TECHNICAL TEAM

HEAD OF TECHNICAL PRACTICE

CHEMISTRY / MANUFACTURING & CONTROLS

Process Development / Manufacturing

Analytical Development

Quality Assurance

REGULATORY AFFAIRS

CLINICAL

NONCLINICAL

COMMERCIAL TEAM

HEAD OF COMMERCIAL PRACTICE

NEW PRODUCT PLANNING

MARKET RESEARCH / FORECASTING

COMMERCIAL STRATEGY / OPERATIONS

REIMBURSEMENT / MARKET ACCESS

BUSINESS DEVELOPMENT / LICENSING / PARTNERING

EUROPEAN COMMERCIALIZATION / OPERATIONS

INFORMATION SPECIALIST

TECHNICAL TEAM

HEAD OF TECHNICAL CONSULTING PRACTICE

Adriana E. Manzi, PhD

Biologics CMC / Analytics / Glycobiology / Technical Strategic Planning


With over 25 years of experience in biomolecules R&D, since 2006 Dr. Manzi’s consulting work has spanned the areas of recombinant, fusion and transgenic proteins, dendritic cell vaccines, biosimilars, analytical method development and validation, CMC, selection  and management of CMOs /CROs, due diligence and writing of expert opinions. As a consultant, Adriana has led the CMC efforts for several virtual companies through their first successful IND filing, interacted with regulators in the US and EU, advised international investors, provided technical opinions to law firms and participated in global due diligence efforts.

Previously, 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).

The therapeutic areas in which she has worked include: oncology, renal disease, xenotransplantation, orphan diseases, heart disease and ophthalmology (AMD).

Dr.Manzi received her B.S. (Chemistry) / M.S. (Industrial Chemistry and Food Sciences), and her PhD in Organic Chemistry (suma cum laude) from the University of Buenos Aires, Argentina.  Dr. Manzi 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 28 original research articles and 20 book chapters. She is a member of the Advisory Board of Bioprocess International and Laureate Biopharmaceuticals, Inc. and active in professional organizations.

Languages: Spanish, French (reading).

(Top of page)

CHEMISTRY / MANUFACTURING & CONTROLS


Process Development / Manufacturing

Robert Hershberg, PhD

Downstream Process Development & Manufacturing


Dr. Hershberg has worked for over 30 years in downstream processing of biopharmaceuticals specializing in process development, formulation and implementation of processes into manufacturing. At Hoffman-L Roche, he managed a group responsible for production, isolation, purification, and formulation of natural and recombinant alpha-interferon.  At Genentech, he managed an integrated development team involved in large-scale recovery operations utilizing both bacterial and mammalian cell culture technologies. He worked on processes and/or formulations for the following products: Roferon™, Actimmune™, Pulmozyme™, Nutropin AQ™, Kogenate™, Herceptin™, and Hepatitis B vaccine. In addition, at Amgen, he led a group that contributed to the development of processes for commercial manufacture of Enbrel™ and Denosumab™.

(Top of page)

Dagmar Meissner, MS

Downstream Process Optimization & Scale up


Dagmar has 18 years of extensive experience in the biotech field, including cell based therapies, biopolymers, sustained drug delivery, mammalian cell recovery, recombinant protein isolation with strong skills in Process Optimization and Scale-up, Technology Transfer, and Project Management.  Dagmar has directed process development activities at MicroIslet, Inc., Monsanto/CP Kelco (formerly Kelco Biopolymers), Pacira Pharmaceuticals (formerly DepoTech Corp), and Biogen Inc to support preclinical and clinical studies (Phase I-III). ). In 2009 she founded BioProcess Solutions LLC and has been working as an independent consultant. As a consultant she has worked on the Process Development of vaccine and protein products in Phase I-III and CMC support, including process optimization, process characterization, risk assessment, and process validation, as well as project management. She received her BS in chemical engineering from Fachhochschule für Technik Mannheim (PolyTechnic Institute) in Germany, and her MS in Chemical Engineering from Tufts University.

(Top of page)

Joe Rininger, PhD

Process Development & Manufacturing


Dr. Rininger possesses over 18 years of experience in basic biomedical research and biopharmaceutical product development program management with an emphasis on vaccines and adjuvants.  At Protein Sciences Corporation, he successfully oversaw project teams for the development of upstream and downstream processes for transfer to cGMP manufacturing of four vaccine candidates and two biologics.  Most recently, he was the program manager for the advanced development and commercialization of Flublok®, the first approved recombinant hermagglutinin-based subunit vaccine for influenza.  This encompassed planning and leading a cross-functional team in the execution of tasks involving all areas of recombinant vaccine development (process development, formulation development and stability, pre-clinical efficacy and toxicology, quality control/quality systems, process and facility validation, manufacturing process transfer, regulatory affairs and clinical development).  He also has experience in rAAV-based gene therapies and had a supportive regulatory role in the approval of Glybera®, the first gene therapy to attain regulatory approval.  He also managed a rAAV process development program targeting Duchenne’s Muscular Dystrophy.  He has experience and solid skills in international business development and business strategy from serving as Director, Business Development at Protein Sciences Corporation and as a scientific liaison at CuraGen Corporation.  He has a Ph.D. from Cornell University in toxicology and a B.S. in marine biology from Fairleigh Dickinson University.

(Top of page)

Laura Weston, BS, MBA

CMC / Small Molecules


Pharmaceutical scientist with over 20 years of experience facilitating the development, approval and launch of novel small molecule and biologic drug products. Expertise in preparing CMC sections of regulatory filings, method development and validation, contract facility oversight (domestic and ex-US), regulatory compliance, building teams, and formulation development. Strengths include project management, international partner relations, system development, and technical writing.

Before joining Atheln, Laura was Sr. Director, Pharmaceutical Technology at Santarus Inc. where she worked for thirteen years holding positions of increasing responsibility. As Sr. Director, she provided technical direction, strategic planning, and leadership for the group responsible for supporting the development and commercialization of small molecule and biologic products. Conducted strategic due diligence analysis, participated in audits, and made specific recommendations relating to new product acquisitions, mergers, and partnerships. Prior to Santarus, Laura spent six years at Elan Pharmaceuticals and three years at Molecular Biosystems.

Laura holds and MBA from the University of Southern California and a BS in Chemistry from the University of California Davis.

Location: San Diego, Southern CA, USA

(Top of page)

Florian Wurm, PhD

Cell Line Development & Upstream Process Development


Dr. Wurm has been working in the field of manufacturing sciences and with CHO cells for the production of recombinant proteins in bioreactors for three decades.  He was employed at Behringwerke (Marburg, Germany), was a visiting Scientist at Harvard University, and worked at Genentech (San Francisco USA) for 15 years during the earlier parts of his career. His work at Genentech contributed to the establishment of high-yielding manufacturing processes for some of today’s leading protein products (such as Herceptin®, Pulmozyme®, TNKase® and TPA). In 1995, he was appointed Professor for Biotechnology at the Swiss Federal Institute of Technology where he established a research program in process sciences. In 2001, he founded ExcellGene SA (Monthey, Switzerland) a contract manufacturing and research service company using animal cells in bioreactors for protein production. Dr. Wurm is a previous Chairman of the European Society of Animal Cell Technology. He has published more than 200 papers, is editor and reviewer for many scientific journals in biotechnology and is a frequent lecturer in the area of DNA to process/product in mammalian cells. Innovative contributions and insights to mammalian cell technology range from gene transfer and amplification, to host and recombinant cells with high performance in suspension cultures, to novel tools for cell culture such as single use bioreactors using orbital shaking as the mixing principle. He was trained as a biologist and geneticist in Germany, receiving his Biology degree and PhD from Justus Liebig University of Giessen.

Languages: German.

(Top of page)

Analytical Development

Dianne Fishwild, PhD

Bioassay Development, Qualification and Validation


Dr. Fishwild has more than 25 years of experience in assay development, qualification and validation.  She has held positions of increasing responsibility from Scientist to Senior Director at Cutter Biologics, Xoma Corporation, GenPharm International, Affymax Research Institute, Guava Technologies, Geron and Asterias Biotherapeutics.  Dr. Fishwild is a dynamic scientific leader with extensive experience in R&D and GMP assay development for cell-based, biological and small molecule drugs.  Her primary focus has been on cell-based assays such as flow cytometry, immunocytochemistry, proliferation and immune function, but she is adept at ELISA and qPCR assays among others.  Dr. Fishwild has successfully launched assays and products that met specifications and design control requirements, participated in regulatory aspects of drug development as well as development of an IVD product, and  wrote and reviewed documentation for product manufacture, product testing and customer support.  She received her BS in Chemistry from the University of Colorado at Denver and her PhD in Biochemistry from the University of Colorado Health Sciences Center.

(Top of page)

Elizabeth Fowler, PhD

Analytical development / Biopharmaceutical Technical Operations / Single-use Bioreactors


Dr. Fowler is an expert in biotechnology research and development activities with extensive experience in leading teams focused on biopharmaceutical and vaccine projects at various stages ranging from basic academic research through to clinical development, validation and NDA/BLAs. She has quality, analytical and regulatory expertise in biological and chemically synthesized drugs with expertise in implementation of single use equipment in manufacturing operations, including design and quality specifications, supplier qualification, validation, GMP procedures, and training, as well as applying Quality be Design principles to manufacturing and testing of biopharmaceuticals, and planning and executing CMC strategies.  She has held positions at Xcellerex, Inc. and Millenium Pharmaceuticals, Inc., Autoimmmune, Inc., and Ciba-Geigy, as well as faculty positions at several universities. Dr. Fowler has a PhD from Harvard University.

Languages: French, German (reading).

(Top of page)

Quality Assurance

Paul Bacchus, MS

Quality Assurance / Quality by Design


Mr. Bacchus has 15 years of experience working with ex-FDA investigators and district directors to assist 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 has a unique strength in 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), Quality Engineering techniques, Training on various Quality Engineering and Regulatory topics (e.g. CAPA, Problem Solving) and Quality System Remediation. Mr. Bacchus was a Chemist/Group Leader with Drug Manufacturer of IV Solutions and IV Pumps before moving into Quality Management in Medical Device manufacturing. He has held several management positions with McGaw Laboratories (now B.Braun), Sorin Biomedical/Mallinckrodt Medical, PS Medical/Medtronic and Baxter. He has experience with manufacturing of implantable heart valves, oxygenators, heart lung machines, ventilators, cardiac monitoring systems, catheters, tracheotomy and respiratory devices, silicone neurological and pain implants, vascular grafts and related delivery systems, tissue staining devices, and IV Solutions and pumps. Mr. Bacchus has been responsible for Quality Control (Inspection), Supplier Quality, Metrology (Calibration), Product Complaint handling and CAPA systems, Software Quality Assurance, and Training.  Mr. Bacchus received his B.S. in Chemistry from Loma Linda University and Graduate School Certification in Advanced Manufacturing Technology from the UC Irvine.

(Top of page)

Zenaida Power, BS

Quality Assurance / CMC Compliance


Zenaida has over 25 years of experience in the pharmaceutical, medical device, IVD, biologics and nutritional supplements industries, specializing in Quality/Regulatory CGMP, GCP, GLPs, ICH and ISO compliance.  She has been a consultant for over 10 years, assisting companies domestically and internationally with quality assurance and compliance programs, and the design and implementation of quality systems from early development to commercial stages. Prior positions include supervisory and manager roles at GensiaSicor, Inc., Regulatory Compliance/QA & Professional Services; BioRad Laboratories, Inc., Manufacturing Quality and Technical Services; J&J Ortho Diagnostics, Manufacturing Lab.; and Central Jersey Blood Bank, Laboratory. Zenaida has a BS in biology from Jersey City State College.

Languages: Spanish.

(Top of page)

Paul Stockbridge, PhD

Quality Assurance / CMC Compliance


Dr. Stockbridge has over 40 years of experience in quality, compliance, and manufacturing.  He specializes in quality and compliance services, including auditing, GMP training, regulatory strategy, due diligence, pre- and post-inspection compliance, and quality structure and support for both small molecule and biotechnology industries.  Dr. Stockbridge served as Corporate/ Director of Quality at Cobra Biomanufacturing PLC/ Cobra Biologics LTD, and held quality function positions at Aventis Pharma and Eli Lilly.  Prior to Eli Lilly, he spent several years as Head of Fermentation at Dista Products LTD (now Eli Lilly).   Dr. Stockbridge has a BSc (Hons) and PhD from University of Aston in Birmingham.

(Top of page)

Deborah Wild

Quality Assurance / CMC Compliance


Deborah has 25 years of experience in Quality Assurance , compliance, technology transfer, and supply chain management with organizations including executive positions at Genentech, and Victory Pharma. She is a strategic thinker who has evaluated facilities, manufacturing, and quality units for compliance with cGMP and develop plans to bring companies into GMP compliance. Deborah has also conducted due diligence assessments of pharmaceutical, biological products and medical devices facilities and developed Quality Assurance systems and training modules. She has a sociology degree from Austin Peay State University and served in the U.S. Army.

(Top of page)

REGULATORY AFFAIRS

Louis-Christian Clauss, PhD, IAE, RAC

Global Regulatory Affairs and Quality – Biopharmaceuticals / Medical Devices


Dr. Clauss has over 30 years of experience spanning from International Regulatory Affairs (EMEA, FDA, EU National Global development) to new product development and Quality Assurance/ ISO certifications. He 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 New Product Development, BioScience, for Baxter World Trade. In those posts, he led the development of numerous products including pharmaceuticals, stents, implantable devices, and biotherapeutics, Cprotin, CD20, AdNC, including biosimilars, EPO, rFactorVIIa.

Dr. Clauss has been involved in over 75 regulatory submissions and 30 agency meetings with EMA and FDA. He has more than 70 publications and conference presentations, and is a member of numerous Professional Societies, including DIA, RAPS (former General Secretary, RACS), EUCOMED (former chairman of the FRG), and APIMCA (former President elect).

Dr. Clauss holds a Masters degree in Bio-Pharmacy, a PhD in Pharmacy and a degree in Business administration (IAE).

Languages: French, Swedish

Location: Prague, Czech Republic

(Top of page)

Nevine Erian, MSQA, MBA, CQE

Regulatory Affairs / Quality Assurance & Compliance – Medical Devices


Nevine has over 20 years experience in regulatory compliance, quality management and engineering. Prior to her consulting career she held senior positions at BeneChill as SVP Quality and Regulatory Compliance, VP Quality at ASP Johnson & Johnson, and VP Quality Systems and Technical Operations at Del Mar Medical Systems. Her medical device experience includes endoscope re-processors, disposable and capital equipment in orthopedic implants, IV catheters, EKG monitoring, sterilizers, cooling devices, drug eluting stents, and biocide solutions. Nevine also spent the first 6 years of her career in aerospace, as a test engineer and a quality engineer.

Ms. Erian holds a MBA from the University of La Verne, a MS in Quality Assurance and a BS in Electrical Engineering from the California State University. She is a Certified Quality Engineer since 1995.

Location: Dana Point, Southern CA, USA

(Top of page)

Natalie J Kennel, RAC ASQ CQE & CQMgr

Regulatory Affairs and Quality Management, Medical Devices/Diagnostics


Natalie Kennel is a senior quality and regulatory affairs professional with over 25 years experience in medical device and other high tech manufacturing industries. Her experience with medical devices spans across a number of markets including orthopedics, surgical instruments, electro-mechanical devices, infusion pumps, blood glucose monitors, orbital implants, intraocular lenses and medical device software. In the area of diagnostics, Natalie has worked with both in-vitro diagnostics and molecular diagnostics along with pharmacogenetics. As a consultant, Natalie has prepared or supported more than thirty 510(k) submissions, more than 20 pre-submissions and supplements and developed product test plans to support regulatory submissions. She has designed and implemented Quality Systems compliant to FDA QRS & ISO 13485, MDD, IVDD, and Canadian Medical Device Regulations. In addition, Natalie has developed quality and GCP training programs, and conducted software validation strategies. She has also written clinical study protocols and IDE final reports.

Prior to consulting, Natalie was at number of companies with increasing responsibility (J&J Ortho-Clinical Diagnostics, LSI Solutions, Alaris Medical Systems, PLUS Orthopedics, and Eastman Kodak).
Natalie holds a BS in Chemical Engineering from the University of Rochester. In 2001, she received her Regulatory Affairs Certification (RAC) and has been ASQ certified since 1999.

Location: San Diego, CA, USA

(Top of page)

CLINICAL

Robin Allgren, MD, PhD, MBA, RAC

Clinical Development and Trial Design, Medical Affairs


Dr. Allgren has over 20 years of experience in clinical development and regulatory affairs for biotech, pharma, medical device, diagnostic and stem cell products as Founder of Breakthrough Bio Development, Senior VP of Development (Ansata Therapeutics, Inc.),   VP of Clinical Research & Medical Affairs (Innercool Therapies, Inc.), VP of Clinical Development (SkyePharma, Inc.), and VP of Clinical Research (Scios, Inc.). She possesses extensive experience in the design and execution of Phase 1-4 clinical studies and FDA interactions, including IND and NDA preparation as well as in Pharmacovigilance/ Medical Monitoring activities as well as in the development of devices for intravascular intra-operative temperature management. Therapeutic areas included CNS disease (stroke, Parkinson’s Disease), cardiovascular disease, oncology, nephrology, dermatology, inflammatory, anti-infective, pain management, GI, and endocrine.  Marketed FDA-approved products include Natrecor®, DepoCyt®, DepoDur™ and the Celsius Control™ System.  Dr. Allgren holds a MD/PhD from Stanford Medical School and a MBA in Health Services Management from Golden Gate University in San Francisco.

(Top of page)

Moraye Bear, MS, MA

Statistics and Data Management


Ms. Bear has over 25 years of experience in the application of statistical methodology in clinical research at all phases of drug development. She spent 16 years at Amgen in biostatistics where she served as a Department Head for Biostatistics and Data Management for North American Medical Affairs overseeing a Department of 54 statisticians, programmers and data managers. She was the Clinical Studies Team Leader of an international multidisciplinary clinical team responsible for the successful approval of Anakinra for the treatment of rheumatoid arthritis and was the primary presenter at the FDA Advisory Panel and CPMP Oral Hearing for the approval of Anakinra. Ms. Bear has a BA in Psychology and a MA in Social Psychology from Cal State Northridge, as well as a MS in Biometry from University of Southern California.

(Top of page)

Selma Boussen, MD, PhD

Clinical Development and Medical Affairs


Dr. Boussen is a seasoned professional in clinical development having served as Global Head of Clinical and Medical Department (LFB Biotechnologies), European Medical Affairs Director (Pharmion Corp., Ortho Biotech Europe, Searle Monsanto), European Medical Marketing Director (Pharmacia Corp.), and Medical Director (Amgen Europe). She has managed and lead over 20 clinical development programs in all phases of development including post marketing. Her primary therapeutic focus has been with oncology and hematology products, including Vidaza, Thalidomide, Refludan, Satraplatin, Eprex, Velcade, Celebrex, Abelcept, and Neupogen. Dr. Boussen received her PhD in Human Genetics from the Faculte de Sciences, Tunis and her MD from the Faculte de Medecine Cochin-Port Royal, Paris.

Languages: French, Arabic.

(Top of page)

NONCLINICAL

Robyn Phelps, PhD

Safety Pharmacology, Toxicology


Dr. Phelps is a nonclinical drug safety evaluation scientist and director with over 25 years of industry, global pharmaceutical development, contract research, and academic experience in Toxicology, Safety Pharmacology, and Risk Assessment.  In compliance with ICH global development practices, she provides comprehensive, responsive, flexible, and innovative nonclinical scientific direction.  Dr. Phelps is  experienced in strategic drug development program planning/ evaluation; idenitfication and development of novel delivery devices for compound-specific toxicological/physiological evaluations; CRO contract negotiations and placement; study design and management; preparation of regulatory documentation; and agency interactions as nonclinical representative. She has held positions at Allergan and Battelle Memorial Institute, and received a BS in mammalian physiology from Michigan State University, a MS in cardiovascular dynamics from University of North Carolina, and a PhD in cardiovascular physiology from University of British Columbia.

(Top of page)

Stanley Roberts, PhD, DABT

Non-clinical Pharmacology, PK/ADME and Toxicology


Dr. Roberts is a pharmaceutical toxicologist with over 29 years of conducting and leading research in toxicology, drug metabolism and pharmacokinetics. He is an experienced executive in small biotech and large pharmaceutical companies (Vice President – Preclinical Development at CovX Research, LLC,  Global Director – Preclinical Drug Metabolism and PK at Abbott Laboratories, and Section Head – Department of Toxicology at Sandoz Research Institute) with proven success for process improvement, innovative management and broad based integration of scientific disciplines to more efficiently identify the best new candidate compounds for further development. Dr. Roberts has demonstrated excellence in drug development across a broad range of therapeutic classes, targets, and disease areas with scientific and regulatory experience in both small molecules and biotherapeutics (e.g., 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 has a MS and PhD in Pharmacology and Toxicology from Purdue University.

(Top of page)

Patrick Trown, PhD

R&D, Non-clinical Experiment Design, Technical Management


Dr. Trown has been active in the Pharmaceutical/Biopharmaceutical industry for over 45 years. He held positions of increasing responsibility from researcher to Vice President at Lederle Laboratories, Hoffmann La Roche, Xoma Corporation, Onyx Pharmaceuticals and Jennerex Inc. He has extensive experience in the direction of research, preclinical development, the chemistry, manufacture and control of biopharmaceuticals, and interaction with FDA and international regulatory agencies.

Drugs for which he had a significant role in their development include alpha-interferon Roferon A®, a 5FU pro-drug Xeloda®, an immunosuppressive immunoconjugate CD5 Plus, an anti-sepsis monoclonal antibody E5®, a recombinant human protein for trauma/sepsis Neuprex®, a raf kinase inhibitor Nexavar®, selectively-replicating adenoviruses, e.g. ONYX-015, an enzyme replacement therapy for Mucopolysaccharidosis 1, Aldurazyme®, a vaccinia virus for the treatment of cancer JX-594 and a novel chimeric antibody-like molecule for the treatment of angiogenesis-related diseases hI-con1.

Over the past 10 years, Dr. Trown has consulted for various biotechnology companies, including Iconic Therapeutics, BioMarin Pharmaceutical, Onyx Pharmaceuticals, Astex Technology Ltd., Gryphon Therapeutics, Ultragenyx and Cell Genesys on preclinical development of biopharmaceuticals and low molecular weight drugs.

Languages: French.

(Top of page)

COMMERCIAL TEAM


HEAD OF COMMERCIAL CONSULTING PRACTICE

Monica Alfaro Welling, MBA

Commercial Strategy/New Product Planning


With over 20 years of experience in new product planning, strategic planning, portfolio analysis, market development and sales/marketing of pharmaceuticals, biotechnology, and medical devices, Monica has had a unique career in the life science industry. She has been involved in every aspect of the development and commercialization process of early and late stage technologies and new therapeutic applications. Her experience spans across a multitude of therapeutic areas including endocrinology, CNS, pain, addiction, ophthalmology, aesthetics, dermatology, oncology, and orphan diseases. It also includes managing a multi-disciplinary drug development and drug delivery team while at Novo. In addition, Monica has launched products, drug delivery systems, and new product indications, both domestically and internationally. Her 11 years working in Europe enabled her to gain extensive experience working with and managing multi-national teams and the European markets. Prior to her consulting career, she held executive and management roles at Allergan, Novo Nordisk, and a start-up company. She has a MBA from Odense University in Denmark, as well as a BS in Biology and a BA in Economics from the University of California, Irvine.

Languages: Danish, Norwegian (reading), Spanish (proficient).

(Top of page)

NEW PRODUCT PLANNING

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 20 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, as well as strategic vision from her experience in a number of therapeutic categories. 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).  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. She has a PhD in Pharmacy Administration with minor in marketing from University of South Carolina.

(Top of page)

David Power, MS, MBA

Commercial Market Analysis


Mr. Power has a broad background including more than 30 years of experience in research and development, product sales and marketing, global strategic marketing and international commercialization of ethical pharmaceuticals with a strong focus on the area of ophthalmology. Mr. Power worked for more than 21 years for Allergan Pharmaceuticals specializing in the area of dry eyes and glaucoma, and had commercial responsibility for the development and successful launch of Restasis®.  In 2005, Mr. Power became the President and CEO of Alacrity Biosciences.  Mr. Power has a MS degree from Fairleigh Dickinson University and an MBA from Seton Hall University.

(Top of page)

MARKET RESEARCH/ FORECASTING

Ramon Seva, MBA

Market Research, Forecasting, Commercial Market Analysis, Strategy,


Ramon is a highly experienced professional with 20 years of biotechnology and pharmaceutical industry commercialization experience.  Over the past 10 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 and gastroenterology. Prior to working in consulting, he worked for two major bio-pharma companies:  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. He has a MBA from Duke University, as well as a BS Chemical Engineering from the University of California, San Diego.

(Top of page)

COMMERCIAL STRATEGY/ OPERATIONS

Ambaw Bellete

Commercial Strategy/Operations,  New Product Planning, Brand Management, Sales and Marketing


Ambaw has 22 years of experience with the last 13 years in multiple senior executive roles in the medical device and pharmaceutical industry across multiple specialty therapeutic areas such as immunology and oncology.  Senior leadership positions have been across multiple brands with responsibility for development and commercialization including full P&L responsibility for a $700 million multi-product portfolio business across multiple global geographies.  This also includes being involved in the launch of over twenty products including Camptosar®, Detrol®, Framin®, Lovenox®, Taxotere®, and Celebrex®.  Ambaw has held senior executive roles at MCS Inc., Sanofi and Pfizer.  He has a B.S. in Biology and Chemistry from MSU and has completed advanced executive education certificate programs at Kellogg School of Business at Northwestern University, Harvard Business School and at the Wharton School of Business at the University of Pennsylvania.

(Top of page)

Jane Hart, MBA

Commercial Strategy/Operations, Sales Management, Marketing, Business Development


With over 25 years of experience in pharmaceutical sales and marketing, Jane has worked in numerous acute and chronic therapeutic and life style products while at AstraZeneca, Roche, and Sanofi.  She has been involved in multiple product launches, along with transitioning products from branded to generic and to OTC, both from a sales and marketing perspective. Jane has built and managed high performing sales and marketing teams targeting physician practices, institutional accounts, and managed care.  Throughout her career, she has been involved in many in-/out-licensing deals as well as business development activities.  Currently, she is on the board of Medrisk Inc., and TherimuneX Inc. Jane has a BA in French, BS in Education from Miami University, and a MBA from Wharton School of Business at the University of Pennsylvania.

(Top of page)

Veronica Kang, PhD

Commercial Strategy/Operations, Market Analysis, Sales & Marketing


Dr. Kang is a highly effective molecular biochemist with B2B expertise. She has built on her research experiences in biochemistry, molecular biology, cell biology, and protein production with revenue generating business development sales & marketing experience in API drug substance cGMP manufacturing and In Vitro Diagnostics.  She has provided technical troubleshooting and strategic planning, closed contracts, performed market analysis, and facilitated new market penetration.  Dr. Kang has held executive positions in Business Development at Senn Chemicals (Switzerland), Ferro Pfanstiehl Laboratories, and IRIX Pharmaceuticals.  She was a Product Development Manager/ Senior Scientist at Echelon Biosciences/University of Utah and Post-doctoral Scholar at NIH/NIAID Laboratory of Immunoregulation.  Dr. Kang has a PhD from Georgetown University.

(Top of page)

REIMBURSEMENT / MARKET ACCESS
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 the 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. She obtained her Bachelor Degrees in Nuclear Medicine Technology and Pharmacy and her MBA from the State University of New York at Buffalo.

(Top of page)

BUSINESS DEVELOPMENT / LICENSING / PARTNERING

Linda Pullan, PhD

Business Development, Licensing, Partnering

Dr. Pullan 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 upfronts 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.  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.  Dr. PUllan then joined Kosan Biosciences as VP of Business Development and experienced all the tasks of out-licensing and business development in a small company. She has a Ph.D. in Biochemistry from UC Riverside and a B.S. in Chemistry from University of Utah.

(Top of page)

EUROPEAN COMMERCIALIZATION / OPERATIONS

Luis Silva, MSc

European Commercialization, Sales and Marketing


Luis has in depth knowledge of the pharmaceutical industry at domestic, international and corporate headquarters level.  Director and board level experience in companies as well as NGOs and Industry Associations. Over twenty-one years of experience in the pharmaceutical industry, 15 at management level and six of these as General Manager / Vice President.  He has worked in endocrinology, hematology, and women’s health. 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. He has held positions at Novo Nordisk  Pharma S.A. and Schering AG. He has a MS in Molecular Biology from Universidad Complutense de Madrid and is a Spanish national, based in Madrid.

Languages: Spanish.

(Top of page)

INFORMATION SPECIALIST

Amy Tetervin, MLIS

Information Specialist


Amy has over  20 years  of experience as an Information Specialist within the pharmaceutical industry. Prior to consulting Amy started her career as a biomedical researcher. She was involved in a number of areas including genetic toxicology, diagnostics development, interferon production methods, monoclonal antibody research and gene synthesis. From the lab, she transitioned to pharmaceutical research libraries as an expert information provider serving all levels of the organization at Bristol-Meyers Squibb.  Amy received here BS in Animal Science from University of Maryland.