Boston 2018

Cambrex

ISR Reports

 Life Science Leader

Life Science Training Institute

Outsourced Pharma

Skyland Analytics

Adesis, Inc.

AGC Biologics

Albemarle

Alcami

Avista Pharma Solutions

Berkshire Sterile Manufacturing

Boston Analytical

Boston Institute of Biotechnology

Coating Place, Inc.

CordenPharma International

Cytovance

Dottikon Exclusive Synthesis

Emergent Biosolutions

Howell Marketing Services

IDBS

ISR Reports

Jubilant Chemsys

Lifecore Biomedical

Life Science Training Institute

LSNE

Lyophilization Technologies

Masy BioServices

Metrics Contract Services

Myoderm

Olon Ricerca Bioscience LLC

Patheon, part of Thermo Fisher Scientific

PCI Pharma Services

PCI Synthesis

PharmAssist

Pharmatech Associates, Inc

Piramal Pharma Solutions

Procos SpA

Quotient Sciences

Raffles PharmaTech

Safebridge Consultants, Inc

Sherpa Clinical Packaging

SynConnection

Toxikon

Registration, Exhibit Hall Open, & Networking Breakfast

Collect your badge at registration and head over to the catered breakfast spread to enjoy while you mingle with fellow attendees.

Welcome & Conference Chair Opening Remarks

Louis Garguilo, Chief Editor / Conference Chair of Outsourced Pharma, kicks off the morning with opening remarks.

Help! The 7 Critical Areas Where Sponsors Need More Support

Executives at sponsor companies explore their seven most critical support needs for drug development and manufacturing. Learn how a lack of support in each area impacts their plans, and join a discussion on how sponsors and CDMOs can work together to solve each challenge.

• Mark Butchko, Sr. Dir., Quality Assurance | Eli Lilly and Company
• Sachin Chandran, Director, Pharmaceutical Sciences | Catabasis Pharmaceuticals
• Thomas Hazel, SVP, Research | Neuralstem
• Greg Zarbis-Papastoitsis, VP Process & Manufacturing | Compass Therapeutics
• Julia O'Neill, Principal | Tunnell Consulting (Moderator)

Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

How To Survive – And Even Benefit From – Your CDMO’s M&A

Your CDMO is being acquired or merging: How do you ensure your projects and company continue to receive the attention they deserve? Sponsors with firsthand experience detail specific steps you can – and should – take to ensure you don’t get lost in the M&A shuffle.

• Vince Ammoscato, VP, Site Head | Piramal Pharma Solutions
• David Brown, VP, Tech Ops | Alcresta Therapeutics
• Brian Scanlan, Managing Partner | Freedom Bioscience Partners
• Heinrich Schlieker, SVP Technical Operations | SAGE Therapeutics
• Lisa Wyman, Head, Quality | Mersana Therapeutics
• Mark Butchko, Sr. Dir., Quality Assurance - Development | Eli Lilly And Company (Moderator)

Networking Lunch

Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.

New Business Models With CDMOs Include Better Pricing

Today’s more creative sponsor-CDMO business models now include improved pricing strategies. Can these enlightened models and strategies work for you and your service provider? Here are some answers from three real-life case studies.

• Christine Carberry, COO | Keryx Biopharmaceuticals
• Hugh Wight, Vice President, Technical Operations | Allena Pharmaceuticals
• Eileen McCullough, VP Project and Program Management | Potenza Therapeutics 
• Stephen Lam, Head of Biologics | Thermo Fisher Scientific
• Patricia Seymour, Sr. Consultant | BioProcess Technology Consultants (Moderator)

Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

Spotlight Technology: Lowering Risk To Your Physical Supply Chain

Will your shipments of raw materials or finished goods get stolen, diverted, counterfeited … or simply disappear? Our experienced panelists present on the state of our physical supply, how to evaluate security risk in key areas of your supply chain, and lead you in a discussion of security technologies. Big or small, all biopharma companies should attend this session.

• Carl J. Accettura, Vice President and General Manager | PharmoRx Therapeutics
• Mike Long, Sr. Dir., Consulting Services & Principal Consultant | Concordia ValSource
• Chirag V. Shah, Director, Global Product Security | Sanofi
• Lee Spach, Director, Global Product & Supply Chain Security | Biogen
• Ron Guido, President | Lifecare Services (Moderator)

Networking Reception

You're invited to join us for an open bar reception featuring heavy hor d'oeuvres, desserts, and live music!

Exhibit Hall Open & Networking Breakfast

Head over to the catered breakfast spread to enjoy while you mingle with fellow attendees.

Conference Chair Day Two Opening Remarks

Louis Garguilo, Chief Editor / Conference Chair of Outsourced Pharma, kicks off day two with opening remarks.

How Small Sponsors Can Compete For Attention At Their CDMOs

Start-ups, virtuals, biotechs and smaller pharma compete with bigger sponsors for capabilities, capacity, better pricing … and just to maintain a service provider’s full attention. Some break through, while others feel marginalized. Our experienced professionals will offer strategies to help, and also discuss your experiences.

• Vincent Kosewski, SVP, Manufacturing & Supply Chain Management | Kala Pharmaceuticals
• Jim Nolan, Head, CMC Operations | Kyn Therapeutics
• Michael Markey, CMC Director | Radius Health, Inc.
• Thomas Holmes, Sr. Dir., Global External Manufacturing | Biogen
• Julia O'Neill, Principal | Tunnell Consulting (Moderator)

Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

Does Your Risk Management Plan Satisfy The FDA and SEC?

Regulatory scrutiny of your outsourcing activities isn’t limited to the FDA. The SEC is paying more attention to how you manage and disclose operational risks. Any drug developer receiving funding needs to listen to this panel discuss risk management and disclosure, best practices for data integrity and IP protection, and supply and quality agreements.

• Ranjani Prabhakara, Team Leader | FDA
• Robert Di Scipio, CEO | Skyland Analytics, Inc.
• John Lee, SVP, Pharmaceutical Development | Decibel Therapeutics
• Jason Foss, Managing Director | Results Healthcare 
• Jonathan Lieber, Chief Financial Officer | Histogenics (Moderator)

Networking Lunch

Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.

Aspects & Considerations For Dealing With Challenging CDMO Relationships

Shire will lead this discussion with a mini case-study about “inheriting" a CDMO relationship when it obtained a new product, and the resulting challenges with change control, deviation management, and regulatory implications that might end in difficulties if not handled correctly. We’ll get advice from all our panelists — and answer your questions — on dealing with the more challenging outsourcing relationships sponsors may face today.

• Barbara Glantschnig, VP, Quality | Shire
• Suzanne Murray, VP, Quality | Agios Pharmaceuticals
• Scott Willett, VP Biopharmaceutical Development | Promedior
• Brian Clark, Principal | GMP Operations Consulting, LLC (Moderator)

Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

Spotlight Leadership Company: Mersana Therapeutics

The President & CEO, CSO, and SVP of CMC for Mersana Therapeutics — an exciting Boston-area biotech reliant on strategic partnering — will provide best practices, advice, and real experiences in the art of outsourcing drug development and manufacturing.

• Anna Protopapas, President and CEO | Mersana Therapeutics
• Timothy Lowinger, Chief Scientific Officer | Mersana Therapeutics
• Tom Wagler, Executive Director, Drug Substance Development | Mersana Therapeutics
• Michael Kaufman, SVP, CMC | Mersana Therapeutics
• Louis Garguilo, Conference Chair and Chief Editor | Outsourced Pharma (Moderator)

Conference Chair Closing Remarks

Louis Garguilo, Chief Editor / Conference Chair of Outsourced Pharma, finishes the afternoon with closing remarks.