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

side background

 

Speakers by Show

San Diego | August 22 - 23, 2017

Confirmed speakers include:
Astellas | Brian Mendelsohn, Principal Scientist
Backfield PLLC | Katlin Backfield, Consultant
Biogen | Dan Gage, Senior Scientist
Eli Lilly and Company | Mark Butchko, Sr. Dir., QA, Product Research & Dev.
Elusys Therapeutics | Dennis Knox, Sr. Mgr., Quality
Latham Biopharma | Susan Dexter, Managing Director
MabVax Therapeutics | Paul Maffuid, EVP, Research and Dev.
Merck | Rachael Atlee, Regional Dir., ExM Sterile Tech-Ops
Neurocrine Biosciences | Scott Zook, VP, CMC Dev.
Nanomedical Diagnostics, Inc. | Francie Barron, VP, Biology & Regulatory Affairs
NovMetaPharma | Peter Lee, Vice President
Outsourced Pharma | Louis Garguilo, Conference Chair & Chief Editor
Packaging Technologies & Inspection | Oliver Stauffer, CEO
Pacira Pharmaceuticals, Inc. | Ray Kaczmarek, VP, Commercial Mfg. & Supply Ops.
Pfizer | Firelli Alonso, Sr. Dir., Biotherapeutics & Vaccines Outsourcing
Pfizer | Bernie Huyghe, Sr. Director
Pfizer | Sylvie Sakata, Sr. Dir., External Research Solutions
Quality Consulting Associates | Mitchell Rosner, Principal Consultant
Rondaxe | Brian James, SVP, Operations
STA Pharmaceutical, A WuXi AppTec Company | Antonio Garrido-Montalban, Executive Dir.
Tioga Research, Inc. | John Newsam, CEO
Vertex Pharmaceuticals | Ben Littler, Sr. Dir., Process Chemistry

 

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

Firelli Alonso

Firelli Alonso

Sr. Dir., Biotherapeutics & Vaccines Outsourcing | Pfizer
San Diego | Antibody-Drug Conjugates: ADCs As An Innovation Model For Outsourcing

Dr. Firelli Alonso is Senior Director, External Supply at Pfizer, Inc. She heads the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. Fi has more than 33 years of combined experience in research, development, and cGMP production of biological products and vaccines, and more than 11 years of experience in outsourcing, project / contract management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and vaccine development, biotherapeutics and vaccine process development and cGMP production, project management, technology transfer, outsourcing, and budgets and operations. She obtained her Ph.D. in Microbiology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University Center for Advanced Biotechnology and Medicine. Prior to working for Wyeth / Pfizer in 1996, Fi was at The Salk Institute (Government Services Division), a vaccine contract manufacturer for the U.S. Army.

Rachael Atlee

Rachael Atlee

Regional Director, ExM Sterile Tech-Ops | Merck
San Diego | You Can’t Outsource Data Integrity | The Fast And Slow Of Tech Transfer: Success In The Balance

Biography coming soon.

Katlin Backfield

Katlin Backfield

Attorney at Law & Consultant | Backfield PLCC
San Diego | Regulatory Dynamics For Innovation: Safety First, Please |  You Can’t Outsource Data Integrity

With over 15 years of experience as a pharmaceutical regulatory attorney, including 10 years at the Food and Drug Administration, Katlin McKelvie Backfield uses her extensive expertise to help companies navigate the pre- and post-approval stages of development. Katlin served as Associate Chief Counsel for Drugs with the Office of Chief Counsel at FDA for nine years. She was a regulatory counsel in the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research at FDA from 2006 to 2008. Prior to joining FDA, Katlin was an associate at Hogan Lovells, LLP, and a law clerk for the Honorable Douglas P. Woodlock of the U.S. District Court for the District of Massachusetts. She graduated cum laude from Georgetown University Law Center in 2001 and received her undergraduate degree from Davidson College. Katlin is a member of the Food and Drug Law Institute's Academic Programs Committee and has served as a speaker for multiple FDLI training programs.

Francie Barron

Francie Barron

VP, Biology & Regulatory Affairs | Nanomedical Diagnostics, Inc.
San Diego | Regulatory dynamics for innovation: Safety first, please

Biography coming soon.

Mark Butchko

Mark Butchko

Sr. Dir., QA, Product Research & Development | Eli Lilly and Company
San Diego | Spotlight Technology: Yes, You Need To Take The Pulse Of Packaging Now

Dr. Butchko is currently Senior Director of Quality Assurance for Eli Lilly and Company in Indianapolis, IN, supporting Lilly’s Product Research & Development organization. Mark has over 17 years of experience in the pharmaceutical industry, joining Lilly in 2000 as a Senior Organic Chemist to develop, optimize, and scale-up manufacturing routes for Lilly’s Active Pharmaceutical Ingredients (API’s). He subsequently served as Manager of Lilly’s Technical Services organization, supporting day-to-day cGMP commercial manufacturing activities in Lafayette, IN. In his current role, Mark provides Quality oversight for internal and external cGMP activities associated with Lilly’s clinical development pipeline and interacts extensively with global collaboration partners and regulatory agencies. He received his Ph.D. in Chemistry from the University of Notre Dame (Notre Dame, IN), and his B.S. Degree in Chemistry from King’s College (Wilkes-Barre, PA).

Susan Dexter

Susan Dexter

Managing Director | Latham Biopharma
San Diego | Panel TBA

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.

Dan Gage

Dan Gage

Senior Scientist | Biogen
San Diego | Is Your CMO Listening: Different Breeds and Different Needs of Sponsor Companies | The Fast And Slow Of Tech Transfer: Success In The Balance

Biography coming soon.

Louis Garguilo

Louis Garguilo

Chief Editor & Conference Chair | Outsourced Pharma
San Diego | Panel TBA

Louis Garguilo is chief editor and conference chair for Outsourced Pharma, and a contributing editor to Life Science Leader magazine. He studied public relations and journalism at Syracuse University (and holds a Master’s in English), and has 30+ years of international experience in business communications and development positions. Louis spent a decade at a global pharmaceutical contract research, development and manufacturing organization; served under the governor of New York in the state’s economic development agency, as liaison to the pharmaceutical/biotechnology industry; was chief strategic officer for an e-learning software company; and spent most of the ‘80s and ‘90s in Japan as an educator, author, and business communications consultant, including for the Osaka Medical Center for Cancer and Cardiovascular Diseases.

Antonio Garrido-Montalban

Antonio Garrido-Montalban

Executive Dir., San Diego Facility Site Head | STA Pharmaceutical, a WuXi AppTec Company
San Diego | The fast and slow of tech transfer: Success in the balance | New methods for qualifying your service providers, and benchmarking performance

Antonio started his chemistry career as a laboratory technician in the than chemical giant Hoechst AG in Frankfurt, Germany. After obtaining his chemical engineering degree from the University of Applied Sciences in Darmstadt, Germany, he moved on to complete an MSc and PhD in Synthetic Organic Chemistry at the University of East Anglia, England, under the direction of Prof. McKillop. Antonio then joined Prof. Barrett’s group at Imperial College London to pursue postdoctoral studies and stayed on as an Assistant Professor before accepting a medicinal chemistry position at the San Diego based biotech company Kemia. More recently, he was the Head of Chemical R&D at Arena Pharmaceuticals and now the Executive Director and Site Head of the STA San Diego site.

Bernie Huyghe

Bernie Huyghe

Sr. Director | Pfizer
San Diego | Regulatory Dynamics For Innovation: Safety First, Please

A Biopharmaceutical professional with a proven record of effectively managing research, development operations and manufacture of biological therapeutics both internally and outsourced. Technical expertise includes development of novel technologies, recombinant mammalian, microbial and synthetic systems: monoclonal antibodies, first-in-class protein conjugates, antibody drug conjugates (ADCs), synthetic peptides, recombinant proteins, DNA plasmid and viral vector gene therapy products. Expert in purification process development, analytical methods development, formulation development, ADME characterization, process scale-up, and technical transfers. Extensive experience in outsourced cGMP manufacture, contract negotiations, CMC regulatory maintenance, Due Diligence exercises, Quality auditing, Quality Assurance Agreements and authoring IND CMC sections. Regulatory Affairs Certified (RAC).

Brian James

Brian James

SVP, Operations | Rondaxe
San Diego | You Can’t Outsource Data Integrity

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

Ray Kaczmarek

Ray Kaczmarek

VP, Commercial Mfg. & Supply Ops. | Pacira Pharmaceuticals, Inc.
San Diego | Spotlight Technology: Yes, you need to take the pulse of packaging now | New methods for your service providers, and benchmarking performance

Biography coming soon.

Dennis Knox

Dennis Knox

Sr. Mgr., Quality | Elusys Therapeutics
San Diego | Is Your CMO Listening: Different Breeds and Different Needs of Sponsor Companies

Biography coming soon.

Peter Lee

Peter Lee

Vice President | NovMetaPharma
San Diego | New methods for qualifying your service providers, and benchmarking performance

Biography coming soon.

Ben Littler

Ben Littler

Sr. Dir., Process Chemistry | Vertex Pharmaceuticals
San Diego | The Fast And Slow Of Tech Transfer: Success In The Balance | Regulatory Dynamics For Innovation: Safety First, Please

Ben Littler received his BA in Chemistry from the University of Oxford and his PhD in Organic Chemistry from the University of Bristol. After completing postdoctoral studies at North Carolina State University he joined the Chemical Development team at AMRI in Albany, NY in 1999. In 2004 Ben joined Vertex Pharmaceuticals in Boston, MA, and since 2005 he has led the Process Chemistry team in San Diego, CA. During his time at Vertex he has worked on over 20 clinical candidate molecules in disease areas including cystic fibrosis, hepatitis C, oncology and pain, at all stages of development ranging from pre-clinical development to Phase 3 manufacture, in roles from bench scientist to global project leader. Ben is currently a Senior Director in the Process Chemistry team, the leader of Vertex’s global cross-functional team to implement continuous manufacturing for small molecule APIs, the author of 14 journal publications and an inventor on 15 patents.

Paul Maffuid

Paul Maffuid

EVP, Research & Development | MabVax
San Diego | Antibody-Drug Conjugates: ADCs As An Innovation Model For Outsourcing | Is Your CMO Listening: Different Breeds and Different Needs of Sponsor Companies

Biography coming soon.

Brian Mendelsohn

Brian Mendelsohn

Principal Scientist | Astellas
San Diego | Antibody-Drug Conjugates: ADCs As An Innovation Model For Outsourcing

Biography coming soon.

John Newsam

John Newsam

CEO | Tioga Research, Inc.
San Diego | The Fast And Slow Of Tech Transfer: Success In The Balance | Is Your CMO Listening: Different Breeds and Different Needs of Sponsor Companies

John M Newsam is CEO of Tioga Research, a CRO that specializes in the research and early development of formulations applied topically. Much of Tioga Research’s global reputation derives from special expertise in formulation innovation (especially leading to patentable compositions) and in performance measurement (with strong capabilities for measuring skin permeation and delivery both by conventional techniques and by high throughput experimentation). John has served in executive roles since 1996. He was CSO of Molecular Simulations Inc. (now Accelrys - from 1996, acquired by Pharmacopeia, Inc. in 1998), Office of the President for hte Aktiengesselschaft (from 2000, acquired by BASF in 2008), CEO of fqubed, Inc. (from 2002, acquired by Nuvo Research in 2005), CEO of Bio4Front, Inc., and Senior VP of Business Development for Nuvo Research, Inc. (from 2009, CA:NRI). John serves as ‘Chemistry Expert’ for the American Chemical Society, and as Chair Elect of the Section on Industrial Science and Technology of the American Association for the Advancement of Science. .

Julia O'Neill

Julia O'Neill

Principal | Tunnell Consulting
San Diego | Regulatory Dynamics For Innovation: Safety First, Please

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.

Mitchell Rosner

Mitchell Rosner

Principal Consultant | Quality Consulting Associates
San Diego | Antibody-Drug Conjugates: ADCs As An Innovation Model For Outsourcing

Mitchell H Rosner received his BS in Chemistry from George Washington University (1982) and MS in Toxicology (1985) plus PhD in Pharmacology and Toxicology with a minor in Pharmaceutical Sciences (1989) from the University of Arizona. He began his career as a toxicologist but changed his scope of work to include analytical and process development, formulation development, instrumentation design, technology transfer, validation, quality control and quality assurance. Mitch began his industrial career as an analytical biochemist at IDEC Pharmaceuticals (Biogen) and continued his applied analytical career at CV Therapeutics (Gilead Sciences) and Nektar Therapeutics (Novartis). His roles progressed from Scientist to Senior Director including positions in Quality Control, Analytical Development, and Pharmaceutics. After serving as acting COO at an instrumentation start-up Infrasign, he joined Algenol Biofuels as Senior Director of Analytics and Bioinformatics and at Synthetic Genomics heading Analytical Chemistry and Quality. Mitchell Rosner, PhD is currently Principal Consultant at Quality Consulting Associates.

His work at virtual and start-up companies and large multi-nationals entities has enabled him to provide value-added contributions at all types of organizations. He has contributed to 7 approved products and has multiple patents. These categories of the products have been therapeutic, diagnostic and nutritional supplements. Mitch has held several leadership positions in his career. He is a certified chemist (ACS), project manager (MPM through AAPM), HACCP manager (NEHA) and auditor (CBA and CQA through ASQ).

Sylvie Sakata

Sylvie Sakata

Senior Director, External Research Solutions | Pfizer
San Diego | New Methods For Qualifying Your Service Providers, and Benchmarking Performance

Biography coming soon.

Oliver Stauffer

Oliver Stauffer

CEO | Packaging Technologies & Inspection
San Diego | Spotlight Technology: Yes, You Need To Take The Pulse Of Packaging Now

Biography coming soon.

Scott Zook

Scott Zook

VP, CMC Development | Neurocrine Biosciences
San Diego | The Fast And Slow Of Tech Transfer: Success In The Balance

Biography coming soon.