ABOUT US

Dr. Emily Burke is a biopharma communication expert and is a medical writer for ScienceMedia. She has developed and delivered customized courses for Biotech Primer for 11 years both nationally and internationally, and has been an invited speaker on behalf of Biotech Primer at many high profile events including the annual BIO International Convention and the California Life Science HR Conference. She also wrote the Biotech Primer WEEKLY blog and authored two books; The Biotech Primer One and The Biotech Primer Two both available on Amazon.com. Prior to joining Biotech Primer, Dr. Burke 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 and worked as a patent writer for ISIS Pharmaceuticals in Carlsbad, 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. Tulloch has more than 30 years of pharmaceutical and biotech experience in clinical development, R&D management, and business roles—both in Europe and the USA. He is Chief Medical Officer for Faraday Pharmaceuticals and 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.

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.

Shane P. Desselle received his B.S. in pharmacy and PhD in health care administration from University of Louisiana at Monroe. He 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. 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. Dr. Desselle won the American Association of Colleges of Pharmacy (AACP) Sustained Contribution in Pharmaceutical Social and Administrative Sciences Award in 2019 in recognition of his research, teaching, and service in pharmacy education. In 2020, he co-authored a manuscript earning the Wiederholt Award for best paper published in the Journal of the American Pharmacists Association that year.

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).

Russ Belden is a biotech commercialization leader with over 33 years of senior leadership experience in strategic marketing, sales management, sales training, and product development. Starting as employee 10 in Genentech’s SSF Commercial organization, he spent 16 years there launching products/indications across multiple therapeutic areas, including playing a pivotal role in launching their BioOncology franchise and left as the Director of Hematology Sales.

As Founder/President & CEO of Bridge Consulting LLC, he has worked with over 60 emerging biotech companies over the past 17 years. In addition to commercial assessments for preclinical to Phase 2 companies, Russ provides critical commercial leadership to Phase 3 emerging biotech companies as an interim Chief Commercial Officer (iCCO). As the company’s iCCO he leads all the commercialization imperatives, establishes the “blueprint” for the Commercial / Medical Affairs organization and develops a 3-year expense budget including all commercialization costs enabling the company to successfully position its lead product(s) for commercial launch while absorbing the risk of a potentially negative Phase 3 readout. Russ is currently the iCCO at three Phase 3 companies. He also serves as the Commercial Expert for the California Life Sciences Institute’s (CLSI) FAST program. Russ earned a BS in Pharmacy from the University of New York @ Buffalo and completed 2/3 of a Masters in Marketing program from the University of Texas @ Dallas.

William P. Cacheris has over 30 years of experience in the healthcare and pharmaceutical industries of which over 20 years has been focused on consulting and business analytics. As the founder and president of Tessellon, Bill has extensive knowledge of epidemiology and forecasting across many therapeutic areas. In particular, he is a master of global oncology epidemiology data sources and various disease registries. Using this vast knowledge and experience, Bill uses his forecasting and modeling skills to develop robust and meaningful market assessments that are essential in business planning for pharmaceutical companies ranging from epidemiology, patient segmentation, disease treatment patterns, market analysis and trends, future market dynamics, and forecasted products sales.

Bill’s academic qualifications include a Ph.D. in inorganic chemistry from Florida State University and his M.B.A. from University of Missouri, St. Louis. His background in metal chelates led him to the world of magnetic resonance contrast agents and blood substitute industries which he served for over 7 years. His knowledge of science and business led him to the consulting firm of the Mattson Jack Group as Vice President, S&T and Strategic Products, where he lead the global product offerings for forecasting, epidemiology, and oncology for over 10 years. During his tenure at the Mattson Jack Group, Bill not only gained valuable skills in forecasting and product databases, but also extensive global business experience extending to Europe, China, and Japan, which has enabled Bill to establish key partnerships for Tessellon in these geographies.

Dr. Kevin Curran is currently a biotech consultant in the field of gene therapy. Kevin provides market research and scientific insight on new genetic therapies in the disease categories of hemophilia, Duchenne muscular dystrophy and spinal muscular atrophy. These disease areas are currently being transformed by AAV viral vector gene therapies, anti-sense oligonucleotides and genome editing technology.

Kevin received his Bachelors of Science in Biology from Southern Oregon University and his PhD in 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 cancer progression. Dr. Curran then worked in the stem cell field at UCSF and behavioral neuroscience at the Salk Institute.

For the past six years, Kevin has served as the biotech consultant at Biotech Primer. He delivers two day seminars on the science behind emerging medical therapies.

Chief Scientific Officer, Foundation Fighting Blindness

Dr. Gelfman joined the Foundation Fighting Blindness as Chief Scientific Officer in April 2021. She is responsible for leading the overarching scientific strategy for the organization with a focus on research initiatives designed to accelerate new treatments and cures for inherited retinal diseases and dry age-related macular degeneration (AMD). Additionally, she oversees the Foundation’s non-clinical research portfolio, including gene therapy-based early translational and pre-clinical research programs, and serves as the primary scientific contact with the Foundation’s Scientific Advisory Board, the Research Oversight Committee, academic institutions, and government science agencies.

She was previously Vice President, Pharmaceutical Development, at Adverum Biotechnologies, an ocular gene therapy company developing gene therapy-based treatments for wet AMD and inherited retinal diseases. In her role there, she led AAV-based gene therapy efforts for ocular delivery, focusing on capsid biology as well as optimization of gene expression. Prior to that, she was the Senior Director, Scientific Services/Preclinical and Translational Science at Ora, Inc., an ophthalmic contract research organization (CRO) providing pre-clinical, regulatory, and clinical trial services for companies worldwide. She designed preclinical and translational strategies and integrated them 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.

Dr. Gelfman received a postdoctoral fellowship award from the National Eye Institute to study changes in gene expression in the retinal pigmented epithelium at the University of California, Davis, where she also taught and mentored both undergraduate and graduate students. Her experience covers more than 25 years in drug discovery and development in ophthalmology, spanning academia, the CRO industry, and the biotechnology sector. 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.

Al Hawkins has 25 years of experience in translating new therapies out of academic institutions into start-up companies. He co-founded gene therapy company Abeona Therapeutics, a NASDAQ-listed company that has brought two AAV therapies for lysosomal storage diseases into clinical studies. Al also co-founded Milo Biotechnology, a mid-clinical stage AAV gene therapy company that established clinical proof-of-concept in two muscular dystrophy indications. Al is currently co-founder of Amplo Biotechnology, a late preclinical AAV gene therapy focused on diseases of the neuromuscular junction, with lead therapies licensed from Oxford University, the University of Tokyo and Nagoya University, and co-founder of Myogenica, an early clinical stage muscle cell therapy spin out of the University of Minnesota. He is incubating a handful of additional academic cell and gene therapy start-ups and advises university tech transfer offices.

Previously, Al served as VP of Business Development BioMotiv, CEO in Residence at Bioenterprise, and as Director of the Boston University Venture Fund. He received an SM in Health Sciences and Technology from the Harvard-MIT Institute of Health Sciences, an MBA from University of Wisconsin Madison and a BA from Emory University.

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.

Dr. Jones has been a scientific adviser and master instructor for Biotech Primer since 2001. Currently, he is the coordinator for the Biotechnology Program at Montgomery College. In this capacity Dr. Jones works closely with a number of Maryland Biotech companies including Bioreliance Sigma Millipore, AstraZeneca, Lonza, GlaxoSmithKline, Catalent and Regenx to develop and maintain curricula to train the Maryland Biotechnology workforce. Prior to his appointments, Dr. Jones spent ten years as a research scientist at the National Institutes of Health in Bethesda, Maryland. He serves as a member of the Montgomery County Life Science business incubator review board, the advisory board for the Master’s Program in Biotechnology at Johns Hopkins University and several other local colleges. He is a regular presenter at the Dwight D. Eisenhower National Defense University Biotechnology working group.Dr. Jones spent ten years at the National Institute of Health as a research scientist. While at the National Cancer Institute his research focused on liver toxicity and liver cancers caused by environmental pollutants, including PCBs. After receiving an National Research Council grant Dr. Jones transitioned to the National Institute on Aging where he worked on the development of in vivo and in vitro methods to image phospholipid mediated signal transduction in the brain. Dr. Jones received his PhD in Biochemistry from the University of Maryland and his BS in Biochemistry with a mathematics minor from Albright College.

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.

Kenneth J. Olivier Jr., PhD, has been developing drugs for 15 years and is currently Head of Nonclinical Development at Torque Therapeutics 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.

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.

Mr. Jeff Roeseler has 20 years of management and senior leadership experience in the biopharmaceutical industry. He currently serves as the managing partner at Biocentric, LLC, providing strategic advisement to commercial and clinical stage companies as they advance their clinical portfolios and prepare for commercialization. Over the course of his career Mr. Roeseler has leveraged his broad commercial experience to optimize strategy and execute successfully, product launches across a range of categories and disease states: rare /orphan diseases, buy-and-bill biologic devices and blockbuster CNS products.

Prior to starting Biocentric, Mr. Roeseler was the head of global marketing at Insmed where he led the development and global commercialization of a novel first-in-class therapy for a rare, life-threatening respiratory orphan disease. From 2001- 2013 he held various management roles across the commercial organization at Shire.

Janet Rose Rea is an independent consultant providing regulatory services (e.g., Quality, Regulatory Affairs, Clinical, etc.) for organizations developing small molecule and biologic drugs with a variety of modalities, including gene and cellular therapies, rDNA biologics, and biosimilars. Her industry career has spanned over 40 years, from development through commercialization, with increasing levels of responsibility and scope in the areas of oncology and rare diseases. She has extensive interactions with worldwide health regulatory authorities, especially with the FDA.

She most recently worked for AVM Biotechnology and Atossa Therapeutics. Companies for whom she has worked include Immunex (Amgen), MDS Panlabs, Targeted Genetics, AVI Biopharma (Sarepta) and Protein Sciences Corp (Sanofi), and a number of other companies as a consultant. She was an Assistant Clinical Professor for the University of Washington in the Department of Pharmacy and is currently an instructor for Biotech Primer.

Dr. Selbie received her PhD 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.