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What is the training program called the Drug Development Boot Camp®?

Someone from the SAS said, "They train you to do certain things, and then you have to do them tired." The Drug Development Boot Camp is a little like that. Come prepared to work very hard.  If you want to sit back, fall asleep, and drop in and out of lectures for two days, Drug Development Boot Camp(R) is not for you." - Dr. Lorna Speid, Founder and Co-chair.

 

Autumn/Winter versus Spring

After thirteen years of holding the Drug Development Boot Camp(R) in the Autumn / Winter, a decision has been made to switch to Spring.  The goal of moving to Spring is to avoid the "colds and flu" season.  Ultimately, we believe this change will be beneficial. 

 

The dates for the 2024 Spring Drug Development Boot Camp(R) are 10 to 11 April. Register now. The intensive training will be held VIRTUALLY.

 

Face to Face versus VIRTUAL

During the COVID19 crisis, the Drug Development Boot Camp(R) was held completely VIRTUALLY in real-time. We perfected this format and those trained in this way have since achieved great things, including starting new companies.  They were not at a disadvantage by taking the training VIRTUALLY.  In fact, it was the exact same training and we added additional features to improve the extent of participant to participant interaction.  Had they waited until we could get back to a face to face format, they would have been behind in their careers.

 

 

Why VIRTUAL in 2024?

We were hoping and making tremendous effort to return to the face-to-face format in April 2024. Unfortunately, there are still ramifications to be grappled with as a result of the COVID19 crisis. We are sharing those here with you, so that you can understand what went into the decision to continue with the VIRTUAL format for the 2024 training.

 

Costs increases for face to face format

The facility that we wanted to return to, that could meet our standards of excellence, were much more expensive than before COVID19. The reason for this is that the amount of space had been reduced as a result of the losses withstood during COVID19. The space that remained was now much more expensive, than budgeted for in our current registration prices. Consequently, when we return to the face to face format, our registration rates could double.

 

Unfair contracts at other facilities

Another challenge was the fact that other facilities that could meet our standards, were staffed with unionized staff. Their contracts required us to agree to day of cancellations, with no recourse. Of course, we refused to sign those types of contracts.

 

High non refundable deposits

Another challenge we faced was that staff tasked with negotiating the contracts did not inspire confidence that non-refundable deposits would not just be kept after the contract was signed.

 

COVID19 contractual provisions

Some facilities that we evaluated required us to guarantee that all participants would be injected with one of the COVID19 injections. They cited out of date data and statements. We believe in medical freedom, risks versus benefits, and that the individual must make those decisions, not the Chair of a training program.  Hopefully, those provisions will be removed from contracts by 2025.  

 

Hotel rooms guarantee

We evaluated meeting space in top hotels in Boston.  Although the space was exactly what we needed, and the hotels could produce food to our standards, they all required that we guarantee that a high number of hotel bedrooms would be booked. Top hotels do not operate at full capacity by design. They make their money on the bedrooms, not the meeting space. In future, if we run the training in a hotel, we may build the hotel room cost into the registration fee. These are decisions that cannot be made a few months before the next training program. We need at least a year to get to grips with them.

 

Why not hold Face-to-Face at your office?

We can work with Pharma, Biotech, Academic Institutions to facilitate the registration of large teams, that can take the training VIRTUALLY, but together in the office. The companies and institutions can order in the food for the teams. This would be a good team building exercise, and assure the training of large teams to very high levels, difficult if not impossible to achieve elsewhere. 

 

Special Guest Speaker: Mr. Colin Maclachlan SAS, Delta Force, Navy Seal

Speid & Associates trains the best, and we send them out as Special Forces to solve difficult challenges that impact the pharmaceutical industry.  This year, for the first time, we are delighted that Colin Maclachlan will be speaking to the participants, just before we send them out as Special Forces to solve difficult challenges.

 

Colin is exceptionally qualified to address the participants. Here is his bio:

 

Colin Maclachlan, star of Channel Four's (UK TV) captivating reality TV drama SAS: Who Dares Wins and Channel 5’s ‘Secrets of the SAS’ is an operator with over 25 years of security and risk related experience.

 

Colin joined the army in 1989 and after 9 years in the Royal Scots passed selection first time aged 23 into 22 SAS. Colin was fortunate enough to have been involved in some of the more high profile and daring missions of the recent period. Only a handful of men have been involved in hostage negotiations, hostage rescue and been a hostage themselves and Colin is one of them. He waded through stinking swamps in Sierra Leone in West Africa to hunt down the West Side Boys, a guerilla gang holding five British soldiers hostage. It was a mission so daring and dangerous they nicknamed it Operation Certain Death. The SAS recce teams secured the hostages' building and neutralised any West Side Boys prior to the main assault arriving and secured the prison building before the rest of the unit arrived wiping out the terrorists in 2000.

 

He was also the first sniper on the scene when a hijacked Afghan flight with 180 passengers landed in London in the same year, sparking a stand-off that lasted four days and was the longest standing hostage siege on UK soil to date. But four years later Colin found himself on the other side of a rescue mission after he was taken hostage in the Iraqi city of Basra. Blindfolded, battered and stripped naked, he felt a gun pressed to his head and heard them pull the trigger in what was a mock execution. Father-of-two Colin only survived long enough for British troops to rescue him because the terrorists who held him wanted to film his suffering in a propaganda video before they executed him.

 

Colin left the SAS shortly after doing an exchange programme with both Delta Force and Seal Team 6 and after doing security consultancy for the Saudi Royal Family, A-List Celebrities and US Media Networks decided to fund himself through university where he attained a First Class MA (Hons.) in History from Edinburgh University and an M.Litt in Terrorism from St. Andrews University. Colin is now involved in TV, Book, Radio and Video Games and also does a lot with charity being involved as Ambassador for the Lee Rigby Foundation, Pilgrim Bandits and NSPCC among others. He has also just founded his own charity Who Dares Caresthat aims to link and support veterans as well as others that encounter stress.

 

Having had both an exciting and varied career, Colin is an excellent speaker on a wide variety of topics including Resilience, Teamwork, Leadership, Risk, Motivation, Conflict Resolution, Change Management, Negotiation and Performance. He is also an experienced presenter and host for events and is co-founder of Stoic Events.

 

Waiting List for 2025 Face to Face

Why would anyone wait until 2025 to take the training, just so they can attend it face to face?  Yet, if this is your preference, we will be creating a wait list. The space will be limited.  An email will be advised in due course for you to add yourself and / or team members to the wait list.  Please remember that the costs will be doubled and may need to include the hotel room costs, if we move to a Boston hotel.

 

Drug Development Skills are Difficult to Acquire

The pharmaceutical industry has its fair share of Ph.D.s, and MDs, and yet qualifications do not translate into understanding of the drug development process. In fact, even Nobel Laureate scientists can find the drug development process bewildering.

As drug development costs increase, the process of drug development is becoming more and more complex. Those involved with the process of developing new therapeutics (drugs, devices, combination products and diagnostics) must understand the process and be able to navigate it with great skill. These skills are difficult to acquire. At the same time that the process is becoming more complex, researchers and developers are becoming more specialized. The challenge is there is a need to gain a thorough understanding of other areas of research and development in order to be effective in their own areas.

The Drug Development Boot Camp® was founded by Dr. Lorna Speid. The 2024 Boot Camp will be the fourteenth Drug Development Boot Camp®. It will be held VIRTUALLY. Huge discounts are given for early BIRD registrations.

The Boot Camp is a very intensive training program designed for those that have relevant experience in the research and development of New Chemical and New Biological Entities. This is a very challenging program not only because of the content, but also because of the amount that must be accomplished in two full days. Participants that complete the Boot Camp can be proud of their accomplishment and the Certificate of Completion that they have earned. 

 

Prospective participants are interviewed in order to find out their aspirations and goals in taking the Drug Development Boot Camp(R). They are also given reading materials so that they can prepare for the Drug Development Boot Camp(R). They will take a survey so that the Faculty can gain an understanding of the needs of the participants, before they attend.

 

Participant Feedback From Drug Development Boot Camp® VIRTUAL [2021]

Participant Feedback from the second Drug Development Boot Camp® VIRTUAL

The feedback from the second Drug Development Boot Camp® VIRTUAL held on 17-18 November 2021 is provided below. The VIRTUAL presentation of the intensive training in real time was transformative.  We had an almost 100% completion of the training. 

 

 

"Thank you again for the bootcamp! Everything was very well planned, and I learned a lot. I would recommend it to a colleague or friend, and even take it again, should the opportunity present itself!"   

 

"Dear Dr. Lorna Speid,

Please see my participant response form. Thank you so much to you and your team for putting this program together. This was so valuable for my understanding and career. Even though I had to drink 3 shots of coffee for two days to make it through, I am so glad I was able to actively participate and really learn from the speakers. Also, I really appreciate you making this fun with the wonderful piano recital and the “Team Courage” and “Team Bravery” videos. You were so professional throughout (and on the West Coast too)! I am glad I was exposed to the whole process of drug development early on in my career so it can activate my thinking and actually have the context to understand what different functional groups like CMC and Toxicology are saying as it pertains to work."

"Thank you for the great boot camp."

 

Participant Feedback From Drug Development Boot Camp® VIRTUAL [2020]

Participant Feedback from the very first Drug Development Boot Camp® VIRTUAL

The feedback from the very first Drug Development Boot Camp® VIRTUAL held on 18-19 November 2020 is provided below. The experience was truly remarkable for the commitment shown by all Participants to complete the training VIRTUALLY.

 

“Dear Lorna

Here is my participant survey. This Workshop was super informative. Thank you!”

 

“Good morning Lorna –

Please see attached feedback and reporting back forms.  Thank you again for a fantastic boot camp.” 

 

“The thorough and robust content makes this course.  I am excited to apply the learning to my day-to-day activity.  Excellent job overcoming the virtual challenge.”

 

“An excellent, comprehensive program diving deep into the drug development process with engaging discussion leaders and real-world application workshops.  I highly recommend this training for the pharmaceutical professional looking to develop a holistic understanding of drug development.”

 

“Dr. Speid and Lorraine and Team thank you so much for the intense training – wealth of information.   I really appreciated all of your hard work to put this event on in a virtual manner!Have a great holiday season!”

 

“Comments/ Feedback:   be prepared for a lot of reading and watching videos as this is indeed intense.   I think your team did a great job with preparations and it’s astounding the amount of work your team accomplished to make this training so great.   I learned so so much!  I have a great appreciation for all the work our company does to get more medicines to patients!!!!!!!!!!!!!!”

 

“The faculty you have involved in the training are unbelievably smart and great teachers.  Such patient people as well.   They really are experts in drug development.  They make this training well worthwhile.”

 

“Dear Dr. Speid:

Thank you so much for conducting such an informative training program. Though it was very intensive program, I am really glad that I have undertaken the Drug Development Boot Camp as it helped me learn a lot about the complex drug development processes and understand the intricacies of decision making processes. It was really very interesting working with individuals of diverse background and the faculty was simply amazing. You really have done a good job in bringing in the diverse team together and creating an environment that promoted supportive learning. I would also like to extend my sincere thanks to Lorraine, Anna and all faculty members. I have attached the PDF file containing, the participant survey, reporting back form and comments form.”

 

“Dear Lorna,

Thank you kindly for the update. I have attached my Reporting Back, Survey, and Quote Me forms to this email. A huge thanks to you and the faculty for such a successful and educational virtual boot camp!”

 

“I believe the Drug Development faculty handled the virtual format with great skill! The zoom breakout rooms were very successful, and I enjoyed the various faculty who popped in from time to time to give advice. For a virtual environment, the whole event felt very connected. This has been a demanding and highly rewarding course. I would highly recommend the Drug Development Boot Camp to anyone who is up to the challenge and interested in expanding their knowledge in everything drug development.”

 

“The Virtual Drug Development Boot Camp® was an intensive training that I have undergone in a virtual  platform. The Workshop sessions were beneficial and Faculty members joining to give context to the assignments was helpful. I learned a lot about the drug development process in the context of the life threatening and non-life-threatening drug development. The acceleration presentations by the faculty members before each session was informative in concisely outlining each session. Really appreciate the time and efforts that each Faculty member and staff took in formulating such as concise, well rounded intensive boot camp in the virtual platform. It was fascinating to see the thought processes of my classmates (in the assigned company and group) during the workshop sessions. Throughout the camp. The environment was very supportive and promoted learning. I will surely. Recommend this boot camp training program to my colleagues and peers. It was unfortunate that each of us was not able to have a networking opportunity with broader team members who attended the virtual boot camp."

 

"Thank you again for allowing me to attend the course. It was tremendously helpful.  Please see attached survey.  I would highly recommend this course to anyone planning to move into management level and higher in the pharmaceutical industry. This is very helpful in ways to understand how all the different functions impact each other, and how to better strategize. I think this training should be a requirement for anyone going into CMC.”

 

“Dear Lorna,

Thank you kindly for the update. I have attached my Reporting Back, Survey, and Quote Me forms to this email. A huge thanks to you and the faculty for such a successful and educational virtual boot camp!”“Dear Dr. Speid:

 

Thank you so much for conducting such an informative training program. Though it was very intensive program, I am really glad that I have undertaken the Drug Development Boot Camp as it helped me learn a lot about the complex drug development processes and understand the intricacies of decision making processes. It was really very interesting working with individuals of diverse background and the faculty was simply amazing. You really have done a good job in bringing in the diverse team together and creating an environment that promoted supportive learning. I would also like to extend my sincere thanks to Lorraine, Anna and all faculty members. I have attached the PDF file containing, the participant survey, reporting back form and comments form.”

 

“I believe the Drug Development faculty handled the virtual format with great skill! The zoom breakout rooms were very successful, and I enjoyed the various faculty who popped in from time to time to give advice. For a virtual environment, the whole event felt very connected. This has been a demanding and highly rewarding course. I would highly recommend the Drug Development Boot Camp to anyone who is up to the challenge and interested in expanding their knowledge in everything drug development.”

 

Participant Feedback From Previous Drug Development Boot Camp®s

Participants to the Drug Development Boot Camp® have come from the US, Australia, Belgium, Canada, Germany, Israel, India, the Netherlands, Singapore, South Korea, Sweden, Switzerland, United Kingdom.  This is a selection of their feedback.

"Please Quote Me!"

You can read the outstanding feedback that our most recent participants have given us permission to cite on their behalf. These comments give you compelling feedback about the value of the Drug Development Boot Camp® to them. This was a very discerning and experienced group of drug developers and researchers.

 

“A very good overview of drug development A to Z.”

 

“A comprehensive learning experience in drug development.  Terrific experience!”

 

“I think this intensive course should be taken by any academic considering a drug development start-up. There is much to think about and properly plan ahead for drug development to approval.”

 

“Intensive Drug Development Boot Camp that everyone who is interested in building a career in drug development should take. Complete life cycle management from Discovery to Commercialization.”

 

“The mock projects are extremely helpful, and help with Teamwork.”

 

“This was a very helpful overview of the drug development process.”

 

“Great immersive learning experience.”

 

“Well organized materials and sessions. The Boot Camp has equipped me with new knowledge. I'll never approach / see drug development the same again!”

 

“Excellent overview of later stages of drug development.  Great workshops, informative and thought provoking.”

 

“Overall excellent course.”

 

“This Boot Camp enhanced my knowledge in the drug development aspects and will help me to better function as a program officer for translational sciences portfolio at NIH.”

 

“Comprehensive training towards a drug development Blackbelt!”

 

“DDBC is built for a diverse audience. I found tremendous value in the camp, even a member of the animal health pharmaceutical industry.”

 

“Congratulations on completing 10 years of Drug Development Boot Camp®! Great sessions!”

 

“Very enjoyable few days with valuable workshop break-out sessions and very experienced speakers …. Maybe Day 1 was too much and would love more time on PKPD and toxicology and trial design.”

 “It is a well organized course, which provides a lot of useful information for drug development.”

 

“It is a well organized course, which provides a lot of useful information for drug development.”

 

“Fantastic overview of the interconnected pieces of drug development. Would certainly recommend to my colleagues and anyone involved in advancing novel therapeutics into patient.”

 

“Great all-around intro to overall drug development. Good for anyone in the industry.”

 

“Very comprehensive overview of different aspects of drug development.”

 

“The most comprehensive Drug Development course! Two days of great learning, collaborating to solve problems, and getting the Big Picture of Drug Development! I would do it again!”

 

“I wish I had taken this class on Day 1 in pharma.”

 

“Very well-organized learning experience.”

 

“Speakers fantastic, even on somewhat dry subjects.”

 

“Diverse and very nice attendees.”

 

“Excellent coverage of the many areas relevant to drug development.”

 

“I work in R&D (disease modeling, phenotype discovery and early drug discovery) and this Boot Camp was a great and productive way to learn about all the downstream processes and challenges in drug development pipeline.”

 

“I wish I had this training years ago - it was very insightful into all drug development areas, including preclinical and CMC.”

 

“Case studies were really useful.”

 

“Food and location were great.”

 

“This gave me a very comprehensive understanding of drug development process with all elements from GLP tox to clinical trials to commercialization.”

 

“Loved the setup. Lectures and network opportunities. Thank you.”                                                                                                                  

 “Content was great, presenters were WONDERFUL, cases were very engaging.”

 

“An intense but informative 2-day session. Engaging speakers and team activities made for a great learning experience.”

 

“Speakers/presenters were fantastic!”

 

“Breakout workshops were the most valuable aspects of the Boot Camp.”

 

“Meticulously planned and executed.”

 

“High quality speakers. Very well laid out learning materials.”

 

“The workshops are excellent in getting to know other attendees, their expertise, and different ways of looking at our industry, and how to do things better.”

 

“A very informative course that provides all elements of drug development with good tools for future reference during the day to day activities.”

 

“Excellent program. Highly recommended.”

 

“Excellent program. Highly recommended.”

 

Overall Boot Camp Experience

“It was a great overview of the different disciplines and the right amount of time was spent on each piece.”

 

“Very well organized Workshop; learned a lot in short time. Very good quality of participants.”

 

“Good overview of entire drug development processes with the latest technologies. Case study and group workshop are efficient format.”

 

“Great program with broad topic coverage. Case studies and workshops were very useful.”

 

“Excellent Faculty, superbly organized. Subject lectures followed by workshops drove home concepts.”

 

“Overall, great presentation.” 

 

“Very good design and well managed!  Speakers were wonderful.” 

 

“Developing preclinical and CMC strategy was very informative. Workshops are the key element of going over what was learnt in each session.”

 

“Great sessions and reading materials. Schedule is intense but results are apparent.”

 

“It was a decent overview of the material.” 

 

“Overall great overview and gives a better understanding of the other aspects of drug development that are related to my day to day work.”

 

“I really enjoyed learning about the whole pharmaceutical process from start to end. As I am embedded in early discovery in my day to day job, this was a good way to understand the later stages.

The Workshops were fantastic for applying what we were learning and to even learn from others in our Workshop groups who may have been in that area.“

 

“I greatly appreciate the time and expertise shared by the speakers. Really enjoyed the breakout session with the various groups on different scenarios. It is invaluable to directly interact with peers for

problem solving.“

 

“I like that participants were each required to report back.”.

 

“Workshops were *FANTASTIC*”

 

“Engaging speakers. Thank you!”

 

“Very informative training!”

 

“Intense --- in the best way possible. All subjects were covered thoroughly at a level that could be understood. Thank you for the background reading!” 

 

“I was quite worried that I might not have enough background knowledge to get much out of the course.  However, the pre-readings helped boost my knowledge in areas I was familiar with, while introducing the basics for those I was not well-versed in.  The spirit of learning together that the other participant brought was also helpful in forming a collaborative environment, especially for the Workshops.”

 

“Comprehensive review of all functions and integration required for development.”

 

“Comprehensive modules covering key aspects of drug development.  I found it very useful to study these topics and get new insight; Also met new colleagues from various organizations.”

 

“Tremendous!  I love the case study methodology.”

 

“In depth coverage of multiple areas.”

 

“Workshops”

 

“Faculty/support excellent!”

 

“Very efficient crash course to cover an enormous knowledge space. This will change how I think about my research program.”

 

“Great people here of very diverse expertise backgrounds, and this was great to experience.”

 

“Workshop 2 was very good.” 

 

“People (including me) really enjoyed Dr. Chang's talk and thought that getting feedback on the examples beneficial.  Very few speakers gave direct feedback.”

 

“Brilliant organization and highly professional set-up.”

 

“It takes a Team to create value. Well you have a great Team and this course definitely added a lot of value to me. Thank you.”

 

“The Boot Camp provides a great opportunity to see drug development end-2-end, understand how different components play together, and define better ways to achieve the challenging mission to bring a new medicine to patients.”

 

“Thorough and digestible approach to learning the key aspects of drug development.”

 

“An excellent overview of drug development.”

 

“The best overview of a complex industry I've ever been exposed to. Helps to streamline the Thinking process and defines the frame for overall development strategy.

Thank you,  Lorna and the Faculty!”

 

“The case studies are very interesting and informative.” 

 

“Worth every minute. By far the best overview of Drug Development I've seen.”

 

“Great course for people new to pharma, biotech. Good refresher for others.

Workshops are most valuable.”

 

“Wonderful materials. Will keep for constant reference.”

 

“Well hosted, well run, and lots of enjoyable work. Amazing facility. Thank you.”

 

“Definitely recommend to others. Very educational for commercial, CMC and clinical design.”

 

“Thank you for including adaptive design. It was important to me, and will be done.”

 

“Very informative Tufts data presentation about industry snapshot. “

 

“Cost driver specifics were eye-opening and helpful.”

 

“Consider building in the role of Quality in the various puzzle pieces. They touch on all processes and it was disappointing to be excluded.”

 

“I enjoyed the Workshop groups and workshop sessions and think it may be worth decreasing the formal presentations and increasing the Workshops further.”

 

“I registered for the Boot Camp with quite some doubts about how much we could learn from a short two day period. It turned out the camp was very well organized; with pre-reading, lectures by industry experts, and hands-on practice for each of the major aspects of drug development. “

 

“I had a great experience from learning from the panel members and the attendees through plenty of discussions.”

 

“A thorough overview of  the drug development process. Great opportunities to share experiences with peers in the workshops.”

 

“A great way to see a lot in a very condensed format.”

 

“Loved the venue!”

 

“I would definitely recommend this program to my colleagues who are passionate about drug development.”

 

“I found the workshops to be very useful and will be recommending it to my colleagues.”

  

“I wish I had taken this course 10 years ago. It filled in a lot of gaps in my understanding of drug development.” 

 

Commercial Session

“It was very helpful to learn about medicinal chemistry and target optimization considerations. I usually come into the process later and need an understanding of this work.”

 

“I liked the comparison / contrast between chronic and life threatening disorders. It also made me think of marketing early something I generally don’t think about.”

 

“Starting to think about what package / argument/ data to provide to payers, and how it's not going to be the same as the FDA approval.”

 

“Case study was very good exercise.”

 

“This was an excellent session.”

 

“Very balanced overview to connect the end to end overview of drug development.””

 

“Excellent session.”

 

“Great session. Importance of considerating all the different stakeholders and criteria for making a commercial decision to move forward.”

 

“Tony Sarraino is a great presenter”

 

“Enjoyed case.”

 

“Understanding payers influence my customers' decisions and the EEF concept for prioritization - my partners are performing that now to justify next year's budget.”

 

“Greater understanding of the complexity associates with drug discovery activity.”

 

“Liked Workshops very much.”

 

“I have many questions to take home to my company.”

 

“Enjoyed the case study - vaccine market is not one I'm familiar with so good learnings.”

 

“Great session.”

 

“Good engaging speakers  - the difficulty of reimbursement was well covered.”

 

“Considerations regarding market access and commercial value should be considered from the beginning of the development program, and not just during clinical development. It's not just about regulatory approval.”

 

“Great session.”

 

“Interesting new insights into business strategies.”

 

“Increasing benefit of molecular biomarker to predict perspective.”

 

“Good insight on how to select leads, and importance of studying metabolites.”

 

“Now I understand the marketing and reimbursement perspective of drug development. Very useful.”

 

“The need to understand target product profile and the druggability and consideration and not just efficacy and toxicity.”

 

“Well laid out.”

 

“Commercial decisions are based on very detailed financial calculations (ROI). This seems like it should be obvious, but on the discovery we don't often get to see the math behind the decisions reflected in our companies' press releases.”

 

Global and Strategic Regulatory Affairs Session

“A wonderful overview! Essential! It's all laid out.”

 

“I found "7 Mistakes" presentation to be very helpful.”

 

“Seven Mistakes  - #6 CMC. Very relevant to me with gene therapy space. Plasmid vector more complicated than small molecules.”

 

“The 7 Mistakes. We think we are doing these things but may only be doing them in part or not following through with our own initial targets or safety.”

 

“Very much appreciated "7 Mistakes " to avoid.”

 

“7 Mistakes to avoid.”

 

“We are working on a TPP at my company right now. I like the idea of defining go/no-go product criteria.”

 

“The different requirements for approval in the EU and Japan. It was good to delve into the best ways to approach those regulatory authorities.”

 

“Interesting insights into Priority Review Voucher.”

 

“Very informative to delineate the differences between the IND/CTA.”

 

Very important to understand the 7 Mistakes. Helpful to be told this.”

 

“I will Keep the 7 most common mistakes listed on my mind throughout the programme development.”

 

“Carlos was great.”

 

“Keep the 7 most common mistakes listed on my mind throughout the programme development.”

 

“I liked the idea of a strong plot for development of CTD/regulatory strategy.”

 

“Be the expert on your drug.”

 

“I learned about the difference between plan and strategy.”

 

“Importance of creating a regulatory strategy early with review often.”

 

“7 Mistakes to avoid for IND/.CTA - failure to develop a TPP etc.”

 

“As this impacts many other development disciplines as well, one could put more emphasis on this topic.”

 

“7 Mistakes in Regulatory Affairs.”

 

“Things I haven't even considered before - good perspectives.”

 

“Learnt how important it is to have a comprehensive regulatory strategy.”

 

“Plan your TPP so you can determine key Go/No Go details early. Don't rush talk with FDA. Open a dialogue.”

 

“7 Mistakes was a nice reminder. Don't let questions become justifications.”

 

“The 7 Mistakes. Will print this out and keep on my desk.”

 

“Importance of the Target Product Profile.”

 

“Importance of TPP.”

 

“Very informative session.”

 

“To design proper studies that will define the TPP.”

 

“This session gave a thorough understanding on the IND/CTA application and about registration of drugs.”

 

“Terminology relevant for various regulatory requirements (CTA, etc.).”

 

“Developing relationships with FDA.”

 

Preclinical Efficacy Session

“Amount of guidelines available is astounding! ICH S9 for rare / ICH M3 for non life threatening.”

 

“Safety, Safety, Safety! Modeling can help predict safe and efficacious dose. Early simulation could help me with prioritizing on my team.”

 

“Modeling workshop was very insightful.”

 

“I enjoyed playing around with PK/PD simulations.”

 

“I liked the tool presented.”

 

“I thought the preclinical modeling is a great tool to use when approaching the FDA and to inform clinical trial design. It wlil be something I aim to implement.”

 

“Good oveview of PK/PD essentials.”

 

“Very interesting discussion on delayed effects.”

 

“Information and content was clear even though the topic is foreign and distant for me.”

 

“The mathematical modeling to determine dosing was very relevant. The exercise we were given was extremely useful.”

 

“This was an excellent session. How PK relates to PD using the applied math software.”

 

“The Workshop questions were great and really reinforced the learnings.”

 

“Mathematical modeling is fun.”

 

“I now understand PK/PD data and how to interpret the data.”

 

“The bath tub model is a great way to conceptualize PK model.”

 

“Stronger appreciation for the importance of PK/PD relationship for clinical trial progression.”

 

“Information and content was clear even though the topic is foreign and distant for me.”

 

“The mathematical modeling to determine dosing was very relevant. The exercise we were given was extremely useful.”

 

“This was an excellent session. How PK relates to PD using the applied math software.”

 

“The Workshop questions were great and really reinforced the learnings.”

 

“Mathematical modeling is fun.”

 

“The bath tub model is a great way to conceptualize PK model.”

 

“PK/PD models can help us make predictions about as yet unstudied scenarios.”

 

“Much better understanding of PK/PD”

 

“Great introduction to PK/PD. Modeling helps.”

 

“Modeling - is this something I can discuss with my sponsors?  Yes!  This will help me understand the evaluation they have gone through.  Great presentation!  Learnt a lot.”

 

“Ability to understand the importance and utility of PK/PD data.”

 

“The bathtub analogy for PK/PD is fantastic.”

 

“Very interested in computerized model for planning.

 

Ability to model different dosage levels/schedules.”

 

“Super helpful for me. Good charts for cross species.”

 

“Interesting to see how physiology affects PK/PD.”

 

Fast! But good overview of preclinical. Would like to hear more about preclinical R&D and tox and MABEL approach to FIH biologics.”

 

“PK/PD modeling and the Workshop were very helpful and I really learned a lot.”


“Really interesting modeling workshop. Good speakers.”

 

“Very good”

 

“Use of the pharmacology software was a great way to apply the information offered during the lecture part.”

 

“PK/PD software is great.”

 

“PK/PD modeling is very very useful.”

 

“Enjoyed the session.”

 

“So far I have only been thinking about primary PD. This session gave me thoughts on secondary PD.

using the software to model PK/PD was eye opening. I had seen similar graphs before but really felt like I grasped the concepts better after the simulation.”

 

“Simple definition of PK.”

 

Toxicology Session

 “Toxicology work is comprehensive. I need to review those as a Medical Monitor.”

 

“I have now done a toxicology dose calculation - not part of my everyday work, but all knowledge is good.”

 

“Better understanding of PK variables and what they mean.”

 

“What you need to know to start Phase 1. Life threatening vs non life threatening. Relevant species. Justify your starting dose. I can use this to better assess tox studies I am reviewing.”

 

“An excellent presentation followed by the workshop.”

 

“Very useful workshop exercise. I liked the practical data based approach.”

 

“I learned how to calculate human equivalent dose.”

 

“The computational model - compute animal to human was quite useful.”

 

“It was valuable to see that you do not need to do as many Phase 1 and 2 tox studies to enable the clinical program.”

 

“Very good overview of what is needed to start the different clinical development stages.”

 

“Very good Workshop feedback on how to carefully interpret toxicology findings.”

 

“I found this well structured and very informative. Scott Boley did a fantastic job on toxicology.”

 

“Great material. Well presented. The Workshop exemplified how to determine dosage. Too tired to get the most out of this session.”

 

“Another excellent session and Workshop exercise.”

 

“This will definitely change the way I look at risk mitigation strategy prior to the FIH studies.”

 

Case studies very helpful to understand principles.”

 

“I found this well structured and very informative. Scott Boley did a fantastic job on toxicology.”

 

“Great material. Well presented. The Workshop exemplified how to determine dosage. Too tired to get the most out of this session.”

 

“Another excellent session and Workshop exercise.”

 

“This will definitely change the way I look at risk mitigation strategy prior to the FIH studies.”

 

 “How to calculate the starting dose in Phase 1.”

 

“Scott was great.”

 

“Greater understanding of how doses are determined for early phase trials.”

 

“It was helpful to learn how type of compound affects tox development path.”

 

“Would like to hear more about toxicology of bio layer molecules.”

 

“Best lecture of the first day. Liked simple rules for FIH dose. Complex issues made simple so those outside expertise have some framework.”

 

“Enjoyed the review of how to develop development plan.”

 

“Very good overview of small molecule vs biologic - learned a lot about small molecule development. Also good overview of differences for "chronic non life threatening" vs acute life threatening approaches.”

 

“Interesting review of tox for biopharmaceuticals.”

 

“The human equivalence dose calculation table with be a tool I can refer back to again and again.”

 

“The key differences between small molecules, biologics, and life threatening  vs non life threatening diseases.”

 

“Good session”

 

“Great session! Really enjoyed the toxicology workshop.”

 

“The conversion formulas for animals to human.”

“How to design toxicology studies from previous data.”

 

“Very interesting session!”

 

“Toxicology session and workshop - thoroughly enjoyed.”

 

“Very interesting session.”

 

“How to design toxicology studies relevant to or leading to IND/CTA Phase 1/2.”

 

“Very well laid out. Can use this as a checklist for myself.”

 

“I really appreciated hearing about which tox studies are required in which situations. I feel like I can understand my tox colleagues efforts much better.”

 

“Dose selection strategies and conversion tables.”

 

Chemistry Manufacturing Controls Session

“Better understanding of CMC.”

 

“I have much more experience with CMC and preclinical areas of drug development.”

 

“Great session!”

 

“Very useful to have insight into manufacturing  - usually takes place somewhere distant from rest of process.”

 

“I will definitely use the impurity decision tree.”

 

“I have a lot to learn!”

 

“The different requirements needed for CMC between Phase 1 and 2 trials,a s well as comparability requirements when scaling up.

 

“Good overview and introduction of quality by design (QbD) -- also the importance of QTPP.”

 

“It was great to hear mistakes not to make.”

 

“Understood the increased amount of variability for biologics. Relly liked the "scaling up" challenges description by Seshu: Building/Country/Org.”

 

“Great session, positioned importance clearly and in a digestible manner.”

 

“Key points and how to avoid mistakes.”

 

“Good session.”

 

“Fabulous! Brought great key messages for me to use.”

 

“That CMC can be quite fun. Excellent Faculty.”

 

“I have a better appreciation for the variety of challenges respect to manufacturing - particularly the academia - industry transition.”

 

“Good session.”

 

“An excellent, engaging session.”

 

“Liked very much Biologics section.”

 

“Very informative.”

 

“Education of CMC tasks, challenges, time needed, and complexity is very much needed by all the personnel involved in drug development.”

 

“Very good coverage of a complex topic.”

 

“Could be a bit less detailed to allow other sessions to have more time. This was excellent though!”

 

“Very nice presentations!”

 

“Increased appreciation for this function.”

 

“Very informative session.”

 

“Both CMC sessions were great.”

 

“Now I know why my Chemistry colleagues get so excited about process improvements!”

 

Clinical Session

“Adaptive designs!!”

 

“Better understanding of dosing regimens.”

 

“I will consider incorporating adaptive designs, whenever possible.”

 

“Considerations for type of study design.”

 

“Giving actual examples of drugs that used adaptive designs would be extremely useful.”

 

“Resources for planning clinical trials and the variety of approaches.”

 

“I haven't worked on adaptive designs before and can bring some ideas back to the team.”

 

“It was great working as a team!”

 

“It was great to work with a cross functional team to approach a problem no one of us could accomplish alone.”

 

“Workshop with statistical modeling was good.”

 

“I learnt about the use of appropriate designs!”

 

"I'll consider adaptive design for upcoming Phase 2 study.”

 

“I liked the format.”

 

“Think, rethink and challenge myself / others to design "smart clinical trials."

 

“Use of the stats software was great. Should have spent more time on it.”

 

“Dr. Chang's statistic program for Adaptive design was exceptionally useful for clinical designs.”

 

“I have developed a much more comprehensive understanding of clinical trial design in conjunction with process development. All of this will enable me to make better decisions and ask the right questions.”

 

“Very good explanation / examples of Trial Designs (Adaptive).”

 

“Interesting to learn how clinical trials are designed.”

 

“Use of adaptive design.  Better understanding of how to better design clinical trials.”

 

Day 2 Afternoon Workshop Session

“Enjoyed it very much!”

 

“Loved this. Really liked working through the case study.”

 

“Learnt a lot about toxicology (was in the toxicology break out group)”

 

“This was so helpful in bringing all of our learnings together - great session!”

 

“A strategic perspective of how to incorporate all aspects in a full program.”

 

“Very interesting case.”

 

“This activity was excellent.”

 

“The real-world development story is stirring. I am so impressed!”

 

“Even with limited CMC CMC expertise we could make useful comments.”

 

“Good collaborative team work.”

 

“An understanding of the challenges in the preclinical lead optimization phase.”

 

“During the final reporting back was great to see the actual development unfold. Very well structured.”

 

“Very good case! Very interesting to see the real-life story.”

 

“A little bit of a struggle, but very productive.”

 

Final Session: Sending Out the Special Forces!

“Informative presentation.”

 

“The economic framework and holistic picture on the industry are crical for participants to understand drivers behind drug development trends.”

 

“Understanding the major cost driver is clinical trial cost (Tuft's analysis).” 

 

“The economic framework and holistic picture on the industry are critical for participants to understand drivers behind drug development trends.”

 

"Need for efficiency in our industry due to the cost of bringing a drug to market."

 

"The key major take home message is "Think out of the box."

 

"The figures were revealing about the trends - certainly delivering programs is getting tougher, competition for patients is driving up costs and timelines."

 

"Great insight into the driving forces around the future directions of the industry."

 

“Interesting look at costs and collaborative opportunities. Adequate scope of due diligence and consequences of decisions.”

 

“Tufts data provides nice call to action to plan to increase productivity.”

 

“Great presenters”

 

“Very interesting. Right tempo.”

 

“Interesting to have broad view of the industry.”

 

“This session really completes our learning on drug development.”

 

“Very informative session.”

___________________________________________________

Why Drug Development Boot Camp®?

Dr. Speid is a global regulatory affairs and drug development expert. After watching many of her client companies make expensive and avoidable mistakes, she decided to help as many as possible avoid making the same mistakes over and over again.

Who Should Attend?

  • Large Pharma / Large Biotech - whole project teams can, and have been trained
  • Small Medium and Virtual Biotech companies - CEOs, CFOs, COOs, officers, executives
  • Executives involved with the drug development process
  • Small and virtual company executives
  • Drug researchers and laboratory-based scientists and senior scientists
  • Large pharma professionals involved in silos of drug development, but who want to understand the whole process.
  • NIH/NCI, FDA, BPharm, MHRA, and professionals from major regulatory authorities
  • Regulatory affairs professionals, clinical research professionals, senior research scientists, toxicologists
  • Clinical investigators who would like to gain an understanding of drug development, or improve their understanding of the drug development process
  • Venture capitalists, investors.
  • Those involved with due diligence.

What Will You Learn?

This is not an entry level program. It is an extremely intensive training program. It is intended for those involved with R&D of new drugs. If you make drug development decisions on a daily basis, the Boot Camp is for you. A minimum of 5 years of relevant drug research or drug development experience is required in order to be accepted onto the Drug Development Boot Camp® because of the depth and intensity of the program.

This is a unique opportunity to be totally immersed in drug development for two days and to mix with a Faculty that has proven themselves by bringing drugs to market, or that has contributed to this success.  For this reason, the number of spaces is limited.

Those who do not attend the Drug Development Boot Camp® or a similar program are at risk of the following:

  • Wasting huge sums of investors' money on patent prosecution which will ultimately be useless, lead to costly litigation and prevent the asset from finding an appropriate exit.
  • Spend many years and huge sums of money developing a drug or drugs that the market does not want, and will not pay for.
  • Make costly mistakes throughout the development process, which will ultimately cost the company, one's reputation and may even lead to safety problems in those administered the company's products.
  • Experience a lack of direction from the top management team because of a failure to take the time to receive real training in drug development.
  • Clinical hold situations which are extremely costly.
  • Failure to design a clinical program/clinical programs which could lead to registration of the drug.
  • A US-centric approach, rather than a global approach to drug development.  This will lead to many problems later in development.
  • End up with a "good drug bad development syndrome".
  • Face expensive CRO and consulting bills, with no additional assurance of success.
  • Be forced to rely on the input from CROs.   There is a likelihood that you will be assigned the E Team by the CRO because of inability to tell the difference between an A Team and an E Team.
  • Inability to take the drug to the market in the timeframe promised to investors, analysts, the Board of Directors and patient groups.
  • Inability to manage the expectations of the Board of Directors.
  • Ineffective decision making mechanisms.
  • Inability to raise funds or to find an appropriate exit.
  • Inability to work effectively wtih major health authorities.
  • Loss of company, job and reputation.

I have been in the pharmaceutical industry for many years and have a lot of experience. I don't need to attend the Boot Camp!

If only the many years that people have been in the industry would translate into experience and results, we would not have the current attrition rate evident in the pharmaceutical industry. Sadly many years in the industry do not denote experience or expertise. Likewise, attendance at many conferences and even courses, will not necessarily improve one's drug development experience level. You need the Drug Development Boot Camp®. The unique total immersion, open and interactive atmosphere, promotes hands-on learning, and is quite unique.

Start Pre-Boot Camp course work today! Register now.

As with any intensive training process, participants should prepare in advance. All participants are given reading assignments that are relevant for their day to day work. All participants are encouraged to avail themselves of the opportunity to discuss their drug development needs with Dr. Speid.  All participants will be asked to complete a detailed questionnaire about their research and/or development experience after registration.  Register today and take advantage of this Pre-Boot Camp preparation process.

 

Closing Date for Registration

Registration is open immediately.  Early registrants are given a sliding scale of discounts the earlier they register.  The advantage of early registration is that registrants can benefit from the reading and reflection exercises that form a part of Pre-Boot Camp. These will benefit their day to day research and development activities. Early bird prices are adhered to strictly. The closing date for registration is 30 March 2024.

 

Bulk Registrations

If a large pharmaceutical company, a biotechnology company, a university or other institution registers ten participants, two free Scholarships (excluding travel) will be provided to that organization. All participants must be registered at the same time.

 

Cancellation Policy

After registration, funds cannot be refunded for any reason. One substitution will be permitted (for one paid registration) up to the 2nd February 2024. Additional substitutions can be made up to 30 March for a supplement of 500 USD. After the 30 March we regret that no substitutions are feasible.  We cannot hold registrations over to future years.

 

Register Now!

The true per person cost of taking the Drug Development Boot Camp(R) VIRTUAL in 2024 is $5,550.  To be fair to all registrants, we will not entertain requests for discounts from the registration policy, already pre-set.

 

Bulk Registrations

Discounts are provided for registrations that include five or more participants.  

 

Academia and Institutions on Budgets

For organizations and institutions (Universities, Hospitals, small biotech) on low budgets, please register prior to 15 April 2023. 

 

Email Dr. Speid at LSPEID@SNDTM.COM to receive a registration Invoice immediately if you cannot pay using the registration system on the website at www.drugstomarket.com/drugbootcamp. Payment can be collected by a payment terminal. Wire transfers for bulk registrations are also feasible.

 

Public Health Policy

Speid & Associates follows common sense approaches to public health, and believes in bodily autonomy, and the right of the individual to full informed consent.  Speid & Associates does not discriminate, and we will never intrude in your personal medical decisions.

 

 

Drug Development Boot Camp(R) VIRTUAL 2024

 

The next Drug Development Boot Camp(R) will be held only VIRTUALLY.  We look forward to welcoming everyone looking for a transformative training program in new medicine development.  

 

   
Speid and Associates
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Drug Development
Boot Camp® VIRTUAL
APRIL 10-11, 2024

Cost
$ 5,500.00  USD per participant if paid today
Register