Syner-G Pharma CMC Consulting | Our Team
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Our Team

Prabu

Prabu Nambiar, Ph.D. MBA, RAC

Principal and Founder

Prabu acquired his Ph.D. in Organic Chemistry from Oregon State, completed his post-doctoral training at Brown University and got his Executive MBA from Boston University.  He has over 25 years of industry experience including last 20 years in CMC Regulatory Sciences.  His extensive CMC experience includes resolution of complex CMC/Quality and Compliance issues (regulatory starting materials, Genotox impurities, specifications, QbD implementation, PAI responses) using science and risk-based approaches and leading NDA/Regulatory Teams.  He has worked in various therapeutic areas and on a broad range of dosage forms including immediate and modified release oral products, inhalation products, sterile injectables and drug-device combination products.  He has led the filing and approval of 11 NDAs, numerous sNDAs, INDs and international filings.  He is a member of RAPS, ACS and AAPS and was the chair of Regulatory Science section at AAPS.

Binesh Prabhakar, MBA

Partner

At Syner-G, Binesh leads business strategy and operations. He has more than twelve years of experience in Life Sciences, mainly supporting IT functions including Compliance, Auditing, and Validation. In addition to Syner-G, Binesh is a Partner at Cambridge IT Compliance, an IT organization supporting Life Sciences.

Binesh received his Bachelor of Science in Engineering from St. Joseph’s College of Engineering (affiliated to the University of Madras, India); his Masters of Science in Environmental Science from Texas A&M University-Corpus Christi, Texas, and his Masters of Business Administration from Babson College, Massachusetts. Outside of work, Binesh plays cricket for United Athletic Association Cricket Club, affiliated to Massachusetts State Cricket League.

Drew Barlow, M.P.H.

Vice President, Head of Regulatory Affairs

Drew holds a BS Degree in Biology from Mount St. Mary’s College and a Master’s in Public Health from University of North Carolina at Greensboro.  Drew has over 14 years of regulatory experience, including 4 years with the US FDA as a GMP investigator. He maintains extensive knowledge of global pharmaceutical CMC regulations and guidance documents pertaining to products in clinical development through post-marketing applications commercialization with emphasis in the EU, USA, Canada, Japan, China and Australia.  His areas of expertise include: devising and implementing CMC strategies, IND/IMPD/NDA/MAA preparation, post-approval compliance and regulatory reporting, GMP inspection readiness, and Quality by Design implementation.

Edward Ciolkowski, Ph.D.

Vice President, Head of Technical Development and Outsourcing Management

Ed received his Ph.D. in Analytical Chemistry from University of North Carolina, Chapel Hill and has over 20 years of industry experience in pharmaceutical development and management at Pharmacia-Upjohn, Pfizer and Bausch and Lomb.  At Syner-G, Ed heads up the Technical Development and Outsourcing function and his team is responsible for providing both strategic stewardship and tactical solutions for the scientific and technical aspects of drug development programs, including biopharmaceutical components such a dissolution and bioequivalence.  His team is also responsible for identifying and managing CRO/CMO/CDMOs for Syner-G’s clients to support drug substance, drug product and analytical development activities.

Ray Forslund, Ph. D

Vice President, Head of CMC Development and Project Management

Ray received his Ph.D. in Organic Chemistry from the University of Illinois at Chicago and completed his MBA from Babson College. Ray has over 13 years of experience in the Pharmaceutical industry working for both pharmaceutical and CRO/CMO companies. At Syner-G, Ray is a member of the Senior Leadership team having responsibility for leading the CMC and Project Management business units. His team is responsible for providing scientific solutions for drug development programs including identifying and managing CRO/CMO/CDMOs for Syner-G’s clients to support drug substance, drug product and analytical development activities. Ray’s scientific team is also tasked with providing strategic and Program Management oversite of development and clinical stage programs. Previously, Ray was part of the Senior Leadership team at Laurus Synthesis Inc. (LSI), a Boston based CRO/CMO where he led the Project Management group. He began his pharmaceutical career as a process chemist at Vertex Pharmaceuticals then moved on to Ironwood Pharmaceuticals holding several scientific positions of increasing responsibility leaving as a Senior Manager of Operations.

Marsha Marande, Ph.D.

Vice President, Regulatory Affairs

Marsha received her Ph.D. in inorganic chemistry from the University of New York at Binghamton and her BA in Chemistry from Hamilton College. She is an experienced pharmaceutical professional with extensive experience in global CMC regulatory affairs (26 years) for both biotechnology and small molecule products in all phases of clinical development and post-approval. She has extensive experience in process validation, QbD, comparability assessments and protocols, authoring global submissions and responses to Agency queries. She is experienced in defining CMC strategy for early development and late-stage/commercial development of both for biologics and small molecules. She is an accomplished regulatory leader/manager in both early development projects (resulting in successful CTA and IND submissions) and full development programs overseeing the preparation of and successful submission of marketing applications (4 NDAs, 5 MAAs, 3 BLAs). Demonstrated leadership in leading and managing Teams (comprised of internal members as well as partners and vendors) through complex global submissions, difficult supply issues, formal meetings and interactions with numerous global health authorities (including FDA, EMA, Health Canada & several regional health authorities).

Jay Samudralwar, Ph.D.

Director, Regulatory Affairs

Jay received his Ph.D. in Analytical Chemistry from India and completed his post-doctoral training at University of Kentucky, Lexington.  Jay has over 17 years’ experience in Global Regulatory CMC & Conformance, Quality Operations and Quality Control in Pharmaceutical & Biotechnology Industry. He started is pharmaceutical career at Merck and subsequently worked at Wyeth/Pfizer.  Jay has a proven track record of developing global regulatory strategies, execution, eCTD submissions and direct interactions with the Boards of Health for developmental / established products (Branded & Generics).  He has led technology & site transfer projects for APIs, sterile, non-sterile, biotechnology products and supported PAI/cGMP inspections with successful outcomes.

Sarah Hlavachek, B.S.

Director, Regulatory Affairs

Sarah holds a BS in Chemistry from University of Wisconsin, Madison. She began her career in pharmaceutical development as an analytical chemist at PPD Development and Sepracor and then moved to CMC regulatory affairs.  Sarah has over 16 years of experience in CMC regulatory affairs for small molecules, biotechnology products and drug device combination products. She has managed several regulatory submissions at various companies across all stages of development, from pre-submission consultation meetings (pre-IND), Phase 1 through 3 clinical trial applications, to marketing applications and post-approval supplements.  Her global CMC experience includes submissions in the US, Europe, Japan and Canada for investigational and marketed products.

Sam Salamone, MS, MBA, RAC

Director, Regulatory Affairs

Sam received his MS in Organic Chemistry from Florida State University and completed his MBA from University of Florida. Sam also maintains a regulatory affairs certification. Sam has over 13 years of experience in Regulatory CMC, Project Management, and Technical Operations for both Pharmaceutical and Medical Device companies. He has extensive broad knowledge on pharmaceutical CMC regulations and guidance documents with expertise in devising overall CMC program and regulatory strategies. Most recently, Sam was a senior project manager for Johnson and Johnson (J&J) for the development and commercialization of combination products. While at J&J, Sam had responsibilities for ophthalmic pharmaceutical/medical device/combination products (IND/NDA) and pain management API development (DMF). He began his pharmaceutical career as a process chemist and technical operations manager at Vertex Pharmaceuticals for a hepatitis C drug candidate then moved on to Johnson and Johnson holding several scientific, regulatory, and managerial positions of increasing responsibilities.

Velvizhi Heine, Ph.D., RAC

Director, Regulatory Affairs

Velvizhi earned her Ph.D. in Biochemistry from the Cancer Institute in Chennai, India and her BS/MS from the University of Madras in India. She is a pharmaceutical professional with strong background and experience in CMC Regulatory/Quality and Analytical Sciences for biologics, medical device and IVD industries. She has strong experience in method development and validation of analytical assays including bioassays and process impurity assays for a wide range of biopharmaceutical products including monoclonal antibodies, recombinant proteins, biosimilar, blood coagulation factors, enzymes and cell derived vaccine. Track record experience in QC, Analytical development, CMC and CRO management. Authored sections for BLA, 510K and PMA submissions; hold US Regulatory Affairs Certification (US RAC). Experience in drug product release sample testing, support for internal and external lab audits; proven record of scientific presentations at several national and international conferences. Strong organizational and communication skills with the ability to manage multiple projects simultaneously.

Dan Gee, Ph.D., MBA

Director, CMC Development

Dan earned his Ph.D. in Biochemistry from the University of California, Riverside and his MBA from Pepperdine University. He has been affiliated in both the biopharmaceutical industry and academia for over 25 years through Baxter, American Red Cross, Chiron (Novartis), Sanofi-Genzyme, TKT (Shire), and the University of Massachusetts Medical School. He has a diverse background in process development, technology transfer, troubleshooting, facility renovation/buildout, compliance, and cGMP clinical/commercial production. While in these roles, Dan has been involved in several biologic/biotech products that were successfully commercialized. At Syner-G, he supports drug substance/product development and production activities for clinical stage candidates through his role in the CMC/Project Management business units.

Anuj Kumar, Ph.D.

Associate Director, Pharmaceutical Development/CMC Project Management

Anuj has a Ph.D. in Pharmaceutical Sciences from the University of Wisconsin, Madison and over 11 years of industry experience in pharmaceutical development at Vertex Pharmaceuticals. His areas of expertise include enabling formulation technologies such as amorphous spray dried dispersions (SDD), solid nanocrystalline dispersions (SNCD), lipid based formulations and nanosuspensions for the development of BCS class II compounds. Anuj has a strong background in materials science and a deep understanding of the interplay between functionality and bioperformance of a dosage form. He has authored relevant CMC sections for IND/CTA filings and is well versed with the change control system in a regulated environment. At Syner-G, Anuj is responsible for providing technical solutions to support/troubleshoot the development of client’s compounds.

Lyndon Marble, Ph.D.

Associate Director, CMC Development and Project Management

Lyndon has a Ph. D. in Organic Chemistry from the University of Illinois at Urbana-Champaign and over 16 years experience in the pharmaceutical industry. For five years he was a team leader in the Medicinal Chemistry division at Johnson Matthey Pharma Services. The remaining time he has been in process chemistry research and development at both small biotech and CRO/CMO companies. His area of expertise is successful drug substance development, including route screening, route selection, and analytical method development, through to GMP Phase II kilo lab campaigns. He has participated in successful tech transfers to internal and external partners and has contributed to several CMC sections. Previously, Lyndon was a Senior Research Scientist at Laurus Synthesis, Inc., in Woburn, leading teams in process chemistry R&D for internal and external clients. His responsibilities at Syner-G are chemistry and project management support for clients’ drug substance development efforts.

Heather Mariani, B.S.

Associate Director, Quality and Compliance

Heather has a B.S. degree from Boston University in Biomedical Laboratory and Clinical Research Sciences and has worked in Quality Assurance for 16 years in both small and large molecules. Previously, Heather worked for Sanofi (formerly Genzyme) as a Manager of External Manufacturing Quality Assurance and lead efforts to manage QA oversight of manufacturing, distribution and testing operations by CMO’s and CTL’s. At Syner-G Heather is responsible for providing Quality and Compliance consulting services to Syner-G’s clients and leading the growth of the QA/cGMP Compliance function within Syner-G.

Outside of work, Heather is an Executive Director for East Coast Canine Rescue volunteering her time to help save dogs and provide them with loving, forever homes.

Melody Mak-Jurkauskas, Ph.D.

Senior Manager, Regulatory Affairs

Melody received her Ph.D. in Biophysical Chemistry from Brandeis University and then went on to a complete a Postdoctoral year at MIT. She earned her undergraduate degree at the University of Toronto. Most recently she worked for Xtuit, BIND, Amgen and Alkermes. At Syner-G, Melody will work with the Regulatory Affairs team to offer CMC analytical support to clients. She has various experience operating as an analytical technical lead in drug development activities. Melody will also be working other members of the regulatory team to support numerous pre and post approval submissions to US FDA and other global health authorities.

Venkata Ratnala, Ph.D.

Senior Manager, Regulatory Affairs

Venkata received his Ph.D. in Biochemistry and Biophysics from Leiden University, The Netherlands and then went on to a complete his Postdoctoral Fellowship at Stanford University, USA. At Syner-G, Venkata is a member of the Regulatory team, he authors various regulatory documents including CMC documents, provides pre-and post-approval submissions, and offers CMC analytical support for clients. In his ten years in the industry, he has advanced various biologics, peptides and small molecules candidates under development to commercial by performing process development, analytical methods, formulation development and stability. Prior to Syner-G, he worked for CuriRx, UCB Pharma and Vertex Pharmaceuticals.

Amy Clark-Stasiw

Manager, Regulatory Submissions and Documentation

Amy has over 20 years of experience in the pharmaceutical industry. She started out as a microbiologist/bench chemist and worked her way through the different facets of the business including quality, analytical, stability and lastly regulatory. Ms. Clark-Stasiw has authored IND, IMPD, NDA, ANDA, CBE and PAS submissions, as well as, Annual Reports for regulatory agencies in the US, Canada and Europe. Ms. Clark-Stasiw is also very experienced in preparing submissions for electronic publication (gateway ready documents) and understands the publishing needs of regulatory operations teams.

Bharathi Mamidipudi, M.S.

Consultant II, Regulatory Affairs

Bharathi has a Bachelor’s degree in Pharmacy from India and Master’s degree in Regulatory Affairs of Drugs, Biologics and Medical Devices from Northeastern University, MA.  Bharathi has comprehensive knowledge of CMC regulatory requirements for investigational and marketed products. Bharathi has 4 years of CMC Quality and Regulatory experience, including 3 years of CMC regulatory affairs in developmental and post marketing activities. Her experience includes authoring and reviewing Module 3 and Module 2.3 (CMC) sections of CTD submissions in both small and large pharma settings.  She has supported numerous of pre and post approval submissions to US FDA and other global health authorities for various clients.

Rajan Thumar, M.S.

Regulatory Consultant II

Rajan has a Bachelor’s degree in Pharmacy from India and Master’s degree in Regulatory Affairs from Massachusetts College of Pharmacy.  Prior to Syner-G, Rajan worked as regulatory team member at RiconPharma LLC, NJ where he was involved with entire product life-cycle pertaining to regulatory affairs, quality assurance and compliance.  Rajan has thorough understanding in pharmaceutical manufacturing, quality control as well as the CMC regulatory requirements for investigational medicinal products and post-approval marketed products.  He has provided CMC authoring and regulatory support for INDs, sNDAs and IND/NDA Annual Reports for various clients.

Avani Shah, M.S.

Jr. Consultant, Regulatory Affairs

Avani has a Master’s degree in Pharmaceutical Sciences from India and a second Masters in Regulatory Affairs from Massachusetts College of Pharmacy. Avani has worked as a Regulatory Associate at Zimmer Biomet where she was involved in authoring Summary Technical Documents for Legacy Products. At Syner-G, Avani is responsible for authoring post approval submissions and IND Amendments for numerous clients. She also manages electronic document management systems for archival and life cycle management of regulatory submissions. Avani also has experience providing regulatory support and authoring for IND/NDA annual reports for various clients.

Matt Pereira, B.S.

Business Operations Manager

Matt holds a B.S. in biology from Boston University and five years of experience in the pharmaceutical industry. Prior to joining Syner-G, Matt worked for four years as office manager for a Massachusetts-based CRO where he was responsible for various operational tasks including invoicing, generation of proposals and overall handling of client relationships. At Syner-G, Matt is responsible for developing and executing client proposals and contracts, placement of off-site consultants and marketing initiatives as well as management of the Boston office. Matt also heads up other operational activities such as accounts receivable and human resources for Syner-G.

Advisors

Dr. Patrick DeLuca
Professor Emeritus, Pharm. Sciences
University of Kentucky

Dr. Neal Anderson 
President, Anderson’s Process Solutions
Ex-BMS
API Process and Manufacturing

Dr. Steven Koepke
SRK Consulting, LLC
Ex-FDA Deputy Director

Dr. Gary Maier
MaierMetrics Consulting
Ex-Sanofi/Sepracor/Sunovion
Biopharmaceutics

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