A team of industry experts providing customized and integrated product development and commercial solutions
Atheln is a biopharma/biotech/medtech product development and commercial strategy consulting group. Our team of over 100 industry seasoned experts come from Fortune 500 companies, have between 20-40 years of global strategic and operational experience, and know how to tailor solutions to the dynamics of small companies given their experience working in or with start-up and emerging growth companies.
We have been involved in developing and commercializing products from concept to regulatory approval, and from new product planning to pre-launch, launch, and life cycle management. We are highly adept at maximizing the value of our Client’s products through our ability to foresee risks and implement mitigation strategies while integrating commercial drivers and key stakeholder needs into strategic and operational plans.
Our story
Atheln was founded in 2010 by two biopharma executives with over 25 years of experience each in development and commercialization in the US and globally. Having navigated the landscapes of large multinational biopharma/biotech firms, startups, and consulting, the founders possess a comprehensive perspective gained from roles on both sides of the industry spectrum. Their firsthand knowledge underscores the pivotal importance of early collaboration between development and commercial teams, recognizing the profound impact on assessing the commercial viability of products. Strategic alignment, they learned, is instrumental in optimizing outcomes related to managing expectations, budgets, and portfolio decisions with key stakeholders. The founders also recognized the valuable role of consultants in bridging resource gaps and providing diverse experiences to solve complex challenges.
It is against this backdrop of industry insight that Atheln was established. Atheln offers a distinctive value proposition: end-to-end integrated and cross-functional product development and commercial strategies and plans that are not only comprehensive but also implementable across companies ranging from startups to more mature enterprises.
Founded with a core team of highly experienced consultants, carefully selected based on previous collaborations in the industry, Atheln has since expanded to include over 100 industry-seasoned consultants. Under the leadership of Adriana and Monica, who serve as team leaders for each project, the company prioritizes transparent communication, continuity, and the development of integrated product development and commercial strategies. The name “Atheln,” derived from an ancient South-American native language, reflects the company’s ethos: “Understanding people helps get the job done.” This encapsulates Atheln’s approach to partnering with clients to achieve successful outcomes.
Adriana E. Manzi, PhD
Monica Alfaro Welling, MBA
Team directory
The Atheln team covers all core areas critical for integrated product development and commercialization or due diligence solutions. Discover the wealth of knowledge and expertise that fuels our success by exploring the diverse backgrounds and exceptional experiences of some of the experts
Team directory
Team Leadership
Adriana E. Manzi, PhD
Technical leader / integrated product development
Dr. Manzi is the Co-founder and Managing Director of Atheln, Inc since 2010. With over 30 years of experience in R&D, Adriana is a technical leader with extensive experience on due diligence, technical strategic and operational planning, troubleshooting and problem solving and solid business acumen rooted on her extensive global work with multidisciplinary teams in many therapeutic areas.
As a consultant, Adriana has led Integrated Product Development (IPD) programs for drugs, biologics and combination products, interacted with regulators in the US and EU, advised international investors, provided technical opinions to law firms and participated in global due diligence efforts. Since founding Atheln, Adriana has been IPD team leader for over 50 programs and has advised over 100 startup companies globally.
Prior to consulting, Dr. Manzi was Sr. Director of Research for Baxter Healthcare Corp., Director of Analytical Development / Quality Control at Nextran Inc., and Cytel Corporation as well as Director of the Glycobiology Core Facility at the University of California San Diego (UCSD).
Dr. Manzi received her BS (Chemistry) / MS (Industrial Chemistry and Food Sciences), and her PhD in Organic Chemistry (suma cum laude) from the University of Buenos Aires, Argentina. She completed her Postdoctoral Research in biochemistry and glycobiology at the University of California San Diego Cancer Center where she became an Assistant Professor. She is an expert on structural analysis of complex biomolecules, including glycosylation, and has taught glycobiology for UCSD, SDSU and IBC as well as the FDA and the National Institute of Standards and Technologies (NIST). Dr. Manzi has published 29 original research articles and 21 book chapters. She is a member of the Advisory Board of Bioprocess International and active in professional organizations.
Monica Alfaro Welling, MBA
Integrated product development and commercialization, portfolio and strategic panning, early-stage strategist
As a Co-founder and Managing Director of Atheln, Monica is a biopharma executive with over 30 years of experience working in a variety of strategic and operational executive positions in multi-national biopharma companies, start-ups, and boutique consulting firms.
She is a strategy expert spanning the entire value chain of both early- and late-stage product development and commercialization. Monica excels at incorporating critical market drivers and key stakeholder needs when developing risk-mitigated development and commercial strategies and plans. Her experience spans across all phases of product development, strategic planning, portfolio analysis, early- and late-stage commercialization and due diligence in a variety of therapeutic areas and technologies including medtech. Monica has built and led high performing teams in the US and internationally and led cross-functional product development teams resulting in numerous IND clearances and regulatory approvals. She has global experience in building billion-dollar brands like BOTOX® and launching products/new therapeutic applications globally while at Novo Nordisk. With an extensive network, Monica is a connector of people and companies, and opening doors to new opportunities.
Before co-founding Atheln, Monica held management and executive roles at Novo Nordisk's corporate headquarters in Denmark, as well as with prominent U.S. entities including Allergan and a publicly traded emerging growth healthcare services company. With a proven track record in P&L management, a successful tenure as a turnaround CEO in the oncology sector, and various other C-suite positions, Monica's extensive experience extends to fundraising in both private and public markets. This background equips her to engage effectively in boardroom discussions and build successful relationships with key stakeholders.
She has an MBA from Southern University of Denmark, and a BS in Biology and a BA in Economics from the University of California, Irvine.
Chemistry Manufacturing & Controls (CMC)
Rahul Bhagat, MS
Design & manufacturing - medical devices & combination products
Rahul is a plastics engineer with over 35 years of experience in the medical device industry focusing on Ocular Drug Delivery. Rahul has extensive experience in the process development and manufacturing of drug-device combination products including compounding, micro extrusion, injection molding and micro molding. He holds multiple patents for hot melt extrusion used for biodegradable implants and ocular drug delivery devices.
He was Director of Device & Packaging Engineering for Allergan where he was CMC Team Leader in the development of Ozurdex that Allergan acquired from Oculex Pharmaceuticals. At Oculex, Rahul was responsible for the development of the implant and the corresponding drug delivery device, including manufacturing operations for Phase 3 clinical trials. This was the first biodegradable controlled release ocular drug implant that was approved by the FDA and EMA.
Rahul has a Master’s Degree in Plastics Engineering from the University of Massachusetts at Lowell and a Certificate of Business Management from UCLA.
Wendy Blanda, PhD
Formulation and process development - combination products
Dr. Blanda is a multidisciplinary scientist and engineer with over 35 years of R&D experience in the pharmaceutical industry. Wendy has extensive experience in concept-to-launch drug-device combination product systems. She has technical expertise in formulation, process development, and analytical characterization of drug delivery systems and is experienced in managing contract manufacturing, formulation development and testing with CMOs and CROs, including product scale-up and technology transfer and commercialization readiness in cGMP environments. Wendy is also experienced authoring drug substance and drug product sections of eCTD Module 3 for INDs, NDAs and CTAs.
Prior to consulting, Wendy was Director of Drug Delivery/CMC at Spyglass Pharma, Director of CMC at Titan Pharmaceuticals, Assoc. Director of CMC at International Partnership for Microbiocides, Sr. Scientist at Allergan Inc. and Sr. Scientist for Formulation Development at Oculex, Inc.
Dr. Blanda holds a PhD in Macromolecular Science and Engineering from the University of Michigan at Ann Arbor, an MS in Engineering Management from California State, Northridge, and a BS in Chemistry from the California Polytechnic University, San Luis Obispo. She holds 26 US patents in drug delivery.
Dana Copenhaver, MS
Analytical development – small molecules
Dana has 19 years of experience in the pharmaceutical industry focusing on small molecule analytical development from early stage through commercialization.
Dana’s expertise includes analytical method development/validation/transfer, analytical data analysis, characterization of drug substance/raw materials/intermediates, drug substance process development and scale-up support, conducting drug substance stability studies, and managing analytical outsourcing. She has thorough understanding of FDA/ICH guidelines and thorough understanding of CMC regulations as well as extensive experience authoring regulatory submissions.
Dana held positions of increasing responsibility for 14 years at AbbVie (formerly Allergan) and initiated her career at BioScreen Testing Services.
Dana holds a MS in Regulatory Sciences from the University of Southern California and a BS in Chemistry from California State Univ, Fullerton.
Karen De Jongh, PhD
Analytical and process development - biologics
Dr. De Jongh is a biotechnology expert with over 25 years of experience in protein therapeutics from preclinical to clinical development and on to validation, commercial licensure and post approval support. She has extensive experience in CMO oversight, process and analytical development, process and product characterization and preparing CMC regulatory submissions for pre-IND, IND, BLA and post approval stages.
Karen has held positions of increasing responsibility at ZymoGenetics, a Bristol-Myers Squibb Company up to Director of Analytical Development and Testing.
Karen received her PhD in Biochemistry from the University of New South Wales in Sydney, Australia and completed postdoctoral studies in the Department of Chemistry at Macquarie University in Sydney, Australia and in the Department of Pharmacology at the University of Washington, US.
Larry Dumont, BS
Analytical development - biologics
Larry has over 30 years of experience developing analytical strategies for biopharmaceuticals and diagnostics. His expertise covers analytics to support process, characterization, and formulation development of protein therapeutics, including highly glycosylated proteins, monoclonal antibodies, fusion proteins and biosimilars.
Prior to consulting, Larry was Sr. Director of Analytical Sciences and Quality Control at Nuvelo, Inc. (now Arca Biopharma, Inc.) and held positions of increasing responsibility at Protein Design Labs, Inc, Beckman Instruments and SmithKline Diagnostics.
Larry holds a BA in Biology from Colby College in Waterville, Maine.
Elizabeth Lin, PhD
Analytical development - small molecules
Dr. Lin has 32 years of experience in the pharmaceutical industry from early development to product registrations and life-cycle management. Her expertise is on phase-appropriate analytical strategy, method development and validation, stability, structure elucidation, cGMP compliance, selection and management of CROs and analytical technology transfers. She is also experienced in writing CMC sections of regulatory filings and participating in FDA meetings.
Elizabeth held positions of increasing responsibility at Johnson & Johnson, Schering-Plough (now Merck), Allergan and Nektar Therapeutics. She worked on various oral and injectable dosage forms as well as drug-device combination products.
Elizabeth obtained her PhD in Organic Chemistry at the University of Washington and was a post-doctoral fellow at the Scripps Research Institute.
David Marsh, PhD
Formulation development - small molecules / ophthalmics
Dr. Marsh is a scientist with over 40 years of R&D experience in the pharmaceutical industry in manager- and director-level positions at Baxter Healthcare, Bausch & Lomb, Alcon, and Allergan. He has extensive knowledge in pharmaceutical formulation, drug delivery, device development, chemistry, sterilization processes, patent writing, and regulatory compliance. His experience includes a variety of drug formulations and drug-device combinations used for various modes of ophthalmic administration from topical to various sites of injections (i.e., intravitreal, sub-Tenons, choroidal).
David holds a BS in Pharmacy and MS in Medicinal Chemistry from Northeastern University and a PhD in Pharmaceutical Chemistry from the University of Rhode Island. He holds more than 50 U.S. and international patents and has authored over 55 papers and presentations.
Harish Ravivarapu, PhD
CMC small molecules final dosage form
Dr. Ravivarapu is a pharmaceutical scientist with over 25 years of industry experience with CMC regulatory focus covering all stages of product development as well as commercial products.
Harish career included technical positions at Supergen/Astex Pharmaceuticals, Dynvax and Atrix Laboratories. His focus has been formulation and process development, transfer and scale-up, cGMP manufacturing, and validation of oral solids and sterile injectables. He has extensive experience authoring regulatory documents for all stages of development, including NDAs AND MAAs, pre-approval supplements and annual reports as well as in interactions with FDA. He is experienced working with world-wide CMOs and establishing supporting supply chains.
Harish holds a B. Pharm. (Hons.) and a M. Pharm. (Pharmaceutics) from Birla Institute of Technology & Science, India and a PhD (Pharmaceutics) from the University of Georgia College of Pharmacy.
Elizabeth T. Syage, PhD
CMC small molecule APIs – chemical synthesis & contract manufacturing
Dr. Syage is a pharmaceutical development professional with over 30 years of experience in the pharmaceutical industry and broad knowledge in synthetic organic chemistry, medicinal chemistry, drug substances and formulations, contract manufacturing, and global pharmaceutical regulatory requirements. Her area of expertise is the early phase development of small molecule APIs, including early strategy, technical and regulatory considerations, early development chemistry, sample synthesis and scale up, process validation, GMP manufacturing and testing including the procurement of contract research and manufacturing organizations as well as writing regulatory dossiers.
Prior to consulting, Liz previously was VP of Process Chemistry at Allergan where she held positions of increasing responsibility in the chemistry research organization for 30 years.
Liz received her a PhD in Organic Chemistry from Brown University.
Janet Tamada, PhD
Product development - medical devices & combination products
Dr. Tamada has over 30 years of experience in product development for drug-device combination products and medical devices. She specializes in drug delivery systems, including transdermal, parenteral, inhaled, ophthalmic, otic, and nasal, as well as biosensors and wearable and implanted medical devices. She has worked on product development from concept to first-in-human and through commercialization and life cycle management.
Prior to consulting, Janet was Vice President of Engineering at ArKal Medical, Director of Early Development at ALZA, a Johnson & Johnson company, Senior Director of Product Development at Alexza, and Executive Director of R&D and Medical Affairs at Cygnus, Inc.
Janet holds a BS in Chemical Engineering from Caltech, and a PhD in Chemical Engineering from UC Berkeley. She was a post-doctoral fellow in the laboratory of Professor Robert Langer at MIT. She is a Fellow of the American Institute of Biomedical Engineering (AIMBE) for her work on developing the first FDA-approved real-time continuous glucose monitor for diabetes management.
Brian Turner, PhD
CMC - biologics
Dr. Turner is a biotechnology professional with over 35 years of experience in the industry. Brian has extensive experience in development and lifecycle management, process design and manufacturing, tech transfer and scale up, comparability exercises, process validation and regulatory filings.
Brian has held senior positions at Sanofi Genzyme, Ipsen, Shire and Abbott (now Abbvie). He played critical roles in the development and approval of Humira®, and, more recently, second-generation manufacturing processes for Cerezyme® and Fabrazyme®.
Brian received his MS and PhD degrees in Chemical Engineering from Purdue University, and a bachelor’s degree in Chemical Engineering from the University of Massachusetts.
Nonclinical
Thomas A. Baillie, PhD
Drug metabolism
Dr. Baillie's distinguished research career focused on the understanding of drug metabolism through the application of mass spectrometry and allied techniques. His expertise on mechanistic studies on the metabolism of foreign compounds, with emphasis on the generation of chemically-reactive, potentially toxic, products of biotransformation, is key to his consulting services.
He earned BS (Hons) and PhD degrees in Chemistry from the University of Glasgow and MS in Biochemistry from the University of London. Following postdoctoral research at the Karolinska Institute in Stockholm, Sweden, Dr. Baillie held successive faculty positions at the University of London, the University of California San Francisco, and the University of Washington.
Thomas was Global Vice President of Drug Metabolism & Pharmacokinetics at Merck Research Laboratories in West Point, PA, for 10 years before returning to academia. He recently retired as Dean Emeritus of the School of Pharmacy at the University of Washington.
He has co-authored over 200 peer-reviewed publications, serves on the Advisory Boards of various journals and academic research centers. In addition to receiving various prestigious awards, Dr. Baillie was elected as a Fellow of the Royal Society of Chemistry, the Japanese Society for the Study of Xenobiotics and the American Chemical Society.
Sharon A. Baughman, PhD
Drug metabolism & pharmacokinetics (DMPK)
Dr. Baughman is a biotechnology expert with over 40 years of experience in the industry. She has been consulting for over 14 years specializing in Pharmacokinetics and Drug Metabolism, GLP and GCP compliance, and regulatory submissions.
Prior to consulting, Sharon was Executive Director in Global Research and Development Compliance and Director of Pharmacokinetics and Drug Metabolism, for therapeutic proteins and small molecules, at Amgen. Prior to joining Amgen, Sharon was Ass. Director and Scientist at Genentech Inc. where she worked on the development of many protein therapeutics, including Herceptin®, Rituxan®, Avastin®, Protropin®, Nutropin® and Pulmozyme®.
Her experience includes performing research and development of protein therapeutics throughout North America, Asia, Australia, and Europe. She has actively been involved with the FDA Critical Path Initiative and the development of biomarkers to improve the drug development timeline.
Dr. Baughman received her Ph.D. in Chemistry from Rice University and a BS in Chemistry from the University of New Orleans.
Terry Podoll, PhD
Drug metabolism & pharmacokinetics (DMPK) & bioanalysis
Dr. Podoll is a Medicinal Chemist with over 26 years of industry experience conducting research and development of small molecule drugs in large pharma organizations and CDMOs serving the industry. He has extensive experience in preclinical and clinical DMPK, including on the development and validation of bioanalytical methods.
Terry started his career at Cedra Corporation, and continued at Pharmacia, Pfizer, MPI Research, KAR Bioanalytical, Ricerca Biosciences, Acucela, and Acerta Pharma BV.
Terry earned a M.S. in Chemistry and a Ph.D. in Medicinal Chemistry from the University of Washington, Seattle.
Stanley Roberts, PhD, DABT
Non-clinical toxicology and PK/ADME
Dr. Roberts is a pharmaceutical toxicologist with over 40 years of industry experience conducting and leading research in toxicology, drug metabolism and pharmacokinetics.
Stan has worked across a broad range of therapeutic classes, targets, and disease areas with scientific and regulatory experience in both small molecules and biotherapeutics (e.g., cell therapies, stem cell therapies, oligonucleotides, peptides, proteins and antibodies) with direct and significant contributions to numerous registration packages including designing, monitoring and reporting studies plus composing and editing position papers and submission packages. He also has presented to the FDA and has prepared numerous worldwide regulatory plans/documents/submissions (e.g., USA, Europe and Japan). He has conducted hundreds of animal toxicology studies, and his experience includes both rodent and non-rodent animal models and diverse administration routes, including non-standard formulations. He has extensive experience in mechanistic toxicology/ADME/PK, scientific problem solving and integrating science with strategy in all preclinical disciplines.
Prior to consulting, Stan was VP of Preclinical Development at CovX Research, LLC, Global Director of Preclinical Drug Metabolism and PK at Abbott Laboratories, and Section Head for the Department of Toxicology at Sandoz Research Institute.
Stan has a BS (Animal Science), MS and PhD (Pharmacology & Toxicology) from Purdue University and post-doctoral fellowship in Molecular Toxicology from the Medical University of South Carolina.
Michael Shiue, PhD
DMPK / ADME
Dr. Shiue is a Drug Metabolism and Pharmacokinetics (DMPK) and Absorption, Distribution, Metabolism and Excretion (ADME) scientist with 30 years of ocular research and 24 years of pharmaceutical and biotechnology industry experience.
Mike’s consulting centers on his comprehensive knowledge of drug discovery and development across a wide range of therapeutic areas (ophthalmology, oncology, CNS, inflammation, metabolic disorders, biosimilars, etc.) and modalities (small molecules, biologics, devices, and gene therapy products) and advises on the design of drug development strategies in accordance with regulatory guidelines.
Prior to consulting, Mike was Sr. Principal Scientist and a member of the Ocular Safety Council with Pfizer Global R&D and Sr. Scientist with Amgen. Mike worked on various marketed products, including Xalatan®, Xalacom®, Macugen®, Xeljanz®, Viagra® and Revatio®, Taxotere®, Protonix®, Genotropin® and Zirabev®.
Mike holds a PhD in Pharmaceutical Sciences / Ocular Physiology, Pharmacology and Drug Delivery from the University of Southern California, and a BS in Biological Sciences from the University of California at Irvine.
Brian Short, DVM, PhD, DACVP
Toxicology and pathology
Dr. Short is an accomplished nonclinical drug development expert with over 35 years of experience in the pharmaceutical industry, including small molecules, biologics, oligonucleotides, and gene and cell therapy. Brian is a highly skilled toxicologist, board-certified veterinary pathologist and a recognized expert in ocular drug and device development. His consulting focuses on designing and implementing nonclinical development plans, including toxicology studies supporting R&D portfolios as well as interpretation of clinical and anatomic pathology data within toxicology reports including pathology peer reviews. He is an author and reviewer of regulatory filings including Pre-IND, IND, Type C, End-of-Phase 2 and NDA submissions and supports regulatory meetings. Previously he was at Allergan as Sr Director of Toxicology and Sr. Director of Pathology and held positions at GlaxoSmithKline (formerly SmithKline Beecham). Brian has worked on a variety of approved drugs for ocular (Durytsta®, Restasis®, Ozurdex®, Lumigan®, Alphagan®, Trivaris®, Refresh/Optive®, Inveltys®, Eysuvis® and Qlosi®), dermatologic (Rhofade®, Tazorac®, and Aczone®), neurologic and urologic (BOTOX®) and cardiovascular (Giapreza®) indications.Brian holds a DVM from the University of California, Davis, a PhD in Experimental Pathology from the University of North Carolina, Chapel Hill.
Rose Verhoeven, MTox
Nonclinical development
Rose is a nonclinical expert with 20 years of experience in the pharmaceutical industry. Her experience includes designing and executing nonclinical development strategies for innovative ophthalmic products and ocular drug delivery systems. Rose is also an experienced author and reviewer of nonclinical and clinical sections of 505(b)(1) and 505(b)(2) pre-IND Briefing Packages, INDs, Annual Reports, EOP2 packages, and NDAs.
Rose’s pharmaceutical development work has included therapeutic programs for dry eye, corneal wound healing, cataract, presbyopia, glaucoma, ocular post-operative inflammation, ocular anesthesia, neurotrophic keratitis, uveitis, diabetic macular edema, age-related macular degeneration, and various ophthalmic orphan indications.
Prior to consulting, Rose was Director of Toxicology and Pharmacokinetics for Aerie Pharmaceuticals, Executive Director of Nonclinical Development for Envisia Therapeutics, and Director of Nonclinical Development for Clearside Biomedical. Earlier she was Manager of Toxicology and Pharmacokinetics for Chimerix and Inspire Pharmaceuticals.
Rose holds a Master of Toxicology from the Department of Molecular and Environmental Toxicology and a Bachelor of Science from the Department of Biological Sciences, both from North Carolina State University in Raleigh, North Carolina.
Clinical
Robin Allgren, MD, PhD, MBA, RAC
Clinical development and trial design
Dr. Allgren has over 30 years of clinical development experience spanning biotech, pharma, medical devices, and diagnostics.
Robin is experienced on designing and conducting clinical development activities from the preclinical stage through IND filing, Phase 1-3 clinical studies, NDA/MAA filings, market launch, and Phase 4 post-marketing studies. She has extensive experience preparing clinical sections of regulatory submissions (INDs, NDAs, etc.) and presenting to FDA at meetings and FDA Advisory Panels. Her experience includes parenteral, oral and topical drug products for a variety of therapeutic areas, including endocrinology, CNS disease, cardiovascular disease, oncology, nephrology, dermatology, wound healing, inflammatory diseases, anti-infectives, pain management, and GI.
Prior to consulting, Robin was Senior VP of Development at Ansata Therapeutics, Inc., VP of Clinical Research & Medical Affairs at Innercool Therapies, Inc., VP of Clinical Development at SkyePharma, Inc., and VP of Clinical Research at Scios, Inc.
Robin holds a MD/PhD from Stanford Medical School and an MBA in Health Services Management from Golden Gate University in San Francisco and is Board-certified in Internal Medicine.
Susan Jerian, MD
Clinical development & regulatory affairs – hematology / oncology
Dr. Jerian is an expert in hematology and oncology with over 27 years of experience on clinical development and regulatory affairs in the Pharmaceutical/Biotechnology Industry and the Food and Drug Administration (FDA) with a track record of product approvals (over 20) and successful clinical programs. Her areas of focus are: strategic oncology product development including drugs, biologics (antibodies, therapeutic proteins, tumor vaccines, cellular and gene therapies), and devices (stem cell selection devices and in vitro diagnostics), clinical trial design and regulatory strategy for all phases of product development.
Since 2006, she has been President of ONCORD, Inc. providing regulatory and clinical development consulting in oncology. Prior to consulting, she served as a Supervisory Medical Officer at the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER; 1995-2003) and Global Medical Director at Amgen Inc. (2003-2005). At FDA, she led a team of oncologists conducting clinical regulatory reviews and oversight for a portfolio of hundreds of INDs as well as multiple license applications and supplements for multiple product classes. She was the primary clinical reviewer for over a hundred INDs and multiple license applications and supplements.
Susan holds a BS from Occidental College, an MD from George Washington University, conducted her residency in Internal Medicine at the University of Arizona, Tucson and was a fellow in Medical Oncology at the National Cancer Institute in Bethesda.
John H. Powers III, MD, FACP, FIDSA
Clinical trial design
Dr. Powers is a clinician with over 30 years of experience in the design, conduct and analysis of clinical trials. Currently he is a Professor of Clinical Medicine with George Washington University School of Medicine in Washington DC.
Prior to teaching, John was the Lead Medical Officer for Antimicrobial Drug Development and Resistance Initiatives in the Office of Antimicrobial Products at the FDA and a co-chair for the Inter-Agency Task for Antimicrobial Resistance. Earlier, John was on faculty in the Division of Infectious Diseases at the University of Maryland School of Medicine and the Chair of the ISPOR Task Force for Clinical Outcome Assessments. He continues to actively care for patients with infectious diseases and has been an investigator on over 60 clinical trials. His area of research is in outcomes and endpoints for clinical trials. Dr. Powers has been consulting since leaving the FDA on development programs for multiple therapeutic areas.
John holds a BS (magna cum laude) from the University of Pennsylvania, an MD from Temple University School of Medicine, where he conducted his residency and served as Chief Resident. His infectious diseases training was at the University of Virginia School of Medicine, and he is board certified in internal medicine and infectious diseases. He has authored several book chapters and over 100 peer-reviewed publications, including papers on clinical trial design and guidelines on development of Clinical Outcomes Assessments.
Denise Remigio, MPH
Clinical development & operations
Denise has over 25 years of experience in clinical development in the pharmaceutical and device industries. Her areas of focus include aesthetics and neurology/pain with neurotoxins, urology, dermatology, cardiovascular and aesthetic medicine. Denise has managed clinical project teams for Phase I-IV studies in North America, Europe and Asia. She has experience identifying and managing CROs. Denise has experience developing and writing clinical protocols and study reports.
Denise has a MS in Public Health from San Diego State University, a BS in Biology, and a BA in Psychology and Social Behavior from University of California Irvine.
Richard Stead, MD
Clinical development
Richard has over 30 years of experience in the biotechnology and pharmaceutical industry, directing clinical trials, designing and executing clinical and regulatory strategy, in- and out- licensing and due diligence activities and evaluation of licensing opportunities. Richard therapeutic areas of primary focus are: oncology (including cervical cancer), immunology, hematology, and nephrology for various technologies.
Prior to consulting, Richard held management roles at Amgen and Immunex and has served as acting Chief Medical Officer for several companies including Affymax, Coherus, IRX Therapeutics, ISA Pharmaceuticals, Nephros and Vitagen.
Richard received his MD from Stanford Medical School, has a Diplomate in Hematology and Internal Medicine, and received his BS in Molecular Biology from University of Madison.
Regulatory Affairs
Louis-Christian Clauss, PhD, IAE, RAC
Global regulatory affairs
Dr. Clauss has over 40 years of experience spanning from International Regulatory Affairs (EMEA, FDA, EU National Global development) to new product development and Quality Assurance/ ISO certifications.
Louis served as a Resident Biologist in Public Hospitals before moving to the Multinational Health Care Industry both in the Medical Devices field and in Pharmaceuticals (Institut Mérieux, now Sanofi Aventis; Dow Corning; Boston Scientific; Clintec; Becton Dickinson; Baxter). He was the Global Director Regulatory Affairs for New Product Development, BioScience, for Baxter Healthcare Corporation. He has led the development of pharmaceuticals, stents, implantable devices, and biotherapeutics, including biosimilars. Louis directed Medical Device regulatory programs in the U.S. and Europe, including regulatory strategies, new product licenses and life cycle management as well as obtaining CE marking for hundreds of products.
Louis has been involved in over 100 regulatory submissions and agency meetings with EMA and FDA. He has over 70 publications and conference presentations and is a member of numerous professional associations.
Louis holds a Masters degree in Bio-Pharmacy from Paris VI University, a PhD in Pharmacy from Paris V University, and a degree in Business administration (IAE). He is a registered Qualified Person in Europe.
David Essayan, MD, FACP
Regulatory affairs and clinical development
Dr. Essayan is an expert in therapeutic product preclinical and clinical development and regulatory affairs, with over 25 years of experience across multiple clinical areas including rheumatologic, pulmonary, neurologic, infectious disease, gastrointestinal, endocrinologic, orthopedic and ophthalmologic diseases. His expertise spans small molecules, biologics, cell, tissue and gene therapeutics.
David served as Supervisory Medical Officer at CBER, FDA for 6 years and Principal Investigator in the Laboratory of Tumor Molecular Biology, CBER/FDA for 3 years. He then served as Executive Director of Regulatory Affairs at Amgen Inc. for 4 years where he was the Global Regulatory Leader for products in the Inflammation and General Medicine therapeutic areas, ranging from preclinical through phase 4. Since 2007, he has been Executive Vice President of ONCORD, Inc. providing regulatory, preclinical, and clinical development consulting services.
David holds a BS in Chemistry from Yale University, an MD from University of Pennsylvania School of Medicine. He conducted his residency in Internal Medicine at Temple University Hospital and was a postdoctoral fellow in Clinical Immunology, Assistant Professor of Medicine and Instructor of Medicine at Johns Hopkins University School of Medicine. He is Board Certified in Internal Medicine and Allergy/Clinical Immunology.
Pierre-Louis Lezotre, PhD
Global regulatory affairs
Dr. Lezotre is a Regulatory Affairs professional with over 25 years of industry experience specializing in global regulatory strategy and international regulations. He has extensive experience as a regional and global regulatory leader for small molecule and biologic/biotech programs in various stages of development (from early discovery to life cycle management) and has successfully managed communications with numerous worldwide Drug Regulatory Authorities.
Pierre-Louis has held positions of increasing responsibility in the pharmaceutical industry starting in France at Merck, Sanofi, Biogen and Allergan, and later in the US where he spent 12 years at Allergan and 5 years at Avanir. He has successfully led regulatory teams in supporting global registrations in various therapeutic areas including Dermatology, Urology, Psychiatry, Neurology and Pain.
Pierre-Louis is now the President and CEO of the GRA Group, a regulatory consulting company providing expertise in Global Regulatory Affairs with regional experts in US, EU, Canada, Australia and Asia.
Pierre-Louis holds a BS in Health Sciences and MS in Health Engineering, both specialized in Drug Development ( Univ. of Pharmacy, Montpellier, France), and MS in Regulatory Sciences and a PhD in Law (Univ. of Law, Lille, France). He has authored a book on international regulations and lectures on this subject matter at the Univ. of Southern California.
Quality Assurance & Compliance
Paul Bacchus, MS
Quality assurance / quality by design – medical devices
Paul has over 35 years of experience assisting clients in the drug, medical device and biotechnology industries to develop and implement quality assurance, manufacturing, software validation and regulatory strategies for compliance with FDA regulations during routine operations, under consent decree or other adverse regulatory scenarios.
He focuses on the design and implementation of sustainable and effective Quality Systems to improve productivity and compliance. His expertise includes Mock FDA Inspections, Auditing (CFR820, 210/211, Software Validation), implementing Quality Engineering techniques, training on various Quality Engineering and Regulatory topics and Quality System Remediation.
Prior to consulting, Paul held management positions with McGaw Laboratories (now B. Braun), Sorin Biomedical/Mallinckrodt Medical, PS Medical/Medtronic and Baxter.
Paul received his B.S. in Chemistry from Loma Linda University and Graduate School Certification in Advanced Manufacturing Technology from the UC Irvine.
Brian Druce, BS
Quality assurance and compliance
Brian is a Quality Assurance professional with over 40 years of experience within the pharmaceutical and biotechnology industries both in commercial and clinical phases. His areas of expertise include quality systems, aseptic processing, fill & finish manufacturing operations, validation, Quality Information Systems (QIS), computer system validation, change control, and CFR Part 11 compliance.
Brian has held leadership roles in Quality, Compliance, and Manufacturing at several leading biotechnology, biologics and pharmaceutical companies. He was VP of Quality at Five Prime Therapeutics, Inc. an early clinical-stage biotechnology company, where he developed and implemented the Quality Management System, oversaw Supplier Compliance, led GMP and clinical phase audits and oversight of domestic and international CMOs. Earlier he was Sr. Quality Director at Genzyme, Bayer, Novartis, Chiron, Biogen Idec, Genentech, Alpha Therapeutic, and Allergan. He has hosted regulatory inspections and defended site Quality Systems to the FDA, EMEA, MHRA, as well as regulatory inspectors from Mexico and Brazil.
Brian holds a BS in Biological Sciences from the Univ. of California, Irvine.Zenaida (Zeny) Power, BS
Quality assurance and compliance
Zeny is a QA professional with over 40 years of extensive hands-on and management experience in the pharmaceutical, medical device, IVD, biologics, cell-therapies and nutritional supplements industries. She has experience with FDA and EMA regulations, the Medical Device Directive (MDD), the Medicines Control Agency if the UK, Health Canada (HPFBI), Mexican Health Authority, the Pharmaceutical & Medical Device Agency (PMDA) and the Japanese Ministry of Health (MHLW), and applicable ISO and ICH Standards as well as compliance with the Controlled Substances Act (§ 827) enforced by the Drug Enforcement Administration (DEA).
As a consultant, Zeny has been assisting companies domestically and internationally with quality assurance and compliance programs, and in the design and implementation of quality management systems from early development to commercial stages. Her expertise includes the application of risk-based strategies, developing corrective action plans to address deficiencies, presenting GMP/QSR training, conducting GxP audits, providing PAI support and assisting clients during regulatory inspections.
Prior positions include supervisory and manager roles in Quality Assurance and Regulatory Compliance at GensiaSicor, Inc., BioRad Laboratories, Inc., J&J Ortho Diagnostics, Manufacturing Lab., and the Central Jersey Blood Bank Laboratory.
Zenaida has a BS in biology from Jersey City State College.
Manta Trivedi-Hunt, MS
Quality assurance and compliance
Mamta is a Quality Assurance and Compliance expert with over 35 years of experience within the pharmaceutical and biotechnology industries. She has extensive experience on GxP and ISO regulations, Quality Control, Data Management, Supply Chain and Quality Assurance for biologics and small molecules.
Manta has experience developing and implementing Quality Management Systems and an extensive background in analytical method development, process validation, LIMS implementation as well as strong understanding of statistical analysis and metrics. She has supported complex clinical studies and hosted and supported global regulatory inspections, including FDA, EMA, MHRA, ANVISA, FDA-China, FDA-Korea, MOH-India/Mexico/Saudi Arabia, among others.
Mamta held positions of increasing responsibility from Research Scientist to VP of Quality in Specialty, Inc., Biosource, Amgen, Inc., Quintiles, Regeneron, Spectrum Pharmaceutical, Biorasi, LLC, and Vial Health Technologies, LLC.
Mamta holds a Master of Management, from the University of Phoenix, Woodland Hills, CA and a BS in Microbiology / Chemistry, from the University of Gujarat, India.
Commercial Strategy/New Product Planning
Greg Brooks
Commercial market analysis, strategy, new product planning, sales and marketing
Greg is a life science executive with over 35 years of extensive industry experience in biotech franchise planning, new product market assessment, health economics and pricing value planning, market access, and global commercialization for biologics, specialty drugs and medical devices. Greg has worked on a multitude of therapeutic areas As a member of the industry advisory board for OCTANE over the last 10 years he guides early-stage life science companies on the development of business plan strategies for investor financing, regulatory development and commercialization
Prior to his consulting career, Greg was Chief Commercial Officer at Neurosigma responsible for developing multiple application for an eTNS targeting epilepsy, PTSD, Depression and ADHD. He held senior executive and management roles at Allergan as VP of Marketing responsible for the Global BOTOX Neurology and Urology specialty business franchise. Greg also established Allergan's Health Economics organization.
Greg has a BS in Commerce & Marketing Management from Rider University and Harvard Executive Education Program–Finance
Rhonda Daley, MA, MBA
Commercial operations / sales & marketing
Rhonda has over 20 years of pharma and healthcare experience in business development, strategic planning, and communications. Her marketing and business development expertise includes; strategy, product launch, and market development. Prior to consulting, Rhonda founded and served as Executive Director of Kontinuum Care, an intensive outpatient program (IOP) for addictions. Previous roles include; Behavioral Health Network Manager, Quartet Health, Provider Network Director, Director of Business Development, HealthlinkNow (telepsychiatry), Regional Outreach Director of Elements Behavioral Health, and Sierra Tucson Treatment Center.
While in pharmaceutical roles, Rhonda helped launch Suboxone/Subutex product line with Reckitt Benckiser. She was a significant contributor with other pharmaceutical product launches including Forest Pharmaceutical, Eli Lilly, and Astra Zeneca. Rhonda spearheaded new healthcare initiatives, products, telehealth services, and behavioral health treatment protocols.
Rhonda holds an MBA from the Peter Drucker Graduate School of Management and has a MA in Applied Psychology from Tuoro University.
Chris Dax, MBA
Commercial strategy / sales & marketing
Commercial Strategy / sales & marketing senior executive with over 30 years experience in commercializing pharmaceutical, biologics, and medical devices as well as general management experience with a proven track record of exceeding business objectives. Chris combines his background in marketing, sales, managed care, reimbursement and business operations with demonstrated cross-functional team leadership. He has experience across multiple therapeutic areas. Before consulting, Chris served as SVP of Marketing at Masimo, overseeing 10+ global medical device launches. He also held the role of VP of Marketing at Ista Pharmaceuticals, leading U.S. Product and Payor Access Marketing. Chris was SVP at Elan Pharmaceuticals for the Autoimmune business and Director of Marketing at Allergan, contributing significantly to the Dermatology business. His career began at Novartis, progressing through roles such as Regional Sales Manager and Marketing Director. Chris began his career as a sales representative at Novartis and later served in positions of increasing responsibility as Regional Sales Manager, Product Manager, Director of Managed Care Marketing and Marketing Director. Chris earned his BS in Marketing from Lehigh University and his MBA from Case Western Reserve University.Sydney Edwards, PhD, MBA
Commercial strategy/portfolio management
Dr. Edwards has over 20 years of experience in new product planning, commercialization and portfolio analytics and R&D strategic planning. He worked for Kite Pharma in corporate strategic planning, cell therapy-oncology, R&D strategic planning and portfolio management. Sydney also worked for Allergan for over 12 years as Head of Portfolio Management specializing in product valuation, trade-off analysis, portfolio prioritization resulting in significant expansion of the development and commercial pipeline. This effort led to funding and development of several new products such as BOTOX for Migraine headache, Botox for Overactive Bladder and Ozurdex for Age-Related Macular Degeneration. He also had responsibility for project leadership and successful launch of Latisse®.
Sydney has a PhD in Biochemistry from the Pennsylvania State University, an MBA from the Massachusetts Institute of Technology and BA in Biochemistry from UC Berkeley.
Robert Levak, MBA
Commercial market analysis, new product planning, marketing
Robert brings over 25 years of experience in oncology with over 20 years in biotech commercialization – marketing & sales including new product planning (Avastin, Perjeta, Kadcyla, Adcetris and Tukysa), in-line marketing (Adcetris), sales and sales management (Herceptin, Tarceva, Tukysa), diagnostic and competitive strategy (Adcetris, Tukysa) and early pipeline commercial strategy. At Seagen Inc. he led the initial Global Marketing for tucatinib, ladiratuzumab vedotin and other pipeline programs. In addition, Robert partnered with the Business Development group on external asset commercial assessments and was the Commercial lead on the $614M Cascadian acquisition driven by the market valuation of tucatinib and the $2B licensing deal with Immunomedics for sacituzumab govitecan.
Robert was the Head of Global Marketing, Oncology at Zymeworks Inc. where he oversaw strategic commercial development of ZW-25 (zanidatamab) and ZW-49.
Robert holds a Bachelor of Science in Biochemistry from the University of British Columbia, a Baccalaureate Diploma in Clinical Cytogenetics from the British Columbia Institute of Technology and a Master of Business Administration from Kellogg School of Management, Northwestern University.
Titus Plattel, MSc, MBA
Commercial market analysis, new product planning, market research, business development
With a career spanning more than 25 years in global biotech companies, Titus brings extensive expertise encompassing all aspects of product development and the commercialization of innovative therapies across diverse therapeutic areas. His professional experience spans key functions of product development, varying from program management to portfolio analyses, building market knowledge through applying market research and gaining insights through competitive intelligence to the implementation of market conditioning program in a prelaunch setting to the final product launch by all sales and marketing functions involved.
qTitus commenced his career in the Netherlands in sales functions, gradually advancing to assume domestic launch responsibilities for Neupogen/Amgen. He expanded his global reach by orchestrating the international product launch for chronic plaque psoriasis at Biogen in Paris. While at Biogen's Cambridge (MA) location, Titus spearheaded the global launch of Amevive and contributed to the in-licensing of tecfidera. Subsequently, he held executive and management roles at Therion Biologics (VP Marketing – Oncology), Tolerx (VP Marketing & Commercial Strategy – T1DM), and Bavarian Nordic (VP BD - Oncology), seamlessly integrating product development and commercialization responsibilities.Titus received his MBA from Pepperdine University and his MSc from the University of Nijmegen, The Netherlands.
Luis Silva, MSc
European commercialization, sales and marketing
Luis has over 21 years of experience in the pharmaceutical industry, 15 at management level and 6 of these as General Manager / Vice President. He has in depth knowledge of the pharmaceutical industry at domestic, international and corporate headquarters level. He has Director and board level experience in companies as well as NGOs and Industry Associations.
He has held positions at Novo Nordisk Pharma S.A. and Schering AG. While Head of Sales and Marketing at Novo Spain, he built and managed national sales forces and marketing teams and was involved in the pre-launch and launch of numerous products. Luis has built an extensive network of Key Opinion Leaders and leaders within the European pharma industry and has worked in several therapeutic areas.
Luis holds a MS in Molecular Biology from Universidad Complutense de Madrid.
Market Research & Analysis/Forecasting
Susanne Hayes, MSc
Commercial market analysis
Susanne brings over 15 years national and international pharmaceutical and health care product management experience. In addition, she has experience evaluating and prioritizing early-stage life science companies seeking investments from angel groups. Susanne’s commercial experience covers strategic / tactical marketing, interactive education, planning, execution & performance analytics. She has extensive experience working cross-functionally as leader/member of matrix-based teams.
Prior to consulting, Susanne was at Novo Nordisk, Perc, and Hythiam.
Susanne holds a MSc in International Business & Marketing and a BA in Economics & Business Administration from University of Aarhus, Denmark.
Lavonda Miley, PhD
Commercial market analysis, new product planning, market research, business development
Dr. Miley offers extensive experience in market research, pre-launch commercial development and business development. She has over 25 years’ experience working for major pharma companies in new product commercialization, marketing and market research. Dr. Miley has worked at director level for large pharma companies where she led new product commercialization activities. She offers expertise in new product assessment and strategic planning. She has worked in a range of therapeutic areas, including GI, CNS, lipid lowering, antibiotics, cardiovascular, alcohol abuse, pain, anti-inflammatory, respiratory, women’s health, and oncology.
At Altana Pharma, Lavonda was Director of Marketing and led commercialization of GI and respiratory products. At Bristol Myers Squibb, as Director of cardiovascular new product marketing, Lavonda led commercialization planning for a new antihypertensive, and assessments of potential cardiovascular acquisition candidates. During her career, she also worked for Pfizer and Burroughs Wellcome, where she managed commercial strategic planning and tactical activities in various therapeutic areas. She has participated on international pharma development teams covering all phases and aspects of product development (clinical, regulatory, pharmacology, etc).
Lavonda has a PhD in Pharmacy Administration with minor in marketing from University of South Carolina.
Larry Milocco
Commercial market analysis, market research, forecasting
Larry is an experienced healthcare professional with over 20 years of biotechnology, pharmaceutical and life sciences commercial experience. Larry has experience in commercial strategy development, marketing, forecasting, strategic planning, and product positioning.
Prior to consulting, Larry worked at Life Technologies, Suneva Medical, La Jolla Pharmaceuticals and Ligand Pharmaceuticals in the areas of global market development, product marketing, qualitative and quantitative market research, and forecasting. Larry has extensive experience in commercial strategy development and marketing in the areas of oncology (bladder, breast, colorectal, head and neck, GBM, melanoma, liver, lung, pancreatic, prostate, ovarian, renal as well as hematologic indications), autoimmune disorders, rheumatoid arthritis and many other therapeutic areas.
Larry has a BS Biochemistry and Cell Biology from the University of California, San Diego.
Ramon Seva, MBA
Market research, forecasting, commercial market analysis and strategy
Ramon is a highly experienced professional with over 20 years of biotechnology and pharmaceutical industry commercialization experience. Over the past 11 years, he has worked in a consulting capacity with biopharma clients on commercial strategy development for new products, strategic planning, forecasting, and due diligence for licensing. Ramon has worked on a wide range of projects from primary care markets (insomnia, gout, diabetes) to specialty markets such as oncology, rheumatology, neurology, dermatology, respiratory, gastroenterology, pain, immunology, cardiovascular, orphan diseases. Within oncology, Ramon has experience with solid tumors (Breast, prostate, lung, bladder, colorectal, pancreatic, ovarian, renal, GBM, melanoma, liver and hematologic (NHL, CTCL, PTCL, CLL, AML, APL, Multiple Myeloma) as well as supportive care.
Prior to consulting, he worked for Amgen Inc. and Agouron Pharmaceuticals in the areas qualitative and quantitative marketing research, forecasting, strategic planning, and business development for both domestic and global markets where he worked on biologic and small molecule products
Ramon has an MBA from Duke University, as well as a BS Chemical Engineering from the University of California, San Diego.
Reimbursement & Market Access
Neelima Firth, MBA
Managed care, reimbursement, market access, commercial strategy
Neelima has had a successful 30-year career in clinical, reimbursement and strategy for startup and Fortune 500 companies including Amgen, Bristol Myers, GSK and the Alfred Mann Foundation. She has had extensive consulting and work experience in reimbursement including Medicare, Medicaid and Managed Care strategies, marketing, project management and financial analysis and developing reimbursement and commercial plans. While at Amgen she developed the Amgen UK Medical Information Service including sales and marketing training, policies and procedures for regulatory review of promotional materials, pharmacovigilance and product complaint management. At Amgen US she held a variety of roles including Associate Director of Medicare and Medicaid Marketing, Lead on compendia and AMCP dossier creation for new products, and Director of Strategic Planning for Enbrel, managing the alliance relationship with Wyeth and the development of the business plan. At the Alfred Mann Foundation, she led the team to evaluate, prioritize and monetize projects and was involved in due diligence projects.
Therapeutic areas in which she has worked include Ophthalmology, Oncology, Hematology, Inflammatory Disease, Diabetes, Rheumatoid Arthritis, Neurology, Multiple Sclerosis, Pain, Overactive Bladder, and Neurostimulation
Neelima has an MBA (summa cum laude) from Pepperdine and a BSC in Information Science from Leeds Metropolitan University. She is a past President of the Association for Strategic Planning, an iCorp California evaluator for Biotechnology and an Entrepreneur in Residence at the Children’s Hospital of Los Angeles.
Renee Rizzo Fleming, RPh, MBA
Managed care, reimbursement, pricing, market access
Renee has over 20 years experience within various sectors of managed care pharmacy (e.g. Commercial, Self-Insured, Consumer Driven Health Plans, Medicare Part D and Managed Medicaid). Her expertise includes employer group benefit design & management, product & pricing/contracting strategy, clinical assessment of pharmaceuticals vs. marketplace competition, medical & pharmacy policy review and strategic consulting using payer research & reimbursement analysis.
Previously, Renee held the position of VP for Corporate Pharmacy Services at HealthNow New York, Inc. (parent company of BlueCross Blue Shield of Western New York and BlueShield of Northeastern New York). During her 17-year tenure at HealthNow New York, she was actively involved in numerous managed care pharmacy activities including formulary and drug therapy management, coordinating the P&T Committee, pharmacy network and pharmaceutical manufacturer partnerships, provider, employer group and broker relations, physician education, benefit design, as well as disease and health management activities.
Renee served as a representative on the Blue Cross Blue Shield National Council of Physician Executives and Location: Amherst, New Yorkthe BCBSA Drug and Pharmacy Advisory Group. She is currently an editorial board member for Biotechnology Healthcare and is a peer reviewer for the journals, Managed Care, American Journal of Health-System Pharmacy and American Health and Drug Benefits. Renee has been an active member of the Academy of Managed Care Pharmacy (AMCP) over the past 15 years. Additionally, she is an active member of the American Pharmaceutical Association, American Society of Health-System Pharmacists.
Renee obtained her Bachelor Degrees in Nuclear Medicine Technology and Pharmacy and her MBA from the State University of New York at Buffalo.
Business Development
Linda Pullan, BS, PhD
Business development, licensing & partnering
Dr. Pullan has more than 20 years of drug industry experience, beginning in drug discovery at Monsanto/Searle/now Pfizer and ICI/Zeneca/now AstraZeneca. She contributed to and led teams that put AstraZeneca’s multi-billion-dollar antipsychotic Seroquel® and other molecules into development.
Her business development experiences began with in-licensing technology and early drug candidates in all therapeutic areas at what is now AstraZeneca, and continued as head of oncology and hematology licensing for Amgen. Linda then joined Kosan Biosciences as VP of Business Development and experienced all the tasks of out-licensing and business development in a small company.
Linda has been providing biotech and pharmaceutical companies solutions in identification, evaluation, valuation, negotiation and strategy for partnering in or out. She has an extensive deal sheet ranging from company acquisitions to Phase III compounds and from preclinical candidates to technologies with up-fronts ranging from $10K to $100M. She also served as President and CEO of Viriome, Inc. and on the board of directors of Paloma Pharmaceuticals, Inc.
She has a PhD in Biochemistry from UC Riverside and a BS in Chemistry from University of Utah.
Project Management
Michael Gaskell, PhD
Program and project management
Dr. Gaskell is a Drug Development Program and Project Manager with expertise in the biotech and pharma industries in the USA and UK. Extensive experience leading and managing global cross-functional oncology teams through the drug commercialization process.
Michael has held positions of increasing responsibilities in project management in the biopharmaceutical industry for 28 years. His initial project management engagement was for 8 years with GlaxoWellcome (UK), followed by 13 years at Amgen (Thousand Oaks, CA) and 2 years with Pfizer (La Jolla, CA) among others.
Michaels holds a PhD in Biochemistry from the University of Nottingham (Nottingham, UK) and a BS in Biochemistry from the University of Sheffield (Sheffield, UK). He is certified as Project Management Professional (PMP) by the Project Management Institute.
Paola Lanza, PhD, PMC
Program and project management
Dr. Lanza is a professional in Program and Alliance Management with over 25 years of experience in the drug development industry. She is experienced on managing GxP programs with emphasis on third-party contractors. Additionally, she is experienced developing protocols for preclinical and human clinical trials in support of IND and preparing IBs. She has managed activities of clinical development in support of clinical trials, manufacturing of drug substance and drug product outsourced to CMOs, as well as preclinical studies outsourced to CROs.
Paola has held various industry positions, including VP of Strategic Planning at HUYABIO International, Director of Program Management, R&D Strategy and Planning at Acadia Pharmaceuticals, Director Program Management at Conatus Pharmaceuticals, and Ansun Biopharma; Assoc. Director of QA and Sr. Project Manager at Molecular Diagnostics Services; Sr. Scientist at Calmune Corp.; Assoc. Director of Research, at Androclus Therapeutics; and Research Scientist at Immune Response Corp. Paola was also an Assistant Professor of Immunology at the University of Chile, Santiago and Assistant Research Professor of Medicine at the Cancer Center, Univ. of California, San Diego.
Paola holds a PhD in Biological Sciences from the Univ of Pavia (Italy), a Certificate in Project Management from the University of California, San Diego and an Alliance Management Certificate from the Association of Strategic Alliance Professionals. She has also published 20 original research articles in international journals.
