Emily Burke, PhD, Director of Curriculum | Instructor | WEEKLY Editor
Dr. Emily Burke is the Director of Curriculum and is charged with customizing training for clients, delivering training sessions, and writing the Biotech Primer WEEKLY, a free electronic newsletter that explains the science behind the headlines. Dr. Burke delivers training nationally and internationally, and has been an invited speaker at many high profile events including the annual BIO International Convention and the California Life Science HR Conference. Prior to joining Biotech Primer, Dr. Burke worked as a patent writer for ISIS Pharmaceuticals in Carlsbad, CA, taught biology and biotechnology classes at San Diego Miramar College, and conducted post-doctoral research on the molecular pathogenesis of respiratory syncytial virus and Lassa fever virus at The Scripps Research Institute in La Jolla, CA. Dr. Burke received her B.S. in Biological Sciences from Carnegie Mellon University and her Ph.D. in Molecular Biology from the University of South Alabama. Dr. Burke has been with Biotech Primer for nine years.
Leo Adalbert, MBA, Strategic Commercialization Expert | Instructor
Leo Adalbert, Founder and Principal Consultant of StraNexa Biopharm Commercialization Consultancy LLC, brings more than 25 years of deep cross-functional commercial and clinical development experience across both biologics and small molecules. Leo has built brands across multiple therapeutic areas, with particular expertise in specialty, rare disease, and Orphan Drug markets across all phases of drug development.
Leo is an insightful, collaborative, and creative leader with a proven track record spanning global marketing, business development/transactions, and alliance leadership. This cross-functional perspective enables Leo to look at challenges holistically and to critically assess the major market drivers, strategies, and tactics vital to building competitive advantage through a science-driven, market-led, patient-focused approach that maximizes product value to patients, clinicians, and payers through a product’s lifecycle.
Prior to founding StraNexa, Leo held various leadership roles across marketing, business development, and alliance leadership at leading firms such as AstraZeneca, Merck, Astra Merck, and Regeneron. Leo earned an MBA from Harvard Business School (fellowship), a BS in Business Administration from West Virginia University (summa cum laude), and executive leadership certifications from Northwestern University (Kellogg) and University of Pennsylvania (Wharton). He has also recently completed extensive coursework in biological sciences, earning high honors (Phi Theta Kappa distinction).
Simon J. Tulloch, MD, Drug Development Expert | Instructor
Dr. Tulloch has more than 25 years of pharmaceutical and biotech experience in clinical development, R&D management, and business roles—both in Europe and the USA. He consults to the industry on strategic R&D issues, clinical development, and medical issues.
Dr. Tulloch has been the Chief Medical Officer at InfaCare Inc.—a privately funded biotech company—and spent ten years at Shire Pharmaceuticals. He moved to the USA to establish Shires U.S. research and development organization. Dr. Tulloch built the organization in all areas of drug development, and successfully conducted the development and NDA approval of Adderall XR. During that time, his organization also developed and got NDA approvals for Fosrenol (Shire’s first global NCE) and Equetro, as well as providing CMC, preclinical, and marketing medical support to all of Shire’s U.S. products. Latterly, he assumed the role of head of the global CNS Business Unit.
Prior to his time at Shire, Dr. Tulloch spent eight years with Johnson and Johnson companies, including five years as clinical research director for R.W. Johnson PRI’s European R&D facility in Zurich, Switzerland, working on multiple projects in various therapeutic areas and stages of development.
He trained in medicine at Oxford University, has a degree in physiology, a diploma in pharmaceutical medicine, and worked for a number of years for the UK National Health Service in hospital posts.
Jim Macemon, Medical Device Expert | Instructor
Mr. Macemon is a medical device executive with extensive experience in diagnostics, critical care, patient monitoring, imaging, and lab products. During his 40+ year medical device focused career, he led numerous Research & Development and manufacturing teams, successfully launching products to aid laboratory and health care professionals and improve patient care.
Mr. Macemon received his undergraduate degree in engineering from Georgia Institute of Technology, followed by a Masters in Administrative Science from The Johns Hopkins University. During his career, he held senior positions with such companies as Baxter Healthcare, Richardson-Vicks, and SpaceLabs Medical, leading programs to develop laboratory and point-of-care diagnostic systems. Mr. Macemon’s focus during the last 20 years has been with Venture Capital funded start-up companies developing revolutionary diagnostic and imaging technology.
Mr. Macemon’s experience as a trainer also spans many decades. As an invited speaker at several Q1 Productions Medical Device conferences, he spoke on a variety of topics related to product development, quality and manufacturing. And during his 14 years at Baxter Healthcare, he frequently provided customer, company and trainer training covering a variety of product and Quality Management System topics.
Currently Mr. Macemon is Chief Operating Officer at DNAe, leading the development and manufacturing program for a device that will enable pathogen identification from a whole blood sample in less than 2 hours, enabling clinicians to prescribe appropriate antibiotics for their septic patients days sooner than is possible with current technology. He has 13 patents issued and several more pending.
Kevin Curran, PhD Biotechnology Expert | Instructor
Dr. Curran received his B.S. in Biology from Southern Oregon University and his PhD in Developmental Genetics from the University of Washington in Seattle. Prior to joining Biotech Primer, Dr. Curran worked in the field of cancer research at Memorial Sloan Kettering Cancer Center, where he analyzed the effect of small molecule therapies on apoptosis, or programmed cell death. Dr. Curran then worked in the stem cell field at UCSF, helping design procedures to generate replacement heart tissue for mammals. Most recently, he has worked in the field of behavioral neuroscience at the Salk Institute, exploring the manner that serotonin modulates various human behaviors, such as phobias and anxiety. He is currently teaching cell biology at the University of San Diego.
Collins Jones, Ph.D., Biotechnology Expert | Instructor
Dr. Jones received his Ph.D. from University of Maryland in Biochemistry. Dr. Jones has been a scientific adviser and lead instructor for Biotech Primer since 2001. Currently, he is the coordinator for the Biotechnology Program at Montgomery College. Working closely with a number of leading biotechnology companies, including BioReliance, Human Genome Sciences, Qiagen and EntreMed, Dr. Jones develops and implements curriculum that is current and industry relevant. Prior to his appointments, Dr. Jones spent ten years as a research scientist at the National Institutes of Health in Bethesda, Maryland.
Joseph H. Quinn, Biopharmaceutical Regulatory Expert | Instructor
Mr. Quinn is an independent Regulatory Affairs Consultant in the biopharmaceutical industry. He has more than thirty years of experience in the field of biologics/vaccines, including assignments in Quality Control, Research, Product Development & Scale-Up, Bioanalytical Development & Validation, Project Management, and Regulatory Affairs. Mr. Quinn was employed by Sanofi Pasteur for twenty-eight years, most recently in the position of Senior Director, Head of North American Regulatory Affairs. Mr. Quinn teaches graduate-level courses in the Temple University Regulatory Affairs and Quality Assurance program. Mr. Quinn holds a Master of Science degree in Quality Assurance and Regulatory Affairs (Temple University School of Pharmacy), Master of Science degree in Chemistry (University of Scranton), Bachelor of Science degree in Biochemistry (The Pennsylvania State University), and Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.
Claire Gelfman, PhD, Drug Development Expert | Instructor
Claire M. Gelfman, Ph.D., is the Senior Director of Scientific Services at Ora, Inc., an ophthalmic contract research organization (CRO) providing preclinical, regulatory, and clinical trial services for companies worldwide. Her responsibilities in this role include the design and implementation of preclinical translational strategies and their integration into the clinical development process for the advancement of therapeutics to treat major unmet medical needs. Prior to Ora, Dr. Gelfman spent 12 years at Lexicon Pharmaceuticals in the area of molecular genetics where she was involved in early drug target discovery using molecular, cellular, and biochemical approaches, and directed in vivo pharmacology efforts in the areas of ocular inflammation and retinal degeneration. Her experience covers 17+ years’ in drug discovery and development, spanning academia, biopharma, and the CRO industry. Dr. Gelfman holds a BA in Biology from Washington University in St. Louis, and a Ph.D. in Biochemistry from The University of Texas at Austin.
Robert Johnson, Medical Device Expert | Instructor
Mr. Johnson has an extensive background in the medical device industry across many functions including new ventures, marketing and business development. Mr. Johnson has led product development and commercialization efforts in devices, instrumentation and diagnostics used in cardiology, radiology, obstetrics/gynecology, urology, pulmonology and critical care. In addition, he has completed numerous transactions including financings, acquisitions, licenses and strategic alliances. Throughout his career, Mr Johnson has worked in executive capacities for medical device companies including Johnson & Johnson, Mallinckrodt, C.R. Bard and Respironics/Philips. Most recently, he worked at BioEnterprise, a firm engaged in entrepreneur mentoring and growth acceleration of several start up medical device companies. Johnson has a B.S. in Business Administration from Loyola University in Baltimore, Maryland.
Marc LeMaitre, PhD, Biotechnology Expert | Instructor
Marc Lemaitre holds a first degree in Organic Chemistry and a PhD in Biochemistry (specializing in DNA repair and cancer) from the University of Liège, Belgium, and since 1980 the “fil rouge” of Marc’s professional interests has been the study of the Nucleic Acids. After pioneering work on Antisense and oligo delivery in Montpellier, France, followed by 2 years in the lab of Nobel Prize winner Dr. Luc Montagnier at the Pasteur Institute in Paris, Marc held positions of increasing seniority in R&D, operational management, business development, and general management within CMO’s, Pharma and Biotech companies. He moved to the USA in 2006 in a leadership role with Glen Research, before being recruited in 2009 as CEO of Girindus America, a CMO with a focus on the cGMP manufacture of oligonucleotides for therapeutic applications. In this role, Marc also held the legal responsibility of “Sprecher des Vorstands” (President of the management board) of the German listed company Girindus AG, adding invaluable experience of leadership of a public company.
Having negotiated the merger between Nitto-Denko Avecia and the US operations of Girindus, Marc agreed to stay for a year to facilitate the integration of the newly merged entities. With that project now complete, he is working as an independent consultant helping companies on various strategic and/or technical projects, including: company creation, operational improvement and streamlining, fund raising, interim executive management, turn-around projects and due diligence for licensing and acquisitions.
Shane P. Desselle, RPh, PhD, FAPhA, Drug Development Expert | Instructor
Shane P. Desselle, PhD, FAPhA received his B.S. in pharmacy and PhD in health care administration from University of Louisiana at Monroe. He has an extensive academic career, including serving as department chair, associate dean, and Dean. He also is President of Applied Pharmacy Solutions, a research company aimed at finding solutions regarding prescription drug
benefit design, labor economics, and patient medication adherence interventions. He has 80 peer-reviewed publications and is the founder and chief editor of the international peer-reviewed journal, Research in Social and Administrative Pharmacy, which has the highest Impact Factor score of any journal in pharmacy. He also co-edits the leading pharmacy management textbook, worldwide. Dr. Desselle has been consulted for many projects for pharmaceutical manufacturers and professional and philanthropic organizations, including studies related to prescription drug advertising, selecting appropriate migraine headache therapy, and patient understanding of Medicare Part D benefits.
Kenneth J. Olivier Jr., PhD, Drug Development Expert | Instructor
Kenneth J. Olivier Jr., PhD, has been developing drugs for 15 years and is currently Head of Nonclinical Development at Acceleron (XLRN) Pharmaceuticals in Cambridge, MA. Dr. Olivier’s work experience includes biotechnology and pharmaceutical companies, spending time at Regeneron, Biogen, GlaxoSmithKline, and Merrimack Pharmaceuticals developing diagnostics, small molecule drugs, and biologics for indications in cardiology, neurology, neuromuscular, immunology, rare disease, infectious disease, fibrosis and oncology. Though his primary duties have been safety evaluations, Dr. Olivier has held the role of Project Leader, Head of Project Management, Head of Regulatory, Head of Pharmacokinetics, Head of Bioanalytical Development, Validation and Sample Analysis and Head of Nonclinical supporting multiple INDs, IMPDs, CTAs, NDAs, BLAs, PLEs and IDEs. In addition, Dr. Olivier is an adjunct faculty member at Oklahoma State University and has taught drug development courses at Harvard, MIT and through the American College of Toxicology, for which he is currently serving on the Editorial Board (International Journal of Toxicology) and as an elected Council Member. Just 2 years ago, he created what is currently the Oklahoma State graduate course on drug development attended largely by faculty, medical and veterinary students. Dr. Olivier has spent the past 9 years training CSOs, CEOs, CMOs, Project Team Leaders, Functional Heads and Team members on how to transition from discovery to development to market approval (within private and public companies), covering all topics related to drug development. Dr. Olivier has chaired/co-chaired/presented symposia and taught drug development annually over the past 14 years, covering all areas and specific topics such as safety pharmacology, stem cells, computational modeling, antibody-drug conjugates, and the art of clinical dose level selection. In addition to teaching and developing much needed diagnostics/devices/therapies, Ken enjoys participating on Scientific Advisory Boards, including a DARPA funded project at MIT and a start-up company in San Francisco. Dr. Olivier’s publications include evaluations of toxicity related to novel therapeutics in immunology and oncology, such as interferons, bispecific antibodies, targeted liposomal nanotherapies and Intellitrap® technology. Most recently (2016), he published a book on the development of ADCs covering chapters from discovery through post-market approvals with topics spanning all aspects of drug development, including CMC, Nonclinical, Regulatory and Clinical strategies. Dr. Olivier obtained a BS in Toxicology from the University of Louisiana at Monroe and a PhD in Veterinary Biomedical Sciences from Oklahoma State University.
Karin Lucas, Ph.D., Scientific Advisor | Instructor
Dr. Lucas is the Associate Director, Scientific Communications at Sarepta Therapeutics. Prior to joining Sarepta, Dr. Lucas was the Director of Training and Education for Biotech Primer for 2 years. Her duties included new product development and client training customization for Biotech Primer. Dr. Lucas has been an invited speaker at many events including the annual BIO International Conventions, the Sarawak Biodiversity Centre in Malaysia, and the National Biotechnology Week in Canada. Dr. Lucas worked as a scientist at Biogen where she developed protein pharmaceuticals for the treatment of cancer and multiple sclerosis and as a scientist and project director at Cardinal Health where she worked on the development of over 25 products with multiple pharmaceutical and biotechnology companies.
Ron McCullough, PhD Diagnostic Expert | Instructor
Dr. McCullough has been an innovator in the pharmaceutical and clinical diagnostic industry for over 15 years. His experience spans the spectrum of the industry from initial ideation and proof of concept work, through commercial launch and regulatory approval, and finally operational optimization, technology licensing, and product life-cycle management.
Dr. McCullough received BS degrees in Chemistry and Biochemistry from the University of Arizona where his focus was on analytical testing and methodologies. His Doctorate was received in Molecular and Cellular Biology and Biochemistry at Boston University working in the Center for Advanced Biotechnology. His focus was on development of novel genomic molecular based assays for research and therapeutic applications, including collaborations with MIT, Harvard Medical School, the Broad Institute, Boston Medical School, University of Pennsylvania State, and the Chinese University of Hong Kong. Recognizing the need to incorporate the business aspects into the increasingly commercial biotechnology industry, he received his MBA from the University of San Diego with a focus in new venture and leadership management, which included international work in Europe and North Africa.
Most notable is his extensive work on the disruptive technology behind the laboratory developed test for non-invasive prenatal diagnostic testing (NIPT) which has been featured on The Today Show, in the New York Times and Wall Street Journal. His role in bringing this technology to market included greenfield build-up of CLIA, CAP and New York State approved laboratories on both coasts with creation of supporting operational, quality, analytical, and technical business units. This success was repeated internationally leading to a global technology distribution. Currently he is focused on leveraging his diverse industry knowledge to identify potential innovations across the biotechnology industry and support them with best practices and strategic planning.
Lisa A. Selbie, PhD, Biotechnology Expert | Instructor
Dr. Selbie received her Ph.D. in Biochemistry, Molecular Biology and Cell Biology at Northwestern University. Dr. Selbie lives in Sydney, Australia and teaches all Australian-based BioTech Primer classes. Dr. Selbie began her career in the biosciences as both a scientist and a project leader at the Garvan Institute of Medical Research in Sydney, Australia. Dr. Selbie then moved to England where she worked at Queens Medical School as a Research Fellow for 4 years. She has since returned to Sydney, Australia and in addition to working with BioTech Primer, she works as a lecturer and project coordinator for the Johns Hopkins University’s Australian Biotechnology Initiative and as a biotechnology consultant for a private company.
Ryan Burnette, PhD, BioSafety Expert | Instructor
Dr. Burnette is the Vice President, Biosafety at WIRB-Copernicus Group which provides a full range of services for biotechnology and pharmaceutical companies, biological process scale-up, and assistance with biosafety plans, reviews and audits. Dr. Burnette consults as a scientist and project manager on full-discipline engineering projects for medical testing, as well as the design and implementation of biosafety operations and audit programs. Dr. Burnette has extensive expertise with regard to biosafety compliance issues, drawing both from his own microbiological bench research experience and his extensive contact and familiarity with the CDC’s Biosafety in Microbiological and Biomedical Laboratories and the NIH Design Policy and Guidelines, as well as other pertinent regulatory policies.
Jonathan Richmond, PhD, RBP, Biosafety Expert | Instructor
Dr. Richmond has had a distinguished career as a biological safety expert for more than 30 years. He currently serves as a consultant to the World Health Organization (WHO), and was previously the Director of the WHO Collaborating Center for Applied Biosafety and Training. He has had numerous important roles, including the Director for the Office of Health and Safety for the Centers for Disease Control and Prevention (CDC), the Chief of the Safety Operations Section, Occupational Safety and Health Branch for the National Institutes of Health (NIH) Division of Safety, the Biological Safety Officer at the Plum Island Animal Disease Center for the USDA and others. Dr. Richmond has consulted on many high-containment laboratory projects for private, academic and government institutions in the U.S. and countries around the world, providing design guidance, facility commissioning and training.
Dr. Richmond received his Ph.D. in genetics from Hahnermann University in 1967, his M.S. in genetics from the University of Connecticut in 1964 and is recognized by the American Biological Safety Association (ABSA) as a Registered Biosafety Professional (RBP). He is the co-editor of the 3rd & 4th editions of the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL), a contributing editor to the 5th edition of the BMBL, and is a contributing editor to the WHO’s Laboratory Biosafety Manual. He is the editor of ABSA’s Anthology of Biosafety series and has authored numerous scientific publications.
Robert J Hawley, PhD, RBP, CBSP, Biosafety Expert | Instructor
Dr. Hawley is easily one of the most recognized and respected authorities in biological safety. With decades of experience, Dr. Hawley has provided expertise to countless clients, Federal agencies, domestic and foreign governments, spanning issues of biological safety, public health and microbiological research. He has held numerous positions, such as a Safety and Occupational Health Specialist and eventually the Chief, Safety and Radiation Protection Division, at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and served as the Command Biological Safety Officer for the U.S. Army Medical Research and Materiel Command. In addition, Dr. Hawley has served as a consultant to the World Health Organization (WHO), the Environmental Protection Agency (EPA) and the Department of Homeland Security. He is also a member of several response teams, including the United Nations Special Commission (UNSCOM) Inspection Team, in Baghdad, Iraq and the Defense Science Board Task Force on Defense Against Terrorist Use of Biological Weapons to the Office of the Secretary of Defense.
Dr. Hawley is the recipient of a Ph.D. in Microbiology from the College of Medicine and Dentistry of New Jersey, an M.S. in Microbiology from Catholic University of America and a bachelor’s degree in Biology from Pennsylvania Military College. Dr. Hawley is recognized as both a Registered Biosafety Professional (RBP) and a Certified Biological Safety Professional (CBSP), and served as the President of ABSA from 2006-2007. Previously, he was also the President of the Chesapeake Affiliate of ABSA.
Patricia L. Larrabee, MS, Biopharma Facilities Expert | Instructor
Pat is the founder and President of Facility Logix. She has over 30 years of experience in the biotechnology real estate industry, including several years as a bench researcher. For the past 20 years, Ms. Larrabee has applied her technical end‐user knowledge to the facility‐related needs of the industry. She has advised developers and institutions across the United States and overseen facility expansion and implementation programs for clients such as Covance, George Mason University, the Vaccine & Gene Therapy Institute, and Xceleron. Pat has also conducted feasibility studies for a variety of wetlab incubators and developed life science strategies for various public entities nationwide.
Prior to founding Facility Logix, Pat served as an Executive Vice President for Scheer Partners, where she was responsible for the company’s Biotech Services Group, a fully integrated real estate services organization serving the needs of the biotechnology industry in Maryland.
Pat holds an MS in Biotechnology Management from the University of Maryland University College and a BA in Biology from the University of Vermont. She has authored several articles for nationally distributed publications and has been a speaker at Gene Acres and Lab Design Conferences and has developed and delivers a one and two day course on Biotech Facilities. Pat sits on the Board of Directors for Seeding Labs and Women In Bio. She is a supporter and participant in the Labs21 Initiative.