This interactive Forum will help attendees understand the FDA and how to achieve maximum success and avoid common pitfalls when working with the agency in early drug development. Our panel of experts, including a former FDA investigator, will cover the following topics: 

• Overview of the FDA’s structure and function
• How did we get here? The Evolution of FDA                                                   
• Getting into the Clinic: The IND and Case Studies
• Chemistry, Manufacturing and Controls – Why is CMC is so Important to FDA?

Come join the discussion and take away a deeper understanding of FDA expectations and valuable tips for improved communication.

Speaker:

• Drew Barlow, M.P.H., Senior Director, Regulatory, Syner-G Pharma CMC Consulting
• Julia Morteo, Associate Director, Regulatory Affairs, Stealth BioTherapeutics

Moderator:

• David S. Mantus, Ph.D., Vice President Regulatory Affairs & Quality Assurance, BIND Therapeutics

Bios:

Drew Barlow, M.P.H., Senior Director, Regulatory, Syner-G Pharma CMC Consulting

Drew Barlow has over 15 years of experience in CMC regulatory affairs & quality compliance.  After a stint in clinical research at Wake Forest University, Drew began his tenure with the Food and Drug Administration in the Office of Regulatory Affairs.  With the Agency Drew carried out investigations, inspections and other assignments over FDA regulated industries, specializing in pharmaceutical manufacturers and GMP compliance.  Joining Vertex Pharmaceuticals in 2006, Drew established the post approval CMC regulatory group and oversaw numerous small molecule development projects in a variety of disease areas. He then brought his regulatory CMC strategy expertise to Alkermes plc where he led multiple global late phase programs. Drew joined the Syner-G team in January of 2015. His areas of expertise include devising & implementing CMC strategies for worldwide marketing applications, agency meeting planning & facilitating, post approval regulatory reporting, IND and IMPD preparation, GMP inspection readiness, and Quality by Design implementation.  Drew received a B.S in Biology from Mount Saint Mary’s College in Maryland and a Master’s in Public Health from The University of North Carolina at Greensboro.

David S. Mantus, Ph.D., Vice President Regulatory Affairs & Quality Assurance, BIND Therapeutics

Dave Mantus has been working in Regulatory Affairs for 23 years both in industry, as a consultant and as a professor. Dr. Mantus served as Vice President, Regulatory Affairs at Cubist Pharmaceuticals and held various regulatory roles at Sention Inc., Shire Biologics, PAREXEL, the Massachusetts Public Health Laboratory, and Procter and Gamble Pharmaceuticals. He is a co-author of a book on regulatory affairs, “FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics,” that is in its third edition, and has published numerous scientific papers and done presentations around the world. In 2009, Dr. Mantus was named Citizen Schools (www.citizenschools.org) “Citizen Teacher of the Year” for his work teaching at the Edwards Middle School in Charlestown, MA. Dr. Mantus received his B.S. in Chemistry at the College of William and Mary, his M.S. and Ph.D. in Chemistry from Cornell University and was a post-doctoral research fellow in Biomedical Engineering at the University of Washington.

Julia Morteo, Associate Director, Regulatory Affairs, Stealth BioTherapeutics

Julia has nearly 10 years of extensive Regulatory Affairs experience, serving functions in Regulatory Operations, Regulatory-CMC, and Regulatory Strategy.  Julia spent 8 years at Cubist Pharmaceuticals, where she helped bring eCTD submission capabilities in house, was responsible for the CMC content of marketing applications for CUBICIN® in over 50 countries worldwide, and provided Regulatory support on pre- and post-approval programs.  For the past several years, Julia has functioned as the Global Regulatory Strategy lead on more than 10 development programs ranging from pre-clinical to Phase 3 across multiple therapeutic areas.  Julia has led numerous successful IND submissions, IND amendments, and FDA meetings.  Julia has been with Stealth BioTherapeutics since 2014, where she is the Regulatory lead on Stealth’s Phase 2 neurologic rare disease and CV/Renal programs.  Julia graduated from Mount Holyoke College, where she was a double major in Religion and a self-designed major in Science and Medicine in Cultural Perspective. 

DeltaV Implementation I

CEUs: 3.2

Course: September 28, 2015 - October 2, 2015

REGISTRATION DEADLINE: August 28, 2015

This 4.5-day course covers a complete DeltaV System implementation. Upon completion of this course the student will be able to define system capabilities, define nodes, run diagnostics, configure continuous and sequential control strategies, operate the system and define users and security.

This course is taught by a certified Emerson Process Management instructor in conjunction with the New England Controls office in Massachusetts.

*MassBio members are elligible for a 10% discount off of select DeltaV courses in 2015  - use promo code "MassBio" during registration

Price per student = $4,600 (includes lunch each day & equipment)

Enroll Now!

Synthetic Biology Career Fair at the iGEM Giant Jamboree

As part of the iGEM 2015 Giant Jamboree weekend, iGEM is hosting a  career fair for the synthetic biology community.

This unique opportunity offers you a chance to meet with our talented pool of iGEM participants and discuss career opportunities. 

The event features a career fair format with the opportunity for you to address attendees at the start of the event with you message and needs.

• Companies looking to hire can connect with our large community of highly knowledgeable and talented participants working in synthetic biology.

• Universities with synthetic biology programs are invited to exhibit and promote their school, program and post-doc or graduate openings to the iGEM attendees.

For more information on this event and how to participate please click here or contact us at hq@igem.org

About The iGEM Program and Giant Jamboree

iGEM, the International Genetically Engineered Machine Competition, a non-profit organization and a community of over 18,000 young scientists and leaders in synthetic biology. Inspiring learning and innovation in synthetic biology through competition, the iGEM program is the premiere synthetic biology competition for both university and high school students.

Our main event, the Giant Jamboree (held on September 24-28, 2015, Boston, MA), is the culminating event of the iGEM 2015 competition season. This 5-day event showcases synthetic biology achievements of both collegiate and high school participating teams spanning all disciplines, backgrounds and interests. The Jamboree features team presentations and exhibition hall poster sessions, workshops, networking sessions, panel discussions, an award ceremony and much more!  For more on the iGEM experience click here: video compilation of iGEM teams, their projects and their experiences

The one-day science symposium will focus on the explosion of knowledge about past and present DNA, and will include discussions about possible directions and applications for future research. The event will include experts in ancient DNA, de-extinction, human origins, population genetics, forensic science, ethics, business, future synthetic life, and the personal genome.  

This event is free and open to the public.

Registration is required. You can register by going to https://www.radcliffe.harvard.edu/event/2015-past-present-future-dna-symposium

What you need to be doing now, to ensure a successful experience in January!

The annual JP Morgan Healthcare Conference (JPM) in San Francisco is one of the largest and most informative healthcare investment meetings in the industry.  It brings together global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.  Each year hundreds of organizations deliver presentations to over 4,000 investors. In addition, thousands of participants in the biotech and pharma universe descend upon San Francisco to network, attend meetings and gain an inside view for the year ahead outside of the conference itself.

Are you ready to make the most of the 34th JPM which will be held January 11 – 15, 2016?

Join us for a JPM 2016 primer event where veteran participants will provide guidance and share tips on topics such as:

• Factors to consider in deciding to attend JPM
• Why you need to plan your JPM strategy early
• Preperation tactics for the most productive conference possible
• How to navigate the main invitation-only conference and the satellite events
• Understanding the goals of other participants
• How to get your organization noticed at JPM
• General do’s and don’ts

Speakers:

• Frank Borriello, MD, PhD, VP, Head of Search and Evaluation, Global Business Development, Baxalta US Inc.
• Ann Dewitt, PhD, MBA, Senior Director of Investments, Sanofi-Genzyme BioVentures
• John Dyer, MBA, Managing Director, Aquilo Partners
• Barbara S. Fox, PhD, Founder & CEO, Avaxia Biologics, Inc.

Moderator:

• Marcia A. Kean, Chairman, Strategic Initiatives, Feinstein Kean Healthcare

Bios:

Frank Borriello, MD, PhD, VP, Head of Search and Evaluation, Global Business Development, Baxalta US Inc.

Frank has been a pharmaceutical industry professional since 1999 beginning in Clinical Research and transitioning to business development  by way of a 7-year stint in the financial industry as a biotech buy-side analyst. Now a pharmaceutical BD professional since 2008 beginning with Millennium, (later Millennium: The Takeda Oncology Company), Shire and now Head of Search and Evaluation at Baxalta since 2014.

A physician-scientist trained in clinical pathology and immunology research with a broad practical hands-on experience in all aspects of business development including search, technical due diligence, commercial, financial and strategic evaluation. 

Prior to joining the industry Frank was a faculty member at the Brigham and Women’s Hospital where he conducted basic immunology research in the field of T –cell costimulation. 
Frank is a graduate of NYU and the Albert Einstein College of Medicine.

Ann DeWitt, PhD, MBA, Senior Director of Investments, Sanofi-Genzyme BioVentures

Ann joined SGBV in 2013 with a background in biotech partnering and early stage investment. Prior to SGBV, Ann was  Senior Director, Corporate Development at Permeon Biologics and also a Senior Associate at Flagship Ventures. Before HBS, she worked at 3M Company in corporate research and in business units, including 3M Pharmaceuticals, and was a Technical Circle of Excellence Award winner. Ann holds a Ph.D. from MIT in systems biology, and an M.B.A. from Harvard Business School, and she is on the Life Sciences Council of Springboard Enterprises, an organization dedicated to building high-growth technology-oriented companies led by women.

John Dyer, Managing Director, Aquilo Partners

John joined Aquilo Partners in 2009 from JP Morgan, where he was an Executive Director in the healthcare investment banking group. Joining JP Morgan in 2006, John advised public and private biotechnology clients on a wide range of strategic and financing engagements. From 2000 to 2006, John was a member of the healthcare investment banking group at Cowen and Company in New York and San Francisco, where he focused on small and mid-cap public and private biotechnology clients.

His experience includes biotech/pharma partnering, sellsides, acquisitions, divestitures, IPOs and follow-on offerings in the biotechnology, specialty pharma and diagnostics sectors. Prior to joining Aquilo, John's advisory transaction experience includes Medivation's collaboration with Pfizer, Myriad Genetics' spin-off of its pharmaceutical business and Agensys' sale to Astellas. John also led financings for Seattle Genetics, Genomic Health, Array BioPharma, Myriad Genetics and MannKind.
John received a Masters in International Business Administration from the Moore School of Business at the University of South Carolina, where he graduated Beta Gamma Sigma, and a BA from the University of Virginia.

In July 2012, John opened Aquilo’s office in Cambridge, MA.

Barbara S. Fox, PhD, Founder & CEO, Avaxia Biologics, Inc.

Barbara S. Fox, PhD, is founder and CEO of Avaxia Biologics, a leader in the growing field of gut-targeted therapeutics. Avaxia’s lead clinical candidate, AVX-470, is an oral anti-TNF antibody for inflammatory bowel disease. Dr. Fox’s previous positions have included Affiliated Entrepreneur at Oxford Bioscience Partners; founder and CSO of Recovery Pharmaceuticals; VP Discovery and Immunology at ImmuLogic Pharmaceutical Corp.; and Associate Professor of Rheumatology at the U. Maryland School of Medicine. Dr. Fox received her AB in chemistry from Bryn Mawr, her PhD in chemistry from MIT and trained as a post-doc in cellular immunology at the NIH. She was an EY Entrepreneur Of The Year™ 2014 Award finalist in New England.

Marcia A. Kean, MBA, Chairman, Strategic Initiatives, Feinstein Kean Healthcare

Marcia Kean has driven Feinstein Kean Healthcare’s unique national role as a strategy and communications consultancy in the life sciences and healthcare since the firm’s inception almost 30 years ago.  She served as the Chief Executive Officer of the firm from 2002 to 2011, and became Chairman, Strategic Initiatives in 2011.  Throughout her career, Marcia has stood alongside innovators whose disruptive technologies and ideas have transformed the landscape of biomedicine.  She has counseled dozens of senior management teams in corporate positioning and product communications, crisis communications, investor relations, policy development and constituency-building.  Her clients include Big Pharma; biopharma, device, informatics, and digital health start-ups; policy organizations; academic/medical centers; patient advocacy groups; and federal government agencies.  

In recent years, Marcia has spearheaded Turning the Tide Against Cancer, a multi-stakeholder policy initiative dedicated to preserving innovation in cancer research and care.  She also leads Feinstein Kean’s partnering role in iConquerMS™, a PCORI-funded patient-driven research initiative in the field of multiple sclerosis.

Marcia serves on the Board of Directors of Atentiv, Inc.  She holds an M.B.A. in finance from New York University and a B.A. from the University of California at Berkeley.

There is a pressing need for pediatric research and the development of an ethical framework to protect the children that participate.
 
Children are not mini-adults and differ in many aspects of clinical development, including capabilities for drug administration, age appropriate end-points, medicine-related toxicity, and taste preferences. To ensure adequate treatment of all children in pediatric clinical research, different routes may be required.  
 
In this Forum we will explore:

• Best approaches to develop the appropriate pediatric clinical study protocols
• The continued prioritization and recognition of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers
• Clinical feedback and practice-based evidence on the impact of novel formulations and how to use existing data to facilitate pediatric formulation development
• Regulatory considerations (requirements and incentives) and timing for pediatric drug development
• Strategy and Pharmacoeconomics
• Transparent market access evidence requirements in the EU

Come join the conversation and hear our panel of experts discuss case-studies and learn how physicians, formulators, regulatory and market access experts are working together to address these challenges.  

Speakers:

• Julia A. Gaebler, PhD, Vice President, Global Market Access, Health Advances
• David Goldman, PhD, Formulation and Process Director, ex Biogen
• Donna E. Supko, PhD, Senior Director,  Regulatory Affairs, Sanofi
• Blythe Thomson, MD, Senior Medical Director, Pediatric Oncology Clinical Research, Epizyme

Co-Moderators:

• Eleni Dokou, PhD, Senior Director, Formulation Development, Vertex Pharmaceuticals
• Angelos Dovletoglou, PhD, Executive Director, Preclinical Development & Acting Head of Regulatory Affairs, Epizyme, Inc.

Bios:

Angelos Dovletoglou, PhD, Executive Director, Preclinical Development & acting Head of Regulatory Affairs, Epizyme, Inc.

Angelos has served as the head of preclinical development at Epizyme since 2011 and acting head of regulatory affairs since Jan 2105.  Prior to joining Epizyme was responsible for all small molecules CMC teams supporting neurology, and immunology oncology programs from discovery to commercial launch at Biogen Idec and coordinated the CMC development and manufacturing plans for the oral MS drug Tecfidera (BG-12).  Prior to that, at Merck Research Labs and Momenta Pharma Angelos managed early- and late-stage CMC development activities, and developed and implemented CMC strategies in support of global filings.  Over the last 20 years has contributed to 20+ INDs, six NDA/WMA filings and commercial manufacturing launches and multiple FDA pre-approval inspections.  He has been a member of the SAB at Cocoon Biotech since 2013 developing novel OA therapies.  Dr. Dovletoglou earned his Ph.D. in Inorganic Chemistry from the University of North Carolina at Chapel Hill and B.S. in Chemistry from the University of Athens, Greece.

Julia A. Gaebler, PhD, Vice President, Global Market Access, Health Advances

Julia has accumulated over 15 years of experience in pharmacoeconomics, market access, health policy, and health services research in both the biopharma industry and academic research. A mathematical modeler by training, she leads Health Advances’ Global Market Access and Health Economic capabilities.

Immediately prior to joining Health Advances, Julia worked at Biogen Idec as Senior Director, Global Medical Outcomes Strategy where she provided strategic leadership and technical health outcomes expertise to ensure that medical product strategies and tactics anticipated the evolving demands of the global payer landscape.  At Biogen she was also Director, Global Market Access where she built and managed a team of Health Economics and Outcomes Researchers (HEOR) responsible for payer value evidence development for the Company’s late stage development products, and led the global reimbursement and market access launches for TECFIDERA and FAMPYRA for Multiple Sclerosis.  Julia has also held related positions at Amylin Pharmaceuticals and Hoffmann-La Roche where she supported payer and ‘Real World Evidence’ development for Phase II/III products in Diabetes, Obesity, HIV/AIDs and Hepatitis.  In addition to her leadership positions in industry, Julia was Health Policy Researcher at the RAND Corporation where she applied her decision analytic methods to international and domestic health policy issues. Using a range of modeling and micro-costing methods, her research has explored the effectiveness and cost-effectiveness of health, medical, and diagnostic interventions for multiple infectious diseases, diabetes and hypertension, and the transmission of antibiotic drug resistance.

Julia holds a Doctorate in Health Policy and Decision Analysis from Harvard University, a Masters in International Economics from Johns Hopkins University, and a BA from the University of Pennsylvania.  She has held Adjunct Faculty positions at UCSD Division of Global Public Health and at the RAND Corporation and has published many articles on health technology assessment in journals such as Nature, Health Services Research, Diabetes Medicine, and Plos Medicine.

David Goldman, PhD, Formulation and Process Director, ex Biogen

David has over thirty years of pharmaceutical experience with a focus on activities related to new product development.  His most recent work has been with Cambridge based companies developing small molecule drug products including formulation development, process development and commercial manufacturing.  His prior Pharma experience was with Biogen, Bayer Pharmaceuticals, Hoffmann-La Roche and Wyeth Laboratories.  He founded MedCrystalForms (MCF), a drug delivery company and has led MCF in the development of progesterone and other natural hormonal products.  He is the inventor of MCF’s solubility enhancing technology.   MCF’s lead products have progressed through preclinical studies and proof of concept clinical PK trials.  He has also served on topical microbicide grant review committees for the NIH and obtained a grant from CONRAD for the solubility enhancement of UC781 which is used as a potential HIV preventive treatment.
David received his PhD in Medicinal Chemistry from SUNY Buffalo and undergraduate degree in Pharmacy from Idaho State University.

Donna E. Supko, PhD, Senior Director, Regulatory Affairs, Sanofi

Donna has over 20 years of regulatory experience supporting development and commercialization of drugs, biologics, and Class III medical devices.  After starting her career at the National Institutes of Health (NIAID/DAIDS) she has worked in a variety of therapeutic areas for both large and small pharmaceutical companies in the Boston area.  She has been with Sanofi for the past 3 years leading regulatory strategy for cardiovascular and oncology programs.  Her educational background is in pharmacy with a BS from the Philadelphia College of Pharmacy, MS in Pharmaceutics and Pharmaceutical Chemistry and PhD in Pharmacology from the Ohio State University.   

Blythe Thompson, MD, Senior Medical Director, Pediatric Oncology Clinical Research, Epizyme, Inc.

Blythe received her MD from the Ohio State University.  Following completion of her Pediatric Hematology/Oncology fellowship at Fred Hutchinson Cancer Research she held academic appointments at Riley Hospital in Indianapolis, Cincinnati Children¹s and Seattle Children¹s.  At Seattle Children’s Hospital, she was a Clinical Professor and the Medical Director of the Pediatric Clinical Research Center. In April, 2014, she joined Epizyme in Cambridge, MA as a medical director and currently leads their clinical investigations for the DOT1L inhibitor, pinometostat for MLL rearranged leukemia and EZH2 inhibitor, tazemetostat in NHL and solid tumors.

CALLING ALL ENTREPRENEURS!

On Thursday, October 8^th, 2015, senior leaders from Boehringer Ingelheim and Boehringer Ingelheim venture fund will host the first ever Boston Innovation Prize!

All innovators, early-stage entrepreneurs, intrapreneurs and spin-outs, pursuing life science therapeutic platform technologies and therapeutics agnostic of indication and modality are invited to apply to participate in the first ever Boehringer Ingelheim Boston Innovation day for a chance to win a $50,000 cash prize.

For more information on how to apply –read the BI official announcement.

When: Thursday, October 8^th, 2015

Time: 2:00 p.m. – 7:30 p.m.

Where: MassBio offices and Catalyst restaurant at 300 Technology square, Cambridge

APPLICATION DEADLINE – September 30th, 2015 C.O.B

APPLY NOW

For question, please contact Rakhshita Dhar or Anna Christo at Rakhshita.dhar@massbio.org at Anna.christo@massbio.org

Devin Leake, Ph.D., VP of Research and Development at Gen9, Inc. will present methods and scientific examples of how the BioFab process and the megabases of DNA it creates is changing how molocular biology is done. 

Lunch will be provided. 

“Value" is becoming is increasingly critical for innovators to deliver to both patients and the healthcare system overall -  without value there may be approval but neither reimbursement by payers, adoption by providers nor acceptance by patients.  

Large biopharma companies have active programs in this area, including significant investments in real-world data and advanced clinical analytics to model clinical trials, drive value and pragmatic studies, and to deploy new value-focused patient services.

To date early stage biopharma have had a limited ability to make these investments, access these assets, or incorporate value criteria in the structure of their therapeutics programs and early phase clinical designs.  

MassBio, Accenture, and Altius Strategy Consulting have created a three part Value series as a way to create awareness and establish a set of forums wherein large pharma/biopharma, early stage companies and technology providers can convene to:

• Define the needs around Value
• Determine current capabilities
• Explore new models for collaboration
• Create an agenda for support and infrastructure that can inform regional development initiatives

Please join us on October 5^th as of a group of key opinion leaders make The Case for Value.

Presentation:

• Peter Neumann, Tufts Center for Evaluation of Value and Risk

Moderator/Chair:

• Josh Miller, Digital Health & Predictive Intelligence Engagement Lead, Accenture

Panelists:

• Peter Neumann, Tufts Center for Evaluation of Value and Risk
• Paul Bleicher, CEO, Optum Labs
• Jeff Elton, Managing Director, Life Sciences & Predictive Health, Accenture

The Case For Value will be followed by a session on Calculating Value on October 30, 2015, and led by Michael Lamoreaux, Analytics & Global Technology Consultant, Accenture, and the third session (date TBD) will be led by Leora Schiff of Altius Strategy Consulting and focus on Collaborations & The Road Ahead.

You are invited to be part of the 23rd annual Making Strides Against Breast Cancer in Boston, on Sunday, October 4, 2015!  Sign-up and participate with your family, friends and colleagues as a team : www.MakingStridesWalk.org/BostonMA  or learn more about how your biotechnology or pharmaceutical company can become more involved: karin.oliveira@cancer.org.

The special event will unite the community to honor and celebrate breast cancer survivors, educate about the importance of prevention and early detection, and raise funds to help finish the fight against breast cancer. Since its inception in 1993, Making Strides of Boston has raised nearly $58 million to help the American Cancer Society do the most for those with breast cancer today and strive to find cures to end the disease tomorrow.

Last year  MAKING STRIDES AGAINST BREAST CANCER of BOSTON Welcomed more than 40,000 participants and raised almost $3 million dollars. Here are a few highlights about our event:

• Held at the DCR Memorial Hatch in downtown Boston, the event is highly visible and provides a great route along the bank of the Charles River

• Attended by many community leaders including Mayor Marty Walsh and Speaker Robert Deleo

• Almost 10 various media outlets were in attendance and provided coverage of the event.

• Over 900 survivors of various cancer types participated in the events in our Survivor Tent.

• Over 40,000 participants joined us for the event, as well as over 1,000 volunteers

Celebrate Oktoberfest with Cisbio - complimentary beer, wine & snacks.  Have fun and win door prizes.  Interaction is Everything!

Join us at The Asgard: 

350 Massachusetts Ave, Cambridge, MA 01238

Register Here

Join Cisbio at Booth 48 at Discovery On Target and learn  to enhance your cell biology, molecular biology and biochemistry for drug development using HTRF technology.  www.cisbio.com

Register at:     http://www.discoveryontarget.com/

Conference runs from October 5th - October 9th.

IQPC’s 13th Cold Chain GDP & Temperature Management Logistics Global Forum brings more than 800 supply chain stakeholders together to discuss today’s hottest topics in temperature control logistics for life science products, biotechnology and quality management. It is the largest event of its kind in the world covering all temperature ranges and life science products. Not to mention, the forum features the largest exhibition of more than 120 solution providers for temperature controlled products.

Conference Features:

• Monday, October 5:  2 Full Day Master Classes
• Tuesday, October 6: 8 Workshops
• Wednesday, October 7 & Thursday, October 8: 4 Main Conference Tracks to choose from and 60+ sessions dedicated to discussing the latest regulatory updates, best practices and case studies to help balance compliance and cost savings
• Friday, October 9: International Focus Day highlighting challenging global markets

Join us in Boston at the Seaport Hotel & Seaport World Trade Center from October 5-9, 2015 and be a part of the cold chain industry’s most comprehensive event and community.

Discounted packages are available for early bird and group registrations. Click here for more info. 

Learn more & register

October 5, 19, 26, and November 2, 2015
Mondays 6:00pm - 9:00pm
$629 + $35 book fee

It has become increasingly more important to use solid project management principles throughout  the clinical research process. This course will benefit professionals interested in pursuing a clinical research career by providing a clear understanding of project management principles and processes.

Learn industry trends and best practices through real-world examples involving team projects and case studies presented by experts in the industry. Through discussion, presentation, and interaction, this course will broaden the participants' knowledge of the project management process in clinical research.

This course will provide an overview of the project management processes: Initiation, planning, project life cycle, effective team building, execution, monitoring, tracking, risk management, change management, contingency planning, and close-out processes and procedures.  

The use of consultants by start-up companies is widespread.  This seminar will discuss when using an independent contractor or consultant is appropriate, considerations when using consultants, and potential pitfalls that can arise.  This dynamic presentation will have ample time for questions, and we encourage an interactive dialogue.

Presented by Sheehan Phinney Bass & Green PA

Consultant Agreements 

Many early-stage companies   rely on consultants and independent contractors to provide important   services.  This type of engagement involves different issues than those   raised in the employment context, however.  We will discuss some of the   key terms that every consulting agreement should include, and issues that can   arise in drafting or negotiating these agreements. 

Presented by Alexander H. Pyle 

Non-Competes   and Non-Solicitation Agreements 

NDAs, Non-competes and   non-solicitation agreements all provide protection of your intellectual   property.  We will discuss what each does (and does not do), and key   provisions to consider when drafting your next agreement.

Presented by John H.   Perten

Classification of Employees vs. Consultants 

Over the past several   years, federal and state agencies have increased their focus on whether   workers should be treated as employees, as opposed to consultants or   independent contractors.  We will discuss practical steps you can take   to make sure that your workforce is classified correctly, as well as the   risks and possible costs if you misclassify workers. 

Presented by Karen A. Whitley 

Preserving   Your Intellectual Property Rights 

Consultants and independent   contractors can play a roll in helping to develop your technology.    Sometimes significant intellectual property rights can arise out of such   engagements.  We will discuss ownership of these rights.  We will   also talk about things you can do to help ensure that your company will end   up owning what you want it to end up owning. 

Presented by William   P. O'Sullivan 

“Value" is becoming is increasingly critical for innovators to deliver to both patients and the healthcare system overall -  without value there may be approval but neither reimbursement by payers, adoption by providers nor acceptance by patients.  

Large biopharma companies have active programs in this area, including significant investments in real-world data and advanced clinical analytics to model clinical trials, drive value and pragmatic studies, and to deploy new value-focused patient services.

To date early stage biopharma have had a limited ability to make these investments, access these assets, or incorporate value criteria in the structure of their therapeutics programs and early phase clinical designs.  

MassBio, Accenture, and Altius Strategy Consulting have created a three-part value series as a way to create awareness and establish a set of forums wherein large pharma/biopharma, early stage companies and technology providers can convene to:

• Define the needs around value
• Determine current capabilities
• Explore new models for collaboration
• Create an agenda for support and infrastructure that can inform regional development initiatives

Please join us on October 5^th as of a group of key opinion leaders make The Case for Value.

Presentation:

• Peter Neumann, Tufts Center for Evaluation of Value and Risk

Moderator/Chair:

• Josh Miller, Digital Health & Predictive Intelligence Engagement Lead, Accenture

Panelists:

• Peter Neumann, Tufts Center for Evaluation of Value and Risk
• Paul Bleicher, CEO, Optum Labs
• Jeff Elton, Managing Director, Life Sciences & Predictive Health, Accenture

The Case For Value will be followed by a session on Calculating Value on October 30, 2015, and led by Michael Lamoreaux, Analytics & Global Technology Consultant, Accenture, and the third session (date TBD) will be led by Leora Schiff of Altius Strategy Consulting and focus on Collaborations & The Road Ahead.

Increased personalization of medicine and more accessible, affordable diagnostics can help scientists collect important genetic data necessary for advancements in the detection and prevention of certain diseases, says Mirza Cifric, CEO of Veritas Genetics. Cifric will discuss trends in personalized diagnostic products – and how integrative medicine incorporating patient genetic data can be leveraged to advance industry knowledge, early detection, prevention, and personalized treatment. Networking time followed by the presentation. Pizza, salad, and soft drinks provided.

$5 for NSTC members and Alliance Partners with preregistration, $15 for non-members.

Please pre-register on the NSTC website.

For more information, email FirstFridayBiosci@nstc.org

MassBio is proud to present: ARCHEMY -- an art exhibit from Dan Jay that showcases science-influenced art and fourteen ARCHEMY pieces from his Liquid Nitrogen, Periodic Table and Gunpowder series.

Light refreshments will be served.

About the Artist

Dan Jay is a Boston-based artist and also a Professor of Developmental Molecular and Chemical Biology at Tufts University School of Medicine.  He received his B.Sc. from the University of Toronto, and his Ph.D. from Harvard University.  He was a junior fellow in the Harvard Society of Fellows and the John L. Loeb Associate Professor of the Natural Sciences at the Harvard Biological Laboratories before moving to Tufts.  He has studied art with Will Riemann and Paul Stopforth.  Having done both art and science seriously for 30 years, he brings to his work the unusual combination of a scientist’s mind and an artist’s eye.  His recent work called ARCHEMY uses chemicals and chemical reactions to make novel marks on paper.  He has had recent solo shows at the Massachusetts State House, Tufts Aidekman Arts Center, the Tufts Center for European Studies (Talloires, France) and the Boston Convention Center.  Jay’s mission is to inspire young artists and scientists to work at the interface.  Towards this mission, in addition to showing his work, he gives lectures and conducts workshops on applying science to art, as a proponent of the emerging field of Sci-Art.      See more at www.danjayart.com