Upcoming program speakers

Speakers who have been there, done that from both the sponsor and service side attend Outsourced Pharma to openly dialogue with you. In our sessions, authentic discussion between panelists is equaled by the energetic participation of attendees. True story: a panelist described the audience involvement as so boisterous, "it was like they were on the panel!"

Check out the top-shelf line-up.

Speakers by Show Speaker Bios

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Speakers by Show

Boston | April 26-27, 2017

Early-confirmed candidates include:
Agios Pharmaceuticals | Bob Sheroff, SVP Technical Operations
AMAG Pharmaceuticals | James Lucie, Associate Director
Berkshire Sterile Manufacturing | Shawn Kinney, CEO
Biogen | Tobias Blackburn, Supervisor, Technical Development
Biogen | Walter Charles, Chief Procurement Officer
Biogen | Evan Guggenheim, Sr. Manager Technical Development
Biogen | Thomas Holmes, Sr. Dir. Global External Manufacturing
Biogen | Clive Patience, VP, Asset Development & Program Management
Biogen | Patrick Soares, Sr. Director External Manufacturing
Boston Institute of Biotechnology | Peng Jiao, CEO
Boston Institute of Biotechnology | Jared Kaufman, Associate Scientist
Bristol-Myers Squibb | Keirnan LaMarche, Senior Research Investigator
CMC Turnkey Solutions | Barbara Berglund, COO
Eli Lilly and Company | Mark A. Butchko, Ph.D., Sr. Dir. - QA - Development
Emergent  BioSolutions | BJ Hull, VP/GM
Fortress Biotechnology | George Avgerinos, SVP Biologics Operations
Freedom Bioscience Partners | Brian Scanlan, Managing Partner
Genentech | Todd Mabe, Head of Biologics, Drug Substance
Johnson & Johnson | Milan Shah, Head, Publishing, Global Capabilities IDAR
Latham Biopharma | Susan Dexter, Managing Director
MedImmune
| Steve Cook, Head Global Biologic Supply Chain Ops
Merck | Anand Ekambaram, Executive Director, Global Technical Operations
Merck | Pamela Rizos, Associate Director Regulatory Affairs
Merck | Kurt Wolf, Director
Metrics Contract Services | Charles Waldroup, Director of Project Management
Outsourced Pharma | Louis Garguilo, Conference Chair & Chief Editor
Patheon | Franco Negron, President Drug Product Services
Rondaxe Pharma | Brian James, SVP Operations
Sanofi Genzyme | Piet Houwen, Head of Contract Manufacturing Operations
Snapdragon Chemistry | Matthew Bio, President and CEO
Sunovion Pharmaceuticals | Vince Kosewski, VP Supply Chain Operations
Tunnell Consulting | Julia O'Neill, Principal
Vertex Pharmaceuticals | Michelle Bailey, Assoc. Dir. Validation Continuous Manufacturing
Xenetic Biosciences | Henry Hoppe, VP Drug Development
Candidates will be reviewed and selected in early 2017 for San Diego and San Francisco programs.

 

Past Programs

We're proud of the speakers who've given their time and talent to our programs. Below are just a few of our past participants - bravo!
Achaogen | Tina Larson, VP Technical Operations
ADC Therapeutics | Michael Mulkerrin, VP, Head of CMC
Agensys | Brian Mendelsohn, Leader of ADC Chemistry Group
Allergan | Sesha Neervannan, SVP Pharmaceutical Development
Alnylam Pharmaceuticals | John Frenz, VP Manufacturing
Amunix Operating Inc. | Ulrich Ernst, SVP Manufacturing & Quality Operations
Arcturus Therapeutics | Joseph Payne, President and CEO
BalinBac Therapeutics | John Gregg, President and CEO
Biogen | Thomas Holmes, Sir. Dir. Global External Manufacturing
Capricor Therapeutics | Denise McDade, VP of Quality
Cerulean Pharma | Marc Wolfgang, VP Technical Operations
CytRx | Carrie Helland, VP Project Management and Manufacturing
Depomed | Gerd Kochendoerfer, VP Pharmaceutical Development
Eleven Biotherapeutics | Greg Zarbis-Papastoitsis, VP Process and Manufacturing Sciences
Endocyte | Michael Brinkley, VP Quality
EPRIUS Biopharmaceuticals | Charles Laranjeira, VP Supply Operations
FORMA Therapeutics | Mary Kachinsky, VP Strategic Sourcing & Operations
Genentech | Todd Mabe, Head of External Quality, Biologic Drug Substance
Genzyme | Piet Houwen, Head of External Manufacturing
Innovent Biologics | Claudia Lin, VP Quality
J&J | Courtney Billington, VP Global Pharmaceutical Supply Chain
Medivation | Thomas Templeman, SVP Pharmaceutical Operations
Merck | Bob Kanuga, VP External Manufacturing
Mirati Therapeutics | Dennis Hester, VP Product Development and Head of CMC
Moderna Therapeutics | Hari Pujar, VP Tech Development & Manufacturing
Nektar | Maninder Hora, SVP Pharmaceutical Development and Manufacturing Operations
Neurocrine Biosciences | Scott Zook, Vice President, CMC Development
Orexigen | Philip Roberts, VP Technical Operations
Pernix Therapeutics | Terry Novak, COO
Polynoma | Pat Mallon, COO
Retrophin | Nils Olsson, VP CMC
Revance Therapeutics | Azita Nejad, VP Quality
Shire | Charlene Banard, SVP Quality
Shire | Mani Sundararajan, VP & Head Global Pharmaceutical Technology
Stemline Therapeutics | Joan Connolly, VP Manufacturing
Sorrento Therapeutics | Jeffrey Su, EVP & COO
Sunovion | Vincent Kosewski, VP Supply Chain Operations
Theravance Biopharma | Junning Lee, SVP Technical Operations
Versartis | Patrick Murphy, VP Manufacturing
XenoPort | Sami Karaborni, VP Development Operations

 

Speaker Biographies

George Avgerinos

George Avgerinos

SVP Biologics Operations | Fortress Biotechnology
Boston | Panel: Costs and price pressures rise...best efforts notwithstanding

Dr. Avgerinos has served as Senior Vice President, Biologics Operations at Fortress Biotechnology since June 2013. Dr. Avgerinos joined Fortress from AbbVie Inc., where he was Vice President, HUMIRA® Manufacturing Sciences and External Partnerships. In his 23 year career at AbbVie, formerly Abbott Laboratories, formerly BASF Bioresearch Corporation (BASF), Dr. Avgerinos had responsibility for many aspects of Biologics development and operations. These included the HUMIRA® operations franchise, global biologics process and manufacturing sciences, biologics CMC, manufacturing operations, and third party manufacturing. During his tenure, Dr. Avgerinos led and participated in the development of numerous clinical candidates which included the launch of HUMIRA®. He supported expansion of the supply chain to over $9 Billion in annual global sales. Dr. Avgerinos’ efforts on HUMIRA® have been recognized with numerous awards, including the prestigious Abbott's Chairman's award in 2011.Dr. Avgerinos started his career at Biogen, Inc. in 1981 and subsequently joined Collaborative Research Inc. while serving as Adjunct Associate Professor of Chemical Engineering at Tufts University. Dr. Avgerinos has authored numerous publications in the area of biotechnology product development and manufacturing and holds a number of product and process patents. Dr. Avgerinos received a B.A. in Biophysics from the University of Connecticut and a Ph.D. in Biochemical Engineering from the Massachusetts Institute of Technology.

Michelle Bailey

Michelle Bailey

Associate Director Validation Continuous Manufacturing | Vertex Pharmaceuticals
Boston | Panel: Spotlight Technology: Continuous manufacturing and its broadest impacts

In her current role, Michelle provides strategic direction and logistical oversight for validation function supporting GMP Manufacturing including Continuous Manufacturing. She is responsible for the building out of new validation function and validation activities associated with implementation and PAI readiness for new technologies driving continuous manufacturing initiatives and corporate objectives.

Barbara Berglund

Barbara Berglund

COO | CMC Turnkey Solutions
Boston | Panels: Learning To Fly: How to support incremental innovative solutions | Project Managers from the frontlines: Four ways to avoid the worse battles

For the last 15 years, Barbara has enjoyed positions in the pharmaceutical, medical device, and chemical industries. These include regulatory, QA, QC, operations, and project management and a deep knowledge of 21 CFR 210, 211 and 820. Barbara has enabled the ISO 17025 accreditation of a QC lab and have extensive procedure validation and transfer experience. Her specialties include: ISO 9001; ISO 17025 & 17043; ISO 13485; ISO 15189; QA oversight of GLP and GMP laboratories; QA and QC of procedure transfer and validation; procedural monographs; preparation of manuals and guidelines.

Matthew Bio

Matthew Bio

President & CEO | Snapdragon Chemistry
Boston | Panel: Spotlight Technology: Continuous manufacturing and its broadest impacts

Matthew Bio brings substantial experience in process development to Snapdragon Chemistry and is driven by a passion for developing new technologies in organic synthesis; enabling safer, more efficient processes; and providing access to new chemical architectures. Mathew earned his Ph.D. in Chemistry from Columbia University and went on to work as a process development chemist at Merck Research Laboratories. In 2006, Mathew moved to Amgen, where he was promoted to Director of Process Development and led the development of both batch and continuous processes for clinical candidates. Throughout his career, Mathew has been involved in the development of more than 50 clinical candidates and the launch of three new drugs to the market, and is author or inventor on numerous regulatory filings and more than 30 peer-reviewed publications and patents.

Tobias Blackburn

Tobias Blackburn

Supervisor, Technical Development | Biogen
Boston | Panel: Winning Workforce: A new generation in the supply chain

Tobias is a biotechnology professional with 8 years of work experience and Engineering and MBA degrees from top schools. He is a strategic thinker with a pragmatic approach to initiating, driving, and implementing operational innovation. Tobias has demonstrated an ability to thrive in ambiguity and flex into roles across the matrix. His diversified qualitative and quantitative skillset include relationship management, process automation, project and resource management, operations improvement and business process management, and short- and long-term strategic planning. He is adept at communicating with and managing cross-functional business partners and external vendors to deliver on portfolio and pipeline priorities.

Mark Butchko

Mark Butchko

Sr. Director, QA - Development | Eli Lilly & Company
Boston | Panel: FDA, regulatory and quality dynamics for innovative outsourcing

Biography coming soon.

Walter Charles

Walter Charles

Chief Procurement Officer | Biogen
Boston | Panel: Spotlight Leadership Company: Biogen

Walter leads an innovative medical device company to save more lives and improve the quality of life with people suffering from cardiovascular disease.

Steve Cook

Steve Cook

Head Global Biologic Supply Chain Ops | MedImmune
Boston | Panel: A Buyer's or seller's market? The truth about capacity and your supply chain needs

Steve is an engaging, high performance Supply Chain and Technical Operations executive with over 25 years of visionary, entrepreneurial leadership of end-to-end Supply Chain, including complex manufacturing and distribution networks, small molecule, oral solid dose, parenteral, semi-solids/cream & ointment technical commercial manufacturing experience in both branded and generics. Steve also has warehousing, distribution, logistics, procurement, supplier management, and inventory management Supply Chain leadership experience.
Additional accomplishments include:
- Developed and executed Global Product Technical Operations and Supply strategies to maximize product revenue and profit growth
- Lead development and execution of multi-site manufacturing sourcing and distribution center fulfillment strategies
- Successful deployment of Lean Manufacturing and Six Sigma tools, delivering continuous improvement in process, quality, safety, productivity, and profitability
- Improved global customer service and delivery through aggressive Supply Network Planning and exceptional execution

Susan Dexter

Susan Dexter

Managing Director | Latham Biopharm
Boston | Panels: Costs and pressures rise...best efforts notwithstanding | Spotlight Technology: Continuous manufacturing and its broadest impacts

Susan's experience Includes:
- Broad and deep understanding of drug development, process development and manufacturing of biopharmaceuticals from pre-clinical through commercial
- Project Management experience, PMI member
- Significant contract negotiations experience, able to evaluate and understand CMO capabilities and identify best fit for outsourcing needs
- In depth experience in the use of disposable biomanufacturing technologies
- Experience in in-licensing and out-licensing of technologies (gene expression, bioproducts)
Susan is interested in providing consultancy services to virtual/small/mid-sized companies needing to outsource biologics process development and manufacturing as well as providing consultancy services to identify the most suitable technologies for development of your pipeline.

Anand Ekambaram

Anand Ekambaram

Executive Director, Global Technical Operations | Merk
Boston | Panels: A buyer's or seller's market? The truth about capacity and your supply chain needs | Costs and price pressures rise...best efforts notwithstanding

Anand is an accomplished leader with a 24-year track record of success in the manufacture of Vaccines, Biologics and Sterile Drug Products.
Anand's core competencies include:
- External Manufacturing
- Technical operations for Vaccines, Biologics, Sterile Drug Products
- Aseptic Processing
- Technology transfers
- Facility design, startup, regulatory approval
- Acquisitions and post-acquisition integrations
- Portfolio management

Louis Garguilo

Louis Garguilo

Chief Editor and Conference Chair | Outsourced Pharma
Boston | Panel: Spotlight Leadership Company: Biogen

Louis Garguilo is chief editor of OutsourcedPharma.com and executive editor Life Science Leader magazine, and on the executive team for the Outsourced Pharma conferences, all within the Life Science Connect media group. He studied public relations and journalism at Syracuse University and holds a Master’s in English. Prior to joining Life Science Connect, Louis spent nearly a decade in positions of increasing importance at a global pharmaceutical contract research, development and manufacturing organization; he left AMRI the end of 2013 as vice president for global business development and head of marketing communications. Louis also served under the governor of New York for six years in the state’s economic development agency, as liaison to the pharmaceutical/biotechnology, and photonics/semiconductor industries. Louis was also chief strategic officer for an e-learning software company. He spent most of the ‘80s and ‘90s in Japan as an educator, author, and communications consultant to organizations such as Osaka Medical Center for Cancer and Cardiovascular Diseases.

Evan Guggenheim

Evan Guggenheim

Sr. Manager Technical Development | Biogen
Boston | Panels: Learning To Fly: How to support incremental innovative solutions | Winning Workforce: A new generation in the supply chain

Dr. Guggenheim is a proven team leader in biopharmaceutical drug development. A trained biochemist, he has focused his career on managing the interdisciplinary divide between collaborating scientists, engineers, and management functions. In his current role, Dr. Guggenheim leads a team focused on outsourcing, laboratory automation, and program management. Dr. Guggenheim and his team are working to transform the CRO-Sponsor relationship through the implementation of a practical strategic sourcing model, accompanied by a collaborative automated data sharing platform.

Thomas Holmes

Thomas Holmes

Sr. Dir. Global External Manufacturing | Biogen
Boston | Panel: Learning To Fly: How to support incremental innovative solutions | Spotlight Leadership Company: Biogen

Tom is the Senior Director of External Manufacturing at Biogen reporting through Manufacturing Operations. His primary responsibilities include all external manufacturing operations in North America and two Strategic Suppliers globally. The external manufacturing network at Biogen includes just over 25 suppliers mostly in Europe & North America with an annual spend of $210M. Tom has 20+ years of experience in pharmaceutical Supply Chain Operations serving in Procurement, Logistics, and External Mfg. Prior to Biogen, he spent two years at Wyeth in Cambridge MA. Tom earned his Master of Science in Business from Salem State University.

Henry Hoppe

Henry Hoppe

VP Drug Development | Xenetic Biosciences
Boston | Panel: FDA, Regulatory and Quality Dynamics for Innovative Outsourcing

Henry Hoppe IV, Ph.D. joined Xenetic in April of 2012 as Vice President of Drug Development. He is a biotechnology process development executive with more than 20 years of experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies. Dr. Hoppe has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, including those for Cerezyme®, Fabrazyme®, Myozyme® and Thyrogen®, four currently marketed products coming out of Genzyme Corporation. He has experience with all aspects of therapeutic development from the bench through Phase 2 clinical trials including managing Clinical Manufacturing Organizations (CMOs) in both the United States and Europe. Between 1980 and 1984, He held positions at the Harvard Medical School and the University Hospital of Boston. From 1984 to 2001, Dr. Hoppe worked for Genzyme Corporation focusing on therapies for rare genetic diseases. He was subsequently appointed Vice President of Therapeutic Development for ViaCell Inc. where he delivered stem cells to clinical trials and designed Phase 2 manufacturing processes. In 2004, Dr. Hoppe founded his own consultancy business, BioDevelopment Consulting, to provide expertise in advancing therapies from research into Phase 1 and Phase 2 clinical trials. Dr. Hoppe has Inventor status on four US granted patents addressing oncology, anaemia and cystic fibrosis diseases. He has authored numerous articles in noted scientific journals and has been the keynote speaker at a number of leading industry conferences. Dr. Hoppe holds a Ph.D. in Genetic Toxicology from Massachusetts Institute of Technology.

Piet Houwen

Piet Houwen

Head of Contract Manufacturing Operations | Sanofi Genzyme
Boston | Panels: Learning To Fly: How to support incremental innovative solutions | FDA, Regulatory and Quality Dynamics For Innovative Outsourcing

Piet Houwen is Head of Contract Manufacturing Operations at Genzyme. In this global role he oversees the network of external manufacturing partners. Prior to this role he held the position of Vice President & General Manager of Genzyme Geel,one of Genzyme’s strategic global manufacturing operations producing monoclonal antibodies and an enzyme replacement therapy for the treatment of Pompe disease. During his 20-year professional career, Piet has built up a strong track record in manufacturing in a dynamic international environment including Fast Moving Consumer Goods (Procter & Gamble), Food Manufacturing (Procter & Gamble, Geest), Pharmaceuticals (Janssen Pharmaceutica, Genzyme) and Consulting (PriceWaterhouseCoopers Consulting). He has experience in human resources, process engineering, project & line management and general management. Piet is recognized for his ability to work effectively across organizational and cultural boundaries. He has a passion for leading organizational change and motivating teams and individuals to adapt effectively to these changes. Piet graduated in 1992 from the Delft University of Technology and holds a Masters Degree in Mechanical Engineering.

BJ Hull

BJ Hull

VP/GM | Emergent Biosolutions
Boston | Panel: Costs and pressures rise...best efforts notwithstanding

BJ has over 24 years of experience in Quality, Engineering, Manufacturing, External Manufacturing, Operational Excellence, and Distribution in fast-paced, cGMP regulated facilities. He has technical expertise in all types of pharmaceutical manufacturing including: Sterile, Aseptic, Parenteral, Tablets, Semi-Solids and Biologics. BJ has proven success in leading continuous improvement in Pharmaceutical and Medical Device manufacturing environments using the latest equipment technologies and Lean/ Six Sigma methodologies. He has held the manufacturing site leadership role with full P&L responsibility for 3 companies as well as Regional Responsibilities for North America.

Brian James

Brian James

SVP Operations | Rondaxe
Boston | Panel: Costs and pressures rise...best efforts notwithstanding

Dr. James is a Vice President of Operations and has been with Rondaxe since 2006. Brian oversees project management, API synthesis design and API/Formulation sourcing support to our clients. He manages and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining Rondaxe, he was with Bristol-Myers Squibb for 7 years, where he honed his skills and expertise in API synthesis and sourcing strategies. Brian received both his Ph.D. in Chemistry from University of California, his M.B.A. from Le Moyne College, and performed his post-doctoral fellowship at Colorado State University

Peng Jiao

Peng Jiao

CEO | Boston Institute of Biotechnology
Boston | Panels: FDA, regulatory and quality dynamics for innovative outsourcing | Winning Workforce: a new generation in the supply chain

Dr. Peng Jiao has more than 25 years’ experience in bioprocess development, fermentation, mammalian cell culture, protein expression, technology transfer, scale-up/scale-down, and bio-manufacture. He has brought more than 8 products, including small molecules and protein products, from the R&D labs to the commercial productions. He has an in-depth knowledge of biochemical engineering and therapeutic protein expression. For years, he devoted himself to the next generation (advanced) bioporecess development and biomanufacturing technologies. He established and led a new lab from scratch for protein expression and fermentation at Novartis Biology (USA). Later on, Peng led the process development and commercialization production team and was responsible for some key projects on Advanced (next generation) Biomedical Development & Manufacture technologies from BARDA, HHS (Biomedical Advanced Research and Development Authority, Department of Health & Human Service) at Lonza Biologics (USA). Thereafter, Peng became the CEO of NewWay Biotech (China) and the CTO at Conagen (USA), and built up a state-of-the-art bio-manufacture facility (~1,000,000 square foot) in China. He also serviced as the Vice President of the Society for Biotechnology Industrialization during that period (China). In 2015, Peng founded Boston Institute of Biotechnology (USA), and has serviced as the President and CEO since then.

Jared Kaufman

Jared Kaufman

Associate Scientist | Boston Institute of Biotechnology
Boston | Panel: Winning Workforce: a new generation in the supply chain

Jared is a creative, diligent, and motivated Laboratory Research Associate with over five years Pharmaceutical industry experience and a strong background in academic research.

Shawn Kinney

Shawn Kinney

CEO | Berkshire Sterile Manufacturing
Boston | Panel: Learning To Fly: How to support incremental innovative solutions

Berkshire Sterile Manufacturing’s CEO, Dr. Kinney, is a seasoned chief executive with a technical background and more than 35 years of experience in sterile drug manufacturing and the filling of vials, pre-filled syringes, and custom containers. He utilized this knowledge by building a state-of-the-art fill/finish facility that utilizes isolators and flex filling, along with numerous industry innovations, to improve BSM’s clients sterility assurance and flexibility in their outsourcing needs. Prior to establishing Berkshire Sterile Manufacturing, Inc. (BSM), in 2014, Dr. Kinney was Vice President of Operations at Anika Therapeutics Inc. where he was responsible for sterile fill/finish of medical device and drug products in pre-filled syringes. In 1999 Dr. Kinney founded Hyaluron, Inc., a contract manufacturer providing aseptic manufacturing and filling services to the pharmaceutical, biotech and medical device industries. Among many successful initiatives as CEO, Dr. Kinney was responsible for bringing the first high speed vacuum filling/stoppering syringe filler to the United States, pioneered bubble-free filling, and authored two patents on the process. After the sale of Hyaluron to AMRI Global in 2010, and before launching BSM, Dr. Kinney provided technical and marketing consulting services to SiO2 Medical Products, focusing on the development of plasma-enhanced chemical vapor deposition (PECVD) coated parenteral containers. Dr. Kinney is a long-time member of the Parenteral Drug Association (PDA). He has Co-Chaired the Pre-Filled Syringe Conference and given numerous presentations at the PDA Pre-Filled Syringe and other industry conferences. Dr. Kinney holds a Doctorate in Chemistry from the University of Massachusetts at Amherst, an MS in Medicinal Chemistry from Northeastern University and a Bachelor of Science from Southeastern Massachusetts University.

Vince Kosewski

Vince Kosewski

VP Supply Chain Operations | Sunovion Pharmaceuticals
Boston | Panel: Costs and price pressures rise...best efforts notwithstanding

As Vice President, Supply Chain Operations at Sunovion Pharmaceuticals Inc, Vincent is responsible for contract manufacturing operations, production planning, technical services, warehousing and distribution. He also serves on multiple Joint Steering Committees for strategic alliances. Vincent joined Sunovion (formerly Sepracor) in 1998, and has held a series of positions of increasing responsibility, including Vice President and General Manager of Sepracor Canada Ltd, Sunovion’s active pharmaceutical ingredient manufacturing company, from 2010 to 2014. Prior to joining Sepracor, Vincent worked at Astra USA for eleven years, holding positions in quality assurance, manufacturing, procurement, supply chain management, business development and licensing. Vincent received a B.S in Chemistry from Fairfield University, and an MBA from Bryant University.

Keirnan LaMarche

Keirnan LaMarche

Senior Research Investigator | Bristol-Myers Squibb
Boston | Panel: Spotlight Technology: Continuous manufacturing and its broadest impacts

Keirnan LaMarche is a senior research investigator for the Drug Product Science and Technology department of Bristol-Myers Squibb. He has worked on innovative approaches to formulation and process development for solid dosage forms at BMS since 2008. While at BMS he has focused on developing material sparing approaches to understand the mechanisms of tablet compaction. Keirnan received his PhD in chemical engineering from Rutgers University in 2008. While at Rutgers he studied the impact of electrostatics on the flow of granular materials. Keirnan also received his master’s degree in chemical engineering from Rutgers in 2005 and his bachelor’s in chemical engineering from the Cooper Union for the Advancement of Science and Art in 2002.

James Lucie

James Lucie

Associate Director | AMAG Pharmaceuticals
Boston | Panel: Project Managers From The Frontlines: Four ways to avoid the worst battles

James's current responsibilities include commercial and clinical packaging, labeling and distribution. He has experience in clinical trials from phase 2-4, domestic and global studies, vendor management, and supply agreement negotiations.

Todd Mabe

Todd Mabe

Head of Biologics, Drug Substance | Genentech
Boston | Panel: Learning To Fly: How to support incremental innovative solutions

Todd Mabe is the Head of Commercial Biologic Drug Substance for External Quality where he leads 7 teams who oversee the Quality of product manufactured at CMOs for Genentech/ Roche. He is involved in the CMO lifecycle for selection, implementation, management and decommissioning. His team ensures that quality expectations are met for deviation management, change management, lot release, CAPA, APR, risk management, regulatory filings and inspections. In addition, he provides management oversight for product transfers of commercial Drug Substance to CMOs. His past experiences in the Biotech and the Pharmaceutical industry include QC release testing, Quality Management, Validation Management and Quality Consulting for multinational companies. His efforts helped Roche receive the 2010 “ISPE Facility of the Year Award” in Singapore.

Franco Negron

Franco Negron

President Drug Product Services | Patheon
Boston | Panel: A buyer's or seller's market? The truth about capacity and your supply chain needs

With more than 20 years of experience in the pharmaceutical industry, Mr. Negron joined Patheon in November 2009 as Vice President and General Manager of the company’s operations in Puerto Rico. Prior to joining Patheon, he served in various senior positions, including Global Vice President at Novartis Consumer Health, Over-the-Counter and Pharmaceutical Products with specific focus on global process improvement initiatives. Prior to that, he served as Vice President, Manufacturing and Supply at Valeant Pharmaceuticals and Site General Manager at McNeil Consumer Healthcare. Mr. Negron holds a Bachelor of Science in electrical engineering from the University of Puerto Rico.

Julia O'Neill

Julia O'Neill

Principal | Tunnell Consulting
Boston | Panels: FDA, Regulatory & Quality Dynamics For Innovative Outsourcing | Winning Workforce: A new generation in the supply chain

Julia is a global pharmaceutical leader with over 30 years of data science and process analytics experience in the vaccines, biologics, pharmaceutical and chemical industries. Her technical expertise spans research and development, manufacturing, corporate and direct customer support functions. She has a proven record of consistently building and leading technical teams to creative positive change and deliver transformational results. Prior to joining Tunnell, Julia was Director, Engineering, Global Technical Operations at Merck and Co. where she was responsible for development and deployment of process robustness strategy for manufacturing. Her team designed and deployed Continued Process Verification for vaccines and biologics, and supported CPV for all human health products. Previous positions include Senior Scientific Fellow – Statistics in Regulatory & Analytical Sciences at Merck; Director, Engineering, Vaccines and Biologics Technical Operations at Merck; and Powder Coatings Process Development Leader at Rohm and Haas Co. Julia is a Master Black Belt and expert in resolving challenging problems using statistical, engineering and Six Sigma methods. . MS, Statistics, University of Wisconsin BS, Chemical Engineering, University of Maine

Clive Patience

Clive Patience

VP, Asset Development & Program Management | Biogen
Boston | Panel: Spotlight Leadership Company: Biogen

Biography coming soon.

Brian Scanlan

Brian Scanlan

Managing Partner | Freedom Biosicence Partners
Boston | Panel: A buyer's or seller's market? The truth about capacity and your supply chain needs

Brian Scanlan has amassed more than 25 years of senior business, sales and strategic advisory executive management experience within the pharmaceutical services industry from startups through large, multinational corporations. With more than two decades of experience leading aggressive top and bottom line performance improvements, Scanlan has established himself as a leader in driving organic/inorganic growth in the pharma services sector including active pharmaceutical ingredient (API) development & manufacturing, proprietary technologies, solid state & analytical chemistry, formulation development, process chromatography, from early preclinical development to commercial production and global launch. As a senior corporate executive, sales turnaround specialist and interim executive/advisor assessing and overcoming business and leadership obstacles, Scanlan has developed a consistent success record in delivering rapid, high-impact results and establishing a refined, defendable strategy for future growth. As Founder & Managing Partner of Freedom Bioscience Partners, he leads management consulting services engagements providing a full range of service offerings and capabilities to pharmaceutical services companies (CROs/CMOs), technology companies, private equity firms, and investment banks. Prior to launching Freedom Bioscience Partners, L.L.C., he served as Chief Executive Officer/President, Chief Business Officer and Vice President of Corporate Development for Cambridge Major Laboratories. Prior to joining CML, Scanlan managed business development and technology marketing for Rhodia Chirex, a multinational pharmaceutical technology, development and manufacturing firm focused on API’s. In addition to his executive and sales leadership experience, Scanlan has also served on various industry and community boards and task forces, including serving on the Board of Governors and Bulk Pharmaceutical Task Force with the Society of Chemical Manufacturers & Affiliates (SOCMA), Founder of SE WI BioNet, Board of Directors with BioForward and Board of Trustees with The Leukemia & Lymphoma Society. Scanlan received his Master of Business Administration degree from the Illinois Institute of Technology in Chicago and a Bachelor’s degree in Chemistry from Northern Illinois University.

Milan Shah

Milan Shah

Head, Publishing, Global Capabilities IDAR | Johnson & Johnson
Boston | Panel: Project Managers From The Frontlines: Four ways to avoid the worst battles

Biography coming soon.

Bob Sheroff

Bob Sheroff

SVP Technical Operations | Agios Pharmaceuticals
Boston | Panel: A buyer's or seller's market? The truth about capacity and your supply chain needs

Bob Sheroff joined Agios in June 2015 as senior vice president, technical operations and has extensive manufacturing and quality teams leadership experience. Prior to joining Agios, Mr. Sheroff was vice president of technical operations for Fibrocell Sciences, a company focused on cell and gene therapy. Prior to this role, he served as the senior vice president of global supply chain at Biogen and was responsible for supply-chain logistics and external manufacturing. Earlier, he led the supply group and operations for the pharmaceutical sector of J&J, where he successfully introduced numerous new products across a range of therapeutic categories. Prior to that, he was worldwide vice president of quality for Warner Lambert where he was responsible for both pharmaceutical and consumer divisions of quality. Bob Sheroff is a graduate of Rutgers College of Pharmacy and earned his M.B.A. in pharmaceutical marketing from Fairleigh Dickinson University.

Patrick Soares

Patrick Soares

Sr. Director External Manufacturing | Biogen
Boston | Panel Spotlight Leadership Company: Biogen

Biography coming soon.

Charles Waldroup

Charles Waldroup

Director of Project Management | Metrics Contract Services
Boston | Panel: Project Managers From The Frontlines: Four ways to avoid the worst battles

Biography coming soon.

Kurt Wolf

Kurt Wolf

Director | Merck
Boston | Panel: Winning Workforce: A new generation in the supply chain

Kurt has over twelve years of experience in the pharmaceutical and medical device industries focusing on international finance operations, outsourcing, business development, process improvements, and operating strategy development.