WHENNovember 16, 2016 @ 8:00am - 5:00pm
Drug Development Boot Camp 2016

 Harvard University with the Office of Technology Development and Speid & Associates, Inc.

Date: 16 – 17 November 2016
Location: 374 Commonwealth Avenue, Boston, Mass
Cost to SABPA 3100 USD up to 14th of November when the code SABPA98421 is entered at the end of your surname when registering at the Boot Camp website.  Pay and then the 100 USD will be refunded to the credit card.   
Type of Training
Intensive training in drug development for experienced drug developers.
For more information contact Dr. Lorna Speid at +1 858 793 1295 or LSPEID@SNDTM.COM


What is Drug Development Boot CampTM?

The Drug Development Boot CampTM is a unique, intensive, integrated drug development training which immerses the participants in Drug Development. Boot CampTMusing a unique approach pioneered by Dr. Lorna Speid. A world quality expert Faculty that has worked togetherfor seven years to develop the Boot Camp materials will teach the Boot Camp. Not only will you have fun at the Boot Camp, but you will be totally immersed in the principles of drug development for two days, allowing you to take your drug development skills to another level.
Prior to the participation at the Drug Development Boot CampTM, each registered participant is interviewed by Dr. Speid to determine their goals in taking the Boot Camp. They will also be requested to complete a Questionnaire that will be provided to the Faculty. This information will allow the Faculty to prepare customized content for the audience that will take the Boot Camp.  Finally, participants are required to complete a reading assignment before they take the Boot Camp. This all ensures that the Boot Camp experience commences long before participants arrive on the Day 1 of the Boot Camp. Participants should expect to be challenged by the intensity of the program and the pace at which it is run.  Participants report benefits long after Boot Camp.

Why Drug Development Boot CampTM?

Why is there a need for training in drug development? Drug development is a complex process. Each compound or molecule that enters drug development requires a unique drug development program to be devised by the Project Team.  Even after many years of working in drug development, many drug developers with decision-making authority lack the in-depth understanding of the drug development process.  It becomes harder and harder to gain this knowledge the longer one is in the drug development arena. Who wants to admit in front of colleagues that they don’t understand everything discussed in project team meetings.
In smaller and virtual companies, many are started by lab researchers on the basis of exciting technology. Unfortunately, many recognize that they lack the in-depth knowledge of the drug development process. They are at a disadvantage and will most likely fail unless this deficiency is addressed. These challenges are not unique to small organizations. In large and mid-sized pharmaceutical companies, many have tended to become specialized. They know the jargon, but do not really know what is behind terminology and commonly used phrases. Many feel at a disadvantage when detailed discussions take place. They know that they need to fix this shortcoming, but have few options to get the training that is challenging enough to meet their needs.

The Drug Development Boot Camp was founded by Dr. Lorna Speid. She is a global regulatory affairs and drug development expert. After watching many of her clientsmake avoidable and expensive mistakes, she decided to help as many as she could avoid those mistakes.  The Boot Camp uses accelerated learning techniques to train executives and people working at the cutting edge of new drug R&D, in drug development. The seventh Boot Camp will be held with Harvard University OTD at the Harvard Club on November 16-17, 2016.

Registration Discount for SABPA members

The current early Bird price is 3200 USD, increasing mid-October to the true price.   Every member from SABPA will be granted a 100 USD discount off the advertised price. We are seeking to register at least ten participants. Each SABPA member must quote the Code ID SABPA98421 at the end of their surname when registering atwww.drugstomarket.com/harvarddrugbootcamp.

Some Participant Feedback from the 2015 Drug Development Boot CampTM
Participants for the 2015 Drug Development Boot Camp came from Canada, Germany, Belgium, Israel, The Netherlands, Spain, and the USA.

Overall Boot Camp Experience
“I think the breadth and depth of the camp was excellent.”
“Janis Fraser – Excellent talk which taught me that should try to patent anything (might not work though). ”
Commercial Session
“Helped me better understand how pharma selects candidates. Ironically uses the SAME financial models we use to select products to develop. Was GREAT!”
“This session made me realize that it’s very valuable to think about the target product profile very early and that the commercial assessment should be considered earlier.”
“Thrilled by Paul Gallagher.”
“Tony Sarraino’s talk was fantasti”c
Regulatory Affairs Session
“All talks were great – especially on a topic such as this which can be DRY!”
“Good overview of modules needed for IND and CTA packages. Important to have a good regulatory strategy at an early stage of the process.”
“I liked Lorna’s examples of Tegenero/U Penn cases of mistakes.”
“Seven Mistakes to Avoid with IND/CTAs was concise and fantastic takeaway points.”
“The mistakes session (7 Mistakes) was great”

Preclinical Efficacy Session
“This was an interesting session – Lots presented in short time.”
“PK/PD session. Very helpful to use the PK/PD models.”
“Iain M. was charismatic and engaging. I liked his slides. Some didn’t make sense (picture of bath) but overall I liked his method of explanation.”
“Great workshop! Hands-on Matlabs software was very informative”
“Very informative. The conversion chart between species very useful!”
“I did like John Burke’s session a lot.”
“Scott was GREAT!”
“I learned the comprehensive nature of toxicology considerations companies go through, including how drugs are assessed if being in-licensed.”
“Allometric scaling is not as complex as I thought it was.”
“Understanding that nonclinical safety studies objective and scope allows me to better understand the design of the safety studies in my current projects.”
“Great session! Learned lot about small molecules vs biopharmaceuticals Workshop was very informative.”
“Scott Boley was the best speaker. He brought us from the basic to complex. Very good and helpful tox information.”
Chemistry Manufacturing Controls
“Better understanding of tech transfer and how we can modify our messages and products to address the needs of pharma.”
“Really well presented.”
“Eye opening session due to my lack of expertise and also importance of the process and non-clinical toxicology.”
“Like the presentation of highlights of both small molecules and biologics.”
“One REALLY has to plan early. I now understand my CMC colleagues a lot better.”
Clinical Session
“I enjoyed the clinical design information, especially the augmented design.”
“Great case study and workshop”
“Benefits of adaptive design. Great discussion after the Workshop.”
Day 2 Workshop Session
“Great experience!”
“Good example of team work as we had good discussion.”
“Good to see what really happened to the drug in the case study.”
“Great workshop. Enjoyed working in group as a team.”
“Experience of other attendees was very high.”

I can’t afford the cost of the tuition to attend the Boot Camp
The mistakes that are made by companies are incredibly expensive.  The price of the Boot Camp was set deliberately low to encourage participation by those that need to attend. The cost of not taking this course will far outweigh the cost of this very reasonably priced Boot Camp.

Why should I attend the Boot Camp since my company will hire consultants and contract research organizations?
Without a thorough understanding of drug development you will be at the mercy of those that have more understanding than you have. You will be unable to understand when consultants and contract research organizations are giving you the best advice, versus giving you the advice that serves their interests best.