Faculty

  • Bindu Ajit
  • Program Director
  • Qualification: Post-Grad, Analytical Chemistry | Degree: Education

About

Bindu Ajit is the Program Director of Biocon Academy and is responsible for all the programs offered by the academy. She is a post-graduate in Analytical Chemistry and also has a degree in Education.

Her total experience is of around 18 years, which includes over 14 years of leadership and Operational Management in the learning function, predominantly in the finance and IT domain, and 4 years in schools and colleges.

  • SS.Easwaran
  • Academic Director, Biocon Academy
  • Qualification: M.Sc., Microbiology | M.Phil, Life Sciences | GCP Certification | PG Dip. Marketing Management | MDP

About

SS.Easwaran is the Academic Director at Biocon Academy, Bangalore where he is responsible for executing Biocon-KGI Certificate Program in Biosciences. Prior to joining Biocon Academy, he was General Manager for Technology and Services, BIOZEEN, responsible for the Biopharmaceutical Production Training and Regulatory Services departments.

  • Dr. S. Ramgopal Rao
  • Academic Manager, Biocon Academy
  • Qualification: PhD, Plant Biotechnology | M.Sc., Plant Sciences | MBA Professionals | PG Diploma in Patents Law

About

Dr. Ramgopal is the Academic Manager at Biocon Academy, Bangalore where he is responsible for managing the activities of Biocon-KGI Certificate Program in Biosciences. Prior to joining Biocon Academy, he worked as Associate Professor in Biotechnology wherein he taught for M. Tech / B. Tech Biotechnology Programs for 12 years. He has guided many PhD students in Biotechnology, has executed funded R&D projects in Biotechnology & published research papers in International/National Journals/Conferences. His academic interests include Cell & Molecular Biology, Genetics, Plant Biotechnology, Bioethics, Biosafety & Intellectual Property Rights. Ramgopal has research experience in the areas of Biotechnology of Oilseeds & Medicinal Plants and Biofuels from Microalgae. He has trained faculty and students in Biotechnology, IPRs, Effective Teaching Learning and Soft Skills.

  • Eddie Crabbe
  • Adjunct Professor, Bioprocessing
  • Qualification: PhD

About

Eddie Crabbe has over 12 years experience in aerobic and anaerobic fermentation process development for recombinant protein and bioenergy production, technology transfer, and manufacturing support. Currently, Eddie works at Allergan in Irvine, California as a Senior Scientist in Biologics Development Process Sciences. In this role, he leads the design, development, scale up, characterization, and transfer of fermentation and primary recovery processes for the production of biologics and enzymes. He provides technology transfer expertise to in-house and external development and commercial manufacturing partners as well as contributing to manufacturing sections for CMC regulatory filings. Prior to joining Allergan, he worked as a Senior Scientist in Kam Biotechnology in Surrey, Canada where he developed a lab scale platform for microbial hydrogen production from biological waste streams, provided proof-of-concept for a two-step continuous bioethanol production process, and supported manufacturing of bio-based (fungal and bacterial) products for applications in wastewater treatment.

Eddie has a PhD in Food Science and Technology (Microbial Biotechnology option) from Kyushu University, Fukuoka, Japan, and holds a BS (honors) and an MPhil in Biochemistry from the University of Ghana, Legon, Ghana. He also undertook post-doctoral studies in methane steam reforming to hydrogen TonenGeneral Corporation (an ExxonMobil affiliate in Saitama, Japan) and lysine production by a thermo-tolerant bacillus species from methanol in Professor Mike Flickinger's Lab in the Biotechnology Institute at the University of Minnesota, St. Paul.

  • Jean Anne Mire
  • Professor of Practice of Clinical and Administrative Sciences
  • Qualification: BS Pharm, MBA

About

Ms. Mire joins the faculty from Harding University College of Pharmacy in Searcy, AR where she was assistant professor of pharmacy practice. At Harding, Ms. Mire taught biostatistics and literature evaluation, financial analysis and co-coordinated clinical pharmacology for the physician assistant program. She is proficient in numerous software applications in the PC and Mac OS environments and provided technical support to faculty and students.

Ms. Mire's academic interests include biostatistics, literature evaluation, evidence-based medicine, comparative effectiveness research, and financial analysis and business planning. Before joining the faculty KGI, Ms. Mire worked in the biotechnology industry, primarily in business development and investor relations. She has extensive experience in the financial services and investment banking industry, and in hospital pharmacy practice.

Ms. Mire completed her pharmacy studies at the University of Louisiana at Monroe. She completed an ASHP-accredited residency in hospital pharmacy at University Hospitals in Birmingham, AL and earned her MBA in finance at Tulane University. Ms. Mire is a member of the American Academy of Colleges of Pharmacy (AACP).

  • Mary Ellen Cosenza
  • Regulatory Consultant
  • Qualification: PhD, DABT, ATS, RAC

About

Mary Ellen Cosenza, PhD, DABT, ATS, RAC is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. Most recently, she served as the Executive Director, U.S. Regulatory Affairs, at Amgen, Inc. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as an Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership roles in Regulatory Affairs, she also served as the Senior Director of Toxicology at Amgen. Prior to joining Amgen, she served as a Principal Scientist for the Medical Research Division of American Cyanimid Company (now Pfizer).

While at Amgen, Mary Ellen was responsible for both early- and late-stage development programs resulting in numerous successful IND, CTA, NDA, MAA, and BLA submissions in a broad variety of therapeutic areas and modalities. In addition, she played a key leadership role in preparing teams for global health authority meetings with FDA, EMA, and regional country health authorities, including several FDA Advisory Committee Meetings. Mary Ellen is also experienced in the implementation of corporate integrity agreements and review of promotional materials.

Ms. Mire completed her pharmacy studies at the University of Louisiana at Monroe. She completed an ASHP-accredited residency in hospital pharmacy at University Hospitals in Birmingham, AL and earned her MBA in finance at Tulane University. Ms. Mire is a member of the American Academy of Colleges of Pharmacy (AACP).

She is recognized as an expert in preclinical biologic drug development as demonstrated by her participation as a member of an Expert Working Group, operating under the auspices of the International Conference on Harmonisation (ICH), where she influenced international policy guiding the development of both biologics and traditional small molecules in the U.S., Europe, and Japan.

Mary Ellen is a Diplomat of the American Board of Toxicology, a Fellow of the Academy of Toxicological Sciences, member of the Society of Toxicology (SOT), Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS), and holds Regulatory Affairs Certification for both the U.S. and EU. Mary Ellen has been a member of ACT since 1988, serving as an active speaker and session chair. Most notably, she developed the first Study Director Training Course in 2001 and has served as a member of the ACT Education Committee, as Councilor, and as Treasurer. Mary Ellen is a Past-President of ACT. She is also an instructor at the University of Southern California where she teaches a graduate level course on Food and Drug Toxicology.

Mary Ellen received her PhD from St. John’s University, New York, and her MS in Regulatory Science from the University of Southern California, Los Angeles.

  • Srikanth Kolluru
  • Associate Professor of Biopharmaceutical Sciences
  • Qualification: PhD

About

Dr. Srikanth Kolluru holds a PhD in medicinal chemistry with a BS and MS in Pharmacy. Prior to his appointment at KGI School of Pharmacy, He worked at Texas A&M University, College of Pharmacy as an Assistant Professor for more than five and half years. He played a key role in building a new pharmacy program at Texas A&M University. He was a recipient of number of teaching excellence awards in both individual and as well as team teaching. He had his post-doctoral training from the University of Minnesota, Minneapolis. Dr. Kolluru's research involves both scholarship of teaching as well as drug discovery involving the development of novel assessment and instructional methods to effectively integrate basic sciences courses with clinical courses and development of antiviral drugs & allosteric modulators for cannabinoid receptors respectively. He published extensively in both areas in journals like American Journal of Pharmaceutical Education, Journal of Medicinal Chemistry and Bioorganic & Medicinal Chemistry to mention a few. He has extensive experience in the curriculum development and assessment areas of pharmacy program. Dr. Kolluru was elected as a secretary of the medicinal chemistry section of AACP (American Association of Colleges of Pharmacy), member of Rho Chi, Phi Lambda Sigma and Phi delta Chi. He is a reviewer of number of journals in teaching as well as drug discovery including American Journal of Pharmaceutical Education, Currents in Pharmaceutical teaching & learning, Bioorganic & Medicinal Chemistry and Journal of Molecular Graphics and modeling etc. He also served in writing board exam questions for National Association of Boards of Pharmacy. Dr. Kolluru also holds an adjunct faculty position with the chemistry department of Texas A&M University, Kingsville.

  • Pukar Ratti
  • Executive System Director of Research

About

Pukar Ratti currently serves as the Executive System Director of Research at CHRISTUS Health in Dallas, Texas. Prior to that, he has worked as Director of Clinical Research and Biobank at Ochsner Health System in Louisiana, and the Department Head of the Office of Research & Sponsored Projects at Leonard J. Chabert Medical Center, part of the Louisiana State University Health System. He passionately holds concurrent academic appointments at University of California Irvine (CA), Rutgers University (NJ), Keck Graduate Institute (CA/India), Dillard University (LA), and University of Phoenix (AZ). He has previously served as an Institutional Review Board (IRB) member on Ochsner Clinic Foundation’s IRB. With multiple graduate degrees in Healthcare Management, Biochemistry and Chemical Engineering, plus active certifications as Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA) and Certified IRB Manager (CIM) from National Association of IRB Leaders (NAIL), Pukar has over 15 years of combined experience in Research Administration, Clinical Research, Preclinical research, Basic Science Research, Behavioral Research, Clinical Research Revenue Cycle, Project Management, IRB services, Contract negotiations, Student Mentorship, Operational Redesign, Grants Portfolio Management, Policy-making, Personnel Development, Strategic Planning, and Biobanking. Today, Pukar is one of the only 47 medical professionals in the entire State of Texas to have earned the prestigious title of Fellow of American College of Medical Practice Executives (FACMPE).

  • Susan Bain
  • Professor of Practice, Clinical, Regulatory and Quality; Program Director, MBS Clinical and Regulatory Affairs
  • Qualification: DRSc

About

Dr. Bain has a strong background in Regulatory Affairs, Quality Assurance, Compliance and Operations, with more than 25 years of managerial experience at leading pharmaceutical, biotech and medical device firms, as well as at the FDA.

Her corporate experience includes serving as a Vice President in charge of Quality/Regulatory Assurance and Operations at the Huntington Beach-based SpineWorks LLC, a medical device company which focuses on implant design and development, assisting people with complex spine conditions. Prior to that, she was the Manager of Regulatory Affairs and then the Manager of Corporate Quality Assurance at Watson Pharmaceuticals in Corona, CA. Her responsibilities included initiating and coordinating product recalls, ensuring product destruction met FDA guidelines and regulations, post-approval drug manufacturing changes and reporting, and reviewing and submitting labeling per FDA guidelines, among other duties. She also held managerial positions in Quality Assurance and Control and/or Regulatory Affairs at Techniclone Corporation (Peregrine Pharmaceuticals), Baxter Health Care Corporation and Alpha Therapeutic Corporation (Grifols) in Los Angeles.

As a FDA Consumer Safety Officer based in Irvine, she investigated complaints against FDA-regulated products, conducted audit recall checks and monitored compliance to injunctions and seizures. In addition, as a certified medical device investigator, she inspected various pharmaceutical, medical device, IVD and veterinary medicine firms for compliance to all regulations for product licensure and cGMP compliance.

She received a Doctorate of Regulatory Science (DRSc), a Master of Science in Regulatory Science from the University of Southern California (USC) and a Bachelor of Science in Biological Science from Cal Poly, Pomona. She holds a graduate certificate in Effective Supervision from Cal Poly Pomona and is a member of the Orange County Regulatory Association.