary Drug Development Programs. In 1999, Oncogene Science was acquired by Bayer HealthCare (BHC) where Walt continued as the President of the Oncogene Science Diagnostic business and participated in many programs aimed at developing circulating biomarkers and IHC tests for cancer drugs such as Nexavar at BHC. These programs allowed Walt to gain considerable experience in linking diagnostics with therapeutics with the objective of selecting the right drug for the right patient and thus an early adopter of personalized and precision medicine.   In addition, Walt and his team put in place a GMP manufacturing facility and a quality system at Oncogene Science in order to conduct clinical trials for a blood test that quantitated the circulating extracellular domain of the HER-2 protein.  As Head of Oncogene Science and part of BHC, Walt was not only responsible for discovering the circulating HER-2 protein in blood but was also responsible for obtaining FDA clearance (Class 2 IVD) and the CE MARK for the HER-2 blood test for breast cancer.  The serum HER-2 blood test was able to track patient response or failure to a variety of therapies including HER-2 targeted therapies such as Trastuzumab and Tarceva. In addition, Walter worked with a team of reimbursement specialists to obtain a new CPT code (83950) from CMS for the HER-2 blood test, which received a reimbursement of $89.99. In 2010, Walt joined a company called On-Q-ity as CSO and shortly thereafter assumed the dual role of acting CEO and CSO. On-Q-ity was an innovative diagnostics company developing proprietary technologies for capturing circulating tumor cells and developing IHC biomarkers. In Feb 2012, Walt joined Wilex, the pharmaceutical company that acquired Oncogene Science, where he continued as Head of the diagnostics business. In 2013, Wilex Inc. was acquired by Nuclea Biotechnology and Walt continued as the leader of the business until 2015.  In 2015, he created the Walt Carney Biomarkers Consulting, LLC, to provide advice in areas of cancer biology, immuno-oncology, companion diagnostic development especially with respect to liquid biopsies and tissue based biomarkers.  As a former CEO and CSO, Walt provides high level executive expertise, especially for start-up Diagnostic and Pharmaceutical companies concerning strategies for pre-clinical R&D studies, product development, product commercialization and Companion Dx.  In addition, to being awarded numerous USA and European patents related to the ras and HER-2 oncogenes, Walt has published over 100 full length manuscripts and over 200 abstracts due to his collaborative interactions with many innovative scientists.

Simon Fricker has over 25 years of experience in the biopharmaceutical industry. Simon obtained his training in the UK with a Ph.D. in Chemistry and Molecular Science from the University of Warwickand postdoctoral training at the University of Cambridge. As a successful leader of pharmaceutical R&D he has worked in small company and large multi-national corporate environments, in the UK, Canada and USA. He was a member of the UK team which was awarded the Queen’s Award for Technology for the discovery of the cancer drug Paraplatin™. Simon was a founding member and Director of Biology of a Canadian biopharma company AnorMED taking two drugs into clinical development with IND filing in FDA divisions of virology (HIV) and oncology and the subsequent NDA and clinical approval of Mozobil™, a CXCR4 antagonist for hematopoietic stem cell mobilization for patients with multiple myeloma and non-Hodgkin’s lymphoma. As a Distinguished Scientific Fellow at the sanofi/Genzyme, R&D Center he led a research team working on immune-mediated diseases. He generated projects on chemokine receptor pharmacology for autoimmune and oncology diseases, and held a strategic role to identify innovative concepts for targeting multiple sclerosis. Simon has been the science lead on out-licensing and in-licensing business development opportunities. Currently Simon is an independent consultant to biopharma.

Masha Fridkis-Hareli, M.Sc., Ph.D., is an immunologist, consultant and inventor with over 20 years of experience in academia and industry. She is Founder and President of ATR, a scientific consulting and laboratory services company providing expertise in immunoassay development for discovery and pre-clinical drug development phases. During her post-doctoral training at Harvard University, she designed and developed a group of novel compounds for treatment of autoimmune diseases, which advanced into Phase II clinical trials. Dr. Fridkis-Hareli served as Principal Investigator of the Molecular Immunology Foundation at the Dana Farber Cancer Institute, and held positions with increasing responsibilities at a number of biotechnology companies and a global CRO.

In the role of Associate Scientific Director, Dr. Fridkis-Hareli contributed to discovery and development of Taligen Therapeutics’ drug pipeline leading to acquisition by Alexion Pharmaceuticals. Her areas of expertise include in vitro pharmacology, protein- and cell-based assays, flow cytometry, and preclinical immunotoxicology. Dr. Fridkis-Hareli is a co-author of over 100 publications and 17 issued patents. She is an Adjunct Professor at several local universities’ graduate biopharmaceutical programs, including Harvard Extension School, Northeastern University, and Worcester Polytechnic Institute. In addition to her professional affiliations, Dr. Fridkis-Hareli is actively involved on boards of several professional organizations, which include serving as a co-chair of the Drug Discovery Working Group at the Massachusetts Biotechnology Council and as a Past President of the Association for Women in Science in Massachusetts.

Dr. Fridkis-Hareli holds a B.A. in Biology from Technion, Israeli Institute of Technology; an M.Sc. in Molecular Microbiology from the Hebrew University; and a Ph.D. in Immunology from the Weizmann Institute of Science, Israel.

Steve Gullans, Ph.D., is a biotech investor, scientist, entrepreneur, and author. He is Managing Director at Excel Venture Management where he invests in young life science companies with transformative technologies. Currently he is Interim CEO and Board Director at Gemphire Therapeutics [NASDAQ: GEMP], Molecular Templates, Cleveland HeartLab, N-of-One, and Orionis Biosciences. Steve loves innovation and has spoken widely, including at TED, TEDMED, and TEDx. He recently co-authored Evolving Ourselves, a book that provides a sweeping tour of how humans are changing the course of evolution—sometimes intentionally, sometimes not. Previously he was a professor at Harvard Medical School where he published more than 130 scientific papers and was elected Fellow of the American Association for the Advancement of Science.

Dr. Leach received a Ph.D in Biochemistry and Molecular Biophysics from the Medical College of Virginia, in 1999, studying the hepatitis B virus. From there he completed a post-doctoral fellowship at the Massachusetts Institute of Technology in Biological Engineering.  In 2004 he started at Merck and Co in the Drug Metabolism and Pharmacokinetics department working in Cancer and Alzheimer’s disease.  In 2009 he began working at Shire Pharmaceuticals in the Pre-Clinical Department working in rare diseases and became a diplomate of the American Board of Toxicology in 2010.  In 2014 he joined Retrophin where he is currently employed and is a Sr. Director of Non-Clinical Development and Translational Research.  He also serves on the board of the Wellesley Cancer Prevention Project, a non-profit organization that works with the community to advise and educate on cancer prevention.  He is the author of several publications and abstracts and two patents.

Meta Mitchell has over twenty years experience in industrial research and development, specializing in realizing the potential of novel pharmaceuticals from scientific first concepts to commercial product. Areas of expertise include: Quality Assurance - controlling production and release of clinical supplies of new drug candidates or commercial drugs so as to minimize risks to human health and Quality Control - ensuring data and information has been correctly recorded, backed-up and interpreted. Meta has a Ph.D. in organic chemistry from Leeds University, UK. Her postgraduate research, performed in collaboration with Glaxo plc, was on the synthesis of broad spectrum anti-microbials.

The highlights of Meta’s professional career to date include direct involvement in the commercial launch of an anticancer drug that is currently used to treat ovarian cancer, the culmination of 15 years continuous work and investment. Meta was also a founder member of a successful start-up drug research and development company taking a drug into late stage, Phase III trials, of clinical research, which gained market approval for multiple myeloma and non-Hodgkin’s lymphoma.

Meta has expertise in Good Manufacturing Practice, Good Clinical Practice and Good Laboratory Practice, setting up Quality Assurance Systems, policies and procedures to support potential drugs through early and late stage development, and compliance and auditing. Meta currently consults in Quality Assurance, in particular focusing on clinical trial management.

Michael Naill has over 10 years of experience in the biopharmaceutical industry, primarily in the area of chemistry, manufacturing, and control (CMC) development. Michael received a BS with distinction in Chemical Engineering from the University of Illinois at Urbana-Champaign and a PhD in Chemical Engineering from the University of Massachusetts, Amherst. In his career, Michael has held roles of increasing responsibility in process development, manufacturing science/technical operations, CMC program management, and CMC regulatory affairs. Michael has led teams in developing manufacturing processes for biologics, technical transfer teams, and CMC project development during clinical development. He has experience with both clinical stage and commercial stage programs. Michael currently works at bluebird bio in Cambridge, MA.

Imran is the Director of Innovation Sourcing, located in Boston. Imran is responsible for forging business relationships within the Boston/Cambridge life-science ecosystem among, venture capital, family funds, angel investors, academia, biotech and other stakeholders.

Imran brings over 20 years and a rich synthesis of life sciences corporate development (emerging and early stage), intellectual property and licensing, and policy experience. 

Recently, Imran was Head of Strategic Alliances for T1D Exchange – an innovative non-profit start-up in the type 1 diabetes space. Prior to T1D Exchange, Imran was the Chief Business Officer for the Massachusetts Biotechnology Council, where he was responsible for building MassBio's business development and investor outreach programs to enable members companies raise capital and identify strategic partnering and licensing opportunities. Among his accomplishments there, he founded MassConnect and Pharma Days, two of Massbio’s most successful programs.

Imran worked for blue chip biotechnology companies Genzyme Genetics and Millennium Pharmaceuticals. At Genzyme, Imran served as a Director of Business Development and Licensing for oncology molecular diagnostics and women’s health.  At Millennium Pharmaceuticals, Imran served as Associate Director of BD&L within Millennium’s corporate development group focusing on early stage transactions ranging from R&D platforms, early-stage inflammation and oncology assets, and FTO licensing.  Imran started his career in academic licensing, first as a licensing professional at Mayo Clinic and later as director of licensing for Dana Farber Cancer Institute.

Paul Partovi has over 20 years of experience in the biopharmaceutical industry. Paul graduated with a Bachelor of Science in Microbiology from the California State University of Long Beach and has a Master of Liberal Arts in the Field of Management from Harvard. Paul started his career as a quality control Microbiologist at Baxter supporting recombinant factor VIII and Small Pox vaccine manufacturing operations.  Paul Continued his Career at Amgen as a microbiologist and then transitioned into a Quality Assurance role supporting the manufacturing and release of Enbrel. At Alkermes, Paul worked on small molecule projects for Inhaled Insulin system,

before moving on to his current Role. Currently, Paul has a leadership role in overseeing the Quality aspects of upstream, downstream, and Final Filling for the clinical manufacturing operations At Sanofi. Also, he is responsible for quality oversight of new drug development processes. As a certified Quality auditor, part of his job entails auditing contract laboratory and manufacturing facilities. His goal is to bring the industry into the classroom and transfer classroom learning to real-world applications.

Dr. Sharma has been the Vice President of Biometrics in Biopharmaceutical and contract research organization (CRO) settings. He is a biostatistics professional with over 25 years of experience in all phases of drug development. Dr. Sharma has both domestic and international experience in many therapeutic areas including ADHD, AIDS, anti-infectives, biosurgery (devices and cell therapies), cardiology, gastrointestinal, genetic diseases, hematology, oncology, ophthalmics, neuroscience, and organ transplant.

At Hurley Consulting Dr. Sharma is responsible for the design and conduct of statistical analyses. He assures that timely and high-quality analyses are conducted, utilizing appropriate statistical techniques, in accordance with the protocol, the statistical analysis plan, health authority guidelines, and Good Clinical Practice. He oversees the preparation and validation of CDISC-compliant datasets. He also evaluates and supervises the design of electronic data capture databases created by third parties for data entry. In addition, he is responsible for the statistical interpretation of data analyses, and in conjunction with the person responsible for the scientific and/or clinical interpretation of the data, he determines the final data interpretation. He is responsible for providing the results of statistical analyses to Scientific Affairs and the Vice President, Regulatory Affairs, and for supporting the creation of nonclinical and clinical reports and summary documents.

Before joining Hurley Consulting, Dr. Sharma worked for two years as an independent consultant, providing strategic global biometric drug development services in biotech and pharmaceutics in all therapeutic areas. He has also worked at Cubist Pharmaceuticals, Shire Pharmaceuticals, Genzyme, and Aventis. Dr. Sharma began his career at Merck as a biostatistics consultant and progressed to Associate Director, Clinical Biostatistics, Analysis and Research Data Systems (CBARDS) MRL. During his ten years at Merck, he led and assisted filing activities in several therapeutic areas (cardiovascular, AIDS, ophthalmic, neuroscience, and gastrointestinal) and provided biometrics support for mega-trials with emphasis on data safety monitoring boards and steering committees.

Dr. Sharma holds a bachelor’s degree in statistics/mathematics from the University of Delhi and both a master’s and a doctoral degree in statistics from the University of Florida. He is a member of the American Statistical Association, the International Biometrics Society, and the Eastern North American Region (ENAR).

Keith received his undergraduate degree in Physiology and Biochemistry from the University of Southampton in England, followed by a PhD in Neuropharmacology. Following periods of postdoctoral research at the University of Cambridge, England and Harvard University in Boston, Keith embarked upon a career in neuroscience drug discovery, working initially for Merck, Sharp and Dohme, and then Parke-Davis, at research centers established by both companies in England in the early 1980s. In 1994, he moved to the United States to take up a position as Director of New Product Development with Research Biochemicals International, a small Massachusetts company that specialized in providing innovative neurochemicals for use as research tools by the neuroscience research community. In 1997, RBI was purchased by Sigma-Aldrich Corporation, a major life science and high technology company. From 2000, Keith held leadership positions in a variety of areas within Sigma-Aldrich, including strategic marketing, operations and business development. He is currently Site Director at MilliporeSigma, Natick - a business of Merck KGaA, Darmstadt, Germany -where he oversees the production of a range of bioactive small molecules used in both life science research, and diagnostics and testing.